U.S. patent application number 12/478245 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, Patrick S. Young, Stanislaw L. Zukowski.
Application Number | 20100049293 12/478245 |
Document ID | / |
Family ID | 40908544 |
Filed Date | 2010-02-25 |
United States Patent
Application |
20100049293 |
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) ; Young;
Patrick S.; (Flagstaff, AZ) |
Correspondence
Address: |
GORE ENTERPRISE HOLDINGS, INC.
551 PAPER MILL ROAD, P. O. BOX 9206
NEWARK
DE
19714-9206
US
|
Family ID: |
40908544 |
Appl. No.: |
12/478245 |
Filed: |
June 4, 2009 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61058770 |
Jun 4, 2008 |
|
|
|
Current U.S.
Class: |
623/1.11 ;
623/1.13 |
Current CPC
Class: |
A61F 2/97 20130101; A61F
2/07 20130101; A61F 2/954 20130101; A61F 2002/072 20130101; A61F
2/89 20130101; A61F 2002/075 20130101; A61F 2002/9511 20130101;
A61F 2002/9505 20130101; A61F 2/95 20130101 |
Class at
Publication: |
623/1.11 ;
623/1.13 |
International
Class: |
A61F 2/86 20060101
A61F002/86 |
Claims
1. An apparatus, comprising: a catheter having a proximal end
portion and distal end portion; a stent arranged on the proximal
end portion of the catheter, the stent having an inner surface and
an outer surface; a graft member arranged about the stent member;
and a movable element connected to a torsional member, wherein the
torsional member is capable of retracting a portion of the movable
element and thereby radially compressing at least a portion of the
stent.
2. The apparatus of claim 1, further comprising a tube having a
proximal end portion and distal end portion arranged on at least a
portion of the stent, wherein at least a portion of the torsional
member extends within a portion of the tube.
3. The apparatus of claim 2, wherein the distal end portion of the
tube extends to a hub arranged on the distal end portion of the
catheter.
4. The apparatus of claim 2, wherein the tube comprises two
lumens.
5. The apparatus of claim 1, wherein the movable element comprises
a filament.
6. The apparatus of claim 5, wherein the filament comprises a
wire.
7. The apparatus of claim 5, wherein the filament comprises a
polymer.
8. The apparatus of claim 7, wherein the polymer comprises a
fluoropolymer.
9. The apparatus of claim 8, wherein the fluoropolymer comprises
polytetrafluoroethylene.
10. The apparatus of claim 9, wherein the polytetrafluoroethylene
comprises expanded polytetrafluoroethylene.
11. The apparatus of claim 5, wherein the filament is arranged
circumferentially around the graft member and is threaded between
adjacent undulations of the stent.
12. The apparatus of claim 1, wherein the tubular graft member is
positioned on an inside portion of the stent.
13. The apparatus of claim 2, wherein the tube is positioned on an
inside portion of the stent.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to provisional application
U.S. Ser. No. 61/058,770, 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.
[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] An embodiment of the present invention provides an
apparatus, comprising a catheter having a proximal end portion and
distal end portion. A hub can be arranged on a distal end portion
of the catheter. A stent member is arranged on the proximal end
portion of the catheter, the stent member has an inner surface and
an outer surface. The stent can be configured in any suitable
manner. In an embodiment of the invention, the stent is configured
from multiple turns of an undulating element. Such a stent member
can have substantially in-phase undulations. A graft member can be
arranged about the stent member. Moreover, an element can be
connected to a torsional member, wherein the torsional member is
capable of retracting a portion of the element and thereby radially
compressing at least a portion of the stent.
[0009] In another embodiment, the present invention provides an
apparatus substantially as described above, further comprising a
tube having a proximal end portion and distal end portion arranged
on at least a portion of the substantially tubular shaped stent
member, wherein at least a portion of the torsional member extends
within a portion of the tube.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The accompanying drawings are included to provide a further
understanding of the invention and illustrate certain aspects of
the invention.
[0011] In the drawings:
[0012] FIG. 1A is a medical apparatus according to an aspect of the
invention, having an external torsional member.
[0013] FIG. 1B is an enlarged simplified view of the medical
apparatus of FIG. 1A according to an aspect of the invention.
[0014] FIG. 1C is a medical apparatus according to an aspect of the
invention, having an internal torsional member.
[0015] FIGS. 2A and 2B are a medical apparatus according to an
aspect of the invention, having flexible straps connected to a
torsional member.
[0016] FIG. 3A is a medical apparatus according to an aspect of the
invention, having an external torsional member connected to a
flexible sleeve with a rip cord.
