US20060089706A1 - Anti-stenotic method and product for occluded and partially occluded arteries - Google Patents
Anti-stenotic method and product for occluded and partially occluded arteries Download PDFInfo
- Publication number
- US20060089706A1 US20060089706A1 US11/247,571 US24757105A US2006089706A1 US 20060089706 A1 US20060089706 A1 US 20060089706A1 US 24757105 A US24757105 A US 24757105A US 2006089706 A1 US2006089706 A1 US 2006089706A1
- Authority
- US
- United States
- Prior art keywords
- artery
- segment
- lining
- plaque
- vascular
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00008—Vein tendon strippers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/32075—Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/06—Measuring instruments not otherwise provided for
- A61B2090/062—Measuring instruments not otherwise provided for penetration depth
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2002/065—Y-shaped blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/902—Method of implanting
- Y10S623/903—Blood vessel
Definitions
- the present invention relates generally to restoration of flow capacity to occluded and partially occluded vessels, including arteries, and more particularly to a procedure by which at least an interior lining is in the form of a vascular graft placed in an artery as an anti-stenotic measure.
- balloon catheter angioplasty of patients with focal stenosis has demonstrated benefit primarily because of its minimal invasiveness, thereby reducing cost and recovery time. It is, however, limited to short focal stenoses through which the balloon can be positioned. It has a significant rate of restenosis in longer or diffuse lesions, where its use is not indicated.
- catheter based laser and mechanical atherectomy devices have recently been developed and studied. The hope has been to obtain the benefits of reducing costs, morbidity, and recovery time available from using less-invasive, catheter-based methods while still obtaining the overall good patient results comparable to by-pass grafting.
- the present invention overcomes or substantially alleviates the limitations of previous catheter-based techniques for treating SFA disease, while obtaining the benefits of proven by-pass grafting techniques.
- the present invention overcomes or substantially alleviates the above-mentioned pre-existing problems.
- the present invention provides for removal of all or nearly all atheroma from within an arterial segment of any length and then placement of a vascular graft, which may be of any suitable material, with only one point of entry.
- the atheroma alone can be removed or the atheroma and the tunica intima alone or together with the tunica media of the arterial segment can be removed.
- Other vessels can also be treated and vascularly lined without departing from the scope of the invention.
- the present invention provides the benefits of minimally invasive surgery, overcomes or substantially alleviates the limitation of recurrent stenosis, and allows treatment of any occlusive lesion regardless of length.
- Another object of importance is the provision of a method and product by which an atheroma is removed from an artery and provision is made to prevent or alleviate the likelihood of a later redevelopment of another atheroma at the removal site.
- a further significant object is to provide a method and product by which substantially full blood flow is surgically restored to a stenotic artery.
- Another dominant object is the provision of a method and product which substantially eliminates an atheroma from an artery and eliminates or significantly reduces the likelihood of restenosis at the prior atheroma site.
- An additional object of substantive importance is the provision for removal of stenotic deposits from an artery with or without removal of an interior portion of the artery followed by insertion of a vascular graft along the length of the removal site as an anti-stenosis measure.
- One more object of value is the provision of a method of and product for substantially removing stenotic deposits in an artery and substantially preventing or alleviating recurrence thereof independent of the arterial length of the deposits.
- An additional paramount object is the provision of a novel method and product by which a vessel of a medical patient is lined for the purpose of establishing and/or maintaining full blood flow.
- FIG. 1 is a line drawing diagrammatically illustrating in cross-section a single arteriotomy in an occluded superficial femoral artery of a medical patient;
- FIG. 2A is a line drawing schematically illustrating in cross-section a double arteriotomy in an occluded superficial femoral artery of a medical patent;
- FIG. 2B is a line drawing schematically illustrating in cross-section access using a hollow needle to a site upstream of an atheroma in a superficial femoral artery of a patient;
- FIG. 3 is a line drawing diagrammatically illustrating in cross-section the atheroma of FIG. 1 with a guide wire extending through the atheroma;
- FIG. 4 is a line drawing diagrammatically illustrating in cross-section placement of a dynamic wire guide through the arteriotomy sufficient for the distal region of the dynamic wire guide to extend completely through the atheroma accommodating passage of a guide wire through a lumen in the dynamic wire guide before the dynamic wire guide is withdrawn;
- FIG. 5 is a line drawing diagrammatically illustrating in cross-section the advancement of a dynamic disrupter, over a guide wire for traversing the stenotic obstruction site in the superficial femoral artery;
- FIG. 6 is a line drawing diagrammatically illustrating in cross-section the advancement of a coring catheter along a guide wire spanning the atheroma obstruction in the artery to enlarge the lumen by removal of plaque;
- FIG. 7 is a line drawing diagrammatically illustrating in cross-section the artery showing an expandable cutting catheter or atherotome displaceable along the guide wire and expansion of blades of the cutter so as to cut plaque from the atheroma, using as many passes as appropriate with or without flushing or irrigating of the lumen;
- FIG. 8 is a line drawing diagrammatically illustrating in cross-section removal of the tunica horr endothelium and tunica media collectively from an artery at a natural interface of weakness existing between the tunica media and the tunica adventitia;
- FIG. 9 is a line drawing diagrammatically illustrating in cross-section separation of a length of the tunica intima endothelium together with the tunica media from the tunica adventitia along a natural interface of weakness using a Hall loop;
- FIG. 10 is a line drawing diagrammatically illustrating in cross-section a vascular graft according to the present invention having collapse resistant characteristics placed in the knee of a patient;
- FIG. 11 is a line drawing diagrammatically illustrating in fragmentary cross-section use of a Scanlan Endarsector to separate conjointly a length of the tunica intima endothelium and tunica media from the tunica adventitia along a natural interface of weakness;
- FIG. 12 is a line drawing diagrammatically in cross-section a Simpson Atherocath performing an atherectomy
- FIG. 13 is a line drawing diagrammatically illustrating in cross-section performance of a balloon angioplasty
- FIG. 14 is a line drawing diagrammatically illustrating in cross-section the performance of an atherectomy using a laser
- FIG. 15 is a line drawing diagrammatically illustrating in cross-section performance in an artery of ultrasound angioplasty
- FIG. 16 is a line drawing diagrammatically illustrating in perspective one suitable pre-formed cylindrical or sleeve-shaped vascular graft for lining arteries in accordance with the present invention
- FIG. 17 is a line drawing diagrammatically illustrating in perspective a tapered, pre-formed vascular graft for carrying out the present invention.
- FIG. 18 is a line drawing diagrammatically illustrating in perspective, with parts broken away for clarity, the utilization of a vascular graft, pre-formed and cylindrical or sleeve-shaped in configuration, having internal ring reinforcements;
- FIG. 19 is a line drawing diagrammatically illustrating in perspective, with parts broken away for clarity, a vascular graft, pre-formed and cylindrical or sleeve-shaped in configuration, having internal helically-shaped reinforcement, for carrying out the present invention
- FIG. 20 is a line drawing diagrammatically illustrating in perspective a bifurcated vascular graft for carrying out the present invention
- FIG. 21 is a line drawing diagrammatically illustrating in perspective a vascular graft, pre-formed and cylindrical or sleeve-shaped in configuration, having tissue in-growth material along a portion of the exterior surface thereof;
- FIG. 22 is a line drawing diagrammatically illustrating in perspective, with a portion broken away for clarity, a vascular graft, pre-formed and cylindrical or sleeve-shaped in configuration, having an expandable stent internally sutured at the distal end thereof in the contracted state, for carrying out the present invention
- FIG. 23 is a line drawing diagrammatically illustrating in cross-section placement of a dilator/sheath along a guide wire into the artery for placement of a vascular graft;
- FIG. 24 is a line drawing diagrammatically illustrating in cross-section the sheath of FIG. 23 with the distal portion thereof in the artery after the dilator has been removed;
- FIG. 25 is a line drawing diagrammatically illustrating in elevation a vascular graft placement mandrel having a vascular graft attached to the mandrel shaft for placement in an artery;
- FIG. 26 is a line drawing diagrammatically illustrating in cross-section of the vascular graft and the distal end of the mandrel of FIG. 25 being advanced into the artery through the sheath of FIG. 24 ;
- FIG. 26A is a cross-section taken along line 26 A- 26 A of FIG. 26 ;
- FIG. 27 is a line drawing diagrammatically illustrating in cross-section partial removal of the sheath of FIG. 25 after the distal end of the mandrel shaft and the vascular graft has been placed in the desired position in the artery through the sheath, with the graft being held by the mandrel while the sheath is withdrawn;
- FIG. 28 is a line drawing diagrammatically illustrating in cross-section the existence of the vascular graft in the artery after both the sheath and the mandrel have been removed therefrom;
- FIG. 29 is a line drawing diagrammatically illustrating in cross-section a balloon catheter disposed in the vascular graft after the graft has been positioned as illustrated in FIG. 28 ;
- FIG. 30 is a line drawing diagrammatically illustrating in cross-section the vascular graft firmly contiguous with the inside surface of the artery after the vascular graft has been expanded by use of the balloon catheter illustrated in FIG. 29 and the balloon catheter but not the guide wire has been removed;
- FIG. 31 is a line drawing diagrammatically illustrating in cross-section the disposition of the vascular graft in the artery after all other paraphernalia has been removed;
- FIG. 32 is a line drawing diagrammatically illustrating in cross-section the vascular graft of FIG. 32 linearly disposed within and sutured proximally near the wall of the superficial femoral artery;
- FIG. 33 is a line drawing diagrammatically illustrating in cross-section grasping of the distal end of a vascular graft in the treated artery using forceps;
- FIG. 34 is a line drawing diagrammatically illustrating in cross-section a vascular graft, sutured at the distal end thereof to the distal end of a mandrel both disposed in a treated artery;
- FIG. 35 is a line drawing diagrammatically illustrating in cross-section placement of the distal end of a vascular graft in an artery by use of a placer/suturer;
- FIG. 36 is a line drawing diagrammatically illustrating in fragmentary cross-section the securing of both ends of a vascular graft in an artery using one or more sutures at each end;
- FIG. 37 is a line drawing diagrammatically illustrating in fragmentary cross-section securing of a vascular graft in a treated artery using staples at both the distal and proximal ends of the vascular graft;
- FIG. 38 is a line drawing diagrammatically illustrating in cross-section a vascular graft secured at its distal end in an artery using an expanded stent;
- FIG. 39 is a line drawing diagrammatically illustrating in cross-section placement of a coating on the treated interior surface of an artery to form in place a vascular graft.
- FIG. 40 is a line drawing diagrammatically in cross-section a balloon catheter having the balloon thereof partially inflated within a vascular graft prior to joint insertion into a treated artery;
- FIG. 41 is a line drawing diagrammatically in cross-section the partially inflated balloon catheter and vascular graft after placement in a treated artery.
- the illustrated embodiments demonstrate and are representative of methods by which a partially or totally occluded artery or other vessel of a patient is recanalized and the risk of restenosis is substantially reduced or eliminated by use of a vascular graft within the treated artery.
- While the present invention may be used in a vessel other than an artery, the primary benefit lies in application to an artery.
- Artery flow is either conduit or branch flow.
- the iliac, femoral, and more distal arteries are most likely to occlude, either totally or partially. All arteries are strong, durable, three-layer vessels while veins are thin, single layer conduits.
- the arterial wall layers are, inside out, the tunica intima endothelium (intima), the tunica media (media), and the tunica adventitia (adventitia). It has been found that in diseased arteries typically the interface between the adventitia layer and the media layer becomes a region of naturally occurring weakness. In fact, it has been found that plaque not only accumulates within the lumen of the artery but infiltrates both the intima and media causing a tissue breakdown there.
- plaque deposits may form in some arteries and not at all or slightly in other arteries of the same person.
- a plaque deposit in a specific area or region of an artery is sometimes called an atheroma.
- the artery Under appropriate anesthesia the artery is exposed, clamped, and at least a single arteriotomy is performed distal to the clamp and proximal to the occlusion. Under some circumstances two arteriotomies are performed, one upstream and the other downstream of the atheroma although a single arteriotomy is preferred. In some situations access to the artery can be by use of percutaneously placed hollow needle, instead of by use of an arteriotomy.
- a guide wire is advanced through an upstream arteriotomy until the guide wire extends beyond the atheroma.
- a guide wire can be advanced through a clogged artery, but not always.
- a dynamic wire guide or a dynamic dirupter is preferably used to centrally loosen and/or displace the centrally disposed plaque followed by central insertion of the guide wire through the hollow interior in the dynamic wire guide or disrupter. Thereafter, the dynamic wire guide or disrupter is removed.
- plaque is severed from the inner wall of the intima.
- plaque may be so severed by a coring catheter or by using an atherotome having one or more expandable blades to accommodate insertion and one or more passes through the atheroma, each pass at an increased blade diameter.
- Atherectomy devices such as a Simpson Atherocath, an Auth Rotablator, a Kensey device, or an Intervertional Technologies Transluminal Extraction Catheter (TEC device) may be used.
- TEC device Intervertional Technologies Transluminal Extraction Catheter
- an endarterectomy is the preferred medical choice.
- an endarterectomy is often best when the disease of the artery is substantially advanced, causing a natural interface of weakness between the media and the adventitia.
- a cutting atherotome may be used to initially cut through the diseased intima and media to the adventitia at the distal end of the site of the endarterectomny creating a taper at that location followed by advancement in a proximal direction until the entire undesired length of intima and media have been excavated.
- the intima and media may be cut radially or on a bevel adjacent both a first and second arteriotomy located above and below the atheroma.
- a taper is used at both ends of the endarterectomy where the enlarged lumen produced connects across a beveled tapered to the normal lumen of the artery, both distally and proximally the dispensed material is loosened from the wall using any suitable instrument, such as a surgical spatula. Forceps may be used to grasp and pull upon a loosened part of the intima and media to be removed causing the intima and media between the two cuts together with the ateroma contained therein to be removed from the artery as a cylindrical unit.
- a Hall loop may be advanced from one arteriotomy to the other after the two above-mentioned cuts have been made.
- the loop in the nature of a piano wire loop held on the end of a staff is positioned at the above-mentioned natural interface of weakness.
- the loop is positioned and displaced along the interface by pushing on the staff until the intima, the media, and the atheroma to be removed have been unitarily severed following which the cylindrical unit may be grasped and removed from the artery using forceps, for example.
- a Scanlan Endarsector or a cutter having rotating blades may be used to assist in the performance of the endarterectomy.
- an instrument of expansion is used to enlarge or open and enlarge the blood flow accommodating lumen at the atheroma.
- Mechanical instruments, equipment for performing balloon angioplasty, laser instruments, and instrumentation for ultrasound angioplasty may be used to achieve the angioplasty.
- Vascular graft is intended to mean any of the following: 1. conventional and novel artificial grafts made of any material, including but not limited to fabrics such as dacron, or expanded PTFE GortexTM thin wall sleeve material, in any density from very soft and low density to very stiff and high-density, constructed in any shape including straight, tapered, or bifurcated, and which may or may not be reinforced with rings and spirals or other reinforcement, and which may or may not have one or more expandable stents incorporated into the graft at one or both ends or along its length, 2.
- fabrics such as dacron, or expanded PTFE GortexTM thin wall sleeve material, in any density from very soft and low density to very stiff and high-density, constructed in any shape including straight, tapered, or bifurcated, and which may or may not be reinforced with rings and spirals or other reinforcement, and which may or may not have one or more expandable stents incorporated into the graft at one or both ends or along its length, 2.
- vascular graft any combination of the foregoing vascular graft options.
- the exterior of the vascular graft or part of it may and preferably does comprise tissue in-growth material.
- tissue in-growth material Where a pre-formed tubular vascular graft of synthetic material is used, the material thereof may be and preferably is dimensionally stable. However, if desired, it may be radially expandable material.
- the vascular graft of choice may be introduced into the treated artery or other vessel in any suitable way including but not limited to use of a dilator/sheath, placement of the vascular graft upon a mandrel shaft and/or use of long-nose forceps.
- the distal ends of the tubular graft and the mandrel shaft may be temporarily sutured together or the distal end of the vascular graft sutured together over the mandrel to accommodate unitary displacement into the vein, for example through a sheath after the dilator has been removed.
- the diametral size of the graft may be enlarged in contiguous relationship with the inside arterial surface using a balloon catheter.
- a balloon catheter may also be used to bring a folded or partially collapsed vascular graft which is dimensionally stable into contiguous relation with the interior surface of the remaining artery wall.
- the tubular graft may also comprise a biologically inert or biologically active anti-stenotic coating applied directly to the treated area of the remaining arterial inner surface to define a lumen of acceptable blood flow capacity.
- the graft once correctly positioned and contiguous with the interior vascular wall, is usually inherently secure against inadvertent migration within the artery or other vessel due to friction and infiltration of weeping liquid accumulating on the inside artery wall. It is preferred that the length of the vascular graft be selected to span beyond all of the treated region of the artery.
- One or both ends of the vascular graft may be sutured or surgically stapled in position on the treated wall to prevent undesired displacement or partial or complete collapse under cardiovascular pressure.
- the upstream end of a graft placed in an artery must be secure to prevent a flap of the graft from being pushed, by arterial blood flow, into a position where it occludes, in whole or in part, the vessel.
- One or both ends may be held open by one or more stents disposed within the tubular graft. Forceps may be used to hold a free end of the vascular graft while the other end is secured to the vascular wall.
- the proximal end of the tubular vascular graft to the treated vascular wall and to bias dilate the distal end of the tubular vascular graft by use of a balloon catheter and/or arterial pressure.
- the distal exterior of the sleeve-shaped vascular graft comprises tissue in-growth material, as is preferred as in-growth occurs it becomes immaterial how the initial dilating bias was achieved.
- FIG. 1 illustrates the juncture between the common femoral artery and the superficial femoral artery and profunda femoris artery, respectively located at a site near the groin of a medical patient.
- FIG. 1 further illustrates the existence of a surgically crated arteriotomy 50 providing access to the superficial femoral artery 52 at a location proximal of an atheroma, generally designated 54 .
- the atheroma 54 comprises a centrally located, relatively soft central plaque portion 56 surrounded by a calcified plaque portion 58 .
- FIG. 2A is similar to FIG. 1 and further illustrates a second arteriotomy 50 ′ located distal of the atheroma 54 , providing a second access site to the artery 52 , as explained herein in greater detail.
- FIG. 2B illustrates the same artery 52 to which access is provided solely by percutaneous placement of a needle 60 into the hollow of the artery 52 upstream (proximal) of the atheroma 54 .
