WO1997024081A1 - Method and apparatus for forming vascular prostheses - Google Patents

Method and apparatus for forming vascular prostheses Download PDF

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Publication number
WO1997024081A1
WO1997024081A1 PCT/US1996/020868 US9620868W WO9724081A1 WO 1997024081 A1 WO1997024081 A1 WO 1997024081A1 US 9620868 W US9620868 W US 9620868W WO 9724081 A1 WO9724081 A1 WO 9724081A1
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WO
WIPO (PCT)
Prior art keywords
tissue
frame
tubular
component
attaching
Prior art date
Application number
PCT/US1996/020868
Other languages
French (fr)
Other versions
WO1997024081A9 (en
Inventor
Charles S. Love
Original Assignee
Ramus Medical Technologies
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Ramus Medical Technologies filed Critical Ramus Medical Technologies
Priority to AU15692/97A priority Critical patent/AU720362B2/en
Priority to EP96945441A priority patent/EP0874603B1/en
Priority to JP9524612A priority patent/JP2000502586A/en
Priority to US09/091,942 priority patent/US6494904B1/en
Priority to DE69636438T priority patent/DE69636438D1/en
Publication of WO1997024081A1 publication Critical patent/WO1997024081A1/en
Publication of WO1997024081A9 publication Critical patent/WO1997024081A9/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • A61L27/3687Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
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    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
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    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3604Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
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    • A61F2/00Filters 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
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    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/848Devices 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
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    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/072Encapsulated stents, e.g. wire or whole stent embedded in lining
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    • A61FFILTERS 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
    • A61F2/00Filters 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
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006Properties of materials and coating materials
    • A61F2002/30062(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
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    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
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    • A61F2220/00Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2220/0016Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
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    • A61F2250/006Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063Nested prosthetic parts
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/901Method of manufacturing prosthetic device

