CA2231560C - Apparatus and method for percutaneous sealing of blood vessel punctures - Google Patents
Apparatus and method for percutaneous sealing of blood vessel punctures Download PDFInfo
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- CA2231560C CA2231560C CA002231560A CA2231560A CA2231560C CA 2231560 C CA2231560 C CA 2231560C CA 002231560 A CA002231560 A CA 002231560A CA 2231560 A CA2231560 A CA 2231560A CA 2231560 C CA2231560 C CA 2231560C
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- catheter
- introducer
- distal end
- puncture
- vessel
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
- A61B17/085—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00672—Locating means therefor, e.g. bleed back lumen
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
Abstract
A device for promoting hemostasis in a blood vessel puncture is employed with an introducer that accesses the puncture through an incision. The introducer has an open distal end positionable at the puncture, an external portion with an open proximal end, and an axial channel therebetween. The device includes a hollow catheter, dimensioned to pass through the introducer channel, having a distal end to which is attached an expansible compression element, which may be an inflatable balloon, a collapsible prong assembly, or a resilient foam pad. Pressure is applied to the compression element through the introducer to promote hemostasis by the compression of subcutaneous tissue adjacent the puncture. The device preferably includes a locator member passing through the catheter and into the blood vessel through the puncture. The locator member may be either a guide wire, or a hollow tube with a locating balloon, disposed near the portion of the tube insertable into the vessel.
Description
CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 APPARATUS AND METHOD FOR PERCUTANEOUS
3 Background of the Invention 4 The present invention relates generally to the field of apparatus 5 and methods for sealing wounds in the blood vessels of humans or 6 ~nim~l~. More specifically, the invention relates to a guided vascular 7 compression device for percutaneously sealing arterial or venous 8 punctures subsequent to surgical procedures, by promoting in situ g hemostasis.
A large number of medical therapeutic and diagnostic procedures 11 involve the percutaneous introduction of instrumentation into a vein or 12 artery. For example, percutaneous translllmin~l coronary angioplasty 13 (PTCA), most often involving access to the femoral artery, is performed 14 hundreds of thousands of times annually, and the number of other such l S vessel-piercing procedures performed, e.g., percutaneous coronary 16 angiography and atherectomy, has exceeded two million per year.
17 In each event, the closing and subsequent healing of the resultant 18 vascular puncture is critical to the successful completion of the 19 procedure. Traditionally, the application of external pressure to the ~O skin entry site by a nurse or physician has been employed to stem 21 bleeding from the wound until clotting and tissue rebuilding have sealed 22 the perforation. In some situations, this pressure must be maintained 23 for half an hour to an hour or more, during which the patient is 24 uncomfortably immobilized, often with sandbags and the like. With 25 externally applied manual pressure, both patient comfort and 26 practitioner efficiency are impaired. Additionally, a risk of hematoma 27 exists since bleeding from the vessel may continue until sufficient 28 clotting effects hemostasis. Also, external pressure devices, such as CA 02231~60 1998-03-10 W O 97/09934 PCT~US96/14486 femoral compression systems, may be unsuitable for patients with 2 sub~t~nti~1 amounts of subcutaneous adipose tissue, since the skin 3 surface rnay be a considerable distance from the vascular puncture site, 4 thereby rendering skin compression inaccurate and thus less effective.
6 More recently, devices have been proposed to promote 7 hemostasis directly at the site of the vascular perforation. One class of 8 such puncture sealing devices features intralllmin~l plugs, as disclosed 9 in U.S. Patents Nos. 4,852,568 - Kensey; 4,890,612 - Kensey; 5,021,059 -Kensey et al.; and 5,061,774 - Kensey. This class of device is 11 characterized by the placement of an object within the bloodstream of 12 the vessel to close the puncture.
3 Another approach to subcutaneous puncture closure involves 4 delivery of tissue adhesives to the perforation site, as disclosed in U.S.
Patent No. 5,383,899 - Hammerslag. Some likelihood exists of 6 introducing the adhesive so employed disadvantageously into the 1 7 bloodstream. U.S. Patent No. 4,929,246 - Sinofsky discloses the concept 18 of applying pressure directly to an artery, and relies on the directing of 19 laser energy through an optical fiber to cauterize the wound.
Yet another proposed solution to obviate the reliance on skin 21 surface pressure is disclosed in U.S. Patent No. 5,275,616 - Fowler, 22 wherein a cylindrical plug is inserted along the shaft of a catheter 23 segment extending from the skin surface to the blood vessel. The 24 catheter is then removed so that the plug can expand as fluid is drawn into the plug from the vessel and surrounding tissue. Unless pressure is 26 applied, however, bleeding may occur around the plug into the 27 subcutaneous tissue. Another approach that similarly deposits a plug CA 02231~60 1998-03-lO
W O 97/09934 PCT~US96/14486 into the tissue channel is disclosed in U.S. Patent No. 5,391,183 -2 Janzen et al., which discloses a variety of plug delivery devices including 3 threaded plug pushers and multilegged channels. As in the other 4 disclosed methods for introducing a foreign plug into the incision, the Janzen et al. plug material, generally resorbable, is not removed from 6 the patient once installed. Such permanent placement of foreign 7 material into the body may result in inflammation or scar formation in 8 the long term.
g Furthermore, many of the prior art devices rely on tactile sensation alone to indicate to the surgeon the proper placement of the 11 puncture closing instrumentation, and may require upstream clamping 12 of the blood vessel to reduce intralnmin~l pressure to atmospheric at 13 the puncture site.
14 As the foregoing description of the prior art demonstrates, none of the heretofore proposed solutions fulfills the need for a relatively 16 simple, non-cautery apparatus and method for subcutaneously applying 17 pressure directly to the vicinity of the vessel puncture by means of a 18 pressure element that is removed from the patient once sealing of the 19 puncture is achieved. There is a further need for a puncture sealing system that features use of instruments already in place at the access 21 site so that the position for possible reentry is not lost, and the time 22 required for the physician to change instrumentation is minimi7ed.
23 There is a still further need for a system that m~int~in~ pressure on the 24 puncture site by lightweight mechanical means, thereby relieving the patient from the discomfort of external compression means, and freeing 26 hospital personnel from constant surveillance of cumbersome external 27 pressure structures for the duration of the hemostasis. There is also a CA 02231~60 1998-03-lO
W O 97/09934 PCTrUS96/14486 need for a hemostatic device that can be effectively employed 2 regardless of the thickness of the tissue between the skin and the 3 puncture site, by applying localized pressure close to the puncture site, 4 rather than remote, diffused pressure to the skin surface.
Summa~ of the Invention It is an object of this invention to provide a method and 7 apparatus for sealing post-surgical vascular punctures that overcome the 8 foregoing deficiencies.
g It is a further object to apply pressure directly to the vicinity of the vascular puncture access site utili7ing a subcutaneous pressure 11 element that is removed permanently from the patient once hemostasis 12 iS achieved.
13 It is another object to employ an introducer instrument already 14 in place at the access site to minimi7e instrumentation ch~ngin~ time, and to maintain access during an initial clotting period to facilitate 16 possible reentry.
17 It is yet another object to m~int~in adequate hemostatic pressure 18 on an adipose or fatty tissue layer above the puncture site in order to 19 close the puncture naturally, to reduce the potential for pseudo-aneurysm formation, and to maintain such pressure by 21 lightweigh~, non-labor intensive, mechanical means, thereby reducing 22 patient discomfort.
23 The present invention involves a method for sealing a puncture 24 site in a blood vessel, and apparatus for performing that method, wherein use is made of an introducer sheath (commonly referred to in 26 the medical community as an "introducer") which is usually already in 27 place inside the puncture site when a medical practitioner has CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 completed a procedure that requires intravascular access. Locator 2 means, preferably either a locator tube (having an infl~t~ble locating 3 balloon), or a standard guidewire, is passed through the introducer and 4 into the lumen of the vessel.
A semi-rigid catheter, including an expandable compression 6 element at its distal end, and either two axial lumens (used in a 7 compression balloon embodiment) or a single axial lumen (used in 8 other embodiments), is inserted along the locator means fully into the g introducer so that the expandable compression element at the distal 10 end of the catheter is contained in an unexpanded state within the 11 distal end of the introducer when the introducer is in a first or distal 12 position relative to the catheter.
A large number of medical therapeutic and diagnostic procedures 11 involve the percutaneous introduction of instrumentation into a vein or 12 artery. For example, percutaneous translllmin~l coronary angioplasty 13 (PTCA), most often involving access to the femoral artery, is performed 14 hundreds of thousands of times annually, and the number of other such l S vessel-piercing procedures performed, e.g., percutaneous coronary 16 angiography and atherectomy, has exceeded two million per year.
17 In each event, the closing and subsequent healing of the resultant 18 vascular puncture is critical to the successful completion of the 19 procedure. Traditionally, the application of external pressure to the ~O skin entry site by a nurse or physician has been employed to stem 21 bleeding from the wound until clotting and tissue rebuilding have sealed 22 the perforation. In some situations, this pressure must be maintained 23 for half an hour to an hour or more, during which the patient is 24 uncomfortably immobilized, often with sandbags and the like. With 25 externally applied manual pressure, both patient comfort and 26 practitioner efficiency are impaired. Additionally, a risk of hematoma 27 exists since bleeding from the vessel may continue until sufficient 28 clotting effects hemostasis. Also, external pressure devices, such as CA 02231~60 1998-03-10 W O 97/09934 PCT~US96/14486 femoral compression systems, may be unsuitable for patients with 2 sub~t~nti~1 amounts of subcutaneous adipose tissue, since the skin 3 surface rnay be a considerable distance from the vascular puncture site, 4 thereby rendering skin compression inaccurate and thus less effective.
6 More recently, devices have been proposed to promote 7 hemostasis directly at the site of the vascular perforation. One class of 8 such puncture sealing devices features intralllmin~l plugs, as disclosed 9 in U.S. Patents Nos. 4,852,568 - Kensey; 4,890,612 - Kensey; 5,021,059 -Kensey et al.; and 5,061,774 - Kensey. This class of device is 11 characterized by the placement of an object within the bloodstream of 12 the vessel to close the puncture.
3 Another approach to subcutaneous puncture closure involves 4 delivery of tissue adhesives to the perforation site, as disclosed in U.S.
Patent No. 5,383,899 - Hammerslag. Some likelihood exists of 6 introducing the adhesive so employed disadvantageously into the 1 7 bloodstream. U.S. Patent No. 4,929,246 - Sinofsky discloses the concept 18 of applying pressure directly to an artery, and relies on the directing of 19 laser energy through an optical fiber to cauterize the wound.
Yet another proposed solution to obviate the reliance on skin 21 surface pressure is disclosed in U.S. Patent No. 5,275,616 - Fowler, 22 wherein a cylindrical plug is inserted along the shaft of a catheter 23 segment extending from the skin surface to the blood vessel. The 24 catheter is then removed so that the plug can expand as fluid is drawn into the plug from the vessel and surrounding tissue. Unless pressure is 26 applied, however, bleeding may occur around the plug into the 27 subcutaneous tissue. Another approach that similarly deposits a plug CA 02231~60 1998-03-lO
W O 97/09934 PCT~US96/14486 into the tissue channel is disclosed in U.S. Patent No. 5,391,183 -2 Janzen et al., which discloses a variety of plug delivery devices including 3 threaded plug pushers and multilegged channels. As in the other 4 disclosed methods for introducing a foreign plug into the incision, the Janzen et al. plug material, generally resorbable, is not removed from 6 the patient once installed. Such permanent placement of foreign 7 material into the body may result in inflammation or scar formation in 8 the long term.
g Furthermore, many of the prior art devices rely on tactile sensation alone to indicate to the surgeon the proper placement of the 11 puncture closing instrumentation, and may require upstream clamping 12 of the blood vessel to reduce intralnmin~l pressure to atmospheric at 13 the puncture site.
14 As the foregoing description of the prior art demonstrates, none of the heretofore proposed solutions fulfills the need for a relatively 16 simple, non-cautery apparatus and method for subcutaneously applying 17 pressure directly to the vicinity of the vessel puncture by means of a 18 pressure element that is removed from the patient once sealing of the 19 puncture is achieved. There is a further need for a puncture sealing system that features use of instruments already in place at the access 21 site so that the position for possible reentry is not lost, and the time 22 required for the physician to change instrumentation is minimi7ed.