- Needle 60 accommodates plaque removal and placement of a lining within the artery 52 .
- FIGS. 1, 2A , and 2 B illustrate an atheroma which completely occludes the artery 52
- the present invention applies to both partial and complete occlusion due to plaque.
- the overall objective is to restore substantially full blood flow to the artery and prevent restenosis.
- the artery receiving treatment is temporarily deprived of blood flow altogether, using known methods of temporary occlusion. Prior to temporary occlusion, systemic or regional heparinization may be effected.
- a guide wire 62 is advanced distally through the arteriotomy 50 and through the atheroma 54 along the softer plaque portion 56 thereof.
- the guide wire 62 alone cannot be manually caused to traverse the atheroma 54
- other medical instruments may be used to create a passageway through the atheroma 54 following which the guide wire 62 may be appropriately inserted so as to traverse the atheroma 54 .
- a dynamic wire guide 64 may be advanced and operated so as to create a lumen through the softer plaque 56 of the atheroma 54 as diagrammatically illustrated in FIG.
- the guide wire 62 is advanced through the lumen within the dynamic wire guide 64 , following which the dynamic wire guide is withdrawn leaving the guide wire 62 in position, as a guide for instruments by which the soft and hard plaque 56 and 58 are removed.
- a dynamic disrupter 66 having a rotating enlarged rounded tip 67 , may be used in lieu of the dynamic wire guide described above to penetrate the softer plaque region 56 sufficient to accommodate concentric insertion of the guide wire 62 through the dynamic disrupter 66 , with the dynamic distributor 66 after being removed along the guide wire while the guide wire is retained in its inserted position.
- the preferred dynamic disrupter is the one disclosed in pending U.S. patent application Ser. No. 07/973,514, filed Nov. 9, 1992, assigned to Endo Vascular Instruments, the assignee of the present application, although other dynamic disrupters could be used.
- FIG. 6 illustrates diagrammatically utilization of a coring catheter 70 , advanced along the guide wire 62 through the arteriotomy 50 so as to cut the plaque 58 from the artery 52 using as many passes along the atheroma 54 as necessary.
- the coring catheter has a cutting head 72 which is caused to be rotated by the surgeon. It is currently preferred that the coring catheter 70 be that which is disclosed in the assignee's co-pending U.S. patent application Ser. No. 07/973,514, which was filed Nov. 9, 1992, although any suitable coring catheter may be utilized.
- the lumen across the atheroma 54 can be enlarged using an expandable cutter, having diametrally expandable cutting blades as illustrated in FIG. 7 .
- the expandable cutter 74 is initially advanced along the guide wire 62 in an unexpanded state.
- Expandable cutter 74 has a diametrally adjustable cutting head 76 which, when expanded and pulled forward atherectomy 50 will cut or shave the plaque at deposits 58 .
- the expandable cutter may be utilized in a fashion in which the expandable cutting blades, when expanded, engage and grab hold of a section of the plaque.
- the expandable cutter When the expandable cutter is pulled, it both cuts the junction with the remaining distal plaque and allows a cylindrical length of the plaque which lies proximal of the cutting blades to be removed all in one segment. Typically, a plurality of passes of the cutting head 76 , each with a slightly greater diameter are required to completely excavate plaque 58 .
- the expandable cutter disclosed in assignee's U.S. Pat. No. 5,11,651 be utilized.
- FIG. 8 illustrates, in part, one way in which the intima 100 and the media 102 are collectively separated from the adventitia 104 along a natural interface of weakness 106 , which typically exists in diseased arteries.
- a first and second arteriotomy 50 and 50 ′ may be made proximal and distal of the atheroma and a radial or tapered cut at or near each arteriotomy made through the intima and media layers to the interface 106 .
- the loosened part is available for grasping, using a suitable instrument such as forceps 108 illustrated in FIG. 8 .
- a suitable instrument such as forceps 108 illustrated in FIG. 8 .
- all arteries comprise three layers, the intima, the media, and the adventitia.
- Atherectomy and endarterectomy are somewhat arbitrary, as it depends upon whether the material being removed consists exclusively of atheroma only, or of a combination of atheroma and material characteristic of the inner lining of the vessel. Pathology analysis of such removed material frequently indicates the presence of cells and other material characteristic of both plaque and the media and intima, so it is probably most correct to refer to this procedure as an endarterectomy.
- an endarterectomy is performed using the dynamic disrupter and the expandable cutter.
- the dynamic disrupter is first advanced over the guide wire both to loosen the plaque and the intima and media along the natural interface of weakness, and to enlarge the channel or lumen through the artery.
- the dynamic disrupter may be advanced one or more times. If multiple advances are used, the repeated advancements may be done using the same tip size, or they may be done using successively larger tip sizes.
- the expandable cutter is employed to remove the material that has been loosened. With the blades unexpanded, the expandable cutter is advanced a suitable distance into the atheromatous region, and then the blades expanded. When the expandable cutter is withdrawn, it engages the plaque and arterial lining, and exerts force upon the natural interface of weakness.
- the plaque and arterial lining are withdrawn by the expandable cutter in the form of a cylindrical plug of material, which may be short or long depending upon how far into the plaque the cutter is advanced before it is expanded.
- the blades After removing the plug of material from the cutter, the blades are returned to the unexpanded position and re-advanced into the artery, this time to a position further than the previous advancement, so that a new length of atheromatous material can be engaged.
- the blades are once again expanded, and a new plug of material is engaged and withdrawn.
- any desired length of artery may be excavated of its plaque and inner lining.
- the distal tapered shape that the blades assume when expanded leaves behind the desired tapered shape as it cuts and removes the final plug of material from the artery. This eliminates any need to make the second arteriotomy 50 ′, for the purpose of making the distal radial cut, when the expandable cutter if employed.
- an endarterectomy may be performed using a Hall loop, as diagrammatically illustrated in FIG. 9 .
- the artery containing the atheroma 54 is accessed, as illustrated in FIG. 2A , by first and second arteriotomies 50 and 50 ⁇ .
- the first radial or beveled cut through the intima and media is made, as described above, and the media is severed along interface 106 at one end or the other (usually the upstream, proximal end) for a short distance to allow the loop 110 to be placed at the interface, with the flexible shaft 112 extending in the direction of the pull and through the more remote arteriotomy.
- the loop When power is applied, the loop is caused to oscillate as the Hall loop is advanced along the interface 106 until complete severance has occurred, following which forceps may be used to pull the removed intima and media layers from the artery through the proximal arteriotomy after the second radial or beveled cut through the intima and media is made, attempting to leave a tapered contour to the remaining material at the distal end of the endarterectomy.
- the Hall loop is more fully described in U.S. Pat. No. 3,730,185.
- the endarterectomy may similarly be performed using a Scanlan Endarsector, as generally illustrated in FIG. 11 .
- the Scanlan Endarsector 114 is a commercially available instrument, sold by Scanlan International, Inc., 1 Scanlan Plaza, St. Paul, Minn. 55107, and my be used alone or in conjunction with other instruments to perform the endarterectomy.
- the Scanlan Endarsector 114 comprises a handle (not shown) from which an elongated U-shaped shaft extends.
- FIGS. 12 through 15 illustrate various ways in which an atherectomy may be performed when that procedure is the treatment of choice, in whole or in part, for enlarging the blood flow lumen of artery 52 at atheroma site 54 .
- the atherocath comprises an outside, hollow shaft 118 through which extends a rotatable inner shaft 120 to which a rotating cutter head 122 is non-rotatably attached.
- the rotating cutting head 122 cuts plaque 58 from the interior of the artery 52 as the atherocath is advanced.
- a balloon 124 is inflated on the side opposite the cutting head 122 to thereby bring pressure to bear against the artery and urge the cutting head firmly against the plaque.
- a chamber 126 At the distal end of the atherocath is located a chamber 126 , which functions to collect plaque shavings removed by the cutting head 122 .
- the atherocath 116 is inserted and removed along guide wire 62 .
- the Simpson Atherocath is commercially available from Devices for Vascular Intervention, division of Eli Lilly, 26201 YNEZ Road, Temecula, Calif. 92591.
- FIG. 13 diagrammatically represents the use of balloon angioplasty to enlarge the lumen of an atheroma-ridden artery.
- a balloon 302 of a balloon catheter 300 is advanced along guide wire 62 until it is disposed within the atheroma 54 .
- the balloon 302 is expanded, which radially expands the plaque 58 .
- This process ordinarily creates cracks in the plaque, but nevertheless results in an enlarged lumen through the plaque 58 although, typically, the plaque 58 is not intentionally removed.
- FIG. 14 diagrammatically illustrates use of a laser instrument, generally designated 130 to remove plaque 58 from artery 52 .
- the laser instrument 50 comprises a source 132 of laser energy. The laser energy is processed along a bundle of optical fibers disposed within a catheter 134 .
- Laser beams 136 are emitted from the instrument 130 through a plurality of laser emitters 138 .
- the laser beams 136 cut plaque from deposits 58 as the distal end of the catheter 134 is advanced distally into the plaque 58 .
- the laser instrument 130 is illustrated as being concentrically disposed upon guide wire 62 for insertion, advancement, and ultimate removal. Thus, an atherectomy may be performed in accordance wit the principles of the present invention by use of one or more laser beams.
- a suitable laser instrument is the Laserprobe PLR or Lasercath-PRL, used with the Optilase Laser Source System, all of which are available from Trimedyne, Inc., 1815 East Carnegie Avenue, Santa Ana, Calif. 92705.
- FIG. 15 illustrates diagrammatically an ultrasound instrument, generally designated 140 .
- Instrument 140 comprises a source of ultrasound energy, i.e., ultrasound transducer 142 .
- Transducer 142 connects via an ultrasound shaft 144 to an ultrasound head 146 .
- the ultrasound shaft 144 is substantially concentrically disposed within an ultrasound catheter 148 .
- a guide wire is not used. Release of ultrasound energy from head 146 is caused to impinge upon plaque 58 fracturing the same progressively, thereby enlarging the blood flow lumen of the artery 52 .
- a suitable ultrasound instrument for removal of plaque is the Sonocath, available from Angiosonics, Wayne, N.J., (201) 305-1770.
- the present invention includes placement of a lining or vascular graft so as to extend preferably co-extensively along the full length of the treated portion of the artery.
- the nature of the vascular graft will vary depending upon the circumstances, the artery in question, the length over which the artery has been treated, and perhaps other factors.
- the vascular graft may be of any suitable biologically inert material including, but not limited to, a dacron sleeve of medical grade fabric, a sleeve of expanded PTFE (such as GOR-TEX® polytetrofluoroethelene vascular graft tubing available from W.L.
- the material may be dimensionally stable or capable of being expanded, for example, using a balloon catheter and/or one or more stents.
- vascular graft 200 ( FIG. 16 ) may be used.
- Vascular graft 200 is illustrated as having blunt ends, is cut to a length commensurate with the treated artery and comprises exterior and interior surfaces respectively comprising a uniform diameter along the entire length of the vascular graft 200 .
- the wall thickness is also illustrated as being uniform.
- tapered vascular graft 202 may be preferable, the degree of taper being selected so as to match the taper of the artery subjected to one or more of the treatments described above.
- vascular graft 204 may be used, the configuration thereof being adapted to conform specifically to the nature of the shape, size, and disposition of the branched artery subjected to treatment.
- vascular graft 204 may be straight or tapered or straight in part and tapered in part.
- the vascular graft may be reinforced, particularly when no expansion thereof is required during placement.
- Two typical forms of reinforcement are illustrated in FIGS. 18 and 19 , respectively, which depict vascular graft 206 and vascular graft 208 , respectively.
- Vascular graft 206 comprises reinforcement in the form of a plurality of rings 210 . While illustrated as being embedded within the material 212 from which the vascular graft 206 is formed, the reinforcing rings could be placed either internally or externally in respect to the graft 206 itself.
- vascular graft 208 is illustrated in FIG. 19 as comprising a continuous, helical reinforcement 214 embedded in the material 216 from which the vascular graft 208 is formed.
- the reinforcement 214 could be placed as well either internally or externally of the vascular graft 208 itself.
- the reinforcement e.g., rings 210 and helix 24 can be of any suitable biologically inert material such as an implantable grade of thermoplastic material, e.g., polypropylene or nylon.
- tissue in-growth material at the exterior of all or part of the vascular graft may be desirable.
- FIG. 21 diagrammatically illustrates the existence of tissue in-growth material 220 disposed along approximately the distal one-half of the hollow cylindrically-shaped vascular graft 222 .
- the value of the tissue in-growth material is that it becomes, in due course of time, the primary connector between the treated arterial surface and the vascular graft.
- FIG. 22 there is diagrammatically illustrated a hollow cylindrical vascular graft 224 to which an expandable stent 226 has been connected interiorly at the proximal end thereof using sutures 228 .
- the stent 226 is conventionally expanded to bias the proximal end of the vascular graft 224 contiguously against the treated arterial surface to retain the position of placement. This condition is illustrated in FIG. 38 . While illustrated as being placed internally inside of graft 224 , the stent could also be placed externally or it could be embedded within the material from which the vascular graft 224 is formed.
- Utilization of a vascular graft within the context of the present invention significantly tends to provide a barrier between the bloodstream and the vessel wall which is believed to reduce restenosis, provides a conduit through which the blood can flow which is known to be well-tolerated by the bloodstream, preserves the area available for blood flow, prevents an aneurysm, promotes rapid healing without excessive weeping or adhesion of blood at the lining site between the vascular graft and the adventitia layer, and provokes minimal scarring. Plaque, it has been determined, does not form on and adhere to the vascular graft.
- the treated arterial wall e.g., at interface 106
- the treated arterial wall may be lined using a liquid coating of suitable material applied as a spray or otherwise and allowed to cure until a hollow lumen is defined within the cured coating and the treated arterial surface is concealed by the coating, or allowed to remain in place long enough to cause the artery to form a stable, hollow lumen.
- FIG. 39 illustrates the presence of a manually controlled nozzle 230 forming a part of a surgical spraying instrument by which a coating 232 is applied to the treated arterial surface at interface 106 .
- Suitable coatings for example, having the requisite biologically inert characteristics and wall adherence characteristics would include pharmaceutical-grade collagen available from Collagen Corp., 1850 Embariadero Road, Palo Alto, Calif. 94303.
- vascular graft of choice has been selected, other than an in-place coating, insertion of the vascular graft into the treated artery must be achieved.
- a commercially available dilator/peel-away sheath generally designated 250 ( FIGS. 23, 24 , 26 and 27 ).
- a solid (non-peel-away) sheath may also be utilized or the graft may be inserted directly into the vessel without use of a sheath.
- the dilator/sheath 250 in assembled condition, is passed concentrically along the guide wire 62 through the access opening to the artery 52 .
- the access opening may be an arteriotomy 50 or a percutaneous venipuncture caused by insertion of needle 60 ( FIG. 2B ) followed by advancement of the guide wire through the needle 60 and subsequent removal of the needle.
- the dilator 252 at the tapered distal tip 254 enlarges the radial size of the puncture as does the sheath 256 (slightly) as the dilator-sheath 250 is advanced through the puncture concentrically around the guide wire 62 until the dilator-sheath 250 is positioned as illustrated in FIG. 23 .
- the medical attendant simply manually retracts the dilator along the guide wire 62 until it is fully removed, leaving the sheath 256 in place with the proximal end thereof exposed, as diagrammatically illustrated in FIG. 24 .
- steps are taken to insert the vascular graft through the sheath and locate the graft in the treated artery so as to be, preferably, at least co-extensive with the treated artery surface, with the guide wire inside the graft.
- the treated artery surface shown in FIGS. 23-24 and 26 - 27 is interface 106 .
- One way in which insertion may be consummated is by use or a graft placement long-nose forceps, generally designated 260 ( FIG. 25 ) which comprises a control handle 262 from which a mandrel shaft 264 distally extends.
- Activation of the control 262 causes bifurcated tips 266 located at the distal end of the mandrel shaft 264 to open and close, to grasp or clamp and release, respectively, the distal end 268 of a hollow tubular vascular graft 270 .
- tips 266 located at the distal end of the mandrel shaft 264 to open and close, to grasp or clamp and release, respectively, the distal end 268 of a hollow tubular vascular graft 270 .
- the vascular graft follows the mandrel shaft 264 as it is advanced over the guide wire 62 and through the sheath 256 as illustrated in FIGS. 26 and 27 .
- the forceps 260 and graft 270 are held in a stationary position, the forceps grasping the graft, as the sheath is withdrawn.
- peel-away sheath 256 as the sheath is withdrawn it is manually split into two pieces, as illustrated in FIG. 27 , following which each piece is discarded.
- the forceps 260 and the graft 270 with the guide wire 62 passing centrally through the graft, are left in position and the sheath 256 has been entirely removed. Thereafter, the guide wire and graft 270 are held stationary, the mandrel control 262 manipulated to open the tips 266 causing the distal end 268 of the graft 270 to be released, following which the forceps 260 are withdrawn while the guide wire 62 and the graft 270 are retained in position as illustrated in FIG. 28 .
- the sheath may be placed correctly in the artery 52 using a hollow mandrel, generally designated 280 ( FIG. 34 ).
- the sheath 270 is concentrically disposed around the hollow mandrel 280 with the distal ends of each being sutured together using apertures 282 located in the distal end of the mandrel 280 .
- a suture 284 helically through the apertures 282 and through the adjacent thickness of the vascular graft 270 , the vascular graft and the mandrel are secured together.
- the suture 284 may be extended through the hollow of the mandrel 280 and through the arteriotomy 50 for access by the medical attendant. Once fully positioned in the artery, one end of the suture 284 is pulled by the medical attendant, causing the suture to helically unwind at the distal end of the vascular graft 270 for complete removal of the suture 284 , following which the mandrel 280 is fully retracted leaving the vascular graft 270 correctly disposed in the artery 52 , with the guide wire 62 inside the graft.
- an elongated, long-nose forceps 290 may be used as well for correct placement of the vascular graft 270 .
- Long-nose forceps 290 may be of any suitable type, such as commercially available pediatric bronchoscopy forceps or retrieval forceps, such as Storz's. More specifically, the forceps 290 comprise exposed jaws 292 which are controlled at the proximal end of the forceps 290 accommodating opening and closing of the jaws 292 .
- the vascular graft 270 is now correctly located in the artery 52 , with the guide wire 62 passing though the center of the vascular graft 270 , as illustrated in FIG. 28 .
- Insertion of a tubular graft of choice into the treated artery often involves folding or other forms of reduction in the diametral size occupied by the vascular graft during insertion, for example, to accommodate a size which will allow displacement through the sheath 256 .
