AU697083B2

AU697083B2 - A method of securing a graft

Info

Publication number: AU697083B2
Application number: AU74253/96A
Authority: AU
Inventors: Larry G. Baughman; Alec A. Piplani; Dinah B. Quiachon
Original assignee: Endovascular Technologies Inc
Current assignee: Endovascular Technologies Inc
Priority date: 1993-08-05
Filing date: 1996-12-11
Publication date: 1998-09-24
Anticipated expiration: 2014-06-15
Also published as: AU7425396A

Description

I 1 Regulation 3.2

AUSTRALIA

Patents Act 1952 COMPLETE SPECIFICATION FOR A STANDARD PATENT

(ORIGINAL)

Name of Applicant: ft 0f0 f *1 ftr ft *ft 0 ft ft.

*ftft ft**ft Actual Inventors: Address for Service: Invention Title: EndoVascular Technologies, Inc.

1360 O'Brien Drive Menlo Park, Ca. 94025-1436 United States of America Dinah B. QUIACHON Alex A. PIPLANI Larry G. BAUGHMAN DAVIES COLLISON CAVE, Patent Attorneys, 1 Little Collins Street, Melbourne, 3000.

A Method of Securing a Graft ft of ftfofttf 0fttsf The following statement is a full description of this invention, including the best method of performing it known to us: -1p~ 9 iC P:\OFER\GQ\64747.DIV 10/1296 2 A METHOD OF SECURING A GRAFT BACKGROUND OF THE INVENTION This invention relates to a method for emplacing a graft in C a corporeal lumen.

20 It is well established that various fluid conducting body or corporeal lumens, such as veins and arteries, may deteriorate or suffer trauma so that repair is necessary. For example, "various types of aneurysms or other deteriorative diseases may affect the ability of the lumen to conduct fluids and in turn .o 25 may be life-threatening. In some cases, the damaged lumen is repairable only with the use of prosthesis such as an artificial a s vessel or graft.

For repair of vital vessels such as the aorta, surgical repair is significantly life-threatening. Surgical techniques 3 known in the art involve major surgery in which a graft resembling the natural vessel is spliced into the diseased or obstructed section of the natural vessel. Known procedures include surgically removing or bypassing the damaged or diseased portion of the vessel and inserting an artificial or donor graft inserted and stitched to the ends of the vessel which were created by the removal of the diseased portion.

It is known within the art to provide a prothesis for intraluminal repair of a vessel, such as an abdominal aorta having an aneurysm. The art has taught to provide a prothesis positioned in a vessel then securing the prothesis within the vessel with hooks or staples that are mechanically extended by the user. The early prior art devices were large in diameter, mechanically complex and in turn were susceptible to mechanical failure. Prior intraluminal grafting systems *ir have embodied capsule catheters or balloon catheters, but were relatively stiff and of a relatively high profile. Similarly, the prior art systems were configured in such a way that the graft was relatively difficult to deploy the prothesis. In addition, prior systems having capsule catheter means were usually configured such that the prothesis was disposed within a unitary capsule.

In recent years, several devices have been developed to attempt to treat an aortic aneurysm through intraluminal S25 repair. For example, U.S. Pat. No. 4,140,126 (Feb. 20, 1979), Choudhury, discloses a method and article for performing an aneurysm repair, wherein a prosthetic graft is utilized to replace the damaged segment of the blood vessel. A plurality cl P -L -F

A.

IN

4 of radially spaced anchoring pins are located adjacent each end of the graft and provide means for securing the graft to the wall of the vessel. Means is provided for moving the graft within the vessel and permanently anchoring the graft to the wall of the vessel.

U.S. Pat. No. 4,562,596 (Jan. 7, 1986), Kornberg, discloses a bifurcated aortic graft constructed for intraluminal insertion having a plurality of struts having angled hooks with barbs at their superior ends. Means for inserting the graft and implanting the hooks into the vessel lumen is also disclosed.

U.S. Pat. No. 4,787,899 (Nov. 29, 1988), Lazarus, discloses an intraluminal grafting system including a hollow graft having an attachment means located at one end of the graft. The system includes positioning means for moving the graft within the vessel, the positioning means having a capsule e 0o positioned at one end for covering the graft attachment means.

o. The disclosed positioning means further includes an inflatable member for securing the attachment means within the lumen.

EPO Pub. No. 0 461 791 Al (Dec. 18, 1991), Barone et .al. discloses an aortic graft and apparatus for repairing an 0 aneurism. The disclosed system includes a tube graft secured oo within the aorta and an attachment means at each end of the graft. Intraluminal delivery is accomplished using a catheter having a balloon for expanding and securing the attachment oi means. The graft and attachment means are preferably enclosed by a sheath which covers the entire graft and attachment means.

.i -~1 5- EPO Pub. No. 0 466 518 A3 (Jan. 15, 1992), Lazarus et al., discloses an intraluminal grafting system including a catheter having a capsule formed of a helical wrap of metal ribbon. A tubular graft having attachment means at both ends is removably disposed within the capsule. Means is provided for moving the graft from the capsule, and an inflatable member is provided for securing the attachment means within a vessel lumen.

U.S. Patent No. 5,104,399 (Apr. 14, 1992), Lazarus, discloses an intraluminal grafting system including a tubular graft having attachment means positioned at both ends. The system includes a positioning means for transporting the graft through a vessel lumen and for deploying the graft within the lumen. The positioning means includes an inflatable member, a capsule and means for removing the graft from the capsule.

The capsule is disclosed as a rigid cylindrical member covering o the entire graft.

EPO Pub. No. 0 508 473 A2 (Oct. 14, 1992), Piplani et 'a" al., discloses an intralumihal grafting system including a catheter having a capsule formed of a helical wrap of metal ribbon. A bifurcated graft having attachment means is S removably disposed within the capsule. Means is provided for moving the graft from the capsule, and an inflatable member is provided for securing the attachment means within a vessel lumen.

:The foregoing patents and publications are incorporated herein by reference.

P\OPE\GCP64747.DIV 10/12/96 -6 To provide consistency with the common usage of terms used in the medical surgical arts in the United States, the terms "proximal, distal, inferior and superior" are used with a certain regularity within the present specification. Proximal refers to parts of the system, such as catheters, capsules and wires, which are closest to the user and closest to the portion of the system outside or exterior of the patient. Distal refers to the point farthest from the user and typically most interior to the corporeal lumen. The term superior refers to a location situated above and is used herein in description of the graft and attachment means. Inferior refers to the point situated below and again is used herein with the graft and attachment means. Thus, for applications in the abdominal aorta which use i a femoral approach, the superior end of the graft resides within i 15 the most distal portion of the balloon catheter. Likewise, the Sinferior end of the graft resides within the proximal capsule which is on the most distal portion of the capsule catheter.

r SUMMARY OF THE INVENTION 446 i! In general, it is an object of the present invention to provide a grafting method which overcomes the disadvantages of the prior art systems.

•.According to the present invention there is provided a method for securing a graft in a corporeal lumen, said graft having a superior end and an inferior end, said graft further o °having superior attachment means disposed proximate the superior end and having inferior attachment means disposed rroximate the inferior end, said method comprising the steps of: providing placement means having distal capsule means for Q:\OPER\GCP\74253,SPE 11/8/98 -7containing said superior attachment means and the superior end of said graft, said placement means further having an inflatable member, said placement means further having proximal capsule means for containing said inferior attachment means and the inferior end of said graft; positioning said placement means and said graft at a desired location within the corporeal lumen; withdrawing said distal capsule means from the superior end of said graft and said superior attachment means; S: i0 withdrawing said proximal capsule means from the inferior end of said graft and said inferior attachment means; activating said inflatable member to secure said graft within the corporeal lumen; and removing said placement means from the corporeal lumen, 15 wherein said graft remains secured within the corporeal lumen.

Oo..

.The invention also provides a method for implanting a graft in a corporeal lumen having a wall, said graft having superior and inferior ends, said graft further having superior attachment means disposed proximate the superior end and having inferior oe 20 attachment means disposed proximate the inferior end, said S method comprising the steps of: providing placement means having distal capsule means for removably retaining said superior attachment means and the superior end of said graft, said placement means having proximal capsule means for removably retaining said inferior attachment means and the inferior end of said graft, and said placement means having an inflatable member; positioning said placement means and said graft at a desired location within the corporeal lumen; removing said distal capsule means from the superior end of said graft and said superior attachment means; activating said inflatable member to engage said superior attachment means with the wall of the corporeal lumen; P-\OPR\GC 4747.DIV 10/12/96 -8removing said proximal capsule means from the inferi3: end of said graft and said inferior attachment means; and activating said inflatable member to engage said inferior attachment means with the wall of the corporeal lumen.

