U.S. patent application number 10/621126 was filed with the patent office on 2004-05-20 for method and device for the treatment of vulnerable tissue site.
Invention is credited to Gertner, Kevin, Sirhan, Motasim, Yan, John.
Application Number | 20040098104 10/621126 |
Document ID | / |
Family ID | 24883982 |
Filed Date | 2004-05-20 |
United States Patent
Application |
20040098104 |
Kind Code |
A1 |
Sirhan, Motasim ; et
al. |
May 20, 2004 |
Method and device for the treatment of vulnerable tissue site
Abstract
The present invention is directed to method and apparatus for
treating vulnerable tissue sites, such as aneurysms in the
abdominal area or in the thoracic cavity, and expanded tissues on
various organs and body surfaces such as the heart. The apparatus
of the present invention, are containment members for at least
partially containing the vulnerable tissue site, thus preventing or
minimizing the further vulnerability or growth of the site.
Additionally, or alternatively, the containment members can apply
resistive force to the vulnerable tissue site. The force can be
compressive against the exterior surface of the tissue site. The
containment members of the present invention can be used alone or
in combination with support members, such as stent/grafts, in
treating a tissue site. In this embodiment, the support member is
disposed within the inner lumen of the vulnerable tissue site with
the containment member disposed on the exterior surface of the
lumen.
Inventors: |
Sirhan, Motasim; (Sunnyvale,
CA) ; Yan, John; (Los Gatos, CA) ; Gertner,
Kevin; (Los Gatos, CA) |
Correspondence
Address: |
Edward J. Lynch
DUANE MORRIS LLP
One Market
Spear Tower, Suite 2000
San Francisco
CA
94105
US
|
Family ID: |
24883982 |
Appl. No.: |
10/621126 |
Filed: |
July 16, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10621126 |
Jul 16, 2003 |
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09717910 |
Nov 20, 2000 |
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6648911 |
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Current U.S.
Class: |
623/1.15 |
Current CPC
Class: |
A61F 2250/0067 20130101;
A61B 17/064 20130101; A61F 2002/075 20130101; A61B 2017/0649
20130101; A61F 2250/0068 20130101; A61F 2002/072 20130101; A61B
17/12 20130101; A61F 2002/077 20130101; A61F 2/88 20130101; A61F
2/07 20130101; A61F 2230/0054 20130101; A61F 2220/0008 20130101;
A61B 17/12009 20130101 |
Class at
Publication: |
623/001.15 |
International
Class: |
A61F 002/06 |
Claims
What is claimed is:
1. A method for treating a vulnerable tissue site of an
intracorporeal body, comprising, providing a containment member
adjacent to an exterior surface of the site.
2. The method of claim 1 wherein the member is positioned to apply
resistive force to the tissue site.
3. The method of claim 2 wherein the force substantially minimizes
the further vulnerability of the tissue site.
4. The method of claim 3 wherein the force is compressive against
the exterior surface of the site.
5. The method of claim 1 wherein the containing is achieved by a
containment member.
6. The method of claim 4 wherein the force is applied by a
containment member.
7. The method of claim 5 wherein the containment member at least
partially covers the exterior surface of the tissue site.
8. The method of claim 6 wherein the containment member at least
partially covers the exterior surface of the tissue site.
9. The method of claim 5 wherein the containment member at least
partially encloses the exterior surface of the tissue site.
10. The method of claim 6 wherein the containment member at least
partially encloses the exterior surface of the tissue site.
11. The method of claim 5 wherein the containment member is secured
at least in part to the tissue site.
12. The method of claim 6 wherein the containment member is secured
at least in part to the tissue site.
13. The method of claim 5 wherein the containment member is further
extended to an adjacent tissue site.
14. The method of claim 6 wherein the containment member is further
extended to an adjacent tissue site.
15. The method of claim 13 wherein the containment member is
further secured at least in part to the adjacent tissue site.
16. The method of claim 14 wherein the containment member is
further secured at least in part to the adjacent tissue site.
17. The method of claim 1 wherein the vulnerable tissue site is not
native to the intracorporeal body.
18. The method of claim 4 wherein the vulnerable tissue site is not
native to the intracorporeal body.
19. A method for treating a vulnerable tissue site of an
intracorporeal body, comprising: providing a containment member;
disposing the containment member about the vulnerable tissue site
so as to at least partially cover at least a portion of the
exterior surface of the tissue site.
20. The method of claim 19 wherein the containment member at least
partially encloses the tissue site.
21. The method of claim 19 wherein the containment member further
disposed at least partially about a tissue site adjacent the
vulnerable tissue site.
22. The method of claim 19 wherein the vulnerable tissue site is
not native to the intracorporeal body.
23. The method of claim 19 further including the step of delivering
the containment member to the tissue site through an access
site.
24. The method of claim 19 wherein the access site is on the
surface of the intracorporeal body.
25. The method of claim 19 wherein the access site is within the
intracorporeal body.
26. The method of claim 20 wherein the tissue site is part of a
first tubular body having a first lumen.
27. The method of claim of claim 26 wherein the containment member
is advanced through the first lumen of the first tubular member and
through the access site in a wall of the first tubular member and
disposed about an exterior surface of the tissue site.
28. The method of claim 27 wherein the containment member at least
partially contains at least a portion of the length of the tissue
site.
29. The method of claim 25 or 26 wherein the access site is part of
a second tubular body member having a second lumen and disposed, at
least in part, substantially parallel or adjacent the tissue
site.
30. The method of claim 29 wherein the containment member is
advanced through the second tubular body and through the access
site located in a wall of the second tubular body and disposed
about an exterior surface of the tissue site.
31. The method of claim 23 wherein the tissue site is accessed
laparoscopically.
32. The method of claim 23 wherein the containment member is
advanced through the access site endoscopically.
33. The method of claim 23 wherein at least a portion of the
containment member includes a radiopaque material.
34. The method of claim 23 further including the step of delivering
therapeutic fluid to the tissue site.
35. The method of claim 23 wherein the intracorporeal body
including the vulnerable tissue site includes any one of thoracic
cavity, abdominal cavity, cerebral cavity, blood vessel, tissue,
vein graft, vein, gland, heart, vessel, nerve, stomach, or
liver.
36. The method of claim 29 wherein the second tubular body includes
any one of esophagus, trachea, vena cava, vein, artery, sinus,
aorta, heart, stomach, duct, or intestines.
37. The method of claim 19 further including providing a catheter
for introducing the containment member into the intracorporeal
body.
38. The method of claim 37 wherein the containment member is
released into the intracorporeal body after the disposing step.
39. A method for treating a vulnerable tissue site of an
intracorporeal tubular member, comprising: providing a support
member; providing a containment member; disposing the support
member along the interior lumen of the tubular member along at
least a portion thereof which includes the vulnerable tissue site;
disposing the containment member about an exterior surface of the
vulnerable tissue site so as to at least partially cover at least a
portion of the exterior surface of the tissue site.
