U.S. patent application number 13/709234 was filed with the patent office on 2013-06-20 for anti-leakage prosthesis.
This patent application is currently assigned to Cook Medical Technologies LLC. The applicant listed for this patent is Cook Medical Technologies LLC. Invention is credited to Ciaran Toomey.
Application Number | 20130158673 13/709234 |
Document ID | / |
Family ID | 47602956 |
Filed Date | 2013-06-20 |
United States Patent
Application |
20130158673 |
Kind Code |
A1 |
Toomey; Ciaran |
June 20, 2013 |
Anti-Leakage Prosthesis
Abstract
A prosthesis and a method for directing flow through a
passageway formed between a first bodily lumen and a second bodily
lumen are provided. The prosthesis includes a body having a
proximal portion, a distal portion and a lumen extending
therethrough. The prosthesis also includes a sleeve operably
connected to the body at a connected portion. The sleeve has a
proximal portion, a distal portion, and a sleeve lumen extending
therethrough. At least a portion of the body is positioned within
at least a portion of the sleeve lumen and the distal portion of
the sleeve is free from connection to the distal portion of the
body and extendable away from the body to contact a wall of the
first bodily lumen. The sleeve is configured to allow fluid flow
through the sleeve lumen from the first bodily lumen to the second
bodily lumen.
Inventors: |
Toomey; Ciaran; (Rathcormac,
IE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Cook Medical Technologies LLC; |
Bloomington |
|
IN |
|
|
Assignee: |
Cook Medical Technologies
LLC
Bloomington
IN
|
Family ID: |
47602956 |
Appl. No.: |
13/709234 |
Filed: |
December 10, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61576152 |
Dec 15, 2011 |
|
|
|
Current U.S.
Class: |
623/23.7 |
Current CPC
Class: |
A61F 2/94 20130101; A61F
2/07 20130101; A61F 2002/075 20130101; A61F 2250/0039 20130101;
A61F 2/064 20130101; A61M 27/008 20130101; A61B 17/22 20130101;
A61B 17/1114 20130101; A61B 2017/2215 20130101; A61F 2/04 20130101;
A61B 2017/22034 20130101; A61F 2/86 20130101; A61B 2017/22044
20130101; A61B 17/221 20130101; A61F 2002/041 20130101; A61F 2/82
20130101; A61B 2217/005 20130101 |
Class at
Publication: |
623/23.7 |
International
Class: |
A61F 2/82 20060101
A61F002/82 |
Claims
1. A prosthesis for directing flow through a passageway formed
between a first bodily lumen and a second bodily lumen, the
prosthesis comprising: a body having a proximal portion, a distal
portion and a lumen extending therethrough; and a sleeve operably
connected to the body at a connected portion, the sleeve having a
proximal portion, a distal portion, and a sleeve lumen extending
therethrough, at least a portion of the body positioned within at
least a portion of the sleeve lumen and the distal portion of the
sleeve being free from connection to the distal portion of the body
and extendable away from the body to contact a wall of the first
bodily lumen, wherein the sleeve is configured to allow fluid flow
through the sleeve lumen from the first bodily lumen to the second
bodily lumen.
2. The prosthesis of claim 1, wherein the body comprises a
self-expanding stent.
3. The prosthesis of claim 1, wherein the body comprises a
non-expandable stent.
4. The prosthesis of claim 1, wherein the body comprises a
retention device at the proximal portion or the distal portion of
the body or both the proximal portion and the distal portion of the
body.
5. The prosthesis of claim 4, wherein the retention device
comprises an expanded diameter at a distal end portion of the body
or a proximal end portion of the body or both.
6. The prosthesis of claim 4, wherein the retention device
comprises a pigtail configuration.
7. The prosthesis of claim 1, wherein the sleeve comprises
polytetrafluoroethylene (PTFE).
8. The prosthesis of claim 1, wherein the sleeve comprises a fluid
impermeable, flexible material so that the distal portion of the
sleeve can conform to the wall of the first bodily lumen.
