U.S. patent application number 12/478331 was filed with the patent office on 2010-02-25 for controlled deployable medical device and method of making the same.
Invention is credited to Edward H. Cully, Keith M. Flury, Michelle L. Gendron, Stanislaw L. Zukowski.
Application Number | 20100049294 12/478331 |
Document ID | / |
Family ID | 40983305 |
Filed Date | 2010-02-25 |
United States Patent
Application |
20100049294 |
Kind Code |
A1 |
Zukowski; Stanislaw L. ; et
al. |
February 25, 2010 |
Controlled deployable medical device and method of making the
same
Abstract
Controlled deployable medical devices that are retained inside a
body passage and in one particular application to vascular devices
used in repairing arterial dilations, e.g., aneurysms. Such devices
can be adjusted during deployment, thereby allowing at least one of
a longitudinal or radial re-positioning, resulting in precise
alignment of the device to an implant target site.
Inventors: |
Zukowski; Stanislaw L.;
(Flagstaff, AZ) ; Cully; Edward H.; (Flagstaff,
AZ) ; Flury; Keith M.; (Flagstaff, AZ) ;
Gendron; Michelle L.; (Flagstaff, AZ) |
Correspondence
Address: |
GORE ENTERPRISE HOLDINGS, INC.
551 PAPER MILL ROAD, P. O. BOX 9206
NEWARK
DE
19714-9206
US
|
Family ID: |
40983305 |
Appl. No.: |
12/478331 |
Filed: |
June 4, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61058776 |
Jun 4, 2008 |
|
|
|
Current U.S.
Class: |
623/1.11 |
Current CPC
Class: |
A61F 2/07 20130101; A61F
2002/9505 20130101; A61F 2002/9534 20130101; A61F 2/954 20130101;
A61F 2002/9511 20130101; A61F 2002/065 20130101 |
Class at
Publication: |
623/1.11 |
International
Class: |
A61F 2/84 20060101
A61F002/84 |
Claims
1. An apparatus, comprising: a catheter having a proximal end
portion and distal end portion; a stent member arranged on the
proximal end portion of the catheter, the stent member has an inner
surface and an outer surface; a tube extending from the catheter
proximal end portion to the distal end portion; and at least one
movable element having a first end and second end in communication
with the stent member, wherein the first and second end of the
movable element are capable of extending out a distal end portion
of the tube and is capable of radially compressing at least a
portion of the stent member.
2. The apparatus of claim 1, further comprising: a second movable
element in communication with the movable element, wherein the
second movable element surrounds the stent member and the movable
element is looped over the second movable element.
3. The apparatus of claim 1, wherein distal end portion of the tube
comprises a twisted configuration.
4. The apparatus of claim 1, wherein the tube comprises two
lumens.
5. The apparatus of claim 1, wherein the first movable element
comprises a filament.
6. The apparatus of claim 5, wherein the filament comprises a
polymer.
7. The apparatus of claim 1, wherein a graft member is arranged
about the stent member.
8. An apparatus, comprising: a catheter having a proximal end
portion and distal end portion; a stent member arranged on the
proximal end portion of the catheter, wherein the stent member has
an inner surface and an outer surface; a tube having a continuous
lumen, the tube extending from the catheter proximal end portion to
the distal end portion; and a release pin contained within the tube
lumen and extending from the catheter proximal end portion to the
distal end portion.
9. The apparatus of claim 8, further comprising: a first movable
element at least a portion of which is contained within the tube
lumen.
10. The apparatus of claim 9, further comprising: a second movable
element releasably attached to the first movable element.
11. The apparatus of claim 10, wherein at least a portion of the
second movable element is contained within the tube lumen.
12. The apparatus of claim 10, wherein the second movable element
is released from the first movable element by translating the
release pin in a distal direction.
13. The apparatus of claim 10, wherein the second movable element
is capable of radially compressing the stent member.
14. The apparatus of claim 8, wherein a graft member is arranged
about the stent member.
15. An apparatus, comprising: a catheter having a proximal end
portion and distal end portion; a stent member arranged on the
proximal end portion of the catheter, wherein the stent member has
an inner surface and an outer surface; a first sheath material
covering at least a portion of the stent member, wherein the first
sheath material is capable of holding the stent member at a first
diameter; and a second sheath material covering at least a portion
of the stent member, wherein the second sheath material is capable
of holding the stent member at a second diameter, wherein the
second diameter is greater than the first diameter.
16. The apparatus of claim 15, further comprising a tube extending
from the catheter proximal end portion to the distal end
portion.
17. The apparatus of claim 16, wherein the distal end portion of
the tube comprises a twisted configuration.
18. The apparatus of claim 16, wherein the tube comprises two
lumens.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to provisional application
Ser. No. 61/058,776, filed Jun. 4, 2008.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The invention relates generally to devices that are retained
inside a body passage and in one particular application to vascular
devices used in repairing arterial dilations, e.g., aneurysms. More
particularly, the invention is directed toward devices that can be
adjusted during deployment, thereby allowing at least one of a
longitudinal or radial re-positioning of the device prior to final
placement of the device.
