U.S. patent application number 16/698816 was filed with the patent office on 2020-03-26 for methods and devices for anchoring a gastroenterologic sleeve.
This patent application is currently assigned to Ballast Medical Inc.. The applicant listed for this patent is Ballast Medical Inc.. Invention is credited to David J. Blaeser, Michel Gagner, Dale A. Spencer.
Application Number | 20200093585 16/698816 |
Document ID | / |
Family ID | 40913289 |
Filed Date | 2020-03-26 |
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United States Patent
Application |
20200093585 |
Kind Code |
A1 |
Gagner; Michel ; et
al. |
March 26, 2020 |
Methods And Devices For Anchoring A Gastroenterologic Sleeve
Abstract
A gastroenterologic sleeve is anchored within the digestive
tract, without tissue-puncturing mechanisms, by providing anchoring
mechanisms that utilize the inherent shape of the stomach to
prevent sleeve migration. In at least two embodiments, the
anchoring mechanism expands to conform to the interior stomach
walls. In other embodiments, internal pessary rings are held in
place at the gastroesophageal junction by an external band. A
delivery device is provided for implanting the various device
transesophageally.
Inventors: |
Gagner; Michel; (Montreal,
CA) ; Blaeser; David J.; (Brooklyn Park, MN) ;
Spencer; Dale A.; (Wayzata, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Ballast Medical Inc. |
Montreal |
|
CA |
|
|
Assignee: |
Ballast Medical Inc.
Montreal
CA
|
Family ID: |
40913289 |
Appl. No.: |
16/698816 |
Filed: |
November 27, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12865706 |
Dec 15, 2010 |
10517709 |
|
|
PCT/US2009/032737 |
Jan 30, 2009 |
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16698816 |
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61025500 |
Feb 1, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/00818
20130101; A61F 5/0076 20130101; A61F 2/04 20130101; A61F 2002/041
20130101; A61F 2002/045 20130101 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1. A device implantable in a digestive tract comprising a duodenum
and a stomach having a body, an antrum, a pylorus and a pyloric
sphincter, the device comprising: a sheath having a distal portion
positionable within the duodenum and a proximal end configured to
terminate within the pylorus when the device is positioned in the
digestive tract, the sheath comprising a section extending between
the distal portion and the proximal end, the section being
configured to extend through the pyloric sphincter and to yield
upon closure of the pyloric sphincter; and an anchoring device
configured to prevent migration of the sheath through the digestive
tract without puncturing tissue of the digestive tract, the
anchoring device comprising: a ring engaged with the proximal end
of the sheath, the ring having an original configuration and being
compressible to a collapsed configuration for delivery into the
digestive tract, and converting to a sitting configuration once
positioned within the digestive tract for sitting against a portion
of the digestive tract uptract of the pyloric sphincter.
2. The device of claim 1, wherein the sitting configuration
corresponds to the original configuration.
3. The device of claim 1, wherein the anchoring device further
comprises: at least one additional ring provided in a spaced-apart
relationship relative to the ring; and a connecting mechanism
connecting the ring and the at least one additional ring.
4. The device of claim 3, wherein the sheath is engaged to a
distalmost one of the ring and the at least one additional
ring.
5. The device of claim 1, wherein the anchoring device further
comprises: a plurality of additional rings provided in a
spaced-apart relationship relative to each other, at least one of
the plurality of the additional rings being positionable within the
antrum of the stomach; and a connecting mechanism connecting the
ring and the at least one additional ring; wherein the sheath is
engaged to a distalmost one of the ring and the at least one
additional ring.
6. The device of claim 5, wherein at least one of the plurality of
the additional rings is positionable within the body of the
stomach.
7. The device of claim 3, wherein the connecting mechanism
comprises a plurality of elongated connectors.
8. The device of claim 3, wherein the connecting mechanism
comprises a sleeve.
9. The device of claim 8, wherein the sleeve is semi-permeable.
10. The device of claim 8, wherein the anchoring device is
configured to control an amount of food entering the stomach that
is permitted to interact with the stomach.
11. A method for reducing interaction between food and a digestive
tract comprising a duodenum and a stomach having a body, an antrum,
a pylorus and a pyloric sphincter, the method comprising: inserting
a device comprising a sheath and an anchoring device into the
digestive tract, the anchoring device comprising: a ring having an
original configuration and being engaged with a proximal end of the
sheath, the ring being configurable to a collapsed configuration
for insertion within the digestive tract; positioning a distal
portion of the sheath within the duodenum and the ring in the
pylorus such that a section of the sheath extends through the
pyloric sphincter and the proximal end of the sheath terminates
within the pylorus, wherein following the positioning, the ring is
convertible to a sitting configuration for sitting against a
portion of the digestive tract without puncturing tissue, and the
section of the sheath is configured to yield upon closure of the
pyloric sphincter.