9. The prosthesis of claim 1, wherein a diameter of the sleeve
distal portion is greater than a diameter of a mid portion of the
sleeve.
10. The prosthesis of claim 1, wherein a diameter of the proximal
portion of the sleeve is greater than a diameter of a mid portion
of the sleeve.
11. The prosthesis of claim 1, wherein a diameter of a mid portion
of the sleeve is greater than a diameter of a mid portion of the
body and the mid portion of the sleeve and a mid portion of the
body coaxially extend between the first body lumen and the second
bodily lumen.
12. The prosthesis of claim 1, wherein the proximal portion of the
sleeve is connected to the proximal portion of the body.
13. The prosthesis of claim 1, wherein the sleeve extends proximal
to the proximal portion of the body.
14. The prosthesis of claim 1, further comprising a valve
configured to restrict flow from the second bodily lumen toward the
first bodily lumen.
15. The prosthesis of claim 1, wherein the body comprises at least
one involuted portion configured to facilitate flow through the
lumen of the sleeve.
16. A method of directing flow through a passageway formed between
a first bodily lumen and a second bodily lumen, the method
comprising: delivering a prosthesis to a first bodily lumen and a
second bodily lumen; positioning a distal portion of a sleeve and a
distal portion of a body of the prosthesis within the first bodily
lumen; positioning a proximal portion of a sleeve and a proximal
portion of a body of the prosthesis within the second bodily lumen
so that a portion of the body and a portion of the sleeve extend
across the peritoneum between the first bodily lumen and the second
bodily lumen; allowing the distal portion of the sleeve to extend
away from the distal portion of the body and to conform to a wall
of the first bodily lumen; and fluidly connecting the first bodily
lumen to the second bodily lumen through a lumen of the sleeve.
17. The method of claim 16, further comprising delivering the
prosthesis through the second bodily lumen to the first bodily
lumen.
18. The method of claim 16, comprising delivering the prosthesis
using an endoscopic ultrasound device.
19. The method of claim 16, comprising delivering the prosthesis to
the first bodily lumen with the sleeve positioned against to the
body.
20. The method of claim 16, comprising expanding the body
comprising a self-expanding stent so that the expanded body has a
diameter at a mid portion that is less than a diameter of the
sleeve at a mid portion of the sleeve.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/576,152, filed Dec. 15, 2011, which is
incorporated by reference herein in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to medical devices and methods
and in particular to a prosthesis having a sleeve to prevent
leakage after a medical procedure in the gastrointestinal
tract.
BACKGROUND OF THE INVENTION
[0003] Endoscopic biliary stenting is typically used to treat bile
duct obstruction. In some cases, ERCP treatment of the bile duct
fails or is not a viable treatment and surgery or percutaneous
biliary drainage may be needed. However, surgery and percutaneous
biliary drainage have a relatively high complication rate.
Recently, transgastric endoscopic ultrasonography (EUS) has been
used to provide imaging of the left lobe of the liver, especially
of dilated intrahepatic ducts in patients with biliary obstruction.
Using EUS guidance, biliary drainage can be provided by
hepaticogastrostomy or choledochoduodenstomy approaches for placing
a stent for biliary decompression. Hepaticogastrostomy or
choledochoduodenstomy approaches have been shown to have lower
complication rates than surgery or percutaneous drainage.
[0004] One potential complication of the hepaticogastrostomy or
choledochoduodenstomy approach to treating biliary obstruction is
the potential for bile to leak into the peritoneum. Bile leaks into
the peritoneum when the bile flows outside of the wall of a stent
placed between the hepatic biliary system (including extrahepatic
bile ducts and/or intrahepatic bile ducts) and the stomach or the
duodenum.
[0005] What is needed in the art is a prosthesis and a method for
biliary decompression that minimizes the potential for peritoneal
biliary leakage.