[0004] 2. Discussion of the Related Art
[0005] The invention will be discussed generally with respect to
deployment of a bifurcated stent graft into the abdominal aorta but
is not so limited and may apply to device deployment into other
body lumens. When delivering a stent graft by intraluminal or
endovascular methods, it is important to know the precise location
of the device in the vasculature. Controlling this precise location
is particularly important when the device is intended to be
deployed in close proximity to branch vessels or adjacent to
weakened portions of the aortic wall. Typical stent grafts used to
repair an aortic aneurysm incorporate a proximal (i.e. portion of
the stent graft closest to the heart) anchoring system intended to
limit longitudinal displacement of the stent graft. Often this
anchoring system must be precisely placed to avoid occlusion of a
branch vessel or to avoid placement within a compromised and
damaged portion of the aortic wall.
[0006] An improved delivery system for such stent grafts would
include a means for allowing precise longitudinal and rotational
placement of the stent graft and anchoring system. The precise
position of the stent graft and anchoring system would be adjusted
and visualized prior to full deployment of the device. Ideally the
delivery system would allow the device to be repositioned if the
prior deployment position was undesirable.
SUMMARY OF THE INVENTION
[0007] The present invention is directed to a controlled deployable
medical device and method of making the same that substantially
obviates one or more of the problems due to limitations and
disadvantages of the related art.
[0008] A first embodiment of the present invention provides an
apparatus comprising a catheter having a proximal end portion and
distal end portion, a stent member arranged on the proximal end
portion of the catheter, the stent member has an inner surface and
an outer surface. A graft member can be arranged about at least a
portion of the stent member. Moreover, a tube extends from the
catheter proximal end portion to the distal end portion. A first
movable element, having a first and second end, is in communication
with the stent member, wherein the first and second end of the
first movable element are capable of extending out the distal end
portion of the tube and the first movable element is capable of
radially compressing at least a portion of the stent member.
[0009] In another embodiment, the present invention provides an
apparatus comprising a catheter having a proximal end portion and
distal end portion, a stent member arranged on the proximal end
portion of the catheter, the stent member has an inner surface, an
outer surface. A graft member can be arranged about at least a
portion of the stent member. Moreover, a tube having a continuous
lumen extends from the proximal end portion to a distal end portion
of the catheter. A release pin is contained within the tube lumen
and extends from the catheter proximal end portion to a distal end
portion of the catheter.
[0010] In another embodiment, the present invention provides an
apparatus comprising a catheter having a proximal end portion and
distal end portion. A stent member is arranged on the proximal end
portion of the catheter, the stent member has an inner surface and
an outer surface. A graft member can be arranged about at least a
portion of the stent member. A first sheath material covers at
least a portion of the stent member. The first sheath material is
capable of holding the stent member at a first dimension. A second
sheath material covers at least a portion of the stent member. The
second sheath material is capable of holding the stent member at a
second dimension, with the second dimension being greater than the
first dimension.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The accompanying drawings are included to provide a further
understanding of the invention and illustrate certain aspects of
the invention.
[0012] In the drawings:
[0013] FIG. 1A is a medical apparatus according to an embodiment of
the invention.
[0014] FIG. 1B is an enlarged simplified view of the medical
apparatus according to an embodiment of the invention.
[0015] FIG. 1C is a medical apparatus according to an embodiment of
the invention.
[0016] FIG. 1D is an enlarged simplified view of the medical
apparatus according to a second embodiment of the invention.
[0017] FIG. 2A is a medical apparatus according to an embodiment of
the invention.
[0018] FIG. 2B is an enlarged simplified view of a medical
apparatus according to an embodiment of the invention.
[0019] FIG. 2C is a medical apparatus according to an embodiment of
the invention.
[0020] FIG. 2D is an enlarged simplified view of a medical
apparatus according to an embodiment of the invention.
[0021] FIG. 3A is a medical apparatus according to an embodiment of
the invention.
[0022] FIG. 3B is an enlarged simplified view of a medical
apparatus according to an embodiment of the invention.
[0023] FIG. 3C is an enlarged simplified view of a medical
apparatus according to an embodiment of the invention.
[0024] FIG. 4A is a medical apparatus according to an embodiment of
the invention.
[0025] FIG. 4B is an enlarged simplified view of a medical
apparatus according to an embodiment of the invention.
[0026] FIG. 5A is a medical apparatus according to an embodiment of
the invention.
[0027] FIG. 5B is an enlarged simplified view of a medical
apparatus according to an embodiment of the invention.
[0028] FIG. 6A is a medical apparatus according to an embodiment of
the invention.
[0029] FIG. 6B is an enlarged simplified view of a medical
apparatus according to an embodiment of the invention.
[0030] FIG. 7A is a medical apparatus according to an embodiment of
the invention.
[0031] FIG. 7B is an enlarged simplified view of a medical
apparatus according to an embodiment of the invention.
[0032] FIGS. 8A-8C is a medical apparatus according to an
embodiment of the invention.
[0033] FIG. 9A is an apparatus according to an embodiment of the
invention.
[0034] FIG. 9B is a cross-sectional view of FIG. 9A along line A to
A'.
[0035] FIGS. 10A-10H illustrates a deployment procedure of an
apparatus according to FIGS. 2A-2B.
DETAILED DESCRIPTION
[0036] The invention relates generally to a novel medical apparatus
that includes a device capable of being retained inside a body
passage and in one particular application to vascular devices. More
particularly, the invention is directed toward devices that can be
adjusted during deployment, thereby allowing at least one of a
longitudinal or radial re-positioning of the device.