40. The method of claim 39 wherein the containment member is
further disposed in part on a tissue site adjacent the vulnerable
tissue site.
41. The method of claim 40 wherein the containment member extends
along at least a portion of the vulnerable tissue site.
42. The method of claim 41 wherein the containment member is
longitudinally disposed on either side of the support member.
43. The method of claim 39 wherein the support member has an outer
and an inner surface and an inner lumen defined by the inner
surface and configured for passage of fluid therethrough.
44. The method of claim 40 wherein the containment member defines a
neck on the vulnerable tissue site on at least one end of the
containment member.
45. The method of claim 44 wherein the support member abuts the
neck formed by the containment member.
46. A containment member for containing a region of a vulnerable
tissue of predetermined dimensions, and providing a containment
surface of sufficient dimensions to at least partially encircle the
region of vulnerable tissue.
47. The containment member of claim 46 wherein the containment
member includes at least one free end.
48. The containment member of claim 47 wherein the containment
member includes at least one atraumatic end.
49. The containment member of claim 46 wherein the containment
member comprises a strand.
50. The containment member of claim 49 wherein the strand forms a
tubular member.
51. The containment member of claim 49 wherein the strand includes
a wire member.
52. The containment member of claim 49 wherein the strand includes
a ribbon member.
53. The containment member of any one of claims 49, 50, 51, or 52
wherein the strand includes a plurality of longitudinally oriented
strands transversely spaced apart and attached to an adjacent
strand with an attachment mean.
54. The containment member of claim 53 wherein the longitudinally
oriented strands have a width ranging from about 0.001 to about 2
centimeters.
55. The containment member of any one of claims 49, 50, 51, or 52
wherein the strand includes a plurality of longitudinally oriented
strands transversely spaced apart and a plurality of transversely
oriented strands longitudinally spaced apart, the longitudinally
oriented strands connected to one another by at least one of the
transversely oriented strands.
56. The containment member of claim 55 wherein the longitudinally
oriented and transversely oriented strands have a width,
independently, ranging from about 0.0001 to about 2
centimeters.
57. The containment member of any one of claims 49, 50, 51, or 52
wherein the strand is formed of a material from the group
consisting of polymers, metals, shape memory alloys, biodegradable
material, and a combination thereof.
58. The containment member of claim 56 wherein the shape memory
alloy includes nickel titanium.
59. The containment member of any one of claims 49, 50, 51, or 52
wherein the strand is in the form of a coil.
60. The containment member of claim 59 wherein the coil has a
constant diameter.
61. The containment member of claim 59 wherein the coil has a
variable diameter.
62. The containment member of claim 59 wherein the coil is tapered
at either or both ends.
63. The containment member of claim 59 wherein at least some of the
turns of the coil when disposed about the exterior of the tissue
site wrap around the circumference of the tissue site.
64. The containment member of claim 59 wherein the turns of the
coil when disposed about the exterior of the tissue site form an
arcuate structure.
65. The containment member of claim 59 wherein the coil in a
relaxed configuration has a pitch between adjacent turns ranging
from about 0.002 to about 20 centimeters.
66. The containment member of claim 65 wherein the pitch ranges
from about 0.002 to about 2 cm.
67. The containment member of claim 65 wherein the pitch ranges
from about 2 to about 10 cm.
68. The containment member of claim 65 wherein the pitch ranges
from about 10 to about 20 cm.
69. The containment member of claim 65 wherein the coil has a
variable pitch.
70. The containment member of claim 65 wherein the containment
member has means to secure the adjacent turns of the coil.
71. The containment member of claim 70 wherein the securing means
includes any one of coil, wire, or strand.
72. The containment member of claim 49 wherein the containment
member has a longitudinal dimension ranging from about 1 mm to
about 50 cm.
73. The containment member of claim 49 wherein the containment
member includes multiple lumens.
74. The containment member of claim 73 wherein at least one of the
multiple lumens is configured to be an inflation lumen, a
therapeutic fluid delivery lumen, or a strand lumen.
75. The containment member of claim 49 wherein the containment
member has outer and inner surfaces defining at least in part a
wall, a lumen disposed within the wall, and a containment surfaces
defined at least in part by the inner surface of the wall.
76. The containment member of claim 75 wherein the containment
member is configured to deliver therapeutic fluids to the tissue
site.
77. The containment member of claim 75 wherein the lumen defined by
the containment member inner and outer surfaces is a fluid lumen,
either or both the containment member outer and inner surfaces
including at least one aperture fluidically connectable to the
containment member fluid lumen.
78. The containment member of claim 77 wherein the aperture size
ranges from about 1 micron to about 2 millimeters.
79. The containment member of claim 78 wherein the aperture size
ranges from about 1 micron to about 1 cm.
80. The containment member of claim 77 wherein the fluid lumen is
fluidically connectable to a source of therapeutic fluid.
81. The containment member of claim 50 wherein the containment
member has an outer diameter and an inner diameter defined by the
inner surface.
82. The containment member of claim 81 wherein the inner diameter
is configured to have a variable dimension.
83. The containment member of claim 82 wherein the containment
member has outer and inner surfaces and a fluid lumen defined
therebetween and a containment lumen defined by the inner surface,
and the inner diameter of the containment member is decreased upon
the expansion of the containment member fluid lumen.
84. The containment member of claim 83 wherein the fluid lumen is
fluidically connectable to a source of inflation lumen.
85. The containment member of claim 49 wherein the containment
member further includes a sleeve disposed on at least a portion of
an exterior surface of the containment member.
86. The containment member of claim 85 wherein the sleeve includes
multiple lumens.
87. The containment member of claim 86 wherein at least one of the
multiple lumens of the sleeve is configured to be an inflation
lumen.
88. The containment member of claim 85 wherein the sleeve has an
inner and outer surface and an inner lumen disposed
therebetween.
89. The containment member of claim 88 wherein the containment
member has an inner diameter defined by an inner surface of the
containment member, the containment member inner diameter
decreasing upon the expansion of the sleeve inner lumen.
90. The containment member of claim 89 wherein the sleeve inner
lumen is fluidically connectable to a source of inflation
fluid.
91. The containment member of claim 75 wherein the containment
member is configured to at least partially encircle at least a
portion of the tissue site.
92. The containment member of claim 91 wherein the containment
member is configured to at least partially encircle at least a
portion of a tissue site adjacent the vulnerable tissue site.
93. The containment member of claim 75 wherein the containment
member inner surface has a curvature substantially less than
360.degree..
94. The containment member of claim 75 wherein the containment
member inner surface includes an adhesion promoter.
95. The containment member of claim 94 wherein the adhesion
promoter is selected from the group consisting of fibrin and
cyanoacrylates.
96. The containment member of claim 50 wherein the containment
member has an outer surface defining an outer diameter and an inner
surface defining an inner diameter.
97. The containment member of claim 96 wherein the vulnerable
tissue site has a first thickness and a tissue site adjacent the
vulnerable tissue site has a second thickness.