12. The method of claim 11, wherein the sitting configuration
corresponds to the original configuration.
13. The method of claim 11, wherein the device is insertable into
the digestive tract via an endoscopic delivery device, and wherein
the ring returns to its original configuration upon exiting the
endoscopic delivery device.
14. The method of claim 13, wherein the endoscopic delivery device
comprises an endoscopic catheter and a sheath catheter surrounding
the endoscopic catheter, the endoscopic catheter and the sheath
catheter defining a tubular space therebetween to receive the ring
when the ring is in the collapsed configuration.
15. The method of claim 14, wherein the endoscopic catheter
comprises a pulling wire and an attachment mechanism at a distal
end thereof, and the device is engaged with the endoscopic delivery
device via the attachment mechanism.
16. The method of claim 15, further comprising retracting the
pulling wire into the endoscopic catheter once the ring is deployed
from the collapsed configuration to the original configuration.
17. The method of claim 11, further comprising positioning an
additional ring of the anchoring device within the stomach and in a
spaced apart relationship relative to the ring positioned in the
pylorus.
Description
RELATED APPLICATIONS
[0001] This application claims priority to patent application Ser.
No. 12/865,706, filed Dec. 15, 2010 (371(c) date), entitled Methods
And Devices For Anchoring A Gastroenterologic Sleeve, which claims
priority to International Patent Application No. PCT/US2009/032737,
filed Jan. 30, 2009, entitled Methods And Devices For Anchoring A
Gastroenterologic which claims benefit of and priority to U.S.
Provisional Application Ser. No. 61/025,500 filed Feb. 1, 2008
entitled Methods And Devices For Anchoring A Gastroenterologic
Sleeve, all of which are hereby incorporated herein by reference in
their entireties.
BACKGROUND OF THE INVENTION
[0002] The present invention relates generally to improved methods
and devices for anchoring a gastroenterologic sleeve within the
stomach without reliance on sutures, staples, or other mechanisms
that puncture the stomach wall. In addition to leaving the stomach
walls free of punctures, the anchoring system of the present
invention prevents movement of the sleeve in both directions,
thereby preventing the sleeve from being passed through the
digestive system but also from refluxing up the esophagus.
[0003] According to the Center for Disease Control (CDC), sixty six
percent of American are overweight, and thirty two percent are
obese, presenting an overwhelming health problem. From an economic
standpoint, it is estimated that more than 100 billion dollars are
spent on obesity and treating its major co-morbidities. This figure
does not include psychological and social costs. Many health care
experts consider obesity the largest health problem facing
westernized societies and considered obesity an epidemic. From a
medical standpoint, obesity is the primary risk factor for type 2
diabetes and obstructive sleep apnea. It increases the chances for
heart disease, pulmonary disease, infertility, osteoarthritis,
cholecystitis and several major cancers, including breast and colon
cancers. Despite these alarming facts, treatment options for
obesity remain limited.
[0004] Treatment options include dietary modification, very
low-calorie liquid diets, pharmaceutical agents, counseling,
exercise programs and surgery. Diet and exercise plans often fail
because most individuals do not have the discipline to adhere to
such plans. When diet and exercise fail, many try dietary
supplements and drugs or other ingestible preparations promoted as
being capable of suppressing appetite or inducing satiety. In
general, these techniques for treating compulsive
overeating/obesity have tended to produce only a temporary effect.
The individual usually becomes discouraged and/or depressed after
the initial rate of weight loss plateaus and further weight loss
becomes harder to achieve. The individual then typically reverts to
the previous behavior of compulsive overeating.
[0005] Surgical procedures that restrict the size of the stomach
and/or bypass parts of the intestine are the only remedies that
provide lasting weight loss for the majority of morbidly obese
individuals. Surgical procedures for morbid obesity are becoming
more common based on long-term successful weight loss result.
[0006] Bariatric surgery is a treatment for morbid obesity that
involves alteration of a patient's digestive tract to encourage
weight loss and to help maintain normal weight. Known bariatric
surgery procedures include jejuno-ileal bypass, jejuno-colic shunt,
biliopancreatic diversion, gastric bypass, Roux-en-Y gastric
bypass, gastroplasty, gastric banding, vertical banded
gastroplasty, and silastic ring gastroplasty. A more complete
history of bariatric surgery can be found on the website of the
American Society for Bariatric Surgery at http://www.asbs.org, the
contents of which are incorporated by reference herein in their
entirety.