Definitions

  • the present invention relates generally to medical methods and devices, and more particularly to a method and apparatus for forming vascular prostheses from host tissue sources .
  • Coronary and peripheral atherosclerosis are characterized by partial or total occlusion of the arteries resulting from the accumulation of lipids, smooth muscle cells, connective tissue, and glycosaminoglycans on the arterial wall .
  • Atherosclerosis of the coronary arteries is a particular problem and can cause angina and myocardial infarction (heart attack) .
  • CABG coronary artery bypass graft
  • CABG surgery relies on the surgical attachment of a vascular graft to bypass the arterial occlusion in order to restore blood flow to the coronary vasculature .
  • the nature of the vascular graft can have a significant impact on the ultimate success of the procedure.
  • a preferred vascular graft is formed from autologous internal mammary artery (IMA) , where the resulting grafts have a patency rate approaching 95% ten years following the procedure.
  • IMA grafts is limited by their length, and the need to harvest the artery from the patient can result in post-surgical complications.
  • the autologous saphenous vein is a second common source for vascular grafts. While generally available in the necessary lengths, the saphenous vein is not ideally suited for replacement as an arterial vessel, and patency rates at ten years are often below 50%. Moreover, removal of the saphenous vein from the leg can also cause post-surgical complications.
  • Non-autologous biological conduits which have been utilized as vascular prostheses include human umbilical vein grafts and bovine internal mammary arteries. Synthetic grafts have also been seeded with human and other mammalian cells or proteins, e.g., collagens, in an effort to improve their long- term patency rate. Presently, however, none of these approaches has demonstrated long-term patency, particularly in smaller diameter grafts.
  • vascular prostheses from autologous pericardium.
  • Pericardial tissue is harvested from the patient and formed into a tubular graft by suturing along a longitudinal line. While promising, the use of sutures can result in an irregular seam which, in turn, can cause turbulent blood flow and result in clot formation.
  • grafts are unsupported and subject to kinking and collapse.
  • the grafts further lack an inherently round geometry and are subject to dimensional changes, e.g., elongation and aneurysmal formation. Because of the dimensional uncertainty, it is difficult to match such grafts to the precise dimensional requirements of the particular application, e.g, caliber and length.
  • vascular prostheses from pericardium are labor intensive and time consuming, and the resulting structures are subject to rupture and other structural failure. Thus, the outcome of using sutured pericardial tissue grafts is uncertain at best. For these reasons, it would be desirable to provide improved vascular prostheses for use in CABG and other procedures.
  • Such prostheses should be biocompatible with the patient, resistant to kinking and collapse, and easy to implant.
  • the prostheses should be non-thrombogenic, resistant to infection, and easy to sterilize and store.
  • vascular prostheses from autologous tissue sources, where the prostheses can be prepared in a range of diameters and lengths, and can be readily assembled in the operating room after the tissue has been harvested.
  • the vascular prostheses should be readily assemblable, preferably without suturing, in a manner that allows precise and uniform dimensions and preferably be available in a kit form to facilitate assembly.
  • U.S. Patent No. 4,502,159 describes a vascular prosthesis made by suturing glutaraldehyde-treated pericardial tissue along a longitudinal seam.
  • SU 1217362 (Abstract) describes reinforcing arteries by securing pericardial tissue over the artery.
  • U.S. Patent No. 3,562,820 describes forming tissue-containing prostheses over removable mandrels. The use of glutaraldehyde and other agents for treating tissue and prosthetic devices to reduce antigenicity is described in U.S. Patent Nos. 3,988,782; 4,801,299; 5,215,541, and Brazilian applications 89/03621 and 90/03762.
  • 4,539,716 describes the fabrication of an artificial blood vessel from collagen and other natural materials.
  • U.S. Patent Nos. 3,894,530 and 3,974,526 describe the formation of vascular prostheses from the arteries or veins present in the umbilical cord.
  • U.S. Patent No. 5,372,821 describes the use of tissue for forming artificial ligament grafts for use in orthopedic procedures.
  • U.S. Patent No. 3,408,659 describes the preparation of vascular artificial prostheses from other body lumens.
  • French application FR 2,714,816, (Abstract) discloses a helically supported vascular prosthesis.
  • a number of medical literature publications describe the use of vascular prostheses formed form tissue. See, for example, Rendina et al. (1995) J.
  • Patents and published applications relating to kits for preparing replacement heart valves from pericardial and other autologous tissue sources are described in U.S. Patent Nos. 5,163,955; 5,297,564; 5,326,370; 5,326,371; 5,423,887; and 5,425,741.
  • the present invention provides improved vascular prostheses and methods for their preparation.
  • the vascular prostheses are formed in part from animal tissue, usually autologous tissue from the patient receiving the prostheses, which is supported on a separate support frame.
  • the tissue is pericardial, fascial, rectus sheath, venous tissue, or other tissue harvested from the patient immediately before the CABG or other implantation procedure.
  • the tissue is usually but not necessarily treated in a stabilizing medium, such as a cross-linking agent, and then attached to the frame in the operating room.
  • the frame precisely defines the length and dimensions of the vascular graft and inhibits kinking and collapse of the graft after implantation.
  • the tissue will be rolled or otherwise formed over the frame so that adjacent longitudinal edges are overlapped to seal the resulting lumen of the graft and prevent blood leakage. In this way, suturing of the graft can be avoided.
  • Such vascular prostheses have a number of advantages.
  • the grafts are biocompatible and non-immunogenic.
  • the grafts are durable, and use of the separate frame provides dimensional stability and inhibits unintended dilation, rupture, elongation, and kinking.
  • the vascular prosthesis may be prepared in a range of diameters and lengths, with the tissue sources providing a relatively unlimited source of prosthetic material .
  • the vascular prostheses are relatively easy to fabricate, with attachment of the tissue to the frame being readily performable in an operating room environment .
  • the frame components of the graft are easy to store and sterilize prior to use.
  • Other advantages include non-thrombogenicity and a compliance which approximates that of natural blood vessels .
  • a tubular vascular prosthesis is formed by providing a sheet of tissue and a tubular support frame.
  • the tissue is then attached to the tubular support frame to define a substantially unrestricted blood flow lumen therethrough.
  • the tissue sheet may be obtained from the host or from other human or animal (non-autologous) sources.
  • the tissue is trimmed into a shape to facilitate rolling onto the frame, usually a rectangular shape.
  • the tissue will usually be pericardium, fascia, rectus sheath, venous tissue, or the like, and will preferably but not necessarily be treated with a cross-linking agent or other stabilizing agent (preservative) prior to formation.
  • the tubular support frame may have a variety of configurations.
  • the tubular support frame includes at least an inner frame component and an outer frame component, where the attaching step comprises capturing the tissue sheet between the inner component and the outer frame component.
  • the inner and outer frame components may be in the form of helices, longitudinally spaced-apart rings, or other conventional intravascular stent structures and the like.
  • the inner and outer frame components comprise concentric mating structure which clamp the tissue therebetween without suturing. The frame thus supports the clamped tissue along the entire length of the graft to provide support and precise dimensional control.
  • the tubular support frame may include a single frame member having a plurality of fasteners disposed thereover.
  • the attaching step comprises attaching the tissue to the fasteners, for example by penetrating the fasteners through the tissue.
  • the tissue may be attached to a single frame using separate fasteners, such as staples which are penetrated through the tissue and into the frame.
  • the attaching step may comprise disposing a sleeve over the tissue which in turn is disposed over the tubular frame.
  • Systems for forming tubular prostheses comprise a cutter and a tubular frame.
  • the cutter is designed to trim the sheet of harvested tissue into a predetermined pattern, typically a rectangular pattern.
  • the tubular frame is capable of supporting the tissue trimmed by the cutter and a tubular geometry having a substantially unrestricted flow lumen therethrough.
  • a plurality of cutters and a plurality of tubular frames will be provided with matched pairs of cutters and frames used for forming tubular prostheses having different dimensions.
  • the system may further include a mandrel for holding the tissue as the tissue is attached to the frame, and may still further include a cross-linking agent or other stabilizing agent or preservative for treating the tissue prior to attachment to the frame.
  • the frame may comprise any of the structures described above.
  • a tubular frame for supporting tissue in a tubular geometry with a substantially unrestricted flow lumen therethrough comprises a first tubular frame component having tissue attachment means thereon.
  • the tubular frame typically has a diameter in the range from 1 mm to 30 mm, preferably from 3 mm to 25 mm, and a length in the range from 1 cm to 30 cm, preferably from 5 cm to 15 cm.
  • the length will be determined at least in part by the length and amount of tissue available from an individual patient. In some cases, frames even longer than 30 cm might find use, but the resulting longer grafts will rarely be needed.
  • the length of the tubular frame will be adjustable, for example by cutting a desired length of frame or frame components from a relatively long frame stock.
  • the frame will usually be composed of a resilient metal, and may comprise either a helical element or a plurality of longitudinally spaced-apart ring elements.
  • Attachment means may comprise any one of a second tubular frame component configured to mate with the first tubular frame component, e.g., a pair of nesting helical frame elements, a plurality of fasteners disposed over the first tubular frame component, a sleeve which is received over the exterior of the first tubular frame component, staples for attaching the tissue to the frame component, or the like.
  • two or more frames or frame segments may be linked together to create longer grafts, with the frames or frame segments being interlocked and/or overlapped to create a continuous lumen through the resulting assembly.
  • FIG. 1 is a perspective view of a vascular prostheses constructed in accordance with the principles of the present invention, shown with portions broken away.
  • Fig. 2 is a cross-sectional view taken along line 2- 2 of Fig. 1.
  • Fig. 3 is a partial, longitudinal cross-sectional view of the prostheses of Fig. 1.
  • Fig. 4 is a partial cross-sectional view of an alternative embodiment of the prosthesis of the present invention.
  • Figs. 5-8 illustrate a method for preparing the vascular prosthesis of Fig. 1.
  • Fig. 9 illustrates an alternative construction of a vascular prostheses constructed in accordance with the principles of the present invention, shown in an exploded view.
  • Fig. 10 illustrates yet another alternative environment of a vascular prosthesis constructed in accordance with the principles of the present invention.
  • Figs. 11 and 12 illustrate another method for attaching tissue to a tubular frame member according to the method of the present invention.
  • vascular prostheses also referred to as vascular grafts, intended for use in medical procedures requiring replacement or bypass of a patient's blood vessels.
  • vascular prostheses will be used in peripheral vascular bypass, coronary artery bypass (CABG) procedures, but they also may find use in aneurysm repair; vascular access shunts; vessel reconstruction, such as pulmonary outflow tract and aortic outflow tract; as a conduit for valvular repair; and the like.
  • CABG coronary artery bypass
  • the tissue employed in the vascular prosthesis will be obtained from a human or other animal source, usually but not necessarily being obtained from the patient or host into which the prosthesis is to be implanted.
  • the tissue may comprise any body tissue having sufficient strength and elasticity to act as the primary component of the prosthesis, usually being obtained from the pericardium or a fascial layer, such as the fascia lata.
  • Other tissue sources include rectus sheath and venous tissues.
  • the tissue will be harvested by conventional techniques, such as those described in Love, Autologous Tissue Heart Valves, R.G. Landes Co., Austin, Texas, 1993, Chapter 8.
  • the present invention can be employed to strengthen conventionally harvested and prepared saphenous veins using any of the inner stent/outer stent combinations described below.
  • the primary difference when using a saphenous vein tissue material source is that the tissue will not be rolled or layered over itself as will be the case with sheet-like tissue sources.
  • the amount of tissue harvested will depend on the size of the vascular prosthesis to be prepared.
  • the sheet of tissue initially obtained will be generally rectangular, having a length in the range from about 5 cm to 35 cm, usually 5 cm to 15 cm for pericardium, and a width in the range from about 2 cm to 20 cm, usually about 2 cm to 5 cm for pericardium.
  • the tissue After harvesting, the tissue will be trimmed to size, usually using a cutting die, stencil, or other pattern-forming device capable of trimming the tissue to the precise dimensions required.
  • a presently preferred technique uses parallel, spaced-apart cutting blades (such as two circular, rolling blades attached to a single handle) which may be used to cut tissue having a precisely defined width.
  • the particular dimensions will depend on the dimensions of the vascular prosthesis to be formed.
  • the sheet will be cut into a rectangular pattern having a length and width in the ranges set forth above.
  • the tissue After harvesting but usually before trimming, the tissue will be treated by conventional methods to enhance its stability and durability. For example, the tissue may be briefly immersed in a cross-linking solution, such as glutaraldehyde, in order to fix the tissue. It has been found that glutaraldehyde-treated tissue remains antigenically compatible with the host from which it has been harvested. Suitable techniques for treating the harvested tissue with glutaraldehyde are described in Love, supra . , Chapter 5.
  • tissue be obtained from the patient in which the vascular prosthesis is to be implanted (referred to as "autologous" tissue)
  • tissue could be obtained from human cadavers, including frozen (cryo-preserved) cadaver tissue, treated with the cross-linking or other preserving agent, and then employed to make vascular prostheses according to the teachings herein.
  • Tissue could also be obtained from non-human animal sources, such as bovine tissue, porcine tissue, and the like. It would also be possible to use luminal tissues, such as venous tissues, e.g., human and non-human saphenous veins.
  • the use of the frames of the present invention would also be advantageous in supporting saphenous vein grafts along their lengths.
  • the saphenous or other veins can either be split longitudinally, and formed as described hereinafter for other flat tissue sources, or alternatively could be placed intact over an inner stent with a second stent or sheath then being placed over the exterior of the vein.
  • the grafts of the present invention will be formed from a single piece of tissue having a length which is generally equal to the length of the graft and having a single overlap extending longitudinally down the length of the graft. Other graft constructions, however, will be possible.
  • a single long, relatively narrow strip of tissue could be wrapped spirally around the graft, thus having a spiral overlap extending down the length of the graft .
  • two or more tissue sections could be wrapped around the frame to form the graft of the present invention in a variety of geometries. While the preferred tissue geometry will be illustrated and described hereinafter, it is appreciated that the present invention is not so limited.
  • the tubular support frame of the vascular prosthesis will typically be composed of a non-biologic material having sufficient strength to maintain the rolled tissue in a tubular geometry with a substantially unrestricted lumen therethrough, but with sufficient flexibility to allow the prosthesis to be bent and with sufficient compliance to allow the prosthesis to accommodate pulsatile blood flow.
  • the tubular support will be made from a spring metal, such as a spring stainless steel or a shape memory alloy in its superelastic state, such as a nickel-titanium alloy.
  • a spring metal such as a spring stainless steel or a shape memory alloy in its superelastic state, such as a nickel-titanium alloy.
  • Exemplary materials include alloy MP35N (Maryland Specialty Wire, Inc.,
  • the frame could also be formed from plastic materials having the requisite strength and flexibility requirements, such as thermoplastics.
  • a third alternative would be thermoplastic- covered metal wires .
  • the use of both plastics and thermoplastic-covered wires is advantageous if the frame is trimmed prior to use since the plastic materials will reduce the formation of sharp edges on the frame.
  • Thermoplastic frame materials can also permit sewing or suturing through the frame.
  • Both metal and plastic frame components may optionally be covered with polyester (Dacron ® ) in order to enhance biocompatibility and non-immunogenicity.
  • the dimensions of the tubular support frame will define the dimensions of the vascular prosthesis.
  • the support frame will have a diameter in the range from about 1 mm to 30 mm, usually from 3 mm to 25 mm, and a length in the range from 1 cm to 35 cm, usually from 1 cm to 25 cm, and may usually range from 5 cm to 15 cm.
  • the rolled tissue supported by the frame will often extend slightly beyond the ends of the frame, typically by a distance in the range from 1 mm to 10 mm, usually from 2 mm to 6 mm. Such tissue extensions can facilitate suturing of the prosthesis to form end-to-end and end-to-side anastomoses in performing CABG and other procedures .
  • the tubular support frame will usually include at least two components, such as an inner frame component and an outer frame component, as described in more detail below.
  • the tubular support frame will include two or more separate, longitudinally-separated segments or components which may be unattached or attached by overlapping or by other non- permanent fastening.
  • the use of multiple, longitudinal segments may be advantageous in enhancing flexibility and/or facilitating the design and fabrication of longer tubular grafts.
  • tissue will be rolled into the desired tubular configuration and attached to the tubular support frame so that the tissue is maintained in its desired tubular geometry.
  • Tissue attachment may be provided in a variety of ways.
  • the tissue will be attached to the frame without suturing or otherwise penetrating the sheet of tissue. In that way, integrity of the tissue is enhanced and leakage of blood or other fluids through the prostheses is reduced.
  • the tissue may be attached to the tubular support frame using penetrating attachment means, such as hooks, barbs, staples, or the like.
  • the tissue will not be sutured to the frame or otherwise to enhance closure of the tubular tissue structure.
  • leakage from the tubular tissue structure will be prevented by overlapping the adjacent (rolled) edges of the tissue by an arc of at least 35°, usually being in the range from 45° to 720° or more, preferably being about 360° (i.e., twice- wrapped) .
  • the tissue will be overlapped by the requisite amount and will be held together by the tubular support frame, as described in detail hereinafter.
  • adhesives such as fibrin glues, biological adhesives, synthetic glues (cyanoacrylates) , or the like, to bond the overlapping layers.
  • a preferred tubular support frame will comprise an inner frame component and an outer frame component, where the rolled sheet of tissue is captured between the inner and outer components.
  • both the inner and outer frame components are helical elements, usually having identical diameters and pitches.
  • the helical turns will include a secondary serpentine or zig-zag pattern to improve the support for the tissue therebetween.
  • the sheet of tissue is rolled over a first of the helical support elements, which acts as the inner support .
  • the second helical component is then placed over the tissue, typically so that the outer helical support runs between the turns of the inner helical support.
  • Other embodiments utilize longitudinally spaced- apart support rings or other structures, such as those conventionally used in vascular stents.
  • a vascular prosthesis 10 comprising a rolled sheet of tissue 12, an outer helical support element 14, and an inner helical support element 16, is illustrated.
  • the tissue 12 is rolled from a rectangular sheet so that longitudinal edges 18 and 20 are parallel to each other and overlap by an arc in the range set forth above. Such overlapping will inhibit the leakage of blood or other body fluids which are being carried through lumen 22 of the graft 10.
  • the helical support elements 14 and 16 may have identical dimensions, i.e., diameter, length, and pitch.
  • the diameter and length will be within the ranges set forth above, and the pitch, i.e., distance between successive turns of the helix, will usually be in the range from 1 mm to 10 mm, usually being from 1 mm to 6 mm, and preferably being from about 2 mm to 4 mm. It is desirable to increase the pitch as much as possible, while maintaining sufficient capture of the tissue therebetween to prevent leakage of fluent from the prosthesis. Thus, it will frequently be possible to increase the pitch of the helical support elements 14 and 16 by also increasing the amount of overlap between the parallel edges 18 and 20.
  • the outer stent formed from slightly larger diameter wire than is the inner stent, e.g. 0.007 in. and 0.0057 in., respectively.
  • the outer stent may also have a slightly larger diameter than the inner stent by about one wire diameter, e.g. 0.005 in.
  • an outer sleeve 30 may be placed over the tissue layer 12, as illustrated in Fig. 4.
  • the inner helical support element 16, and other features of the graft, may be identical to those of the vascular prosthesis 10 of Figs. 1-3.
  • Use of an outer sleeve may have certain advantages.
  • an elastic material may facilitate placement of the sleeve over the tissue and underlying frame component.
  • Porous membrane materials may also be employed in the sleeve in order to enhance tissue ingrowth.
  • the use of elastic sleeve materials may enhance the compliance of the tubular prosthesis.
  • tissue layer 12 could be glued, welded (e.g. using laser energy) , sutured, or otherwise attached to the sleeve 30 so that the sleeve provides complete support for the tissue.
  • tissue layer could be laminated to the sleeve material 30 in a generally flat configuration, and the laminated structure rolled to form the vascular prothesis.
  • the inner stent 16 (in any of the embodiments) could be formed from a biodegradable material that erodes, typically over at least one week and usually over several weeks or months.
  • Suitable erodible materials are composed of at least one polymer system selected from the group consisting of lactic acid/glycolic copolymer, carbophenoxy propane/sebacic acid, polycaprolactones, polyanhydride and poly ortho-esters.
  • the inner stent will be removable. The purpose of erodible and/or removable inner stents will be to avoid possible obstructions on the inner surface of the lumen created by the graft . The surface irregularities formed by the inner lumen in some cases could act as a site for thrombus formation, although it is presently believed that it will not be necessary to remove the inner stent.
  • a sheet of tissue T is harvested from the patient or other animal source, as described previously.
  • the sheet will usually be treated with glutaraldehyde or other fixative or cross-linking agent, as also described previously. It is desirable that the tissue be treated prior to trimming since treatment can cause a slight shrinkage.
  • the tissue sheet T will then be trimmed, preferably using a cutter 40 or similar device capable of cutting the tissue into a rectangular pattern P, as shown on the tissue in broken line.
  • the inner helical support element 16 is typically placed over a mandrel 50, as shown in Fig. 6.
  • the trimmed sheet of tissue 12 is then rolled over the mandrel, as shown in Fig. 7.
  • the outer helical support element 14 may then be placed over the tissue 12, typically by expanding the diameter of the helix and, after properly positioning over the tissue 12, allowing the helix to contract onto the tubular form of the tissue, as shown in Fig. 8.
  • the mandrel 50 is then removed.
  • the prosthesis 10 is then ready to be used in a conventional vascular bypass or replacement procedure.
  • the outer helical support element may be applied by screwing the helices together or by winding the coils of the outer helical support element over the tissue wrapped over the inner helical support element 16 and mandrel 50.
  • the prosthesis comprises a tubular support frame including an inner frame member 60 and an outer frame member 62.
  • the inner frame member 60 includes a plurality of ring elements 64 which are longitudinally spaced-apart along a longitudinal spine 66.
  • a plurality of pins 68 are disposed along the upper surface of the spine 66 and are disposed in a radially outward direction.
  • the outer frame member 62 also comprises a longitudinal spine 70 and includes a plurality of ring elements 72 longitudinally spaced-apart on the spine.
  • the ring elements 72 are open so that each ring forms a C- clamp.
  • Tissue 74 is rolled over the inner frame member 60, with a plurality of apertures 76 formed to receive the pins 68.
  • the outer frame member 70 is then placed over the rolled tissue 74, with apertures 78 and the spine 70 also being received over pins 68.
  • the rings 72 are spaced so that they are received between each of the rings 64 in the inner frame member 60.
  • Prosthesis 80 comprises a plurality of independent ring elements 82, each of which includes a plurality of "mushroom” fasteners disposed about its inner periphery.
  • the fasteners 84 project radially inward so that a rolled tissue can be pressed onto the fasteners 84, as illustrated.
  • the tissue could be perforated prior to placement over the ring elements 82 to facilitate placement over the fasteners 84. It would also be possible to connect the ring members 82 with one or more longitudinal members if it is desired to increase the column strength.
  • FIG. 11 A further alternative approach for attaching a tissue layer 90 to a supporting ring element 92 is illustrated in Figs. 11 and 12.
  • the tissue 90 is placed over a mandrel having a cross-sectional shape which matches that of the ring element 92.
  • the ring element 92 includes a plurality of peaks 94, each of which includes a pair of channels 96 therein.
  • the channels 96 are aligned so that staples 98 may be inserted therethrough, allowing stapling of the ring element 92 to the tissue, as shown in Fig. 12.
  • the supporting mandrel 100 is shaped to conform to the ring elements 92.

