U.S. patent application number 10/300337 was filed with the patent office on 2003-09-04 for endovascular graft having bifurcation and apparatus and method for deploying the same.
Invention is credited to Piplani, Alec A., Quiachon, Dinah B., Sterman, Wesley D..
Application Number | 20030167087 10/300337 |
Document ID | / |
Family ID | 24746386 |
Filed Date | 2003-09-04 |
United States Patent
Application |
20030167087 |
Kind Code |
A1 |
Piplani, Alec A. ; et
al. |
September 4, 2003 |
Endovascular graft having bifurcation and apparatus and method for
deploying the same
Abstract
Graft having a bifurcation for repairing an aneurysm in the
vicinity of an aortic bifurcation in a patient comprising a main
tubular body and first and second tubular legs joined to said main
body in a bifurcation. The main body and the legs are formed of a
flexible surgically implantable material. The main body and each of
the first and second legs having an opening therein in
communication with the other openings. Expandable spring
attachments are secured to the main body adjacent the opening in
the main body. An additional expandable spring attachment is
secured to one of said legs adjacent the opening in said one
leg.
Inventors: |
Piplani, Alec A.; (Mountain
View, CA) ; Quiachon, Dinah B.; (San Jose, CA)
; Sterman, Wesley D.; (San Francisco, CA) |
Correspondence
Address: |
FULWIDER PATTON LEE & UTECHT, LLP
HOWARD HUGHES CENTER
6060 CENTER DRIVE
TENTH FLOOR
LOS ANGELES
CA
90045
US
|
Family ID: |
24746386 |
Appl. No.: |
10/300337 |
Filed: |
November 20, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10300337 |
Nov 20, 2002 |
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10144977 |
May 13, 2002 |
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10144977 |
May 13, 2002 |
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09877799 |
Jun 5, 2001 |
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6395022 |
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09877799 |
Jun 5, 2001 |
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09420931 |
Oct 19, 1999 |
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6241759 |
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09420931 |
Oct 19, 1999 |
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08742311 |
Nov 1, 1996 |
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6132459 |
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08742311 |
Nov 1, 1996 |
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08166069 |
Dec 10, 1993 |
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5609625 |
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08166069 |
Dec 10, 1993 |
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08066414 |
May 21, 1993 |
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5489295 |
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08066414 |
May 21, 1993 |
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07684018 |
Apr 11, 1991 |
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Current U.S.
Class: |
623/1.35 ;
623/1.36 |
Current CPC
Class: |
A61F 2002/065 20130101;
A61B 90/39 20160201; A61F 2002/075 20130101; A61F 2/958 20130101;
A61F 2/88 20130101; A61F 2/07 20130101; A61F 2/954 20130101; A61F
2250/0098 20130101; Y10S 623/903 20130101; A61F 2/89 20130101; A61F
2002/8486 20130101 |
Class at
Publication: |
623/1.35 ;
623/1.36 |
International
Class: |
A61F 002/06 |
Claims
1. A graft having a bifurcation for repairing an aortic aneurysm
close to or involving the aortic bifurcation in a patient
comprising a main tubular body and first and second tubular legs
joined to said main body in a bifurcation, said main body and said
legs being formed of a flexible surgically implantable material,
said main body and said first and second legs each having an
opening therein in communication with the other openings,
expandable anchor means secured to the main body adjacent the
opening in the main body and additional expandable anchor means
secured to one of said legs adjacent the opening in said one
leg.
2. A graft as in claim 1 wherein said expandable anchor means and
said additional expandable anchor means are in the forming spring
attachment means, each having hook-like elements disposed outwardly
therefrom adapted to come into engagement with the arterial wall of
the patient.
3. A graft as in claim 1 together with a lead line removably
connected to the other of said legs.
4. A graft as in claim 3 wherein said lead line includes a single
line which is looped through said material forming said other leg
and a knot formed in said pull line remote from said leg.
5. A graft as in claim 4 together with the flexible tubular member
extending over said pull line into a region in close proximity to
the other leg, means carried by said tubular member engaging said
knot to prevent said tubular member from accidentally being removed
from said pull line, said flexible tubular member having cutout
therein.
6. In a major deployment device, a capsule catheter and a balloon
catheter, said capsule catheter comprising a flexible elongate
tubular member having proximal and distal extremities, a flexible
capsule mounted on the distal extremity of the flexible elongate
tubular member, said capsule having an open end, a graft disposed
within the capsule, said balloon catheter comprising a flexible
elongate tubular member having proximal and distal extremities,
balloon secured to the distal extremity of the flexible elongated
tubular member of the balloon catheter, said flexible elongated
tubular member of the balloon catheter extending through the graft
and through the capsule in which the graft is disposed and through
the flexible elongated tubular member secured to the capsule,
retention means carried by the flexible elongated tubular member of
the balloon catheter and engaging the graft, a control mechanism
having a handle adapted to be grasped by a human hand and having
first and second parts movable relative to each other, means for
securing the flexible elongate tubular member of the capsule
catheter to the first part, said flexible elongate tubular member
of the balloon catheter extending through said first part and
through said control mechanism and means carried by the control
mechanism for causing movement of the first part with respect to
the second part to thereby permit the capsule to be withdrawn from
over the graft and permitting the retention means to retain the
graft in a position so that it is ejected from the capsule as the
first part is moved relative to the second part.
7. A device as in claim 6 wherein said graft has expandable anchor
means capable of moving outwardly as soon as the expandable anchor
means clears the capsule.
8. A device as in claim 6 wherein said means for causing relative
movement between the first and second parts includes a rack and
pinion.
9. A device as in claim 6 wherein said control mechanism includes
means for preventing longitudinal movement of the flexible elongate
tubular member of the balloon catheter relative to the control
mechanism.
10. A device as in claim 9 wherein said control mechanism includes
means for operating on said means for preventing longitudinal
movement of the flexible elongate tubular member of the balloon
catheter to permit longitudinal movement of the flexible elongate
tubular member of the balloon catheter relative to the control
mechanism.
11. A device as in claim 6 wherein said graft is in the form of a
main body and first and second legs adjoining the main body and
extending away from the main body to provide a bifurcation, one of
said legs being folded over and lying generally parallel to the
main body when the graft is disposed within the capsule.
12. A device as in claim 11 together with a lead tube connected to
the folded-over leg and extending out of said capsule.
13. A device as in claim 12 together with a single pull line
secured to said leg and extending through said leg and having its
free ends knotted together, said lead tube extending over the pull
line into the vicinity of said capsule and means formed in the tube
engaging the knot to prevent the lead tube from being pulled off of
the pull line.
14. A device as in claim 13 wherein said lead tube is provided with
a cutout proximal of the knot.
15. In a minor deployment device, a capsule catheter and a balloon
catheter, said capsule catheter comprising a flexible elongated
tubular element having proximal and distal extremities, a capsule
secured to the distal extremity, a fitting provided on the proximal
extremity, the balloon catheter comprising a flexible elongate
tubular element having proximal and distal extremities, a balloon
carried by the distal extremity, the balloon being disposed
distally of the capsule and having the flexible elongate tubular
member of the balloon catheter extending through the capsule and
through the flexible elongate tubular member of the capsule
catheter and a fitting mounted on the proximal extremity of the
flexible elongate tubular member of the balloon catheter for
inflating and deflating the balloon, said flexible elongate tubular
member of the catheter having retention means provided thereon and
disposed within the capsule, and an expandable spring attachment
means disposed within the capsule and being in engagement with the
retention means.
16. A minor deployment device as in claim 15 together with a guide
wire extending through the balloon catheter.
17. In a method for deploying a graft having bifurcation with a
main body and first and second legs for deployment across an aortic
bifurcation of a patient to repair an aneurysm close to or
involving the aortic bifurcation and the associated first and
second iliac arteries, folding the second leg of the graft so it
lies substantially parallel to the main body of the graft to
provide a folded-over second leg, introducing the graft with the
folded-over second leg through the first iliac artery until the
graft is disposed proximal of the bifurcation, securing the
proximal extremity of the graft with the first leg of the graft
being disposed in the first iliac artery, pulling down the
folded-over second leg into the second iliac artery, securing the
distal extremity of the first leg in the first iliac artery and
thereafter securing the second leg of the graft in the second iliac
artery.
18. A method as in claim 17 wherein said folded-over leg is
provided with a lead tube, the steps of using the lead tube to pull
the folded-over second leg into the second iliac artery.
19. A method as in claim 18 wherein the graft is provided with an
opening in the main body and an opening in each of the legs
together with expandable spring attachment means secured to the
graft in the vicinity of the opening in the main body and
additional expandable spring attachment means secured to the first
leg of the graft adjacent the opening of the leg, together with a
capsule catheter having a flexible elongate tubular member with
proximal and distal extremities and with a capsule mounted on the
distal extremity and having an open end, together with a balloon
catheter having an inflatable balloon, and a deployment device with
a supplemental expandable spring attachment disposed therein, said
graft being disposed in said capsule so that the first named and
additional expandable spring attachment means are disposed within
the capsule, the steps of introducing the capsule into the arterial
vessel of the patient so that the distal extremity of the capsule
is disposed proximal to the aortic bifurcation and proximal of the
proximal extremity of the aneurysm, withdrawing the capsule while
retaining the graft therein stationary to cause the expandable
spring attachment means in the vicinity of the opening in the main
body to be ejected from the capsule to permit the expandable spring
attachment means to expand, retracting the balloon catheter so that
the balloon is disposed in the first named expandable spring
attachment means, inflating the balloon to urge the first named
expandable spring attachment means into engagement with the wall of
the aorta, further withdrawing the capsule so that the folded over
second leg clears the capsule, pulling down the folded-over second
leg into the second iliac artery, still further withdrawing the
capsule until the additional spring attachment means carried by the
first leg of the graft clears the capsule and is permitted to
expand, deflating the balloon of the balloon catheter, bringing the
deflated balloon into the additional expandable spring attachment
means, expanding the balloon to urge the additional expandable
spring attachment means into engagement with the wall of the first
iliac artery, using a deployment device to introduce supplemental
expandable spring attachment means into the second iliac artery and
into the second leg of the graft, urging the supplemental
expandable spring attachment means out of the deployment device and
permitting the supplemental expandable spring attachment means to
expand into engagement with the graft and into the wall of the
second iliac artery and removing the capsule catheter and the
balloon catheter.
20. A method as in claim 19 together with an additional balloon
catheter, and including the steps of advancing the additional
balloon catheter into the supplemental expandable spring attachment
means, expanding the balloon into engagement with the supplemental
spring attachment means to urge the supplemental spring attachment
means into engagement with the second leg of the graft and the wall
of the second iliac artery, removing the additional balloon
catheter and removing the lead tube.
Description
[0001] This invention relates to an endovascular graft having
bifurcation and an apparatus and a method for deploying the
same.
[0002] In Kornberg U.S. Pat. No. 4,617,932 there is disclosed a
bifurcated graft which has two legs with one leg being longer than
the other leg. There is also disclosed a device and a method for
inserting the graft into an artery. However, there is a need for an
improved endovascular bifurcated graft and an apparatus and a
method for deploying the same.
[0003] In general, it is an object of the present invention to
provide an endovascular graft having bifurcation and an apparatus
and a method for deploying the same which makes it possible to
secure the graft firmly in place traversing the aortic bifurcation
with an apparatus and method which facilitates rapid deployment and
placement of the same.
[0004] Another object of the invention is to provide a graft of the
above character which has a body portion that can be firmly fixed
in place in this aorta and has legs which can be firmly fixed in
place in the iliac arteries.
[0005] Another object of the invention is to provide an apparatus
which is relatively simple in construction and which greatly
facilitates placement of the graft.
[0006] Another object of the invention is to provide a method of
the above character which is relatively simple and error free.
[0007] Additional objects and features of the invention will appear
from the following description in which the preferred embodiments
are set forth in detail in conjunction with the accompanying
drawings.
[0008] FIG. 1 is a plan view of the apparatus for deploying an
endovascular graft having a bifurcation of the present invention in
which the graft is disposed within the capsule ready for
deployment.
[0009] FIG. 2 is a cross-sectional view taken along the line 2-2 of
FIG. 1.
[0010] FIG. 3 is an enlarged cross-sectional view showing the
sliding seal assembly utilized in the device shown in FIG. 1.
[0011] FIG. 4 is an enlarged perspective view of a graft having a
bifurcation incorporating the present invention.
[0012] FIG. 5 is an enlarged schematic view of the capsule showing
the manner in which the graft having bifurcation is stored therein
for deployment.
[0013] FIG. 6 is an elevational view partially in cross section of
a minor deployment device utilized as a part of the apparatus for
deploying the graft of the present invention.
[0014] FIG. 7 is an elevational view partially in cross section of
the balloon dilatation catheter utilized in the minor deployment
device shown in FIG. 6.
[0015] FIG. 8 is a perspective view of the hook assembly forming a
part of the minor deployment device shown in FIG. 6 to be utilized
with the graft shown in FIG. 4.
[0016] FIGS. 9-19 are cartoons showing the method and apparatus
utilized in deploying the graft of the present invention.
[0017] In general the graft having a bifurcation for repairing an
aneurysm in the aorta extending to or beyond the aortic bifurcation
in a patient comprising a main tubular body and first and second
tubular legs joined to said main body in a bifurcation. The main
body and the legs are formed of a flexible surgically implantable
material. The main body and the first and second legs each have an
opening therein in communication with the other openings.
Expandable spring attachment means is secured to the main body
adjacent the opening in the main body. Additional spring attachment
means is secured to the first leg adjacent the opening in that leg.
The major deployment device comprises a capsule catheter and a
balloon catheter. The capsule catheter comprises a flexible
elongate tubular member having proximal and distal extremities. A
capsule is mounted on the distal extremity of the flexible elongate
tubular member and has an open end. A graft is disposed within the
capsule. The balloon catheter comprises a flexible elongate tubular
member having proximal and distal extremities. A balloon is secured
to the distal extremity of the flexible elongate tubular member of
the balloon catheter. The flexible elongate tubular member of the
balloon catheter extends through the graft and through the capsule
in which the graft is disposed and through the flexible elongated
tubular member of the capsule catheter. Retention means is carried
by the flexible elongate tubular member of the balloon catheter and
engages the graft. A control mechanism is provided and has a handle
portion adapted to be grasped by a human hand and has first and
second parts movable relative to each other. Means is provided for
securing the flexible elongate tubular member of the capsule
catheter to the first part. The flexible elongate tubular member of
the balloon catheter extends through the first part and through the
control mechanism. Means is carried by the control mechanism for
causing movement of the first part with respect to the second part
to thereby cause the capsule to be withdrawn from over the graft
and permitting the retention means to retain the graft in position
so that it is ejected from the capsule as the first part is moved
relative to the second part.
[0018] The method for deploying a graft having bifurcation with a
main body and first and second legs for deployment across the
aortic bifurcation and into the first and second iliac arteries of
a patient to repair an aneurysm therein comprising folding one of
the legs of the graft so it lies substantially parallel to the main
body of the graft, introducing the graft through the femoral artery
until the distal portion of the graft is disposed proximal of the
aortic aneurysm, securing the proximal extremity of the graft with
the other leg of the graft being disposed in the first iliac
artery, pulling down the folded over leg into the second iliac
artery securing the distal extremity of the first leg of the graft
in the first iliac artery and thereafter securing the second leg of
the graft in the second iliac artery.
[0019] The apparatus for deploying a graft 20 having a bifurcation
of the present invention consists of a major deployment device 21
which is shown particularly in FIG. 1 and a minor deployment device
22 which is shown in FIG. 6. The major deployment device 21
incorporates a capsule catheter 26 which is very similar to a
capsule catheter disclosed in co-pending application Ser. No.
07/553,530 filed Jul. 13, 1990. As disclosed therein, the capsule
catheter 26 is provided with a flexible elongated tubular member 27
formed of a plastic which is loaded with a radiopaque material so
that it will be visible under X-rays. An inner liner 28 of
lubricous material is disposed within the tubular member 27. A
flexible capsule 31 is secured to the distal extremity of the
tubular member 27. The capsule can have a length ranging from 10-40
centimeters and a diameter ranging from 6-9 millimeters.
[0020] A control mechanism 36 is secured to the proximal extremity
of the tubular member 27. The control mechanism 36 is provided with
a multipart housing 37, a portion of which serves as a handle
adapted to be engaged by the adult human hand. The housing 37 is
formed in two parts 37a and 37b of a suitable material such as
plastic. The part 37a serves as a cylindrical pinion housing which
has a longitudinally extending bore 39 formed therein opening
through one end thereof. A smaller bore 41 is provided in the
pinion housing 37a and extends axially thereof and opens into the
bore 39. The part 37b is secured to the part 37a by suitable means
such as ultrasonic bonding. The part 37b serves as a rack housing.
A generally cylindrical rack member 42 is slideably mounted in the
bore 39. Means is provided for causing relative movement between
the rack member 42 and the pinion housing 37a and consists of a
rack and pinion assembly 43. The rack and pinion assembly 43
consists of a rack 44 which is mounted in a flat 46 provided on the
rack member 42. The rack 44 is engaged by a pinion 47 mounted on a
shaft 48. The shaft 48 extends through the pinion housing 37a and
is provided with an enlargement 48a on one end. A knob 49 is
mounted on the other end of the shaft 48 and is provided for
rotating the shaft 48 by fingers of one hand of the operator. The
other hand of the operator holds the control mechanism 36.
[0021] A detent assembly 51 is provided for permitting step-by-step
rotation of the knob 49 in one direction but preventing rotation in
an opposite direction. The detent assembly 51 consists of a plastic
cylindrical housing 52 mounted in the wall of part 37a and has a
plunger 53 slideably mounted therein which is yieldably urged in a
direction towards the knob 49 by a coil spring 54. The plunger 53
serves as a detent which is adapted to engage the circumferentially
spaced notches 56 provided in the knob 49. The notches 56 are
shaped so that the knob 49 can only be rotated in one direction and
not in the other direction.
[0022] The distal extremity of the rack housing 37b is provided
with a bore 61 (see FIG. 3) which opens through the distal
extremity of the same. A smaller bore 62 is provided within the
rack member 42 and extends axially of the bore 61 and opens into
the bore 61 and also opens through the proximal extremity of the
rack member 42. A sliding seal housing 63 is provided within the
bore 61 and is secured therein by suitable means such as an
adhesive. The housing 63 is provided with a bore 64 which opens
through the proximal extremity of the housing 63 and a smaller bore
66 extending axially of the bore 64 and opening into the bore 64
and opening through the distal extremity of the housing 63. The
sliding seal housing 63 is provided with an annular recess 67 on
its distal extremity which is adapted to receive the proximal
extremity of the flexible elongate member 27 and is bonded thereto
by suitable means such as an adhesive.
[0023] The major deployment device 21 also includes a balloon
catheter assembly 71 of the type described in co-pending
application Ser. No. 07/553,530 filed Jul. 13, 1990, and as
disclosed therein consists of a flexible elongate tubular member in
the form of a balloon catheter shaft 72 having a single lumen
therein and formed of a suitable material such as irradiated
polyethylene tubing. A separate balloon 74 is secured to the distal
extremity of the balloon catheter shaft 72 and is formed of a
suitable material such as polyethylene. The balloon catheter shaft
72 can have a suitable outside diameter such as 0.050" and extend
into a metal hypo tube 76 formed of a suitable material such as
stainless steel having a suitable outside diameter, for example
0.062". The metal tube 76 extends into the inner liner 28 and
extends into the bore 66 of the sliding seal housing 63 and into
the bore 64 where it engages a pair of the spaced-apart cylindrical
numbers 77 and 78 formed of a suitable material such as
polycarbonate and a pair of spaced-apart silicone O-rings 79 and
81, all of which are disposed within the bore 64 to form sliding
seals. These sliding seals formed by the cylindrical members 77 and
78 in conjunction with the O-rings 79 and 81 serve to prevent body
fluids from coming into contact with operating parts of the control
mechanism 36 as for example, the rack pinion assembly 43. The
stainless steel hypo tube 76 extends rearwardly towards the
proximal extremity through the passage 62 of the rack member 42 and
into the bore 41 of the pinion housing 37a. A collet 82 is provided
on the proximal extremity of the pinion housing 37a. Means is
provided for permitting free rotational movement of the hypo tube
76 in a fixed longitudinal position and consists of a collet
housing 83 having a threaded split cylindrical protrusion 83a with
a collet cover 84 threaded thereon. The collet cover 84 has a hole
85 therein through which the hypo tube 76 passes. The collet
housing 83 is rotatably mounted by an isolation ball bearing
assembly 86 on a base 87 provided on the housing part 37a. When the
collet cover 84 is rotated in one direction, the collet housing
protrusion 83a is permitted to move to its normally open position
to permit the collet 82 to open allowing the tube 76 to pass
therethrough. When the collet cover 84 is rotated in an opposite
direction it will close the housing protrusion 83a and lock the
collet 82 onto the tube 76. A Luer-type fitting 88 is mounted on
the proximal extremity of the hypo tube 76.
[0024] A stabilization wire 89 of a suitable material such as
stainless steel and of a suitable diameter as, for example, 0.018"
is disposed within the balloon catheter shaft 72 and extends the
length thereof. The proximal extremity 89a of the pusher wire 89 is
secured in a fixed position to the luer fitting 88 in a suitable
manner such as by embedding in the wall of the fitting 88 as shown
in FIG. 1. The pusher wire 89 extends through the lumen of the
balloon catheter shaft 72 into the balloon 74 where it is fastened
in a fixed position in the distal extremity of the balloon 74. A
flexible, pre-shaped spring-like guide wire 91 is secured to the
distal extremity of the balloon 74 by use of a plug 92 which also
receives the distal extremity of the pusher wire 89.
[0025] Means is provided as a part of a control mechanism 36 for
supplying liquids for injection into the capsule 31 and consists of
a fitting 96 (see FIG. 3) which is mounted in the rack member 42
and which is provided with a bore 97 in communication with the bore
66. A flexible tube 99 is connected to the fitting 96 and is
provided with a Luer-type fitting 101 having a stop cock 102
therein. The rack housing or cover 37b is provided with a slot 103
through which the tube 99 extends and can move longitudinally
during rectilinear movement of the rack member 42.
[0026] A stabilization button 106 is mounted on the balloon
catheter shaft 72 in a fixed position spaced a predetermined
distance from the proximal extremity of the balloon 74 as for
example, a distance of 5-10 centimeters. A pair of spaced-apart
radiopaque markers 107 in the form of platinum bands are provided
on the balloon catheter shaft 72 within the balloon 74.
[0027] The endovascular graft 20 having a bifurcation is shown in
FIG. 4. The graft 20 has many characteristics which are similar to
the expandable intraluminal vascular graft disclosed in co-pending
application Ser. No. 07/553,530 filed Jul. 13, 1990. However, the
graft 20 differs significantly from the graft disclosed therein in
that it is provided with a bifurcation as hereinafter described.
The graft 20 is an expandable intraluminal vascular graft which is
provided with a main deformable cylindrical body 112 having an open
end 113. The body 112 is provided with a bifurcation or crotch 114
at the other end which opens into first and second legs 116 and
117, having open ends 118 and 119 generally opposite the open end
113. Continuous walls form the body 112 and the legs 116 and 117
and are woven of surgically implantable material such as
Dacron-type fiber. One material found to be particularly
satisfactory is a USCI DeBakey soft woven Dacron vascular
prosthesis. The main body 112 can have a length ranging from 5 to
30 centimeters with each of the legs having a length ranging from 2
to 15 centimeters. The body 112 can have a maximum expandable
diameter ranging from 12 to 30 millimeters whereas the legs 116 and
117 can have maximum diameters ranging from 6 to 12
millimeters.
[0028] Radiopaque markers 121 are provided on the main body 112 and
also on the legs 116 and 117 and can be formed of a suitable
material such as lengths of platinum wire secured to the fabric of
the graft by suitable means such as Dacron sutures.
[0029] Expandable spring attachment means 126 is secured to the
expandable main body adjacent the opening 113. Also expandable
spring attachment means 127 is secured to the first leg 116
adjacent the opening 118. These expandable spring attachment means
126 and 127 serve as anchoring means for securing the graft 20 to
vessel wall in which the graft 20 is disposed. The expandable
spring attachment means 126 is constructed in a manner similar to
that described in copending application Ser. No. 07/553,350 filed
Jul. 13, 1990, and serves to yieldably urge the opening 113 in the
main body 112 from an initial compressed or collapsed position to a
subsequent expanded position. Similarly, the expandable spring
attachment means 127 serves to yieldably urge the open end 118 from
an initial compressed or collapsed position to a subsequent
expanded position. As explained in said co-pending application Ser.
No. 07/553,350 filed Jul. 13, 1990, the expandable spring
attachment means 126 and 127 are formed of a plurality of vees 131
with the apices 132 being formed with helical coil springs 133 to
yieldably urge the legs 134 and 136 of each of the vees 131
outwardly in directions in the planes in which the vees lie. As
disclosed in the co-pending application Ser. No. 07/553,350 filed
Jul. 13, 1990, the apices 133 lie in three longitudinally
spaced-apart parallel planes extending transversely of the axis of
the expandable spring attachment means in which the first plane is
disposed internally of the open end and the second plane lies in a
position which is external of but in close proximity to the open
end and the third plane is spaced a substantial distance beyond the
open end.
[0030] Hook-like elements 141 are provided at the apices 132 which
are disposed beyond the open end 113 for the attachment means 126
and the open end 118 for the attachment means 127. The hook-like
elements 141 are bonded to the legs 136 of the vees 131 by suitable
means such as welding. The hook-like elements 141 have hooks 142
which are of a length which is sufficient to penetrate into the
vessel wall and slightly beyond the vessel wall in which the graft
is to be placed. The expandable spring attachment means 126 and 127
are secured to the graft by Dacron polyester suture material 144 as
shown particularly in FIG. 4.
[0031] A pull line 146 is secured to the leg 117 in a region which
is closely approximate the end of the leg 117 at the opening 119.
The pull line can be formed of a suitable material such as Nylon
having a diameter from 0.005"-0.010". The pull line 146 is
continuous and extends through small holes 147 provided in the
material forming the graft 20. The pull line 146 which is doubled
over onto itself and has a doubled-over length of approximately
40-60 centimeters with the ends of the pull line 146 being tied
together in a knot 148. A lead tube 151 with a lumen 152 is
positioned over the pull line 146 so it is adjacent the leg 117.
The lead tube 151 is necked down at 153 by suitable means such as
by heat in a region distal of the knot 148 (see FIG. 4) so that the
lead tube 151 is retained on the pull line 146. A cutout 154 is
provided in the lead tube 151 proximal of the knot 148.
[0032] The balloon catheter assembly 71 is disposed within the
capsule 31 in a manner also shown in FIG. 5 in which the balloon
tube or shaft 72 extends coaxially of the main body of the graft
112 coaxially of the first leg 116. The stabilization button 106 is
preferably disposed within the graft in a position which is just
proximal of the bifurcation or crotch 114. By positioning the
pusher button 106 where shown in FIG. 5, it is near to the major
portion of the material forming the graft 20 which is folded up
within the capsule 31. This is desirable because the mass of
material provided in that region of the capsule facilitates pushing
the graft 20 out of the capsule as hereinafter described.
[0033] The minor deployment device 22 as particularly shown in FIG.
6 consists of a capsule catheter 161, a balloon catheter 162 and a
separate expandable spring attachment means 163. The separate
balloon catheter 162 is shown in greater detail in FIG. 7 and the
separate spring attachment means 163 is shown in FIG. 8. The
capsule catheter 161 consists of a flexible tubular member 166
formed of a suitable material such as polyethylene having an inside
diameter ranging from 0.050 to 0.080" and an outside diameter
ranging from 0.075 to 0.100". The tubular member 166 can have a
suitable length as for example, 15-25 centimeters. The tubular
member 166 has a lumen 167 extending the length thereof and has
proximal and distal extremities 168 and 169. A conventional Tuohy
Borst adapter 171 is mounted on the proximal extremity 168. A small
capsule 172 formed of suitable material such as stainless steel is
mounted on the distal extremity 169 of the tubular member 166. It
can be of a suitable size, as for example a length of 10 to 30
millimeters and an inside diameter of 4 to 6 millimeters with a
wall thickness ranging from 0.006 to 0.015". The capsule 172 is
provided with an open end 173 through which the separate expandable
spring attachment means 163 is adapted to be inserted.
[0034] The balloon catheter 162 as shown in FIG. 7 consists of a
flexible elongated tubular member 176 formed of a suitable material
such as polyethylene and which serves as the balloon shaft and is
provided with an outside diameter ranging from 0.04 to 0.0060" and
an inside diameter ranging from 0.015 to 0.030". An expandable
balloon 177 is formed integral with the flexible elongate tubular
member 176 near the distal extremity thereof. The balloon 177 is
formed of the same polyethylene material as the tubular member 176
and can have a diameter ranging from 6 to 12 millimeters and a
length ranging from 1 to 2 centimeters. A wye adapter 179 is
mounted on the proximal extremity 181 of the flexible elongated
tubular member 176. A Tuohy Borst adapter 182 is mounted on the
main arm 183 of the wye adapter 179. A stop cock 184 is mounted on
the side arm 186 of the wye adapter 179.
[0035] An additional elongate flexible tubular member 188 of a
suitable material such as polyethylene is provided and extends from
the Tuohy Borst adapter 182 through the lumen 189 provided in the
tubular member 176 and through the balloon 177 where the distal
extremity of the elongate flexible tubular of the member 188 is
bonded to the distal extremity of the tubular member 176 to provide
an airtight seal for the balloon 177. The tubular member 188 is
provided with a lumen 191 extending the length thereof as adapted
to receive a guide wire 196 of a suitable size as for example, one
having a diameter of 0.018" so that the guide wire 196 can extend
through the tubular member 176 and through the balloon 177 and
extend beyond the distal extremity of the tubular member 176. The
guide wire 196 is of a conventional type and is utilized for
guiding the balloon catheter as hereinafter described. A pair of
spaced-apart radiopaque markers of a suitable material such as gold
bands 198 are provided on the tubular member 188 within the balloon
177.
[0036] The coaxial annular space between the exterior of the
tubular member 188 and the interior of the tubular member 176
serves as an annular balloon inflation passage and is in
communication with the sidearm 186 so that the inflation and
deflation of the balloon can be controlled by the stop cock
184.
[0037] The expandable spring attachment means 163 shown in FIG. 8
has a construction very similar to the expandable spring attachment
means 126 and 127 hereinbefore described. The expandable spring
attachment means 163 is provided with a plurality of vees 201
having apices 202 formed by coil springs 203 which have legs 204
and 206 expandable and contractible within the plane of the vee.
The vees 201 are configured in such a manner so that the apices 202
lie in only two spaced-apart parallel planes perpendicular to the
longitudinal axis of the expandable spring attachment means, rather
than the three planes disclosed for expandable spring attachment
means 126 and 127. Hook-like elements 207 are bonded to the legs or
struts 204 or 206. The hook-like elements 207 are provided with
hooks 208 which face outwardly of the expandable spring attachment
means and in a direction towards the other end of the spring
attachment means. Additional hook-like elements 209 are provided on
the other end of the spring attachment means 163 by bonding the
same by suitable means such as welding to the struts 204 and are
provided with hooks 211 which face outwardly and extend in an
opposite direction to the hooks 208, toward the other end of the
spring attachment means. In this way it can be seen that the hooks
208 and 211 face in opposite directions, hooks 208 being angled
slightly distally and hooks 211 being angled slightly proximally,
and serve to prevent distal and proximal migration of the graft leg
117 to which the expandable attachment means 163 is attached as
hereinafter described.
[0038] The expandable spring attachment means 163 is adapted to be
compressed and mounted within the capsule 172 as shown particularly
in FIG. 6. Means is provided for pushing the expandable spring
attachment means 163 out of the open end 173 of the capsule 172 and
consists of a stabilization button 216 which is formed on the
balloon shaft or flexible elongate tubular member 176. The pusher
member 216 can be formed in a suitable manner such as by forming a
ring of longitudinally compressed polyethylene on the shaft
176.
[0039] Operation and use of the apparatus hereinbefore described
for performing the method of the present invention for deploying an
endovascular graft having bifurcation may now be briefly described
as follows.
[0040] In conjunction with the cartoons which are set forth in
FIGS. 9-19, let it be assumed that it is desired to repair an
aneurysm in the abdominal aorta 222 close to or involving the
aortic bifurcation 221 and possibly involving the left and right
iliac arteries 223 and 224 in a human patient. In this example, the
left iliac artery 223 is referred to as the first iliac artery, and
the right iliac artery 224 is referred to as the second iliac
artery. Graft legs 116 and 117 are identified similarly. Initially
the patient is prepared with either general, regional, or local
anesthesia. A cut-down is performed in the left femoral artery as
indicated by the opening 226 in the first leg 223. Similarly, a
cut-down or percutaneous access is performed in the right femoral
artery as indicated by the opening 227 in the second leg 224. A
guide wire 231 of a conventional type, as for example a guide wire
having a diameter of 0.038", is introduced through the opening 226
in the left femoral artery 223 and then is passed over the aortic
bifurcation 221 and down through the right artery 224 and out
through the opening 227 in the right femoral artery. This procedure
is accomplished in a conventional manner under fluoroscopy as shown
in FIG. 9.
[0041] Thereafter as shown in FIG. 10 the lead tube 151 which is
extending out of the distal extremity of the capsule 31 is threaded
over the guide wire 231 extending out of the hole 226 in the first
artery 223 and thence into the left cut-down or hole 226 and over
the guide wire 231 in the left artery, over the guide wire 231 in
the aortic bifurcation 221 and then down the second artery 224
through the right cut-down 227 so that the distal extremity of the
lead tube 151 extends for a substantial distance out of the
cut-down 227. During the time that the lead tube 151 is being
advanced, the distal extremity of the guide wire 231 is caused to
pass through the cut-out 154 so that the distal extremity of the
guide wire 231 is accessible and can be held steady while the lead
tube 151 is advanced over it.
[0042] Thereafter, the guide wire 231 can be pulled out by grasping
the proximal extremity of the guide wire 231 the cut-out 154 in the
lead tube 151 and pulling out the guide wire 231 while holding the
distal extremity of the lead tube 151 so as to prevent the lead
tube 151 from being pulled back into the cut-down 227. The distal
extremity of the lead tube 151 is then clamped with a hemostat 236
as shown in FIG. 11 to be sure that the lead tube 151 is not pulled
back into the cut-down 227 during future steps in the method of the
present invention. The major deployment device 21 is then
introduced into the left cut-down 226 by first passing the balloon
guide wire 91 and then the balloon 74 through the left cut-down 226
followed by the capsule 31, which is advanced to the position shown
in FIG. 11 by pushing on the tubular member 27. During the
advancement, the operator may need to place gentle traction on the
lead tube 151 to facilitate advancement of the capsule 31 toward
the aortic bifurcation 221. When the capsule 31 reaches the aortic
bifurcation 221, it is necessary for the operator holding the lead
tube 151 to permit more of the lead tube 151 to enter the cut-down
227 to permit further advancement of the capsule 31 up the aorta so
that the distal spring attachment means 126 of the graft 20 within
the capsule 31 can be positioned in a region which is 1-2
centimeters proximal of the proximal extremity of the aneurysm to
be corrected by the graft 20 being deployed. As shown in FIG. 12
the distal extremity of the capsule 31 is deployed well beyond the
aortic bifurcation 221. As soon as the physician has determined
that the capsule 31 is in the proper position, the physician uses
one hand to hold the control mechanism 36 while at the same time
using the fingers of the other hand to rotate the knob 49 and the
pinion 47 to retract the rack member 42. This causes retraction of
the tubular member 27 and the capsule 31 mounted thereon while the
hypo tube 76 is retained in a stationary position by the collet 82
that is retained by the collet housing 83. As the capsule 31 is
withdrawn, the stabilization button 106 carried by the tubular
member 72 in engagement with the graft 20 as shown particularly in
FIG. 5 causes the graft 20 to be gradually ejected from the capsule
31 as the capsule 31 is withdrawn. Upon continued retraction of the
capsule 31, the proximal expandable spring attachment means 126
will clear the capsule 31 and will spring outwardly to cause the
hooks 142 carried thereby to come into engagement with the aortic
vessel wall proximal to the aneurysm to be repaired as shown in
FIG. 12.
[0043] The physician, using one hand to hold the control mechanism
36, uses his other hand to release the collet 82 in order to unlock
the tube 76 by rotating the collet cover 84 relative to the control
mechanism 36. The physician repositions the hand not holding the
control mechanism 36 so as to grasp the portion of the metal hypo
tube 76 extending proximally of the control mechanism 36. The hypo
tube 76 is then pulled rearwardly or proximally. The balloon 74 is
thereby drawn into the proximal extremity of the main body portion
112 of the graft 20 as shown in FIG. 13 so that the intermediate
portion of the balloon 74 is in general registration with the
expandable spring attachment means 126. The balloon 74 is then
inflated by supplying gas to the balloon inflation lumen by
attachment of a syringe or other suitable inflation means to the
Luer fitting 88. Upon inflation of the balloon 74 the hooks 142
carried by the proximal expandable spring attachment means 126 are
firmly seated circumferencially in the normal aortic wall proximal
to the aortic aneurysm. With the balloon 74 still inflated and
firmly holding the proximal attachment means 126 against the aortic
wall, the capsule 31 is then further retracted by holding tube 76
in fixed position release to the patient with one hand and
retracting the handle 36 with the other hand in order to expose the
entire length of the second leg 117 as shown in FIG. 13. The
capsule 31 is still further retracted to clear most of the first
leg 116 as shown in FIG. 14. As this is being accomplished, the
second leg 117 of the graft 20 is pulled down into the artery 224
by pulling on the lead tube 151 so that the entire length of the
leg 117 of the graft 20 is disposed in the arterial vessel 224 and
extends substantially below the bifurcation 221 and below the
aneurysm which is to be repaired. Further retraction of the capsule
31 is accomplished by holding tube 76 fixed with one hand and
retracting the handle 36 with the other hand until the distal
expandable spring attachment means 127 carried by the first leg 116
clears the capsule 31 and springs into engagement with the wall of
the arterial vessel 223. It should be appreciated that during the
foregoing procedures, the balloon 74 remains inflated in the
attachment means 126 to prevent any accidental dislodgement of the
Attachment means 126 during the removal of the capsule 31 and
during the placement of the second leg 117 of the graft 20 into the
artery 224 by pulling on the lead line 151.
[0044] The balloon 74 is then deflated so that it is in a collapsed
position and the balloon is withdrawn from the attachment means 126
into the first leg 117 until its intermediate portion is in
registration with the attachment means 127. The balloon 74 is then
reinflated to expand the hooks 142 of the attachment means 127 into
firm engagement with the arterial wall of the vessel 223 as shown
in FIG. 15.
[0045] After this has been accomplished, the balloon 74 is again
deflated and is advanced up through the main body of the graft 112
and again into the attachment means 126. The balloon 74 is then
reinflated as shown in FIG. 16 and serves to hold the graft 20 in
place while the procedures for securing the distal extremity of the
second leg 117 are accomplished. It is likely in many instances
that this step of again securing the proximal extremity of the
graft by inflating the balloon in the attachment means 126 may be
unnecessary. However to ensure that the graft 20 will not move
after it has been deployed, as additional insurance, the balloon 74
can be positioned in the attachment means 126 and reinflated.
[0046] The minor deployment device 22 is next utilized. The guide
wire 196 forming a part thereof is introduced through the cutdown
227 into the second artery 224 so that it extends into the second
leg 117 of the graft 20 and beyond the bifurcation. The balloon
catheter 162 is threaded onto or advanced over the guide wire 196.
The balloon catheter 162 is disposed within the capsule catheter
161. The minor deployment device 22, with its balloon catheter 162
and capsule catheter 161, is advanced into the cutdown 227 while
applying gentle traction to the lead tube 151 to keep the second
leg 117 of the graft 20 taut. The balloon 177 and the capsule 172
are thus introduced into the second leg 117. The capsule 172 is
positioned so that when the expandable spring attachment means 163
contained therein is deployed therefrom, the spring attachment
means 163 will be at the distal extremity of the second leg 117 of
the graft 20 as shown in FIG. 16. The expandable spring attachment
means 163 is then forced out of the capsule 172 by the physician
using one hand to grasp the wye adapter 179 and hold it in a fixed
position relative to the patient and using the other hand to grasp
the Tuohy Borst adapter 171 and gradually withdraw the same to
retract the capsule 172 from over the expandable spring attachment
means 163 which is held in the desired position by the
stabilization button 216 carried by the tubular member 176. As soon
as the expandable spring attachment means 163 clears the capsule
172 it will spring out with one row of hooks 208 moving into
engagement with the distal extremity of the second leg 117 and with
the other row of hooks 211 moving into engagement with the wall of
the arterial vessel 224. Alternatively the capsule 172 is
positioned so that when the expandable spring attachment means 163
contained therein is displaced therefrom, the expandable spring
attachment means 163 is disposed within the second leg 117 so that
both rows of hooks 208 and 211 move into engagement with the distal
extremity of the leg 117 and engage the wall of the vessel 224.
[0047] In order to firmly implant the hooks 208 and 211 of the
expandable spring attachment means 163, the balloon 177 in its
deflated condition is brought down into the attachment means 163 so
that its intermediate portion is disposed within the attachment
means 163. This is accomplished by pulling on the wye adapter 179
which applies a pulling force to the tubular member 176 to pull the
balloon 177 towards the distal extremity of the leg 117 of the
graft 20 while at the same time withdrawing, if so desired, the
capsule catheter 161 by pulling on the adapter 171 which applies a
pulling force to the tubular member 166. As soon as the balloon 177
is in the proper position, the balloon 177 is inflated by suitable
inflation means as, for example, a syringe attached to the stop
cock fitting 184 and inflating the balloon 177 to the desired
pressure to force the hooks 208 and 211 firmly into the distal
extremity of the leg 117 of the graft 20 and the arterial vessel
224.
[0048] After the inflation of the balloon 177 has been
accomplished, the balloon 177 can be deflated by removing the
syringe opening the stop cock 184. The balloon catheter 162 and the
capsule catheter 161 then can be removed through the cutdown 227 so
that all that remains is the lead tube 151 extending through the
cutdown 227. The lead tube 151 is cut distal to the knot 148 in the
vicinity of the necked down section 153 and the lead tube 151 is
pulled off of the pull line 146. One end of the Nylon pull line 146
is then grasped to pull out the Nylon pull line 146 by having the
free end travel up into the cutdown 227 and pass through the distal
extremity of the leg 117 of the graft 20. It is then removed in its
entirety through the cutdown 227. The right cutdown 227 is then
repaired. Following that, the balloon 74 is deflated. The hypo tube
76 is retracted relative to the control mechanism 36 to move the
balloon into engagement with the capsule 31. The collet 82 is then
locked onto the hypo tube 76 by turning the knob 84 relative to the
control mechanism 36. The control mechanism 36 is then withdrawn to
remove the capsule catheter 27, the balloon catheter shaft 72, and
the balloon 74 through the cutdown 226. The left cutdown 226 is
then repaired. This completes the steps for deployment of the graft
20 across an aortic bifurcation to repair an aneurysm. The patient
can then be brought out of general anesthesia if employed.
[0049] It should be appreciated that the graft having bifurcation
can have legs of various lengths depending upon the type of
aneurysm which is to be repaired. For example, one leg can be
longer than the other. The legs can both be short in cases in which
the aneurysm has a short distal aortic neck and does not include
the iliac arteries. They would be longer in aneurysms which involve
the iliac arteries as well. It is generally desirable that the
graft extend at least one centimeter beyond the most distal portion
of the most distal aneurysm in the vessels.
[0050] From the foregoing it can be seen that there has been
provided a graft having a bifurcation in which the main body of the
graft as well as the legs are firmly attached in the arterial
vessels so that they accidentally cannot become dislodged from the
location in which they are fixed in the arterial walls. The method
which is utilized for deploying the graft with legs is relatively
simple and can be accomplished within a relatively short period of
time. The major and minor deployment devices which are utilized in
the procedure are constructed in such a manner that they are easy
to utilize with a minimum of training. The use of a folded-over
second leg of the graft in the capsule makes it unnecessary to move
the main body of the graft as high in the aorta as would be
otherwise necessary in order to permit the second leg of the graft
to clear the aortic bifurcation thereby permit the second leg to be
placed in the second iliac artery. Thus, the risk incurred by
moving the graft and its capsule and any associated debris past the
renal arteries located well above the aortic bifurcation is greatly
reduced thereby reducing the chance of occluding the renal arteries
and causing embolization to the renal arteries.
* * * * *