23 There is a still further need for a system that m~int~in~ pressure on the 24 puncture site by lightweight mechanical means, thereby relieving the patient from the discomfort of external compression means, and freeing 26 hospital personnel from constant surveillance of cumbersome external 27 pressure structures for the duration of the hemostasis. There is also a CA 02231~60 1998-03-lO
W O 97/09934 PCTrUS96/14486 need for a hemostatic device that can be effectively employed 2 regardless of the thickness of the tissue between the skin and the 3 puncture site, by applying localized pressure close to the puncture site, 4 rather than remote, diffused pressure to the skin surface.
Summa~ of the Invention It is an object of this invention to provide a method and 7 apparatus for sealing post-surgical vascular punctures that overcome the 8 foregoing deficiencies.
g It is a further object to apply pressure directly to the vicinity of the vascular puncture access site utili7ing a subcutaneous pressure 11 element that is removed permanently from the patient once hemostasis 12 iS achieved.
13 It is another object to employ an introducer instrument already 14 in place at the access site to minimi7e instrumentation ch~ngin~ time, and to maintain access during an initial clotting period to facilitate 16 possible reentry.
17 It is yet another object to m~int~in adequate hemostatic pressure 18 on an adipose or fatty tissue layer above the puncture site in order to 19 close the puncture naturally, to reduce the potential for pseudo-aneurysm formation, and to maintain such pressure by 21 lightweigh~, non-labor intensive, mechanical means, thereby reducing 22 patient discomfort.
23 The present invention involves a method for sealing a puncture 24 site in a blood vessel, and apparatus for performing that method, wherein use is made of an introducer sheath (commonly referred to in 26 the medical community as an "introducer") which is usually already in 27 place inside the puncture site when a medical practitioner has CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 completed a procedure that requires intravascular access. Locator 2 means, preferably either a locator tube (having an infl~t~ble locating 3 balloon), or a standard guidewire, is passed through the introducer and 4 into the lumen of the vessel.
A semi-rigid catheter, including an expandable compression 6 element at its distal end, and either two axial lumens (used in a 7 compression balloon embodiment) or a single axial lumen (used in 8 other embodiments), is inserted along the locator means fully into the g introducer so that the expandable compression element at the distal 10 end of the catheter is contained in an unexpanded state within the 11 distal end of the introducer when the introducer is in a first or distal 12 position relative to the catheter.
13 The introducer and the catheter are partially withdrawn together 14 (moved proximally) from the puncture site until a preferred location 15 above the vessel is achieved, the relative axial positions of the 16 introducer and the catheter rem~ininE unchanged, so that the 17 introducer remains in its first or distal position relative to the catheter.
18 This location is chosen to provide for a layer of fatty tissue above the 19 puncture site between the compression element and the vessel. The 20 extent of partial withdrawal is determined by the tactile sense of the 21 practitioner, aided by a marker on a locator tube for the embodiment 22 employing a locating balloon as the locator means, or by fluoroscopic 23 viewing of a contrast medium, for the embodiment employing a ~ 24 guidewire as the locating means.
When the location is achieved, the introducer is moved to a 26 second or proximal position relative to the catheter until the 27 expandable compression element is revealed and expanded to bear on CA 02231~60 1998-03-lO
W O 97/09934 PCT~US96/14486 the fatty tissue layer.
2 In another embodiment, the expandable compression element 3 comprises an expandable prong assembly including a resilient sp~nning 4 sheet for compressing the fatty tissue layer. In still another embodiment, the expandable compression element comprises a foam 6 pad element bearing directly on the fatty tissue layer upon expansior 7 when deployed from the introducer.
8 Once the compression element (balloon, prongs or foam tip) is in g place, a lightweight holding arrangement is employed to maintain hemostatic pressure. The holding arrangement comprises an adhesive 11 skin patch and fastener strips or bands bringing d~wllward pressure on 12 a sheath cuff clamped to the introducer. After an initial period of 13 hemostasis, (approximately one to five minutes), the locator means 14 (locator balloon tube or guidewire) is removed from the puncture and the apparatus. After another five to twenty-five minutes of pressure on 16 the puncture, the expandable distal end element (compression balloon, 17 prongs or iEoam) is collapsed, and the introducer and catheter are 18 permanently removed from the patient.
19 These and other features and advantages of the present invention will be more readily apparent from the Detailed Description that 21 follows.
22 Brief Description of the Drawings 23 Fig. l is an elevational view, partially in cross section, illustrating 24 a first preferred embodiment of the present invention;
Fig. lA is an elevational view, partially in cross section, 26 illustrating the initial position in a puncture site of the distal portion of 2 7 the apparatus of Fig. 1;
CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 Fig. lB is an elevational view, partially in cross section, 2 illustrating the apparatus of Fig. lA in a preferred operational position;
3 Fig. lC is an elevational view, partially in cross section, 4 illustrating the apparatus of Fig. lA with the compression balloon revealed and not yet inflated;
6 Fig. lD is a cross sectional view taken along lines lD-lD of Fig.
7 1, illustrating the dual lumen configuration of a catheter element of the 8 apparatus of Fig. l;
g Fig. 2 is an elevational view, partially in cross section, of a secondl O preferred embodiment of the present invention, showing the 11 compression mech~ni~m of this embodiment in a retracted state near a 12 vascular puncture site;
13 Fig. 2A is a perspective view of the embodiment of Fig. 2, 14 showing the compression mech~ni~m in an expanded state;
Fig. 2B is a view ~imil~r to that of Figure 2, showing the 16 compression mech~ni~m deployed, in its expanded state, at a vascular 17 puncture site;
18 Fig. 3 is an elevational view, partially in cross section, of a third 19 preferred embodiment of the present invention, showing the compression mech~nicm of this embodiment in a retracted state near a 21 vascular puncture site;
22 Fig. 3A is a view, similar to that of Fig. 3, illustrating the 23 compression mech~ni~m in an expanded state;
24 Fig. 4 is a perspective view of a fourth preferred embodiment of the present invention;
26 Fig. 4A is an elevational view, partially in cross section, 27 illustrating the initial position in a puncture site of the introducer and CA 02231~60 1998-03-10 guidewire elements of the apparatus of Fig. 4;
2 Fig. 4B is a view simil~r to that of Fig. 4A, but showing a a 3 catheter contained within introducer when the introducer is in a first 4 axial position relative to the catheter;
s Fig. 4C is an elevational view, partially in cross section, 6 illustrating the apparatus of Fig. 4A in a preferred operational position;
7 Fig. 4D is an elevational view, partially in cross section, 8 illustrating the apparatus of Fig. 4A with the compression balloon g revealed and not yet inflated, the introducer having been moved to a second axial position relative to the catheter;
11 Fig. 4E is a perspective view, partially in cross section, illustrating12 the compression balloon of the apparatus of Fig. 4D in an inflated 13 state;
14 Fig. 4F is an elevational view, partially in cross section, illustrating the apparatus of Fig. 4E with the guidewire element 16 withdrawn; and 17 Figo 5 is an elevational view, partially in cross section, illustrating18 a modification of the embodirnent of Fig.1.
19 Detailed Description of the Preferred Embodiments 1. Structure of the Apparatus 21 A percutaneous blood vessel se~ling device, or percutaneous 22 hemostatic device 10, which applies hemostatic sealing pressure directly 23 to tissue adjacent a vascular puncture site, without employing implanted 24 materials, is shown in Fig. 1.
In each exemplary embodiment described herein, an introducer 26 sheath ("introducer") 12, well known in the art, is present in an incision 27 14 that extends from the skin surface 16 to a blood vessel (artery or CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 vein) 18 of a patient at the site of a blood vessel puncture 20. The 2 introducer 12 has normally been inserted previously to provide access to 3 the vessel 18 for instrumentation (not shown) used in performing a 4 vascular procedure immediately preceding the need to seal the puncture 20. The initial position of an introducer 12 so inserted is most clearly 6 illustrated in Fig. 4A, which shows a tapered distal end 22 of the 7 introducer 12 at a puncture site 24, inserted within a vascular puncture 8 20. Typically, the introducer 12 will have a size of approximately 7 g French (2.3 mm in diameter), and a length of approximately 130 mm, although a size as large as 14 French (4.7 mm in diameter) may be used 11 for larger punctures.
12 A working channel 26, best seen in Fig. lD, extends axially from 13 the proximal end 28 of the introducer 12 through its tapered distal end 14 22. In the first preferred embodiment of Figures 1 through lD, a hollow locator tube 30 extends coaxially through the introducer 12 and 16 into the vessel 18 through the puncture 20. Guided by the locator tube 7 30 into the introducer working channel 26 is a semi-rigid catheter 32 18 having a catheter proximal end 33, and a catheter distal end 34 (Fig.
19 lA). The introducer 12 is movable axially with respect to the catheter 32, and is disposed initially at a first axial position, or distal position, in 21 which the catheter distal end 34 is enclosed or sheathed within the 22 distal end 22 of the introducer 12.
23 The catheter 32 is a dual-lumen device having a first axial lumen 24 36 (Fig. lD) which encompasses the locator tube 30 when the catheter 32 is inserted into the working channel 26 of the introducer 12. A
26 second axial lumen 38 is provided with an inflation orifice 40 near its 27 distal end, the inflation orifice communicating with the interior of a CA 02231~60 1998-03-lO
W O 97/09934 PCTrUS96/14486 compression balloon 42 that concentrically surrounds a portion of the 2 length of trhe catheter 32 extending proximally from its distal end 34.
3 The compression balloon 42 is initially enclosed, in an llninfl~ted state, 4 within the distal end 22 of the introducer 12, as illustrated in Fig. lA.
The opposite (proximal) end of the second axial lumen 38 6 communicates with a compression balloon inflation port 44 through an 7 inflation tube 45, as shown in lFigures 1 and 4. Overall, the catheter 32 8 has an outer diameter sufficiently small to be freely insertable into the g introducer 12, and a length that is greater than that of the introducer 12, i.e., in the range of about 130 mm to about 750 mm.
11 At the proximal end 28 of the introducer 12 is a well-known luer 12 type lock fitting 46 configured to mate with a catheter proximal end 13 luer fitting 48 when the introducer 12 and the catheter 32 are in a final 14 operational position, as determined by manipulation of the locator tube 30, as will be described below. The locator tube 30 has an infl~t~ble 16 intrav~c~ r locating balloon 50 at its distal end portion, shown in Fig.
1 7 lA in an llninfl~ted state. The interior of the locating balloon 50 is in 18 fluid communication with the hollow interior of the locator tube 30 19 through a suitable inflation orifice (not shown), as is well known in conventional balloon catheters and the like.
21 Although the luer locks 46, 48 may be employed for both the 22 locator balloon embodiment (Figures 1 through lD) and for 23 embodiments (described below) featuring expandable compression 24 elements other than the compression balloon 42, a version using no luer locks will be described below that is specifically adapted for use with 26 the compression balloon 42. Both the luer and non-luer versions are 27 suitable for embodiments employing either the inflatable locating CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 balloon 50 or a guidewire locating means, to be described below.
2 Returning now to Figures lA through lC, a progression of 3 locating positions for the device 10 is illustrated. Figure lA shows the 4 locator tube 30, having the llninfl~ted locating balloon 50 near its distal end, inserted into the vessel 18 through the introducer 12 and the 6 vascular puncture 20. It is advantageous to construct the locator tube 7 30 so that a length of tube extends distally beyond the location of the 8 locating balloon 50 into the vessel 18 to facilitate re-access through the g vascular puncture 20, if required. The entire apparatus 10 (including the introducer 12 and the catheter 32) is in its initial position relative to 11 the vessel; that is, the distal tip 22 of the introducer 12 is located 12 adjacent to or within the puncture 20, while the introducer 12 is in its 13 above-described first axial position or distal position relative to the 14 catheter 32, in which the catheter distal end 34 and the llninfl~ted compression balloon 42 are enclosed within the distal end 22 of the 16 introducer 12.