Abstract

A vascular prosthesis (10) comprises pericardial, fascial, or other tissue (12) formed over a tubular support frame. A first exemplary tubular support frame comprises an inner helical member (16) and an outer helical member (14), where the tissue is rolled and captured therebetween. A second exemplary tubular support frame (60, 62) comprises a plurality of ring elements (64, 72) which are located alternately on the outside and on the inside of the rolled tissue. Other exemplary frames employ fasteners (84, 98) for penetrating the rolled tissue and attaching tissue to frame elements. The tissue is preferably obtained from the patient who is to receive the vascular prosthesis, with the tissue being mounted over the frame immediately prior to use.

Description

METHOD AND APPARATUS FOR FORMING VASCULAR
PROSTHESES
BACKGROUND OF THE INVENTION 1. Field of the Invention
The present invention relates generally to medical methods and devices, and more particularly to a method and apparatus for forming vascular prostheses from host tissue sources . Coronary and peripheral atherosclerosis are characterized by partial or total occlusion of the arteries resulting from the accumulation of lipids, smooth muscle cells, connective tissue, and glycosaminoglycans on the arterial wall . Atherosclerosis of the coronary arteries is a particular problem and can cause angina and myocardial infarction (heart attack) . Although many coronary lesions can be treated with percutaneous techniques, such as angioplasty and atherectomy, more tortuous and severely diseased arteries frequently require surgical intervention and bypass, commonly referred to as coronary artery bypass graft (CABG) surgery.
CABG surgery relies on the surgical attachment of a vascular graft to bypass the arterial occlusion in order to restore blood flow to the coronary vasculature . The nature of the vascular graft can have a significant impact on the ultimate success of the procedure. A preferred vascular graft is formed from autologous internal mammary artery (IMA) , where the resulting grafts have a patency rate approaching 95% ten years following the procedure. The use of IMA grafts, however, is limited by their length, and the need to harvest the artery from the patient can result in post-surgical complications. The autologous saphenous vein is a second common source for vascular grafts. While generally available in the necessary lengths, the saphenous vein is not ideally suited for replacement as an arterial vessel, and patency rates at ten years are often below 50%. Moreover, removal of the saphenous vein from the leg can also cause post-surgical complications.
Because of the limitations on autologous vascular sources, a variety of synthetic and non-autologous biological prostheses have been proposed. Common synthetic prostheses are formed from Dacron® and PTFE, and can perform well when employed in larger diameters, i.e., above 6 mm. Smaller synthetic prostheses, however, occlude at a relatively high rate. Non-autologous biological conduits which have been utilized as vascular prostheses include human umbilical vein grafts and bovine internal mammary arteries. Synthetic grafts have also been seeded with human and other mammalian cells or proteins, e.g., collagens, in an effort to improve their long- term patency rate. Presently, however, none of these approaches has demonstrated long-term patency, particularly in smaller diameter grafts.
Of particular interest to the present invention, preparation of vascular prostheses from autologous pericardium has been proposed. Pericardial tissue is harvested from the patient and formed into a tubular graft by suturing along a longitudinal line. While promising, the use of sutures can result in an irregular seam which, in turn, can cause turbulent blood flow and result in clot formation. Moreover, such grafts are unsupported and subject to kinking and collapse. The grafts further lack an inherently round geometry and are subject to dimensional changes, e.g., elongation and aneurysmal formation. Because of the dimensional uncertainty, it is difficult to match such grafts to the precise dimensional requirements of the particular application, e.g, caliber and length. The suturing of vascular prostheses from pericardium is labor intensive and time consuming, and the resulting structures are subject to rupture and other structural failure. Thus, the outcome of using sutured pericardial tissue grafts is uncertain at best. For these reasons, it would be desirable to provide improved vascular prostheses for use in CABG and other procedures. Such prostheses should be biocompatible with the patient, resistant to kinking and collapse, and easy to implant. Moreover, the prostheses should be non-thrombogenic, resistant to infection, and easy to sterilize and store. It would be particularly desirable to provide improved methods and apparatus for preparing vascular prostheses from autologous tissue sources, where the prostheses can be prepared in a range of diameters and lengths, and can be readily assembled in the operating room after the tissue has been harvested. In particular, the vascular prostheses should be readily assemblable, preferably without suturing, in a manner that allows precise and uniform dimensions and preferably be available in a kit form to facilitate assembly.
2. Description of the Background Art
U.S. Patent No. 4,502,159, describes a vascular prosthesis made by suturing glutaraldehyde-treated pericardial tissue along a longitudinal seam. SU 1217362 (Abstract) describes reinforcing arteries by securing pericardial tissue over the artery. U.S. Patent No. 3,562,820, describes forming tissue-containing prostheses over removable mandrels. The use of glutaraldehyde and other agents for treating tissue and prosthetic devices to reduce antigenicity is described in U.S. Patent Nos. 3,988,782; 4,801,299; 5,215,541, and Brazilian applications 89/03621 and 90/03762. U.S. Patent No. 4,539,716, describes the fabrication of an artificial blood vessel from collagen and other natural materials. U.S. Patent Nos. 3,894,530 and 3,974,526, describe the formation of vascular prostheses from the arteries or veins present in the umbilical cord. U.S. Patent No. 5,372,821, describes the use of tissue for forming artificial ligament grafts for use in orthopedic procedures. U.S. Patent No. 3,408,659, describes the preparation of vascular artificial prostheses from other body lumens. French application FR 2,714,816, (Abstract) discloses a helically supported vascular prosthesis. A number of medical literature publications describe the use of vascular prostheses formed form tissue. See, for example, Rendina et al. (1995) J. Thorac . Cardiovasc . Surg. 110:867- 868; Hvass et al. (1987) La Presse Medicale 16:441-443; Allen and Cole (1977) J. Ped . Surg. 12:287-294; and Sako (1951) Surgery 30:148-160. Other patents and published applications relating to synthetic vascular grafts include U.S. Patent Nos. 4,728,328; 4,731,073; 4,798,606; 4,820,298; 4,822,361; and 4,842,575; and PCT publications WO 94/22505 and WO 95/25547. Patents and published applications relating to kits for preparing replacement heart valves from pericardial and other autologous tissue sources are described in U.S. Patent Nos. 5,163,955; 5,297,564; 5,326,370; 5,326,371; 5,423,887; and 5,425,741.
SUMMARY OF THE INVENTION The present invention provides improved vascular prostheses and methods for their preparation. The vascular prostheses are formed in part from animal tissue, usually autologous tissue from the patient receiving the prostheses, which is supported on a separate support frame. Typically, the tissue is pericardial, fascial, rectus sheath, venous tissue, or other tissue harvested from the patient immediately before the CABG or other implantation procedure. After harvesting, the tissue is usually but not necessarily treated in a stabilizing medium, such as a cross-linking agent, and then attached to the frame in the operating room. The frame precisely defines the length and dimensions of the vascular graft and inhibits kinking and collapse of the graft after implantation. Preferably, the tissue will be rolled or otherwise formed over the frame so that adjacent longitudinal edges are overlapped to seal the resulting lumen of the graft and prevent blood leakage. In this way, suturing of the graft can be avoided. Such vascular prostheses have a number of advantages. When using autologous tissue, the grafts are biocompatible and non-immunogenic. The grafts are durable, and use of the separate frame provides dimensional stability and inhibits unintended dilation, rupture, elongation, and kinking. Moreover, the vascular prosthesis may be prepared in a range of diameters and lengths, with the tissue sources providing a relatively unlimited source of prosthetic material . The vascular prostheses are relatively easy to fabricate, with attachment of the tissue to the frame being readily performable in an operating room environment . The frame components of the graft are easy to store and sterilize prior to use. Other advantages include non-thrombogenicity and a compliance which approximates that of natural blood vessels .
According to the method of the present invention, a tubular vascular prosthesis is formed by providing a sheet of tissue and a tubular support frame. The tissue is then attached to the tubular support frame to define a substantially unrestricted blood flow lumen therethrough. The tissue sheet may be obtained from the host or from other human or animal (non-autologous) sources. Typically, the tissue is trimmed into a shape to facilitate rolling onto the frame, usually a rectangular shape. The tissue will usually be pericardium, fascia, rectus sheath, venous tissue, or the like, and will preferably but not necessarily be treated with a cross-linking agent or other stabilizing agent (preservative) prior to formation. The tubular support frame may have a variety of configurations. In a first embodiment, the tubular support frame includes at least an inner frame component and an outer frame component, where the attaching step comprises capturing the tissue sheet between the inner component and the outer frame component. The inner and outer frame components may be in the form of helices, longitudinally spaced-apart rings, or other conventional intravascular stent structures and the like. In a preferred aspect of the present invention, the inner and outer frame components comprise concentric mating structure which clamp the tissue therebetween without suturing. The frame thus supports the clamped tissue along the entire length of the graft to provide support and precise dimensional control.
Alternatively, the tubular support frame may include a single frame member having a plurality of fasteners disposed thereover. In such case, the attaching step comprises attaching the tissue to the fasteners, for example by penetrating the fasteners through the tissue. As yet another alternative, the tissue may be attached to a single frame using separate fasteners, such as staples which are penetrated through the tissue and into the frame. In yet another alternative, the attaching step may comprise disposing a sleeve over the tissue which in turn is disposed over the tubular frame.
Systems for forming tubular prostheses according to the present invention comprise a cutter and a tubular frame. The cutter is designed to trim the sheet of harvested tissue into a predetermined pattern, typically a rectangular pattern. The tubular frame is capable of supporting the tissue trimmed by the cutter and a tubular geometry having a substantially unrestricted flow lumen therethrough. Usually, a plurality of cutters and a plurality of tubular frames will be provided with matched pairs of cutters and frames used for forming tubular prostheses having different dimensions. The system may further include a mandrel for holding the tissue as the tissue is attached to the frame, and may still further include a cross-linking agent or other stabilizing agent or preservative for treating the tissue prior to attachment to the frame. The frame may comprise any of the structures described above.
In another aspect of the present invention, a tubular frame for supporting tissue in a tubular geometry with a substantially unrestricted flow lumen therethrough comprises a first tubular frame component having tissue attachment means thereon. The tubular frame typically has a diameter in the range from 1 mm to 30 mm, preferably from 3 mm to 25 mm, and a length in the range from 1 cm to 30 cm, preferably from 5 cm to 15 cm. The length will be determined at least in part by the length and amount of tissue available from an individual patient. In some cases, frames even longer than 30 cm might find use, but the resulting longer grafts will rarely be needed. In some cases, the length of the tubular frame will be adjustable, for example by cutting a desired length of frame or frame components from a relatively long frame stock.
The frame will usually be composed of a resilient metal, and may comprise either a helical element or a plurality of longitudinally spaced-apart ring elements. Attachment means may comprise any one of a second tubular frame component configured to mate with the first tubular frame component, e.g., a pair of nesting helical frame elements, a plurality of fasteners disposed over the first tubular frame component, a sleeve which is received over the exterior of the first tubular frame component, staples for attaching the tissue to the frame component, or the like. Optionally, two or more frames or frame segments may be linked together to create longer grafts, with the frames or frame segments being interlocked and/or overlapped to create a continuous lumen through the resulting assembly.
BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a perspective view of a vascular prostheses constructed in accordance with the principles of the present invention, shown with portions broken away.
Fig. 2 is a cross-sectional view taken along line 2- 2 of Fig. 1. Fig. 3 is a partial, longitudinal cross-sectional view of the prostheses of Fig. 1.
Fig. 4 is a partial cross-sectional view of an alternative embodiment of the prosthesis of the present invention. Figs. 5-8 illustrate a method for preparing the vascular prosthesis of Fig. 1.
Fig. 9 illustrates an alternative construction of a vascular prostheses constructed in accordance with the principles of the present invention, shown in an exploded view.
Fig. 10 illustrates yet another alternative environment of a vascular prosthesis constructed in accordance with the principles of the present invention.
Figs. 11 and 12 illustrate another method for attaching tissue to a tubular frame member according to the method of the present invention. DESCRIPTION OF THE SPECIFIC EMBODIMENTS The present invention provides vascular prostheses, also referred to as vascular grafts, intended for use in medical procedures requiring replacement or bypass of a patient's blood vessels. Most commonly, vascular prostheses will be used in peripheral vascular bypass, coronary artery bypass (CABG) procedures, but they also may find use in aneurysm repair; vascular access shunts; vessel reconstruction, such as pulmonary outflow tract and aortic outflow tract; as a conduit for valvular repair; and the like.
The tissue employed in the vascular prosthesis will be obtained from a human or other animal source, usually but not necessarily being obtained from the patient or host into which the prosthesis is to be implanted. The tissue may comprise any body tissue having sufficient strength and elasticity to act as the primary component of the prosthesis, usually being obtained from the pericardium or a fascial layer, such as the fascia lata. Other tissue sources include rectus sheath and venous tissues. The tissue will be harvested by conventional techniques, such as those described in Love, Autologous Tissue Heart Valves, R.G. Landes Co., Austin, Texas, 1993, Chapter 8.