98. The containment member of claim 97 wherein the dimension of the
inner diameter of the containment member in a relaxed configuration
is substantially the same or slightly larger than the thickness of
the vulnerable tissue site.
99. The containment member of claim 97 wherein the dimension of the
inner diameter of the containment member in a relaxed configuration
is substantially larger than the thickness of the vulnerable tissue
site.
100. The containment member of claim 99 wherein the dimension of
the inner diameter of the containment member in a relaxed
configuration is about 25% larger than the thickness of the
vulnerable tissue site.
101. The containment member of claim 97 wherein the dimension of
the inner diameter of the containment member in a relaxed
configuration is substantially between the first thickness of the
vulnerable tissue site and second thickness of the adjacent tissue
site.
102. The containment member of claim 97 wherein the dimension of
the inner diameter of the containment member in a relaxed
configuration is substantially the same as the second thickness of
the adjacent tissue site.
103. The containment member of claim 97 wherein the dimension of
the inner diameter of the containment member in a relaxed
configuration is slightly less than the second thickness of the
adjacent tissue site.
104. The containment member of claim 97 wherein the dimension of
the inner diameter of the containment member in a relaxed
configuration is about 10% less than the second thickness of the
adjacent tissue site.
105. The containment member of claim 101 wherein the vulnerable and
adjacent tissue sites are part of a first tubular member and the
first and second thicknesses are defined by outer diameters of the
vulnerable and adjacent tissue sites, respectively.
106. The containment member of claim 77 wherein the aperture is
configured to delivered hardenable material to the exterior surface
of vulnerable tissue site.
107. A containment member for containing a region of a vulnerable
tissue of predetermined dimensions, and configured to provide a
containment surface of sufficient dimensions to be at least
partially disposed about a portion of an exterior surface of the
region of vulnerable tissue.
108. The containment member of claim 107 wherein the containment
member includes at least one free end.
109. The containment member of claim 108 wherein the containment
member includes at least one atraumatic end.
110. The containment member of claim 107 further configured for
attachment to a positioning means.
111. The containment member of claim 110 wherein the positioning
means is configured for securing the containment member to an
adjacent tissue site or body part to minimize further vulnerability
of the tissue site.
112. The containment member of claim 111 wherein the containment
member is configured to provide a compressive force against the
vulnerable tissue.
113. The containment member of claim 112 wherein the positioning
means is configured to be biased against an adjacent healthy tissue
site or body part.
114. The containment member of claim 113 wherein the containment
member is configured to provide a compressive force against the
vulnerable tissue.
115. A containment member for containing a region of a vulnerable
tissue of predetermined dimensions, providing a containment area of
sufficient dimensions to cross over the region of the vulnerable
tissue and be secured to healthy tissue adjacent to the region or
two opposing sides of the region.
116. A delivery system for delivering a containment member to
vulnerable tissue site of an intracorporeal body, comprising: a
catheter for slidably housing the containment member therein and
further having proximal and distal portions and having a curve at a
distal end thereof to bring about the desired deflection at the
catheter distal end to negotiate the catheter through tortuous
anatomy during treatment.
117. The system of claim 116 wherein the curve is formed within up
to about 2 mm to 20 cm of the catheter distal end.
118. The system of claim 116 wherein the distal end has a curvature
ranging from about 0.5 to about 3 cm.
119. The system of claim 116 wherein the distal end is configured
to have an angle ranging from about -180 degrees to +180
degrees.
120. The system of claim 116 wherein the catheter has multiple
deflection points.
Description
FIELD OF INVENTION
[0001] This invention relates to the fields of intervention,
surgery, and more particularly to method and apparatus for
treatment of aneurysms.
BACKGROUND OF THE INVENTION
[0002] An aneurysm is a condition in which a portion of a vessel
has a weakened wall that results in the expansion of the vessel due
to internal pressures. Aneurysm may be an aortic aneurysm occurring
in the abdominal area or in other areas, including but not limited
to: aneurysm in the thoracic aorta and neurovascular aneurysms.
[0003] Aortic aneurysm results from abnormal dilation of the artery
wall and is often associated with arteriosclerotic disease. Unless
treated, an aneurysm can rupture, leading to severe and often fatal
hemorrhaging. Treating an aortic aneurysm generally involves
transplanting a prosthetic graft to bridge or bypass the affected
portion of the aorta. Surgical implantation of the graft is
possible but this treatment causes considerable trauma, results in
high mortality and morbidity and, even when completely successful,
requires a lengthy recuperation period. Due to the difficulty of
the operation, surgical replacement is even less attractive when it
must be performed on an emergency basis after the aneurysm has
ruptured.
[0004] A less invasive alternative involves the use of a catheter
for intraluminal delivery of a graft. Graft delivery systems can
employ a graft with expandable portions that anchor the graft in
the aorta. Often, the systems use an inflatable balloon on the
delivery catheter to expand the anchoring portion of the graft as
disclosed in U.S. Pat. No. 5,275,622 (Lazarus et al.) which is
hereby incorporated in its entirety by reference thereto. This
latter example requires the use of a bulky capsule to store the
graft and a complicated pushrod system to deploy the graft.
[0005] The success of a percutaneous vessel repair depends in large
part on getting the graft to the location of the vasculature in
need of repair and deploying the graft effectively. A difficulty
associated with graft deployment and its effectiveness is blood
flow-by which occurs when blood can pass between the graft and the
patient's vessel wall, bypassing the graft.
[0006] Although the referenced prior art systems and others employ
many different stent and graft configurations, the limitation of
complete aneurysm containment has not been met.
[0007] These systems are frequently too bulky and inflexible to
access many regions of a patient's vasculature. In addition when
using endovascular stent grafting, it is important to know the
diameter, length, and healthy neck length segment of the aneurysm
in order to prevent perigraft leaks caused by poor arterial
apposition or by foreshortening of the endovascular graft.
[0008] In the neurovascular applications, a particular example for
aneurysm repair is the treatment of an aneurysm by placing
radiopaque materials within an aneurysm pouch. For example, it is
known to push embolic coils through an introducer catheter.
However, once the embolic coils leave the introducer catheter they
are no longer under control and may become repositioned away from
the desired location. This might occur, for example, when the
treatment site is located near a vessel having a larger lumen, as
when the embolic coil, having migrated to the larger vessel, would
travel to a remote location. Other disadvantages include the
possibility of the coils rupturing the wall of the aneurysm sac or
the further expansion of the aneurysm.
[0009] Another example of vulnerable tissue sites other than
aneurysms include vein grafts implanted as a bypass graft in CABG
procedures. A disadvantage of a vein graft is that it may degrade
over time as a result of the vein structure not being adept to
effectively handle high arterial pressure (e.g., being a weaker
structure against pressure), thereby degrading and occluding over
time. Typically, by the time intervention takes place, the vein
graft has degraded or occluded thus making it difficult to salvage
or treat.
[0010] Thus, what has been needed is a method and device that can
provide less invasive and more effective treatment of vulnerable
tissue sites, in particular arterial and other aneurysms. The
present invention satisfies at least some of this and other
needs.