1 7 Figure lB illustrates the device 10 after the locating balloon 50 18 has been inflated by fluid introduced into it via the locator tube 30.
19 The entire device 10 (including the introducer 12 and the catheter 32) has been partially withdrawn from the puncture site 24 in the direction 21 of the arrow 52 (i.e., in the proximal direction), to a "preferred 22 operational position", in which the locating balloon 50 is lodged against 23 an interior wall 54 of the vessel 18. The introducer 12 remains in its 24 first or distal position, in which the portion of the catheter 32 carrying the llninfl~ted compression balloon 42 is enclosed within the distal end 26 22 of the introducer 12.
27 In Figure lC, the introducer 12 has been moved axially, relative CA 02231~60 1998-03-lO
to the catheter 32, in the direction of the arrow 52 (i.e., proximally), to 2 its second axial position, or proximal position. The movement of the 3 introducer 12 to this second or proximal position uncovers the 4 llninfl~ted compression balloon 42.
s The compression stage of the device 10 is illustrated next in Fig.
6 1. The compression balloon 42, inflated via the second axial lumen 38 7 (Fig. lD), rests in an optimal position to effect natural hemostasis, viz.,8 above a l~min~r portion 56 of the fatty tissue adjacent the puncture site 9 24. An optimal distance from the vessel 18 to the catheter distal end 34 is in the range of 2 mm to 10 mm. This distance will dispose a layer 11 of fatty tissue 56 between the vessel 18 and the catheter 32, minimi7:in~
12 the potential for pseudo-aneurysm. The introducer luer lock 46 is 13 shown engaged with the catheter luer lock 48, assuring that a holding 14 force applied to the introducer 12 will be transmitted as well to the catheter 32. In addition, a visible marker band 57 on the exterior of 1 6 the locating tubing 30 may advantageously be provided to align the 1 7 proximal ends of the introducer 12 and the catheter 32 in 18 correspondence with the location of the distal ends 22, 34 thereof when 19 the locator balloon 50 is lodged against the inner wall 54 of vessel 18.
An adhesive skin patch 58 with a sheath cuff 60 clamped onto 21 the external portion of the introducer 12 to apply downward force (in 22 the direction of the arrow 62, i.e., distally) on the introducer 12 is 23 shown in Figures 1 and 4. Fastener strips 64 secure the adhesive patch 24 58 to the sheath cuff 60. The fastener strips 64 may be elastic bands with suitable adhesive areas, or hook and loop strips (such as the type 26 marketed under the trademark VELCR0) that adhere to areas of 27 complementary material on the patch 58. Pressure m~int~ined by the CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 introducer sheath cuff60 on the catheter 32 provides hemostatic 2 pressure on the compression balloon 42 to bear on the tissue layer 56 3 for a first period of time, whereupon the locating tube 30 is withdrawn 4 (the locator balloon S0 having first been deflated), and a second period of time elapses, after which all instrumentation is removed from the 6 patient as will be noted when the method for sealing the puncture 20 is 7 described in detail below.
8 Another embodiment of the present invention is illustrated in g Figures 2, 2A, and 2B, which show a collapsible prong assembly compression element 66 attached to the catheter distal end 34. The 11 prong assembly 66is radially compressed or collapsed when enclosed 12 within the introducer 12, when the introducer is in its first or distal 13 position. The prong assembly 66 expands radially when the introducer 14 12 is partially withdrawn from the vessel 18 (Figures 2A and 2B), by moving the introducer 12 to its second or proximal position in a 16 manner similar to the partial withdrawal of introducer 12 in the 17 direction of arrow 52 as described previously in connection with the 18 compression balloon embodiment.
19 The prong assembly 66 comprises a plurality of spaced-apart resilient prongs 68, the proximal ends of which are attached to the 21 catheter 32, and the distal ends of which are attached to a collapsible 22 sp~nning film sheet or dam 70, shown expanded in Figures 2A and 2B.
23 The sheet or dam 70 allows the application of hemostatic pressure on 24 the tissue 56 above the vessel 18. A central aperture 72 in the sheet or dam 70 permits the locator tube (not shown) to project through the 26 catheter 32 into the vessel 18 as described previously. Since there is no 27 compression balloon to be inflated, a catheter with a single axial lumen CA 02231~60 1998-03-10 W O 97/09934 PCT~US96/14486 36 is adequate for this application. Materials for the sp~nning sheet or 2 dam 70 may include polyurethane and polyethyleneterephthalate (PET).
3 Still another embodiment of the invention is illustrated in Figures 4 3 and 3A~ which show a foam pad compression element 74 attached to the catheter distal end 34. The foam pad element 74 is compressed 6 when enclosed within the introducer 12 when the introducer is in its 7 first or distal position. The foam pad compression element 74 then 8 expands when the introducer 12 is partially withdrawn from the vessel 9 18, as shown in Fig. 3A, by moving the introducer 12 to its second or proximal position, as described above with respect to the first and l l second embodiments. Hemostatic pressure is simil~rly exerted on the 12 tissue 56 above the vessel 18. An axial channel 76 in the foam pad 74 13 permits the locator tube (not shown) to project through the catheter 32 14 into the vessel 18, as described previously. As with the exp~n~lin~
prong embodiment above, since there is no compression balloon to be 16 inflated, a catheter with a single axial lumen 36 is adequate for this 1 7 embodiment. Materials for the foam pad 74 may include various 8 polymeric foams, such as polyurethanes, as are well-known in the art.
19 The foam pad 74 may be impregnated with a coagulant such as thrombin or protamine to effect local hemostasis.
21 The foregoing embodiments, featuring both the luer locking of 22 the introducer 12 with the catheter 32, and a variety of expandable 23 compression elements 42, 66, 74 at the catheter distal end 34, employ a 24 locator tube 30 with a locating balloon 50 to determine the optimal operational location for the apparatus 10. In lieu of a locating balloon 26 50, a guidewire 78 may be utilized for the location determin~tion of the 27 apparatus 10, as illustrated in Figures 4 through 4F.
CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 In Fig. 4A, a standard guidewire 78, typically 3 French (1 mm in 2 diameter), shown coaxially located within the introducer 12, has a distal 3 end 82 extending out of the introducer distal end 22 into the puncture 4 20 of the vessel 18.
s The catheter 32 is shown in Fig. 4B having been inserted into the 6 introducer 12 and guided to the distal end 22 of the introducer by the 7 guidewire 78. At the distal end 34 of the catheter 32 is a radiopaque 8 marker 84 for -viewing under fluoroscopy, as shown in Fig. 4D.
g Figure 4C shows an optimal location for catheter distal end 34, radiopaque contrast medium (not shown) having been introduced into 11 the catheter lumen 36, and the apparatus 10 ha-ving been partially 12 withdrawn from the vessel 18 in the direction of the arrow 52 (i.e., 13 proximally). An e~llavasation 85 of the radiopaque contrast medium is 14 shown marking the desired distance between the vessel 18 and the catheter distal end 34, as will be explained when the method for sealing 16 the puncture is described below.
1 7 The introducer 12 is shown in Fig. 4D having been moved, in the 18 direction of the arrow 52, to its second or proximal position to reveal 19 the l-ninfl~ted compression balloon 42 in position for inflating. Figure 4E illustrates the apparatus 10 with the compression balloon 42 inflated 21 and in place above the fatty layer 56 to apply hemostatic pressure for a 22 first period of time in order to effect initial closure of puncture site 24.
23 Figure 4F shows the apparatus 10 after the guidewire 78 has been ~ 24 removed from the apparatus 10 and pressure is applied for a second period of time to close the puncture 20.
26 In analogous fashion, the guidewire 78 and radiopaque 27 positioning of an expandable compression element at the distal end 34 CA 02231~60 1998-03-lO
WO 97/09934 PCTnUS96/14486 of the catheter 32 may be employed with the prong assembly and foam 2 pad embodiments described above in connection with the locator tube 3 30. For introducing the radiopaque or contrast medium (not shown) into the catheter lumen 36, a standard hemostatic "Y" 86 is used, as s~o~wn mFig. 4. The '~" 86 has a main leg 88 for receiving the 6 guidewire 78 into the axial lumen 36 of the catheter 32, while a side 7 port 90 of the '~" 86 is used for introducing the contrast medium into 8 the same lumen.
g A modification of the first (compression balloon) 10 embodimemt of the present invention is shown in Fig. 5, where an 11 apparatus 110 has an introducer 112 having no luer connection with a 12 catheter 1~2. Since the cuff 60 applies d~wllward force in the direction 13 of the arrow 62 only to the introducer 112, and not to the catheter 132, 14 the distal end 122 of the introducer 112 must bear directly on the 15 compression balloon 42 to exert hemostatic pressure on the balloon 42.
6 Although this modification is suitable only for the compression balloon 7 embodiment of this invention, both the locator tube 30 and the 18 guidewire 78 may be utilized in this modification for optimal positioning ls of the catheter distal end 34.
20 2. Method for Sealing V~sc~ r Punctures 21 A brief review of a typical vascular entry procedure may be of 22 value in describing the puncture closure technique of the present 23 invention. To init;~te one of the common operations such as the PTCA
24 (Percutaneous Translllmin~l Coronary Angioplasty) mentioned above, a 25 piercing cannula is inserted into the skin of a patient at an angle of 26 from 25 to 45 degrees until it punctures a blood vessel, e.g., the femoral 27 artery. The vessel may be located one centimeter or more beneath the CA 0223l~60 l998-03-lO
surface of the skin. A guidewire is inserted through the cannula into 2 the vessel, the cannula is withdrawn, and a catheter introducer sheath is 3 inserted over the guidewire into the puncture site.
4 The practitioner then uses the introducer to gain access to the vascular lumen for the instrumentation used to perform the particular 6 procedure. At the conclusion of the procedure, the introducer is the 7 last device rem~ining in the puncture, which must then be sealed.
8 The method of the present invention provides a rapid, g permanent, inexpensive sealing of a puncture in a blood vessel, with no foreign implants rem~ining in the patient. The method can be 11 understood with reference to the drawing figures and the previous 12 description of the apparatus of this invention.
13 In Fig. lA, an introducer sheath 12 is shown in a puncture site 24 14 at the conclusion of a vascular procedure. According to one embodiment of the present invention, a locator tube 30 having an 16 inflatable locating balloon 50 adjacent its distal end is inserted axially 17 through the introducer 12, into a puncture 20 and extending the 18 uninflated locating balloon S0 into the lumen of a vessel 18.
19 A dual lumen catheter 32 is passed over the locator tube 30 so that a first lumen 36 (Fig. lD) of the catheter 32 receives the locator 21 tube 30. The locator tube 30 m~int~in~ ~lignment of the catheter 32 22 with the puncture 20 and allows repeated access into the vessel 18, if 23 necessary. The catheter 32, having an inflatable compression balloon 24 42 at its distal end 34, is inserted fully into the introducer 12 until its distal end 34, including the lminfl~ted compression balloon 42, is at the 26 distal end 22 of the introducer 12. At this stage, the locator tube 30 is 27 pushed or pulled until a marker band 57 (shown in Fig. 1) is aligned CA 02231~60 1998-03-10 W O 97/09934 PCTAUS96tl4486 with the pro~mal end 33 of the catheter 32. The marker band 57 is 2 preselected to establish a fixed relationship with the catheter 32 so that 3 a preferred distance may be m~int~ined between the vessel 18 and the 4 distal end 34 of catheter 32 as will be explained below. The introducer 12 being in its first or distal position, the l-ninfl~ted compression 6 balloon 42 is fully enclosed and contained within the working channel 7 26 of the introducer 12, as described above.
8 The practitioner then inflates the locating balloon 50 via the 9 locator tube 30, partially withdrawing the introducer 12, the catheter 32 and the locator tube 30 from the puncture 20 in the direction of the 11 arrow 52, until the locating balloon 50 lodges against the inner wall of 12 the vessel 18 at the puncture 20, as illustrated in Fig. lB. Since the 13 position of the catheter distal end 34 relative to the introducer distal 14 end ~ remains unchanged, the distal end 34 of the catheter is now at the location predetermined by the placement of the marker band 57, 6 preferably about 5 mm to 15 mm from the puncture 20. This distance 7 will allow a layer of fatty subcutaneous tissue 56 to lie between the 18 catheter distal end 34 and the puncture 20.