Although not generally preferred, the present invention can be employed to strengthen conventionally harvested and prepared saphenous veins using any of the inner stent/outer stent combinations described below. The primary difference when using a saphenous vein tissue material source is that the tissue will not be rolled or layered over itself as will be the case with sheet-like tissue sources. The amount of tissue harvested will depend on the size of the vascular prosthesis to be prepared. Typically, the sheet of tissue initially obtained will be generally rectangular, having a length in the range from about 5 cm to 35 cm, usually 5 cm to 15 cm for pericardium, and a width in the range from about 2 cm to 20 cm, usually about 2 cm to 5 cm for pericardium. After harvesting, the tissue will be trimmed to size, usually using a cutting die, stencil, or other pattern-forming device capable of trimming the tissue to the precise dimensions required. A presently preferred technique uses parallel, spaced-apart cutting blades (such as two circular, rolling blades attached to a single handle) which may be used to cut tissue having a precisely defined width. The particular dimensions, of course, will depend on the dimensions of the vascular prosthesis to be formed. Typically, the sheet will be cut into a rectangular pattern having a length and width in the ranges set forth above.
After harvesting but usually before trimming, the tissue will be treated by conventional methods to enhance its stability and durability. For example, the tissue may be briefly immersed in a cross-linking solution, such as glutaraldehyde, in order to fix the tissue. It has been found that glutaraldehyde-treated tissue remains antigenically compatible with the host from which it has been harvested. Suitable techniques for treating the harvested tissue with glutaraldehyde are described in Love, supra . , Chapter 5.
While it is preferred that the tissue be obtained from the patient in which the vascular prosthesis is to be implanted (referred to as "autologous" tissue) , it is also possible to obtain tissue from other human and animal sources . For example, tissue could be obtained from human cadavers, including frozen (cryo-preserved) cadaver tissue, treated with the cross-linking or other preserving agent, and then employed to make vascular prostheses according to the teachings herein. Tissue could also be obtained from non-human animal sources, such as bovine tissue, porcine tissue, and the like. It would also be possible to use luminal tissues, such as venous tissues, e.g., human and non-human saphenous veins. While a particular advantage of the present invention is it allows the use of non-luminal tissues to form vascular and other graft structures, the use of the frames of the present invention would also be advantageous in supporting saphenous vein grafts along their lengths. The saphenous or other veins can either be split longitudinally, and formed as described hereinafter for other flat tissue sources, or alternatively could be placed intact over an inner stent with a second stent or sheath then being placed over the exterior of the vein. Preferably, the grafts of the present invention will be formed from a single piece of tissue having a length which is generally equal to the length of the graft and having a single overlap extending longitudinally down the length of the graft. Other graft constructions, however, will be possible. For example, a single long, relatively narrow strip of tissue could be wrapped spirally around the graft, thus having a spiral overlap extending down the length of the graft . As a further alternative, two or more tissue sections could be wrapped around the frame to form the graft of the present invention in a variety of geometries. While the preferred tissue geometry will be illustrated and described hereinafter, it is appreciated that the present invention is not so limited. The tubular support frame of the vascular prosthesis will typically be composed of a non-biologic material having sufficient strength to maintain the rolled tissue in a tubular geometry with a substantially unrestricted lumen therethrough, but with sufficient flexibility to allow the prosthesis to be bent and with sufficient compliance to allow the prosthesis to accommodate pulsatile blood flow. Usually, the tubular support will be made from a spring metal, such as a spring stainless steel or a shape memory alloy in its superelastic state, such as a nickel-titanium alloy. Exemplary materials include alloy MP35N (Maryland Specialty Wire, Inc.,
Cockeysville, Maryland 21030) and nickel titanium alloy SE508 (Nitinol Device and Component, Inc., Fremont, California) . The frame could also be formed from plastic materials having the requisite strength and flexibility requirements, such as thermoplastics. A third alternative would be thermoplastic- covered metal wires . The use of both plastics and thermoplastic-covered wires is advantageous if the frame is trimmed prior to use since the plastic materials will reduce the formation of sharp edges on the frame. Thermoplastic frame materials can also permit sewing or suturing through the frame. Both metal and plastic frame components may optionally be covered with polyester (Dacron®) in order to enhance biocompatibility and non-immunogenicity. The dimensions of the tubular support frame will define the dimensions of the vascular prosthesis. Typically, the support frame will have a diameter in the range from about 1 mm to 30 mm, usually from 3 mm to 25 mm, and a length in the range from 1 cm to 35 cm, usually from 1 cm to 25 cm, and may usually range from 5 cm to 15 cm. The rolled tissue supported by the frame will often extend slightly beyond the ends of the frame, typically by a distance in the range from 1 mm to 10 mm, usually from 2 mm to 6 mm. Such tissue extensions can facilitate suturing of the prosthesis to form end-to-end and end-to-side anastomoses in performing CABG and other procedures .
The tubular support frame will usually include at least two components, such as an inner frame component and an outer frame component, as described in more detail below.
Generally, however, at least one of the frame components will extend continuously from a proximal end of the graft to a distal end of the graft. It is possible, however, that the tubular support frame will include two or more separate, longitudinally-separated segments or components which may be unattached or attached by overlapping or by other non- permanent fastening. The use of multiple, longitudinal segments may be advantageous in enhancing flexibility and/or facilitating the design and fabrication of longer tubular grafts.
The tissue will be rolled into the desired tubular configuration and attached to the tubular support frame so that the tissue is maintained in its desired tubular geometry. Tissue attachment may be provided in a variety of ways. Preferably, the tissue will be attached to the frame without suturing or otherwise penetrating the sheet of tissue. In that way, integrity of the tissue is enhanced and leakage of blood or other fluids through the prostheses is reduced. In alternative embodiments, the tissue may be attached to the tubular support frame using penetrating attachment means, such as hooks, barbs, staples, or the like. Preferably, the tissue will not be sutured to the frame or otherwise to enhance closure of the tubular tissue structure. Usually, leakage from the tubular tissue structure will be prevented by overlapping the adjacent (rolled) edges of the tissue by an arc of at least 35°, usually being in the range from 45° to 720° or more, preferably being about 360° (i.e., twice- wrapped) .
In the exemplary embodiment, the tissue will be overlapped by the requisite amount and will be held together by the tubular support frame, as described in detail hereinafter. In some cases, however, it may be further desirable to provide adhesives, such as fibrin glues, biological adhesives, synthetic glues (cyanoacrylates) , or the like, to bond the overlapping layers. It may also be possible to provide laser welding of the tissue layers together, also to enhance the bonding. It would also be possible to suture the layers together, although this will generally be less preferred for the reasons set forth above in the Background section. It would further be possible when employing an adhesive to join the adjacent tissue edges together in an abutting fashion, forming an axially extending butt-joint, although this method is not presently preferred.
A preferred tubular support frame will comprise an inner frame component and an outer frame component, where the rolled sheet of tissue is captured between the inner and outer components. In a particularly preferred embodiment, both the inner and outer frame components are helical elements, usually having identical diameters and pitches. In the case of helical stents, it is possible that the helical turns will include a secondary serpentine or zig-zag pattern to improve the support for the tissue therebetween. The sheet of tissue is rolled over a first of the helical support elements, which acts as the inner support . The second helical component is then placed over the tissue, typically so that the outer helical support runs between the turns of the inner helical support. Other embodiments utilize longitudinally spaced- apart support rings or other structures, such as those conventionally used in vascular stents.
Referring now to Figs. 1-3, a vascular prosthesis 10 comprising a rolled sheet of tissue 12, an outer helical support element 14, and an inner helical support element 16, is illustrated. The tissue 12 is rolled from a rectangular sheet so that longitudinal edges 18 and 20 are parallel to each other and overlap by an arc in the range set forth above. Such overlapping will inhibit the leakage of blood or other body fluids which are being carried through lumen 22 of the graft 10.
The helical support elements 14 and 16 may have identical dimensions, i.e., diameter, length, and pitch. The diameter and length will be within the ranges set forth above, and the pitch, i.e., distance between successive turns of the helix, will usually be in the range from 1 mm to 10 mm, usually being from 1 mm to 6 mm, and preferably being from about 2 mm to 4 mm. It is desirable to increase the pitch as much as possible, while maintaining sufficient capture of the tissue therebetween to prevent leakage of fluent from the prosthesis. Thus, it will frequently be possible to increase the pitch of the helical support elements 14 and 16 by also increasing the amount of overlap between the parallel edges 18 and 20. In some cases, it may be preferred to have the outer stent formed from slightly larger diameter wire than is the inner stent, e.g. 0.007 in. and 0.0057 in., respectively. The outer stent may also have a slightly larger diameter than the inner stent by about one wire diameter, e.g. 0.005 in. As an alternative to employing the outer helical support element 14, an outer sleeve 30 may be placed over the tissue layer 12, as illustrated in Fig. 4. The inner helical support element 16, and other features of the graft, may be identical to those of the vascular prosthesis 10 of Figs. 1-3. Use of an outer sleeve may have certain advantages. For example, use of an elastic material may facilitate placement of the sleeve over the tissue and underlying frame component. Porous membrane materials may also be employed in the sleeve in order to enhance tissue ingrowth. Finally, the use of elastic sleeve materials may enhance the compliance of the tubular prosthesis.
In some cases, use of a sleeve 30 could obviate the need for the internal stent 16. For example, the tissue layer 12 could be glued, welded (e.g. using laser energy) , sutured, or otherwise attached to the sleeve 30 so that the sleeve provides complete support for the tissue. Typically, the tissue layer could be laminated to the sleeve material 30 in a generally flat configuration, and the laminated structure rolled to form the vascular prothesis.
As a still further alternative, the inner stent 16 (in any of the embodiments) could be formed from a biodegradable material that erodes, typically over at least one week and usually over several weeks or months. Suitable erodible materials are composed of at least one polymer system selected from the group consisting of lactic acid/glycolic copolymer, carbophenoxy propane/sebacic acid, polycaprolactones, polyanhydride and poly ortho-esters. It is also possible that the inner stent will be removable. The purpose of erodible and/or removable inner stents will be to avoid possible obstructions on the inner surface of the lumen created by the graft . The surface irregularities formed by the inner lumen in some cases could act as a site for thrombus formation, although it is presently believed that it will not be necessary to remove the inner stent.
Referring now to Figs. 5-8, a method for preparing the vascular prosthesis 10 of Figs. 1-3 will be described. A sheet of tissue T is harvested from the patient or other animal source, as described previously. The sheet will usually be treated with glutaraldehyde or other fixative or cross-linking agent, as also described previously. It is desirable that the tissue be treated prior to trimming since treatment can cause a slight shrinkage. The tissue sheet T will then be trimmed, preferably using a cutter 40 or similar device capable of cutting the tissue into a rectangular pattern P, as shown on the tissue in broken line.
The inner helical support element 16 is typically placed over a mandrel 50, as shown in Fig. 6. The trimmed sheet of tissue 12 is then rolled over the mandrel, as shown in Fig. 7. The outer helical support element 14 may then be placed over the tissue 12, typically by expanding the diameter of the helix and, after properly positioning over the tissue 12, allowing the helix to contract onto the tubular form of the tissue, as shown in Fig. 8. The mandrel 50 is then removed. The prosthesis 10 is then ready to be used in a conventional vascular bypass or replacement procedure.
Optionally, the outer helical support element may be applied by screwing the helices together or by winding the coils of the outer helical support element over the tissue wrapped over the inner helical support element 16 and mandrel 50. Referring to Fig. 9, an alternative embodiment of the vascular prosthesis of the present invention will be described. The prosthesis comprises a tubular support frame including an inner frame member 60 and an outer frame member 62. The inner frame member 60 includes a plurality of ring elements 64 which are longitudinally spaced-apart along a longitudinal spine 66. A plurality of pins 68 are disposed along the upper surface of the spine 66 and are disposed in a radially outward direction. The outer frame member 62 also comprises a longitudinal spine 70 and includes a plurality of ring elements 72 longitudinally spaced-apart on the spine. The ring elements 72 are open so that each ring forms a C- clamp. Tissue 74 is rolled over the inner frame member 60, with a plurality of apertures 76 formed to receive the pins 68. The outer frame member 70 is then placed over the rolled tissue 74, with apertures 78 and the spine 70 also being received over pins 68. The rings 72 are spaced so that they are received between each of the rings 64 in the inner frame member 60.
Another vascular prosthesis 80 is illustrated in Fig. 10. Prosthesis 80 comprises a plurality of independent ring elements 82, each of which includes a plurality of "mushroom" fasteners disposed about its inner periphery. The fasteners 84 project radially inward so that a rolled tissue can be pressed onto the fasteners 84, as illustrated. Optionally, the tissue could be perforated prior to placement over the ring elements 82 to facilitate placement over the fasteners 84. It would also be possible to connect the ring members 82 with one or more longitudinal members if it is desired to increase the column strength.
A further alternative approach for attaching a tissue layer 90 to a supporting ring element 92 is illustrated in Figs. 11 and 12. The tissue 90 is placed over a mandrel having a cross-sectional shape which matches that of the ring element 92. The ring element 92 includes a plurality of peaks 94, each of which includes a pair of channels 96 therein. The channels 96 are aligned so that staples 98 may be inserted therethrough, allowing stapling of the ring element 92 to the tissue, as shown in Fig. 12. The supporting mandrel 100 is shaped to conform to the ring elements 92.
Although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that certain changes and modifications may be practiced within the scope of the appended claims.