SUMMARY OF THE INVENTION
[0011] The present invention is directed to a method and apparatus
for treating vulnerable tissue sites such as aneurysms in the
abdominal or thoracic aorta. Other applications of for the method
and apparatus of the present invention include neurovascular
aneurysms, veins, vein grafts, and expanded or thinned tissues on
various organs and body surfaces.
[0012] The apparatus of the present invention, is directed to
containment members for at least partially containing a vulnerable
tissue site, thus preventing or minimizing the further
vulnerability or growth of the site. Additionally, or
alternatively, the containment members can apply resistive force to
the vulnerable tissue site. The force can be compressive against
the exterior surface of the tissue site. The containment members of
the present invention can be used alone or in combination with
support members, such as stent/grafts, in treating a tissue site.
In this embodiment, the support member is disposed within the inner
lumen of the vulnerable tissue site with the containment member
disposed on the exterior surface of the lumen.
[0013] The containment members may totally encircle the vulnerable
tissue site or they may be disposed about less than the entire
circumference of body lumen including the vulnerable tissue site.
In one embodiment, the containment members have a containment
surface of sufficient dimensions to at least partially encircle a
region of the vulnerable tissue. In another embodiment, the
containment member can be configured to provide a compressive force
against the vulnerable tissue. The containment members may be
configured for attachment to a positioning member. The positioning
member can be configured for securing the containment member to an
adjacent tissue site or body part to minimize further vulnerability
of the tissue site. In another embodiment, the positioning member
is configured to be biased against an adjacent healthy tissue site
or body part.
[0014] The various embodiments of the containment members of the
present invention can be configured to deliver agents, such as
therapeutic agents, to the tissue site. Additionally, the
containment members can be configured to accommodate different
anatomical settings having vulnerable tissue sites. The embodiments
include but are not limited to strands, coils, sheaths, omega
shaped coils for structures that can not be looped around entirely,
and inflatable containment members.
[0015] The containment member may be formed of polymeric or
metallic material to remain in place until the removal of the same,
or in the alternative may be formed of bio-degradable material,
degrading over a period of time.
[0016] In operation, the containment members of the present
invention may be introduced to the vulnerable tissue site in one of
several ways, including: (1) surgical methods, such as cut-down or
laparoscopically; (2) intra-endoscopically, i.e., through the same
body conduit or lumen as the one including the vulnerable tissue;
and (3) inter-endoscopically, i.e., through, at least in part, a
body conduit or lumen adjacent the conduit which has the vulnerable
tissue.
[0017] In one embodiment, the containment member is advanced
through the first lumen of the first tubular member including the
vulnerable tissue site and through an access site in a wall of the
first tubular member and is disposed about an exterior surface of
the tissue site.
[0018] In another embodiment, the access site is part of a second
tubular body member having a second lumen and disposed, at least in
part, substantially parallel and adjacent the tissue site. In this
embodiment, the containment member is advanced through the second
tubular body and through the access site located in a wall of the
second tubular body and disposed about an exterior surface of the
tissue site. The containment member can be disposed about the
exterior surface of the first body lumen which includes the
vulnerable tissue site alone or together with the exterior surface
of the second body lumen.
[0019] As defined herein, vulnerable tissue site includes, without
limitation, any tissue site which is or can be weakened, enlarged,
thickened, or thinned, either permanently or periodically (as for
example during different phases, cycles, or conditions). The
vulnerable tissue may be present in any area of a host body, such
as but not limited to: cardiovascular or neurovascular arteries or
veins, vein grafts such as saphenous vein graft for a pass surgery,
aorta including abdominal and thoracic, vena cava including
inferior and superior, organs such as stomach or glands. The
vulnerable tissue site may be native to the intracorporeal body or
it may be a transplanted intracorporeal body such as a saphenous
vein graft introduced to the body as a result of a procedure such
as bypass before it becomes weakened as a result of its new
environment.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 is an elevational view, partially cut away view of a
containment member embodying features of the present invention.
[0021] FIG. 2 is another embodiment of a containment member
embodying features of the present invention taking the form of a
coil.
[0022] FIG. 3A is a side elevational view of a vulnerable tissue
site.
[0023] FIG. 3B is a side elevational view of the vulnerable tissue
site of FIG. 3A having the containment member disposed about its
exterior surface.
[0024] FIG. 4A is a side elevational view of an embodiment of the
containment member of FIG. 2 including apertures.
[0025] FIG. 4B is a transverse cross-sectional view of the
containment member of FIG. 4A taken along lines 4B-4B.
[0026] FIG. 4C is a transverse cross-sectional view of the
containment member of FIG. 4A taken along lines 4C-4C.
[0027] FIG. 5A is another embodiment of a containment member
embodying features of the present invention and having a plurality
of strands and having a circular cross section.
[0028] FIG. 5B is another embodiment of a containment member
embodying features of the present invention and having a plurality
of strands having a flat cross section.
[0029] FIGS. 6A-6C are transverse cross sectional views of
containment members embodying features of the present invention and
having different cross-sectional shapes.
[0030] FIG. 7 is an elevational view of another embodiment of a
containment member having a double helix configuration.
[0031] FIG. 8 is an elevational view of a an omega shaped
containment member.
[0032] FIG. 9 is an elevation view of another embodiment of a
containment member including longitudinal strands with transverse
connecting member.
[0033] FIG. 10 is an elevational view of a containment member
including two sheets disposed around the exterior surface of a
strand.
[0034] FIG. 10A is a cross sectional view of the containment member
of FIG. 10 taken along lines 10A-10A.
[0035] FIGS. 11A and 11B are side elevational views of the
containment member of FIG. 10 in a disposed configuration.
[0036] FIG. 11C is a side elevational view of the containment
member of FIG. 10 disposed around the exterior surface of a body
lumen with the edges of the containment member being longitudinally
set apart.
[0037] FIG. 12 is an elevational view of another embodiment of a
containment member including a plurality of strands disposed
substantially parallel to one another and sealed between two
sheets.
[0038] FIG. 13. is an elevational view of another embodiment of the
containment member of FIG. 12 including an inflation pocket defined
between the two sheets.
[0039] FIGS. 14, 15A and 15B are side elevational views of
containment members including sheets disposed about longitudinal
strands and further including transverse connecting member, the
longitudinal strands having solid or hollow cross-sections.
[0040] FIGS. 16-18 are side elevational views of different
embodiments of transverse connecting.
[0041] FIG. 19 is a side elevational view of a containment member
having a fluid pocket.
[0042] FIG. 20 is a cross sectional view of the containment member
of FIG. 19 taken along line 20-20 with the strand being hollow.
[0043] FIG. 21 is a cross sectional view of the containment member
of FIG. 19 taken along line 21-21 with the strand being solid.
[0044] FIG. 22A is a top elevational view of a containment member
disposed on an exterior surface a vulnerable tissue site being
secured to a body tissue mass.