[0017] FIG. 3B is a medical apparatus according to an aspect of the
invention, having an internal torsional member connected to a
flexible constraining sleeve with a parting line.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0018] 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. The term distal as used
herein denotes a position furthest from the heart, while the term
proximal denotes a position closest to the heart.
[0019] 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 be optionally arranged on a distal
end portion of the catheter assembly. A stent is arranged on a
proximal end portion of the catheter. 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.
[0020] In some embodiments, the stents can be used to fix the
medical apparatus inside a portion of a patient's anatomy. The
stent can be preferably constructed from materials that are
flexible and strong. The stent can be formed from degradable
bioabsorbable 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.
[0021] More specifically, the stents can be fabricated according to
the methods and materials as generally disclosed in, for example,
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 organosilicon
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).
[0022] 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.
[0023] 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.
[0024] 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.
[0025] 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.
[0026] 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.
[0027] 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.
[0028] 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 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.
[0029] 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.
[0030] A graft member 114 is arranged about the stent 104.
[0031] In an embodiment of the invention, 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.
[0032] A torsional member 120 extends from a proximal end portion
to a distal end portion of the catheter assembly 102. In the
figure, the torsional member 120 is positioned adjacent the outer
surface of the stent 104 and graft 114. The torsional member 120 is
attached to the catheter assembly 102 and not attached to the stent
104 or graft 114. A movable element 122 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 torsional member 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.
[0033] As shown in FIG. 1B, the torsional member 120 can be rotated
in the direction shown by arrow 130, tensioning the movable element
122 thereby causing at least a portion of the stent/graft to radial
compress in the direction indicated by arrows 128. The torsional
member 120 can be configured with a side-wall aperture 132 through
which the two ends 124, 126 of the movable element 122 can be
routed. The torsional member 120 can be rotated by turning the
distal end of the tube 120. The torsional member 120 can be rotated
in the opposite direction (of that shown by arrow 130) to allow the
stent/graft to expand in the direction opposite of arrows 128. The
stent/graft can be compressed to allow rotational or longitudinal
displacements within a vessel. When the desired placement is
verified, the stent/graft can be allowed to expand and engage the
vessel wall. Repeated compressions and expansions of the
stent/graft can be utilized as desired. The stent/graft can also be
gradually compressed or allowed to gradually expand by varying the
amount of twist imparted to the torsional member 120. After final
placement of the stent/graft, tension can be applied to one of the
ends 124, 126 of the moveable element 122 to release and withdraw
the movable element.
[0034] FIG. 1C is a medical apparatus according to a further
embodiment of the invention, having a torsional member 120
positioned internal to the stent/graft.
[0035] Referring to FIG. 1C, the medical apparatus is generally
depicted as reference numeral 10B. The medical apparatus of FIG. 1C
is similar to the medical apparatus as shown in FIGS. 1A and 1B.
The medical apparatus includes a stent 104 and/or a graft 114
arranged on the proximal end portion of the catheter assembly.
[0036] A torsional member 120 extends from a proximal end portion
to a distal end portion of the catheter assembly. The torsional
member 120 is positioned internal to the stent 104 and graft 114.
The torsional member 120 is attached to the catheter assembly and
not attached to the stent 104 or graft 114. A movable element 122
having a first end 124 and second end 126 is looped through and
around 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 torsional member 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 of the
stent 104 and graft member 114. As shown in FIG. 1C, the torsional
member 120 can be rotated in the direction shown by arrow 130,
tensioning the movable element 122 thereby causing at least a
portion of the stent/graft to radial compress in the direction
indicated by arrows 128. The torsional member 120 can be configured
with a side-wall aperture 132 through which the two ends 124, 126
of the movable element 122 can be routed. The torsional member 120
can be rotated by turning the distal end of the torsional member
120. The torsional member 120 can be rotated in the opposite
direction (of that shown by arrow 130) to allow the stent/graft to
expand in the direction opposite of arrows 128. The stent/graft can
be compressed to allow rotational or longitudinal displacements
within a vessel. When the desired placement is verified, the
stent/graft can be allowed to expand and engage the vessel wall.
Repeated compressions and expansions of the stent/graft can be
utilized as desired. The stent/graft can also be gradually
compressed or allowed to gradually expand by varying the amount of
twist imparted to the torsional member 120. After final placement
of the stent/graft, tension can be applied to one of the moveable
ends 124, 126 of the moveable element 122 to release and withdraw
the movable element.
[0037] FIGS. 2A and 2B are partial views of the proximal end of a
medical apparatus according to a further embodiment of the
invention, having releasable straps that can radial compress a
stent/graft.