- the sheath handle may accept a graft folded shown in FIG. 26A . This folded configuration may continue the length of the sheath, to allow the easier passage of the graft through the sheath, by de-forming the inside diameter to the shape, or by laying a conventional catheter or wire alongside the graft during insertion to create an indentation in the graft.
- the vascular graft if left alone, tends to be and remain non-contiguous with the treated surface at the interior of the artery, e.g., surface 106 , e.g., retaining the crimped or folded shape it assumes during insertion.
- a balloon catheter 300 of conventional, commercially available design be advanced concentrically around the guide wire 62 until the balloon 302 thereof is positioned within the sheath 270 just inside the distal edge 268 ′ of the sheath 270 . See FIG. 29 .
- the vascular graft 270 is caused to become contiguous with and adhered to the adjacent arterial wall surface, following which the balloon 302 is deflated and the balloon catheter 300 retracted along the guide wire and discarded, leaving the vascular graft 270 postured as illustrated in FIG. 30 .
- one very long balloon catheter can be employed to perform this step in a single balloon expansion, and/or the balloon can be sized to exactly match the graft, e.g., tapered balloon used with tapered graft, etc.
- tubular vascular graft 270 positioned as essentially illustrated in FIG. 31 . It has been found that once the tubular vascular graft is firmly contiguous with the adjacent arterial wall surface, a measure of friction exists which both prevents radial collapse and axial displacement of the vascular graft within the artery. In addition, the treated arterial surface tends to weep slightly which weeping adheres to the exterior surface of the tubular graft and tends to infiltrate the material from which the tubular graft is formed at least to a limited extent further causing the graft to be retained in its expanded stationary position, fully dilated withing the artery.
- proximal end 269 of the vascular graft 270 be physically connected to the adjacent arterial wall, in this case adventitia layer 104 , and that the distal end 268 be left to natural adherence, with the arterial blood pressure holding the distal end 268 in its fully dilated position together with friction at the surface 106 and tissue infiltration into the material from which the graft 270 is fabricated.
- the utilization of one or more sutures 304 is illustrated as the structure by which the proximal end 269 of the vascular graft 270 is physically secured to the arterial wall.
- the graft Over the longer term, the graft will be held open and contiguous with the remaining original wall of the artery throughout its length by arterial blood pressure and, in grafts so constructed, by tissue in-growth into the tissue in-growth material.
- This particular feature of intra-luminal graft placement solves a specific problem of by-pass graft placement where by-pass grafts have previously been placed in tissue tunnels constructed to by-pass the original duct or vessel lumen. Many such grafts are placed in body regions where, under normal activities, the body tends to compress grafts and thereby cut off flow though such grafts when they are placed in tissue tunnels which by-pass the original lumen.
- the example of the human knee joint is illustrated in FIG. 10 .
- FIG. 10 An improved result is obtained using the intra-luminal graft placement described herein is illustrated in FIG. 10 .
- the original artery lumen remains open and patent in the knee even when the knee is bent. More generally, ducts and vessels naturally remain open and patent during the normal range of activities.
- the lumen of the graft which is adhering to the remaining original wall of the artery by tissue in-growth and/or due to the arterial pressure inside the graft, is illustrated as remaining open and patent even while the knee is bent. More generally, intra-luminal grafts held in place in vessels or ducts by tissue in-growth will remain open and patent during the normal range of activities, including activities that tend to obstruct by-pass grafts placed in tissue tunnels.
- FIG. 36 illustrates utilization of one or more sutures 304 to secure both the proximal and distal ends 269 and 268 , respectively, of the vascular graft 270 to the arterial wall 104 . Placement of sutures 304 at the distal end 268 of the vascular graft 270 would ordinarily require a second, downstream arteriotomy.
- vascular graft 270 may be secured to the arterial wall 104 using medical grade staples 306 , as illustrated in FIG. 37 .
- either or both ends of the vascular graft 270 can be expanded and held in contiguous relationship with arterial surface 106 using one or more stents 226 , as explained above and as illustrated in FIG. 38 .
- the distal end 268 of the vascular graft 270 may be grasped using suitable forceps 310 for both positioning the vascular graft 270 and for holding it in position while, for example, the proximal end of the graft is suitably fastened to the arterial wall as explained above. See FIG. 33 .
Abstract
Methods of artificially lining a vessel, especially an artery, of a medical patient to address the existence of a flow-inhibiting atheroma and to significantly alleviate the probability of restenosis, and the resulting products.
Description
- This application is a division of our copending U.S. patent application Ser. No. 09/938,882, which is a continuation of our copending U.S. patent application Ser. No. 09/522,461 filed Mar. 9, 2000, now abandoned, which is a continuation of U.S. patent application Ser. No. 09/183,896, filed Oct. 30, 1998, now U.S. Pat. No. 6,090,135, which is a division of U.S. patent application Ser. No. 09/098,912, filed Mar. 5, 1998, now U.S. Pat. No. 5,904,146, which is a division of U.S. patent application Ser. No. 08/548,569, filed Oct. 26, 1995, now U.S. Pat. No. 5,865,844, which is a continuation of U.S. patent application Ser. No. 08/73,002, filed Jun. 7, 1993, now U.S. Pat. No. 5,571,169.
- The present invention relates generally to restoration of flow capacity to occluded and partially occluded vessels, including arteries, and more particularly to a procedure by which at least an interior lining is in the form of a vascular graft placed in an artery as an anti-stenotic measure.
- During the last thirty (30) years the most common technique for treating arterial stenosis has been surgical construction of a bypass conduit around the site of the occlusion. Bypass grafting in a symptomatic patient with a partially or totally occluded or stenotic superficial femoral artery, using a vein or prosthetic graft, has been the dominant technique for arterial reconstruction. Endarterectomy is also performed in some cases.
- In the last decade balloon catheter angioplasty of patients with focal stenosis has demonstrated benefit primarily because of its minimal invasiveness, thereby reducing cost and recovery time. It is, however, limited to short focal stenoses through which the balloon can be positioned. It has a significant rate of restenosis in longer or diffuse lesions, where its use is not indicated. To address these limitations and to improve the treatment of longer length segments of occlusive disease, a variety of catheter based laser and mechanical atherectomy devices have recently been developed and studied. The hope has been to obtain the benefits of reducing costs, morbidity, and recovery time available from using less-invasive, catheter-based methods while still obtaining the overall good patient results comparable to by-pass grafting. Despite these efforts, by-pass grafting has remained the technique generally used in clinical practice, due to its superior overall results compared to the novel catheter-based techniques heretofore developed. The present invention overcomes or substantially alleviates the limitations of previous catheter-based techniques for treating SFA disease, while obtaining the benefits of proven by-pass grafting techniques.
- In brief summary, the present invention overcomes or substantially alleviates the above-mentioned pre-existing problems. The present invention provides for removal of all or nearly all atheroma from within an arterial segment of any length and then placement of a vascular graft, which may be of any suitable material, with only one point of entry. The atheroma alone can be removed or the atheroma and the tunica intima alone or together with the tunica media of the arterial segment can be removed. Other vessels can also be treated and vascularly lined without departing from the scope of the invention. The present invention provides the benefits of minimally invasive surgery, overcomes or substantially alleviates the limitation of recurrent stenosis, and allows treatment of any occlusive lesion regardless of length.
- Thus, normal capacity blood flow is provided with no or low probability of recurring stenosis. While the present invention has been applied to occlusion in the superficial femoral artery, it is not limited to any particular artery diseased by stenosis.
- With the foregoing in mind, it is a primary object of the present invention to provide an antistenotic method and product by which substantially full blood flow capacity is restored to a wholly or partially occluded artery.
- Another object of importance is the provision of a method and product by which an atheroma is removed from an artery and provision is made to prevent or alleviate the likelihood of a later redevelopment of another atheroma at the removal site.
- A further significant object is to provide a method and product by which substantially full blood flow is surgically restored to a stenotic artery.
- Another dominant object is the provision of a method and product which substantially eliminates an atheroma from an artery and eliminates or significantly reduces the likelihood of restenosis at the prior atheroma site.
- An additional object of substantive importance is the provision for removal of stenotic deposits from an artery with or without removal of an interior portion of the artery followed by insertion of a vascular graft along the length of the removal site as an anti-stenosis measure.
- One more object of value is the provision of a method of and product for substantially removing stenotic deposits in an artery and substantially preventing or alleviating recurrence thereof independent of the arterial length of the deposits.
- An additional paramount object is the provision of a novel method and product by which a vessel of a medical patient is lined for the purpose of establishing and/or maintaining full blood flow.
- These and other objects and feature of the present invention will be apparent from the detailed description taken with reference to the accompanying drawings.
- The Figures described briefly below are line drawing schematics, predicated upon the existence and commercial availability of the various devices and apparatus as shown therein.
-
FIG. 1 is a line drawing diagrammatically illustrating in cross-section a single arteriotomy in an occluded superficial femoral artery of a medical patient; -
FIG. 2A is a line drawing schematically illustrating in cross-section a double arteriotomy in an occluded superficial femoral artery of a medical patent; -
FIG. 2B is a line drawing schematically illustrating in cross-section access using a hollow needle to a site upstream of an atheroma in a superficial femoral artery of a patient; -
FIG. 3 is a line drawing diagrammatically illustrating in cross-section the atheroma ofFIG. 1 with a guide wire extending through the atheroma; -
FIG. 4 is a line drawing diagrammatically illustrating in cross-section placement of a dynamic wire guide through the arteriotomy sufficient for the distal region of the dynamic wire guide to extend completely through the atheroma accommodating passage of a guide wire through a lumen in the dynamic wire guide before the dynamic wire guide is withdrawn; -
FIG. 5 is a line drawing diagrammatically illustrating in cross-section the advancement of a dynamic disrupter, over a guide wire for traversing the stenotic obstruction site in the superficial femoral artery; -
FIG. 6 is a line drawing diagrammatically illustrating in cross-section the advancement of a coring catheter along a guide wire spanning the atheroma obstruction in the artery to enlarge the lumen by removal of plaque; -
FIG. 7 is a line drawing diagrammatically illustrating in cross-section the artery showing an expandable cutting catheter or atherotome displaceable along the guide wire and expansion of blades of the cutter so as to cut plaque from the atheroma, using as many passes as appropriate with or without flushing or irrigating of the lumen; -
FIG. 8 is a line drawing diagrammatically illustrating in cross-section removal of the tunica ultima endothelium and tunica media collectively from an artery at a natural interface of weakness existing between the tunica media and the tunica adventitia; -
FIG. 9 is a line drawing diagrammatically illustrating in cross-section separation of a length of the tunica intima endothelium together with the tunica media from the tunica adventitia along a natural interface of weakness using a Hall loop; -
FIG. 10 is a line drawing diagrammatically illustrating in cross-section a vascular graft according to the present invention having collapse resistant characteristics placed in the knee of a patient; -
FIG. 11 is a line drawing diagrammatically illustrating in fragmentary cross-section use of a Scanlan Endarsector to separate conjointly a length of the tunica intima endothelium and tunica media from the tunica adventitia along a natural interface of weakness; -
FIG. 12 is a line drawing diagrammatically in cross-section a Simpson Atherocath performing an atherectomy; -
FIG. 13 is a line drawing diagrammatically illustrating in cross-section performance of a balloon angioplasty; -
FIG. 14 is a line drawing diagrammatically illustrating in cross-section the performance of an atherectomy using a laser; -
FIG. 15 is a line drawing diagrammatically illustrating in cross-section performance in an artery of ultrasound angioplasty; -
FIG. 16 is a line drawing diagrammatically illustrating in perspective one suitable pre-formed cylindrical or sleeve-shaped vascular graft for lining arteries in accordance with the present invention; -
FIG. 17 is a line drawing diagrammatically illustrating in perspective a tapered, pre-formed vascular graft for carrying out the present invention; -
FIG. 18 is a line drawing diagrammatically illustrating in perspective, with parts broken away for clarity, the utilization of a vascular graft, pre-formed and cylindrical or sleeve-shaped in configuration, having internal ring reinforcements; -
FIG. 19 is a line drawing diagrammatically illustrating in perspective, with parts broken away for clarity, a vascular graft, pre-formed and cylindrical or sleeve-shaped in configuration, having internal helically-shaped reinforcement, for carrying out the present invention; -
FIG. 20 is a line drawing diagrammatically illustrating in perspective a bifurcated vascular graft for carrying out the present invention; -
FIG. 21 is a line drawing diagrammatically illustrating in perspective a vascular graft, pre-formed and cylindrical or sleeve-shaped in configuration, having tissue in-growth material along a portion of the exterior surface thereof; -
FIG. 22 is a line drawing diagrammatically illustrating in perspective, with a portion broken away for clarity, a vascular graft, pre-formed and cylindrical or sleeve-shaped in configuration, having an expandable stent internally sutured at the distal end thereof in the contracted state, for carrying out the present invention; -
FIG. 23 is a line drawing diagrammatically illustrating in cross-section placement of a dilator/sheath along a guide wire into the artery for placement of a vascular graft; -
FIG. 24 is a line drawing diagrammatically illustrating in cross-section the sheath ofFIG. 23 with the distal portion thereof in the artery after the dilator has been removed; -
FIG. 25 is a line drawing diagrammatically illustrating in elevation a vascular graft placement mandrel having a vascular graft attached to the mandrel shaft for placement in an artery; -
FIG. 26 is a line drawing diagrammatically illustrating in cross-section of the vascular graft and the distal end of the mandrel ofFIG. 25 being advanced into the artery through the sheath ofFIG. 24 ; -
FIG. 26A is a cross-section taken alongline 26A-26A ofFIG. 26 ; -
FIG. 27 is a line drawing diagrammatically illustrating in cross-section partial removal of the sheath ofFIG. 25 after the distal end of the mandrel shaft and the vascular graft has been placed in the desired position in the artery through the sheath, with the graft being held by the mandrel while the sheath is withdrawn; -
FIG. 28 is a line drawing diagrammatically illustrating in cross-section the existence of the vascular graft in the artery after both the sheath and the mandrel have been removed therefrom; -
FIG. 29 is a line drawing diagrammatically illustrating in cross-section a balloon catheter disposed in the vascular graft after the graft has been positioned as illustrated inFIG. 28 ; -
FIG. 30 is a line drawing diagrammatically illustrating in cross-section the vascular graft firmly contiguous with the inside surface of the artery after the vascular graft has been expanded by use of the balloon catheter illustrated inFIG. 29 and the balloon catheter but not the guide wire has been removed; -
FIG. 31 is a line drawing diagrammatically illustrating in cross-section the disposition of the vascular graft in the artery after all other paraphernalia has been removed; -
FIG. 32 is a line drawing diagrammatically illustrating in cross-section the vascular graft ofFIG. 32 linearly disposed within and sutured proximally near the wall of the superficial femoral artery; -
FIG. 33 is a line drawing diagrammatically illustrating in cross-section grasping of the distal end of a vascular graft in the treated artery using forceps; -
FIG. 34 is a line drawing diagrammatically illustrating in cross-section a vascular graft, sutured at the distal end thereof to the distal end of a mandrel both disposed in a treated artery; -
FIG. 35 is a line drawing diagrammatically illustrating in cross-section placement of the distal end of a vascular graft in an artery by use of a placer/suturer; -
FIG. 36 is a line drawing diagrammatically illustrating in fragmentary cross-section the securing of both ends of a vascular graft in an artery using one or more sutures at each end; -
FIG. 37 is a line drawing diagrammatically illustrating in fragmentary cross-section securing of a vascular graft in a treated artery using staples at both the distal and proximal ends of the vascular graft; -
FIG. 38 is a line drawing diagrammatically illustrating in cross-section a vascular graft secured at its distal end in an artery using an expanded stent; -
FIG. 39 is a line drawing diagrammatically illustrating in cross-section placement of a coating on the treated interior surface of an artery to form in place a vascular graft. -
FIG. 40 is a line drawing diagrammatically in cross-section a balloon catheter having the balloon thereof partially inflated within a vascular graft prior to joint insertion into a treated artery; and -
FIG. 41 is a line drawing diagrammatically in cross-section the partially inflated balloon catheter and vascular graft after placement in a treated artery. - The illustrated embodiments demonstrate and are representative of methods by which a partially or totally occluded artery or other vessel of a patient is recanalized and the risk of restenosis is substantially reduced or eliminated by use of a vascular graft within the treated artery.
- While the present invention may be used in a vessel other than an artery, the primary benefit lies in application to an artery. Artery flow is either conduit or branch flow. The iliac, femoral, and more distal arteries are most likely to occlude, either totally or partially. All arteries are strong, durable, three-layer vessels while veins are thin, single layer conduits. The arterial wall layers are, inside out, the tunica intima endothelium (intima), the tunica media (media), and the tunica adventitia (adventitia). It has been found that in diseased arteries typically the interface between the adventitia layer and the media layer becomes a region of naturally occurring weakness. In fact, it has been found that plaque not only accumulates within the lumen of the artery but infiltrates both the intima and media causing a tissue breakdown there.
- Removal of the intima and the media from the adventitia and leaving the adventitia of the artery is called an endarterectomy.
- The primary cause of artery occlusion is build-up of plaque, the density of which ranges between very soft to rock-hard calcified deposits. Plaque deposits may form in some arteries and not at all or slightly in other arteries of the same person. A plaque deposit in a specific area or region of an artery is sometimes called an atheroma.
- Under appropriate anesthesia the artery is exposed, clamped, and at least a single arteriotomy is performed distal to the clamp and proximal to the occlusion. Under some circumstances two arteriotomies are performed, one upstream and the other downstream of the atheroma although a single arteriotomy is preferred. In some situations access to the artery can be by use of percutaneously placed hollow needle, instead of by use of an arteriotomy.
- In situations where an arteriotomy is the preferred choice, a guide wire is advanced through an upstream arteriotomy until the guide wire extends beyond the atheroma. Sometimes a guide wire can be advanced through a clogged artery, but not always. In situations where a guide wire alone cannot cross the atheroma, a dynamic wire guide or a dynamic dirupter is preferably used to centrally loosen and/or displace the centrally disposed plaque followed by central insertion of the guide wire through the hollow interior in the dynamic wire guide or disrupter. Thereafter, the dynamic wire guide or disrupter is removed.
- Any technique by which the plaque is severed from the inner wall of the intima is called an atherectomy. Typically, plaque may be so severed by a coring catheter or by using an atherotome having one or more expandable blades to accommodate insertion and one or more passes through the atheroma, each pass at an increased blade diameter.