Claims

WHAT IS CLAIMED IS:
1. A method for forming a tubular prosthesis, said method comprising: providing a sheet of tissue; providing a tubular support frame; and attaching the tissue to the tubular support frame, wherein the frame holds the tissue in a tubular geometry with a substantially unrestricted lumen therethrough.
2. A method as in claim 1, wherein the sheet providing step comprises : harvesting tissue from an animal host; and trimming the tissue into a shape selected to permit attachment to the frame.
3. A method as in claim 2, wherein the tissue is trimmed into a rectangular shape.
4. A method as in claim 1, wherein the tissue is selected from the group consisting of pericardium, fascia, rectus sheath, and venous tissue.
5. A method as in claim 1, further comprising treating the tissue with a cross-linking agent.
6. A method as in claim 5, wherein the tissue is treated by immersion in glutaraldehyde prior to attaching to the tubular support frame.
7. A method as in claim 1, further comprising implanting the prosthesis in a host.
8. A method as in claim 7, wherein the tissue was obtained from the same host into which the prosthesis is implanted.
9. A method as in claim 7, wherein the tissue was obtained from a host other than the host into which the prosthesis is implanted.
10. A method as in claim 1, wherein the tissue sheet is disposed on the frame with parallel edges overlapping along a longitudinal line.
11. A method as in claim 10, wherein the edges are not connected other than by the frame.
12. A method as in claim 11, wherein the edges overlap by an arc of at least 30°.
13. A method as in claim 1, further comprising forming the tissue over a mandrel prior to attaching the tissue to the frame.
14. A method as in claim 1, wherein the tubular support frame includes at least an inner frame component and an outer frame component, wherein the attaching step comprises capturing the tissue sheet between the inner frame component and the outer component .
15. A method as in claim 14, wherein the inner frame component and the outer frame component each comprise a helix, wherein the capturing step comprises aligning the inner helix and the outer helix so that the turns of each helix run in parallel .
16. A method as in claim 15, wherein the helical turns are positioned to be evenly spaced from each other in the longitudinal direction.
17. A method as in claim 14, wherein the inner frame component and outer frame component each comprise a plurality of longitudinally spaced-apart ring elements, wherein the capturing step comprises aligning the inner and outer rings in a selected pattern relative to each other.
18. A method as in claim 17, wherein the inner and outer rings are aligned in an alternating pattern.
19. A method as in claim 17, wherein the inner and outer rings are aligned to lie over each other.
20. A method as in claim 1, wherein the tubular support frame includes a plurality of fasteners disposed thereover and wherein the attaching step comprises attaching the tissue to said fasteners.
21. A method as in claim 20, wherein the fasteners are disposed over an inner luminal surface of the frame.
22. A method, as in claim 21, wherein the attaching step comprises penetrating the fasteners through the tissue.
23. A method as in claim 1, wherein the attaching step comprises stapling the tissue to the frame.
24. A method as in claim 1, wherein the attaching step comprises disposing a sleeve over the tissue which is disposed over the frame.
25. A system for forming a tubular prosthesis from a sheet of harvested tissue, said system comprising: a cutter capable of trimming the sheet of harvested tissue to a predetermined pattern,- and a tubular frame capable of supporting the trimmed sheet of tissue in a tubular geometry with a substantially unrestricted lumen therethrough.
26. A system as in claim 25, further comprising a mandrel for holding the tissue as the tissue is attached to the frame.
27. A system as in claim 25, further comprising a cross-linking agent.
28. A system as in claim 25, wherein the tubular support frame comprises at least an inner frame component and an outer frame component wherein the frame components are configured to capture the trimmed sheet of tissue therebetween.
29. A system as in claim 28, wherein the inner frame component and the outer frame component each comprise a helix.
30. A system as in claim 28, wherein the inner frame component and outer frame component each comprise a plurality of longitudinally spaced-apart ring elements.
31. A system as in claim 25, wherein the tubular frame comprises a frame component having a plurality of tissue fasteners disposed thereover.
32. A system as in claim 31, wherein the tissue fasteners are disposed over an inner luminal surface of the frame component.
33. A system as in claim 25, further comprising staples for attaching the tissue to the frame.
34. A system as in claim 25, further comprising a sleeve for holding the tissue over the frame.
35. A tubular frame for supporting tissue in a tubular geometry with a substantially unrestricted lumen therethrough, said frame comprising a first tubular frame component and means for attaching tissue to the frame.
36. A tubular frame as in claim 35, wherein the first tubular frame has a diameter in the range from 1 mm to 30 mm and a length in the range from 1 cm to 30 cm.
37. A tubular frame as in claim 35, composed of a resilient metal.
38. A tubular frame as in claim 35, wherein the frame comprises a helical element or a plurality of longitudinally spaced-apart ring elements.
39. A tubular frame as in claim 38, wherein the frame is a helical element having a pitch in the range from 1 mm to 10 mm.
40. A tubular frame as in claim 35, wherein the attaching means comprises a second tubular frame component configured to mate with the first tubular frame component to capture the tissue therebetween.
41. A tubular frame as in claim 40, wherein the frame components each comprise a helix.
42. A tubular frame as in claim 40, wherein the frame components each comprise a plurality of spaced-apart ring elements.
43. A tubular frame as in claim 35, wherein the attaching means comprises a plurality of tissue fasteners disposed over a surface of the first frame component.
44. A tubular frame as in claim 43, wherein the tissue fasteners are disposed over an inner luminal surface of the first frame component.
45. A tubular frame as in claim 35, wherein the attaching means comprises a sleeve configured to lie over an exterior surface of the first frame component and to capture the tissue between said exterior surface and an interior surface of the sleeve.
46. A tubular frame as in claim 35, wherein the attaching means comprises a plurality of staples to staple the tissue over the frame.
PCT/US1996/020868 1995-12-29 1996-12-27 Method and apparatus for forming vascular prostheses WO1997024081A1 (en)