19 Once the catheter distal end 34 is in the desired location, the introducer 12 is further withdrawn in the direction of the arrow 52, by 21 moving it to its second or proxirnal position relative to the catheter 32, 22 as described above, to expose the llninfl~ted compression balloon 42, as 23 shown in Fig. lC. The luer fittin~.~ 46, 48 at the proximal ends of the 24 catheter 32 and the introducer 12, respectively, are now connected to each other to lock the catheter 32 and the introducer 12 into a fixed 26 position relative to one another, and the compression balloon 42 is then 27 inflated, as illustrated in Fig. 1, via a second catheter lumen 38 (Fig.
CA 02231~60 1998-03-10 W O 97/09934 PCT~US96/14486 lD). The compression balloon 42 is then pressed down ~g~in~t the 2 fatty layer 56 above the puncture site 24, while gentle traction is 3 maintained on the locating balloon S0, thus compressing the 4 exL,av~scular fatty tissue 56 between the balloons 42, S0. The fatty tissue 56 advantageously minimi7es the potential of pseudo-aneurysm 6 follllation and promotes efficient hemostasis.
7 To assist in maint~ining pressure on the vessel 18, an introducer 8 cuff 60 is clamped onto the introducer 12 and secured to an adhesive g patch 58 by means of elastic or hook and loop fastening strips 64 (Figs.
1 and 4). When the introducer 12 is locked with the catheter 32 by the 11 luer fittings 46, 48, the dowllward force provided by the fastening strips 12 64 is transmitted from the introducer 12 through the semi-rigid catheter 13 32 to the compression balloon 42, maint~ining hemostatic pressure on 14 the puncture site 24 through fatty tissue 56.
After a first period of time (approximately S to lS minutes), 16 initial clotting of the puncture 20 will have occurred. The locating 17 balloon S0 is then deflated and the locator tube 30 withdrawn from the 18 apparatus 10, leaving only a small (e.g., approximately 1 mm in ls diameter) portion of the original puncture 20 to clot. The compression balloon 42 remains in place for an additional (second) period of tirne 21 (approximately S to 25 minutes), providing hemostasis to the puncture 22 20, after which the compression balloon 42 is deflated and retracted 23 proximally into the introducer 12, the luer fittings 46, 48 having first 24 been disconnected. The sealing process having been completed, the apparatus 10 is completely removed from the patient.
26 The foregoing method uses an introducer 12 that is already 27 positioned at the access site so that position is not lost in ch~ngin CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 instruments, bleeding does not occur while devices are positioned, and 2 the locator tube 30 m~int~inc the access location for re-access if needed 3 during the initial clotting of the puncture 20. Furthermore, 4 employment of the present invention requires minim~l physician time and greatly reduces staff time and involvement previously devoted to 6 m~int~ining supradermal pressure for long periods of hemostasis. In 7 addition, the need for operating room time may be reduced by the 8 removal of the locator tube 30, the introducer 12 and the catheter 32 g after the patient is returned to the patient's room. Overall, patient 10 discomfort is significantly lessened through the use of the foregoing 11 method as compared with the traditional manual external compression 12 techniques.
13 Similar steps are followed for implementing the method of the 14 present invention with the second embodiment of the apparatus 15 described above. In the second embodiment, the compression element 16 at catheter distal end 34 conl~rises the collapsible prong assembly 66, as 17 shown in Figures 2, 2A, and 2B. In this second embodiment, once the 8 introducer distal end 22 is in its initial (first or distal) position (about 5 19 to 15 mm from the vessel 18) as shown in Fig. 2, the movement of the 20 introducer 12 to its second or proximal position releases the prong 21 assembly 66 from confinement within the introducer 12, allowing the 22 individual prongs 68 of the prong assembly 66 to expand, as illustrated 23 in Fig. 2A. A resilient sp~nning sheet or dam 70, supported by the 24 ends of the prongs 68, then allows the application of hemostatic 25 pressure on the fatty tissue layer 56, as described earlier in connection 26 with the compression balloon embodiment. The locator tube (not 27 shown) passes through and is withdrawn from the aperture 72 in the CA 02231~60 1998-03-lO
sp~nning film 70.
2 A third embodiment of the method, following steps substantially 3 identical to the above described procedures, involves the use of the 4 compressible foam pad 74 shown in Figs. 3 and 3A as the compression element at the distal end 34 of the catheter 32.
6 In this third embodiment, when the catheter 32 is in the 7 preferred location as shown in Fig. 3, the introducer 12 is moved from 8 its first or distal position to its second or proximal position (in the 9 direction of the arrow 52) to uncover the foam pad 74, allowing it to expand, as illustrated in Fig. 3A. The expanded foam pad 74 exerts 11 hemostatic pressure upon the fatty tissue layer 56, as described 12 previously. The locator tube (not shown) passes through and is 13 ~ithdra~n ~om t~e pad char~nel 76 f~rm~d a~ially ~ th~ fo~m pad 74.
14 If deemed desirable by the practitioner, a coagulant agent such as collagen, thrombin or protamine may be delivered to the vicinity of the 16 puncture site through the pad channel 76 which communicates with the 17 catheter axial lumen 36. Alternatively, the foam pad 74 may be 18 saturated with the agent prior to deployment.
19 The method employed with the apparatus described above may 20 also use a guidewire 78 (Fig. 4) to perform the locating functions 21 provided by the locator tube 30 in the previous embodiments. All three 22 of the compression elements, viz., the compression balloon 42, the 23 expandable prong element 66 and the foam pad 74, may be utilized 24 with the guidewire 78. For purposes of illustration, Figs. 4 through 4F, showing only the compression balloon 42 alternative, may be viewed 26 with the understanding that the method to be described in conjunction 27 therewith applies to all three guidewire 78 embodiments.
CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 Referring now to Fig. 4A, the introducer 12 is shown as i 2 remains in the puncture 20 after a vascular access procedure. A
3 conventional surgical guidewire 78 is extended through the introducer 4 12 so that its distal end 82 extends into the lumen of the vessel 18. The dual lumen catheter 32 is passed over the guidewire 78 so that a first 6 lumen 36 (Fig. lD) of the catheter 32 receives the guidewire 78. The 7 guidewire 78 m~int~in~ ~lignment of the catheter 32 with the puncture 8 20 and allows re-access into the vessel 18 if it becomes necessary. As 9 described earlier, the catheter 32, having an infl~t~ble compression balloon 42 at its distal end 34, is inserted fully into the introducer 12 11 until its distal end 34, including the llninfl~ted compression balloon 42, 2 is enclosed within the working channel 26 at the distal end 22 of the 13 introducer 12, as shown in Fig.4B.
14 A radiopaque contrast medium (not shown) is introduced into the catheter first lumen 36, as illustrated in Fig. 4. A main leg 88 of a 16 conventional hemostasis "Y" 86 may be passed over the guidewire 78 1 7 and attached to the proximal end 33 of the catheter lumen 36. The 18 contrast medium is then introduced into the catheter lumen 36 via a 19 side port 90 of the "Y" 86, and viewed by the practitioner using conventional fluoroscopic techniques. To aid in locating the position of 21 the catheter distal end 34, a radiopaque marker 84 may be provided at 22 the tip of the catheter distal end 34 (Fig. 4D).
23 As the practitioner views the vascular scene under fluoroscopy, 24 the introducer 12 with the catheter 32 is partially withdrawn in the direction of the arrow 52 from the puncture 20. Withdrawal is 26 continued until contrast medium in the catheter lumen 36 escaping 27 from around the guidewire 78 into the vessel 18 is observed to form an CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 ~;~liavasation cloud 85, signifying that the introducer 12 and the 2 catheter 32 have exited the puncture 20. When the practitioner is 3 satisfied through fluoroscopy that the catheter distal end element 34 is 4 the preferred distance of about 5 to 15 mm from the vessel 18, withdrawal of the catheter 32 is halted, as shown in Fig. 4C.
6 The remainder of the closure procedure is essentially the same as 7 described above after the preferred position of the catheter 32 was 8 determined through the locator tube 30 method. The introducer 12 is g moved from its first or distal position relative to the catheter 32 to its second or proximal position, to expose the llninfl~ted compression 11 balloon 42, as shown in Fig. 4D. The compression balloon 42 is then 12 inflated to bear on the fatty tissue layer 56 as shown in Fig. 4E. The 13 locating means (in this embodiment guidewire 78) is then withdrawn 14 from the apparatus after an initial period of clotting (Fig. 4F). As noted previously, the method employing the guidewire 78 may be 16 effectively adapted for use with the expandable prong element and 1 7 foam tip embodiments of the present invention.
18 Still another method of the invention is illustrated in Fig. 5, 19 wherein the apparatus 110 differs from the apparatus 10 in that the introducer 112 and the catheter 132 are not luer-locked together.
21 Figure 5 shows the position of the catheter 132 aligned with a visible 22 marker band 57 on the locator tube 30, just as in the first embodiment 23 described above. It will be readily understood that the method of this 24 "luerless" apparatus 110 may be equally utilized with the guidewire 78 as with the locator tube 30 for the compression balloon embodiment of 26 this invention.
27 When the preferred location of the expanded compression CA 02231~60 1998-03-10 W O 97/09934 PCT~US96/14486 balloon 42 has been achieved as shown in Fig. 5, by applying either the 2 guidewire or the locator tube methods previously explained, force must 3 be applied from above to the compression balloon 42 to m~int~in 4 hemostatic pressure on the fatty tissue layer 56. The practitioner 5 advances the introducer 112 d~Jwllward in the direction of the arrow 62 6 until the introducer distal end 22 makes contact with the surface of the 7 compression balloon 42. This hemostatic pressure is then maintained 8 by securing the introducer sheath cuff 60 to the skin patch 58 via the 9 fastener strips or bands 64. It wiIl be noted that no d(,wl,ward pressure 10 is being exerted on the catheter 132 itself, since it has no mechanical 11 interlock with the introducer 112, as in the previous described 12 embodiments.
13 Although certain exemplary embodiments of the invention have 14 been described hereinabove, it will be appreciated that a number of 1~ variations and mo-lific~tions may suggest themselves to those skilled in 6 the pertinent arts. For example, a coagulant agent may be applied to 7 any of the above-described compression elements. Such variations and 18 modifi-cations are considered within the spirit and scope of the 19 invention as defined in the claims that follow.
When the location is achieved, the introducer is moved to a 26 second or proximal position relative to the catheter until the 27 expandable compression element is revealed and expanded to bear on CA 02231~60 1998-03-lO
W O 97/09934 PCT~US96/14486 the fatty tissue layer.
2 In another embodiment, the expandable compression element 3 comprises an expandable prong assembly including a resilient sp~nning 4 sheet for compressing the fatty tissue layer. In still another embodiment, the expandable compression element comprises a foam 6 pad element bearing directly on the fatty tissue layer upon expansior 7 when deployed from the introducer.
8 Once the compression element (balloon, prongs or foam tip) is in g place, a lightweight holding arrangement is employed to maintain hemostatic pressure. The holding arrangement comprises an adhesive 11 skin patch and fastener strips or bands bringing d~wllward pressure on 12 a sheath cuff clamped to the introducer. After an initial period of 13 hemostasis, (approximately one to five minutes), the locator means 14 (locator balloon tube or guidewire) is removed from the puncture and the apparatus. After another five to twenty-five minutes of pressure on 16 the puncture, the expandable distal end element (compression balloon, 17 prongs or iEoam) is collapsed, and the introducer and catheter are 18 permanently removed from the patient.
19 These and other features and advantages of the present invention will be more readily apparent from the Detailed Description that 21 follows.