- Atherectomy devices such as a Simpson Atherocath, an Auth Rotablator, a Kensey device, or an Intervertional Technologies Transluminal Extraction Catheter (TEC device) may be used.
- In some situations an endarterectomy is the preferred medical choice. For example, an endarterectomy is often best when the disease of the artery is substantially advanced, causing a natural interface of weakness between the media and the adventitia. A cutting atherotome may be used to initially cut through the diseased intima and media to the adventitia at the distal end of the site of the endarterectomny creating a taper at that location followed by advancement in a proximal direction until the entire undesired length of intima and media have been excavated. Alternatively, the intima and media may be cut radially or on a bevel adjacent both a first and second arteriotomy located above and below the atheroma. Ideally, a taper is used at both ends of the endarterectomy where the enlarged lumen produced connects across a beveled tapered to the normal lumen of the artery, both distally and proximally the dispensed material is loosened from the wall using any suitable instrument, such as a surgical spatula. Forceps may be used to grasp and pull upon a loosened part of the intima and media to be removed causing the intima and media between the two cuts together with the ateroma contained therein to be removed from the artery as a cylindrical unit.
- Alternatively, a Hall loop may be advanced from one arteriotomy to the other after the two above-mentioned cuts have been made. The loop, in the nature of a piano wire loop held on the end of a staff is positioned at the above-mentioned natural interface of weakness. The loop is positioned and displaced along the interface by pushing on the staff until the intima, the media, and the atheroma to be removed have been unitarily severed following which the cylindrical unit may be grasped and removed from the artery using forceps, for example.
- Similarly, a Scanlan Endarsector or a cutter having rotating blades may be used to assist in the performance of the endarterectomy.
- In situations where an angioplasty, in whole or in part, is the treatment of choice, an instrument of expansion is used to enlarge or open and enlarge the blood flow accommodating lumen at the atheroma. Mechanical instruments, equipment for performing balloon angioplasty, laser instruments, and instrumentation for ultrasound angioplasty may be used to achieve the angioplasty.
- Once the plaque has been excavated, steps are taken to line the remaining treated arterial or vessel wall. The resulting lining is herein referred to as a vascular graft. Vascular graft, as used herein, is intended to mean any of the following: 1. conventional and novel artificial grafts made of any material, including but not limited to fabrics such as dacron, or expanded PTFE Gortex™ thin wall sleeve material, in any density from very soft and low density to very stiff and high-density, constructed in any shape including straight, tapered, or bifurcated, and which may or may not be reinforced with rings and spirals or other reinforcement, and which may or may not have one or more expandable stents incorporated into the graft at one or both ends or along its length, 2. natural artery or vein material taken from human or animal donors, 3. stents, 4. coating applied to the inside of the treated arterial wall which forms a patent lumen or is biologically active and causes the lining of the vessel or duct to form a patent lumen, and 5. any combination of the foregoing vascular graft options. The exterior of the vascular graft or part of it may and preferably does comprise tissue in-growth material. Where a pre-formed tubular vascular graft of synthetic material is used, the material thereof may be and preferably is dimensionally stable. However, if desired, it may be radially expandable material.
- The vascular graft of choice may be introduced into the treated artery or other vessel in any suitable way including but not limited to use of a dilator/sheath, placement of the vascular graft upon a mandrel shaft and/or use of long-nose forceps. The distal ends of the tubular graft and the mandrel shaft may be temporarily sutured together or the distal end of the vascular graft sutured together over the mandrel to accommodate unitary displacement into the vein, for example through a sheath after the dilator has been removed.
- Where the material of which the vascular graft is formed is expandable and in tubular or sleeve form, once the sheath has been removed the diametral size of the graft may be enlarged in contiguous relationship with the inside arterial surface using a balloon catheter. A balloon catheter may also be used to bring a folded or partially collapsed vascular graft which is dimensionally stable into contiguous relation with the interior surface of the remaining artery wall.
- The tubular graft may also comprise a biologically inert or biologically active anti-stenotic coating applied directly to the treated area of the remaining arterial inner surface to define a lumen of acceptable blood flow capacity.
- The graft, once correctly positioned and contiguous with the interior vascular wall, is usually inherently secure against inadvertent migration within the artery or other vessel due to friction and infiltration of weeping liquid accumulating on the inside artery wall. It is preferred that the length of the vascular graft be selected to span beyond all of the treated region of the artery.
- One or both ends of the vascular graft may be sutured or surgically stapled in position on the treated wall to prevent undesired displacement or partial or complete collapse under cardiovascular pressure. In particular, the upstream end of a graft placed in an artery must be secure to prevent a flap of the graft from being pushed, by arterial blood flow, into a position where it occludes, in whole or in part, the vessel. One or both ends may be held open by one or more stents disposed within the tubular graft. Forceps may be used to hold a free end of the vascular graft while the other end is secured to the vascular wall. Currently, it is preferred to secure the proximal end of the tubular vascular graft to the treated vascular wall and to bias dilate the distal end of the tubular vascular graft by use of a balloon catheter and/or arterial pressure. Where the distal exterior of the sleeve-shaped vascular graft comprises tissue in-growth material, as is preferred as in-growth occurs it becomes immaterial how the initial dilating bias was achieved.
- Reference is now made to the drawings wherein like numerals are used to designate like parts throughout. While the drawings are specifically directed toward the removal of an atheroma in the superficial femoral, it is to be appreciated that the principles of the present invention apply to other arteries as well as to ducts and vessels in the body other than arteries. Specifically,
FIG. 1 illustrates the juncture between the common femoral artery and the superficial femoral artery and profunda femoris artery, respectively located at a site near the groin of a medical patient.FIG. 1 further illustrates the existence of a surgically cratedarteriotomy 50 providing access to the superficialfemoral artery 52 at a location proximal of an atheroma, generally designated 54. Theatheroma 54 comprises a centrally located, relatively softcentral plaque portion 56 surrounded by a calcifiedplaque portion 58. -
FIG. 2A is similar toFIG. 1 and further illustrates asecond arteriotomy 50′ located distal of theatheroma 54, providing a second access site to theartery 52, as explained herein in greater detail. -
FIG. 2B illustrates thesame artery 52 to which access is provided solely by percutaneous placement of aneedle 60 into the hollow of theartery 52 upstream (proximal) of theatheroma 54.Needle 60 accommodates plaque removal and placement of a lining within theartery 52. - While
FIGS. 1, 2A , and 2B illustrate an atheroma which completely occludes theartery 52, it is to be appreciated that the present invention applies to both partial and complete occlusion due to plaque. The overall objective is to restore substantially full blood flow to the artery and prevent restenosis. It is to be appreciated that the artery receiving treatment is temporarily deprived of blood flow altogether, using known methods of temporary occlusion. Prior to temporary occlusion, systemic or regional heparinization may be effected. - Typically, as illustrated in
FIG. 3 , after thearteriotomy 50 has been made near the origin of the superficial femoral artery, aguide wire 62, conventional in construction, is advanced distally through thearteriotomy 50 and through theatheroma 54 along thesofter plaque portion 56 thereof. If theguide wire 62 alone cannot be manually caused to traverse theatheroma 54, as illustrated inFIG. 3 , other medical instruments may be used to create a passageway through theatheroma 54 following which theguide wire 62 may be appropriately inserted so as to traverse theatheroma 54. For example, adynamic wire guide 64 may be advanced and operated so as to create a lumen through thesofter plaque 56 of theatheroma 54 as diagrammatically illustrated inFIG. 4 . Currently, the preferred dynamic wire guide is the one disclosed in pending U.S. patent application Ser. No. 07/973,514, filed Nov. 9, 1992, assigned to Endo Vascular Instruments, the assignee of the present application, although other dynamic and static wire guides could be used. - Once the
dynamic wire guide 64 has penetrated thecentral plaque region 56 so as to traverse thehard plaque portion 58, theguide wire 62 is advanced through the lumen within thedynamic wire guide 64, following which the dynamic wire guide is withdrawn leaving theguide wire 62 in position, as a guide for instruments by which the soft andhard plaque - Alternatively, with reference to
FIG. 5 , adynamic disrupter 66, having a rotating enlargedrounded tip 67, may be used in lieu of the dynamic wire guide described above to penetrate thesofter plaque region 56 sufficient to accommodate concentric insertion of theguide wire 62 through thedynamic disrupter 66, with thedynamic distributor 66 after being removed along the guide wire while the guide wire is retained in its inserted position. Currently, the preferred dynamic disrupter is the one disclosed in pending U.S. patent application Ser. No. 07/973,514, filed Nov. 9, 1992, assigned to Endo Vascular Instruments, the assignee of the present application, although other dynamic disrupters could be used. - While not shown, it is to be appreciated that plaque, separated from the
atheroma 54, cannot be allowed to remain uncollected within the artery and, therefore, conventional instruments and procedures are used appropriately downstream of theatheroma 54 to collect and remove all debris released during treatment of theatheroma 54. - Having established the appropriate placement of
guide wire 62 through theatheroma 54, the surgeon is in a position to enlarge the arterial lumen at the site of theatheroma 54 by removingplaque 58. Such removal is commonly referred to as an atherectomy. The severing, grinding, cutting, chipping, and abrading of theplaque 58 may be mechanically accomplished by any suitable cutting instrument. Exemplary types are illustrated inFIGS. 6 and 7 , respectively.FIG. 6 illustrates diagrammatically utilization of acoring catheter 70, advanced along theguide wire 62 through thearteriotomy 50 so as to cut theplaque 58 from theartery 52 using as many passes along theatheroma 54 as necessary. The coring catheter has a cuttinghead 72 which is caused to be rotated by the surgeon. It is currently preferred that thecoring catheter 70 be that which is disclosed in the assignee's co-pending U.S. patent application Ser. No. 07/973,514, which was filed Nov. 9, 1992, although any suitable coring catheter may be utilized. - Either in conjunction with a coring catheter or in lieu thereof, the lumen across the
atheroma 54 can be enlarged using an expandable cutter, having diametrally expandable cutting blades as illustrated inFIG. 7 . Theexpandable cutter 74 is initially advanced along theguide wire 62 in an unexpanded state.Expandable cutter 74 has a diametrallyadjustable cutting head 76 which, when expanded and pulledforward atherectomy 50 will cut or shave the plaque atdeposits 58. Alternatively, the expandable cutter may be utilized in a fashion in which the expandable cutting blades, when expanded, engage and grab hold of a section of the plaque. When the expandable cutter is pulled, it both cuts the junction with the remaining distal plaque and allows a cylindrical length of the plaque which lies proximal of the cutting blades to be removed all in one segment. Typically, a plurality of passes of the cuttinghead 76, each with a slightly greater diameter are required to completely excavateplaque 58. Currently, it is preferred that the expandable cutter disclosed in assignee's U.S. Pat. No. 5,11,651 be utilized. - Attention is now turned to those situations where an endarterectomy is the procedure of choice. Specific reference is now made to
FIG. 8 which illustrates, in part, one way in which theintima 100 and themedia 102 are collectively separated from theadventitia 104 along a natural interface ofweakness 106, which typically exists in diseased arteries. A first andsecond arteriotomy interface 106. By loosening a length of the twointerior layers artery 52 from the adventitia along theinterface 106 at the radial or beveled cut adjacent thearteriotomy 50, the loosened part is available for grasping, using a suitable instrument such as forceps 108 illustrated inFIG. 8 . By pulling one or more times in the general direction of arrow 1 10 so as to have a substantial axial-component along the length of theartery 52, the cut length of intima and media is severed alonginterface 106 and pulled from the artery througharteriotomy 50. - While not illustrated in all of the Figures (for simplicity of presentation), it is to be appreciated that all arteries comprise three layers, the intima, the media, and the adventitia.
- It is to be understood that the distinction between atherectomy and endarterectomy is somewhat arbitrary, as it depends upon whether the material being removed consists exclusively of atheroma only, or of a combination of atheroma and material characteristic of the inner lining of the vessel. Pathology analysis of such removed material frequently indicates the presence of cells and other material characteristic of both plaque and the media and intima, so it is probably most correct to refer to this procedure as an endarterectomy.
- In one currently preferred embodiment, an endarterectomy is performed using the dynamic disrupter and the expandable cutter. The dynamic disrupter is first advanced over the guide wire both to loosen the plaque and the intima and media along the natural interface of weakness, and to enlarge the channel or lumen through the artery. The dynamic disrupter may be advanced one or more times. If multiple advances are used, the repeated advancements may be done using the same tip size, or they may be done using successively larger tip sizes.
- After the dynamic disrupter has been used and withdrawn over the guide wire, the expandable cutter is employed to remove the material that has been loosened. With the blades unexpanded, the expandable cutter is advanced a suitable distance into the atheromatous region, and then the blades expanded. When the expandable cutter is withdrawn, it engages the plaque and arterial lining, and exerts force upon the natural interface of weakness. The plaque and arterial lining are withdrawn by the expandable cutter in the form of a cylindrical plug of material, which may be short or long depending upon how far into the plaque the cutter is advanced before it is expanded. After removing the plug of material from the cutter, the blades are returned to the unexpanded position and re-advanced into the artery, this time to a position further than the previous advancement, so that a new length of atheromatous material can be engaged. The blades are once again expanded, and a new plug of material is engaged and withdrawn. By a repeated series of such steps, any desired length of artery may be excavated of its plaque and inner lining. When the final advance to the most distal point is performed, the distal tapered shape that the blades assume when expanded leaves behind the desired tapered shape as it cuts and removes the final plug of material from the artery. This eliminates any need to make the
second arteriotomy 50′, for the purpose of making the distal radial cut, when the expandable cutter if employed. - In the alternative, an endarterectomy may be performed using a Hall loop, as diagrammatically illustrated in
FIG. 9 . Preliminarily, the artery containing theatheroma 54 is accessed, as illustrated inFIG. 2A , by first and second arteriotomies 50 and 50═. The first radial or beveled cut through the intima and media is made, as described above, and the media is severed alonginterface 106 at one end or the other (usually the upstream, proximal end) for a short distance to allow theloop 110 to be placed at the interface, with theflexible shaft 112 extending in the direction of the pull and through the more remote arteriotomy. When power is applied, the loop is caused to oscillate as the Hall loop is advanced along theinterface 106 until complete severance has occurred, following which forceps may be used to pull the removed intima and media layers from the artery through the proximal arteriotomy after the second radial or beveled cut through the intima and media is made, attempting to leave a tapered contour to the remaining material at the distal end of the endarterectomy. The Hall loop is more fully described in U.S. Pat. No. 3,730,185. - The endarterectomy may similarly be performed using a Scanlan Endarsector, as generally illustrated in
FIG. 11 . It is to be appreciated that theScanlan Endarsector 114 is a commercially available instrument, sold by Scanlan International, Inc., 1 Scanlan Plaza, St. Paul, Minn. 55107, and my be used alone or in conjunction with other instruments to perform the endarterectomy. TheScanlan Endarsector 114 comprises a handle (not shown) from which an elongated U-shaped shaft extends. By probing with the Scanlan Endarsector along theinterface 106 adjacent portions of themedia 102 andintima 100 which have been loosened, further loosening occurs until the endarterectomy is completed and the severed artery portion removed. - Reference is now made to
FIGS. 12 through 15 which illustrate various ways in which an atherectomy may be performed when that procedure is the treatment of choice, in whole or in part, for enlarging the blood flow lumen ofartery 52 atatheroma site 54. - With specific reference to
FIG. 12 , there is illustrated a mechanical instrument for the performance of an atherectomy, i.e., Simpson Atherocath, generally designated 116. The atherocath comprises an outside,hollow shaft 118 through which extends a rotatableinner shaft 120 to which arotating cutter head 122 is non-rotatably attached. Therotating cutting head 122cuts plaque 58 from the interior of theartery 52 as the atherocath is advanced. Aballoon 124 is inflated on the side opposite the cuttinghead 122 to thereby bring pressure to bear against the artery and urge the cutting head firmly against the plaque. At the distal end of the atherocath is located achamber 126, which functions to collect plaque shavings removed by the cuttinghead 122. Theatherocath 116 is inserted and removed alongguide wire 62. The Simpson Atherocath is commercially available from Devices for Vascular Intervention, division of Eli Lilly, 26201 YNEZ Road, Temecula, Calif. 92591. -
FIG. 13 diagrammatically represents the use of balloon angioplasty to enlarge the lumen of an atheroma-ridden artery. Specifically, aballoon 302 of aballoon catheter 300 is advanced alongguide wire 62 until it is disposed within theatheroma 54. Using the side port of theballoon catheter 300, theballoon 302 is expanded, which radially expands theplaque 58. This process ordinarily creates cracks in the plaque, but nevertheless results in an enlarged lumen through theplaque 58 although, typically, theplaque 58 is not intentionally removed. - Reference is now made to
FIG. 14 which diagrammatically illustrates use of a laser instrument, generally designated 130 to removeplaque 58 fromartery 52. Thelaser instrument 50 comprises asource 132 of laser energy. The laser energy is processed along a bundle of optical fibers disposed within acatheter 134.Laser beams 136 are emitted from theinstrument 130 through a plurality oflaser emitters 138. Thelaser beams 136 cut plaque fromdeposits 58 as the distal end of thecatheter 134 is advanced distally into theplaque 58. Thelaser instrument 130 is illustrated as being concentrically disposed uponguide wire 62 for insertion, advancement, and ultimate removal. Thus, an atherectomy may be performed in accordance wit the principles of the present invention by use of one or more laser beams. A suitable laser instrument is the Laserprobe PLR or Lasercath-PRL, used with the Optilase Laser Source System, all of which are available from Trimedyne, Inc., 1815 East Carnegie Avenue, Santa Ana, Calif. 92705. - In lieu of the above-mentioned ways for performance of an atherectomy, or in conjunction therewith, ultrasound energy may be used. Specific reference is made to
FIG. 15 which illustrates diagrammatically an ultrasound instrument, generally designated 140.Instrument 140 comprises a source of ultrasound energy, i.e.,ultrasound transducer 142.Transducer 142 connects via anultrasound shaft 144 to anultrasound head 146. Theultrasound shaft 144 is substantially concentrically disposed within anultrasound catheter 148. A guide wire is not used. Release of ultrasound energy fromhead 146 is caused to impinge uponplaque 58 fracturing the same progressively, thereby enlarging the blood flow lumen of theartery 52. A suitable ultrasound instrument for removal of plaque is the Sonocath, available from Angiosonics, Wayne, N.J., (201) 305-1770. - Once the interior of the partially or totally occluded artery has been treated using an appropriate procedure including one or more of the procedures described above, the present invention includes placement of a lining or vascular graft so as to extend preferably co-extensively along the full length of the treated portion of the artery. The nature of the vascular graft will vary depending upon the circumstances, the artery in question, the length over which the artery has been treated, and perhaps other factors. The vascular graft may be of any suitable biologically inert material including, but not limited to, a dacron sleeve of medical grade fabric, a sleeve of expanded PTFE (such as GOR-TEX® polytetrofluoroethelene vascular graft tubing available from W.L. Gore and Associates, Inc., Medical Products Division, 1505 N. 4th Street, Central Dock 3, Flagstaff, Ariz. 86002). Another available sleeve formed of expanded PTFE is available from IMPRA, Inc., P.O. Box 1740, Tempe, Ariz. 85280-1740.