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AU15692/97A AU720362B2 (en) 1995-12-29 1996-12-27 Method and apparatus for forming vascular prostheses
EP96945441A EP0874603B1 (en) 1995-12-29 1996-12-27 Method and apparatus for forming vascular prostheses
JP9524612A JP2000502586A (en) 1995-12-29 1996-12-27 Method and apparatus for forming a vascular prosthesis
US09/091,942 US6494904B1 (en) 1996-12-27 1996-12-27 Method and apparatus for forming vascular prostheses
DE69636438T DE69636438D1 (en) 1995-12-29 1996-12-27 METHOD AND DEVICE FOR DESIGNING VASCOSIS THERAPIES

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Cited By (29)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0878173A1 (en) * 1997-05-14 1998-11-18 Jomed Implantate GmbH Stent-graft
WO1999015105A1 (en) * 1997-09-23 1999-04-01 Carlos Vonderwalde Freidberg Non-thrombogenic stent jacket
EP0923912A3 (en) * 1997-12-18 2000-03-15 Schneider (Usa) Inc. Stent-graft with bioabsorbable structural support
EP0984811A1 (en) * 1998-02-26 2000-03-15 World Medical Manufacturing Corporation Delivery system for deployment and endovascular assembly of a multi-stage stented graft
WO2000030564A2 (en) * 1998-11-23 2000-06-02 Medtronic, Inc. Porous synthetic vascular grafts with oriented ingrowth channels
US6245100B1 (en) 2000-02-01 2001-06-12 Cordis Corporation Method for making a self-expanding stent-graft
US6296661B1 (en) 2000-02-01 2001-10-02 Luis A. Davila Self-expanding stent-graft
WO2001082836A3 (en) * 2000-05-04 2002-04-18 Univ Oregon Health Sciences Endovascular stent graft
US6379382B1 (en) 2000-03-13 2002-04-30 Jun Yang Stent having cover with drug delivery capability
US6468300B1 (en) 1997-09-23 2002-10-22 Diseno Y Desarrollo Medico, S.A. De C.V. Stent covered heterologous tissue
GB2379996A (en) * 2001-06-05 2003-03-26 Tayside Flow Technologies Ltd Flow means
US6613082B2 (en) 2000-03-13 2003-09-02 Jun Yang Stent having cover with drug delivery capability
WO2004047687A1 (en) * 2002-11-22 2004-06-10 Cook Incorporated Stent tissue graft prosthesis
WO2004082534A1 (en) 2003-03-18 2004-09-30 Veryan Medical Limited Helical graft
WO2004082533A1 (en) 2003-03-18 2004-09-30 Veryan Medical Limited Helical stent
EP1725188A1 (en) * 2004-03-02 2006-11-29 Boston Scientific Scimed, Inc. Medical devices including metallic films and methods for making same
WO2007035791A3 (en) * 2005-09-19 2007-05-10 Cook Inc Graft with bioabsorbable support frame
EP1785109A3 (en) * 2001-01-12 2007-05-30 Boston Scientific Limited Stent for in-stent restenosis
WO2008144229A1 (en) * 2007-05-14 2008-11-27 Vance Products Incorporated D/B/A Cook Urological Incorporated Stent for implantation
US7862609B2 (en) 2000-11-16 2011-01-04 Cordis Corporation Stent graft having a pleated graft member
USRE42857E1 (en) * 2000-01-27 2011-10-18 3F Therapeutics, Inc. Method of laser cutting pericardial tissue for use with an implantable medical device
EP2380526A3 (en) * 2010-04-23 2013-09-18 Biotronik AG Implant and method for producing the same
US9067026B2 (en) 2009-05-19 2015-06-30 Vascular Flow Technologies Limited Vascular graft
US9498356B2 (en) 2012-12-19 2016-11-22 Cook Medical Technologies, LLC Flexible stent and delivery system
US9572694B2 (en) 2003-03-18 2017-02-21 Veryan Medical Limited Helical graft
US9597214B2 (en) 2008-10-10 2017-03-21 Kevin Heraty Medical device
US9763814B2 (en) 2014-10-24 2017-09-19 Cook Medical Technologies Llc Elongate medical device
US10188532B2 (en) 1998-12-29 2019-01-29 Vascular Flow Technologies Limited Blood-flow tubing
EP3305248A4 (en) * 2015-06-02 2019-02-13 Adeka Corporation Sheet of biological tissue, tubular structure produced from said sheet, and artificial blood vessel comprising said tubular structure