[0037] In an embodiment of the invention, the medical apparatus
includes a catheter assembly having a proximal end portion and
distal end portion. A hub can optionally be arranged on the distal
end portion of the catheter assembly. A stent is arranged on the
proximal end portion of the catheter. The stent has an inner
surface and an outer surface. The stent can be any suitable
configuration. In one embodiment, the stent is configured from
multiple turns of an undulating element. A graft member can be
arranged about at least a portion of the stent. The stent may be
self-expandable, balloon-expandable or a combination of
self-expandable and balloon-expandable.
[0038] A tube extends from the proximal end portion to the distal
end portion of the catheter. A first movable element, having a
first and second end, is arranged around the outer surface of the
stent. The first and second end of the first movable element are
capable of extending out the distal end portion of the tube and the
first movable element is capable of radially compressing at least a
portion of the stent.
[0039] Optionally, a second movable element can be in communication
with the first movable element, wherein the second movable element
is arranged around the outer surface of stent and the first movable
element is looped over the second movable element. A sheath
material can cover at least a portion of the stent, wherein the
sheath material is capable of holding the stent at a first
diameter. A filament can surround the stent and a pin can extend
from the tube and is capable of holding the filament surrounding
the stent at a second diameter which is greater than the first
diameter. The pin extending from the tube is capable of releasing
the filament surrounding the stent to a third diameter which is
greater than the second diameter.
[0040] In some embodiments, the stents can be used to at least fix
the medical apparatus inside a portion of patient's anatomy. The
stent can be constructed from materials that are flexible and
strong. The stent can be formed from, for example, degradable
bioabsorable materials, biodigestible materials, polymeric
materials, metallic materials and combinations thereof. In
addition, these materials may be reinforced and/or coated with
other materials, such as polymeric materials and the like. The
coating may be chosen to reduce acidic or basic effects of the
gastrointestinal tract, e.g., with a thermoplastic coating such as
ePTFE and the like.
[0041] The stents can be fabricated using any suitable methods and
materials. For example, stents can be fabricated according to the
teachings as generally disclosed in U.S. Pat. No. 6,042,605 issued
to Martin, et al., U.S. Pat. No. 6,361,637 issued to Martin, et al.
and U.S. Pat. No. 6,520,986 issued to Martin, et al. For example,
stents can have various configurations as known in the art and can
be fabricated, for example, from cut tubes, wound wires (or
ribbons), flat patterned sheets rolled into a tubular form,
combinations thereof, and the like. Stents can be formed from
metallic, polymeric or natural materials and can comprise
conventional medical grade materials such as nylon, polyacrylamide,
polycarbonate, polyethylene, polyformaldehyde,
polymethylmethacrylate, polypropylene, polytetrafluoroethylene,
polytrifluorochlorethylene, polyvinylchloride, polyurethane,
elastomeric organosilicone polymers; metals such as stainless
steels, cobalt-chromium alloys and nitinol and biologically derived
materials such as bovine arteries/veins, pericardium and collagen.
Stents can also comprise bioresorbable materials such as poly(amino
acids), poly(anhydrides), poly(caprolactones), poly(lactic/glycolic
acid) polymers, poly(hydroxybutyrates) and poly(orthoesters).
[0042] The stents can be formed into a variety of different
geometric configurations having constant and/or varied thickness as
known in the art. The geometric configurations may include many
conventional stent configurations such as a helically wrapped
stent, z-shape stent, tapered stent, coil stent, combinations
thereof, and the like. The stents can be formed in a variety of
patterns, such as, a helix pattern, ring pattern, combinations
thereof, and the like.
[0043] Grafts can have various configurations as known in the art
and can be fabricated, for example, from tubes, sheets or films
formed into tubular shapes, woven or knitted fibers or ribbons or
combinations thereof. Graft materials can include, for example,
conventional medical grade materials such as nylon, polyester,
polyethylene, polypropylene, polytetrafluoroethylene,
polyvinylchloride, polyurethane and elastomeric organosilicone
polymers.
[0044] Stents can be used alone or in combination with graft
materials. Stents can be configured on the external or internal
surface of a graft or may be incorporated into the internal wall
structure of a graft. Stent or stent grafts can be delivered
endoluminally by various catheter based procedures known in the
art. For example self-expanding endoluminal devices can be
compressed and maintained in a constrained state by an external
sheath. The sheath can be folded to form a tube positioned external
to the compressed device. The sheath edges can be sewn together
with a deployment cord that forms a "chain stitch". To release and
deploy the constrained device, one end of the deployment cord can
be pulled to disrupt the chain stitch, allowing the sheath edges to
separate and release the constrained device. Constraining sheaths
and deployment cord stitching can be configured to release a
self-expanding device in several ways. For example a constraining
sheath may release a device starting from the proximal device end,
terminating at the distal device end. In other configurations the
device may be released starting from the distal end. Self expanding
devices may also be released from the device center as the sheath
disrupts toward the device distal and proximal ends.
[0045] Details relating to constraining sheath materials, sheath
methods of manufacture and stent graft compression techniques can
be found in, for example, U.S. Pat. No. 6,352,561 issued to
Leopold, et al., and U.S. Pat. No. 6,551,350 issued to Thornton, et
al.