- The material may be dimensionally stable or capable of being expanded, for example, using a balloon catheter and/or one or more stents. For short lengths, vascular graft 200 (
FIG. 16 ) may be used.Vascular graft 200 is illustrated as having blunt ends, is cut to a length commensurate with the treated artery and comprises exterior and interior surfaces respectively comprising a uniform diameter along the entire length of thevascular graft 200. The wall thickness is also illustrated as being uniform. - For longer lengths, tapered vascular graft 202 (
FIG. 17 ) may be preferable, the degree of taper being selected so as to match the taper of the artery subjected to one or more of the treatments described above. - In cases where the artery being lined is bifurcated (e.g., comprises a branch from one to two arteries), vascular graft 204 (
FIG. 20 ) may be used, the configuration thereof being adapted to conform specifically to the nature of the shape, size, and disposition of the branched artery subjected to treatment. Depending upon the anatomy,vascular graft 204 may be straight or tapered or straight in part and tapered in part. - When strength greater than the mere material from which a vascular graft is formed becomes a consideration, the vascular graft may be reinforced, particularly when no expansion thereof is required during placement. Two typical forms of reinforcement are illustrated in
FIGS. 18 and 19 , respectively, which depictvascular graft 206 andvascular graft 208, respectively.Vascular graft 206 comprises reinforcement in the form of a plurality ofrings 210. While illustrated as being embedded within the material 212 from which thevascular graft 206 is formed, the reinforcing rings could be placed either internally or externally in respect to thegraft 206 itself. - Similarly,
vascular graft 208 is illustrated inFIG. 19 as comprising a continuous,helical reinforcement 214 embedded in the material 216 from which thevascular graft 208 is formed. Thereinforcement 214 could be placed as well either internally or externally of thevascular graft 208 itself. - The reinforcement, e.g., rings 210 and helix 24 can be of any suitable biologically inert material such as an implantable grade of thermoplastic material, e.g., polypropylene or nylon.
- Even in cases where sutures, staples, arid/or stents are used to initially hold the lining or vascular graft contiguously against the treated artery wall, utilization of tissue in-growth material at the exterior of all or part of the vascular graft may be desirable. In this regard, specific reference is made to
FIG. 21 which diagrammatically illustrates the existence of tissue in-growth material 220 disposed along approximately the distal one-half of the hollow cylindrically-shapedvascular graft 222. The value of the tissue in-growth material is that it becomes, in due course of time, the primary connector between the treated arterial surface and the vascular graft. - With reference to
FIG. 22 , there is diagrammatically illustrated a hollow cylindricalvascular graft 224 to which anexpandable stent 226 has been connected interiorly at the proximal end thereof usingsutures 228. Once thevascular graft 224 is properly positioned within a treated artery, thestent 226 is conventionally expanded to bias the proximal end of thevascular graft 224 contiguously against the treated arterial surface to retain the position of placement. This condition is illustrated inFIG. 38 . While illustrated as being placed internally inside ofgraft 224, the stent could also be placed externally or it could be embedded within the material from which thevascular graft 224 is formed. - Utilization of a vascular graft within the context of the present invention significantly tends to provide a barrier between the bloodstream and the vessel wall which is believed to reduce restenosis, provides a conduit through which the blood can flow which is known to be well-tolerated by the bloodstream, preserves the area available for blood flow, prevents an aneurysm, promotes rapid healing without excessive weeping or adhesion of blood at the lining site between the vascular graft and the adventitia layer, and provokes minimal scarring. Plaque, it has been determined, does not form on and adhere to the vascular graft.
- In lieu of a pre-formed straight or tapered sleeve (with or without a bifurcation) the treated arterial wall, e.g., at
interface 106, may be lined using a liquid coating of suitable material applied as a spray or otherwise and allowed to cure until a hollow lumen is defined within the cured coating and the treated arterial surface is concealed by the coating, or allowed to remain in place long enough to cause the artery to form a stable, hollow lumen. In this regard, reference is made toFIG. 39 which illustrates the presence of a manually controllednozzle 230 forming a part of a surgical spraying instrument by which acoating 232 is applied to the treated arterial surface atinterface 106. Suitable coatings, for example, having the requisite biologically inert characteristics and wall adherence characteristics would include pharmaceutical-grade collagen available from Collagen Corp., 1850 Embariadero Road, Palo Alto, Calif. 94303. - Once the vascular graft of choice has been selected, other than an in-place coating, insertion of the vascular graft into the treated artery must be achieved. It is currently preferred to use a commercially available dilator/peel-away sheath generally designated 250 (
FIGS. 23, 24 , 26 and 27). However, a solid (non-peel-away) sheath may also be utilized or the graft may be inserted directly into the vessel without use of a sheath. As is well known in the art, the dilator/sheath 250, in assembled condition, is passed concentrically along theguide wire 62 through the access opening to theartery 52. The access opening may be an arteriotomy 50 or a percutaneous venipuncture caused by insertion of needle 60 (FIG. 2B ) followed by advancement of the guide wire through theneedle 60 and subsequent removal of the needle. In the case of a needle puncture, thedilator 252 at the tapereddistal tip 254 enlarges the radial size of the puncture as does the sheath 256 (slightly) as the dilator-sheath 250 is advanced through the puncture concentrically around theguide wire 62 until the dilator-sheath 250 is positioned as illustrated inFIG. 23 . Once the position ofFIG. 23 has been achieved, the medical attendant simply manually retracts the dilator along theguide wire 62 until it is fully removed, leaving thesheath 256 in place with the proximal end thereof exposed, as diagrammatically illustrated inFIG. 24 . - Next, steps are taken to insert the vascular graft through the sheath and locate the graft in the treated artery so as to be, preferably, at least co-extensive with the treated artery surface, with the guide wire inside the graft. The treated artery surface shown in
FIGS. 23-24 and 26-27 isinterface 106. One way in which insertion may be consummated is by use or a graft placement long-nose forceps, generally designated 260 (FIG. 25 ) which comprises a control handle 262 from which amandrel shaft 264 distally extends. Activation of thecontrol 262 causes bifurcatedtips 266 located at the distal end of themandrel shaft 264 to open and close, to grasp or clamp and release, respectively, thedistal end 268 of a hollow tubularvascular graft 270. By grasping betweentips 266 thedistal end 268 of thevascular graft 270, the vascular graft follows themandrel shaft 264 as it is advanced over theguide wire 62 and through thesheath 256 as illustrated inFIGS. 26 and 27 . - With the
graft 270 correctly positioned in theartery 52, theforceps 260 andgraft 270 are held in a stationary position, the forceps grasping the graft, as the sheath is withdrawn. In the case of peel-awaysheath 256, as the sheath is withdrawn it is manually split into two pieces, as illustrated inFIG. 27 , following which each piece is discarded. - At this point, the
forceps 260 and thegraft 270, with theguide wire 62 passing centrally through the graft, are left in position and thesheath 256 has been entirely removed. Thereafter, the guide wire andgraft 270 are held stationary, themandrel control 262 manipulated to open thetips 266 causing thedistal end 268 of thegraft 270 to be released, following which theforceps 260 are withdrawn while theguide wire 62 and thegraft 270 are retained in position as illustrated inFIG. 28 . - Alternatively, the sheath may be placed correctly in the
artery 52 using a hollow mandrel, generally designated 280 (FIG. 34 ). Wherein thesheath 270 is concentrically disposed around thehollow mandrel 280 with the distal ends of each being sutured together usingapertures 282 located in the distal end of themandrel 280. By placing asuture 284 helically through theapertures 282 and through the adjacent thickness of thevascular graft 270, the vascular graft and the mandrel are secured together. Where only one access opening, such asarteriotomy 50, is used, thesuture 284 may be extended through the hollow of themandrel 280 and through thearteriotomy 50 for access by the medical attendant. Once fully positioned in the artery, one end of thesuture 284 is pulled by the medical attendant, causing the suture to helically unwind at the distal end of thevascular graft 270 for complete removal of thesuture 284, following which themandrel 280 is fully retracted leaving thevascular graft 270 correctly disposed in theartery 52, with theguide wire 62 inside the graft. - Similarly, with or without a dilator/sheath, used in the manner described above, an elongated, long-nose forceps 290 (
FIG. 35 ) may be used as well for correct placement of thevascular graft 270. Long-nose forceps 290 may be of any suitable type, such as commercially available pediatric bronchoscopy forceps or retrieval forceps, such as Storz's. More specifically, theforceps 290 comprise exposedjaws 292 which are controlled at the proximal end of theforceps 290 accommodating opening and closing of thejaws 292. By creasing or folding at 268 thevascular graft 270 and forcing the crease or fold 268 between thejaws 292 when open accommodates clamping of the creaseddistal end 268 when thejaws 292 are tightly closed. Thereafter, theforceps 290 and thevascular graft 270 are jointly advanced through the access site, such asarteriotomy 50, until thevascular graft 270 is correctly located in the treatedartery 52, as illustrated inFIG. 35 . Thereafter, thejaws 292 are opened, thefold 268 at the distal end of thevascular graft 270 is released and theforceps 290 retracted leaving thevascular graft 270 properly disposed within theartery 52. - Independent of the procedure used, the
vascular graft 270 is now correctly located in theartery 52, with theguide wire 62 passing though the center of thevascular graft 270, as illustrated inFIG. 28 . - Insertion of a tubular graft of choice into the treated artery often involves folding or other forms of reduction in the diametral size occupied by the vascular graft during insertion, for example, to accommodate a size which will allow displacement through the
sheath 256. The sheath handle may accept a graft folded shown inFIG. 26A . This folded configuration may continue the length of the sheath, to allow the easier passage of the graft through the sheath, by de-forming the inside diameter to the shape, or by laying a conventional catheter or wire alongside the graft during insertion to create an indentation in the graft. For this reason and because, typically, the walls of a synthetic vascular graft are very supple and lack shape-retaining strength, the vascular graft, if left alone, tends to be and remain non-contiguous with the treated surface at the interior of the artery, e.g.,surface 106, e.g., retaining the crimped or folded shape it assumes during insertion. In order to provide a contiguous relationship between the vascular graft and the adjacent arterial wall and to dilate the vascular graft to its full diameter, it is presently preferred that aballoon catheter 300 of conventional, commercially available design be advanced concentrically around theguide wire 62 until theballoon 302 thereof is positioned within thesheath 270 just inside thedistal edge 268′ of thesheath 270. SeeFIG. 29 . - By sequentially expanding, deflating, slightly displacing and once more inflating, etc., the
balloon 302, thevascular graft 270 is caused to become contiguous with and adhered to the adjacent arterial wall surface, following which theballoon 302 is deflated and theballoon catheter 300 retracted along the guide wire and discarded, leaving thevascular graft 270 postured as illustrated inFIG. 30 . Alternatively, one very long balloon catheter can be employed to perform this step in a single balloon expansion, and/or the balloon can be sized to exactly match the graft, e.g., tapered balloon used with tapered graft, etc. - Thereafter, the
guide wire 62 is fully retracted, leaving the tubularvascular graft 270 positioned as essentially illustrated inFIG. 31 . It has been found that once the tubular vascular graft is firmly contiguous with the adjacent arterial wall surface, a measure of friction exists which both prevents radial collapse and axial displacement of the vascular graft within the artery. In addition, the treated arterial surface tends to weep slightly which weeping adheres to the exterior surface of the tubular graft and tends to infiltrate the material from which the tubular graft is formed at least to a limited extent further causing the graft to be retained in its expanded stationary position, fully dilated withing the artery. - As best illustrated in
FIG. 32 , it is presently preferred that only theproximal end 269 of thevascular graft 270 be physically connected to the adjacent arterial wall, in this case adventitialayer 104, and that thedistal end 268 be left to natural adherence, with the arterial blood pressure holding thedistal end 268 in its fully dilated position together with friction at thesurface 106 and tissue infiltration into the material from which thegraft 270 is fabricated. InFIG. 32 the utilization of one ormore sutures 304 is illustrated as the structure by which theproximal end 269 of thevascular graft 270 is physically secured to the arterial wall. - Over the longer term, the graft will be held open and contiguous with the remaining original wall of the artery throughout its length by arterial blood pressure and, in grafts so constructed, by tissue in-growth into the tissue in-growth material. This particular feature of intra-luminal graft placement solves a specific problem of by-pass graft placement where by-pass grafts have previously been placed in tissue tunnels constructed to by-pass the original duct or vessel lumen. Many such grafts are placed in body regions where, under normal activities, the body tends to compress grafts and thereby cut off flow though such grafts when they are placed in tissue tunnels which by-pass the original lumen. The example of the human knee joint is illustrated in
FIG. 10 . Convention placement of by-pass grafts, which pass through the knee joint, results in the surrounding tissue tending to compress the graft and cut off flow when the knee is bent. Conventionally, this problem has been solved by using a reinforced graft, as previously illustrated inFIGS. 18 and 19 , wherein the reinforcing holds the graft lumen open and patent when external tissue pressure is exerted on the graft. - An improved result is obtained using the intra-luminal graft placement described herein is illustrated in
FIG. 10 . The original artery lumen remains open and patent in the knee even when the knee is bent. More generally, ducts and vessels naturally remain open and patent during the normal range of activities. InFIG. 10 , the lumen of the graft, which is adhering to the remaining original wall of the artery by tissue in-growth and/or due to the arterial pressure inside the graft, is illustrated as remaining open and patent even while the knee is bent. More generally, intra-luminal grafts held in place in vessels or ducts by tissue in-growth will remain open and patent during the normal range of activities, including activities that tend to obstruct by-pass grafts placed in tissue tunnels. - While it is currently preferred that the
distal end 268 of thevascular graft 270 be without manmade connection to the vascular wall, it desired thedistal end 268 may be so secured. Specifically,FIG. 36 illustrates utilization of one ormore sutures 304 to secure both the proximal anddistal ends vascular graft 270 to thearterial wall 104. Placement ofsutures 304 at thedistal end 268 of thevascular graft 270 would ordinarily require a second, downstream arteriotomy. - Similarly, one or both ends of the
vascular graft 270 may be secured to thearterial wall 104 usingmedical grade staples 306, as illustrated inFIG. 37 . - Furthermore, either or both ends of the
vascular graft 270 can be expanded and held in contiguous relationship witharterial surface 106 using one ormore stents 226, as explained above and as illustrated inFIG. 38 . - While ordinarily not necessary, the
distal end 268 of thevascular graft 270 may be grasped usingsuitable forceps 310 for both positioning thevascular graft 270 and for holding it in position while, for example, the proximal end of the graft is suitably fastened to the arterial wall as explained above. SeeFIG. 33 . - The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Claims (12)
1-104. (canceled)
105. A method of treating an artery, comprising the steps of:
enlarging the lumen size of a plaque-ridden segment of an artery;
placing a vascular lining ate the lumen enlarged segment so that the lining covers at least some of the lumen enlarged segment.
106. A method of treating an artery, comprising the steps of:
treating the artery by enlarging the lumen size of a plaque-ridden segment of an artery by removing plaque therefrom;
placing a vascular lining within the artery along at least a portion of the treated segment so as to engage at least some of a residual arterial surface area of the treated segment.
107. A method of treating an artery, comprising the steps of:
enlarging the lumen size of a plaque-ridden segment of an artery using a plaque-removing instrument;
inserting a vascular lining into the artery at the treated segment so that at least a surface of the lining covers at least some of a residual arterial surface of the treated segment;
stabilizing the vascular lining within said artery at said location.
108. A method of treating an artery, comprising the steps of:
enlarging the lumen size of a plaque-ridden segment of an artery;
placing a vascular lining within the artery so as to cover at least part of the lumen enlarged segment;
stabilizing the vascular lining within said artery at said location.
109. A method of restoring reduced or absent blood flow capacity to an artery in a patient, comprising the steps of:
excavating plaque and the like from within a segment of an artery;
placing a vascular lining at a location within and as an internal lining for at least some of the excavated segment;
stabilizing the vascular lining within said artery at said location.
110. A method of restoring reduced or absent blood flow capacity to an artery in a patient, comprising the steps of:
removing plaque and the like from within a segment of an artery;
placing a vascular lining at a location within and as an internal lining for the artery at least co-extensive with at least part of the segment so as to cover at least some of an arterial surface area at the segment.
111. A method of restoring reduced or absent blood flow capacity to an artery in a patient, comprising the steps of:
accessing to the artery through a small man-made passageway;
removing plaque from within a segment of an artery through the small man-made passageway;
placing a vascular lining into the artery through the small man-made passageway;
placing the lining at a location within and as an internal lining for the artery co-extensive at least in part with the segment so as to cover at least some of an arterial surface area at the segment using another instrument;
causing the vascular lining to be contiguously stabilized within said artery at said, location.
112. An uninterrupted method of treating a vessel, comprising the following steps in succession without appreciable delay between steps:
creating an entry site into the vessel;
inserting a treating instrument into the vessel through the entry site;
treating plaque from within a segment of the vessel using the treating instrument;
removing the treating instrument through the entry site;
placing a vascular lining through the entry site and at a location within and as a contiguous internal lining for at least some of the vessel at least con-extensive with and predominantly concealing at least some of the segment using an insertion and placement instrument;
removing the insertion and placement instrument through the entry site;
stabilizing the vascular lining within said vessel at said location.
113. A largely non-invasive method of treating a vessel, comprising the steps of:
enlarging the flow path size of a segment of a vessel, the enlarging step comprising removing plaque;
without delay using a control to introduce and place a vascular lining into the vessel coextensive with at least some of the plaque removal segment;
promptly thereafter securing the vascular lining with the vessel at and so as to cover at least some of an inside surface within the vessel for long term retention without the control.
114. A method of treating an artery, comprising the steps of:
reducing the quantity of plaque from within a segment of an artery;
placing a vascular lining not previously in the artery, at a location within the artery which comprises the segment by displacing the vascular lining through a surgical access site using a control;
securing the vascular lining so that the lining is generally contiguously within and generally covers and conceals at least some of a surface area of said artery at said location.