BRIEF SUMMARY
[0006] Accordingly, it is an object of the present invention to
provide a device and a method having features that resolve or
improve on the above-described drawbacks.
[0007] A prosthesis and a method for directing flow through a
passageway formed between a first bodily lumen and a second bodily
lumen are provided. The prosthesis includes a body having a
proximal portion, a distal portion and a lumen extending
therethrough. The prosthesis also includes a sleeve operably
connected to the body at a connected portion. The sleeve has a
proximal portion, a distal portion, and a sleeve lumen extending
therethrough. At least a portion of the body is positioned within
at least a portion of the sleeve lumen and the distal portion of
the sleeve is free from connection to the distal portion of the
body and extendable away from the body to contact a wall of the
first bodily lumen. The sleeve is configured to allow fluid flow
through the sleeve lumen from the first bodily lumen to the second
bodily lumen.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is a sectional view of a prosthetic device in
accordance with an embodiment of the present invention;
[0009] FIG. 2 is a sectional view of a prosthetic device in
accordance with an embodiment of the present invention;
[0010] FIG. 3 is a sectional view of a prosthetic device in
accordance with an embodiment of the present invention;
[0011] FIG. 4 is a sectional view of a prosthetic device in
accordance with an embodiment of the present invention;
[0012] FIG. 5 is a sectional view of a prosthetic device in
accordance with an embodiment of the present invention;
[0013] FIG. 6 is a cross-sectional view of a prosthetic device in
accordance with an embodiment of the present invention;
[0014] FIG. 7 is a cross-sectional view of a prosthetic device in
accordance with an embodiment of the present invention;
[0015] FIG. 8 is a side view of a prosthetic device in accordance
with an embodiment of the present invention;
[0016] FIG. 9 is a side view of a prosthetic device in accordance
with an embodiment of the present invention;
[0017] FIG. 10 is a sectional view of a prosthetic device in
accordance with an embodiment of the present invention;
[0018] FIG. 11 illustrates an embodiment of a prosthetic device
operably connecting the biliary tract and the gastrointestinal
intestinal tract; and
[0019] FIG. 12-14 illustrate delivery of an embodiment of a
prosthetic device to the gall bladder and the gastrointestinal
tract.
DETAILED DESCRIPTION
[0020] The invention is described with reference to the drawings in
which like elements are referred to by like numerals. The
relationship and functioning of the various elements of this
invention are better understood by the following detailed
description. However, the embodiments of this invention are not
limited to the embodiments illustrated in the drawings. It should
be understood that the drawings are not to scale, and in certain
instances details have been omitted which are not necessary for an
understanding of the present invention, such as conventional
fabrication and assembly.
[0021] As used in the specification, the terms proximal and distal
should be understood as being in the terms of a physician
delivering the prosthesis to a patient. Hence the term "distal"
means the portion of the prosthesis that is farthest from the
physician and the term "proximal" means the portion of the
prosthesis that is nearest to the physician.
[0022] The present invention relates to medical devices, and in
particular to a prosthesis for implantation in a body to form a
conduit between two organs such as the bile duct and the stomach or
the duodenum. As used herein, the term "implantable" refers to an
ability of a medical device to be positioned at a location within a
body, either temporarily, semi-permanently, or permanently.
Permanent fixation of the device in a particular position is not
required. Furthermore, the terms "implantation" and "implanted"
refer to the positioning of a medical device at a location within a
body.
[0023] FIG. 1 illustrates a prosthesis 10 in accordance with an
embodiment of the present invention. The prosthesis 10 includes a
body 12 having proximal portion 14, a distal portion 16 and a lumen
18 extending therethrough. In some embodiments, the body 12 may be
an expandable stent, such as a self-expanding stent. The stent may
be coated or non-coated. In some embodiments, the body 12 may be a
non-expandable tubular stent.