[0045] FIG. 22B is a side elevational view of the tissue site of
FIG. 22A showing the reduction in size of the tissue site at
different time or phase intervals.
[0046] FIG. 22C is a front elevational view of a region of a
vulnerable tissue site, with a containment member having a
containment surface of sufficient dimensions to at least partially
encircle the region of vulnerable tissue, the containment member
being secured to adjacent healthy tissue by positioning member such
as a suture.
[0047] FIG. 22D is a front elevational view of a region of a
vulnerable tissue site, with a containment member having a
containment surface of sufficient dimensions to at least partially
encircle the region of vulnerable tissue and being in substantial
contact with the vulnerable tissue site, the containment member
being secured to adjacent healthy tissue by positioning member such
as a suture.
[0048] FIG. 22E is a front elevational view of a region of a
vulnerable tissue site, with a containment member having a
containment surface of sufficient dimensions to at least partially
encircle the region of vulnerable tissue, the containment member
being secured to adjacent healthy body part by positioning member
such as a strut.
[0049] FIG. 22F is a front elevational view of a region of a
vulnerable tissue site, with a containment member having a
containment surface of sufficient dimensions to at least partially
encircle the region of vulnerable tissue and being in substantial
contact with the vulnerable tissue site, the containment member
being secured to adjacent healthy body part by positioning member
such as a strut.
[0050] FIG. 23 is a side elevational view of a vulnerable tissue
site showing the various access locations.
[0051] FIGS. 24-29 are schematic side elevational views of the
steps of a surgical method of the present invention disposing a
containment member about the exterior surface of a first body lumen
including the vulnerable tissue site.
[0052] FIGS. 30-35 are schematic side elevational views of the
steps of another surgical method disposing a containment member
about the exterior surface of the first body lumen including the
vulnerable tissue site and a second body lumen substantially
parallel and adjacent the first body lumen.
[0053] FIGS. 36-43 are schematic side elevational views of the
steps of another surgical method disposing a containment member
about the exterior surface of the first body lumen which includes
peripheral branches.
[0054] FIGS. 44-47 are schematic side elevational views of the
steps of an intra-endoscopic method introducing a containment
member through an inner lumen of the first body lumen and being
disposed about the exterior surface of the first body lumen.
[0055] FIGS. 48-53 are schematic side elevational views of the
steps of an inter-endoscopic method introducing a containment
member through an inner lumen of the second body lumen and being
disposed about the exterior surface of the first body lumen.
[0056] FIGS. 54-59 are schematic side elevational views of the
steps of another intra-endoscopic method introducing a containment
member through an inner lumen of the first body lumen and being
disposed about the exterior surface of the first and second body
lumens.
[0057] FIGS. 60-62 are schematic side elevational views of the
steps of another intra-endoscopic method introducing a containment
member through an inner lumen of the first body lumen and being
disposed about the exterior surface of the first and second body
lumens and further including an elongate glide for securing the
containment member to the tissue site.
[0058] FIGS. 63-65 are schematic side elevational views of the
containment members embodying features of the present invention and
disposed about the outer surface of host body such as an organ,
showing the reduction in size of the organ at the vulnerable tissue
site, immediately, over time, or at phase intervals.
[0059] FIGS. 66A-66C are side elevational views of the containment
members embodying features of the present invention used in
combination with a stent graft.
[0060] FIGS. 67A-67C are side elevational views of the containment
members embodying features of the present invention used in
combination with a stent graft with the two ends of the containment
member defining a neck and extending onto the adjacent healthy
tissue site.
DETAILED DESCRIPTION OF THE INVENTION
[0061] FIGS. 1 and 2 illustrate containment members 10 and 10A
embodying features of the invention, generally including a strand
13, preferably having atraumatic proximal and distal tips, 16 and
19. The containment member 10, preferably, is wound in a helical
configuration as generally depicted as 10A in FIG. 2. The
containment member 10 forms, as in containment member 10A of FIG.
2, or, can be shaped to form, a tubular body 25 having open
proximal and distal ends, 28 and 31, respectively, with a
containment lumen 34 extending longitudinally therebetween, and
defining an interior surface 37.
[0062] Upon disposing of the containment member 10 about a
vulnerable tissue site 40, such as that shown in FIGS. 3A and 3B,
the interior surface 37 of the containment member 10 comes into
contact, at least in part, with an exterior surface 43 of the
vulnerable tissue site 40, thus containing, at least in part, the
vulnerable tissue site. In one embodiment, in the disposed
configuration, the containment member 10 can apply resistive force
to the tissue site, aiding in the minimizing the further
vulnerability of the vulnerable tissue site. The containment member
10 can also apply a compressive force against the exterior of the
vulnerable tissue. The strand 13 may be formed of any suitable
material such as polymeric or metallic materials, including
thermoplastic and thermosets; stainless steel, nickel titanium
alloys such as Nitinol, and precipitation hardenable material. The
precipitation hardenable material, preferably, is formed of at
least two material selected from the group consisting of nickel,
cobalt, molybdenum, chromium, tungsten, and iron; and a combination
thereof.
[0063] Specific example of such precipitation hardenable material
include, but are not limited to, AISI (American Iron and Steel
Institute) Type 600 series precipitation hardenable stainless
steel; chromium-nickel based single stage martensitic precipitation
hardenable stainless steel having modified proportions of chromium
and nickel and with additional elements of copper and titanium,
commercially available from Carpenter Steel Company of Reading,
Pa., under the designation 455PH or 17-7PH; and a precipitation
hardenable steel available under the trade designation 1RK91 from
Sweden Steel. Other suitable precipitation hardenable stainless
steel include those which are essentially "nickel free" such as
those sold under the designation BioDur 108, available from
Carpenter's Specialty Alloys Operations, Reading, Pa. By way of
example, the nominal composition of BioDur is chromium (21%),
manganese (23%), nitrogen (1%), nickel (less than 0.3%), and iron
(balance).
[0064] Other suitable precipitation hardenable material include
cobalt based alloys such as those including nickel, cobalt,
molybdenum and chromium, also commercially available under the
designation MP35N (UNS (Unified Numbering System) R30035) available
from Carpenter Steel Co. Also useful in the practice of the
invention is a similar alloy that contains a small amount of iron
(less than about 10%) and is commercially available under the trade
designation Elgiloy (UNS R30003) and L605 from Haynes International
of Kokomo, In.
[0065] Alternatively, the strand 13 may be formed of biodegradable
material, preferably degrading over a period of time, as for
example few days to years, preferably within 1 to 10 months. The
biodegradable material may be formed from any suitable
bio-compatible material such as, but not limited to: enzymatically
degradable polymers including polypeptices such as collagens,
gelatin, poly(amino acids); polysaccharides such as amylose
cellulose, dextran, chitin; polyesters such as
poly(.beta.-hydroxyalkanoates), pHB (poly .beta.-hydroxybutyrate)-
; and nucleic Acids; or nonenzymatically degradable polymers,
including, polyesters such as aliphatic polyesters, as for example,
PLA (polylactic acid), PGA (polyglycolic acid), co-polymer of
PLA/PGA; poly(ester-ethers) such as PEG (poly(ethylene glycol));
poly caprolactones; and poly (amideesters).
[0066] As defined herein, vulnerable tissue site refers to any
tissue site which is or can be weakened, enlarged, thickened, or
thinned, either permanently or periodically (as for example during
different phases, cycles, or conditions). The vulnerable tissue may
be present in any area of a host body, such as but not limited to:
cardiovascular or neurovascular arteries and veins, aorta including
abdominal and thoracic, vena cava including inferior and superior,
organs such as stomach or glands, and vein grafts.
[0067] The containment member 10 and other embodiments of the same,
will be further discussed in reference to the figures below,
wherein like reference represent like elements.
[0068] Optionally, and as shown in FIG. 2, the containment member
10, can, optionally, include, one or more connecting bodies 46, for
connecting adjacent turns 49 and 52 of the containment member.
[0069] The containment member 10 for aortic aneurysms, preferably,
has a disposed inner diameter ranging from about 0.25 to about 4
inches, more preferably, from about 0.75 to about 2.5 inches; with
a disposed outer diameter ranging from about 0.27 to about 5
inches, more preferably, from about 0.77 to about 2.6 inches; and a
disposed length ranging from about 1 to about 30 cm (with a
straight length ranging from about 1 to about 50 cm), more
preferably, from about 5 to about 20 cm. However, the containment
member 10 inner and outer diameters and length may vary in size
from those stated above for other applications and size of the
vulnerable tissue site on which the containment member 10 is to be
disposed.
[0070] For example, the containment member in a disposed but
unstrained (or relaxed) condition can have an inner diameter
substantially the same or slightly larger than a first thickness
(outer diameter of the tissue site) of the vulnerable tissue site;
substantially larger than the thickness of the vulnerable tissue
site; about 25% larger than the thickness of the vulnerable tissue
site; substantially between the first thickness of the vulnerable
tissue site and second thickness of a healthy tissue site adjacent
the vulnerable tissue site; substantially the same as the second
thickness of the adjacent tissue site; or slightly smaller, for
example 10% smaller than the second thickness of the adjacent
tissue site. Adjacent tissue site, as used herein, refers to a
tissue site which is adjacent the vulnerable tissue site and is
substantially healthy, or adjacent body part, including but not
limiting to tissue sites, bones, organs, etc.
[0071] The containment member 10A, preferably, has a pitch
(distance between adjacent turns), ranging from about 0.01 to about
3 inches, more preferably, from about 0.04 to about 1 inch.
[0072] In an embodiment features of which are shown in FIGS. 4A
through 4C, the containment member 10B is formed of a hollow strand
13B having a strand lumen 34 extending therein, and further
including one or more apertures 58 extending between the lumen 34
and an strand outer surface 61. The strand lumen 34, and the
apertures 58 when present, are configured to deliver fluids, such
as therapeutic fluids, to and/or from the vulnerable tissue 40.
Optionally, the apertures 58 may be used to deliver a hardenable
material, including bio-degradable and permanent materials,
preferably, bio-degradable over time (such as those described above
in reference to strand material) to the outer surface of the
vulnerable tissue site. In yet another embodiment, the hardenable
material may be delivered to the exterior surface of the vulnerable
tissue site by another delivery device, such as a catheter. It
should be appreciated that the delivery of the hardenable material
can occur, after, concurrently with, or prior to the placement of
the containment member on the vulnerable tissue site. In yet
another embodiment, the hardenable material itself can be the
containment member left in place permanently, or degradable over
time. In this embodiment, the containment member can take any
suitable shape necessary for at least partially containing the
vulnerable tissue site.
[0073] Now referring to FIGS. 5 through 6, the containment member
10, is generally shown in 10C and 10D respectively and includes a
plurality of strands 13, 5A in-phase and 5B out of phase, having
varying cross sections, as for example, substantially circular as
shown in FIG. 6A, substantially flat as in FIG. 6B, substantially
triangular as in FIG. 6C, or other shapes as dictated by a
particular application or anatomy.
[0074] In another embodiment shown in FIG. 7, the containment
member 10E includes a multiple helix configuration having two
counter helix strands 13E and 13F. The strands 13E and 13F can have
identical or differing diameters (inner and/or outer). The counter
helix strands 13E and 13F forming the double helix containment
member 10E can interlock by alternating inner and outer positions
as shown in FIG. 7. Optionally, the proximal and distal ends of the
counter helix strands 13E and 13F, or portions along their length,
can be joined by suitable means, such as connecting member 46 as
shown in FIG. 7, and means in the form of a ring 70 as shown in
FIG. 8.
[0075] Also, the embodiment shown in FIG. 8, can be a containment
member having a omega shape for containing vulnerable tissue sites,
such as those attached to other tissue and or organs such as bones.
One or more omega shaped containment members loops, at least
partially, around the vulnerable tissue site, thus containing the
site. The legs of the containment member can be affixed or secured
to the vulnerable tissue site, or an adjacent structure such as a
bone, with adhesive, staples suture, or strand; or when multiple
containment members are used, each leg can be connected to a leg of
another containment member.
[0076] Now referring to FIG. 9, the containment member 10G includes
a plurality of longitudinal strands 13 transversely set apart, with
transverse connecting member 76 disposed about the inner or outer
surface of the longitudinal strands 13 securing the relative
position of the longitudinal strands 13. The transverse connecting
member 76 may be only secured to the corresponding underlying
longitudinal strands 13, or they may be additionally linked to one
another through linking member 79. Transverse connecting member 76
and linking member 79 can, independently, be made of any suitable
material such as those described above with reference to the strand
13.
[0077] Now referring to FIGS. 10 through 16, containment members of
the present invention described above may further include one or
more sheets disposed around the exterior surface of one or more
strands.
[0078] In the embodiment shown in FIGS. 10 and 10A, an enlarged
section of a containment member 10H is shown having a strand 13
sealingly disposed between two sheets or strips of film or mesh 82.
Optionally, the exterior surface of one or more of the strips of
film, or any strand or containment member, can include a securing
material such as a adhesion promoting material or time-release
adhesive, such as fibrin or cyanoacrylate, to aid in securing the
containment member 10H to the outer surface 43 of the vulnerable
tissue 40. As shown in FIGS. 11A through 11C, after the containment
member 10H is disposed about the vulnerable tissue, per the method
described below, the containment member 10H forms, preferably, a
helical configuration with the edges of the attached films 82
overlapping, to form a tubular structure 25A. When only one of the
films includes the securing material, the containment member 10H
is, preferably, disposed about the exterior of the vulnerable
tissue site 40 such that the side having the securing material
comes into contact, at least in part, with the outer surface 43 of
the vulnerable tissue site 40. Alternatively, and as shown in FIG.
11C the edges of the containment member 10H may be longitudinally
set apart by a gap 85.