[0046] The catheter and hub assemblies can comprise conventional
medical grade materials such as nylon, polyacrylamide,
polycarbonate, polyethylene, polyformaldehyde,
polymethylmethacrylate, polypropylene, polytetrafluoroethylene,
polytrifluorochlorethylene, polyether block amide or thermoplastic
copolyether, polyvinylchloride, polyurethane, elastomeric
organosilicone polymers, and metals such as stainless steels and
nitinol.
[0047] Turning to the figures, FIG. 1A is a medical apparatus
according to an embodiment of the invention. FIG. 1B is an enlarged
simplified view of a portion of the medical apparatus shown in FIG.
1A.
[0048] Referring to FIGS. 1A and 1B, the medical apparatus is
generally depicted as reference numeral 100A. The medical apparatus
100A includes catheter assembly 102, stent 104 arranged on the
proximal end portion of the catheter assembly 102. The stent 104
has an inner surface, an outer surface, and in this embodiment is
configured from multiple turns of an undulating element 105. The
undulating element 105 can be configured, for example, in a ring or
helical pattern.
[0049] The stent 104 has a proximal end portion 106 and distal end
portion 108. The distal end portion 108 is formed into a branch
having a first leg 110 and a second leg 112.
[0050] A graft member 114 is arranged about the stent 104.
[0051] The stent 104 and graft member 114 are constrained into a
compacted delivery state by a first sheath 116 and second sheath
118. As shown in FIG. 1A, the first sheath 116 has been released,
allowing at least a portion of the stent 104 to expand as shown.
The second sheath 118 is coupling the second leg 112 to the
catheter assembly 102 as shown.
[0052] A tube 120 extends from a proximal end portion to a distal
end portion of the catheter assembly 102. In the figure, the tube
120 is positioned adjacent the outer surface of the stent 104 and
graft 114. The tube 120 is attached to the catheter assembly 102
and not attached to the stent 104 or graft 114. A movable element
122 (e.g., a fiber cord, string, wire, etc.) having a first end 124
and second end 126 surrounds the stent 104 and graft member 114.
The first end 124 and second end 126 of the movable element 122
extend out a distal end portion of the tube 120. For example, the
movable element 122 is threaded through the tube from a distal end
to a proximal end and is looped around the proximal end portion 106
of the stent 104 and graft member 114. As shown in FIG. 1B, by
pulling the first end 124 and the second end 126 in a distal
direction the movable element 122 is capable of radially
compressing at least a portion of the stent 104 as indicated by
arrows 128.
[0053] FIG. 1C is a medical apparatus according to an embodiment of
the invention. FIG. 1D is an enlarged simplified view of a portion
of the medical apparatus shown as FIG. 1C.
[0054] Referring to FIGS. 1C and 1D, the medical apparatus is
generally depicted as reference numeral 100B. The medical apparatus
of FIGS. 1C and 1D is similar to the medical apparatus as shown in
FIGS. 1A and 1B. The medical apparatus includes catheter assembly
102, stent 104 arranged on the proximal end portion of catheter
assembly 102. Stent 104 has an inner surface, an outer surface, and
is configured from multiple turns of an undulating element 105. The
undulating element 105 may be configured, for example, in a ring or
helical pattern.
[0055] The stent 104 has a proximal end portion 106 and distal end
portion 108. The distal end portion 108 is formed into a branch
having a first leg 110 and a second leg 112.
[0056] A graft member 114 is arranged about the stent 104.
[0057] The stent 104 and graft member 114 are constrained into a
compacted delivery state by a first sheath 116 and second sheath
118. As shown in FIG. 1C, the first sheath 116 has been released
allowing at least a portion of the stent to expand as shown. The
second sheath 118 is coupling the second leg 112 to the catheter
assembly 102 as shown.
[0058] A tube 120 extends from a proximal end portion to a distal
end portion of the catheter assembly 102. The tube 120 is
positioned adjacent the outer surface of the stent 104 and graft
114. The tube 120 is attached to the catheter assembly 102 and not
attached to the stent 104 or graft 114. A movable element 122A
having a first end 124 and second end 126 surrounds the stent 104
and graft member 114. The first end 124 and second end 126 of the
movable element 122A extend out a distal end portion of the tube
120. For example, the movable element 122A is threaded through the
tube from a distal end to a proximal end and is looped around the
proximal end portion 106 of the stent 104 and graft member 114.
[0059] Moreover, an additional movable element 122B having first
end 132 and second end 134 surrounds the stent 104 and graft member
114. The first end 132 and second end 134 of the additional movable
element 122B extend out a distal end portion of the tube 120. The
additional movable element 122B is threaded through the tube from a
distal end to an intermediate opening 136 in the tube 120 and is
looped around an intermediate portion of the stent 104 and graft
member 114. As shown in FIG. 1D, by pulling the ends of the
moveable elements in a distal direction the movable element 122A
and the additional movable element 122B are capable of radially
compressing at least a portion of the stent 104 as indicated by
arrows 128. It should be understood that additional moveable
elements can be provided.
[0060] FIG. 2A is a medical apparatus according to an embodiment of
the invention, shown in a partially deployed state. FIG. 2B is an
enlarged simplified view of a portion of the medical apparatus
shown in FIG. 2A.