[0007] Most of the surgeries which create malabsorption, such as
the by-pass operations, although effective in weight reduction,
involve permanent modification of the GI tract and have a risk of
short and long term complication and even death. By implanting a
gastroenterologic sleeve, which is essentially a prosthetic liner
for the stomach and/or duodenum, malabsorption can be induced
without permanently modifying the GI tract. The sleeve simply
provides a physical barrier between the food eaten and the
absorptive stomach and duodenic walls.
[0008] Unfortunately, present gastroenterologic sleeve designs
require fastening the sleeve to the tissue of the stomach or
duodenum. Typically, this is accomplished through sutures, staples,
or the like. Because the interior lining of the GI tract is
incredibly slippery, it is very difficult to mechanically fasten
anything to them. Additionally, anytime the walls of the GI tract
are punctured, there is a risk of infection and other
complications.
OBJECTS AND SUMMARY OF THE INVENTION
[0009] The methods and devices of the present invention are
directed to methods and devices for implanting a gastroenterologic
sleeve into the stomach and/or duodenum without using puncturing
fasteners such as staples or sutures.
[0010] In one embodiment, a plurality of pessary rings is
incorporated into a sleeve such that the rings expand until they
contact the stomach walls. This embodiment takes advantage of the
fact that the inlet and outlet of the stomach are much smaller than
the interior of the stomach. Hence, once the rings have expanded,
they are too large to migrate out of the stomach.
[0011] Another embodiment involves the use of a loose, yet
expandable matrix implanted in the stomach. The matrix allows
interaction between the stomach and food yet provides an anchor to
which a sleeve lining the duodenum is attached. Hence, the matrix
eliminates the possibility of the sleeve migrating through the
intestinal tract.
[0012] Another embodiment employs two pessary rings and a band or
other constrictor, such as a lap band. The pessary rings are
installed inside the esophageal-stomach junction and have an
inherent expansive force. A lap band is placed around the outside
of the stomach, between the pessary rings, and has a squeezing
force. Hence, the pessary rings and the lap band interact to lock
each other in place. A sheath, tube or sleeve is attached to the
pessary rings and extends into the stomach to cause food to bypass
some or all of the stomach. The sheath may also extend into the
duodenum such that a portion of the small intestine is also
bypassed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] FIG. 1 is an elevation of an embodiment of the present
invention installed within a stomach;
[0014] FIG. 2 is an elevation of an embodiment of the present
invention installed within a stomach;
[0015] FIG. 3 is an elevation of an embodiment of the present
invention installed within a stomach;
[0016] FIG. 4 is an elevation of an embodiment of the present
invention installed within a stomach; and
[0017] FIG. 5 is a perspective view of a delivery device that may
be used to delivery the devices of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0018] Referring now to the figures and first to FIG. 1 there is
shown an embodiment of the present invention that includes a device
10 for creating a malabsorption condition in the stomach and/or
duodenum. The device 10 generally includes an absorption-limiting
or preventing sheath or tube 20 that is attached at a proximal end
22 to an anchoring device 40.
[0019] The anchoring device 40 includes a plurality of rings 42,
such as pessary rings for example, connected together by thin
connectors 44. The rings 42 are resilient and collapsible such that
they may be compressed into elongate members for introduction into
the stomach via the esophagus with a catheter or endoscope. Upon
release from the delivery device, the rings 42 expand and orient
themselves in a spaced-apart fashion. The rings are sized and
arranged according to the shape of the stomach and it is envisioned
that each device will be sized proportionately to the size of the
patient, if necessary.
[0020] The connectors 44 are thin, thread-like connectors that
prevent the rings 42 from twisting. The connectors 44 also function
to combine the rings 42 into a single anchor and further create
large gaps through which food may contact the stomach walls for
digestion. In the event that it is desired to prevent the food from
contacting the stomach walls, the thin connectors 44 may be
replaced by a sleeve-like material. It is further envisioned that a
combination of thin connectors 44 and connectors made of
sleeve-like material may be used to control the area of the stomach
that participates in the digestive process. It is further
contemplated that the thin connectors 44 may be replaced by a
semi-permeable sleeve material that allows some of the food to come
into contact with stomach acid for digestion.
[0021] FIG. 2 shows another embodiment of a device 50 of the
present invention. The device 50 also includes an
absorption-limiting or preventing sheath or tube 20 that is
attached at a proximal end 22 to an anchoring device 60. The
anchoring device 60 is constructed of a loose, expandable matrix
62. The matrix 62 is constructed such that some or all of the food
entering the stomach is permitted to interact with the stomach in
the digestive process. The matrix may be constructed of a
self-expanding material such as Nitinol, or any suitable,
digestive-resistant material. The anchoring device 60 is sized to
substantially fill the stomach cavity when expanded and also to
conform to the shape of the stomach, thereby providing a stable
anchor for the tube 20.