Families Citing this family (119)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
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
US5607478A (en) * 1996-03-14 1997-03-04 Meadox Medicals Inc. Yarn wrapped PTFE tubular prosthesis
US6352561B1 (en) 1996-12-23 2002-03-05 W. L. Gore & Associates Implant deployment apparatus
US6551350B1 (en) 1996-12-23 2003-04-22 Gore Enterprise Holdings, Inc. Kink resistant bifurcated prosthesis
US6494904B1 (en) * 1996-12-27 2002-12-17 Ramus Medical Technologies Method and apparatus for forming vascular prostheses
US6776792B1 (en) * 1997-04-24 2004-08-17 Advanced Cardiovascular Systems Inc. Coated endovascular stent
US5980565A (en) * 1997-10-20 1999-11-09 Iowa-India Investments Company Limited Sandwich stent
US5957975A (en) * 1997-12-15 1999-09-28 The Cleveland Clinic Foundation Stent having a programmed pattern of in vivo degradation
DE69940507D1 (en) * 1998-06-05 2009-04-16 Organogenesis Inc BIOTECHNICALLY GENERATED VASCOPY THERAPY FOR IMPLANTATION
US6290728B1 (en) 1998-09-10 2001-09-18 Percardia, Inc. Designs for left ventricular conduit
ATE322230T1 (en) 1998-09-10 2006-04-15 Percardia Inc TMR DEVICE
US6254564B1 (en) * 1998-09-10 2001-07-03 Percardia, Inc. Left ventricular conduit with blood vessel graft
US6641610B2 (en) * 1998-09-10 2003-11-04 Percardia, Inc. Valve designs for left ventricular conduits
US6196230B1 (en) 1998-09-10 2001-03-06 Percardia, Inc. Stent delivery system and method of use
US20070219642A1 (en) * 1998-12-03 2007-09-20 Jacob Richter Hybrid stent having a fiber or wire backbone
US20060178727A1 (en) * 1998-12-03 2006-08-10 Jacob Richter Hybrid amorphous metal alloy stent
US20060122691A1 (en) * 1998-12-03 2006-06-08 Jacob Richter Hybrid stent
US20050033399A1 (en) * 1998-12-03 2005-02-10 Jacob Richter Hybrid stent
US8382821B2 (en) * 1998-12-03 2013-02-26 Medinol Ltd. Helical hybrid stent
US20040267349A1 (en) * 2003-06-27 2004-12-30 Kobi Richter Amorphous metal alloy medical devices
AU3999700A (en) * 1999-02-12 2000-08-29 Johns Hopkins University, The Venous valve implant bioprosthesis and endovascular treatment for venous insufficiency
US7033372B1 (en) 1999-08-04 2006-04-25 Percardia, Inc. Corkscrew reinforced left ventricle to coronary artery channel
US6253768B1 (en) 1999-08-04 2001-07-03 Percardia, Inc. Vascular graft bypass
US6638237B1 (en) * 1999-08-04 2003-10-28 Percardia, Inc. Left ventricular conduits and methods for delivery
US6605053B1 (en) 1999-09-10 2003-08-12 Percardia, Inc. Conduit designs and related methods for optimal flow control
US6503273B1 (en) * 1999-11-22 2003-01-07 Cyograft Tissue Engineering, Inc. Tissue engineered blood vessels and methods and apparatus for their manufacture
US6355063B1 (en) 2000-01-20 2002-03-12 Impra, Inc. Expanded PTFE drug delivery graft
US7621947B2 (en) * 2000-03-01 2009-11-24 Medinol, Ltd. Longitudinally flexible stent
US8920487B1 (en) 2000-03-01 2014-12-30 Medinol Ltd. Longitudinally flexible stent
US8202312B2 (en) * 2000-03-01 2012-06-19 Medinol Ltd. Longitudinally flexible stent
US6723119B2 (en) * 2000-03-01 2004-04-20 Medinol Ltd. Longitudinally flexible stent
US7828835B2 (en) 2000-03-01 2010-11-09 Medinol Ltd. Longitudinally flexible stent
US8496699B2 (en) * 2000-03-01 2013-07-30 Medinol Ltd. Longitudinally flexible stent
SG86458A1 (en) 2000-03-01 2002-02-19 Medinol Ltd Longitudinally flexible stent
US7141062B1 (en) * 2000-03-01 2006-11-28 Medinol, Ltd. Longitudinally flexible stent
US7758627B2 (en) * 2000-03-01 2010-07-20 Medinol, Ltd. Longitudinally flexible stent
US6929658B1 (en) 2000-03-09 2005-08-16 Design & Performance-Cyprus Limited Stent with cover connectors
DE60121141T2 (en) * 2000-03-09 2007-05-31 Design & Performance - Cyprus Ltd. STENT WITH HOLLOW FASTENINGS
US20160287708A9 (en) * 2000-03-15 2016-10-06 Orbusneich Medical, Inc. Progenitor Endothelial Cell Capturing with a Drug Eluting Implantable Medical Device
KR100860860B1 (en) 2000-03-15 2008-09-29 오르버스네이치 메디칼 인코포레이티드 Coating that promotes endothelial cell adherence
US8460367B2 (en) * 2000-03-15 2013-06-11 Orbusneich Medical, Inc. Progenitor endothelial cell capturing with a drug eluting implantable medical device
US20070141107A1 (en) * 2000-03-15 2007-06-21 Orbusneich Medical, Inc. Progenitor Endothelial Cell Capturing with a Drug Eluting Implantable Medical Device
US20030229393A1 (en) * 2001-03-15 2003-12-11 Kutryk Michael J. B. Medical device with coating that promotes cell adherence and differentiation
US8088060B2 (en) 2000-03-15 2012-01-03 Orbusneich Medical, Inc. Progenitor endothelial cell capturing with a drug eluting implantable medical device
US9522217B2 (en) 2000-03-15 2016-12-20 Orbusneich Medical, Inc. Medical device with coating for capturing genetically-altered cells and methods for using same
US20070055367A1 (en) * 2000-03-15 2007-03-08 Orbus Medical Technologies, Inc. Medical device with coating that promotes endothelial cell adherence and differentiation
US6736838B1 (en) * 2000-03-22 2004-05-18 Zuli Holdings Ltd. Method and apparatus for covering a stent
US6680126B1 (en) * 2000-04-27 2004-01-20 Applied Thin Films, Inc. Highly anisotropic ceramic thermal barrier coating materials and related composites
US6520984B1 (en) 2000-04-28 2003-02-18 Cardiovasc, Inc. Stent graft assembly and method
AU2001259198A1 (en) * 2000-04-28 2001-11-12 Cardiovasc, Inc. Stent graft assembly and method
US20030114918A1 (en) * 2000-04-28 2003-06-19 Garrison Michi E. Stent graft assembly and method
US6854467B2 (en) 2000-05-04 2005-02-15 Percardia, Inc. Methods and devices for delivering a ventricular stent
EP1275344A1 (en) * 2001-07-09 2003-01-15 Bioring SA Device for vascular anastomosis, maintenance and protection
US6579307B2 (en) * 2001-07-19 2003-06-17 The Cleveland Clinic Foundation Endovascular prosthesis having a layer of biological tissue
US7547322B2 (en) * 2001-07-19 2009-06-16 The Cleveland Clinic Foundation Prosthetic valve and method for making same
US7682669B1 (en) * 2001-07-30 2010-03-23 Advanced Cardiovascular Systems, Inc. Methods for covalently immobilizing anti-thrombogenic material into a coating on a medical device
JP4043210B2 (en) * 2001-10-09 2008-02-06 オリンパス株式会社 Stent
US7399312B2 (en) * 2001-10-10 2008-07-15 Scimed Life Systems, Inc. Stent design with sheath attachment members
AU2002364558A1 (en) * 2001-12-11 2003-06-23 Cytograft Tissue Engineering, Inc. Tissue engineered cellular sheets, methods of making and use thereof
US6911040B2 (en) * 2002-01-24 2005-06-28 Cordis Corporation Covered segmented stent
US20030208258A1 (en) * 2002-05-02 2003-11-06 Tom Reilly Vascular grafts surrounding an expanded stent for transplantation
US20040147868A1 (en) * 2003-01-27 2004-07-29 Earl Bardsley Myocardial implant with collar
US7318836B2 (en) 2003-03-11 2008-01-15 Boston Scientific Scimed, Inc. Covered stent
CH696185A5 (en) * 2003-03-21 2007-02-15 Afksendiyos Kalangos Intraparietal reinforcement for aortic valve and reinforced valve has rod inserted in biological tissue or organic prosthesis with strut fixed to one end
US9155639B2 (en) * 2009-04-22 2015-10-13 Medinol Ltd. Helical hybrid stent
US9039755B2 (en) 2003-06-27 2015-05-26 Medinol Ltd. Helical hybrid stent
EP1673039B1 (en) * 2003-10-10 2008-12-03 William A. Cook Australia Pty. Ltd. Stent graft fenestration
US20050113905A1 (en) * 2003-10-10 2005-05-26 Greenberg Roy K. Endoluminal prosthesis with interconnectable modules
US7901447B2 (en) * 2004-12-29 2011-03-08 Boston Scientific Scimed, Inc. Medical devices including a metallic film and at least one filament
US8632580B2 (en) * 2004-12-29 2014-01-21 Boston Scientific Scimed, Inc. Flexible medical devices including metallic films
US20060142838A1 (en) * 2004-12-29 2006-06-29 Masoud Molaei Medical devices including metallic films and methods for loading and deploying same
US8992592B2 (en) * 2004-12-29 2015-03-31 Boston Scientific Scimed, Inc. Medical devices including metallic films
US8998973B2 (en) * 2004-03-02 2015-04-07 Boston Scientific Scimed, Inc. Medical devices including metallic films
US20050197687A1 (en) * 2004-03-02 2005-09-08 Masoud Molaei Medical devices including metallic films and methods for making same
US8591568B2 (en) * 2004-03-02 2013-11-26 Boston Scientific Scimed, Inc. Medical devices including metallic films and methods for making same
US7497872B2 (en) * 2004-03-08 2009-03-03 Cook Incorporated Retainer for a stent-graft
JP2007535389A (en) * 2004-04-30 2007-12-06 オーバスネイク メディカル インコーポレーテッド Medical device with coating for capturing genetically modified cells and method of use thereof
US9561309B2 (en) 2004-05-27 2017-02-07 Advanced Cardiovascular Systems, Inc. Antifouling heparin coatings
US7763064B2 (en) 2004-06-08 2010-07-27 Medinol, Ltd. Stent having struts with reverse direction curvature
US20050278017A1 (en) * 2004-06-09 2005-12-15 Scimed Life Systems, Inc. Overlapped stents for scaffolding, flexibility and MRI compatibility
WO2006071244A1 (en) * 2004-12-29 2006-07-06 Boston Scientific Limited Medical devices including metallic films and methods for making the same
DE102005003632A1 (en) 2005-01-20 2006-08-17 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Catheter for the transvascular implantation of heart valve prostheses
JP4786668B2 (en) 2005-03-01 2011-10-05 リーマン カーディオヴァスキュラー ソシエテ アノニム Body reinforcement device for biological heart prosthesis and reinforced biological heart valve prosthesis
US7854760B2 (en) * 2005-05-16 2010-12-21 Boston Scientific Scimed, Inc. Medical devices including metallic films
GB2427668A (en) * 2005-06-24 2007-01-03 Veryan Medical Ltd Method of forming artificial graft tubing
US20070050006A1 (en) * 2005-08-31 2007-03-01 Cook Ireland Limited Coaxial dilatation method for stent implantation
EP1978893A2 (en) * 2006-02-03 2008-10-15 Design & Performance - Cyprus Limited Implantable graft assembly and aneurysm treatment
EP2097513A4 (en) * 2006-11-17 2012-11-28 Cytograft Tissue Engineering Inc Preparation and use of cell-synthesized threads
US8002815B2 (en) * 2007-03-09 2011-08-23 Novostent Corporation Delivery system and method for vascular prosthesis
US7896915B2 (en) 2007-04-13 2011-03-01 Jenavalve Technology, Inc. Medical device for treating a heart valve insufficiency
US7815677B2 (en) 2007-07-09 2010-10-19 Leman Cardiovascular Sa Reinforcement device for a biological valve and reinforced biological valve
US11389288B2 (en) * 2007-10-11 2022-07-19 Peter Forsell Implantable tissue connector
WO2009052207A2 (en) 2007-10-17 2009-04-23 Hancock Jaffe Laboratories Biological valve for venous valve insufficiency
BR112012021347A2 (en) 2008-02-26 2019-09-24 Jenavalve Tecnology Inc stent for positioning and anchoring a valve prosthesis at an implantation site in a patient's heart
US9044318B2 (en) 2008-02-26 2015-06-02 Jenavalve Technology Gmbh Stent for the positioning and anchoring of a valvular prosthesis
US20100040663A1 (en) * 2008-06-16 2010-02-18 Cytograft Tissue Engineering, Inc. Arterial Implants
US8641753B2 (en) 2009-01-31 2014-02-04 Cook Medical Technologies Llc Preform for and an endoluminal prosthesis
EP2519189B1 (en) 2009-12-28 2014-05-07 Cook Medical Technologies LLC Endoluminal device with kink-resistant regions
CN103002833B (en) 2010-05-25 2016-05-11 耶拿阀门科技公司 Artificial heart valve and comprise artificial heart valve and support through conduit carry interior prosthese
DE102011115902B4 (en) * 2010-12-22 2021-07-01 Bentley Innomed Gmbh Stent-graft and its use
JP5767494B2 (en) * 2011-03-28 2015-08-19 株式会社カネカ Covered stent, stent delivery catheter, and method for manufacturing covered stent
AU2012203620B9 (en) 2011-06-24 2014-10-02 Cook Medical Technologies Llc Helical Stent
EP3281608B1 (en) 2012-02-10 2020-09-16 CVDevices, LLC Medical product comprising a frame and visceral pleura
WO2014045426A1 (en) * 2012-09-24 2014-03-27 テルモ株式会社 Indwelling device and indwelling device assembled body
CA2900862C (en) 2013-02-11 2017-10-03 Cook Medical Technologies Llc Expandable support frame and medical device
CN105491978A (en) 2013-08-30 2016-04-13 耶拿阀门科技股份有限公司 Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame
EP3632378A1 (en) 2015-05-01 2020-04-08 JenaValve Technology, Inc. Device and method with reduced pacemaker rate in heart valve replacement
RU2615861C2 (en) * 2015-06-16 2017-04-11 Валерий Вильгельмович Петрашкевич Implant device for human and animal blood vessels
GB201516683D0 (en) * 2015-09-21 2015-11-04 Univ Bolton Vascular graft
US11065138B2 (en) 2016-05-13 2021-07-20 Jenavalve Technology, Inc. Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system
EP3484568B1 (en) 2016-07-13 2022-04-27 Perfuze Limited High flexibility, kink resistant catheter shaft
CN110392557A (en) 2017-01-27 2019-10-29 耶拿阀门科技股份有限公司 Heart valve simulation
ES2894768T3 (en) 2017-12-15 2022-02-15 Perfuze Ltd Improved catheters and devices and systems incorporating such catheters
DE102019106488A1 (en) * 2019-03-14 2020-09-17 Advanced Angioneers UG (haftungsbeschränkt) Endoluminally insertable exovascular (perivascular) device and device for improving the elasticity of a stiffened blood vessel
CN109966012A (en) * 2019-05-07 2019-07-05 吉林省一汽总医院 A kind of overlay film and its overlay film frame with zigzag bonded structure
WO2023086763A1 (en) * 2021-11-09 2023-05-19 Atrium Medical Corporation Vascular graft with pulsation damping

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3514791A (en) * 1967-07-25 1970-06-02 Charles H Sparks Tissue grafts
US4666442A (en) * 1984-03-03 1987-05-19 Sorin Biomedica S.P.A. Cardiac valve prosthesis with valve flaps of biological tissue
WO1990014804A1 (en) * 1989-05-31 1990-12-13 Baxter International Inc. Biological valvular prosthesis