[0038] Referring to FIGS. 2A and 2B, the medical apparatus is
generally depicted as reference numeral 200. The medical apparatus
of FIGS. 2A and 2B is similar to the medical apparatus as shown in
FIGS. 1A through 1C with a stent/graft not shown for clarity.
[0039] Shown in FIG. 2A is a partial cross-section of a distal end
of a catheter system 200 having an outer tube 202. Contained within
the outer tube 202 are a first inner tube 204 and a torsional
member 206. Attached to the torsional member is at least one
flexible strap 208. The flexible strap 208 surrounds a distal
portion of a stent/graft (not shown). When the torsional member 206
is rotated as depicted by arrow 210 the strap 208 is further wound
around the torsional member 206, thereby "drawing in" the strap
which will in turn, compress a surrounded stent/graft. The degree
of stent/graft compression can be controlled by varying the amount
of twist imparted to the torsional member. A first end 212 of a
flexible strap 208 can be affixed to the torsional member 206. The
second end 214 of the strap 208 can be wrapped around the torsional
member. When the medical apparatus is properly positioned with a
target site, the torsional member can be rotated in a direction
opposite that shown by arrow 210. This opposite rotation will allow
the stent/graft to fully expand. Further opposite rotation of the
torsional member will cause the strap end 214 to "un-wind" from the
torsional member. The torsional member can then be withdrawn in a
distal direction, pulling the strap with attached end 212 into the
first inner tube. In an alternate method the first inner tube and
the torsional member can be withdrawn together or all three members
(204, 206, 208) can be withdrawn together.
[0040] Shown in FIG. 2B is a non cross-sectional perspective view
of the distal end of the catheter system shown in FIG. 2A. The
flexible straps 208 can be fabricated from various bio-compatible
materials as commonly known in the art.
[0041] FIGS. 3A and 3B are partial perspective views of a medical
apparatus according to a further embodiment of the invention.
[0042] Referring to FIGS. 3A and 3B, the medical apparatus is
generally depicted as reference numeral 300A or 300B. The medical
apparatus 300A and B 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 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.
[0043] 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.
[0044] A graft member 114 is arranged about the stent 104.
[0045] 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 FIGS. 3A and 3B, 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.
[0046] Shown in FIG. 3A is a flexible constraining sleeve 302,
surrounding a proximal portion of the stent/graft. A torsional
member 120 extends from a proximal end portion to a distal end
portion of the catheter assembly 102. In the figure, the torsional
member 120 is positioned adjacent the outer surface of the stent
104 and graft 114. The torsional member 120 is attached to the
catheter assembly 102 and not attached to the stent 104 or graft
114. The flexible sleeve 302 is attached to the torsional member
120 so that when the torsional member 120 is rotated, the flexible
sleeve is compressed which in turn compresses the stent/graft. The
flexible sleeve 302 is shown having a parting or rip cord 304. The
rip cord 304 can be in the form of a thread or wire that is
contained within a secondary tube 306. The secondary tube 306 can
exit the distal end of the catheter assembly 102 with the rip cord
exiting the distal end of the secondary tube. When the medical
apparatus is properly deployed the distal end of the rip cord can
be tensioned, thereby ripping or separating the flexible sleeve
302. Since the flexible sleeve is still attached to the torsional
member 120, the flexible sleeve 302 can then be withdrawn along
with the catheter assembly 102.
[0047] Shown in FIG. 3B is a flexible constraining sleeve 302,
surrounding a proximal portion of the stent/graft. A torsional
member 310 extends from a proximal end portion to a distal end
portion of the catheter assembly 102. In the figure, the torsional
member 310 is positioned adjacent the outer surface of the stent
104 and graft 114. The torsional member 310 is attached to the
catheter assembly 102 and not attached to the stent 104 or graft
114. The flexible sleeve 302 is attached to the torsional member
310 so that when the torsional member 310 is rotated, the flexible
sleeve is compressed which in turn compresses the stent/graft. The
flexible sleeve 302 is shown having a parting line 312. Shown is a
stitched parting line 312 similar to those parting lines
incorporated into the first 116 and second 118 sheaths. The release
of the stitched parting line 312 can be activated by a release cord
314. The release cord 314 can be in the form of a thread or wire
and can be contained within a secondary tube (not shown) or be
contained within a catheter system lumen. The release cord 314 can
exit the distal end of the catheter assembly 102. When the medical
apparatus is properly deployed the distal end of the release cord
314 can be tensioned, thereby un-stitching or separating the
flexible sleeve 302. Since the flexible sleeve is still attached to
the torsional member 310, the flexible sleeve 302 can then be
withdrawn along with the catheter assembly 102.
[0048] 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.
* * * * *