The invention also provides a method for emplacement of a graft into a corporeal lumen having a wall, said graft having a superior end secured to a superior attachment system and an inferior end secured to an inferior attachment system, said method comprising the steps of: providing placement means comprising a balloon catheter having distal capsule means and an inflatable member, said placement means further comprising a capsule catheter having proximal capsule means; placing said superior attachment system in said distal capsule means, wherein the superior end of said graft is removably retained within said distal capsule means; f- oiplacing said inferior attachment system in said proximal capsule means, wherein the inferior end of said graft is a removably retained within said proximal capsule means; inserting said placement means into the lumen; positioning said graft at a desired position within the lumen; a.

removing said distal capsule means from the superior end of said graft and said superior attachment system; inflating said inflatable member to engage said superior attachment system, thereby securing the superior end of said o graft to the wall of the lumen; removing said proximal capsule means from the inferior end of said graft and said inferior attachment system; inflating said inflatable member to engage said inferior S P\OPER\GCPi 747.DIV 10/1296 9 attachment system, thereby securing the inferior end of said graft to the wall of the lumen; and Sremoving said placement means from the lumen.

The invention also provides a method for emplacement of a graft in a corporeal lumen having a wall, the graft having anchoring means and being disposed within placement means comprising a balloon catheter having a distal capsule, an inflatable member and shaft means coupled to the distal capsule and the inflatable member, the placement means further comprising a capsule catheter having a proximal capsule and shaft means coupled to the proximal capsule, said method comprising the steps of: manipulating the placement means to advance the graft, the balloon catheter and the capsule catheter into the corporeal lumen, wherein the graft and the anchoring means are removably retained in the distal and proximal capsules to prevent the anchoring means from contacting the corporeal lumen wall while the graft is being advanced through the corporeal lumen; positioning the graft at a desired location in the corporeal lumen; removing the distal and proximal capsules from the graft and anchoring means; I inflating the inflatable member to engage the graft and anchoring means so that the anchoring means and the graft are secured to the lumen wall; deflating the inflatable member; and withdrawing the placement means from the graft and from the corporeal lumen, wherein the graft is retained within 'the corporeal lumen.

The invention also provides a method for implanting a graft P:\OPER\GC\64747.DIV 10/12/96 10 in a corporeal lumen wall afflicted by an aneurysm having a superior end, the graft having superior anchoring means and inferior anchoring means, said method comprising the steps of: covering the superior anchoring means of the graft with distal capsule means; covering the inferior anchoring means of the graft with proximal capsule means; covering the graft, the distal capsule means and the proximal capsule means with a sheath; introducing an inflatable nlember, the graft, the distal capsule means, the proximal capsule means and the sheath into the lumen and then along the lumen until the graft reaches the aneurysm; uncovering the superior anchoring means when the graft is positioned in the lumen such that the superior anchoring means is superior to the superior end of the aneurysm; inflating the inflatable member to engage the graft and the superior anchoring means with the lumen; o uncovering the inferior anchoring means; deflating the inflatable member; inflating the inflatable member to engage the graft and the inferior anchoring means with the lumen; •deflating the inflatable member; and removing the inflatable member, the distal capsule means, the proximal capsule means and the sheath from the lumen, wherein the graft is retained in the lumen.

The invention also provides a method for implanting a graft in a corporeal lumen having a wall afflicted by an aneurysm having a superior end, the graft including a superior attachment system having wall engaging members, the graft further including deposits and cases where earlier filed applications to be disregarded for Convention purposes.

DAVIES COLLISON CAVE Q:\OPER\GCP\74253.C 11/8/98 P:\OPER\GCP\64747.DIV 10/126 11 an inferior attachment system having wall engaging members, said method comprising the steps of: covering the inferior attachment system of the graft with a proximal capsule, the proximal capsule being coupled to a first shaft; covering the superior attachment system of the graft with a distal capsule, the distal capsule being coupled to a second shaft in fluid communication with a balloon, wherein the second shaft is coaxially and slidably disposed within the first shaft; covering the graft, the distal capsule and the proximal capsule with a sheath slidably disposed over the first and -econd shafts; introducing the graft, the distal capsule, the proximal capsule and the sheath into the lumen; positioning the graft such that the superior attachment system is located superior to the superior end of the aneurysm; removing the sheath from the distal capsule; removing the distal capsule from the superior attachment system; positioning the balloon adjacent the superior attachment system; inflating the balloon to urge the wall engaging members of the superior attachment system into the wall of the lumen; f removing the sheath from the proximal capsule; removing the proximal capsule from the inferior attachment system; delating the balloon; positioning the balloon adjacent the inferior attachment system; inflating the balloon to urge the wall engaging members of I .A Q.\OPER\GO.64747CDIV 11112/96 M16708 I IECD9& Q:\OPER\GCP\74253.SPE 11/8/98 12 I'4 4 4I 4 i S 0 9 the inferior attachment system into the wall of the lumen; deflating the balloon; and removing the balloon, the distal capsule, the proximal capsule, and the sheath from the lumen, wherein the graft is retained in the lumen.

The invention also provides a method for engrafting a prosthesis into a corporeal lumen, said prosthesis having superior and inferior ends, said prosthesis further having a superior attachment means at the superior end and an inferior attachment means at the inferior end, said method comprising the steps of: providing delivery means for positioning said graft in the lumen, wherein said delivery means comprises a distal capsule means for removably retaining said 15 superior attachment means and a proximal capsule means for removably retaining said inferior attachment means; providing an inflatable member for activating said superior attachment means and said inferior attachment means; providing capsule jacket means for removably retaining said graft, said distal capsule means and said proximal capsule means; placing the superior end of said prosthesis and said superior attachment means into said distal capsule means; placing the inferior end of said prosthesis and said inferior attachment means into said proximal capsule means; .0 placing said prosthesis and said delivery means into Q:\OPER\GCP\74253.SPE 11/8/98 13 said capsule jacket means; creating an opening in the lumen for passing said capsule jacket means, said delivery means, said inflatable member, and said prosthesis therethrough; inserting said capsule jacket means, said delivery means, said inflatable member, and said prosthesis into the opening in the lumen; urging said prosthesis to a desired location within the lumen; positioning said superior attachment means of said prosthesis at a desired location within the lumen; i; withdrawing said capsule jacket means proximally to

*'I

expose said distal capsule means, said prosthesis and at least a portion of said proximal capsule means; 15 removing the inferior end of said prosthesis from said *proximal capsule means; removing the superior end of said prosthesis from said distal capsule means; inflating said inflatable member to activate said 6 superior attachment means to secure the superior end of said prosthesis within the lumen; inflating said inflatable member to activate said inferior attachment means to secure the inferior end of said prosthesis within the lumen; removing said delivery means and said inflatable member from the lumen; and closing the opening in the lumen.

Deployment of the graft comprises a series of steps which begins with introducing the placement means into the corporeal *30 lumen using well known surgical techniques. As a single system, B- il t I SQ:\OPER\GCP\74253.SPE 11/8/98 13A the balloon catheter, capsule catheter and capsule jacket are manipulated to position the capsule means containing the graft and attachment means to a desired location within the corporeal lumen. Once the graft is in the desired location, the capsule jacket is withdrawn to expose the distal capsule and a portion of the graft. The distal capsule is then moved relative to the balloon catheter shaft and capsule catheter to expose the superior attachment means.

After the superior portion of the graft is removed from the r 0 capsule means, the inflatable member is moved to within the circumference of the superior attachment means and inflated to *urge wall engaging members into the wall of the corporeal lumen.

The capsule jacket and capsule catheter are then moved relative

I

f f 1* tf -1- I- P,\OPR\GCM\64747.DIV 10/12/ 14 to the graft and balloon catheter shaft to expose the inferior attachment means. The balloon catheter shaft is then moved to position the inflatable member proximate the inferior attachment means. The inflatable member is then expanded to seat the wall engaging members of the inferior attachment means. The placement means is then removed from the corporeal lumen.

Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top plan view of an intraluminal grafting apparatus and system which can be used with the present invention.

FIG. 2 is a top plan view of a guidewire to be used with 1 the endovascular grafting system.

FIG. 3 is a top plan view of the balloon catheter.

FIG. 4 is a top plan view of the distal cap, control wire, 440 guiding tube and control wire handle assembly. FIG. 5 is a top plan view of the prc.imal capsule and capsule catheter assembly.

FIG. 6 is a top plan view of the capsule jacket assembly.

25 FIG. 7 is a top plan view of a graft for use with the o a method of the present invention.

FIG. 8 is a partial cross-sectional view of the distal end of the balloon catheter, capsule catheter and capsule jacket assemblies taken along the line 8-8 of Fig. i.

FIG. 9 is an enlarged perspective view showing an P:\OPER\CPVM747.DIV -10/1296 15 embodiment of the distal capsule, distal end of the control wire and distal cap insert.

FIG. 10 is an enlarged cross-sectional view of one embodiment of the distal capsule means of the balloon catheter.

FIG. 11 is a cross-sectional view taken along the line 11- 11 of Fig. ft 0 6 00 r a I t o 04 04* 0.

440000 44400 replace the damaged segment of the blood vessel. A plurality 16- FIG. 12 is an enlarged perspective view showing an embodiment of the distal capsule, distal end of the c6ntrol wire and distal cap insert.

FIG. 13 is an enlarged cross-sectional view of an embodiment of the distal capsule means of the balloon catheter.

FIG. 14 is a cross-sectional view taken along the line 14-14 of FIG. 13.

FIG. 15 is a partial cross-sectional view of the control wire and control handle mechanism taken along the line 15-15 of FIG. 1.