115. A method of treating an artery, comprising the steps of:
performing an arteriotomy;
parting plaque from within a segment of an artery using an instrument introduced through the arteriotomy;
removing plaque and the instrument through the arteriotomy;
placing a vascular lining carried by a second instrument through the arteriotomy and at a location within and as an internal lining for at least some of a surface area of the artery co-extensive at least in part with the segment;
securing the vascular lining within said artery at said location.
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US11/247,571 US20060089706A1 (en) | 1993-06-07 | 2005-10-11 | Anti-stenotic method and product for occluded and partially occluded arteries |
US11/818,715 US20070260215A1 (en) | 1993-06-07 | 2007-06-14 | Anti-stenotic method and product for occluded and partially occluded arteries |
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/073,002 US5571169A (en) | 1993-06-07 | 1993-06-07 | Anti-stenotic method and product for occluded and partially occluded arteries |
US08/548,569 US5865844A (en) | 1989-08-18 | 1995-10-26 | Anti-stenotic method and product for occluded and partially occluded arteries |
US09/098,912 US5904146A (en) | 1993-06-07 | 1998-03-05 | Anti-stenotic method and product for occluded and partially occluded arteries |
US09/183,896 US6090135A (en) | 1993-06-07 | 1998-10-30 | Anti-stenotic method and product for occluded and partially occluded arteries |
US52246100A | 2000-03-09 | 2000-03-09 | |
US09/938,882 US20020004680A1 (en) | 1993-06-07 | 2001-08-24 | Anti-stenotic method and product for occluded and partially occluded arteries |
US11/247,571 US20060089706A1 (en) | 1993-06-07 | 2005-10-11 | Anti-stenotic method and product for occluded and partially occluded arteries |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/938,882 Division US20020004680A1 (en) | 1993-06-07 | 2001-08-24 | Anti-stenotic method and product for occluded and partially occluded arteries |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/818,715 Continuation US20070260215A1 (en) | 1993-06-07 | 2007-06-14 | Anti-stenotic method and product for occluded and partially occluded arteries |
Publications (1)
Publication Number | Publication Date |
---|---|
US20060089706A1 true US20060089706A1 (en) | 2006-04-27 |
Family
ID=22111093
Family Applications (12)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/073,002 Expired - Lifetime US5571169A (en) | 1989-08-18 | 1993-06-07 | Anti-stenotic method and product for occluded and partially occluded arteries |
US08/698,981 Expired - Fee Related US5782847A (en) | 1993-06-07 | 1996-08-16 | Anti-stenotic method for occluded and partially occluded arteries |
US08/730,421 Expired - Fee Related US5842479A (en) | 1993-06-07 | 1996-10-15 | Method of restoring reduced or absent blood flow capacity |
US08/730,420 Expired - Fee Related US5836316A (en) | 1993-06-07 | 1996-10-15 | Method of restoring reduced or absent blood flow capacity |
US08/731,786 Expired - Fee Related US5843165A (en) | 1993-06-07 | 1996-10-18 | Method for increasing blood flow in vessels |
US08/857,224 Expired - Fee Related US5824057A (en) | 1993-06-07 | 1997-05-16 | Anti-stenotic method and product for occluded and partially occluded arteries |
US08/857,223 Expired - Fee Related US5873905A (en) | 1993-06-07 | 1997-05-16 | Anti-stenotic method and product for occluded and partially occluded arteries |
US09/098,912 Expired - Fee Related US5904146A (en) | 1993-06-07 | 1998-03-05 | Anti-stenotic method and product for occluded and partially occluded arteries |
US09/183,896 Expired - Fee Related US6090135A (en) | 1993-06-07 | 1998-10-30 | Anti-stenotic method and product for occluded and partially occluded arteries |
US09/938,882 Abandoned US20020004680A1 (en) | 1993-06-07 | 2001-08-24 | Anti-stenotic method and product for occluded and partially occluded arteries |
US11/247,571 Abandoned US20060089706A1 (en) | 1993-06-07 | 2005-10-11 | Anti-stenotic method and product for occluded and partially occluded arteries |
US11/818,715 Abandoned US20070260215A1 (en) | 1993-06-07 | 2007-06-14 | Anti-stenotic method and product for occluded and partially occluded arteries |
Family Applications Before (10)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/073,002 Expired - Lifetime US5571169A (en) | 1989-08-18 | 1993-06-07 | Anti-stenotic method and product for occluded and partially occluded arteries |
US08/698,981 Expired - Fee Related US5782847A (en) | 1993-06-07 | 1996-08-16 | Anti-stenotic method for occluded and partially occluded arteries |
US08/730,421 Expired - Fee Related US5842479A (en) | 1993-06-07 | 1996-10-15 | Method of restoring reduced or absent blood flow capacity |
US08/730,420 Expired - Fee Related US5836316A (en) | 1993-06-07 | 1996-10-15 | Method of restoring reduced or absent blood flow capacity |
US08/731,786 Expired - Fee Related US5843165A (en) | 1993-06-07 | 1996-10-18 | Method for increasing blood flow in vessels |
US08/857,224 Expired - Fee Related US5824057A (en) | 1993-06-07 | 1997-05-16 | Anti-stenotic method and product for occluded and partially occluded arteries |
US08/857,223 Expired - Fee Related US5873905A (en) | 1993-06-07 | 1997-05-16 | Anti-stenotic method and product for occluded and partially occluded arteries |
US09/098,912 Expired - Fee Related US5904146A (en) | 1993-06-07 | 1998-03-05 | Anti-stenotic method and product for occluded and partially occluded arteries |
US09/183,896 Expired - Fee Related US6090135A (en) | 1993-06-07 | 1998-10-30 | Anti-stenotic method and product for occluded and partially occluded arteries |
US09/938,882 Abandoned US20020004680A1 (en) | 1993-06-07 | 2001-08-24 | Anti-stenotic method and product for occluded and partially occluded arteries |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US11/818,715 Abandoned US20070260215A1 (en) | 1993-06-07 | 2007-06-14 | Anti-stenotic method and product for occluded and partially occluded arteries |
Country Status (1)
Country | Link |
---|---|
US (12) | US5571169A (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090182224A1 (en) * | 1999-05-18 | 2009-07-16 | Mediguide Ltd. | Method and apparatus for invasive device tracking using organ timing signal generated from MPS sensors |
US20110054308A1 (en) * | 1999-05-18 | 2011-03-03 | Amit Cohen | Method and system for superimposing virtual anatomical landmarks on an image |
US20130166011A1 (en) * | 2001-09-07 | 2013-06-27 | Gera Strommer | System and method for delivering a stent to a selected position within a lumen |
Families Citing this family (150)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5571169A (en) * | 1993-06-07 | 1996-11-05 | Endovascular Instruments, Inc. | Anti-stenotic method and product for occluded and partially occluded arteries |
US5662701A (en) | 1989-08-18 | 1997-09-02 | Endovascular Instruments, Inc. | Anti-stenotic method and product for occluded and partially occluded arteries |
US6179824B1 (en) | 1993-05-10 | 2001-01-30 | Arthrocare Corporation | System and methods for electrosurgical restenosis of body lumens |
US6331188B1 (en) | 1994-08-31 | 2001-12-18 | Gore Enterprise Holdings, Inc. | Exterior supported self-expanding stent-graft |
US6015429A (en) | 1994-09-08 | 2000-01-18 | Gore Enterprise Holdings, Inc. | Procedures for introducing stents and stent-grafts |
US5755770A (en) * | 1995-01-31 | 1998-05-26 | Boston Scientific Corporatiion | Endovascular aortic graft |
US6042605A (en) | 1995-12-14 | 2000-03-28 | Gore Enterprose Holdings, Inc. | Kink resistant stent-graft |
EP0950385A3 (en) | 1995-12-14 | 1999-10-27 | Prograft Medical, Inc. | Stent-graft deployment apparatus and method |
US6273912B1 (en) * | 1996-02-28 | 2001-08-14 | Impra, Inc. | Flanged graft for end-to-side anastomosis |
EP1011521B1 (en) * | 1996-02-28 | 2005-01-26 | Bard Peripheral Vascular, Inc. | Flanged graft for end-to-side anastomosis |
US6022336A (en) * | 1996-05-20 | 2000-02-08 | Percusurge, Inc. | Catheter system for emboli containment |
US6544276B1 (en) | 1996-05-20 | 2003-04-08 | Medtronic Ave. Inc. | Exchange method for emboli containment |
JP2001504017A (en) * | 1996-11-15 | 2001-03-27 | クック インコーポレーティッド. | Separable sleeve, stent deployment device |
US5925074A (en) * | 1996-12-03 | 1999-07-20 | Atrium Medical Corporation | Vascular endoprosthesis and method |
US6010529A (en) * | 1996-12-03 | 2000-01-04 | Atrium Medical Corporation | Expandable shielded vessel support |
US6551350B1 (en) | 1996-12-23 | 2003-04-22 | Gore Enterprise Holdings, Inc. | Kink resistant bifurcated prosthesis |
US6352561B1 (en) | 1996-12-23 | 2002-03-05 | W. L. Gore & Associates | Implant deployment apparatus |
US5827310A (en) * | 1997-01-14 | 1998-10-27 | Endovascular Systems, Inc. | Apparatus for forming custom length grafts after endoluminal insertion |
US6183487B1 (en) | 1997-03-06 | 2001-02-06 | Scimed Life Systems, Inc. | Ablation device for reducing damage to vessels and/or in-vivo stents |
GB9709967D0 (en) * | 1997-05-17 | 1997-07-09 | Harris Peter L | Prosthetic grafts |
CA2287206A1 (en) | 1997-06-13 | 1998-12-17 | Arthrocare Corporation | Electrosurgical systems and methods for recanalization of occluded body lumens |
AU1724099A (en) * | 1997-12-15 | 1999-07-05 | Prolifix Medical, Inc. | Vascular stent for reduction of restenosis |
US6651670B2 (en) | 1998-02-13 | 2003-11-25 | Ventrica, Inc. | Delivering a conduit into a heart wall to place a coronary vessel in communication with a heart chamber and removing tissue from the vessel or heart wall to facilitate such communication |
US6808498B2 (en) | 1998-02-13 | 2004-10-26 | Ventrica, Inc. | Placing a guide member into a heart chamber through a coronary vessel and delivering devices for placing the coronary vessel in communication with the heart chamber |
US20020144696A1 (en) | 1998-02-13 | 2002-10-10 | A. Adam Sharkawy | Conduits for use in placing a target vessel in fluid communication with a source of blood |
AU755190B2 (en) * | 1998-02-13 | 2002-12-05 | Ventrica, Inc. | Methods and devices providing transmyocardial blood flow to the arterial vascular system of the heart |
US6096054A (en) | 1998-03-05 | 2000-08-01 | Scimed Life Systems, Inc. | Expandable atherectomy burr and method of ablating an occlusion from a patient's blood vessel |
US6440124B1 (en) | 1998-07-22 | 2002-08-27 | Endovasix, Inc. | Flexible flow apparatus and method for the disruption of occlusions |
US6139543A (en) | 1998-07-22 | 2000-10-31 | Endovasix, Inc. | Flow apparatus for the disruption of occlusions |
US6210400B1 (en) * | 1998-07-22 | 2001-04-03 | Endovasix, Inc. | Flexible flow apparatus and method for the disruption of occlusions |
US6093194A (en) | 1998-09-14 | 2000-07-25 | Endocare, Inc. | Insertion device for stents and methods for use |
US20050171594A1 (en) * | 1998-12-31 | 2005-08-04 | Angiotech International Ag | Stent grafts with bioactive coatings |
US7025773B2 (en) | 1999-01-15 | 2006-04-11 | Medtronic, Inc. | Methods and devices for placing a conduit in fluid communication with a target vessel |
CA2360587A1 (en) | 1999-01-15 | 2000-07-20 | Darin C. Gittings | Methods and devices for forming vascular anastomoses |
US8034100B2 (en) | 1999-03-11 | 2011-10-11 | Endologix, Inc. | Graft deployment system |
US6261316B1 (en) | 1999-03-11 | 2001-07-17 | Endologix, Inc. | Single puncture bifurcation graft deployment system |
US7285235B2 (en) * | 1999-05-19 | 2007-10-23 | Medtronic, Inc. | Manufacturing conduits for use in placing a target vessel in fluid communication with a source of blood |
US6635214B2 (en) | 1999-09-10 | 2003-10-21 | Ventrica, Inc. | Manufacturing conduits for use in placing a target vessel in fluid communication with a source of blood |
US6241745B1 (en) | 1999-09-16 | 2001-06-05 | David Rosenthal | Apparatus and method for performing an endarterectomy |
DE60021917D1 (en) * | 1999-10-08 | 2005-09-15 | Gen Hospital Corp | Perkutane stentprothese |
US6383171B1 (en) | 1999-10-12 | 2002-05-07 | Allan Will | Methods and devices for protecting a passageway in a body when advancing devices through the passageway |
US6572630B1 (en) * | 2000-01-31 | 2003-06-03 | Rex Medical, L.P | Atherectomy device |
US6579299B2 (en) * | 2000-01-31 | 2003-06-17 | Rex Medical, L.P. | Atherectomy device |
US6419659B1 (en) * | 2000-02-10 | 2002-07-16 | Medventure Technology Corp | Lipid pool aspiration arrangement for the treatment of vulnerable atherosclerosis plaque |
US6676698B2 (en) * | 2000-06-26 | 2004-01-13 | Rex Medicol, L.P. | Vascular device with valve for approximating vessel wall |
US6808533B1 (en) | 2000-07-28 | 2004-10-26 | Atrium Medical Corporation | Covered stent and method of covering a stent |
US6589273B1 (en) | 2000-10-02 | 2003-07-08 | Impra, Inc. | Apparatus and method for relining a blood vessel |
US6506178B1 (en) * | 2000-11-10 | 2003-01-14 | Vascular Architects, Inc. | Apparatus and method for crossing a position along a tubular body structure |
US6451037B1 (en) | 2000-11-22 | 2002-09-17 | Scimed Life Systems, Inc. | Expandable atherectomy burr with metal reinforcement |
US6682542B2 (en) * | 2000-12-12 | 2004-01-27 | William W. Harkrider | Endoluminal knife |
US6641607B1 (en) | 2000-12-29 | 2003-11-04 | Advanced Cardiovascular Systems, Inc. | Double tube stent |
US6800083B2 (en) | 2001-04-09 | 2004-10-05 | Scimed Life Systems, Inc. | Compressible atherectomy burr |
US6500186B2 (en) | 2001-04-17 | 2002-12-31 | Scimed Life Systems, Inc. | In-stent ablative tool |
US20080109030A1 (en) | 2001-04-24 | 2008-05-08 | Houser Russell A | Arteriotomy closure devices and techniques |
US8992567B1 (en) | 2001-04-24 | 2015-03-31 | Cardiovascular Technologies Inc. | Compressible, deformable, or deflectable tissue closure devices and method of manufacture |
US6695804B2 (en) | 2001-04-24 | 2004-02-24 | Charles Dennis Rugenstein | Device for removal of fatty debris from blood |
US8961541B2 (en) | 2007-12-03 | 2015-02-24 | Cardio Vascular Technologies Inc. | Vascular closure devices, systems, and methods of use |
US20020173838A1 (en) * | 2001-05-18 | 2002-11-21 | Frazier O. Howard | Method and apparatus for surgically restoring coronary blood vessels |
US7144381B2 (en) * | 2001-06-20 | 2006-12-05 | The Regents Of The University Of California | Hemodialysis system and method |
US6632231B2 (en) * | 2001-08-23 | 2003-10-14 | Scimed Life Systems, Inc. | Segmented balloon catheter blade |
US20030055486A1 (en) * | 2001-09-19 | 2003-03-20 | Adams John M. | Vascular reinforcement device and method |
US20030077310A1 (en) | 2001-10-22 | 2003-04-24 | Chandrashekhar Pathak | Stent coatings containing HMG-CoA reductase inhibitors |
US6979319B2 (en) * | 2001-12-31 | 2005-12-27 | Cardiac Pacemakers, Inc. | Telescoping guide catheter with peel-away outer sheath |
US6669624B2 (en) | 2002-03-26 | 2003-12-30 | O. Howard Frazier | Temporary heart-assist system |
US20030225439A1 (en) * | 2002-05-31 | 2003-12-04 | Cook Alonzo D. | Implantable product with improved aqueous interface characteristics and method for making and using same |
US20030236565A1 (en) * | 2002-06-21 | 2003-12-25 | Dimatteo Kristian | Implantable prosthesis |
US20040015224A1 (en) * | 2002-07-22 | 2004-01-22 | Armstrong Joseph R. | Endoluminal expansion system |
US7037319B2 (en) * | 2002-10-15 | 2006-05-02 | Scimed Life Systems, Inc. | Nanotube paper-based medical device |
US20040220604A1 (en) * | 2003-04-30 | 2004-11-04 | Fogarty Thomas J. | Tissue separation apparatus and method |
US9861346B2 (en) | 2003-07-14 | 2018-01-09 | W. L. Gore & Associates, Inc. | Patent foramen ovale (PFO) closure device with linearly elongating petals |
US7799043B2 (en) * | 2003-12-01 | 2010-09-21 | Boston Scientific Scimed, Inc. | Cutting balloon having sheathed incising elements |
US7413558B2 (en) * | 2003-12-19 | 2008-08-19 | Boston Scientific Scimed, Inc. | Elastically distensible folding member |
US7338463B2 (en) * | 2003-12-19 | 2008-03-04 | Boston Scientific Scimed, Inc. | Balloon blade sheath |