[0022] FIG. 3 shows an embodiment of a device 70 that includes
sheath 80 connected to an anchoring device 90. The sheath 80 is
sized and constructed to prevent food from contacting the upper
stomach, thereby limiting digestion. At its upper end, the sheath
80 is connected to the anchoring device 90, which includes
components that are internal and external to the gastroesophageal
junction.
[0023] The interior components of the anchoring device 90 include
two pessary rings 92, each connected to the sheath 80. The pessary
rings 92 are self-expanding and, when in place, place a mild
pressure on the inside of the esophagus.
[0024] The exterior components of the anchoring device 90 include a
lap band 94 and an inflation device 96. The lap band 94 is fastened
around the outside of the gastroesophageal junction between the
locations of the pessary rings 92. The anchoring device 90 also
includes a pump 98, such as a hand pump, connected to the lap band
94 via a tube 100. Once the lap band 94 is fastened around the
outside of the gastroesophageal junction between the locations of
the pessary rings 92, the lap band 94 is inflated with an
acceptable fluid, such that the lap band places an inward pressure
on the gastroesophageal junction between the external pressure
points of the pessary rings 92. In this way, the lap band 94 and
the pessary rings 92 cooperate to prevent movement of the anchoring
device 90. It is further contemplated that the lap band 94 can be
controlled using the pump 98 to control the amount and rate that
food can enter the stomach, as well as preventing gastroesophageal
reflux disease (GERD).
[0025] FIG. 4 depicts another embodiment of the device 70 in which
a sheath 110 is attached to the anchoring device 90 is longer and
extends well into the duodenum. This embodiment provides a solution
for completely bypassing the stomach and some or all of the
duodenum. However, it is envisioned that the sheath 110 could be
constructed, partly or entirely, of a semi-permeable material that
allows some gastric interaction between the food and the digestive
system. Doing so may prevent some of the undesirable effects of
malabsorption, such as the various forms of malabsorption
syndrome.
Implantation
[0026] The devices of FIGS. 1 and 2 may be implanted completely
endoscopically, without the use of a general anesthesia. FIG. 5
shows one example of a delivery device 120 for use in implanting
devices 10 or 50. The delivery device 120 includes a endoscopic
catheter 130 surrounded by a sheath catheter 150. A space 152
exists between the endoscopic catheter 130 and the sheath catheter
150 that is sized to allow the device 10 or 50 to be tubularly
loaded therein.
[0027] The endoscopic catheter 130 includes a pulling wire 132 with
an attachment mechanism 134 at a distal end thereof. The endoscopic
catheter 130 also includes an endoscope 136 and a steering device
(not shown). Preferably, a portion of the endoscopic catheter 130,
such as the pulling wire 132, is radiopaque. Alternatively,
radiopaque bands may be incorporated into the distal end of the
delivery device 120.
[0028] In operation, a device 10 or 50 is loaded into the delivery
device 120 such that the endoscopic catheter 130 passes through the
interior lumen of the device 10 or 50 and the sheath catheter 150
surrounds the exterior of the device 10 or 50. The device 10 or 50
is loaded such that the distal end of the device 10 or 50 is at the
distal end of the delivery device 120. The attachment mechanism 134
is attached to the distal end of the device 10 or 50.
[0029] The delivery device 120 is then navigated transesophageally
into and through the stomach and into the duodenum to a desired
depth. The delivery device 120 is then retracted while the pulling
wire 132 is advanced through the endoscopic catheter 130 such that
the distal end of the pulling wire 132 remains somewhat stationary
with respect to the duodenum. Hence, as the delivery device 120 is
retracted, the pulling wire 132 pulls the device 10 or 50 from the
distal end of the delivery device via the attachment mechanism
134.
[0030] As the delivery device 120 is retracted, the endoscope 136
provides an interior view of the device 10 or 50 being deployed.
Hence, verification that the device 10 or 50 is not twisted or
otherwise fouled is provided.
[0031] Once the delivery device 120 is retracted through the
stomach, and the entire device 10 or 50 is deployed, the attachment
device 134 is released from the distal end of the device 10 or 50
and the pulling wire 132 is retracted into the endoscopic catheter
130. Then the entire delivery device 120 is removed from the
body.
[0032] The delivery device 120 may be similarly used to deploy the
device 70 of FIGS. 3 and 4. However, laparoscopic installation of
the lap band 94 is also required.
[0033] Although the invention has been described in terms of
particular embodiments and applications, one of ordinary skill in
the art, in light of this teaching, can generate additional
embodiments and modifications without departing from the spirit of
or exceeding the scope of the claimed invention. Accordingly, it is
to be understood that the drawings and descriptions herein are
proffered by way of example to facilitate comprehension of the
invention and should not be construed to limit the scope
thereof.
* * * * *
References