FIG. 16 is a cross-sectional view taken along the line 16-16 of FIG. FIG. 17 is a cross-sectional view taken along the lir-e 17-17 of FIG. FIG. 18 is a cross-sectional view taken along the line 18-18 of FIG. 1.

FIG. 19 is a cross-sectional view taken along the line 19-19 of FIG. 1.

FIG. 20 is a cross-sectional view taken along the line 20-20 of FIG. 1.

FIG. 21 is a cross-sectional view taken along the line 21-21 of FIG. 1.

FIG. 22 is a cross-sectional view taken along the line 22-22 of FIG. 1.

25 FIG. 23 is a partial cross-sectional view of the graft and attachment means of the present invention.

FIG. 24 is a cross-sectional view taken along the liiie 24-24 of FIG. 23.

17- FIG. 25 is an enlarged perspective view showing a superior attachment means.

i FIG. 26 is an enlarged perspective view showing an j inferior attachment means.

FIG. 27 is a partial cross-sectional view of the intraluminal grafting system shown positioned within the corporeal lumen.

FIG. 28 is a partial cross-sectional view of the intraluminal grafting system, wherein the distal capsule has been removed from the superior end of the graft.

FIG. 29 is a partial cross-section view of the j intraluminal grafting system, wherein the inflatable member has been expanded to seat the attachment means of the graft.

FIG. 30 is a partial cross-sectional view of the 1 15 intraluminal grafting system, wherein the capsule jacket and i capsule catheter have been withdrawn from the inferior end of the graft.

S. FIG. 31 is a partial cross-sectional view of the intraluminal grafting system, wherein the inflatable member 20 has been positioned and inflated to seat the inferior attachment means.

2i?. FIG. 32 is a partial cross-sectional view of the intraluminal grafting system, wherein the inflatable member has been moved proximate the proximal capsule.

FIG. 33 is a partial cross-sectional view of the intraluminal grafting system, wherein the balloon catheter, capsule catheter and capsule jacket have been placed in a position for withdrawal from the corporeal lumen.

position for withdrawal from the corporeal lumen.

_b rru~a~a;* P:\OPM\GC\64747.DIV- 10/ 2 296 18 1i DESCRIPTION OF THE PREFERRED METHODS As shown in the drawings and for purposes of illustration, the method of the invention can be carried out in an intraluminal grafting system of the type having a balloon catheter, a capsule catheter, and a protective sleeve or capsule jacket. One feature of the system is the use of a proximal capsule and a distal capsule t. cover the inferior and superior ends of a graft to be implan:;ed in tee vessel. This feature provides the capability of deploying 'the inferior end of the graft before the superior end or vice versa. Another feature is the use of a sleeve or capsule jacket to create a smooth transition between the proximal capsule and the distal capsule.

SThe uniqueness of the system is accentuated by the control wire and associated handle which provide relative movement between the distal capsule and the balloon catheter.

i In the present system, the graft is comprised of a monoluminal tubular member having superior and inferior extremities. Attachment means are secured to the superior and b' 20 inferior ends of the tubular member. The attachment means are provided with lumen piercing means which are covered by the \1 proximal and distal capsule assemblies. The balloon catheter, capsule catheter and capsule jacket are configured coaxially so that relative movement between them provides for deployment of the graft. The inflatable member of the balloon catheter is used to firmly implant the graft in the lumen.

In more detail, the intraluminal grafting system 50 is shown in FIGS. 1-7. As shown in FIG. 1, the system includes inzerior ena, said method comprising the steps of: providing placement means having distal capsule means for 19 a balloon catheter assembly 51, which is coaxiall' disposed within capsule -heter assembly 52, which is coaxially disposed within capsule jacket assembly 53. The capsule catheter and a distal capsule catheter assembly 90 are used to contain the graft 55. A control wire assembly 54 is coaxially disposed within a lumen of the balloon catheter assembly and configured to move the distal capsule assembly in relation to the other system components. In the preferred embodiment, the system is used as an over-the-wire device, such that the balloon catheter is further configured with a lumen for a guide wire 56. It is contemplated, however, that the system can also be used with well known fixed wire delivery system configurations.

As shown in FIGS. 1 and 3, the intraluminal grafting system 50 also includes a balloon catheter assembly 51 which consists of an inflatable member or balloon 60 secured to a flexible elongate element or balloon catheter shaft 61. As

E

t S. shown in FIG. 18, the balloon catheter shaft is preferably configured with three lumens; however, the balloon catheter 20 may be configured with a single, dual or similar multilumen shaft. A guide wire lumen 63 extends the length of the balloon i catheter shaft. Similarly, a balloon inflation lumen 64 extends from the proximal end 70 of the balloon catheter to o the inflatable member 60, wherein an inflation port 83, FIG.

S• 25 8, is provided to allow inflation fluid to enter and exit the inflatable member. The third lumen 65 is provided for the control wire assembly 54.

c- J.L dCLLc iiL=lL L LLL C activating said inflatable member to engage said superior RAL 4 Sattachment means with the wall of the corporeal lumen; 0 20 The flexible elongate element or balloon catheter shaft 61 is preferably formed of a material suitable for intraluminal i use, such as irradiated polyethylene tubing. The three lumen balloon catheter shaft is preferably extruded to an outside i 5 diameter of 0.08 inches (2.03 mm). The guide wire lumen 63 iI has an inner diameter of 0.042 inches (1.07 mm). The inflation lumen 64 and the control wire lumen 65 have identical inner Si diameters of 0.022 inches (0.56 mm). However, the lumen inside Sdiameter may range from 0.015 to 0.06 inches (0.381-1.52 mm) and the outside diameter may range from 0.035 to 0.1 inches (0.889-2.54 mm) for a multilumen balloon catheter shaft. The balloon catheter may vary in length to suit the application, for example, from fifty to one hundred-fifty centimeters.

Referring to FIG. 1, the proximal extremity 70 of the balloon catheter shaft 61 is secured to a splitting adapter i 71 which splits the guide wire lumen 63 from inflation lumen i 64. The side arm 72 of the adapter 71 has a stop cock 73 mounted at its proximal end which is movable between open and S'.*closed positions. Ths stop cock is provided with a Luer 20 fitting 74 which is adapted to be secured to a syringe for injecting inflation fluid. The side arm 75 of the adapter 71 is connected to female Luer fitting 77 for distal tip injection and to a Touhy Borst adapter 76 which is configured to removably and slidably receive the guide wire 56.

25 The inflatable member or balloon 60 is preferably secured twelve centimeters from the distal extremity 80 of the balloon catheter shaft 61. The balloon is positioned proximal of the distal capsule assembly 90 and the superior end of the graft t i -21- For shorter grafts of four to seven centimeters in length, E the inflatable member may be positioned distal of the distal i capsule assembly. The balloon is formed of suitable material i such as polyethylene. The balloon can vary in diameter from twelve to forty-five millimeters in diameter and can have a i wall thickness ranging from 0.001 to 0.005 inches (0.0254-0.127 i mm). The polyethylene utilized for the balloon is irradiated to achieve an appropriate balloon size. The preferred balloon made in accordance with the present invention has an outside diameter of twenty-four millimeters, a diameter equal to the inner diameter of the graft, and had a wall thickness of approximately 0.003 inches (0.076 mm). In addition, the balloon is pleated along its axis for a low profile which facilitates its introduction into a corporeal lumen of a patient as hereinafter described. Further, the deflated Sballoon is heated to provide it with a memory of its low i profile configuration.

~Balloon catheter shaft 61 is provided with an inflation lumen 64 which is in fluid communication with the inflation 20 port 74. The inflation lumen is used to inflate and deflate *1 tl the balloon 60 by introducing and withdrawing a gas or liquid through the inflation port. The balloon is secured approximately twelve centimeters from the distal extremity of the balloon catheter shaft. The balloon proximal stem 81 25 and balloon distal stem 82 are heat sealed to the balloon catheter shaft to form a fluid tight seal. The length of the proximal stem may vary from 0.5 to 5.0 centimeters so that the proximal stem may vary from 0.5 to 5.0 centimeters so that the

I

ii 22 -22 f balloon will span the distance between the inferior and superior attachment means of the graft The balloon catheter shaft 61 has an inflation port 83 located approximately ten millimeters distal the balloon proximal stem 81. In addition, a radiopaque marker 84 is embedded in the balloon catheter shaft approximately two millimeters distal the balloon inflation port. Preferably, the radiopaque marker is a platinum or tungsten coil one centimeter long with art outer diameter of 0.02 inches (0.508 mm) and is located proximate the center of the balloon It should be appreciated that although a separate inflatable member ha, been described in the drawing, an integral coaxial inflatable member may be provided which is formed of the same tubing from which the balloon catheter shaft is made. This S 15 can be readily accomplished, as is well known to those skilled in the art, by using an additional radiation dose for the balloon region of the shaft.

As shown in FIGS. 3 and 8, a pusher button 85 is slidably mounted on the balloon catheter shaft 61 and is located i 20 proximal the balloon proximal stem 81, for example, .a distance of five to eight centimeters. The pusher button is retained from moving proximal on the shaft by an annular bulb 86 which is formed by localized heating of the shaft. A radiological C. 4 marker band 87 is placed on the shaft just pruximal the annular bulb. The pusher button is preferably cylindrical having a preferred outside diameter of 0.22 inches (5.588 mm), ranging from 0.15 to 0.25 inches (3.81-6.35 mm). The pusher button i I I _rL 1;Cl'Ly 9a b jZ.lV. J..L u111u, ine gran- inc-Lucily a tiuei-. L aIuouI.t system having wall engaging members, the graft further including 23is formed of a suitable material such as 300 series stainless steel to achieve radiopacity.