22 Brief Description of the Drawings 23 Fig. l is an elevational view, partially in cross section, illustrating 24 a first preferred embodiment of the present invention;
Fig. lA is an elevational view, partially in cross section, 26 illustrating the initial position in a puncture site of the distal portion of 2 7 the apparatus of Fig. 1;
CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 Fig. lB is an elevational view, partially in cross section, 2 illustrating the apparatus of Fig. lA in a preferred operational position;
3 Fig. lC is an elevational view, partially in cross section, 4 illustrating the apparatus of Fig. lA with the compression balloon revealed and not yet inflated;
6 Fig. lD is a cross sectional view taken along lines lD-lD of Fig.
7 1, illustrating the dual lumen configuration of a catheter element of the 8 apparatus of Fig. l;
g Fig. 2 is an elevational view, partially in cross section, of a secondl O preferred embodiment of the present invention, showing the 11 compression mech~ni~m of this embodiment in a retracted state near a 12 vascular puncture site;
13 Fig. 2A is a perspective view of the embodiment of Fig. 2, 14 showing the compression mech~ni~m in an expanded state;
Fig. 2B is a view ~imil~r to that of Figure 2, showing the 16 compression mech~ni~m deployed, in its expanded state, at a vascular 17 puncture site;
18 Fig. 3 is an elevational view, partially in cross section, of a third 19 preferred embodiment of the present invention, showing the compression mech~nicm of this embodiment in a retracted state near a 21 vascular puncture site;
22 Fig. 3A is a view, similar to that of Fig. 3, illustrating the 23 compression mech~ni~m in an expanded state;
24 Fig. 4 is a perspective view of a fourth preferred embodiment of the present invention;
26 Fig. 4A is an elevational view, partially in cross section, 27 illustrating the initial position in a puncture site of the introducer and CA 02231~60 1998-03-10 guidewire elements of the apparatus of Fig. 4;
2 Fig. 4B is a view simil~r to that of Fig. 4A, but showing a a 3 catheter contained within introducer when the introducer is in a first 4 axial position relative to the catheter;
s Fig. 4C is an elevational view, partially in cross section, 6 illustrating the apparatus of Fig. 4A in a preferred operational position;
7 Fig. 4D is an elevational view, partially in cross section, 8 illustrating the apparatus of Fig. 4A with the compression balloon g revealed and not yet inflated, the introducer having been moved to a second axial position relative to the catheter;
11 Fig. 4E is a perspective view, partially in cross section, illustrating12 the compression balloon of the apparatus of Fig. 4D in an inflated 13 state;
14 Fig. 4F is an elevational view, partially in cross section, illustrating the apparatus of Fig. 4E with the guidewire element 16 withdrawn; and 17 Figo 5 is an elevational view, partially in cross section, illustrating18 a modification of the embodirnent of Fig.1.
19 Detailed Description of the Preferred Embodiments 1. Structure of the Apparatus 21 A percutaneous blood vessel se~ling device, or percutaneous 22 hemostatic device 10, which applies hemostatic sealing pressure directly 23 to tissue adjacent a vascular puncture site, without employing implanted 24 materials, is shown in Fig. 1.
In each exemplary embodiment described herein, an introducer 26 sheath ("introducer") 12, well known in the art, is present in an incision 27 14 that extends from the skin surface 16 to a blood vessel (artery or CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 vein) 18 of a patient at the site of a blood vessel puncture 20. The 2 introducer 12 has normally been inserted previously to provide access to 3 the vessel 18 for instrumentation (not shown) used in performing a 4 vascular procedure immediately preceding the need to seal the puncture 20. The initial position of an introducer 12 so inserted is most clearly 6 illustrated in Fig. 4A, which shows a tapered distal end 22 of the 7 introducer 12 at a puncture site 24, inserted within a vascular puncture 8 20. Typically, the introducer 12 will have a size of approximately 7 g French (2.3 mm in diameter), and a length of approximately 130 mm, although a size as large as 14 French (4.7 mm in diameter) may be used 11 for larger punctures.
12 A working channel 26, best seen in Fig. lD, extends axially from 13 the proximal end 28 of the introducer 12 through its tapered distal end 14 22. In the first preferred embodiment of Figures 1 through lD, a hollow locator tube 30 extends coaxially through the introducer 12 and 16 into the vessel 18 through the puncture 20. Guided by the locator tube 7 30 into the introducer working channel 26 is a semi-rigid catheter 32 18 having a catheter proximal end 33, and a catheter distal end 34 (Fig.
19 lA). The introducer 12 is movable axially with respect to the catheter 32, and is disposed initially at a first axial position, or distal position, in 21 which the catheter distal end 34 is enclosed or sheathed within the 22 distal end 22 of the introducer 12.
23 The catheter 32 is a dual-lumen device having a first axial lumen 24 36 (Fig. lD) which encompasses the locator tube 30 when the catheter 32 is inserted into the working channel 26 of the introducer 12. A
26 second axial lumen 38 is provided with an inflation orifice 40 near its 27 distal end, the inflation orifice communicating with the interior of a CA 02231~60 1998-03-lO
W O 97/09934 PCTrUS96/14486 compression balloon 42 that concentrically surrounds a portion of the 2 length of trhe catheter 32 extending proximally from its distal end 34.
3 The compression balloon 42 is initially enclosed, in an llninfl~ted state, 4 within the distal end 22 of the introducer 12, as illustrated in Fig. lA.
The opposite (proximal) end of the second axial lumen 38 6 communicates with a compression balloon inflation port 44 through an 7 inflation tube 45, as shown in lFigures 1 and 4. Overall, the catheter 32 8 has an outer diameter sufficiently small to be freely insertable into the g introducer 12, and a length that is greater than that of the introducer 12, i.e., in the range of about 130 mm to about 750 mm.
11 At the proximal end 28 of the introducer 12 is a well-known luer 12 type lock fitting 46 configured to mate with a catheter proximal end 13 luer fitting 48 when the introducer 12 and the catheter 32 are in a final 14 operational position, as determined by manipulation of the locator tube 30, as will be described below. The locator tube 30 has an infl~t~ble 16 intrav~c~ r locating balloon 50 at its distal end portion, shown in Fig.
1 7 lA in an llninfl~ted state. The interior of the locating balloon 50 is in 18 fluid communication with the hollow interior of the locator tube 30 19 through a suitable inflation orifice (not shown), as is well known in conventional balloon catheters and the like.
21 Although the luer locks 46, 48 may be employed for both the 22 locator balloon embodiment (Figures 1 through lD) and for 23 embodiments (described below) featuring expandable compression 24 elements other than the compression balloon 42, a version using no luer locks will be described below that is specifically adapted for use with 26 the compression balloon 42. Both the luer and non-luer versions are 27 suitable for embodiments employing either the inflatable locating CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 balloon 50 or a guidewire locating means, to be described below.
2 Returning now to Figures lA through lC, a progression of 3 locating positions for the device 10 is illustrated. Figure lA shows the 4 locator tube 30, having the llninfl~ted locating balloon 50 near its distal end, inserted into the vessel 18 through the introducer 12 and the 6 vascular puncture 20. It is advantageous to construct the locator tube 7 30 so that a length of tube extends distally beyond the location of the 8 locating balloon 50 into the vessel 18 to facilitate re-access through the g vascular puncture 20, if required. The entire apparatus 10 (including the introducer 12 and the catheter 32) is in its initial position relative to 11 the vessel; that is, the distal tip 22 of the introducer 12 is located 12 adjacent to or within the puncture 20, while the introducer 12 is in its 13 above-described first axial position or distal position relative to the 14 catheter 32, in which the catheter distal end 34 and the llninfl~ted compression balloon 42 are enclosed within the distal end 22 of the 16 introducer 12.
1 7 Figure lB illustrates the device 10 after the locating balloon 50 18 has been inflated by fluid introduced into it via the locator tube 30.
19 The entire device 10 (including the introducer 12 and the catheter 32) has been partially withdrawn from the puncture site 24 in the direction 21 of the arrow 52 (i.e., in the proximal direction), to a "preferred 22 operational position", in which the locating balloon 50 is lodged against 23 an interior wall 54 of the vessel 18. The introducer 12 remains in its 24 first or distal position, in which the portion of the catheter 32 carrying the llninfl~ted compression balloon 42 is enclosed within the distal end 26 22 of the introducer 12.
27 In Figure lC, the introducer 12 has been moved axially, relative CA 02231~60 1998-03-lO
to the catheter 32, in the direction of the arrow 52 (i.e., proximally), to 2 its second axial position, or proximal position. The movement of the 3 introducer 12 to this second or proximal position uncovers the 4 llninfl~ted compression balloon 42.
s The compression stage of the device 10 is illustrated next in Fig.
6 1. The compression balloon 42, inflated via the second axial lumen 38 7 (Fig. lD), rests in an optimal position to effect natural hemostasis, viz.,8 above a l~min~r portion 56 of the fatty tissue adjacent the puncture site 9 24. An optimal distance from the vessel 18 to the catheter distal end 34 is in the range of 2 mm to 10 mm. This distance will dispose a layer 11 of fatty tissue 56 between the vessel 18 and the catheter 32, minimi7:in~
12 the potential for pseudo-aneurysm. The introducer luer lock 46 is 13 shown engaged with the catheter luer lock 48, assuring that a holding 14 force applied to the introducer 12 will be transmitted as well to the catheter 32. In addition, a visible marker band 57 on the exterior of 1 6 the locating tubing 30 may advantageously be provided to align the 1 7 proximal ends of the introducer 12 and the catheter 32 in 18 correspondence with the location of the distal ends 22, 34 thereof when 19 the locator balloon 50 is lodged against the inner wall 54 of vessel 18.
An adhesive skin patch 58 with a sheath cuff 60 clamped onto 21 the external portion of the introducer 12 to apply downward force (in 22 the direction of the arrow 62, i.e., distally) on the introducer 12 is 23 shown in Figures 1 and 4. Fastener strips 64 secure the adhesive patch 24 58 to the sheath cuff 60. The fastener strips 64 may be elastic bands with suitable adhesive areas, or hook and loop strips (such as the type 26 marketed under the trademark VELCR0) that adhere to areas of 27 complementary material on the patch 58. Pressure m~int~ined by the CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 introducer sheath cuff60 on the catheter 32 provides hemostatic 2 pressure on the compression balloon 42 to bear on the tissue layer 56 3 for a first period of time, whereupon the locating tube 30 is withdrawn 4 (the locator balloon S0 having first been deflated), and a second period of time elapses, after which all instrumentation is removed from the 6 patient as will be noted when the method for sealing the puncture 20 is 7 described in detail below.
8 Another embodiment of the present invention is illustrated in g Figures 2, 2A, and 2B, which show a collapsible prong assembly compression element 66 attached to the catheter distal end 34. The 11 prong assembly 66is radially compressed or collapsed when enclosed 12 within the introducer 12, when the introducer is in its first or distal 13 position. The prong assembly 66 expands radially when the introducer 14 12 is partially withdrawn from the vessel 18 (Figures 2A and 2B), by moving the introducer 12 to its second or proximal position in a 16 manner similar to the partial withdrawal of introducer 12 in the 17 direction of arrow 52 as described previously in connection with the 18 compression balloon embodiment.
19 The prong assembly 66 comprises a plurality of spaced-apart resilient prongs 68, the proximal ends of which are attached to the 21 catheter 32, and the distal ends of which are attached to a collapsible 22 sp~nning film sheet or dam 70, shown expanded in Figures 2A and 2B.
23 The sheet or dam 70 allows the application of hemostatic pressure on 24 the tissue 56 above the vessel 18. A central aperture 72 in the sheet or dam 70 permits the locator tube (not shown) to project through the 26 catheter 32 into the vessel 18 as described previously. Since there is no 27 compression balloon to be inflated, a catheter with a single axial lumen CA 02231~60 1998-03-10 W O 97/09934 PCT~US96/14486 36 is adequate for this application. Materials for the sp~nning sheet or 2 dam 70 may include polyurethane and polyethyleneterephthalate (PET).
3 Still another embodiment of the invention is illustrated in Figures 4 3 and 3A~ which show a foam pad compression element 74 attached to the catheter distal end 34. The foam pad element 74 is compressed 6 when enclosed within the introducer 12 when the introducer is in its 7 first or distal position. The foam pad compression element 74 then 8 expands when the introducer 12 is partially withdrawn from the vessel 9 18, as shown in Fig. 3A, by moving the introducer 12 to its second or proximal position, as described above with respect to the first and l l second embodiments. Hemostatic pressure is simil~rly exerted on the 12 tissue 56 above the vessel 18. An axial channel 76 in the foam pad 74 13 permits the locator tube (not shown) to project through the catheter 32 14 into the vessel 18, as described previously. As with the exp~n~lin~
prong embodiment above, since there is no compression balloon to be 16 inflated, a catheter with a single axial lumen 36 is adequate for this 1 7 embodiment. Materials for the foam pad 74 may include various 8 polymeric foams, such as polyurethanes, as are well-known in the art.