US20050182387A1 (en) * | 2004-02-13 | 2005-08-18 | Cardiac Pacemakers, Inc. | Peel-away catheter shaft |
US20050267520A1 (en) | 2004-05-12 | 2005-12-01 | Modesitt D B | Access and closure device and method |
US7976557B2 (en) * | 2004-06-23 | 2011-07-12 | Boston Scientific Scimed, Inc. | Cutting balloon and process |
US7678133B2 (en) | 2004-07-10 | 2010-03-16 | Arstasis, Inc. | Biological tissue closure device and method |
US8048144B2 (en) * | 2004-11-30 | 2011-11-01 | Scimed Life Systems, Inc. | Prosthesis fixation device and method |
EP1885260A4 (en) | 2005-05-12 | 2015-01-21 | Arstasis Inc | Access and closure device and method |
US8709069B2 (en) | 2005-07-01 | 2014-04-29 | C. R. Bard, Inc. | Flanged graft with trim lines |
WO2007022050A1 (en) * | 2005-08-12 | 2007-02-22 | Vance Products Incorporated, D/B/A/ Cook Urological Incorporated | Drainage catheter with extended inflation lumen |
EP1924315B1 (en) | 2005-09-12 | 2019-12-04 | Bridgepoint Medical, Inc. | Endovascular devices |
US11020141B2 (en) | 2005-09-12 | 2021-06-01 | Bridgepoint Medical, Inc. | Endovascular devices and methods |
US7918870B2 (en) | 2005-09-12 | 2011-04-05 | Bridgepoint Medical, Inc. | Endovascular devices and methods |
US8083727B2 (en) | 2005-09-12 | 2011-12-27 | Bridgepoint Medical, Inc. | Endovascular devices and methods for exploiting intramural space |
US8025655B2 (en) | 2005-09-12 | 2011-09-27 | Bridgepoint Medical, Inc. | Endovascular devices and methods |
US9314263B2 (en) * | 2006-06-30 | 2016-04-19 | Atheromed, Inc. | Atherectomy devices, systems, and methods |
US20110112563A1 (en) * | 2006-06-30 | 2011-05-12 | Atheromed, Inc. | Atherectomy devices and methods |
US20090018566A1 (en) * | 2006-06-30 | 2009-01-15 | Artheromed, Inc. | Atherectomy devices, systems, and methods |
US8361094B2 (en) * | 2006-06-30 | 2013-01-29 | Atheromed, Inc. | Atherectomy devices and methods |
US8007506B2 (en) | 2006-06-30 | 2011-08-30 | Atheromed, Inc. | Atherectomy devices and methods |
US8628549B2 (en) * | 2006-06-30 | 2014-01-14 | Atheromed, Inc. | Atherectomy devices, systems, and methods |
US20080045986A1 (en) | 2006-06-30 | 2008-02-21 | Atheromed, Inc. | Atherectomy devices and methods |
US8920448B2 (en) * | 2006-06-30 | 2014-12-30 | Atheromed, Inc. | Atherectomy devices and methods |
KR20090037906A (en) | 2006-06-30 | 2009-04-16 | 아테로메드, 아이엔씨. | Atherectomy devices and methods |
US9492192B2 (en) * | 2006-06-30 | 2016-11-15 | Atheromed, Inc. | Atherectomy devices, systems, and methods |
US20080269774A1 (en) | 2006-10-26 | 2008-10-30 | Chestnut Medical Technologies, Inc. | Intracorporeal Grasping Device |
US10888354B2 (en) | 2006-11-21 | 2021-01-12 | Bridgepoint Medical, Inc. | Endovascular devices and methods for exploiting intramural space |
US9060802B2 (en) | 2006-11-21 | 2015-06-23 | Bridgepoint Medical, Inc. | Endovascular devices and methods for exploiting intramural space |
US11298511B2 (en) | 2006-11-21 | 2022-04-12 | Bridgepoint Medical, Inc. | Endovascular devices and methods for exploiting intramural space |
WO2008124603A1 (en) | 2007-04-05 | 2008-10-16 | Nmt Medical, Inc. | Septal closure device with centering mechanism |
US8852223B2 (en) * | 2007-04-06 | 2014-10-07 | Cordis Corporation | Fixed wire dilatation catheter with an elongateable distal end |
US8070762B2 (en) | 2007-10-22 | 2011-12-06 | Atheromed Inc. | Atherectomy devices and methods |
EP3659664A1 (en) | 2007-10-22 | 2020-06-03 | Bridgepoint Medical, Inc. | Devices for crossing chronic total occlusions |
US10166127B2 (en) | 2007-12-12 | 2019-01-01 | Intact Vascular, Inc. | Endoluminal device and method |
US9603730B2 (en) | 2007-12-12 | 2017-03-28 | Intact Vascular, Inc. | Endoluminal device and method |
US9375327B2 (en) | 2007-12-12 | 2016-06-28 | Intact Vascular, Inc. | Endovascular implant |
US7896911B2 (en) | 2007-12-12 | 2011-03-01 | Innovasc Llc | Device and method for tacking plaque to blood vessel wall |
US10022250B2 (en) | 2007-12-12 | 2018-07-17 | Intact Vascular, Inc. | Deployment device for placement of multiple intraluminal surgical staples |
US8128677B2 (en) * | 2007-12-12 | 2012-03-06 | Intact Vascular LLC | Device and method for tacking plaque to a blood vessel wall |
US8337425B2 (en) | 2008-02-05 | 2012-12-25 | Bridgepoint Medical, Inc. | Endovascular device with a tissue piercing distal probe and associated methods |
JP5631744B2 (en) | 2008-02-05 | 2014-11-26 | ブリッジポイント、メディカル、インコーポレイテッドBridgepoint Medical, Inc. | Crossing occluded parts in blood vessels |
WO2009105699A1 (en) | 2008-02-22 | 2009-08-27 | Endologix, Inc. | Design and method of placement of a graft or graft system |
US20130165967A1 (en) | 2008-03-07 | 2013-06-27 | W.L. Gore & Associates, Inc. | Heart occlusion devices |
US8236040B2 (en) | 2008-04-11 | 2012-08-07 | Endologix, Inc. | Bifurcated graft deployment systems and methods |
WO2009134346A2 (en) | 2008-04-28 | 2009-11-05 | David Bryan Robinson | Methods and apparatus for crossing occlusions in blood vessels |
EP2520320B1 (en) | 2008-07-01 | 2016-11-02 | Endologix, Inc. | Catheter system |
AU2009274127A1 (en) | 2008-07-21 | 2010-01-28 | Arstasis, Inc. | Devices, methods, and kits for forming tracts in tissue |
US8690900B2 (en) * | 2008-07-21 | 2014-04-08 | The Cleveland Clinic Foundation | Apparatus and method for connecting two elongate body tissues |
WO2010048177A2 (en) * | 2008-10-20 | 2010-04-29 | IMDS, Inc. | Systems and methods for aneurysm treatment and vessel occlusion |
KR101773205B1 (en) | 2009-04-09 | 2017-09-12 | 카디오배스큘러 테크놀러지스 인코포레이티드 | Tissue closure devices, device and systems for delivery, kits and methods therefor |
EP2429452B1 (en) | 2009-04-28 | 2020-01-15 | Endologix, Inc. | Endoluminal prosthesis system |
US8956389B2 (en) | 2009-06-22 | 2015-02-17 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
US20120029556A1 (en) | 2009-06-22 | 2012-02-02 | Masters Steven J | Sealing device and delivery system |
US20120109279A1 (en) | 2010-11-02 | 2012-05-03 | Endologix, Inc. | Apparatus and method of placement of a graft or graft system |
EP2680915B1 (en) | 2011-03-01 | 2021-12-22 | Endologix LLC | Catheter system |
US10285831B2 (en) | 2011-06-03 | 2019-05-14 | Intact Vascular, Inc. | Endovascular implant |
US9770232B2 (en) | 2011-08-12 | 2017-09-26 | W. L. Gore & Associates, Inc. | Heart occlusion devices |
US9345511B2 (en) | 2011-10-13 | 2016-05-24 | Atheromed, Inc. | Atherectomy apparatus, systems and methods |
US9504552B2 (en) | 2011-11-30 | 2016-11-29 | Cook Medical Technologies Llc | Hemodialysis graft |
EP3733134A1 (en) | 2012-01-25 | 2020-11-04 | Intact Vascular, Inc. | Endoluminal device |
US20130317481A1 (en) | 2012-05-25 | 2013-11-28 | Arstasis, Inc. | Vascular access configuration |
US20130317438A1 (en) | 2012-05-25 | 2013-11-28 | Arstasis, Inc. | Vascular access configuration |
US10828019B2 (en) | 2013-01-18 | 2020-11-10 | W.L. Gore & Associates, Inc. | Sealing device and delivery system |
JP2016533861A (en) | 2013-09-18 | 2016-11-04 | エクサブルキャス・インコーポレイテッド | System and method for crossing and treating an obstruction |
US9808230B2 (en) | 2014-06-06 | 2017-11-07 | W. L. Gore & Associates, Inc. | Sealing device and delivery system |
KR102262657B1 (en) * | 2014-10-13 | 2021-06-08 | 삼성전자주식회사 | Plasma processing device |
US9375336B1 (en) | 2015-01-29 | 2016-06-28 | Intact Vascular, Inc. | Delivery device and method of delivery |
US9433520B2 (en) | 2015-01-29 | 2016-09-06 | Intact Vascular, Inc. | Delivery device and method of delivery |
CN107624056B (en) | 2015-06-30 | 2020-06-09 | 恩朵罗杰克斯股份有限公司 | Locking assembly and related system and method |
CN105105822B (en) * | 2015-07-24 | 2018-01-16 | 中国人民解放军第二军医大学 | A kind of Occlusive arterial Endarterectomy cutter device |
US10993824B2 (en) | 2016-01-01 | 2021-05-04 | Intact Vascular, Inc. | Delivery device and method of delivery |
US11839398B2 (en) | 2016-09-09 | 2023-12-12 | Endovascular Instruments, Inc. | Adjustable ring stripper for more efficiently and effectively removing plaque from arteries |
US10869689B2 (en) | 2017-05-03 | 2020-12-22 | Medtronic Vascular, Inc. | Tissue-removing catheter |
US11690645B2 (en) | 2017-05-03 | 2023-07-04 | Medtronic Vascular, Inc. | Tissue-removing catheter |
US11660218B2 (en) | 2017-07-26 | 2023-05-30 | Intact Vascular, Inc. | Delivery device and method of delivery |
US10702673B2 (en) * | 2018-01-19 | 2020-07-07 | Medtronic Vascular, Inc. | Expandable balloon sheaths |
US11819236B2 (en) | 2019-05-17 | 2023-11-21 | Medtronic Vascular, Inc. | Tissue-removing catheter |
US11376034B2 (en) | 2019-09-19 | 2022-07-05 | Stryker Corporation | Devices for removing obstructing materials from blood vessels |
US11304723B1 (en) | 2020-12-17 | 2022-04-19 | Avantec Vascular Corporation | Atherectomy devices that are self-driving with controlled deflection |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4921484A (en) * | 1988-07-25 | 1990-05-01 | Cordis Corporation | Mesh balloon catheter device |
US5133732A (en) * | 1987-10-19 | 1992-07-28 | Medtronic, Inc. | Intravascular stent |
US5167614A (en) * | 1991-10-29 | 1992-12-01 | Medical Engineering Corporation | Prostatic stent |
Family Cites Families (148)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US207932A (en) * | 1878-09-10 | Improvement in surgical dilators | ||
US469961A (en) * | 1892-03-01 | Tms nmris | ||
US1693545A (en) * | 1927-03-23 | 1928-11-27 | Broersma Charles | Teat dilator |
US2085368A (en) * | 1935-09-27 | 1937-06-29 | Kendall Charles Marvin | Surgical appliance |
US2944552A (en) * | 1958-12-29 | 1960-07-12 | Richard B Wilk | Surgical instrument |
US3635223A (en) * | 1969-12-02 | 1972-01-18 | Us Catheter & Instr Corp | Embolectomy catheter |
US3730185A (en) * | 1971-10-29 | 1973-05-01 | Cook Inc | Endarterectomy apparatus |
US3868956A (en) * | 1972-06-05 | 1975-03-04 | Ralph J Alfidi | Vessel implantable appliance and method of implanting it |
US3788318A (en) * | 1972-06-12 | 1974-01-29 | S Kim | Expandable cannular, especially for medical purposes |
US4038985A (en) * | 1975-10-07 | 1977-08-02 | Medico Developments, Inc. | Device for repairing arteries |
US4030503A (en) * | 1975-11-05 | 1977-06-21 | Clark Iii William T | Embolectomy catheter |
US4140126A (en) * | 1977-02-18 | 1979-02-20 | Choudhury M Hasan | Method for performing aneurysm repair |
WO1980000007A1 (en) * | 1978-06-02 | 1980-01-10 | A Rockey | Medical sleeve |
US4281658A (en) * | 1979-07-09 | 1981-08-04 | Child Laboratories, Inc. | Dilator |
US4531512A (en) * | 1981-06-15 | 1985-07-30 | Datascope Corporation | Wrapping system for intra-aortic balloon utilizing a wrapping envelope |
CA1204643A (en) * | 1981-09-16 | 1986-05-20 | Hans I. Wallsten | Device for application in blood vessels or other difficulty accessible locations and its use |
JPS5899490A (en) * | 1981-10-19 | 1983-06-13 | Eisai Co Ltd | Phosphoric acid amide derivative, its preparation and pharmaceutical containing the same |
SE445884B (en) * | 1982-04-30 | 1986-07-28 | Medinvent Sa | DEVICE FOR IMPLANTATION OF A RODFORM PROTECTION |
US4512338A (en) * | 1983-01-25 | 1985-04-23 | Balko Alexander B | Process for restoring patency to body vessels |
US4503569A (en) * | 1983-03-03 | 1985-03-12 | Dotter Charles T | Transluminally placed expandable graft prosthesis |
US4787899A (en) * | 1983-12-09 | 1988-11-29 | Lazarus Harrison M | Intraluminal graft device, system and method |
US5104399A (en) | 1986-12-10 | 1992-04-14 | Endovascular Technologies, Inc. | Artificial graft and implantation method |
US5197977A (en) | 1984-01-30 | 1993-03-30 | Meadox Medicals, Inc. | Drug delivery collagen-impregnated synthetic vascular graft |
US4842579B1 (en) * | 1984-05-14 | 1995-10-31 | Surgical Systems & Instr Inc | Atherectomy device |
US4580568A (en) * | 1984-10-01 | 1986-04-08 | Cook, Incorporated | Percutaneous endovascular stent and method for insertion thereof |
US4799479A (en) * | 1984-10-24 | 1989-01-24 | The Beth Israel Hospital Association | Method and apparatus for angioplasty |
US5019075A (en) * | 1984-10-24 | 1991-05-28 | The Beth Israel Hospital | Method and apparatus for angioplasty |
US4577631A (en) * | 1984-11-16 | 1986-03-25 | Kreamer Jeffry W | Aneurysm repair apparatus and method |
US4674506A (en) * | 1984-11-29 | 1987-06-23 | Kirk Alcond | Surgical anastomosis stent |
ES8705239A1 (en) * | 1984-12-05 | 1987-05-01 | Medinvent Sa | A device for implantation and a method of implantation in a vessel using such device. |
US4745919A (en) * | 1985-02-01 | 1988-05-24 | Bundy Mark A | Transluminal lysing system |
US4763653A (en) * | 1985-02-19 | 1988-08-16 | Rockey Arthur G | Medical sleeve |
SE450809B (en) * | 1985-04-10 | 1987-08-03 | Medinvent Sa | PLANT TOPIC PROVIDED FOR MANUFACTURING A SPIRAL SPRING SUITABLE FOR TRANSLUMINAL IMPLANTATION AND MANUFACTURED SPIRAL SPRINGS |
US4699611A (en) * | 1985-04-19 | 1987-10-13 | C. R. Bard, Inc. | Biliary stent introducer |
GB8513702D0 (en) * | 1985-05-30 | 1985-07-03 | Gill S S | Expansible trocar |
US4923464A (en) * | 1985-09-03 | 1990-05-08 | Becton, Dickinson And Company | Percutaneously deliverable intravascular reconstruction prosthesis |
US4705517A (en) * | 1985-09-03 | 1987-11-10 | Becton, Dickinson And Company | Percutaneously deliverable intravascular occlusion prosthesis |
US4650466A (en) * | 1985-11-01 | 1987-03-17 | Angiobrade Partners | Angioplasty device |
US5102417A (en) * | 1985-11-07 | 1992-04-07 | Expandable Grafts Partnership | Expandable intraluminal graft, and method and apparatus for implanting an expandable intraluminal graft |
US4733665C2 (en) * | 1985-11-07 | 2002-01-29 | Expandable Grafts Partnership | Expandable intraluminal graft and method and apparatus for implanting an expandable intraluminal graft |
DE3640745A1 (en) * | 1985-11-30 | 1987-06-04 | Ernst Peter Prof Dr M Strecker | Catheter for producing or extending connections to or between body cavities |
US4681110A (en) * | 1985-12-02 | 1987-07-21 | Wiktor Dominik M | Catheter arrangement having a blood vessel liner, and method of using it |
US4772264A (en) * | 1986-06-23 | 1988-09-20 | Regents Of The University Of Minnesota | Catheter introduction set |
SU1482714A2 (en) | 1986-10-15 | 1989-05-30 | Харьковский научно-исследовательский институт общей и неотложной хирургии | Device for setting prosthesis into blood vessel |
SE455834B (en) * | 1986-10-31 | 1988-08-15 | Medinvent Sa | DEVICE FOR TRANSLUMINAL IMPLANTATION OF A PRINCIPLE RODFORMALLY RADIALLY EXPANDABLE PROSTHESIS |
US4793348A (en) * | 1986-11-15 | 1988-12-27 | Palmaz Julio C | Balloon expandable vena cava filter to prevent migration of lower extremity venous clots into the pulmonary circulation |
US4790310A (en) * | 1987-02-04 | 1988-12-13 | Robert Ginsburg | Laser catheter having wide angle sweep |
US4800882A (en) * | 1987-03-13 | 1989-01-31 | Cook Incorporated | Endovascular stent and delivery system |
US5041126A (en) * | 1987-03-13 | 1991-08-20 | Cook Incorporated | Endovascular stent and delivery system |
US4776533A (en) * | 1987-03-20 | 1988-10-11 | The Jepson Burns Corporation | Aircraft seat track fitting assembly |
JPS63238872A (en) * | 1987-03-25 | 1988-10-04 | テルモ株式会社 | Instrument for securing inner diameter of cavity of tubular organ and catheter equipped therewith |
US4794928A (en) * | 1987-06-10 | 1989-01-03 | Kletschka Harold D | Angioplasty device and method of using the same |
US5059211A (en) * | 1987-06-25 | 1991-10-22 | Duke University | Absorbable vascular stent |
US4795458A (en) * | 1987-07-02 | 1989-01-03 | Regan Barrie F | Stent for use following balloon angioplasty |
US4969458A (en) * | 1987-07-06 | 1990-11-13 | Medtronic, Inc. | Intracoronary stent and method of simultaneous angioplasty and stent implant |
US4792330A (en) * | 1987-07-13 | 1988-12-20 | Lazarus Medical Innovations, Inc. | Combination catheter and duct clamp apparatus and method |
JPS6446477A (en) * | 1987-08-13 | 1989-02-20 | Terumo Corp | Catheter |
US4773665A (en) | 1987-09-14 | 1988-09-27 | Hindle Langley F | Motorcycle stand |