[0061] Referring to FIGS. 2A and 2B, the medical apparatus is
generally depicted by reference numeral 200A. The medical apparatus
200A includes a catheter assembly 202, and stent 204 arranged on
the proximal end portion of the catheter assembly 202. The stent
204 has an inner surface, an outer surface, and is configured from
multiple turns of an undulating element 205. The undulating element
205 can be configured, for example, in a ring or helical
pattern.
[0062] The stent 204 has a proximal end portion 206 and distal end
portion 208. The distal end portion 208 is formed into a branch
having a first leg 210 and a second leg 212.
[0063] A graft member 214 is arranged about the stent 204.
[0064] The stent 204 and graft member 214 are constrained into a
compacted delivery state by a first sheath 216 and second sheath
218. As shown in FIG. 2A, the first sheath 216 has been released
allowing at least a portion of the stent to expand. The second
sheath 218 is coupling the second leg 212 to the catheter assembly
202 as shown.
[0065] A tube 220 extends from a proximal end portion to a distal
end portion of the catheter assembly 202. In this embodiment, the
tube 220 is positioned adjacent the outer surface of the stent 204
and graft 214. In this embodiment, the tube 220 is attached to the
catheter assembly 202 and not attached to the stent 204 or graft
214.
[0066] A second movable element 236 is in communication with a
first movable element 222. The second movable element 236 surrounds
the stent 204 and the first movable element 222 is looped through
the second movable element 236.
[0067] The first end 224 and second end 226 of the first movable
element 222 extend out a distal end portion of the tube 220. For
example, the first movable element 222 is threaded through the tube
from a distal end to a proximal end and is looped through the
second movable element 236.
[0068] As shown in FIG. 2B, when the two ends 224 and 226 of the
first movable element are pulled in a distal direction, the movable
element 222 pulls on the second movable element 236, radially
compressing at least a portion of the stent 204 as indicated by
arrows 228.
[0069] FIG. 2C is a medical apparatus according to an embodiment of
the invention. FIG. 2D is an enlarged simplified view of a portion
of the medical apparatus shown in FIG. 2C.
[0070] Referring to FIGS. 2C and 2D, the medical apparatus is
generally depicted by reference numeral 200B. The medical apparatus
of FIGS. 2C and 2D is similar to the medical apparatus as shown in
FIGS. 2A and 2B.
[0071] Shown in FIGS. 2C and 2D, a second movable element 236A is
in communication with a first movable element 222A. The second
movable element 236A surrounds the stent 204 and the first movable
element 222A is looped through the second movable element 236A.
[0072] An additional first movable element 222B along with an
additional second movable element 236B are incorporated into the
medical apparatus 200B.
[0073] As shown in FIG. 2D, when tension is applied to the two ends
224 and 226 of the first movable element 222A, the first movable
element 222A pulls on the second movable element 236A, radially
compressing at least a portion of the stent 204 as indicated by
arrows 228. Similarly, when tension is applied to the two ends 232
and 234 of the additional first movable element 222B, the
additional first movable element 222B pulls on the additional
second movable element 236B, radially compressing at least a
portion of the stent 204 as indicated by arrows 228.
[0074] FIG. 3A is a medical apparatus according to an aspect of the
invention. FIG. 3B is an enlarged simplified view of a portion of
the medical apparatus shown in FIG. 3A.
[0075] Referring to FIGS. 3A and 3B, the medical apparatus is
generally depicted by reference numeral 300A. The medical apparatus
300A includes a catheter assembly 302, and stent 304 arranged on
the proximal end portion of the catheter assembly 302. The stent
304 has an inner surface, an outer surface, and is configured from
multiple turns of an undulating element 305. The undulating element
305 may be configured in a ring or helical pattern.
[0076] The stent 304 has a proximal end portion 306 and distal end
portion 308. The distal end portion 308 is formed into a branch
having a first leg 310 and a second leg 312.
[0077] A graft 314 is arranged about the stent 104.
[0078] In one preferred embodiment, the stent 304 and graft 314 are
constrained into a compacted delivery state by a first sheath 316
and second sheath 318. As shown in FIG. 3A, the first sheath 316
has been released allowing at least a portion of the stent 304 to
expand as shown. The second sheath 318 is coupling the second leg
312 to the catheter assembly 302 as shown.
[0079] A tube 320 extends from a proximal end portion to a distal
end portion of the catheter assembly 302. The tube 320 is
positioned within and surrounded by the stent 304. The tube 320 is
attached to the catheter assembly 302 and not attached to the stent
304 or graft 314. A movable element 322 having a first end 324 and
second end 326 surrounds the stent 304 and graft 314. The first end
324 and second end 326 of the movable element 322 extend out a
distal end portion of the tube 320. The movable element 322 is
threaded through the tube from a distal end to a proximal end and
is looped around the proximal end portion 306 of the stent 304 and
graft 314. A further embodiment for "surrounding" the stent with
the moveable element includes threading the moveable element 322
through the graft 314 or through the stent 304 as shown in FIG. 3B.
As shown in FIG. 3B, the movable element 322 is capable of radially
compressing at least a portion of the stent 304 as indicated by
arrows 328 when tension is applied to the movable element ends 324
and 326. Additional movable elements may be added similar to those
configurations described in FIGS. 1D and 2D.
[0080] FIG. 3C is an enlarged simplified view of a portion of a
medical apparatus according to an embodiment of the invention. As
shown in FIG. 3C, second movable element 336 is in communication
with first movable element 322. The second movable element 336
surrounds the stent member 304 and the first movable element 322 is
looped through the second movable element 336. The second movable
element 336 may also be threaded through the graft 314 or threaded
through the stent 304 as shown in FIG. 3C.
[0081] The first end 324 and second end 326 of the first movable
element 322 extend out a distal end portion of the tube 320. For
example, the first movable element 322 is threaded through the tube
from a distal end to a proximal end and is looped through the
second movable element 336.
[0082] As shown in FIG. 3C, when tension is applied to the two ends
324 and 326 of the first movable element 322, the first movable
element 322 pulls on the second movable element 336, radially
compressing at least a portion of the stent 304 as indicated by
arrows 328. Additional movable elements may be added similar to
those configurations described in FIGS. 1D and 2D.
[0083] FIG. 4A is a medical apparatus according to an embodiment of
the invention. FIG. 4B is an enlarged simplified view of a portion
of the the medical apparatus shown in FIG. 4A.
[0084] Referring to FIGS. 4A and 4B, the medical apparatus is
generally depicted by reference numeral 400. The medical apparatus
400 includes a catheter assembly 402, and stent 404 arranged on the
proximal end portion of the catheter assembly 402. The stent 404
has an inner surface, an outer surface, and is configured from
multiple turns of an undulating element 405. The undulating element
405 may be configured in a ring or helical pattern.
[0085] The stent 404 has a proximal end portion 406 and distal end
portion 408. The distal end portion 408 is formed into a branch
having a first leg 410 and a second leg 412.
[0086] A graft 414 is arranged about the stent 404.
[0087] The stent 404 and graft 414 are constrained into a compacted
delivery state by a first sheath 416 and second sheath 418. As
shown in FIG. 4A, the first sheath 416 has been released allowing
at least a portion of the stent 404 to expand as shown. The second
sheath 418 is coupling the second leg 412 to the catheter assembly
402 as shown.
[0088] A tube 420 extends from a proximal end portion to a distal
end portion of the catheter assembly 402. The tube 420 is
positioned adjacent the outer surface of the stent 404 and graft
414. The tube 420 is attached to the catheter assembly 402 and not
attached to the stent 404 or graft 414. A second movable element
436 is in communication with a first movable element 422. The
second movable element 436 surrounds the stent 404. The second
movable element 436 is looped through the first movable element
422. A release pin 450 is threaded through the second movable
element 436, thereby releasably attaching the second movable
element 436 to the first movable element 422.
[0089] The first end 424 and second end 426 of the first movable
element 422 extend out a distal end portion of the tube 420 along
with the distal end of the release pin 450.
[0090] As shown in FIG. 4B, when tension is applied to the two ends
424 and 426 of the first movable element 422, the first movable
element 422 pulls on the second movable element 436, radially
compressing at least a portion of the stent as previously shown,
for example, in FIG. 2B.
[0091] The release pin 450 can be translated in a distal direction
as shown by direction arrow 452, thereby releasing the second
movable element 436 from the first movable element 422.
[0092] FIG. 5A is a medical apparatus according to an embodiment of
the invention. FIG. 5B is an enlarged simplified view of a portion
of the medical apparatus shown in FIG. 5A.
[0093] Referring to FIGS. 5A and 5B, the medical apparatus is
generally depicted as reference numeral 500. The medical apparatus
500 includes a catheter assembly 502, and stent 504 arranged on the
proximal end portion of the catheter assembly 502. The stent 504
has an inner surface, an outer surface, and is configured from
multiple turns of an undulating element 505. The undulating element
505 may be configured in a ring or helical pattern.
[0094] The stent 504 has a proximal end portion 506 and distal end
portion 508. The distal end portion 508 is formed into a branch
having a first leg 510 and a second leg 512.
[0095] A graft 514 is arranged about the stent 504.
[0096] In a preferred embodiment, the stent 504 and graft 514 are
constrained into a compacted delivery state by a first sheath 516
and second sheath 518. As shown in FIG. 5A, the first sheath 516
has been released allowing at least a portion of the stent 504 to
expand as shown. The second sheath 518 is coupling the second leg
512 to the catheter assembly 502 as shown.
[0097] A tube 520 extends from a proximal end portion to a distal
end portion of the catheter assembly 502. The tube 520 is
positioned adjacent the outer surface of the stent 504 and graft
514. The tube 520 is attached to the catheter assembly 502 and not
attached to the stent 504 or graft 514.
[0098] A movable element 522 is threaded through the tube 520 and
is circumferentially arranged around the stent 504. The movable
element 522 is looped over release pin 550, thereby releasably
attaching the movable element 522 to the release pin 550.
[0099] As shown in FIG. 5B, when tension is applied to the two ends
524 and 526 of the movable element, the movable element 522
radially compresses at least a portion of the stent as previously
shown, for example, in FIG. 2B. When desired, the release pin 550
can be translated in a distal direction as shown by direction arrow
552, thereby releasing the movable element 522 from the release pin
550 allowing the movable element 522 to be withdrawn.
[0100] FIG. 6A is a medical apparatus according to an embodiment of
the invention. FIG. 6B is an enlarged simplified view of a portion
of the medical apparatus shown in FIG. 6A.
[0101] Referring to FIGS. 6A and 6B, the medical apparatus is
generally depicted as reference numeral 600. The medical apparatus
600 includes a catheter assembly 602, and stent 604 arranged on the
proximal end portion of the catheter assembly 602. The stent 604
has an inner surface, an outer surface, and is configured from
multiple turns of an undulating element 605. The undulating element
605 may be configured in a ring or helical pattern.
[0102] The stent 604 has a proximal end portion 606 and distal end
portion 608. The distal end portion 608 is formed into a branch
having a first leg 610 and a second leg 612.
[0103] A graft 614 is arranged about the stent 604. The stent 604
and graft 614 are constrained into a compacted delivery state (or
first diameter) by a first sheath 616 and second sheath 618. As
shown in FIG. 6A, the first sheath 616 has been released allowing
at least a portion of the stent 604 to expand as shown. The second
sheath 618 is coupling the second leg 612 to the catheter assembly
602 as shown.
[0104] After the release of the first sheath 616, the stent 604 is
allowed to self expand into a second diameter that is greater than
the initial compacted first diameter. The second diameter is
defined by a secondary constraint 654. The secondary constraint 654
can be comprised, for example, of a flexible filament that
encircles a proximal end portion 606 of the stent and graft. The
secondary constraint 654 prevents further self expansion of the
stent.
[0105] As shown in FIG. 6B, the secondary constraint 654 is looped
around the stent (not shown) and is threaded through a first end of
the secondary constraint 654. The second end of the secondary
constraint 654 is looped onto a release pin 650. Once the apparatus
600 is properly positioned within a vessel target site, the
secondary constraint 654 can be released by translating the release
pin 650 in a distal direction as shown by direction arrow 652. By
translating the release pin 650, the stent is released from the
secondary constraint and thereby allowed to further expand into a
third diameter that is greater than the second and first
diameters.
[0106] Optionally, a retrieval cord or filament 656 can be used to
join the secondary constraint 654 to the release pin 650. Therefore
when the release pin is translated distally, the secondary
constraint 654 is withdrawn along with the release pin 650.
[0107] FIG. 7A is a medical apparatus according to an embodiment of
the invention. FIG. 7B is an enlarged simplified view of a portion
of the medical apparatus shown in FIG. 7A.
[0108] Referring to FIGS. 7A and 7B, the medical apparatus is
generally depicted as reference numeral 700. The medical apparatus
700 includes a catheter assembly 702, and stent 704 arranged on the
proximal end portion of the catheter assembly 702. The stent 704
has an inner surface, an outer surface, and is configured from
multiple turns of an undulating element 705. The undulating element
705 may be configured in a ring or helical pattern.
[0109] The stent 704 has a proximal end portion 706 and distal end
portion 708. The distal end portion 708 is formed into a branch
having a first leg 710 and a second leg 712.
[0110] A graft 714 is arranged about the stent 704. The stent 704
and graft 714 are constrained into a compacted delivery state (or
first diameter) by a first sheath 716 and second sheath 718. As
shown in FIG. 7A, the first sheath 716 has been released allowing
at least a portion of the stent 704 to expand as shown. The second
sheath 718 is coupling the second leg 712 to the catheter assembly
702 as shown.
[0111] After the release of the first sheath 716, the stent 704 is
allowed to self expand into a second diameter that is greater than
the initial compacted first diameter. The second diameter is
defined by a secondary constraint 754. The secondary constraint 754
is comprised of a flexible band that encircles a proximal end
portion 706 of the stent graft. The secondary constraint prevents
further self expansion of the stent graft.
[0112] As shown in FIG. 7B, the secondary constraint 754 is looped
around the stent and is threaded through a latch 758 located near a
first end of the secondary constraint 754. A release pin 750 is
threaded through the latch 758 to prevent further expansion of the
secondary constraint 754. Once the apparatus 700 is properly
positioned within a vessel target site, the secondary constraint
754 can be released by translating the release pin 750 in a distal
direction as shown by direction arrow 752. By translating the
release pin 750, the stent 704 is released from the secondary
constraint 754 and thereby allowed to further expand into a third
diameter that is greater than the second and first diameters.
Optionally, a retrieval cord or filament 756 can be used to join
the secondary constraint 754 to the release pin 750. Therefore when
the release pin is translated distally, the secondary constraint
754 is withdrawn along with the release pin 650.
[0113] FIGS. 8A through 8C depict a medical apparatus according to
an embodiment of the invention.
[0114] Referring to FIGS. 8A through 8C, the medical apparatus is
generally depicted as reference numeral 800. The medical apparatus
800 includes a catheter assembly 802, and stent arranged on the
proximal end portion of the catheter assembly 802. As shown in FIG.
8A the medical apparatus 800 has a stent constrained into a small
delivery diameter 856. The stent is held in this small delivery
diameter by constraining sheaths 850 and 854. The sheath 850
constrains the trunk of the stent while the sheath 854 constrains
the extended leg portion of the stent. A third constraining sheath
852 is contained within the sheath 850.
[0115] Referring to FIG. 8B, when the medical apparatus 800 is
positioned within a target site, the sheath 850 can be released,
allowing at least a portion of the stent to expand to a diameter
858 that is larger than the initial small delivery diameter 856.
The sheath 852 therefore constrains the stent 804 to an
intermediate diameter. The sheath 854 constrains the extended leg
portion of the stent onto the catheter assembly 802, thereby
allowing the medical apparatus to be repositioned, rotated or
precisely aligned to the target site. As shown in FIG. 8C, when the
medical apparatus is precisely positioned, the sheath 852 can be
released, allowing the stent to fully expand to a large deployed
diameter 860. The deployed diameter 860 is larger than the
intermediate diameter 858. The intermediate diameter 858 is larger
than the delivery diameter 856 as shown in FIGS. 8A through 8C.
Stent anchoring barbs or hooks 862 (when provided) are therefore
constrained to the intermediate diameter 858 during final
manipulation and positioning of the medical apparatus and allowed
to expand and engage a vessel when the constraining sheath 852 is
released.
[0116] FIG. 9A is a partial side view of a medical apparatus 900,
having a constrained medical device 960 located near or at the
distal end of a catheter assembly 962. The catheter assembly 962
has a catheter shaft 964 and a distal guidewire port 966. FIG. 9B
is a cross-sectional view of the catheter shaft 964. Shown
contained within the catheter shaft 964 is a guidewire 970, a
release member 972 and an adjustment member 974. The release member
can be a cord, thread, wire, pin, tube or other element used to
release a stent (or other medical device) from a constraint,
thereby allowing the device to expand from a first compacted
delivery profile to a second larger profile. The adjustment member
can be a cord, thread, wire, pin, tube or other element used to
alter the second profile of at least a portion of the medical
device. A catheter used to deliver a medical apparatus can have
one, two, three, four or five or more release members combined with
one, two, three, four or five or more adjustment members. The
release members and adjustment members can be contained in separate
or shared lumens within the catheter shaft 964.
[0117] FIGS. 10A and 10B show generalized views of a medical
apparatus according to an embodiment of the invention (previously
described in FIGS. 2A and 2B). Shown in FIG. 10A is a medical
apparatus 1000, comprised of a stent 1002 having anchor barbs or
hooks 1004. Shown is a tube 1006 having a first movable element
1008 located therein. The first movable element 1008 is shown
looped through a second movable element 1010. As shown in FIG. 10B,
when tension 1012 is applied to the ends of the first movable
element 1008, the second movable element 1010 is drawn into the
tube 1006. When the second movable element 1010 is drawn into the
tube 1006, the stent graft is compressed in the direction indicated
by arrows 1014. The anchors or barbs 1004 are therefore retracted
and pulled inwardly away from a vessel wall. The retraction of the
anchors or barbs will allow the medical apparatus 1000 to be
longitudinally and/or rotationally adjusted. When in the precise
target area the tension 1012 on the movable element can be removed,
allowing the stent to self expand and engage the anchors or barbs
into a vessel wall.
[0118] FIGS. 10C through 10H show a generalized delivery sequence
according to an embodiment of the invention. Shown in FIG. 10C is a
medical apparatus 1000, having a first constraining sheath 1020, a
second constraining sheath 1022 and a catheter assembly 1024.
Constrained and contained within the first and second sheaths 1020,
1022 is a bifurcated stent having a trunk, a first short leg and a
second long leg. As shown in FIG. 10D, when the medical apparatus
is positioned at a target site, the first constraining sheath 1020
is released allowing a portion of the stent and first short leg to
self expand. A portion of the stent is held in a constrained small
diameter state by movable element 1026. The movable element 1026 is
located in tube 1028. The stent anchors or barbs 1030 are
constrained and pulled inwardly by the movable element 1026, so
that the anchors or barbs do not engage a vessel wall. The second
constraining sheath 1022 compresses the stent graft second long leg
onto the catheter assembly 1024. Thus the medical apparatus is
captured by the catheter assembly, allowing subsequent
repositioning of the medical apparatus.
[0119] As shown in FIG. 10E, the medical apparatus 1000 can now be
readjusted in the longitudinal direction 1032 and/or in the angular
direction 1034 through manipulations of the catheter assembly
1024.
[0120] As shown in FIG. 10F, when the medical apparatus is
precisely positioned, tension on first movable element 1036 is
relaxed, allowing second movable element 1038 to expand. As second
movable element 1038 expands, the stent is allowed to further
expand in the direction 1040, engaging the anchors or barbs 1030
into a vessel wall.
[0121] As shown in FIG. 10G, the second constraining sheath 1022
can be released, allowing the second long leg to self expand.
[0122] As shown in FIG. 10H, one end of first movable element 1036
can be tensioned, allowing first movable element 1036 to be
un-looped from second movable element 1038. First movable element
1036 can then be withdrawn through the tube 1028. The expanded
stent graft is now unattached from the catheter assembly, allowing
withdrawal 1042 of the catheter assembly.
[0123] It will be apparent to those skilled in the art that various
modifications and variation can be made in the present invention
without departing from the spirit or scope of the invention. Thus,
it is intended that the present invention cover the modifications
and variations of this invention provided they come within the
scope of the appended claims and their equivalents.
* * * * *