The balloon itself can also be observed under x-rays because the blood in the patient's vessel is more opaque than the gas used for inflating the balloon. In addition, increased visibility of the balloon can be obtained by inflating the balloon with a diluted radiopaque contrast solution. In addition, radiopaque bands of a suitable material such as platinum or a platinum-tungsten alloy can be placed on the proximal and distal balloon stems 81 and 82 to aid in ascertaining the position of the balloon. Similarly, radiopaque rods may be inserted in the distal balloon shaft tubing, in the control wire or balloon inflation lumens.

The intraluminal grafting apparatus also includes a control wire assembly 54, which is shown in FIGS. 1 and 4.

The distal end of the control wire assembly consists of a Sdistal capsule assembly 90. As shown in more detail in FIGS.

9-14, the distal capsule assembly comprises a control wire 91 secured within a distal cap 92. A hollow distal capsule 93 is secured to the distal cap and coaxially surrounds the control wire.

The control wire 91 is threaded through aperture 94 in the balloon catheter shaft 61 and is slidably disposed in the balloon catheter shaft lumen 65. Distal e&d 95 of the control wire is embedded in distal cap insert 96 which is secured to the distal cap 92 by means of an adhesive, solvent bonding, ultrasonic welding or by heat shrinking. As shown in FIG. 9, the distal cap insert is formed with radiopaque markers 97 and Z: Y -j L L L j inflating the balloon to urge the wall engaging members of 24- 1 98. Preferably, a 0.04 inch (1.O1 mmun) wide, 0.005 inch (0.127 mm) thick and 2 millimeters long ribbon is disposed in slots formed in the circumference of the insert at a 90 degree angle from the control wire.

S 5 As shown in FIG. 10, balloon catheter proximal cap 100 j is secured to the balloon catheter shaft 61 at a position i distal the balloon distal stem 82 and proximal the aperture The proximal cap is secured to the balloon catheter shaft by adhesive and by means of a retaining bump 101. Retaining sleeve 102 slidably secures the control wire 91 against the balloon catheter shaft. Thus, as the control wire is moved II in a longitudinal manner, the distal end of the control wire distal cap insert 96, the distal cap 92 and distal capsule 93 each move as a single assembly. The proximal edges 103 of the distal capsule are rolled, curved or crimped inward so that the proximal cap will lock into the distal capsule when the distal capsule is advanced.

Referring to FIG. 11, the distal cap 92 may be formed 1, 4 from polycarbonate or other suitable material for insertion 20 through the body lumen. The distal cap is formed with a bore j 104 of approximately the same diameter as the outer diameter of balloon catheter shaft 61. Similarly, the distal cap insert 96 may be formed of the same material as the distal cap, S"wherein the distal cap insert is provided with a bore 105 for receiving the balloon catheter shaft. The distal cap is further provided with a recess 106 or other means for receiving S"the distal end of the distal capsule 93. The distal capsule is preferably formed of stainless steel, but may be formed of meais placing said prosthesis and said delivery means into 25 other suitable biocompatable material, such as a nickel titanium. The distal cap recess is angled to allow crimping of the distal capsule to the distal cap.

The outside diameter of the distal cap 92 and capsule 93 ma- range from 4 to 9 millimeters and is preferably 0.282 inches (7.16 mm) in outer diameter and 0.276 inches (7.01 mm) inner diameter. Similarly, the balloon catheter proximal cap 100 outer diameter is comprised of stainless steel and has an outside diameter slightly less that of the distal capsule so as to provide a smooth transition. The proximal end of the proximal cap is preferably rounded to minimize trauma in the vessel and to facilitate balloon retraction into the graft during the emplacement process. The distal capsule may range in length from one to five centimeters, and preferably is three centimeters long so as to adequately retain the distal end of the graft FIGS. 12-14 show an alternative and embodiment of the 6 distal cap assembly 90. In this embodiment, the core wire 91 00 0 is threaded through an opening 107 in the distal cap insert 20 108. A longitudinal slot 109 is cut out in ths balloon catheter shaft 61 to expose the core wire lumen 65. The control wire is formed in a U-shaped bend over the opening in the distal cap insert and is configured to slide- within the 00 slot and the core wire lumen of the balloon catheter shaft.

The distal end of the control wire resides in the portion of the core wire lumen beyond the end of the slot. This configuration allows the distal cap assembly to move axially along the balloon catheter shaft. The U-shaped bend of the 26 control wire through the distal cap insert, however, prevents the distal cap assembly from rotating in relation to the balloon catheter shaft. As described above, the balloon catheter insert is firmly secured within the distal cap. To prevent rotation of the distal cap, a three centimeter length of the control wire extends distal of the distal cap and is slidably disposed in the balloon catheter shaft lumen As shown in FIGS. 15-17, a handle assembly 110 is secured to the proximal end of the control wire 91. The handle assembly comprises a proximal body 111, a distal body 112, a control knob 113 with threaded shaft 114 and a guiding member 115. The two handle body parts have a central bore for receiving the balloon catheter shaft 61. The guiding member is coaxially disposed over the balloon catheter shaft and extends distally from the central bore in the distal handle body. The proximal end of the guiding member is secured to the balloon catheter shaft approximately one centimeter proximal from the distal end of the distal handle body by means of a polyethylene sealing tube 116 which is heat shrunk over the proximal end of the guiding member. An adhesive may be used to fix the distal handle body to the guiding member.

Guiding member 115 consists of a rigid thin wall tube formed of a suitable material such as stainless steel, e.s a catheter hypotube. The guiding member has a length of about u,#00e* 45 centimeters and has an outside diameter of 0.095 inches (2.41 mm) and an inside diameter of 0.087 inches (2.21 mm).

The control wire 91 preferably consists of an elongate solid flexible stainless steel wire having a FEP or lubricating 27 coating. The coated control wire is about 0.02 inches (0.508 mm) in diameter so as to provide sufficient strength to move the distal capsule assembly 90 without breaking or kinking.

Referring to FIG. 15, the control wire resides in the balloon catheter lumen 65 and extends from the distal capsule assembly to an aperture 117 located in the lumen just proximal of the proximal end of the guiding member.

The proximal end of the control wire 91 is disposed within a longitudinal central bore in a retaining tube 120 approximately six centimeters long. The retaining tube's proximal end is slidably disposed within a longitudinal guiding slot 121 in proximal handle body Ill. Similarly, the retaining tube's distal end is slidably disposed within an longitudinal upper slot 122 in the distal handle body 112. A transverse threaded bore 123 is located approximately 0.25 inches (6.35 mm) from the proximal end of the retaining tube for receiving the threaded shaft 114. The threaded shaft is turned down in the threaded bore to engage the control wire to secure the control wire firmly in the retaining tube.

S o 20 The threaded shaft 114 extends upwardly from the retaining tube 120 through the proximal handle body 111 and movable within the guiding slot 121. The control knob 113 is threaded onto the threaded shaft, wherein the oontrol knob can be turned down and tightened onto the proximal handle body, thereby locking the retaining tube and control wire 91 in a o fixed position relative to the balloon catheter. When the control knob is loosened, any longitudinal movement of the l r~ I-I* 28 control knob causes corresponding movement of the distal capsule assembly As shown in FIGS. 1 and 5, the capsule catheter assembly 52 consists of a proximal capsule catheter assembly 130 secured to the distal end of a flexible elongate tubular member 131 formed of a suitable plastic material such as polyether block amide available under the trademark "PEBAX", available from Atochem Polymers, Glen Rock, N.J. The capsule catheter elongate tubular member is of a suitable length as, for example, 40 to 100 centimeters and preferably approximately centimeters for the abdominal aortic artery and approximately 80 centimeters for the thoracic aortic artery.

The elongate tubular member has a preferred outside diameter of 0.187 inches (4.75 mm) and an inside diameter of 0.125 inches (3.175 mm). The elongate tubular member can be produced in a certain color such as blue. To render the elongate i: tubular member radiopaque under x-rays, its material of construction may contain a radiopaque material, such as twenty percent by weight of bismuth subcarbonate or barium sulfate.

20 The elongate tubular member may have markings or bands distal of the wye adapter 145 at predetermined positions to indicate capsule jacket retraction and locking points.

The proximal catheter assembly 130 has a proximal capsule 132 mounted on the distal extremity of the capsule catheter elongate tubular member 131. The proximal capsule has a preferred diameter ranging from four to nine millimetE rs, which may be configured to accommodate different size grafts. The proximal capsule is configured to match the size of the distal 29capsule assembly 90. Thus, the proximal capsule is preferably made of stainless steel or similar impermeable and rigid, or semi-flexible material. The elongate tubular member also serves as a shaft for advancing the pr-ximil capsule, as hereinafter described. Thus, the elongate tubular member should have a diameter which is less than that of the proximal capsule, preferably having an outside diameter ranging from three to seven millimeters.

Referring to FIG. 8, the proximal capsule 132 is secured to the distal extremity of the elongate tubular member 131 by means of a capsule adapter assembly 133. The capsule adapter assembly comprises a housing 134 and an inner sleeve 135, which may be constructed from polycarbonate. The capsule adapter housing distal extremity 136 is secured in the proximal extremity of the capsule, for example, by crimping, by using a press fit swaging or an adhesive such as a cyanoacrylate ester. The capsule adapter housing distal extremity may be S S angled to facilitate securing the housing to the proximal capsule.

The proximal extremity of the capsule adapter housing 134 is secured to the distal extremity of the elongate tubular member 131 by means of an cyanoacrylate ester adhesive, or other suitable means. To facilitate a mechanical lock, the elongate tubular member distal extremity is molded to form a flange 137, wherein the capsule adapter housing is configured so as to close around the flange. The capsule adapter housing S:o.S.

is further provided with a recess for receiving the capsule adapter inner sleeve 135. The inner sleeve is provided with 24-24 of FIG. 23.

30 a bore of a suitable diameter so as to allow the balloon catheter shaft 61 to reside therein. Ths inner sleeve may further be provided with radiopaque marker rods or flat ribbon i138 for detection of the capsule adapter assembly 130 during fluoroscopy.

A wye adapter 145 is secured to the proximal extremity of the flexible tubular member 131 of the capsule catheter.

The central arm 146 of the wye adapter is connected to a Touhy Borst adapter 147 which tightens around the guiding member 115 disposed in the central arm of the wye adapter. The side arm 148 of the wye adapter has a stop cock 149 mounted therein which is movable between open and closed positions. The stop Scock is provided with a Luer fitting 150 which is configured to accept a syringe for injecting a dye. Air may be purged from the capsule jacket assembly 53 by injecting fluid through the Luer fitting. The injection fluid will exit purge ports 151 and 152, thereby filling the capsule jacket assembly with injection fluid. The Luer fitting may be attached to a saline I drip line during the operative procedure.

20 Referring to FIGS. 1, 6 and 8, the capsule jacket assembly 53 is slidably disposed coaxially over the capsule catheter assembly 52 and the balloon catheter assembly 51.

The capsule jacket assembly is comprised of a main-sheath 160, S.i a capsule jacket support sheath 161 and a locking connector 162. The main and support sheaths are coaxial from their proximal end, to a point approximately 15 centimeters from the distal end 163 of the main sheath, depending on the length of the graft. At the point where the support sheath terminates, *1 31the main sheath flares to an expanded diameter to cover the proximal capsule 132 and the distal capsule 93. The diameter of the main sheath is about 0.263 inches (6.68 mm) at its proximal end and about 0.3 inches (7.62 mm) at the distal end 163. The proximal ends of the sheaths may be secured to the sheath adapter 164 of the locking connector by mechanical means and by adhesive. The distal end of the main sheath of the capsule jacket is provided with radiopaque marker 166.

When the capsule jacket assembly 53 is in its most distal position, the distal end 163 of the capsule jacket main sheath extends to cover at least a portion of the distal capsule assembly 90. Similarly, the capsule jacket locking connector 162 is thereby positioned just proximal the proximal capsule catheter purge port 151. Prior to insetion into the lumen, locking ring 165 is turned down to hold the capsule jacket assembly firmly in place, thereby maintaining a smooth transition surface along the length of the intraluminal grafting system 50 which resides in the body vessels. When the locking ring is released, the capsule jacket assembly may 20 be moved to a furthermost proximal position, wherein at least a portion of the proximal capsule catheter assembly is exposed.

Thus, the locking connector is positioned just distal the capsule catheter wye adapter 145. The locking ring may be otightened at any intermediate position to firmly secure the Ott., capsule jacket assembly at the desired location. In addition, a radiopaque marker 166 is provided at the distal end of the o main sheath to facilitate proper linear positioning of the main sheath.

i ;9 i .3 j i u i -i 32 As shown in FIGS. 1 and 7, the intraluminal grafting apparatus 50 also includes an expandable intraluminal vascular graft 55 for implanting in a body vessel. Referring to FIG.

23, the graft consists of a deformable tubular member 170 which 5 is provided with superior end 171, inferior end 172 and a cylindrical or continuous wall 173 extending between the superior and inferior ends of the graft. The tubular member may have a length in the range of 8 to 20 centimeters, where centimeters is suitable for most patients. The tubular member may have a maximum expandable diameter ranging from 14 to 40 millimeters and a minimum diameter in a collapsed condition of 0.175 to 0.3 inches (4.44-7.62 mm). The continuous wall can be woven of any surgical implantable material such as polytetrafluroethylene or a polyester fiber made from polyethylene terephthalate (PET), such as "DACRON" type 56. One material found to be satisfactory is "DEBAKEY" soft woven "DACRON" vascular prosthesis (uncrimped) sold by C.R. Bard of Billerica, Mass. In order to prevent unraveling of the woven material at the ends, the ends can be melted with heat to provide a small melted bead of material on each end.

Referring to FIG. 23, expandable attachment means 175 is secured adjacent the superior end 171 of the tubular member 170. Similarly, expandable attachment system 176 is secured adjacent the tubular member's inferior end 172. Each 25 attachment system serves to yieldably urge the tubular member from a first compressed or collapsed position to a second expanded position. Each attachment system is formed of a plurality of vees 177 with the outer apices 178 and inner I Cf 1 44..

S4 S9.C 4 C a

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.r.44CC (11- i ~I r- j 33 apices 179 of the vees being formed with helical coil springs 180 to yieldably urge the long legs 181 and short legs 182 of each of the vees outwardly at a direction approximately at right angles to the plane in which each of the vees lie.

As shown in more detail in FIG. 25, the superior attachment system 175 is comprised of a single piece of wire which is formed to provide the vees 177 and also to define the helical coil springs 180 between the legs 181 and 182. The two ends of the single piece of wire can be welded together in one of the legs to provide a continuous spring-like attachment means. In the construction shown in FIG. 23, it can be seen that the attachment means have apices lying in four longitudinally spaced-apart parallel planes which are spaced with respect to the longitudinal axis of the tubular member S 15 170.

The superior and inferior attachment means 175 and 176 are secured to the superior and inferior ends 171 and 172, respectively, of the tubular member 170 by suitable means such as a polyester suture material 190. As shown in FIG. 23, the

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suture material is used for sewing the attachment means onto Sthe wail 173 of the tubular member. Knots 191 are preferably formed on each of the legs or struts 181 and 182 to firmly secure each leg to the graft. The legs may be secured so that the apices lying in each plane are staggered to provide for the minimum profile when the attachment means is placed in its collapsed condition. The inferior attachment means 176 may be attached to the inferior end of the graft 172 in a similar manner.

distal capsule assembly 90 and the superior end of the graft 34 1i As shown in FIGS. 25 and 26, wall engaging members 195 and 196 are preferably secured to the legs 181 and 182 in the vicinity of the outer apices 178 by suitable means such as welding. The wall engaging members have a diameter ranging from 0.01 to 0.018 inches (0.254-0.457 mm) and a length from to 5.0 millimeters. The wall engaging members are preferably sharpened to provide conical tips, and should have a length which is sufficient for the tip to penetrate into and perhaps through the corporeal lumen wall.

The superior attachment means 175 and the wall engaging members 195 secured thereto are formed of a corrosion resistant material which has good spring and fatigue characteristics.

One such material found to be particularly satisfactory is "ELGILOY" which is a cobalt-chromium-nickel alloy manufactured and sold by Elgiloy of Elgin, Illinois. The wire can have a diameter ranging from 0.008 to 0.016 inches (0.203-0.406 mm), with a smaller diameter wire being utilized for the smaller diameter grafts. For example, 0.012 to 0.016 inch (0.305-0.406 i mm) diameter wire for the frame and wall engaging members may 20 be used in the larger grafts of eighteen to twenty-eight it millimeters diameter, and 0.008 to 0.012 inch (0.203-0.305 mm) f diameter wire may be used in the smaller grafts being eight to sixteen millimeters in diameter.

*J 0 It has been found that the spring force created by the 0 helical coils 180 at the apices 178 and 179 is largely determined by the diameter of the wire. The greater the "diameter of the wire, the qreater the spring force applied to the legs 181 and 182 of the vees. Also, the longer the t A 35 distances are between the apices, the smaller the spring force that is applied to the legs. It therefore has been desirable to provide a spacing between the outer extremities of the legs of approximately one centimeter, although smaller or larger distances may be utilized.

To facilitate securing the graft 55 in the corporeal lumen, the wall engaging members 195 and 196 of the superior attachment means 175 and inferior attachment means 176 may be angled with respect to longitudinal axis of the tubular member 170. The wall engaging members face outwardly from the tubular member to facilitate holding the graft in place. Preferably, the wall engaging members on the superior attachment means are inclined from the longitudinal axis and toward the inferior end of the graft 172 by 550 to 850 and preferably about 750* Likewise, the wall engaging members of the inferior attachment means may be inclined towards the superior end of the graft %.175 by 300 to 900 and preferably 850. By angling the wall engaging members so that they resist the force of the blood

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flow, the implanted wall engaging mer 'rs oppose migration of 20 the graft.

The helical coil springs 180 placed at the apices 178 and 179 serve to facilitate compression of the graft 55 to place the superior and inferior attachment means 175 and 176 .within the capsule assemblies 90 and 130, as hereinafter 25 described. The compression of the graft is accomplished by deformation of the coil springs within their elastic limits.

Placing the apices in different planes and staggering or offsetting the wall engaging members 195 and 196 significantly -36reduces the minimum compressed size of the graft. Having the apices in different planes also helps to prevent the wall engaging members from becoming entangled with each other. The i natural spring forces of the helical coil springs serves to expand the graft to its expanded position as soon as the attachment means is free of the capsule means.

The graft 55 preferably contains radiopaque marker means for locating the graft and for detecting any twisting of the graft during deployment. The radiopaque marker means takes the form of two sets of radiopaque markers 197 and 198. The radiopaque markers are made of a suitable material such as a J platinum tungsten alloy wire of a suitable diameter such as 0.004 inches (0.102 mm) which is wound into a spring coil having a diameter of 0.04 inches (0.102 mm). The radiopaque S 15 markers are secured to the tubular member 170 by sutures 199, Susing the same material sued to secure the attachment means to the graft.

As shown in FIG. 23, the radiopaque markers 197 and 198 i i. o are located on the tubular member 170 of the graft 55 in a line .0* 20 .lel to the longitudinal axis of the tubular member. Each Smember preferably has at least two sets of markers such 0. that the first marker is positioned 0.5 centimeters from the superior attachment system 175. Additional markers are .o positioned every one centimeter thereafter for the length of 25 the tubular member. The last marker in each set is centimeters away from the inferior attachment system 176.

Thus, the total number of markers in each set depends upon the length of the graft.

C=l i~ ~bl*M~-au~,~urr~ i 37 Referring also to FIG. 24, each of the first set of radiopaque markers 197 has a preferred length of 3 millimeters.

Each of the second set of markers 198 preferably has a smaller length, for example 2 millimeters, and are positioned along the longitudinal axis of the tubular member 170 at a position 1800 from the first set of markers. By placing markers of different lengths along th= e<is of the tubular member, it is possible to ascertain the position of the graft 55 and to determine whether the graft has twisted between ;hs superior and inferior ends 171, 172. Under fluoroscopy, the two sets markers will be exhibited as two relatively straight lines for an untwisted graft, wherein a twisted graft will be revealed by a non-linear pattern of markers. By placing the markers at equal increments apart, it is possibi' to use fluoroscopy to ascertain longitudinal compression or tension on the graft.

The sizing of the graft 55 may be performed on a patientby-patient basis, or a series of sizes may be manufactured to adapt tc most patient needs. For the repair of an aortic aneurism, the length of the graft is selected so to span approximately one centimeter superior and one centimeter inferior of the aneurysm, wherein the wall engaging members 195 and 196 of the graft can seat within normal tissue of the vessel on both sides of the aneurysm. Thus, the graft should be about two centimeters longer than the aneurysm being 2& repaired. During the preimplant fluoroscopy procedure, a conventional pigtail catheter is used to determine the locations of the renal arteries to ensure the renals will not be covered by the implanted graft. Similarly, the diameter ~c 38of the tubular imber 170 is selected by measuring the j corprreal lumen which will receive the graft by conventional j i radi g-raphic techniques and then selecting a tubular member Shaving a diameter one millimeter larger than that measured.

i 5 FIG. 8 depicts the distal end of the intraluminal grafting system 50 assembled for deployment. The graft 55 is disposed within the proximal capsule assembly 130, the distal capsule assembly 90 and the capsule jacket assembly 53. The superior end of the graft 171 and superior attachment means 175 are removably retained within the distal capsule 93.

Likewise, the inferior end of the graft 172 and inferior attachment means 176 are removably retained within the proximal capsule 132. The distal cap 92 is in its retracted or proximal Sposition adjacent to proximal cap 100. Similarly, core wire 91 is locked via control knob 113 in its retracted or proximal position. During initial deployment, capsule catheter tubular member 131 is in its most distal position in relation to JI balloon catheter assembly 51 and is locked in place by the .locking ring on the Touhy Borst adapter 147.

20 During initial deployment, the distal end of the balloon catheter 80 is positioned such that the balloon 60 resides J/ within the tubular member 170 of the graft 55, as shown in FIG.

8. The proximal cap 100 is positioned just proxima'l the distal 4 cap 92 and is disposed within the distal capsule 93. Likewise, pusher button 85 is disposed just proximal the inferior attachment means 176 of the graft. The capsule jacket assembly •53 is positioned such that the distal end of the capsule jacket main sheath 160 overlaps at least a portion of the distal -39capsule 93. During deployment, capsule jacket locking Sconnector 162 secures the main sheath in place. Thus, when any movement or force is applied to the handle assembly 110, the entire apparatus 50 moves as a single unit.

By way of example, the following describes a method of repair of an aortic aneurism using the method comprising the present invention for intraluminal placement of a graft in an aorta. First, a patient is prepared in a conventional manner by use of a guide wire 56, a dilator and sheath (not shown) to open the femoral artery or vessel of the patient. The distal end of the intraluminal grafting apparatus 50 is then inserted into the sheath, which has previously been placed in the femoral artery. In the preferred embodiment of the present invention, balloon catheter lumen 63 is provided for receiving the guide wire 56. However, the following procedure may also be used when the guiding member is constructed as part of the balloon cathetez.

As shown in FIG. 27, the guide wire 56 is introduced by the physician into the femoral artery and advanced to the 20 desired location in the aorta 200 and adjacent to the diseased or damaged portion of the vessel 201. The balloon catheter assembly 51, the capsule catheter assembly 52, the capsule jacket assembly 53 and the control wire assembly 54 are all .I configured for deployment as shown in FIGS. 1 and 8. Thus, the assemblies are advanced by the physician as a single unit over the guide wire. The physician uses the handle assembly 110 and the proximal end of the balloon catheter 70 to guide the distal end of the assemblies over the guide wire.

'Jne L;U I.I.i. W I.1 bJ.L=. L=.)J.Ly flexible stainless steel wire having a FEP or lubricating 40 Typically, the desired position for implanting the graft will be within the abdominal aorta with the superior extremity 171 of the graft at least one centimeter inferior to the lower renal artery.

When the distal capsule assembly 90 and the superior attachment means 175 are in the desired position, the superior end of the graft 55 is implanted. First, the locking ring 165 of the capsule jacket assembly 53 is loosened to allow movement of the capsule jacket main sheath 160. While using one hand to firmly grasp the capsule catheter assembly 52 and hold it stationary, the physician grasps the sheath adapter 164 with the other hand and gently pulls the sheath adapter proximally towards the capsule catheter wye adapter 145, as shown in FIG.

28. The capsule jacket assembly is moved about 6 centimeters to fully expose the distal capsule assembly, and partially expose the graft. The locking ring is then tightened to hold the capsule jacket assembly in place.

4, o At this point in the procedure, the superior end of the Sgraft 171 is disposed in the distal capsule 93, the inferior 20 end of the graft 172 is securely retained with in the proximal ,o capsule 132 and the distal end of the capsule jacket main sheath 160 is located about midway between the ends of the graft. The control knob 113 is then loosened to permit o:4 relative movement between the distal capsule assembly 90 and the balloon catheter assembly 51 to expose superior end 171 of the graft 55. Again using one hand to firmly grasp the handle assembly 110, the physician slides the control knob distally toward the wye adapter 145. Since the distal cap 92 i i B 41 and distal capsule 93 are secured to the control wire 91, they move in a about a 1:1 ratio with the movement of the control knob. The control knob is moved distally approximately 3 centimeters, which moves the distal capsule from engagement with the superior attachment means 175 and exposes the balloon catheter proximal cap 100. The control knob is then locked in place. As soon as the distal capsule has cleared the superior attachment means 175, the superior extremity of graft expands outwardly under the force of the self-expanding attachment means which springs into engagement with the vessel wall 202.

Once the superior attachment means 175 is exposed, steps are taken to firmly seat or urge the wall engaging members 195 an 196 in the vessel lumen. First, locking ring 165 is loosened, and the capsule jacket assembly 53 is moved proximally to a point where the distal end of the main sheath 160 is positioned just proximal the distal end of the proximal capsule 132 (FIG. 29). The capsule jacket assembly is then locked in place. Then, the locking ring on the capsule 20 catheter Touhy Borst adapter 147 is loosened to permit relative movement between the capsule catheter assembly 52 and the balloon catheter 51. While the p)iysician uses one hand to hold the capsule catheter assembly stationary, the hand-le assembly 110 is grasped by the other hand and pushed distally to position the center of the balloon 60 into the superior extremity of the graft 171. The radiopaque marker 84 is used to align the balloon and attachment means.

Is I ft i t, t *l C..

*r 4s a proximal capsule is configured to match the size of the distal 42 Thereafter, a conventional hand operated syringe or I inflation assembly (not shown) is attached to the balloon lcatheter inflation port 74. The bal-loon is then expanded by Sintroducing a suitable gas such as carbon dioxide or a dilute i 5 radiopaque liquid from the syringe to urge the wall engaging members 195 and 196 outwardly to firmly emplace the attachment system within the vessel wall 202. The balloon may be deflated and inflated repeatedly to ensure the superior attachment means is firmly implanted in the vessel. The balloon may be then deflated or may remain in an inflated position during the next steps of the procedure.

j As shown in FIG. 30, the next step is to implant or I anchor the inferior attachment system 176. With the handle assembly 110 held firmly in place, the capsule catheter assembly 52 is moved proximally until the inferior attachment Ssystem and inferior end of the graft 172 are completely clear of the proximal capsule 132. Once the inferior extremity of the graft is free of the p ximal capsule, the inferior iii attachment system will spring open and the wall engaging 20 members 195 and 196 will engage the vessel wall 202. Leaving the balloon 60 inflated while the capsule catheter assembly is moved ensures that the superior attachment system 175 will remain firmly secured in place. Thereafter, the -balloon may be deflated and the capsule catheter locking ring 147 secured to the guiding member 115, thereby securing the capsule catheter assembly 52 to the balloon catheter assembly 51.

In certain circumstances, an alternate method of deploying the inferior attachment system 176 may be employed.

.L LA. UL i J. J V L" %A CA L adapter inner sleeve 135. The inner sleeve is provided with Ii -43 Such an alternate method may be advantageous when a graft has been chosen that is of a length which exceeds the length of the aorta, thereby jeopardizing a secure emplacement of the inferior extremity of the graft. In such cases, the balloon 60 is deflated so that the balloon catheter assembly 51 can I be freely moved within the corporeal lumen. Next, the capsule catheter assembly 52 is advanced in a distal direction so that Sthe inferior attachment system is positioned in the desired Slocation of the aorta 200.

With the inferior attachment system 176 and the inferior extremity of the graft 172 in the portion of the corporeal ii lumen where the wall engaging members 196 are to engage the i vessel wall 202, the balloon catheter shaft 61 is advanced so that the pusher button 85 and retaining bump 86 engage the S 15 inferior attachment system. Then the user holds the handle i assembly 54 and balloon catheter assembly 51 fixed while moving the capsule catheter assembly 52 in a proximal direction. When i !the proximal capsule assembly 130 moves sufficiently distally, S I 0 the inferior attachment system will be released from the 1 I20 proximal capsule 132. The inferior attachment system and inferior wall engaging members may then be secured with the

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balloon l As shown in FIG. 31, the handle assembly 110 is moved proximally so that the balloon 60 is then retracted further into the graft 55 and placed adjacent the inferior attachment i system 176. Again, the balloon radiopaque marker 84 is used to align the center of the balloon with the attachment means.

The balloon is then inflated, and perhaps deflated and the graft. At the point where the support sheath terminates, -44- 1 inflated, to expand the attachment system and ensure that the i wall engaging members 195 and 196 are firmly urged and i implanted in the vessel wall 202. Thereafter, the balloon is finally deflated.

As shown in FIG. 32, the proximal capsule assembly 130 and balloon 60 are moved proximal the graft 55. First the locking ring 147 is loosened. Then, while holding the capsule catheter assembly 52 in place by grasping the wye adapter 145 with one hand, the balloon catheter assembly 51 is moved proximally by gently pulling the handle assembly 110 with the other hand. Thus, the capsule catheter assembly and balloon catheter are in the same relative position as they were just i prior to deployment (FIG. Also, the proximal end 103 of the distal capsule 93 has been mated with the proximal cap 100 S 15 for smooth transition.

Finally, as shown in FIG. 33, the capsule jacket locking jring 165 is loosened. While holding the capsule jacket sheath adapter 164 in place, the balloon catheter and capsule catheter i assemblies 51 and 52 are moved proximally and in unison by 20 gently pulling the wye 145 of the apsule catheter assembly.

i The catheter assemblies are moved until the distal end of the 62( .main sheath 163 covers the distal capsule 93 or until the proximal capsule adapter housing 134 mates with- the flared transition of the capsule jacket, thereby creating a smooth transition along the entire length of the intraluminal grafting E apparatus 50. Thereafter, the balloon catheter assembly, capsule catheter assembly, capsule jacket assembly 53 and control wire assembly 54 are removed from the aorta through nl~-~-PP aara=~i aaawcaarl 45 the femoral artery. The graft 50 and attachment means 175 and 176 remain secured to the vessel wall 202, thereby sealing the aneurism 201 from blood flow.

The entire procedure described herein can be observed under fluoroscopy. The relative positioning of the graft and the balloon 60 can be readily ascertained by the radiopaque attachment systems 175 and 176, radiopaque markers 197 and 198 provided on the graft, and the radiopaque marker 84 on the balloon shaft 61. If any twisting of the graft has occurred between placement of the superior attachment system and the inferior attachment system, then the twisting can be readily ascertained by observing the series of markers 197 and 198.

Adjustments to eliminate any twisting which may have occurred can be made before exposing the graft's inferior extremity 172 by rotation of the capsule catheter assembly 52. Any excessive o graft compression can be ascertained by observing the 0J radiopaque markers 197 and 198 under fluoroscopy. Adjustments 44 4 w to eliminate graft compression can be made before exposing the inferior extremity of the graft by applying tension on the capsule catheter assembly 52.

Post implant fluoroscopy procedures can be utilized to *4 0 confirm the proper implantation of the device by the use of a conventional pigtail catheter or by injecting dye into the guide wire lumen of the balloon catheter shaft. Thereafter :E 25 the sheath can be removed from the femoral artery and the femoral artery closed with conventional suturing techniques.

Tissues should begin to grow into the graft within two to four weeks with tissue completely covering the interior side of the plurality of vees 177 with the outer apices 178 and inner Q:\OPER\GCP\74253.SPE 11/8/93 46 graft within six months so that no portion of the graft thereafter would be in communication with the blood circulating in the vessel. This establishes a complete repair of the aneurysm which had occurred.

While several particular forms of the invention have been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention. For example, references to materials of construction and specific dimensions are also not intended to be 10 limiting in any manner and other materials and dimensions could 9 be substituted and remain within the spirit and scope of the 0 l invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

Throughout this specification and the claims which follow, 15 unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be *0 understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other C 4 integer or step or group of integers or steps.

I 20

A

Claims

1. A method for securing a graft in a corporeal lumen, said graft having a superior end and an inferior end, said graft further having superior attachment means disposed proximate the superior end and having inferior attachment means disposed proximate the inferior end, said method comprising the steps of: providing placement means having distal capsule means for containing said superior attachment means and the superior end Ii ft of said graft, said placement means further having an inflatable member, said placement means further having proximal capsule means for containing said inferior attachment means and the inferior end of said graft; Ste ,positioning said placement means and said graft at a desired location within the corporeal lumen; St' withdrawing said distal capsule means from the superior end rit of said graft and said superior attachment means; 'withdrawing said proximal capsule means from the inferior end of said graft and said inferior attachment means; activating said inflatable member to secure said graft within the corporeal lumen; and removing said placement means from the corporeal lumen, wherein said graft remains secured within the corporeal lumen.

2. The method of claim 1, wherein the proximal capsule means is withdrawn before the distal capsule means is withdrawn.

3. The method of claim 1 or 2, wherein the positioning step includes placing said graft proximate an aneurysm proximate an aortic bifurcation.

4. A method for implanting a graft in a corporeal lumen having S Y a wall, said graft having superior and inferior ends, said graft L I p:\OPER\OCF\64747.DIV 1011296 S- 48 further having superior attachment means disposed proximate the superior end and having inferior attachment means disposed proximate the inferior end, said method comprising the steps of: providing placement means having distal capsule means for removably retaining said superior attachment means and the superior end of said graft, said placement means having proximal capsule means for removably retaining said inferior attachment means and the inferior end of said graft, and said placement means having an inflatable member; positioning said placement means and said graft at a desired location within the corporeal lumen; removing said distal capsule means from the superior end of said graft and said superior attachment means; activating said inflatable member to engage said superior attachment means with the wall of the corporeal lumen; removing said proximal capsule means from the inferior end of said graft and said inferior attachment means; and activating said inflatable member to engage said inferior attachment means with the wall of the corporeal lumen. The method of claim 4, wherein said proximal capsule means is removed from said inferior attachment means before said distal capsule means is removed from said superior attachment S* means. The method of claim 4 or 5, wherein said positioning step includes making a cutdown in a femoral artery, inserting said placement meains in the femoral artery and placing said graft proximate an aortic aneurysm, such that said removing steps causes the superior end of said graft to be positioned superior p:\OPE\GC\4747.DIV 10/1296 49 the aneurysm and the inferior end of the graft to be positioned inferior the aneurysm.

7. A method for emplacement of a graft into a corporeal lumen having a wall, said graft having a superior end secured to a superior attachment system and an inferior end secured to an inferior attachment system, said method comprising the steps of: providing placement means comprising a balloon catheter having distal capsule means and an inflatable member, said placement means further comprising a capsule catheter having proximal capsule means; placing said superior attachment system in said distal capsule means, wherein the superior end of said graft is removably retained within said distal capsule means; placing said inferior attachment system in said proximal capsule means, wherein the inferior end of said graft is removably retained within said proximal capsule means; inserting said placement means into the lumen; positioning said graft at a desired position within the lumen; removing said distal capsule means from the superior end of said graft and said superior attachment system; inflating said inflatable member to engage said superior S" attachment system, thereby securing the superior end of said r~ri 25 graft to the wall of the lumen; removing said proximal capsule means from the inferior end of said graft and said inferior attachment system; inflating said inflatable member to engage said inferior attachment system, thereby securing the inferior end of said graft to the wall of the lumen; and length of the graft. p:\OPER\GC\64747.DIV 10/1296 50 removing said placement means from the lumen.

8. The method of claim 7, further comprising the steps of: providing a capsule jacket coaxially disposed over said capsule catheter, wherein said balloon catheter is coaxially disposed within said capsule catheter and said capsule jacket covers said graft, said proximal capsule means, and at least a portion of said distal capsule means; axially withdrawing said capsule jacket from the superior end of said graft prior to the first removing step; and axially withdrawing said capsule jacket from the inferior end of said graft prior to the second removing step.

9. The method Of claim 7 or 8, wherein said inserting step includes making a cutdown in a femoral artery and placing said placement means in the femoral artery, and wherein said positioning step includes placing said graft proximate an aortic I aneurysm, such that said removing steps causes the superior end of said graft to be positioned superior the aneurysm and the inferior end of the graft to be positioned inferior the aneurysm. A method for emplacement of a graft in a corporeal lumen 'having a wall, the graft having anchoring means and being disposed within placement means comprising a balloon catheter having a distal capsule, an inflatable member and shaft means coupled to the distal capsule and the inflatable member, the placement means further comprising a capsule catheter having a proximal capsule and shaft means coupled to the proximal capsule, said method comprising the steps of: P:\OPEF.\GCP 747.DIV 10/12M 51 manipulating the placement means to advance the graft, the balloon catheter and the capsule catheter into the corporeal lumen, wherein the graft and the anchoring means are removably retained in the distal and proximal capsules to prevent the anchoring means from contacting the corporeal lumen wall while the graft is being advanced through the corporeal lumen; positioning the graft at a desired location in the corporeal lumen; removing the distal and proximal capsules from the graft and anchoring means; inflating the inflatable member to engage the graft and anchoring means so that the anchoring means and the graft are secured to the lumen wall; deflating the inflatable member; and withdrawing the placement means from the graft and from the corporeal lumen, wherein the graft is retained within the corporeal lumen.

11. The method of claiw 10, wherein the placement means further includes a capsule jacket coaxially disposed over the capsule catheter such that the balloon catheter is coaxially disposed within the capsuile catheter and the capsule jacket covers the graft, the proximal capsule and at least a portion of said distal capsule, said method further comprising the step of axially withdrawing the capsule jacket from the graft prior to removing the graft and anchoring means from the distal and proximal capsules.

12. A method for implanting a graft in a corporeal lumen wall afflicted by an aneurysm having a superior end, the graft having ~L~Lrt-~Crei~l~Ll~t~r~~- '-aa'isasaraa^^aaii .'rIOSPa~J.m.ino,,™ main sheath 160 overlaps at least a portion of the distal P:\OPER\GC\64747.DIV 0A2/96

52- superior anchoring means and inferior anchoring means, said method comprising the steps of: covering the superior anchoring means of the graft with distal capsule means; covering the inferior anchorir.g means of the graft with proximal capsule means; covering the graft, the distal capsule means and the proximal capsule means with a sheath; introducing an inflatable member, the graft, the distal capsule means, the proximal capsule means and the sheath into the lumen and then along the lumen until the graft reaches the aneurysm; uncovering the superior anchoring means when the graft is positioned in the lumen such that the superior anchoring means is superior to the superior end of the aneurysm; inflating the inflatable member to engage the graft and the superior anchoring means with the lumen; m uncovering the inferior anchoring means; Sdeflating the inflatable member; i 20 inflating the inflatable member to engage the graft and the 4 inferior anchoring means with the lumen; S 4 C deflating the inflatable member; and removing the inflatable member, the distal capsule means, the proximal capsule imeans and the sheath from the lumen, wherein the graft is retained in the lumen. 13. A method for implanting a graft in a corporeal lumen having a wall afflicted by an aneurysm having a superior end, the graft including a superior attachment system having wall engaging members, the graft further including an inferior attachment SP;\OPER\GCF\64747.DIV 10/12/96 53 system having wall engaging members, said method comprising the steps of: Scovering the inferior attachment system of the graft with a proximal capsule, the proximal capsule being coupled to a first shaft; covering the superior attachment system of the graft with a distal capsule, the distal capsule being coupled to a second shaft in fluid communication with a balloon, wherein the second shaft is coaxially and slidably disposed within the first shaft; covering the graft, the distal capsule and the proximal capsule with a sheath slidably disposed over the first and second shafts; introducing the graft, the distal capsule, the proximal capsule and the sheath into the lumen; positioning the graft such that the superior attachment system is located superior to ;he superior end of the aneurysm; removing the sheath f the distal capsule; 0 removing the distal le from the superior attachment system; positioning the balloon adjacent the superior attachment system; inflating the balloon to urge the wall engaging members of the superior attachment system into the wall of the lumen; removing the sheath from the proximal capsule; removing the proximal capsule from the inferior attachment system; delating the balloon; positioning the balloon adjacent the inferior attachment system; inflating the balloon to urge the wall engaging members of i i~i y L~rmrrusnnm*l---- n-~ Q:\OPER\GCP\74253,SPE 11/8/98 54 the inferior attachment system into the wall of the lumen; deflating the balloon; and removing the balloon, the distal capsule, the proximal capsule, and the sheath from the lumen, wherein the graft is retained in the lumen. 14. The method of claim 13, wherein the deflating the balloon step is performed prior to the removing the sheath from the proximal capsule step. 0 The method of claim 13 or 14, wherein said introducing step includes providing an opening in a femoral artery and said positioning step includes placing the graft proximate an aortic bifurcation. 16. A method for engrafting a prosthesis into a corporeal lumen, said prosthesis having superior and inferior ends, said prosthesis further having a superior attachment means at the superior end and an inferior attachment means at the inferior 20 end, said method comprising the steps of: providing delivery means for positioning said graft in the lumen, wherein said delivery means comprises a distal capsule means for removably retaining said superior attachment means and a proximal capsule means for removably retaining said inferior attachment means; providing an inflatable member for activating said superior attachment means and said inferior attachment means; providing capsule jacket means for removably retaining J-- k cd, ,vr O S r Q:\OPER\GCP\74253.SPE 11/8/98 55 o o o o o or o or o 6a a O a o ae 0 °or o a a a a a a a a a as a a a a 6 «r said graft, said distal capsule means and said proximal capsule means; placing the superior end of said prosthesis and said superior attachment means into said distal capsule means; placing the inferior end of said prosthesis and said inferior attachment means into said proximal capsule means; placing said prosthesis and said delivery means into said capsule jacket means; creating an opening in the lumen for passing said capsule jacket means, said delivery means, said inflatable member, and said prosthesis therethrough; inserting said capsule jacket means, said delivery means, said inflatable member, and said prosthesis into the opening in the lumen; urging said prosthesis to a desired location within the lumen; positioning said superior attachment :Leans of said prosthesis at a desired location within the lumen; withdrawing said capsule jacket means proximally to expose said distal capsule means, said prosthesis and at least a portion of said proximal capsule means; removing the inferior end of said prosthesis from said proximal capsule means; removing the superior end of said prosthesis from said distal capsule means; inflating said inflatable member to activate said superior attachment means to secure the superior end of said prosthesis within the lumen; A. I~ PtuCi9 i, L I I C ~r L :I I Q:\0pER\GCP\74253.SPE 11/8/98 56 inflating said inflatable member to activate said inferior attachment means to secure the inferior end of said prosthesis within the lumen; removing said delivery means and said inflatable member from the lumen; and closing the opening in the lumen. 17. A method for securing a graft in a corporeal lumen substantially as hereinbefore described with reference to the accompanying drawings. DATED this 11th day of August, 1998 20 ENDOVASCULAR TECHNOLOGIES, INC. By its Patent Attorneys DAVIES COLLISON CAVE a a o s os o a o 0 1, D 0 o a o 00 *o a Ql 0 0 0 e0 0 00 a 00 a 0 0 aoo 00.000 S0 a o o e o OB u °eea a 'VT N csij 0 T o P:\OPER\GCP\4747.DIV 10/1296 ABSTRACT a °o 10 A method for securing a graft in a corporeal lumen, the graft having a superior end and an inferior end, the graft further having superior attachment means disposed proximate the superior end and having inferior attachment means disposed e a proximate the inferior end, the method comprising the steps of: providing placement means having distal capsule means for containing the superior attachment means and the superior end of the graft, the placement means further having proximal capsule I0 "means for containing the inferior attachment means and the 0 inferior end of the graft; positioning the placement means and the graft at a desired location within the corporeal lumen; withdrawing the distal capsule means from the superior end of the graft and the superior attachment means; l withdrawing the proximal capsule means from the inferior end of the graft and the inferior attachment means; and removing the placement means from the corporeal lumen, wherein the graft remains secured within the corporeal lumen.