AU623100B2 (en) | 1987-10-08 | 1992-05-07 | Terumo Kabushiki Kaisha | Instrument and apparatus for securing inner diameter of lumen of tubular organ |
US5782903A (en) | 1987-10-19 | 1998-07-21 | Medtronic, Inc. | Intravascular stent and method |
US4886062A (en) * | 1987-10-19 | 1989-12-12 | Medtronic, Inc. | Intravascular radially expandable stent and method of implant |
US4820298A (en) * | 1987-11-20 | 1989-04-11 | Leveen Eric G | Internal vascular prosthesis |
US4877030A (en) * | 1988-02-02 | 1989-10-31 | Andreas Beck | Device for the widening of blood vessels |
US4886061A (en) * | 1988-02-09 | 1989-12-12 | Medinnovations, Inc. | Expandable pullback atherectomy catheter system |
EP0431160B1 (en) | 1988-03-16 | 1995-05-17 | Kabushiki Kaisha Toshiba | Process for producing thin-film oxide superconductor |
US4889137A (en) * | 1988-05-05 | 1989-12-26 | The United States Of America As Reprsented By The Department Of Health And Human Services | Method for improved use of heart/lung machine |
US4830003A (en) * | 1988-06-17 | 1989-05-16 | Wolff Rodney G | Compressive stent and delivery system |
US5213580A (en) | 1988-08-24 | 1993-05-25 | Endoluminal Therapeutics, Inc. | Biodegradable polymeric endoluminal sealing process |
US5019090A (en) * | 1988-09-01 | 1991-05-28 | Corvita Corporation | Radially expandable endoprosthesis and the like |
SE8803444D0 (en) * | 1988-09-28 | 1988-09-28 | Medinvent Sa | A DEVICE FOR TRANSLUMINAL IMPLANTATION OR EXTRACTION |
CA1322628C (en) * | 1988-10-04 | 1993-10-05 | Richard A. Schatz | Expandable intraluminal graft |
US4994066A (en) * | 1988-10-07 | 1991-02-19 | Voss Gene A | Prostatic stent |
US4913141A (en) * | 1988-10-25 | 1990-04-03 | Cordis Corporation | Apparatus and method for placement of a stent within a subject vessel |
US4994069A (en) * | 1988-11-02 | 1991-02-19 | Target Therapeutics | Vaso-occlusion coil and method |
US4886500A (en) * | 1988-11-07 | 1989-12-12 | Lazarus Harrison M | External guide wire |
US4856516A (en) * | 1989-01-09 | 1989-08-15 | Cordis Corporation | Endovascular stent apparatus and method |
US4966604A (en) * | 1989-01-23 | 1990-10-30 | Interventional Technologies Inc. | Expandable atherectomy cutter with flexibly bowed blades |
US5078726A (en) * | 1989-02-01 | 1992-01-07 | Kreamer Jeffry W | Graft stent and method of repairing blood vessels |
US5163958A (en) * | 1989-02-02 | 1992-11-17 | Cordis Corporation | Carbon coated tubular endoprosthesis |
US5007926A (en) * | 1989-02-24 | 1991-04-16 | The Trustees Of The University Of Pennsylvania | Expandable transluminally implantable tubular prosthesis |
US5100429A (en) * | 1989-04-28 | 1992-03-31 | C. R. Bard, Inc. | Endovascular stent and delivery system |
US4990155A (en) * | 1989-05-19 | 1991-02-05 | Wilkoff Howard M | Surgical stent method and apparatus |
US4994071A (en) * | 1989-05-22 | 1991-02-19 | Cordis Corporation | Bifurcating stent apparatus and method |
US5037392A (en) * | 1989-06-06 | 1991-08-06 | Cordis Corporation | Stent-implanting balloon assembly |
US5116318A (en) * | 1989-06-06 | 1992-05-26 | Cordis Corporation | Dilatation balloon within an elastic sleeve |
US5207695A (en) | 1989-06-19 | 1993-05-04 | Trout Iii Hugh H | Aortic graft, implantation device, and method for repairing aortic aneurysm |
US5571169A (en) | 1993-06-07 | 1996-11-05 | Endovascular Instruments, Inc. | Anti-stenotic method and product for occluded and partially occluded arteries |
US5071424A (en) * | 1989-08-18 | 1991-12-10 | Evi Corporation | Catheter atherotome |
US5282484A (en) | 1989-08-18 | 1994-02-01 | Endovascular Instruments, Inc. | Method for performing a partial atherectomy |
US5662701A (en) | 1989-08-18 | 1997-09-02 | Endovascular Instruments, Inc. | Anti-stenotic method and product for occluded and partially occluded arteries |
US5180368A (en) * | 1989-09-08 | 1993-01-19 | Advanced Cardiovascular Systems, Inc. | Rapidly exchangeable and expandable cage catheter for repairing damaged blood vessels |
US5034001A (en) * | 1989-09-08 | 1991-07-23 | Advanced Cardiovascular Systems, Inc. | Method of repairing a damaged blood vessel with an expandable cage catheter |
US5002560A (en) * | 1989-09-08 | 1991-03-26 | Advanced Cardiovascular Systems, Inc. | Expandable cage catheter with a rotatable guide |
US5226909A (en) | 1989-09-12 | 1993-07-13 | Devices For Vascular Intervention, Inc. | Atherectomy device having helical blade and blade guide |
US5035706A (en) * | 1989-10-17 | 1991-07-30 | Cook Incorporated | Percutaneous stent and method for retrieval thereof |
US5147385A (en) * | 1989-11-01 | 1992-09-15 | Schneider (Europe) A.G. | Stent and catheter for the introduction of the stent |
US5089006A (en) * | 1989-11-29 | 1992-02-18 | Stiles Frank B | Biological duct liner and installation catheter |
US5074841A (en) * | 1990-01-30 | 1991-12-24 | Microcision, Inc. | Atherectomy device with helical cutter |
US5084010A (en) * | 1990-02-20 | 1992-01-28 | Devices For Vascular Intervention, Inc. | System and method for catheter construction |
US5071407A (en) * | 1990-04-12 | 1991-12-10 | Schneider (U.S.A.) Inc. | Radially expandable fixation member |
US5123917A (en) * | 1990-04-27 | 1992-06-23 | Lee Peter Y | Expandable intraluminal vascular graft |
US5078720A (en) * | 1990-05-02 | 1992-01-07 | American Medical Systems, Inc. | Stent placement instrument and method |
GB2245495A (en) | 1990-05-11 | 1992-01-08 | John Stanley Webber | Artery support insertion instrument |
US5395311A (en) * | 1990-05-14 | 1995-03-07 | Andrews; Winston A. | Atherectomy catheter |
US5147185A (en) * | 1990-05-14 | 1992-09-15 | Qed Environmental Systems, Inc. | Pump apparatus for fluid sampling and collection, and the like |
US5199951A (en) | 1990-05-17 | 1993-04-06 | Wayne State University | Method of drug application in a transporting medium to an arterial wall injured during angioplasty |
US5092841A (en) * | 1990-05-17 | 1992-03-03 | Wayne State University | Method for treating an arterial wall injured during angioplasty |
US5085635A (en) * | 1990-05-18 | 1992-02-04 | Cragg Andrew H | Valved-tip angiographic catheter |
DE4018525C2 (en) | 1990-06-09 | 1994-05-05 | Kaltenbach Martin | Expandable area catheter |
US5360443A (en) | 1990-06-11 | 1994-11-01 | Barone Hector D | Aortic graft for repairing an abdominal aortic aneurysm |
US5156619A (en) * | 1990-06-15 | 1992-10-20 | Ehrenfeld William K | Flanged end-to-side vascular graft |
US5201756A (en) | 1990-06-20 | 1993-04-13 | Danforth Biomedical, Inc. | Radially-expandable tubular elements for use in the construction of medical devices |
US5192295A (en) * | 1990-06-20 | 1993-03-09 | Danforth Biomedical, Inc. | Angioplasty dilatation balloon catheter/guidewire system |
US5064435A (en) * | 1990-06-28 | 1991-11-12 | Schneider (Usa) Inc. | Self-expanding prosthesis having stable axial length |
US5196024A (en) | 1990-07-03 | 1993-03-23 | Cedars-Sinai Medical Center | Balloon catheter with cutting edge |
US5122154A (en) * | 1990-08-15 | 1992-06-16 | Rhodes Valentine J | Endovascular bypass graft |
US5139480A (en) * | 1990-08-22 | 1992-08-18 | Biotech Laboratories, Inc. | Necking stents |
US5108417A (en) * | 1990-09-14 | 1992-04-28 | Interface Biomedical Laboratories Corp. | Anti-turbulent, anti-thrombogenic intravascular stent |
US5108366A (en) * | 1990-09-28 | 1992-04-28 | Ovamed Corporation | Delivery catheter |
DE9117152U1 (en) | 1990-10-09 | 1996-07-11 | Cook Inc | Stent |
US5158543A (en) * | 1990-10-30 | 1992-10-27 | Lazarus Harrison M | Laparoscopic surgical system and method |
US5160341A (en) * | 1990-11-08 | 1992-11-03 | Advanced Surgical Intervention, Inc. | Resorbable urethral stent and apparatus for its insertion |
DE4036570A1 (en) | 1990-11-16 | 1992-05-21 | Osypka Peter | CATHETER FOR REDUCING OR REMOVING CONSTRUCTIONS IN VESSELS |
US5161547A (en) * | 1990-11-28 | 1992-11-10 | Numed, Inc. | Method of forming an intravascular radially expandable stent |
US5267954A (en) | 1991-01-11 | 1993-12-07 | Baxter International Inc. | Ultra-sound catheter for removing obstructions from tubular anatomical structures such as blood vessels |
US5178618A (en) * | 1991-01-16 | 1993-01-12 | Brigham And Womens Hospital | Method and device for recanalization of a body passageway |
US5156620A (en) * | 1991-02-04 | 1992-10-20 | Pigott John P | Intraluminal graft/stent and balloon catheter for insertion thereof |
US5135536A (en) * | 1991-02-05 | 1992-08-04 | Cordis Corporation | Endovascular stent and method |
US5181911A (en) * | 1991-04-22 | 1993-01-26 | Shturman Technologies, Inc. | Helical balloon perfusion angioplasty catheter |
US5197978B1 (en) | 1991-04-26 | 1996-05-28 | Advanced Coronary Tech | Removable heat-recoverable tissue supporting device |
US5158545A (en) * | 1991-05-02 | 1992-10-27 | Brigham And Women's Hospital | Diameter expansion cannula |
US5190058A (en) * | 1991-05-22 | 1993-03-02 | Medtronic, Inc. | Method of using a temporary stent catheter |
US5147370A (en) * | 1991-06-12 | 1992-09-15 | Mcnamara Thomas O | Nitinol stent for hollow body conduits |
US5584803A (en) | 1991-07-16 | 1996-12-17 | Heartport, Inc. | System for cardiac procedures |
US5358507A (en) | 1991-07-26 | 1994-10-25 | Pat O. Daily | Thromboendarterectomy suction dissector |
US5302168A (en) * | 1991-09-05 | 1994-04-12 | Hess Robert L | Method and apparatus for restenosis treatment |
US5151105A (en) * | 1991-10-07 | 1992-09-29 | Kwan Gett Clifford | Collapsible vessel sleeve implant |
US5693084A (en) | 1991-10-25 | 1997-12-02 | Cook Incorporated | Expandable transluminal graft prosthesis for repair of aneurysm |
US5387235A (en) | 1991-10-25 | 1995-02-07 | Cook Incorporated | Expandable transluminal graft prosthesis for repair of aneurysm |
US5211658A (en) | 1991-11-05 | 1993-05-18 | New England Deaconess Hospital Corporation | Method and device for performing endovascular repair of aneurysms |
US5192297A (en) * | 1991-12-31 | 1993-03-09 | Medtronic, Inc. | Apparatus and method for placement and implantation of a stent |
US5224945A (en) | 1992-01-13 | 1993-07-06 | Interventional Technologies, Inc. | Compressible/expandable atherectomy cutter |
US5222969A (en) * | 1992-03-16 | 1993-06-29 | Rolando Gillis | Intravascular stent for cardiovascular intervention |
US5201757A (en) | 1992-04-03 | 1993-04-13 | Schneider (Usa) Inc. | Medial region deployment of radially self-expanding stents |
WO1994003230A1 (en) | 1992-08-07 | 1994-02-17 | Boston Scientific Corporation | Support catheter assembly |
US5342348A (en) | 1992-12-04 | 1994-08-30 | Kaplan Aaron V | Method and device for treating and enlarging body lumens |
US5419760A (en) | 1993-01-08 | 1995-05-30 | Pdt Systems, Inc. | Medicament dispensing stent for prevention of restenosis of a blood vessel |
US5824055A (en) | 1997-03-25 | 1998-10-20 | Endotex Interventional Systems, Inc. | Stent graft delivery system and methods of use |
-
1993
- 1993-06-07 US US08/073,002 patent/US5571169A/en not_active Expired - Lifetime
-
1996
- 1996-08-16 US US08/698,981 patent/US5782847A/en not_active Expired - Fee Related
- 1996-10-15 US US08/730,421 patent/US5842479A/en not_active Expired - Fee Related
- 1996-10-15 US US08/730,420 patent/US5836316A/en not_active Expired - Fee Related
- 1996-10-18 US US08/731,786 patent/US5843165A/en not_active Expired - Fee Related
-
1997
- 1997-05-16 US US08/857,224 patent/US5824057A/en not_active Expired - Fee Related
- 1997-05-16 US US08/857,223 patent/US5873905A/en not_active Expired - Fee Related
-
1998
- 1998-03-05 US US09/098,912 patent/US5904146A/en not_active Expired - Fee Related
- 1998-10-30 US US09/183,896 patent/US6090135A/en not_active Expired - Fee Related
-
2001
- 2001-08-24 US US09/938,882 patent/US20020004680A1/en not_active Abandoned
-
2005
- 2005-10-11 US US11/247,571 patent/US20060089706A1/en not_active Abandoned
-
2007
- 2007-06-14 US US11/818,715 patent/US20070260215A1/en not_active Abandoned
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5133732A (en) * | 1987-10-19 | 1992-07-28 | Medtronic, Inc. | Intravascular stent |
US4921484A (en) * | 1988-07-25 | 1990-05-01 | Cordis Corporation | Mesh balloon catheter device |
US5167614A (en) * | 1991-10-29 | 1992-12-01 | Medical Engineering Corporation | Prostatic stent |
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090182224A1 (en) * | 1999-05-18 | 2009-07-16 | Mediguide Ltd. | Method and apparatus for invasive device tracking using organ timing signal generated from MPS sensors |
US20110054308A1 (en) * | 1999-05-18 | 2011-03-03 | Amit Cohen | Method and system for superimposing virtual anatomical landmarks on an image |
US9572519B2 (en) | 1999-05-18 | 2017-02-21 | Mediguide Ltd. | Method and apparatus for invasive device tracking using organ timing signal generated from MPS sensors |
US9833167B2 (en) | 1999-05-18 | 2017-12-05 | Mediguide Ltd. | Method and system for superimposing virtual anatomical landmarks on an image |
US9956049B2 (en) | 1999-05-18 | 2018-05-01 | Mediguide Ltd. | Method and apparatus for invasive device tracking using organ timing signal generated from MPS sensors |
US10251712B2 (en) | 1999-05-18 | 2019-04-09 | Mediguide Ltd. | Method and apparatus for invasive device tracking using organ timing signal generated from MPS sensors |
US10856769B2 (en) | 1999-05-18 | 2020-12-08 | St. Jude Medical International Holding S.àr.l. | Method and system for superimposing virtual anatomical landmarks on an image |
US20130166011A1 (en) * | 2001-09-07 | 2013-06-27 | Gera Strommer | System and method for delivering a stent to a selected position within a lumen |
US10363017B2 (en) * | 2001-09-07 | 2019-07-30 | St. Jude Medical International Holding S.À R.L. | System and method for delivering a stent to a selected position within a lumen |
Also Published As
Publication number | Publication date |
---|---|
US5571169A (en) | 1996-11-05 |
US20020004680A1 (en) | 2002-01-10 |
US5836316A (en) | 1998-11-17 |
US6090135A (en) | 2000-07-18 |
US5873905A (en) | 1999-02-23 |
US5842479A (en) | 1998-12-01 |
US5843165A (en) | 1998-12-01 |
US5904146A (en) | 1999-05-18 |
US20070260215A1 (en) | 2007-11-08 |
US5782847A (en) | 1998-07-21 |
US5824057A (en) | 1998-10-20 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US5824057A (en) | Anti-stenotic method and product for occluded and partially occluded arteries | |
US5622188A (en) | Method of restoring reduced or absent blood flow capacity in an artery | |
US6719769B2 (en) | Integrated anastomosis tool with graft vessel attachment device and cutting device | |
US7357807B2 (en) | Integrated anastomosis tool with graft vessel attachment device and cutting device | |
US6306151B1 (en) | Balloon with reciprocating stent incisor | |
US8109947B2 (en) | Medical grafting methods and apparatus | |
US20100049305A1 (en) | Convertible delivery systems for medical devices | |
US6887251B1 (en) | Method and apparatus for vessel harvesting | |
JPH10507382A (en) | Method and apparatus for forming an endoluminal bifurcated graft | |
US8142457B2 (en) | Percutaneous transluminal endarterectomy | |
US20230119672A1 (en) | Adjustable ring stripper for more efficiently and effectively removing plaque from arteries | |
JP2003507122A (en) | Implant connector, device for introducing the same, and method of manufacturing branch connection | |
US20180070970A1 (en) | Stent/Graft for more efficiently and effective treatment of plaque in arteries | |
CA2187009A1 (en) | Anti-stenotic method and product for occluded arteries | |
US20180070965A1 (en) | More Efficiently and Effectively Removing Stenotic And Restenotic Plaque From Arteries | |
US20180070977A1 (en) | Barbed plaque disunifier, excavator and remover and related methodology for more efficiently and effectively removing plaque from arteries | |
US20050137610A1 (en) | Facilitating catheter assembly | |
US20180070978A1 (en) | More efficiently and effectively removing plaque from arteries | |
WO2019168491A1 (en) | Improvements in treatment of stenosis and restenosis |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |