U.S. patent application number 10/610030 was filed with the patent office on 2004-01-01 for apparatus for relining a blood vessel.
Invention is credited to McDermott, John D..
Application Number | 20040002754 10/610030 |
Document ID | / |
Family ID | 24723066 |
Filed Date | 2004-01-01 |
United States Patent
Application |
20040002754 |
Kind Code |
A1 |
McDermott, John D. |
January 1, 2004 |
Apparatus for relining a blood vessel
Abstract
An apparatus for relining a blood vessel, including a tubular
liner of biocompatible material and an anchoring device connected
to a distal end thereof. The proximal end of the tubular liner is
configured for attachment to a blood vessel following delivery of
the apparatus to the blood vessel. The apparatus can include a
delivery system, preferably having a removable hub that is
initially attached to the tubular liner and a hollow tip that is
positioned over the anchoring device.
Inventors: |
McDermott, John D.; (Mesa,
AZ) |
Correspondence
Address: |
MORRISON & FOERSTER, LLP
555 WEST FIFTH STREET
SUITE 3500
LOS ANGELES
CA
90013-1024
US
|
Family ID: |
24723066 |
Appl. No.: |
10/610030 |
Filed: |
June 30, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10610030 |
Jun 30, 2003 |
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09678505 |
Oct 2, 2000 |
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6589273 |
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Current U.S.
Class: |
623/1.23 ;
623/1.36 |
Current CPC
Class: |
A61F 2002/072 20130101;
A61F 2/915 20130101; A61F 2002/826 20130101; A61F 2/07 20130101;
A61F 2/95 20130101; A61F 2002/075 20130101; A61F 2/958
20130101 |
Class at
Publication: |
623/1.23 ;
623/1.36 |
International
Class: |
A61F 002/06 |
Claims
What is claimed as new and desired to be protected by Letters
Patent of the United States is:
1. An apparatus for relining a blood vessel, comprising a tubular
liner of biocompatible material having a proximal end and a distal
end, and an anchoring device connected to said distal end of said
tubular liner, wherein said proximal end of said tubular liner
extends beyond said anchoring device and is configured for
attachment to said blood vessel following delivery thereto.
2. The apparatus according to claim 1, further comprising a
delivery system, comprising a removable hub attached to said
proximal end of said tubular liner and a hollow tip positioned over
said distal end of said tubular liner, said tip being connected to
a proximal end of said delivery system, wherein at least a portion
of said anchoring device is positioned within said tip.
3. The apparatus according to claim 2, further comprising a stopper
connected to said shaft at said proximal end of said delivery
system, said stopper having a diameter that is greater than a
diameter of said liner.
4. The apparatus according to claim 2, further comprising a balloon
and a balloon hub, wherein said balloon hub is positioned at a
proximal end of said delivery system and is connected to said
shaft, wherein said balloon is positioned around said shaft and in
fluid communication therewith, said shaft comprising a passageway
connecting said balloon to said balloon hub.
5. The apparatus according to claim 2, further comprising a
location marker.
6. The apparatus according to claim 5, wherein said location marker
is positioned on said anchoring device.
7. The apparatus according to claim 5, wherein said location marker
is positioned on said liner.
8. The apparatus according to claim 5, wherein said location marker
comprises a radiopaque material.
9. The apparatus according to claim 4, wherein said balloon further
comprises a location marker.
10. The apparatus according to claim 9, wherein said location
marker comprises radiopaque material on a proximal and distal end
of said balloon.
11. The apparatus according to claim 1, wherein said biocompatible
material is expanded polytetrafluoroethylene.
12. The apparatus according to claim 1, wherein said anchoring
device is a self-expanding stent.
13. The apparatus according to claim 1, wherein said liner further
comprises a luminal layer and an abluminal layer, and wherein said
anchoring device is encapsulated therebetween.
14. The apparatus according to claim 1, further comprising a
plurality of anchoring devices positioned along the length of said
liner.
15. The apparatus according to claim 14, further comprising a
plurality of balloon-expandable stents positioned along the length
of said liner.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
09/678,505, filed Oct. 2, 2000, the entirety of which is expressly
incorporated by reference as if fully set forth herein.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
[0002] Not applicable.
REFERENCE TO A COMPACT DISK APPENDIX
[0003] Not applicable.
BACKGROUND OF THE INVENTION
[0004] The present invention relates generally to the field of
medical devices, and more particularly, to a graft to re-line a
debulked vessel.
[0005] Arterial stenosis is a disease of the artery wherein a
portion of the vessel becomes occluded, primarily with plaque
(atheroma) containing cholesterol, lipid material, macrophages and
proliferating smooth muscle cells, consequently restricting blood
flow and causing further complications. Traditionally, arterial
stenosis has been treated by surgical construction of a bypass
channel to connect healthy parts of the vessel around the atheroma.
While the bypass method may produce good results, a major
disadvantage is the invasiveness of the surgery because the
procedure requires general anesthesia and a substantial
post-surgical healing period.
[0006] Another, less invasive method of treatment includes balloon
catheter angioplasty, where a balloon catheter is inserted into the
diseased portion of the vessel and inflated, pushing the atheroma
outward and opening the vessel. While balloon catheter angioplasty
is much less invasive than bypass surgery, it does not enjoy
similar success rates due to frequent restenosis of the vessel. To
overcome this problem, stents and other similar endoluminal devices
may be inserted to keep the vessel open following angioplasty.
Cellular infiltration through the stents' mesh-like structure makes
the use of bare stents less than optimal, particularly in longer
(>5 cm) legions. Consequently, the stent may be covered with a
biocompatible material such as polytetrafluoroethylene (PTFE) to
prevent cellular infiltration.
[0007] Endarterectomy is a method for treating occluded portions of
a vessel where the atheroma is surgically removed, along with the
inner two layers (intima and media) of the three-layered artery.
Following the endarterectomy, only the adventitia layer remains,
thus the vessel can be prone to cellular accumulation and
thrombosis.
[0008] Artherectomy is a method for treating occluded blood vessels
where a mechanical device is inserted into the vessel, removing
atheroma by cutting or grinding the plaque and creating an open
channel. Similar to endarterectomy, this procedure can trigger a
cellular response that leads to thrombosis and/or restenosis of the
vessel.
[0009] Another term for endarterectomy and artherectomy is
"debulking." Debulking is simply the removal of atheroma, plaque
and other tissue to restore blood flow in a vessel. To prevent the
cellular response that leads to thrombosis and/or restenosis
following a debulking procedure, the vessel can be re-lined with
PTFE or other biocompatible materials.
[0010] Many delivery systems have been used for introducing stents,
grafts, and other endoluminal devices into bodily vessels with
minimum invasiveness. One problem with a number of these systems,
however, is that they require multiple components and procedural
steps to deliver and deploy the device against the vessel wall. In
addition, grafts and other endoluminal devices used to currently
re-line vessels are not optimal due to problems with effectively
anchoring the device within the vessel.
[0011] The present invention overcomes these stated drawbacks by
providing a simple delivery system and device to re-line a vessel
following debulking.
BRIEF SUMMARY OF THE INVENTION
[0012] The present invention is directed to a delivery system and
device for re-lining blood vessels. In particular, following
debulking procedures, a graft containing a stent or other fixation
device is deployed slightly distal to the debulked section of the
vessel. A small balloon on the shaft of the delivery catheter is
inflated to ensure good opposition of the graft to the vessel wall.
Next, the delivery system is removed through the newly implanted
graft, which is sutured proximally to the debulked vessel.
[0013] It is an object of this invention to provide an endoluminal
vascular graft device to re-line a debulked vessel as a less
invasive alternative to traditional surgical bypass.
[0014] It is another object of this invention to provide an
endoluminal vascular graft device that has a minimal profile when
loaded into an insertion system, can be seen with fluoroscopic
imaging and can be deployed quickly and easily.
[0015] It is yet another object of this invention to provide a
delivery system to introduce the endoluminal vascular graft device
quickly, easily and effectively within the debulked vessel.
[0016] These and additional objects are accomplished by delivering
a graft with an attached stent or other support structure to a
debulked vessel. The replacement lining is delivered to the desired
site by using a delivery system, including a tip to house the
stent, a sliding hub attached to the graft lining material, and an
inner shaft connected to the tip.
[0017] To prepare the replacement lining for delivery, the distal
stent is bonded, attached or encapsulated to the graft material.
The graft material can either be supported, unsupported, or a
combination of the two to resist compression. The distal portion is
compressed into the atraumatic tip for delivery to the desired site
within the treated vessel. Ideally, a self-expanding stent is used
for this purpose so that the deployment of the stent occurs
quickly, as soon as it is released from the atraumatic tip, thus
ensuring that the stent can be deployed at the pre-selected
location without migration in either direction within the
vessel.
[0018] The atraumatic tip is connected to an inner shaft that
extends through the compressed stent and graft material to the
proximal end of the delivery device. The connection between the tip
and the shaft allows the device to be maneuvered as it is being
inserted into the vessel. Optionally coupled to the shaft, proximal
to the loaded stent, is a balloon that is positioned to be inside
of the stent after the stent is removed from the atraumatic tip.
Once the stent is removed from the atraumatic tip and expands to
come into contact with the vessel wall, the balloon can be inflated
to ensure a good fit to the vessel wall. A sliding hub is attached
to the proximal end of the graft lining material so that the distal
stent can be pulled out of the atraumatic tip. After the delivery
system is removed from the vessel and the graft lining material is
pulled taut, the sliding hub is cut off of the graft lining
material and the lining material is sutured to the treated
vessel.
[0019] A more complete understanding of the endoluminally placed
vascular graft and delivery system will be afforded to those
skilled in the art, as well as a realization of additional
advantages and objects thereof, by a consideration of the following
detailed description of the preferred embodiment. Reference will be
made to the appended sheets of drawings, which will first be
described briefly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 is a perspective view of a distal end of the vascular
graft device after it has been deployed from the catheter.
[0021] FIG. 2 is a cross-sectional view of a preferred embodiment
of the vascular graft device and delivery system of the present
invention.
[0022] FIG. 3A is a cross-sectional view of the present invention
being delivered in vivo.
[0023] FIG. 3B is cross-sectional view of the present invention
after the stent has been deployed from the atraumatic tip.
[0024] FIG. 3C is a cross-sectional view of the present invention
as the stent is tightly fit to the vessel wall.
[0025] FIG. 3D is a cross-sectional view of the present invention
as the delivery system is being removed from inside the replacement
lining.
[0026] FIG. 4 is a cross-sectional view of an alternate embodiment
of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0027] The following detailed description should be read with
reference to the drawings, in which like elements in different
drawings are identically numbered. The drawings, which are not
necessarily to scale, depict selected preferred embodiments and are
not intended to limit the scope of the invention. The detailed
description illustrates by way of example, not by way of
limitation, the principles of the invention. This description will
clearly enable one skilled in the art to make and use the
invention, and describes several embodiments, adaptations,
variations, alternatives and uses of the invention, including what
is presently believed to be the best mode of carrying out the
invention.
[0028] The present invention satisfies the need for a replacement
lining for a vessel and a method of delivering the lining to a
desired location. This is accomplished by bonding, attaching or
encapsulating a stent at one end of a biocompatible plastic lining
material and loading the stent and lining into a delivery system
including an atraumatic tip, a sliding hub and an inner shaft with
a balloon.
[0029] Referring now to the drawings, in which like reference
numbers represent similar or identical structures throughout, FIG.
1 illustrates a preferred embodiment of the replacement lining of
the present invention. A distal end of a replacement lining 20 is
shown with a shadow view of a stent 22 attached thereto. The stent
22 may be attached to the lining 20 at its distal end in any number
of ways including, but not limited to, direct bonding, bonding with
the use of an adhesive material, and encapsulation with the use of
an additional tubular portion of ePTFE. The stent 22 can be
attached to the luminal or abluminal surface of the lining, or in
the case of encapsulation, the stent can have the lining as its
luminal or abluminal surface. The lining is a biocompatible graft
material, which in the preferred embodiment is expanded
polytetrafluoroethylene (ePTFE). The preferred ePTFE is one
optimized for bond strength as described in U.S. Pat. No.
5,749,880, incorporated by reference herein. In FIG. 1, the stent
22 is self-expanding, thus not requiring any external force to
conform to the sides of the vessel wall in which it is placed.
However, many other stent configurations are possible, including
various self-expanding and balloon-expandable stents.
[0030] FIG. 1 shows encapsulation of the stent 22 as the attachment
method to the lining 20. The stent 22 is encapsulated between two
layers of ePTFE 24 and 26 by utilizing a mandrel assembly. Once the
appropriate ePTFE coverings are placed onto the luminal and
abluminal surfaces, the stent 22 is encapsulated within the
replacement lining 20 at the lining's distal end by connecting or
bonding the luminal covering 26 to the abluminal covering 24. The
replacement lining 20 represents the continuation of the ePTFE
covering whether it be a continuation of the abluminal covering 24
from the stent to the proximal end of the device 10 (see FIG. 2),
the luminal covering 26, or both luminal and abluminal coverings 24
and 26. Encapsulation can be accomplished by a number of methods as
is well-known in the art.
[0031] FIG. 2 illustrates a cross-section of the delivery system 10
containing the replacement lining 20 before introduction into the
vessel of a patient. The delivery system 10 contains an atraumatic
tip 32 that encloses the stent 22 in a small-diameter state, after
it has been reduced in size by any of the known loading methods,
including the method disclosed in U.S. Pat. No. 6,096,027, which is
incorporated by reference herein. Attached to the atraumatic tip
32, extending the length of the delivery system 10, is a shaft 30
that connects the tip 32 to a stopper 36. Built into the stopper 36
is a hub 38 for the inflation of an optional balloon 34 located
proximally a short distance from the loaded stent 22 along the
shaft 30. The optional balloon 34 has radiopaque markers 35
situated at both ends to reveal the proximal and distal ends of the
balloon 34 to assist in the positioning of the balloon 34 with
respect to the stent 22. The stent 22 is attached to the
biocompatible replacement lining 20 at the distal end thereof. At
the proximal end of the replacement lining 20, a sliding hub 28 is
attached to the lining 20 to pull back the replacement lining 20
from the atraumatic tip 32 and deploy the stent 22 and replacement
lining 20 within a vessel.
[0032] FIGS. 3A through 3D illustrate the replacement lining 20 as
it is deployed within a vessel 40. In FIG. 3A, the delivery system
10 is introduced into the vessel 40 through a single entry point
(not shown), distal to the end of the endarterectomy or
atherectomy, in which the replacement lining 20 is to be implanted.
The delivery system 10 can be manipulated through the vessel 40 by
the stopper 36 due to the rigidity of the shaft 30, which is
connected proximally to the stopper 36 and distally to the
atraumatic tip 32 (shown in FIG. 2). In order to monitor the device
10 as it is guided through the treated vessel 40, markers can be
placed on or encapsulated within the replacement liner 20, on the
stent 22, and/or on the optional balloon 34 (as shown in FIGS. 2-4)
when included as a part of the device 10. Once the device 10 has
reached the desired location within the vessel 40, the stent 22 is
removed from the atraumatic tip 32 and deployed within the vessel
40 as shown in FIG. 3B.
[0033] Referring again to FIG. 2, the deployment of the stent 22 is
preferably accomplished by holding the stopper 36 steady while
pulling the sliding hub 28, attached to lining 20, toward the
stopper 36. This action pulls the stent 22 attached to a distal end
of the lining 20 out of the atraumatic tip 32, allowing the stent
22 to self-expand to its pre-loaded diameter to bring it and the
attached lining 20 in close proximity to the vessel wall 42.
Alternatively, the stopper 36 can be pushed toward the sliding hub
28 while the hub is held steady, thereby pushing the atraumatic tip
32 off of the stent 22. The optional balloon 34, when present, is
positioned proximal to the stent 22 so that removal of the stent 22
from the atraumatic tip 32 places the expanding stent 22 over the
top of the balloon 34 as shown in FIG. 3B. The balloon 34, which is
then within the lumen created by the stent 22 as the stent 22
expands close to the vessel wall 42, can be inflated to come into
contact with the stent 22 as shown in FIG. 3C, thus ensuring a
tight fit to the vessel wall 42.
[0034] Referring to FIG. 3D, once the replacement lining 20 has
been implanted within the vessel 40, the delivery system 10 is
withdrawn from the vessel 40 through the replacement lining 20. The
stopper 36, with atraumatic tip 32 in tow, is pulled through the
lining 20 and out of the single incision site (not shown). Prior to
removing the delivery system 10, the sliding hub 28 is detached
from the lining 20 by cutting the lining material near the hub 28.
The remaining lining material is then surgically attached to the
vessel 40 wall through suturing or other accepted medical
procedures, thus completing the proximal anastomosis.
[0035] FIG. 4 illustrates an alternate embodiment of the vascular
graft device and delivery system of the present invention. In this
embodiment, a delivery system 100 contains many of the same
features as those of the delivery system 10 shown in FIG. 2,
including the atraumatic tip 32, the shaft 30 that connects the
atraumatic tip 32 to the stopper 36, and the balloon 34. In this
embodiment, however, in addition to the stent 22 that is initially
constrained within the atraumatic tip 32, there are several small
balloon-expandable stents 42, 52, and 62 located at axially spaced
apart intervals along the replacement lining 20. These stents can
be expanded by the balloon 34 as it is withdrawn in a proximal
direction. Only those areas requiring such support need to have a
stent expanded in the corresponding location in the replacement
lining 20. Thus, any vessel irregularity can be tailored according
to stents that are expanded. It should be appreciated that any
number of stents can be placed along the replacement lining 20. By
having numerous stents placed at spaced apart intervals, the
physician is permitted great flexibility in tailoring the present
invention to each individual procedure.
[0036] Having thus described a preferred embodiment of the
endoluminally placed vascular graft, it will be apparent by those
skilled in the art how certain advantages of the present invention
have been achieved. It should also be appreciated that various
modifications, adaptations, and alternative embodiments thereof may
be made. For example, while replacement linings with ePTFE have
been illustrated, it should be apparent that the inventive concepts
described herein would be equally applicable to other types of
biocompatible covering materials. Moreover, the words used in this
specification to describe the invention and its various embodiments
are to be understood not only in the sense of their commonly
defined meanings, but to include by special definition in this
specification structure, material or acts beyond the scope of the
commonly defined meanings. The definitions of the words or elements
of the following claims are, therefore, defined in this
specification to include not only the combination of elements which
are literally set forth, but all equivalent structure, material or
acts for performing substantially the same function in
substantially the same way to obtain substantially the same result.
The described embodiments are to be considered illustrative rather
than restrictive. The invention is further defined by the following
claims.
* * * * *