Family Cites Families (30)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1492192A1 (en) * 1964-07-25 1969-11-06 Thiele Dr Heinrich Process for the production of artificial veins and vessels, such as aortas and trachea
AT261800B (en) * 1966-08-22 1968-05-10 Braun Internat Gmbh B Process for the manufacture of tubular, smooth or threaded tissue-blood vessel prostheses
US3974526A (en) * 1973-07-06 1976-08-17 Dardik Irving I Vascular prostheses and process for producing the same
US3894530A (en) * 1973-07-06 1975-07-15 Irving I Dardik Method for repairing, augmenting, or replacing a body conduit or organ
US3988782A (en) * 1973-07-06 1976-11-02 Dardik Irving I Non-antigenic, non-thrombogenic infection-resistant grafts from umbilical cord vessels and process for preparing and using same
US4300244A (en) * 1979-09-19 1981-11-17 Carbomedics, Inc. Cardiovascular grafts
US4604762A (en) * 1981-02-13 1986-08-12 Thoratec Laboratories Corporation Arterial graft prosthesis
US4539716A (en) * 1981-03-19 1985-09-10 Massachusetts Institute Of Technology Fabrication of living blood vessels and glandular tissues
US4502159A (en) * 1982-08-12 1985-03-05 Shiley Incorporated Tubular prostheses prepared from pericardial tissue
US5215541A (en) * 1982-11-12 1993-06-01 Baxter International Inc. Surfactant treatment of implantable biological tissue to inhibit calcification
US4801299A (en) * 1983-06-10 1989-01-31 University Patents, Inc. Body implants of extracellular matrix and means and methods of making and using such implants
US4842575A (en) * 1984-01-30 1989-06-27 Meadox Medicals, Inc. Method for forming impregnated synthetic vascular grafts
US4728328A (en) * 1984-10-19 1988-03-01 Research Corporation Cuffed tubular organic prostheses
US4798606A (en) * 1985-02-26 1989-01-17 Corvita Corporation Reinforcing structure for cardiovascular graft
CA1292597C (en) * 1985-12-24 1991-12-03 Koichi Okita Tubular prothesis having a composite structure
US5131908A (en) * 1987-09-01 1992-07-21 Herbert Dardik Tubular prosthesis for vascular reconstructive surgery and process for preparing same
US4820298A (en) * 1987-11-20 1989-04-11 Leveen Eric G Internal vascular prosthesis
US5192311A (en) * 1988-04-25 1993-03-09 Angeion Corporation Medical implant and method of making
US5163955A (en) * 1991-01-24 1992-11-17 Autogenics Rapid assembly, concentric mating stent, tissue heart valve with enhanced clamping and tissue alignment
US5755782A (en) * 1991-01-24 1998-05-26 Autogenics Stents for autologous tissue heart valve
US5281422A (en) * 1991-09-24 1994-01-25 Purdue Research Foundation Graft for promoting autogenous tissue growth
CA2087132A1 (en) * 1992-01-31 1993-08-01 Michael S. Williams Stent capable of attachment within a body lumen
WO1994004099A1 (en) * 1992-08-13 1994-03-03 Autogenics Tissue heart valve with concentric mating stents
US5297564A (en) * 1992-08-27 1994-03-29 Love Jack W Catheter technique for creation of an aortico-pulmonary shunt
US5489296A (en) * 1993-12-17 1996-02-06 Autogenics Heart valve measurement tool
US5509930A (en) * 1993-12-17 1996-04-23 Autogenics Stentless heart valve
US5425741A (en) * 1993-12-17 1995-06-20 Autogenics Tissue cutting die
AU2195095A (en) * 1994-03-24 1995-10-09 University Of Washington Devices and methods for implanting transduced cells
US5556414A (en) * 1995-03-08 1996-09-17 Wayne State University Composite intraluminal graft
EP0853465A4 (en) * 1995-09-01 1999-10-27 Univ Emory Endovascular support device and method of use

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3514791A (en) * 1967-07-25 1970-06-02 Charles H Sparks Tissue grafts
US4666442A (en) * 1984-03-03 1987-05-19 Sorin Biomedica S.P.A. Cardiac valve prosthesis with valve flaps of biological tissue
WO1990014804A1 (en) * 1989-05-31 1990-12-13 Baxter International Inc. Biological valvular prosthesis

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0874603A4 *

Cited By (62)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5916264A (en) * 1997-05-14 1999-06-29 Jomed Implantate Gmbh Stent graft
EP0878173A1 (en) * 1997-05-14 1998-11-18 Jomed Implantate GmbH Stent-graft
AU749285B2 (en) * 1997-09-23 2002-06-20 Amnis Therapeutics Ltd. Non-thrombogenic stent jacket
WO1999015105A1 (en) * 1997-09-23 1999-04-01 Carlos Vonderwalde Freidberg Non-thrombogenic stent jacket
US7108717B2 (en) 1997-09-23 2006-09-19 Design & Performance - Cyprus Limited Stent covered with heterologous tissue
US8882822B2 (en) 1997-09-23 2014-11-11 Design & Performance-Cyprus Limited Non-thrombogenic stent jacket
US20150032199A1 (en) * 1997-09-23 2015-01-29 Design & Performance - Cyprus Limited Non-thrombogenic stent jacket
US6468300B1 (en) 1997-09-23 2002-10-22 Diseno Y Desarrollo Medico, S.A. De C.V. Stent covered heterologous tissue
US6254627B1 (en) 1997-09-23 2001-07-03 Diseno Y Desarrollo Medico S.A. De C.V. Non-thrombogenic stent jacket
EP1400218A1 (en) * 1997-12-18 2004-03-24 Schneider (Usa) Inc. Stent-graft with bioabsorbable structural support
US9833343B2 (en) 1997-12-18 2017-12-05 Boston Scientific Scimed, Inc. Stent-graft with bioabsorbable structural support
EP0923912A3 (en) * 1997-12-18 2000-03-15 Schneider (Usa) Inc. Stent-graft with bioabsorbable structural support
EP0984811A1 (en) * 1998-02-26 2000-03-15 World Medical Manufacturing Corporation Delivery system for deployment and endovascular assembly of a multi-stage stented graft
EP0984811A4 (en) * 1998-02-26 2005-03-09 World Medical Mfg Corp Delivery system for deployment and endovascular assembly of a multi-stage stented graft
WO2000030564A3 (en) * 1998-11-23 2000-11-16 Medtronic Inc Porous synthetic vascular grafts with oriented ingrowth channels
US7727274B2 (en) 1998-11-23 2010-06-01 Medtronic, Inc. Porous synthetic vascular grafts with oriented ingrowth channels
US8187319B2 (en) 1998-11-23 2012-05-29 Medtronic, Inc. Porous synthetic vascular grafts with oriented ingrowth channels
WO2000030564A2 (en) * 1998-11-23 2000-06-02 Medtronic, Inc. Porous synthetic vascular grafts with oriented ingrowth channels
US10188532B2 (en) 1998-12-29 2019-01-29 Vascular Flow Technologies Limited Blood-flow tubing
USRE42857E1 (en) * 2000-01-27 2011-10-18 3F Therapeutics, Inc. Method of laser cutting pericardial tissue for use with an implantable medical device
US8672999B2 (en) 2000-01-27 2014-03-18 Medtronic 3F Therapeutics, Inc. Prosthetic heart valve assemblies
US6296661B1 (en) 2000-02-01 2001-10-02 Luis A. Davila Self-expanding stent-graft
US6245100B1 (en) 2000-02-01 2001-06-12 Cordis Corporation Method for making a self-expanding stent-graft
US6613084B2 (en) 2000-03-13 2003-09-02 Jun Yang Stent having cover with drug delivery capability
US6379382B1 (en) 2000-03-13 2002-04-30 Jun Yang Stent having cover with drug delivery capability
US6613082B2 (en) 2000-03-13 2003-09-02 Jun Yang Stent having cover with drug delivery capability
JP2003531674A (en) * 2000-05-04 2003-10-28 オレゴン ヘルス サイエンシーズ ユニバーシティー Stent graft
AU2001261200B2 (en) * 2000-05-04 2006-02-09 Oregon Health Sciences University Endovascular stent graft
WO2001082836A3 (en) * 2000-05-04 2002-04-18 Univ Oregon Health Sciences Endovascular stent graft
US7686842B2 (en) 2000-05-04 2010-03-30 Oregon Health Sciences University Endovascular stent graft
JP4726382B2 (en) * 2000-05-04 2011-07-20 オレゴン ヘルス サイエンシーズ ユニバーシティー Stent graft
US7862609B2 (en) 2000-11-16 2011-01-04 Cordis Corporation Stent graft having a pleated graft member
EP1785109A3 (en) * 2001-01-12 2007-05-30 Boston Scientific Limited Stent for in-stent restenosis
GB2379996A (en) * 2001-06-05 2003-03-26 Tayside Flow Technologies Ltd Flow means
GB2379996B (en) * 2001-06-05 2004-05-19 Tayside Flow Technologies Ltd Flow means
US6776194B2 (en) 2001-06-05 2004-08-17 Tayside Flow Technologies Limited Flow means
AU2003295797B2 (en) * 2002-11-22 2009-01-29 Cook Biotech, Inc. Stent tissue graft prosthesis
US7914567B2 (en) 2002-11-22 2011-03-29 Oregon Health & Science University Stent tissue graft prosthesis
WO2004047687A1 (en) * 2002-11-22 2004-06-10 Cook Incorporated Stent tissue graft prosthesis
WO2004082533A1 (en) 2003-03-18 2004-09-30 Veryan Medical Limited Helical stent
EP2292183A1 (en) 2003-03-18 2011-03-09 Veryan Medical Limited Helical stent
EP2145601A2 (en) 2003-03-18 2010-01-20 Veryan Medical Limited Helical stent
US8226704B2 (en) 2003-03-18 2012-07-24 Veryan Medical Limited Helical stent
US9572694B2 (en) 2003-03-18 2017-02-21 Veryan Medical Limited Helical graft
WO2004082520A2 (en) 2003-03-18 2004-09-30 Veryan Medical Limited Device for placement externally of a body fluid flow conduit
WO2004082534A1 (en) 2003-03-18 2004-09-30 Veryan Medical Limited Helical graft
US8784476B2 (en) 2003-03-18 2014-07-22 Veryan Medical Limited Helical stent
EP1725188A1 (en) * 2004-03-02 2006-11-29 Boston Scientific Scimed, Inc. Medical devices including metallic films and methods for making same
US7789915B2 (en) 2005-08-31 2010-09-07 Vance Products Incorporated Stent for implantation
WO2007035791A3 (en) * 2005-09-19 2007-05-10 Cook Inc Graft with bioabsorbable support frame
US8663308B2 (en) 2005-09-19 2014-03-04 Cook Medical Technologies Llc Graft with bioabsorbable support frame
AU2006292237B2 (en) * 2005-09-19 2012-01-12 Cook Medical Technologies Llc Graft with bioabsorbable support frame
WO2008144229A1 (en) * 2007-05-14 2008-11-27 Vance Products Incorporated D/B/A Cook Urological Incorporated Stent for implantation
US9597214B2 (en) 2008-10-10 2017-03-21 Kevin Heraty Medical device
US9883961B2 (en) 2008-10-10 2018-02-06 Veryan Medical Limited Medical device
US9067026B2 (en) 2009-05-19 2015-06-30 Vascular Flow Technologies Limited Vascular graft
EP2380526A3 (en) * 2010-04-23 2013-09-18 Biotronik AG Implant and method for producing the same
US10271941B2 (en) 2010-04-23 2019-04-30 Biotronik Ag Implant and method for producing the same
US10893932B2 (en) 2010-04-23 2021-01-19 Biotronik Ag Implant and method for producing the same
US9498356B2 (en) 2012-12-19 2016-11-22 Cook Medical Technologies, LLC Flexible stent and delivery system
US9763814B2 (en) 2014-10-24 2017-09-19 Cook Medical Technologies Llc Elongate medical device
EP3305248A4 (en) * 2015-06-02 2019-02-13 Adeka Corporation Sheet of biological tissue, tubular structure produced from said sheet, and artificial blood vessel comprising said tubular structure

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DE69636438D1 (en) 2006-09-21
CA2240989A1 (en) 1997-07-10
EP0874603B1 (en) 2006-08-09
AU720362B2 (en) 2000-06-01
EP0874603A4 (en) 2000-04-26
AU1569297A (en) 1997-07-28
EP0874603A1 (en) 1998-11-04
US5865723A (en) 1999-02-02
JP2000502586A (en) 2000-03-07

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