[0079] In an alternate embodiment, an enlarged section of a
containment member 10J prior to being disposed about the vulnerable
tissue is shown in FIG. 12. A plurality of strands 13 of the
containment member 10J are disposed substantially parallel to one
another and are sealed between two sheets or strips of film or mesh
82, as described above in relation to FIG. 10. Alternatively, as
shown in FIG. 13, in containment member 10K, the two films 82
together define an inflation pocket 88 sealingly and fluidically
connectable to a source of inflation fluid. Once the containment
member 10K has been disposed about the vulnerable tissue site 40,
the inflation pocket 88 can be used to inflate, with a fluid
(liquid or gas), the containment member 10K thus exerting pressure
on the vulnerable tissue site 40.
[0080] In another embodiment shown in FIGS. 14, 15A and 15B, an
enlarged section of a containment member 10L is shown having
longitudinal strands 13 disposed between two sheets or strips of
film or mesh 82, with transverse connecting member 76 disposed on
the outer or the inner sheets or therebetween. The longitudinal
strands 13 may be solid or hollow (or have closed proximal and
distal ends), as shown in FIGS. 15A and 15B, respectively.
[0081] In another embodiment of a containment member 10M shown in
FIG. 16, transverse connecting member 90 includes a generally
annular body 93 with averted ends 96 which may be used to secure
the transverse connecting member 90 about the longitudinal strand
13. As shown in FIG. 16, the two averted ends 96 may be secured in
place on either side of the longitudinal strand 13 in rings 99
located on an outer surface of the outer sheet 82. Alternatively,
and as shown in FIG. 17, ends 96 of transverse connecting member
90A may hold sutures or other means for connecting the containment
member to other containment members or tissue site. Alternatively,
the member shown in FIG. 17 can itself be a containment member to
be disposed about the vulnerable tissue site individually or in
multiples (as discussed in reference to FIG. 8). In this
embodiment, the containment member can be held in place by suitable
means such as sutures In yet another embodiment as depicted in FIG.
18, transverse connecting member 90B can include a substantially
longitudinal portion 102 with a plurality of encircling portions
105 for encircling the longitudinal strands.
[0082] In another embodiment features of which are shown in FIGS.
19-21, containment member 10N includes a fluid pocket 108 defined
between the outer surface of strand 13 and inner surface of sheath
82. The fluid pocket 108 is fluidically connectable to a source of
therapeutic fluid for delivering the fluid to the vulnerable tissue
and/or the surrounding tissue sites through sheath apertures 111.
The strand 13 may be hollow as shown in FIG. 20 or solid as shown
in FIG. 21.
[0083] Now referring to FIGS. 22A and B, features of a containment
member 10P are shown containing a vulnerable tissue site 40A which
is located on a body site 115 secured to body tissue mass. The
containment member 10P includes strands 13 and is disposed about
less than the circumference of the vulnerable tissue site 40A. The
containment member 10P is secured to the vulnerable tissue site 40A
or adjacent tissue site by sutures 118 or other suitable securing
means. As shown in FIG. 22B, the containment member 10P may be used
to apply pressure onto the vulnerable tissue site 40A, thereby
reducing its size as it is reduced from 40A to 40B to 40C.
[0084] Now referring to FIGS. 22C-D and 22E-F, the containment
member 10R can have a containment member surface 37A of sufficient
dimensions to at least partially encircle at least a region 121 of
the vulnerable tissue 40. The containment member 10R is configured
for attachment to a positioning member, such as 125A in the form of
a suture or C ring, or 125B in the form of a strut. The containment
members may be positioned to simply act as a means to minimize
future vulnerability of the site (i.e., initially there is not
substantial contact between the vulnerable tissue and the
containment member), as for example depicted in FIGS. 22C & E;
or to apply force against the vulnerable tissue (FIGS. 22D and F).
As can be noted from the features of the embodiment shown in FIG.
22F, the containment member can be biased against adjacent healthy
tissue site or body part (including bones).
[0085] In operation, the containment members of the present
invention may be introduced to the vulnerable tissue site in one of
several ways, including: (1) surgical methods, such as cut-down or
laparoscopically; (2) intra-endoscopically, i.e., through the same
body conduit or lumen as the one including the vulnerable tissue;
and (3) inter-endoscopically, i.e., through, at least in part, a
body conduit or lumen adjacent the conduit which has the vulnerable
tissue.
[0086] By way of example, and not as a limitation, in describing
the method of the present invention, only a subset of the various
embodiments of the containment members of the present invention may
be used. It should be appreciated by those skilled in the art that
the more conventional steps of the method may not be individually
described hereinafter.
[0087] Now referring to FIG. 23 in a surgical method (cut-down or
laparoscopically), an access site for accessing the vulnerable
tissue site may be above or below the vulnerable tissue site 40, as
for example, directly above or below, or proximal or distal to the
site, as indicated by 150, 153, 156 and 159, respectively.
[0088] FIGS. 24-29 schematically depict a procedure whereby a
containment member 10R, under imaging guidance; such as
fluoroscopic techniques, ultrasound (e.g. catheter-based on
external), angioscope, direct visualization, MRI, (including
catheter-based and external), and CT scan; is disposed about the
exterior surface of an vulnerable tissue site 40D of a patient
included in a first body lumen 167. The containment member 10R is
introduced over the surface of the aneurysm by percutaneous means
through a lumen 170 of a catheter 173 through an access site 176,
the containment member 10R and the catheter 173 together forming a
delivery system 180. The catheter may be in the form of a hypotube
or tubular member. A distal end of the catheter may include a
curve, or may form a curve on demand. The catheter can be formed of
any conventional material for forming such devices. The distal end
183 of catheter 173 is advanced to a location, distal or proximal,
to the aneurysm 10R. Using a suitable mechanism such as a pusher
rod, the containment member 10R is then advanced within the inner
lumen 170 of the catheter 173, preferably, the catheter having a
detachment mechanism 186 disposed at the catheter distal end 183
(FIG. 28). The detachment mechanism 186 is detachably secured to a
proximal end 189 of the containment member 10R which allows
proximal manipulation of the delivery system 180 to control axial
advancement and retraction containment member 10R within the
catheter 173 and the patient. The containment member 10R is then
distally advanced out of a port 190 in the distal end 183 of the
catheter 173 along the exterior surface of a body site which
includes the vulnerable tissue 40, so as to contain at least a
portion of the length of the vulnerable tissue 40. When the
containment member 10R is appropriately positioned, the containment
member 10R is detached from the delivery system 180 and is left in
place and the catheter 173 is withdrawn from the body. The catheter
173 catheter can have multiple lumens (e.g. separate lumens for
receiving the guidewire, containment member, light or visualization
means, and drug delivery lumen). The catheter can also be inserted
through a guiding catheter or sleeve having a pre-set shape at it
is distal end according to the anatomy to be treated. Furthermore,
the catheter can be a fixed wire type, over the wire type, or rapid
exchange type.