[0024] The prosthesis 10 further includes a sleeve 22 having a
connected portion 24 operably connecting the sleeve 22 to the body
12 at at least one position along the body 12. At least a portion
of the body 12 extends through a portion of a sleeve lumen 23 so
that the sleeve and body coextend, for example, across the
peritoneum. The sleeve 22 is connected to the body 12 in such a way
that fluid can pass through the sleeve lumen 23 between an outer
surface 26 of the body 12 and an inner surface 28 of the sleeve 22.
The connected portion 24 of the sleeve 22 is configured so that the
connected portion 24 still allows fluid flow through the sleeve
lumen 23 generally from a distal portion 32 of the sleeve 22 to a
proximal portion 36 of the sleeve 22. In some embodiments, the
connected portion 24 may be a single connection point. In some
embodiments, the connected portion 24 may be a longitudinally
extending connection so that a majority of a circumference 37 of
the sleeve 22 is unconnected to the body 12. In yet other
embodiments, the connected portion 24 may be a plurality of
connections to the body 12, for example at points spaced apart
around a circumference 38 of the body 12. By way of non-limiting
example, the connected portions 24 may be spaced about by
60.degree., 90.degree., 120.degree., 180.degree. and the like.
Several rows of connected portions 24 may be used. Other connection
configurations are also possible that connect the sleeve 22 to the
body 12 and still allow fluid flow through the sleeve lumen 23
between the sleeve 22 and the body 12. As shown in FIG. 1, the
connected portion 24 may be positioned away from the distal portion
16 of the body 12. In some embodiments, one or more connected
portions 24 may be positioned at or near a mid portion 34 of the
body 12. The connected portion 24 may be positioned so that the
connected portion 24 is positioned within the bile duct or outside
of the bile duct as described in more detail below.
[0025] As shown in FIGS. 1 and 2, the distal portion 32 of the
sleeve 22 is unconnected to the body 12 of the prosthesis 10 and
includes sufficient material to extend away from the body 12 as
will be explained in more detail below. The sleeve 22 is formed of
a liquid impermeable, thin, flexible polymeric material so that the
liquid transported through the sleeve 22 exits at the proximal
portion 36 of the sleeve 22 and not through a wall of the sleeve
22. The distal portion 32 of the sleeve 22 may be collapsed against
the body 12 for delivery of the prosthesis 10 to the bodily lumen
and then the distal portion 32 may be extended away from the body
12 when the prosthesis 10 is in positioned within the bodily
lumen.
[0026] The proximal portion 36 of the sleeve 22 may be sized and
shaped to fit close to the body 12 as shown in FIG. 1 or to include
sufficient material to extend away from the body 12 as shown in
FIG. 2. In some embodiments, the proximal portion 36 of the sleeve
22 may be connected to the body 12 by a connected portion 24. In
other embodiments, the proximal portion 36 of the sleeve 22 may be
unconnected to the body 12 and closely fit to the body 12 or
extended away from the body 12. In some embodiments, the proximal
portion 14 of the body 12 may extend proximal to the proximal
portion 36 of the sleeve 22 as shown in FIG. 1. In some
embodiments, the proximal portion 36 of the sleeve 22 may extend
proximal to the proximal portion 14 of the body 12 as shown in FIG.
3 and described in more detail below. In some embodiments, a
diameter d.sub.1 of the proximal portion 36 of the sleeve 22 may be
smaller than a diameter d.sub.2 of the distal portion 32 of the
sleeve 22 as shown in FIG. 1. In some embodiments, the diameter
d.sub.1 of the proximal portion 36 may be the same or greater than
the diameter d.sub.2 of the distal portion 36 of the sleeve 22. The
diameter d.sub.2 of the distal portion 36 of the sleeve 22 is
greater than a diameter d.sub.3 surrounding the mid portion 34 of
the body 12. In some embodiments, a mid portion 37 of the sleeve 22
surrounding the mid portion 34 of the body 12 is sized so that a
diameter 39 of the mid portion 37 of the sleeve 22 is slightly
larger than a diameter 41 of the mid portion 34 of the body 12.
[0027] As shown in FIG. 3, the proximal portion 36 of the sleeve 22
may extend proximal to the proximal portion 14 of the body 12. As
shown, the proximal portion 36 may close on itself in the absence
of fluid flowing through the body 12 or the sleeve 22. In some
embodiments, the proximal portion 36 may form a one-way valve that
allows bile to flow into the duodenum or the stomach but prevents
contents from the duodenum or the stomach from traveling through
the lumen 18 of the body 12 to the bile duct.
[0028] FIG. 4 illustrates an alternative embodiment of the
prosthesis 10 showing a valve 40 extending proximally from the
proximal portion 14 of the body 12. The valve 40 may be separate
from the sleeve 22 so that the distal portion 36 of the sleeve 22
is distal to the valve 40. The distal portion 36 may be similar to
the distal portions 36 in the embodiments described above. The
valve 40 may be a one-way valve so that contents from the duodenum
or the stomach do not travel through the lumen 18 of the body 12 to
the bile duct. In some embodiments, the valve 40 may be a one-way
valve positioned within the lumen 18 of the body 12 as shown in
FIG. 5.
[0029] FIGS. 6 and 7 illustrate cross-sectional views through the
body 12 of the prosthesis 10. FIG. 6 illustrates the body 12 having
a substantially uniform circumference 38. The connected portion 24
is shown with the sleeve 22 connected to the body 12. The sleeve
lumen 23 and the body lumen 18 are also shown. FIG. 7 illustrates
an alternative embodiment showing the body 12 having one or more
channels 52 involuted from the surface 26 of the body 12. The
connected portions 24 are spaced apart from the channels 52 so that
the sleeve lumen 23 is positioned between the body 12 and the
sleeve 22. The channels 52 allow for fluid to continue flowing
within the lumen 23 in the event that the sleeve 22 is pressed
against the body 12 at an unconnected portion and fluid flow is
inhibited.
[0030] FIGS. 8 and 9 illustrate embodiments of a prosthesis 100.
The prosthesis 100 includes a body 112 having proximal portion 114,
a distal portion 116 and a lumen 118 extending therethrough. As
shown in FIGS. 8 and 9, the body 112 is provided as a
non-expandable tubular stent. The body 112 is shown as a double
pigtail stent but may also be provided having a single pigtail
and/or skived portions on the proximal and/or distal portions 114,
116 to help hold the body 112 in position within the bodily
site.
[0031] The prosthesis 100 further includes a sleeve 122 having a
connected portion 124 to operably connect the sleeve 122 to the
body 112 at at least one position along the body 112. The sleeve
122 is connected to the body 112 in such a way that fluid can pass
through a sleeve lumen 123 between an outer surface 126 of the body
112 and an inner surface 128 of the sleeve 122. The connected
portion 124 of the sleeve 122 is configured so that the connected
portion 124 still allows fluid flow through the sleeve lumen 123
generally from a distal portion 132 of the sleeve 122 to a proximal
portion 136 of the sleeve 122. The connected portion 124 may be
similar to the connected portion 24 described above. As shown in
FIGS. 8 and 9, the distal portion 132 of the sleeve 122 is
unconnected to the body 112 of the prosthesis 100 and includes
sufficient material to extend away from the body 112 as will be
explained in more detail below. The distal portion 132 of the
sleeve 122 may be collapsed against the body 112 for delivery of
the prosthesis 100 to the bodily lumen and then the distal portion
132 may be extended away from the body 112 when the prosthesis 100
is in positioned within the bodily lumen.
[0032] The proximal portion 136 of the sleeve 122 may be sized and
shaped to fit close to the body 112 as shown in FIG. 8 or to
include sufficient material to extend away from the body 112 as
shown in FIG. 9. In some embodiments, the proximal portion 136 of
the sleeve 122 may be connected to the body 112 by a connected
portion 124. In other embodiments, the proximal portion 136 of the
sleeve 122 may be unconnected to the body 112 and sized closely fit
to the body 112 or extended away from the body 112. In some
embodiments, a diameter d.sub.1 of the proximal portion 136 of the
sleeve 122 may be smaller than a diameter d.sub.2 of the distal
portion 132 of the sleeve 122 as shown in FIG. 8. In some
embodiments, the diameter d.sub.1 of the proximal portion 36 may be
the same or greater than the diameter d.sub.2 of the distal portion
36 of the sleeve 22.
[0033] In some embodiments, the prosthesis 100 may include one or
more channels 152 similar to the channels 52 described above.
[0034] FIG. 10 illustrates an embodiment of the prosthesis 10
wherein the body 12 includes an expanded proximal end portion 56
and an expanded distal end portion 58 that have larger diameters
than a central portion 62 of the body 12. The expanded proximal and
distal end portions 56, 58 may be used to help hold the prosthesis
10 in position within the body of the patient. The distal portion
32 of the sleeve 22 is shown expanded away from the distal end
portion 58 of the body 12. Fluid may enter the sleeve lumen 23 or
the body lumen 18 to drain fluid out of the duct as described in
more detail below.
[0035] FIG. 11 illustrates the prosthesis 10 with the distal
portion 16 of the body 12 positioned within the gall bladder or a
hepatic duct 226 of the liver 227. The distal portion 32 of the
sleeve 22 is positioned in the duct 226. The sleeve 22 is shown
extended away from the distal portion 16 of the body 12 and
positioned against a wall 225 of the duct 226. The distal portion
32 of the sleeve 22 is made of a flexible material so that the
distal portion 32 can abut the wall 225 and generally conform to
the shape of the wall 225 so that bile needing to drain from the
duct 226 is captured by the distal portion 32 of the sleeve 22 and
directed to the sleeve lumen 23. The bile can also drain through
the lumen 18 of the body 12. As shown in FIG. 11, the body 12 and
the sleeve 22 extend through the wall 225 of the duct 226, across
the peritoneum 228, through a wall 229 of the gastrointestinal
tract 230 and into the gastrointestinal tract 230. The proximal
portion 14 of the body 12 is positioned within the gastrointestinal
tract 230. The proximal portion 36 of the sleeve 22 also extends
into the gastrointestinal tract 230 so that fluid entering the
sleeve lumen 23 in the duct 226 is released in the gastrointestinal
tract 230 and not the peritoneum 228. The sleeve 22 extends across
the peritoneum 228 and retains the fluid within the lumen 23 of the
sleeve 22 until the sleeve 22 opens within the gastrointestinal
tract 230. The sleeve 22 may be connected to the body 12 at one or
more connected portions 24. For example, the connected portion may
be positioned near the wall 225 so that the distal portion 32 is
free to expand against the wall 225 but once the sleeve 22 exits
the wall 225, the connected portion 24 helps to maintain the sleeve
22 in close proximity to the body 12 so that the sleeve 22 does not
gather together and block flow through the sleeve lumen 23. In some
embodiments, the sleeve 22 may be sized and shaped to closely fit
over the body 12 once the body 12 exits the wall 225 yet allows
fluid flow through the sleeve lumen. In some embodiments, the
sleeve 22 may be formed of stiffer material relative to the distal
portion 32 once the sleeve 22 exits the wall 225. The length of the
body 12 and the sleeve 22 will vary depending on the patient and
will have sufficient length to extend between the duct 226 and the
gastrointestinal tract 230.
[0036] The materials used to manufacture the components of the
prosthetic devices described herein may be any materials known to
one skilled in the art that are suitable for use in patients. By
way of non-limiting example, the body may be formed from metals or
polymers. Suitable exemplary metals include stainless steel and
nitinol. In some embodiments, the body may be woven or provided in
a zig-zag configuration. Sleeves of the prosthetic devices of the
embodiments may be made from any suitable biocompatible material
that is liquid impermeable and that does not degrade in the
presence of fluids or gastric material that comes in contact
therewith. By way of non-limiting example, the sleeve may be made
from a medical grade expanded PTFE, polyurethane material,
silicone, nylon, polyamides such as other urethanes, or other
biocompatible materials that are flexible and acid resistant.
[0037] Delivery of the prosthesis will be explained with reference
to the prosthesis 10 as an example and being positioned between the
gall bladder and the duodenum. One skilled in the art will also
understand that the prosthesis 10, 100 may be positioned between
the hepatic duct and the stomach. FIGS. 12-14 illustrate delivery
of the prosthesis 10. For reference, the pancreatic duct 200 of the
pancreas 210 is shown having an obstruction 214 obstructing the
common bile duct 220 and the pancreatic duct 200. The obstruction
214 prevents the placement of a biliary stent within the common
bile duct 220 to allow the bile to drain.
[0038] Typically an endoscope or an endoscopic ultrasound (EUS)
device that utilizes high frequency sound waves to create an image
of living tissue or an echogenic surface, is positioned in the
duodenum 212. An EUS device 232 is shown in FIG. 12 having an
ultrasonic array of transducers 234 at the distal end 2388 of the
endoscope 232. The transducers 234 may be connected to an imaging
system (not shown) for viewing the image created by the ultrasonic
transducers 234 to facilitate placement of the prosthesis 10. The
transducers 234 generate an ultrasonic scanning plane to permit
real-time monitoring of an insertion needle 242 having an echogenic
surface. As shown in FIG. 12, the needle 242 is used to puncture
the bile duct 226. Bile may be withdrawn through the needle and
contrast may be injected to facilitate delivery of the prosthesis
10. A wire guide 244 may be inserted through the needle 242 and
delivered to the bile duct 226. The prosthesis 10 is delivered from
the duodenum 212 over the wire guide 244 into the gall bladder 226
as shown in FIG. 13. The sleeve 22 is delivered to the site
positioned against the body 12. In some embodiments, an outer
sheath may be placed over the sleeve 22 and body 12 for delivery of
the prosthesis 10 to the site. In some embodiments, the distal
portion 32 of the sleeve 22 may be temporarily secured to the
distal portion 16 of the body 12, for example by a releasable
suture or by a temporary glue that dissolves on contact with bodily
fluids. Other methods for temporarily securing the distal portion
32 of the sleeve 22 to the body 12 are also possible.
[0039] FIG. 14 illustrates the prosthesis 10 positioned in the gall
bladder 226 and extending across the peritoneum 228 into the
duodenum 212. The distal portion 32 of the sleeve 22 is shown
extended away from the distal portion 16 of the body 12 and
positioned against the wall 225 of the gall bladder 226, generally
conforming to the shape of the wall 225 so that bile needing to
drain from the gall bladder 226 is captured by the distal portion
32 of the sleeve 22 and directed to the sleeve lumen 23. The bile
can also drain through the lumen 18 of the body 12. The proximal
portion 14 of the body 12 is positioned within the duodenum 212.
The proximal portion 36 of the sleeve 22 also extends into the
duodenum 212 so that fluid entering the sleeve lumen 23 in the gall
bladder 226 is released in the duodenum 212 and not the peritoneum
228. The sleeve 22 extends across the peritoneum 228 and retains
the fluid within the lumen 23 of the sleeve 22 until the sleeve 22
opens within the duodenum 212. In some embodiments, where the body
12 is an expandable stent, the body 12 may be expanded so that the
diameter of the expanded stent is less than the diameter of the
sleeve, at least at the mid portion of both the body and the
sleeve.
[0040] The above Figures and disclosure are intended to be
illustrative and not exhaustive. This description will suggest many
variations and alternatives to one of ordinary skill in the art.
All such variations and alternatives are intended to be encompassed
within the scope of the attached claims. Those familiar with the
art may recognize other equivalents to the specific embodiments
described herein which equivalents are also intended to be
encompassed by the attached claims.
* * * * *