19 The foam pad 74 may be impregnated with a coagulant such as thrombin or protamine to effect local hemostasis.
21 The foregoing embodiments, featuring both the luer locking of 22 the introducer 12 with the catheter 32, and a variety of expandable 23 compression elements 42, 66, 74 at the catheter distal end 34, employ a 24 locator tube 30 with a locating balloon 50 to determine the optimal operational location for the apparatus 10. In lieu of a locating balloon 26 50, a guidewire 78 may be utilized for the location determin~tion of the 27 apparatus 10, as illustrated in Figures 4 through 4F.
CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 In Fig. 4A, a standard guidewire 78, typically 3 French (1 mm in 2 diameter), shown coaxially located within the introducer 12, has a distal 3 end 82 extending out of the introducer distal end 22 into the puncture 4 20 of the vessel 18.
s The catheter 32 is shown in Fig. 4B having been inserted into the 6 introducer 12 and guided to the distal end 22 of the introducer by the 7 guidewire 78. At the distal end 34 of the catheter 32 is a radiopaque 8 marker 84 for -viewing under fluoroscopy, as shown in Fig. 4D.
g Figure 4C shows an optimal location for catheter distal end 34, radiopaque contrast medium (not shown) having been introduced into 11 the catheter lumen 36, and the apparatus 10 ha-ving been partially 12 withdrawn from the vessel 18 in the direction of the arrow 52 (i.e., 13 proximally). An e~llavasation 85 of the radiopaque contrast medium is 14 shown marking the desired distance between the vessel 18 and the catheter distal end 34, as will be explained when the method for sealing 16 the puncture is described below.
1 7 The introducer 12 is shown in Fig. 4D having been moved, in the 18 direction of the arrow 52, to its second or proximal position to reveal 19 the l-ninfl~ted compression balloon 42 in position for inflating. Figure 4E illustrates the apparatus 10 with the compression balloon 42 inflated 21 and in place above the fatty layer 56 to apply hemostatic pressure for a 22 first period of time in order to effect initial closure of puncture site 24.
23 Figure 4F shows the apparatus 10 after the guidewire 78 has been ~ 24 removed from the apparatus 10 and pressure is applied for a second period of time to close the puncture 20.
26 In analogous fashion, the guidewire 78 and radiopaque 27 positioning of an expandable compression element at the distal end 34 CA 02231~60 1998-03-lO
WO 97/09934 PCTnUS96/14486 of the catheter 32 may be employed with the prong assembly and foam 2 pad embodiments described above in connection with the locator tube 3 30. For introducing the radiopaque or contrast medium (not shown) into the catheter lumen 36, a standard hemostatic "Y" 86 is used, as s~o~wn mFig. 4. The '~" 86 has a main leg 88 for receiving the 6 guidewire 78 into the axial lumen 36 of the catheter 32, while a side 7 port 90 of the '~" 86 is used for introducing the contrast medium into 8 the same lumen.
g A modification of the first (compression balloon) 10 embodimemt of the present invention is shown in Fig. 5, where an 11 apparatus 110 has an introducer 112 having no luer connection with a 12 catheter 1~2. Since the cuff 60 applies d~wllward force in the direction 13 of the arrow 62 only to the introducer 112, and not to the catheter 132, 14 the distal end 122 of the introducer 112 must bear directly on the 15 compression balloon 42 to exert hemostatic pressure on the balloon 42.
6 Although this modification is suitable only for the compression balloon 7 embodiment of this invention, both the locator tube 30 and the 18 guidewire 78 may be utilized in this modification for optimal positioning ls of the catheter distal end 34.
20 2. Method for Sealing V~sc~ r Punctures 21 A brief review of a typical vascular entry procedure may be of 22 value in describing the puncture closure technique of the present 23 invention. To init;~te one of the common operations such as the PTCA
24 (Percutaneous Translllmin~l Coronary Angioplasty) mentioned above, a 25 piercing cannula is inserted into the skin of a patient at an angle of 26 from 25 to 45 degrees until it punctures a blood vessel, e.g., the femoral 27 artery. The vessel may be located one centimeter or more beneath the CA 0223l~60 l998-03-lO
surface of the skin. A guidewire is inserted through the cannula into 2 the vessel, the cannula is withdrawn, and a catheter introducer sheath is 3 inserted over the guidewire into the puncture site.
4 The practitioner then uses the introducer to gain access to the vascular lumen for the instrumentation used to perform the particular 6 procedure. At the conclusion of the procedure, the introducer is the 7 last device rem~ining in the puncture, which must then be sealed.
8 The method of the present invention provides a rapid, g permanent, inexpensive sealing of a puncture in a blood vessel, with no foreign implants rem~ining in the patient. The method can be 11 understood with reference to the drawing figures and the previous 12 description of the apparatus of this invention.
13 In Fig. lA, an introducer sheath 12 is shown in a puncture site 24 14 at the conclusion of a vascular procedure. According to one embodiment of the present invention, a locator tube 30 having an 16 inflatable locating balloon 50 adjacent its distal end is inserted axially 17 through the introducer 12, into a puncture 20 and extending the 18 uninflated locating balloon S0 into the lumen of a vessel 18.
19 A dual lumen catheter 32 is passed over the locator tube 30 so that a first lumen 36 (Fig. lD) of the catheter 32 receives the locator 21 tube 30. The locator tube 30 m~int~in~ ~lignment of the catheter 32 22 with the puncture 20 and allows repeated access into the vessel 18, if 23 necessary. The catheter 32, having an inflatable compression balloon 24 42 at its distal end 34, is inserted fully into the introducer 12 until its distal end 34, including the lminfl~ted compression balloon 42, is at the 26 distal end 22 of the introducer 12. At this stage, the locator tube 30 is 27 pushed or pulled until a marker band 57 (shown in Fig. 1) is aligned CA 02231~60 1998-03-10 W O 97/09934 PCTAUS96tl4486 with the pro~mal end 33 of the catheter 32. The marker band 57 is 2 preselected to establish a fixed relationship with the catheter 32 so that 3 a preferred distance may be m~int~ined between the vessel 18 and the 4 distal end 34 of catheter 32 as will be explained below. The introducer 12 being in its first or distal position, the l-ninfl~ted compression 6 balloon 42 is fully enclosed and contained within the working channel 7 26 of the introducer 12, as described above.
8 The practitioner then inflates the locating balloon 50 via the 9 locator tube 30, partially withdrawing the introducer 12, the catheter 32 and the locator tube 30 from the puncture 20 in the direction of the 11 arrow 52, until the locating balloon 50 lodges against the inner wall of 12 the vessel 18 at the puncture 20, as illustrated in Fig. lB. Since the 13 position of the catheter distal end 34 relative to the introducer distal 14 end ~ remains unchanged, the distal end 34 of the catheter is now at the location predetermined by the placement of the marker band 57, 6 preferably about 5 mm to 15 mm from the puncture 20. This distance 7 will allow a layer of fatty subcutaneous tissue 56 to lie between the 18 catheter distal end 34 and the puncture 20.
19 Once the catheter distal end 34 is in the desired location, the introducer 12 is further withdrawn in the direction of the arrow 52, by 21 moving it to its second or proxirnal position relative to the catheter 32, 22 as described above, to expose the llninfl~ted compression balloon 42, as 23 shown in Fig. lC. The luer fittin~.~ 46, 48 at the proximal ends of the 24 catheter 32 and the introducer 12, respectively, are now connected to each other to lock the catheter 32 and the introducer 12 into a fixed 26 position relative to one another, and the compression balloon 42 is then 27 inflated, as illustrated in Fig. 1, via a second catheter lumen 38 (Fig.
CA 02231~60 1998-03-10 W O 97/09934 PCT~US96/14486 lD). The compression balloon 42 is then pressed down ~g~in~t the 2 fatty layer 56 above the puncture site 24, while gentle traction is 3 maintained on the locating balloon S0, thus compressing the 4 exL,av~scular fatty tissue 56 between the balloons 42, S0. The fatty tissue 56 advantageously minimi7es the potential of pseudo-aneurysm 6 follllation and promotes efficient hemostasis.
7 To assist in maint~ining pressure on the vessel 18, an introducer 8 cuff 60 is clamped onto the introducer 12 and secured to an adhesive g patch 58 by means of elastic or hook and loop fastening strips 64 (Figs.
1 and 4). When the introducer 12 is locked with the catheter 32 by the 11 luer fittings 46, 48, the dowllward force provided by the fastening strips 12 64 is transmitted from the introducer 12 through the semi-rigid catheter 13 32 to the compression balloon 42, maint~ining hemostatic pressure on 14 the puncture site 24 through fatty tissue 56.
After a first period of time (approximately S to lS minutes), 16 initial clotting of the puncture 20 will have occurred. The locating 17 balloon S0 is then deflated and the locator tube 30 withdrawn from the 18 apparatus 10, leaving only a small (e.g., approximately 1 mm in ls diameter) portion of the original puncture 20 to clot. The compression balloon 42 remains in place for an additional (second) period of tirne 21 (approximately S to 25 minutes), providing hemostasis to the puncture 22 20, after which the compression balloon 42 is deflated and retracted 23 proximally into the introducer 12, the luer fittings 46, 48 having first 24 been disconnected. The sealing process having been completed, the apparatus 10 is completely removed from the patient.
26 The foregoing method uses an introducer 12 that is already 27 positioned at the access site so that position is not lost in ch~ngin CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 instruments, bleeding does not occur while devices are positioned, and 2 the locator tube 30 m~int~inc the access location for re-access if needed 3 during the initial clotting of the puncture 20. Furthermore, 4 employment of the present invention requires minim~l physician time and greatly reduces staff time and involvement previously devoted to 6 m~int~ining supradermal pressure for long periods of hemostasis. In 7 addition, the need for operating room time may be reduced by the 8 removal of the locator tube 30, the introducer 12 and the catheter 32 g after the patient is returned to the patient's room. Overall, patient 10 discomfort is significantly lessened through the use of the foregoing 11 method as compared with the traditional manual external compression 12 techniques.
13 Similar steps are followed for implementing the method of the 14 present invention with the second embodiment of the apparatus 15 described above. In the second embodiment, the compression element 16 at catheter distal end 34 conl~rises the collapsible prong assembly 66, as 17 shown in Figures 2, 2A, and 2B. In this second embodiment, once the 8 introducer distal end 22 is in its initial (first or distal) position (about 5 19 to 15 mm from the vessel 18) as shown in Fig. 2, the movement of the 20 introducer 12 to its second or proximal position releases the prong 21 assembly 66 from confinement within the introducer 12, allowing the 22 individual prongs 68 of the prong assembly 66 to expand, as illustrated 23 in Fig. 2A. A resilient sp~nning sheet or dam 70, supported by the 24 ends of the prongs 68, then allows the application of hemostatic 25 pressure on the fatty tissue layer 56, as described earlier in connection 26 with the compression balloon embodiment. The locator tube (not 27 shown) passes through and is withdrawn from the aperture 72 in the CA 02231~60 1998-03-lO
sp~nning film 70.
2 A third embodiment of the method, following steps substantially 3 identical to the above described procedures, involves the use of the 4 compressible foam pad 74 shown in Figs. 3 and 3A as the compression element at the distal end 34 of the catheter 32.
6 In this third embodiment, when the catheter 32 is in the 7 preferred location as shown in Fig. 3, the introducer 12 is moved from 8 its first or distal position to its second or proximal position (in the 9 direction of the arrow 52) to uncover the foam pad 74, allowing it to expand, as illustrated in Fig. 3A. The expanded foam pad 74 exerts 11 hemostatic pressure upon the fatty tissue layer 56, as described 12 previously. The locator tube (not shown) passes through and is 13 ~ithdra~n ~om t~e pad char~nel 76 f~rm~d a~ially ~ th~ fo~m pad 74.