[0089] It should be appreciated that the containment member 10R may
be advanced onto the exterior surface of the aneurysm in an
ascending direction, as shown in the figures, or in a descending
direction, depending on the location of the introduction of the
catheter; from above or below the site.
[0090] Examples of suitable detachment mechanisms include polymeric
links susceptible to chain cleavage upon degradation of the polymer
link, mechanical detachment, electrolytic detachment, shape memory
metal or polymer activation via a temperature change by application
of RF energy, laser energy, ultrasonic energy, heating of a hot
melt adhesive joint, ultrasonic joint degradation, hydrokinetic
activation of a mechanical retaining device, and the like. Various
detachment mechanisms known in the art are discussed in U.S. Pat.
Nos. 5,722,989, J. Fitch et al., U.S. Pat. No. 5,108,407, G.
Geremia et al., U.S. Pat. No. 5,217,484, M. Marks, and U.S. Pat.
No. 5,423,829, P. Pham, which are hereby incorporated by
reference.
[0091] Alternatively, and as shown in FIGS. 30-35, the containment
member 10R may be disposed about both the first body lumen 168
including the vulnerable tissue 40D and a second body lumen 193
substantially parallel to or adjacent the first body lumen. In
FIGS. 30-35, the containment member 10R is laparoscopically
introduced through the access site 176 and is advanced and disposed
about, at least in part, both the esophagus as the second body
lumen and the vulnerable tissue site 40D (e.g. aneurysm) located in
the aorta as the first body lumen.
[0092] Often, the vulnerable tissue 40D, may be located in a part
of the body which includes peripheral branches, as for example,
peripheral branches of aorta. FIGS. 36-43 show the steps associated
with disposing the containment member 10R about the exterior
surface of the first body lumen 167 which includes peripheral
branches 196. In the practice of this method, it is particularly
useful, to use a helical containment member 10A similar to that
previously shown in FIG. 2 (or one or more omega shaped containment
members such as that shown in FIG. 8). The helical configuration of
the containment member allows the advancement of the containment
member along the exterior surface of the length of the first body
lumen without being impeded by the peripheral branches. As shown in
the figures, the containment member may optionally be secured in
place by the use of a suitable device 200 to tie or tighten the
coils with suture 118 or other means. Alternatively, when the
containment member is formed from a shape-memory material, such as
Nitinol, the containment member may be secured in place by the
application of heat or energy, thus, transforming its size and
dimensions. The containment member can be pre-shaped to the desired
configuration (in the disposed configuration) and constrained to a
secondary shape by the catheter such that upon release (e.g.,
disposing about the vulnerable tissue site) the containment member
assumes the desired disposed shape.
[0093] Now referring to FIGS. 44-47 in a intra-endoscopic method,
the catheter 173 is introduced through an inner lumen 203 of a
first body lumen 167 which includes the vulnerable tissue 40D, from
a location proximal or distal (above or below) to the vulnerable
tissue. Similar to the surgical method, the catheter 173 is
advanced along the interior lumen 203 of the first body lumen 167
to an access point 210 being proximal or distal to the vulnerable
tissue 40D, at which point the catheter 173 is advanced through
wall 213 of the first body lumen 167 and unto the exterior surface
of the first body lumen (or body site). The containment member is
then advanced onto the vulnerable tissue similar to the surgical
method described above.
[0094] Now referring to FIGS. 48-53 in a inter-endoscopic method,
the catheter 173 is introduced through an inner lumen 370 of the
second body lumen 193 extending either or both substantially
parallel, at least in part, and adjacent, at least in part, to the
first body lumen 137 which includes the vulnerable tissue 4D. The
catheter 173 is then advanced through access site 219 located in a
wall of the second body lumen and unto the exterior surface of the
first body lumen (or body site). The containment member 10R is then
advanced onto the vulnerable tissue similar to the surgical method
described above.
[0095] The inter-endoscopic method is particularly useful when a
relatively easily accessible second body lumen lies substantially
parallel or adjacent to the first body lumen having the vulnerable
tissue. For example when the aneurysm is located is in the thoracic
cavity, the esophagus can be a suitable second lumen for accessing
the aneurysm located in the thoracic aorta.
[0096] Alternatively, and as depicted in FIGS. 54-59, in the
operation of the inter-endoscopic method, the containment member
10R may be disposed, at least in part, along the exterior surface
of both the first and the second body lumens, 167 and 193, once it
exits the wall of the second body lumen.
[0097] In yet another embodiment, shown in FIGS. 60-62, the
catheter 173 may be equipped to deliver an elongate glide 221 used
to secure the containment member 10R along the exterior surface of
the first body lumen 167. The glide 221, includes loops 224 along
its length. Once advanced out of the catheter 173, the glide 2210
is secured to the first body lumen at various points along its
length. The containment member 10R as it is being advanced along
the exterior surface of the length of the vulnerable tissue, is
looped through the glide loops 224, thus, becoming secure in place.
For example, sutures can be passed through one or more of the glide
loops to secure the glide to the first body lumen. Alternatively,
the containment member 10R may be secured to the exterior surface
of the vulnerable tissue site by other suitable means, such as
adhesives.
[0098] Now referring to FIGS. 63-65, when the vulnerable tissue 40
is on a body site such as an organ, containment member 10S can be
advanced by way of any one of the methods described above and
disposed on the exterior surface of the organ. In operation, one or
more individual containment members may be disposed on the organ in
the same or differing orientations, as shown in the FIGS. 63-65.
The containment member may only act to contain the vulnerable
tissue site minimizing its further growth or it may apply pressure
or compressive force on the vulnerable tissue site 40 tissue
thereby reducing its size, as depicted in FIGS. 63, 64A and 64B;
and or 65A, 65B, and 65C.
[0099] As shown in FIGS. 66 through 67, the containment members of
the present invention can be used in conjunction with a stent/graft
230. In the embodiment shown in FIGS. 66B and 66C, the containment
member 10T is shown enclosing longitudinally, at least in part, the
vulnerable tissue 40. The containment member may only contain the
vulnerable tissue site or it may act to reduce its size,
immediately or over time, as shown in FIG. 66C. Alternatively, as
shown in FIG. 67A, there may not be a well defined neck (such as
238 in FIG. 66A) on either or both sides of the vulnerable tissue
site for having the stent/graft abutting against. In this
configuration, as shown in FIGS. 67B and 67C, either or both the
proximal and distal ends of the containment member 10V can extend
to cover healthy tissue 235 (i.e., not-vulnerable tissue) on either
or both sides of the vulnerable tissue 40 or compress vulnerable
tissue to define a neck, whereby, the compression of the
containment member 10V onto the vulnerable tissue site aids in
creation of a neck 242 thereby aiding in the securing of the of the
stent/graft 230 within the body lumen of the aneurysm. It should be
noted that the containment members, may contain the vulnerable
tissue site 40 with or without application of pressure to the
site.
[0100] While 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. Accordingly, it is not intended that the
invention be limited.
* * * * *