14 If deemed desirable by the practitioner, a coagulant agent such as collagen, thrombin or protamine may be delivered to the vicinity of the 16 puncture site through the pad channel 76 which communicates with the 17 catheter axial lumen 36. Alternatively, the foam pad 74 may be 18 saturated with the agent prior to deployment.
19 The method employed with the apparatus described above may 20 also use a guidewire 78 (Fig. 4) to perform the locating functions 21 provided by the locator tube 30 in the previous embodiments. All three 22 of the compression elements, viz., the compression balloon 42, the 23 expandable prong element 66 and the foam pad 74, may be utilized 24 with the guidewire 78. For purposes of illustration, Figs. 4 through 4F, showing only the compression balloon 42 alternative, may be viewed 26 with the understanding that the method to be described in conjunction 27 therewith applies to all three guidewire 78 embodiments.
CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 Referring now to Fig. 4A, the introducer 12 is shown as i 2 remains in the puncture 20 after a vascular access procedure. A
3 conventional surgical guidewire 78 is extended through the introducer 4 12 so that its distal end 82 extends into the lumen of the vessel 18. The dual lumen catheter 32 is passed over the guidewire 78 so that a first 6 lumen 36 (Fig. lD) of the catheter 32 receives the guidewire 78. The 7 guidewire 78 m~int~in~ ~lignment of the catheter 32 with the puncture 8 20 and allows re-access into the vessel 18 if it becomes necessary. As 9 described earlier, the catheter 32, having an infl~t~ble compression balloon 42 at its distal end 34, is inserted fully into the introducer 12 11 until its distal end 34, including the llninfl~ted compression balloon 42, 2 is enclosed within the working channel 26 at the distal end 22 of the 13 introducer 12, as shown in Fig.4B.
14 A radiopaque contrast medium (not shown) is introduced into the catheter first lumen 36, as illustrated in Fig. 4. A main leg 88 of a 16 conventional hemostasis "Y" 86 may be passed over the guidewire 78 1 7 and attached to the proximal end 33 of the catheter lumen 36. The 18 contrast medium is then introduced into the catheter lumen 36 via a 19 side port 90 of the "Y" 86, and viewed by the practitioner using conventional fluoroscopic techniques. To aid in locating the position of 21 the catheter distal end 34, a radiopaque marker 84 may be provided at 22 the tip of the catheter distal end 34 (Fig. 4D).
23 As the practitioner views the vascular scene under fluoroscopy, 24 the introducer 12 with the catheter 32 is partially withdrawn in the direction of the arrow 52 from the puncture 20. Withdrawal is 26 continued until contrast medium in the catheter lumen 36 escaping 27 from around the guidewire 78 into the vessel 18 is observed to form an CA 02231~60 1998-03-10 W O 97/09934 PCTrUS96/14486 ~;~liavasation cloud 85, signifying that the introducer 12 and the 2 catheter 32 have exited the puncture 20. When the practitioner is 3 satisfied through fluoroscopy that the catheter distal end element 34 is 4 the preferred distance of about 5 to 15 mm from the vessel 18, withdrawal of the catheter 32 is halted, as shown in Fig. 4C.
6 The remainder of the closure procedure is essentially the same as 7 described above after the preferred position of the catheter 32 was 8 determined through the locator tube 30 method. The introducer 12 is g moved from its first or distal position relative to the catheter 32 to its second or proximal position, to expose the llninfl~ted compression 11 balloon 42, as shown in Fig. 4D. The compression balloon 42 is then 12 inflated to bear on the fatty tissue layer 56 as shown in Fig. 4E. The 13 locating means (in this embodiment guidewire 78) is then withdrawn 14 from the apparatus after an initial period of clotting (Fig. 4F). As noted previously, the method employing the guidewire 78 may be 16 effectively adapted for use with the expandable prong element and 1 7 foam tip embodiments of the present invention.
18 Still another method of the invention is illustrated in Fig. 5, 19 wherein the apparatus 110 differs from the apparatus 10 in that the introducer 112 and the catheter 132 are not luer-locked together.
21 Figure 5 shows the position of the catheter 132 aligned with a visible 22 marker band 57 on the locator tube 30, just as in the first embodiment 23 described above. It will be readily understood that the method of this 24 "luerless" apparatus 110 may be equally utilized with the guidewire 78 as with the locator tube 30 for the compression balloon embodiment of 26 this invention.
27 When the preferred location of the expanded compression CA 02231~60 1998-03-10 W O 97/09934 PCT~US96/14486 balloon 42 has been achieved as shown in Fig. 5, by applying either the 2 guidewire or the locator tube methods previously explained, force must 3 be applied from above to the compression balloon 42 to m~int~in 4 hemostatic pressure on the fatty tissue layer 56. The practitioner 5 advances the introducer 112 d~Jwllward in the direction of the arrow 62 6 until the introducer distal end 22 makes contact with the surface of the 7 compression balloon 42. This hemostatic pressure is then maintained 8 by securing the introducer sheath cuff 60 to the skin patch 58 via the 9 fastener strips or bands 64. It wiIl be noted that no d(,wl,ward pressure 10 is being exerted on the catheter 132 itself, since it has no mechanical 11 interlock with the introducer 112, as in the previous described 12 embodiments.
13 Although certain exemplary embodiments of the invention have 14 been described hereinabove, it will be appreciated that a number of 1~ variations and mo-lific~tions may suggest themselves to those skilled in 6 the pertinent arts. For example, a coagulant agent may be applied to 7 any of the above-described compression elements. Such variations and 18 modifi-cations are considered within the spirit and scope of the 19 invention as defined in the claims that follow.
Claims (45)
1. A device for promoting hemostasis in a blood vessel puncture by compressing the subcutaneous tissue adjacent the puncture, wherein the puncture is accessed subcutaneously through an incision by an introduces disposed within the incision, the introduces having a proximal portion disposed externally to the skin surface, a distal end initially positionable within the puncture, and an axial channel therebetween, the device comprising:
a catheter dimensioned to be received within the axial channel and having an axial lumen communicating with an open distal end, the introduces being axially movable relative to the catheter between a distal position and a proximal position, the distal end of the catheter being enclosed within the introduces when the introduces is in its distal position, and being exposed to the subcutaneous tissue distally from the distal end of the introduces when the introduces is moved to its proximal position;
an elongate, flexible locator member extending through the catheter lumen and the distal end of the catheter and having a distal portion extensible into the interior of the vessel through the puncture; and an expansible compression element attached to the distal end of the catheter, the compression element having a collapsed position when the distal end of the catheter is enclosed, and an expanded position when the distal end of the catheter is exposed;
whereby the compression element, in its expanded position, is deployable so as to compress the subcutaneous tissue adjacent the puncture, thereby to promote hemostasis at the puncture.
a catheter dimensioned to be received within the axial channel and having an axial lumen communicating with an open distal end, the introduces being axially movable relative to the catheter between a distal position and a proximal position, the distal end of the catheter being enclosed within the introduces when the introduces is in its distal position, and being exposed to the subcutaneous tissue distally from the distal end of the introduces when the introduces is moved to its proximal position;
an elongate, flexible locator member extending through the catheter lumen and the distal end of the catheter and having a distal portion extensible into the interior of the vessel through the puncture; and an expansible compression element attached to the distal end of the catheter, the compression element having a collapsed position when the distal end of the catheter is enclosed, and an expanded position when the distal end of the catheter is exposed;
whereby the compression element, in its expanded position, is deployable so as to compress the subcutaneous tissue adjacent the puncture, thereby to promote hemostasis at the puncture.
2. The device of Claim 1, wherein the axial lumen of the catheter is a first catheter lumen, wherein the catheter includes a second axial lumen, and wherein the compression element comprises:
an inflatable element in fluid communication with the second catheter lumen and inflatable by a fluid introduced through the second lumen, the compression element being in its collapsed position when the inflatable element is uninflated and in its expanded position when the inflatable element is inflated.
an inflatable element in fluid communication with the second catheter lumen and inflatable by a fluid introduced through the second lumen, the compression element being in its collapsed position when the inflatable element is uninflated and in its expanded position when the inflatable element is inflated.
3. The device of Claim 1, wherein the compression element comprises an assembly of collapsible prongs, each having a proximal end attached to the distal end of the catheter, and a distal end attached to a resilient spanning sheet, the compression element being in its collapsed position when the prong assembly is collapsed radially inwardly, and in its expanded position when the prong assembly is expanded radially outwardly.
4. The device of Claim 1, wherein the compression element comprises a resilient foam pad attached to the distal end of the catheter and having a collapsed position when the distal end of the catheter is enclosed, and an expanded position when the distal end of the catheter is exposed.
5. The device of Claim 1, wherein the locator member comprises:
a hollow locator tube disposed axially through the catheter lumen so as to extend through the distal end of the catheter and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
a hollow locator tube disposed axially through the catheter lumen so as to extend through the distal end of the catheter and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
6. The device of Claim 1, wherein the locator member comprises:
an elongate guide wire disposed axially through the catheter lumen so as to extend through the distal end of the catheter and into the interior of the vessel through the puncture.
an elongate guide wire disposed axially through the catheter lumen so as to extend through the distal end of the catheter and into the interior of the vessel through the puncture.
7. The device of Claim 2, wherein the locator member comprises:
a hollow locator tube disposed axially through the first catheter lumen so as to extend through the distal end of the catheter and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
a hollow locator tube disposed axially through the first catheter lumen so as to extend through the distal end of the catheter and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
8. The device of Claim 2, wherein the locator member comprises:
an elongate guide wire disposed axially through the first catheter lumen so as to extend through the distal end of the catheter and into the interior of the vessel through the puncture.
an elongate guide wire disposed axially through the first catheter lumen so as to extend through the distal end of the catheter and into the interior of the vessel through the puncture.
9. The device of Claim 3, wherein the spanning sheet includes an aperture, and wherein the locator member comprises:
a hollow locator tube disposed axially through the catheter lumen so as to extend through the distal end of the catheter and the spanning sheet aperture, and having a distal portion extensible into the interior of the vessel through the puncture;
and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
a hollow locator tube disposed axially through the catheter lumen so as to extend through the distal end of the catheter and the spanning sheet aperture, and having a distal portion extensible into the interior of the vessel through the puncture;
and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
10. The device of Claim 3, wherein the spanning sheet includes an aperture, and wherein the locator member comprises:
an elongate guide wire disposed axially through the catheter lumen so as to extend through the distal end of the catheter and the spanning sheet aperture into the interior of the vessel through the puncture.
an elongate guide wire disposed axially through the catheter lumen so as to extend through the distal end of the catheter and the spanning sheet aperture into the interior of the vessel through the puncture.
11. The device of Claim 4, wherein the foam pad includes an axial passage, and wherein the locator member comprises:
a hollow locator tube disposed axially through the catheter lumen so as to extend through the distal end of the catheter and the axial passage in the foam pad, the locator tube having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
a hollow locator tube disposed axially through the catheter lumen so as to extend through the distal end of the catheter and the axial passage in the foam pad, the locator tube having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
12. The device of Claim 4, wherein the foam pad includes an axial passage, and wherein the locator member comprises:
an elongate guide wire disposed axially through the catheter lumen so as to extend through the distal end of the catheter and the axial passage in the foam pad, the guide wire having a distal portion extensible into the interior of the vessel through the puncture.
an elongate guide wire disposed axially through the catheter lumen so as to extend through the distal end of the catheter and the axial passage in the foam pad, the guide wire having a distal portion extensible into the interior of the vessel through the puncture.
13. The device of Claim 1, further comprising:
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the catheter lumen.
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the catheter lumen.
14. The device of Claim 2, further comprising:
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the first catheter lumen.
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the first catheter lumen.
15. The device of Claim 1, further comprising:
pressure applying means, engageable with the external portion of the introduces, for applying a downward force to the introduces when the catheter is disposed within the axial channel of the introduces.
pressure applying means, engageable with the external portion of the introduces, for applying a downward force to the introduces when the catheter is disposed within the axial channel of the introduces.
16. The device of Claim 15, wherein the catheter is connected to the introduces so that the downward force is applied to both the introduces and the catheter.
17. The device of Claim 15, wherein the pressure applying means comprises:
a clamping device secured to the external portion of the introduces; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
a clamping device secured to the external portion of the introduces; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
18. The device of Claim 16, wherein the pressure applying means comprises:
a clamping device secured to the external portion of the introduces; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
a clamping device secured to the external portion of the introduces; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
19. A device for promoting hemostasis in a blood vessel puncture by compressing the subcutaneous tissue adjacent the puncture, wherein the puncture is accessed subcutaneously through an incision, the device comprising:
an introducer configured to provide access to the puncture through the incision, the introducer having a proximal portion, a distal end initially positionable within the puncture, and an axial channel therebetween;
a catheter dimensioned to be received within the axial channel and having a first axial lumen communicating with an open distal end and a second axial lumen, the introducer being axially movable relative to the catheter between a distal position and a proximal position, the distal end of the catheter being enclosed within the introducer when the introducer is in the distal position, and being exposed to the subcutaneous tissue distally from the distal end of the introducer when the introducer is moved to its proximal position; and inflatable compression means, attached to the distal end of the catheter and in fluid communication with the second lumen so as to be inflatable with a fluid introduced through the second lumen when the distal end of the catheter is exposed, for compressing the subcutaneous tissue adjacent the puncture sufficiently to promote hemostasis at the puncture when the compression means is inflated.
an introducer configured to provide access to the puncture through the incision, the introducer having a proximal portion, a distal end initially positionable within the puncture, and an axial channel therebetween;
a catheter dimensioned to be received within the axial channel and having a first axial lumen communicating with an open distal end and a second axial lumen, the introducer being axially movable relative to the catheter between a distal position and a proximal position, the distal end of the catheter being enclosed within the introducer when the introducer is in the distal position, and being exposed to the subcutaneous tissue distally from the distal end of the introducer when the introducer is moved to its proximal position; and inflatable compression means, attached to the distal end of the catheter and in fluid communication with the second lumen so as to be inflatable with a fluid introduced through the second lumen when the distal end of the catheter is exposed, for compressing the subcutaneous tissue adjacent the puncture sufficiently to promote hemostasis at the puncture when the compression means is inflated.
20. The device of Claim 19, further comprising:
an elongate, flexible locator member extending through the first catheter lumen and the distal end of the catheter, and having a distal portion extensible into the interior of the vessel through the puncture.
an elongate, flexible locator member extending through the first catheter lumen and the distal end of the catheter, and having a distal portion extensible into the interior of the vessel through the puncture.
21. The device of Claim 20, wherein the locator member comprises:
a hollow locator tube disposed axially through the first catheter lumen so as to extend through the distal end of the catheter and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
a hollow locator tube disposed axially through the first catheter lumen so as to extend through the distal end of the catheter and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
22. The device of Claim 20, wherein the locator member comprises:
an elongate guide wire disposed axially through the first catheter lumen so as to extend through the distal end of the catheter and into the interior of the vessel through the puncture.
an elongate guide wire disposed axially through the first catheter lumen so as to extend through the distal end of the catheter and into the interior of the vessel through the puncture.
23. The device of Claim 19, further comprising:
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the first catheter lumen.
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the first catheter lumen.
24. The device of Claim 19, further comprising:
pressure applying means, engageable with the external portion of the introducer, for applying a downward force to the introducer when the catheter is disposed within the axial channel of the introducer.
pressure applying means, engageable with the external portion of the introducer, for applying a downward force to the introducer when the catheter is disposed within the axial channel of the introducer.
25. The device of Claim 24, wherein the catheter is connected to the introducer so that the downward force is applied to both the introducer and the catheter.
26. The device of Claim 24, wherein the pressure applying means comprises:
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
27. The device of Claim 25, wherein the pressure applying means comprises:
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
28. A device for promoting hemostasis in a blood vessel puncture by compressing the subcutaneous tissue adjacent the puncture, wherein the puncture is accessed subcutaneously through an incision by an introducer disposed within the incision, the introducer having a proximal end disposed externally to the skin surface, a distal end initially positionable within the puncture, and an axial channel therebetween, the device comprising:
a catheter dimensioned to be received within the axial channel and having an axial lumen communicating with an open distal end, the introducer being axially movable relative to the catheter between a distal position and a proximal position, the distal end of the catheter being enclosed within the introducer when the introducer is in its distal position, and being exposed to the subcutaneous tissue distally from the distal end of the introducer when the introducer is moved to its proximal position;
and an assembly of collapsible prongs, each having a proximal end attached to the distal end of the catheter and a distal end attached to a spanning sheet, the prong assembly having a radially inwardly collapsed position when the distal end of the catheter is enclosed, and a radially outwardly expanded position when the distal end of the catheter is exposed;
whereby the prong assembly, in its expanded position, is deployable so as to compress the subcutaneous tissue adjacent the puncture, thereby to promote hemostasis at the puncture.
a catheter dimensioned to be received within the axial channel and having an axial lumen communicating with an open distal end, the introducer being axially movable relative to the catheter between a distal position and a proximal position, the distal end of the catheter being enclosed within the introducer when the introducer is in its distal position, and being exposed to the subcutaneous tissue distally from the distal end of the introducer when the introducer is moved to its proximal position;
and an assembly of collapsible prongs, each having a proximal end attached to the distal end of the catheter and a distal end attached to a spanning sheet, the prong assembly having a radially inwardly collapsed position when the distal end of the catheter is enclosed, and a radially outwardly expanded position when the distal end of the catheter is exposed;
whereby the prong assembly, in its expanded position, is deployable so as to compress the subcutaneous tissue adjacent the puncture, thereby to promote hemostasis at the puncture.
29. The device of Claim 28, wherein the spanning sheet includes an aperture, the device further comprising:
an elongate, flexible locator member extensible through the catheter lumen, the distal end of the catheter, and the spanning sheet aperture, and having a distal portion extensible into the interior of the vessel through the puncture.
an elongate, flexible locator member extensible through the catheter lumen, the distal end of the catheter, and the spanning sheet aperture, and having a distal portion extensible into the interior of the vessel through the puncture.
30. The device of Claim 29, wherein the locator member comprises:
a hollow locator tube extensible axially through the catheter lumen so as to extend through the distal end of the catheter and the spanning sheet aperture, and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
a hollow locator tube extensible axially through the catheter lumen so as to extend through the distal end of the catheter and the spanning sheet aperture, and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
31. The device of Claim 29, wherein the locator member comprises:
an elongate guide wire extensible axially through the catheter lumen so as to extend through the distal end of the catheter and the spanning sheet aperture, and into the interior of the vessel through the puncture.
an elongate guide wire extensible axially through the catheter lumen so as to extend through the distal end of the catheter and the spanning sheet aperture, and into the interior of the vessel through the puncture.
32. The device of Claim 28, further comprising:
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the catheter lumen.
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the catheter lumen.
33. The device of Claim 28, further comprising:
pressure applying means, engageable with the external portion of the introducer, for applying a downward force to the introducer when the catheter is disposed within the axial channel of the introducer.
pressure applying means, engageable with the external portion of the introducer, for applying a downward force to the introducer when the catheter is disposed within the axial channel of the introducer.
34. The device of Claim 33, wherein the catheter is connected to the introducer so that the downward force is applied to both the introducer and the catheter.
35. The device of Claim 33, wherein the pressure applying means comprises:
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
36. The device of Claim 34, wherein the pressure applying means comprises:
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
37. A device for promoting hemostasis in a blood vessel puncture by compressing the subcutaneous tissue adjacent the puncture, wherein the puncture is accessed subcutaneously through an incision by an introducer disposed within the incision, the introducer having a proximal end disposed eternally to the skin surface, a distal end initially positionable within the puncture, and an axial channel therebetween, the device comprising:
a catheter dimensioned to be received within the axial channel and having an axial lumen communicating with an open distal end, the introducer being axially movable relative to the catheter between a distal position and a proximal position, the distal end of the catheter being enclosed within the introducer when the introducer is in its distal position, and being exposed to the subcutaneous tissue distally from the distal end of the introducer when the introducer is moved to its proximal position;
and a resilient foam pad attached to the distal end of the catheter, the pad having a collapsed position when the distal end of the catheter is enclosed, and an expanded position when the distal end of the catheter is exposed;
whereby the pad, in its expanded position, is deployable so as to compress the subcutaneous tissue adjacent the puncture, thereby to promote hemostasis at the puncture.
a catheter dimensioned to be received within the axial channel and having an axial lumen communicating with an open distal end, the introducer being axially movable relative to the catheter between a distal position and a proximal position, the distal end of the catheter being enclosed within the introducer when the introducer is in its distal position, and being exposed to the subcutaneous tissue distally from the distal end of the introducer when the introducer is moved to its proximal position;
and a resilient foam pad attached to the distal end of the catheter, the pad having a collapsed position when the distal end of the catheter is enclosed, and an expanded position when the distal end of the catheter is exposed;
whereby the pad, in its expanded position, is deployable so as to compress the subcutaneous tissue adjacent the puncture, thereby to promote hemostasis at the puncture.
38. The device of Claim 37, wherein the pad includes an axial passage therethrough, the device further comprising:
an elongate, flexible locator member extensible through the catheter lumen, the distal end of the catheter and the axial passage through the pad, and having a distal portion extensible into the interior of the vessel through the puncture.
an elongate, flexible locator member extensible through the catheter lumen, the distal end of the catheter and the axial passage through the pad, and having a distal portion extensible into the interior of the vessel through the puncture.
39. The device of Claim 38, wherein the locator member comprises:
a hollow locator tube extensible axially through the catheter lumen so as to extend through the distal end of the catheter and the axial passage through the pad, and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
a hollow locator tube extensible axially through the catheter lumen so as to extend through the distal end of the catheter and the axial passage through the pad, and having a distal portion extensible into the interior of the vessel through the puncture; and a locating balloon disposed at the distal portion of the locator tube and inflatable through the locator tube when positioned in the interior of the vessel.
40. The device of Claim 38, wherein the locator member comprises:
an elongate guide wire extensible axially through the catheter lumen so as to extend through the distal end of the catheter and the axial passage through the pad, and into the interior of the vessel through the puncture.
an elongate guide wire extensible axially through the catheter lumen so as to extend through the distal end of the catheter and the axial passage through the pad, and into the interior of the vessel through the puncture.
41. The device of Claim 37, further comprising:
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the catheter lumen.
a radiopaque marker at the distal end of the catheter; and means for introducing a contrast medium into the catheter lumen.
42. The device of Claim 37, further comprising:
pressure applying means, engageable with the external portion of the introducer, for applying a downward force to the introducer when the catheter is disposed within the axial channel of the introducer.
pressure applying means, engageable with the external portion of the introducer, for applying a downward force to the introducer when the catheter is disposed within the axial channel of the introducer.
43. The device of Claim 42, wherein the catheter is connected to the introducer so that the downward force is applied to both the introducer and the catheter.
44. The device of Claim 42, wherein the pressure applying means comprises:
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
45. The device of Claim 43, wherein the pressure applying means comprises:
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
a clamping device secured to the external portion of the introducer; and a skin patch secured to the clamping device and adhesively attachable to the surface of the skin.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/528,892 | 1995-09-15 | ||
| US08/528,892 US5645566A (en) | 1995-09-15 | 1995-09-15 | Apparatus and method for percutaneous sealing of blood vessel punctures |
| PCT/US1996/014486 WO1997009934A1 (en) | 1995-09-15 | 1996-09-10 | Apparatus and method for percutaneous sealing of blood vessel punctures |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2231560A1 CA2231560A1 (en) | 1997-03-20 |
| CA2231560C true CA2231560C (en) | 2001-05-01 |
Family
ID=24107636
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002231560A Expired - Fee Related CA2231560C (en) | 1995-09-15 | 1996-09-10 | Apparatus and method for percutaneous sealing of blood vessel punctures |
Country Status (5)
| Country | Link |
|---|---|
| US (1) | US5645566A (en) |
| EP (1) | EP0852478A1 (en) |
| JP (1) | JP2000507838A (en) |
| CA (1) | CA2231560C (en) |
| WO (1) | WO1997009934A1 (en) |
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| CA2231560A1 (en) | 1997-03-20 |
| US5645566A (en) | 1997-07-08 |
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| JP2000507838A (en) | 2000-06-27 |
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