U.S. patent application number 16/530161 was filed with the patent office on 2019-11-21 for gastric bypass system and method.
This patent application is currently assigned to Rex Medical, L.P.. The applicant listed for this patent is Rex Medical, L.P.. Invention is credited to James F. McGuckin, JR..
Application Number | 20190350734 16/530161 |
Document ID | / |
Family ID | 54252152 |
Filed Date | 2019-11-21 |
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United States Patent
Application |
20190350734 |
Kind Code |
A1 |
McGuckin, JR.; James F. |
November 21, 2019 |
GASTRIC BYPASS SYSTEM AND METHOD
Abstract
A system and method for treating obesity including a first
instrument containing a first magnet therein, the first instrument
insertable into a stomach of a patient and the first magnet
deployable into the stomach of the patient and having a first
space. A second instrument contains a second magnet therein, the
second instrument insertable into a bowel of a patient and the
second magnet deployable into the bowel of the patient and having a
second space. A stent is insertable into the first and second
spaces to maintain an opening formed between the stomach and
bowel.
Inventors: |
McGuckin, JR.; James F.;
(Radnor, PA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Rex Medical, L.P. |
Conshohocken |
PA |
US |
|
|
Assignee: |
Rex Medical, L.P.
Conshohocken
PA
|
Family ID: |
54252152 |
Appl. No.: |
16/530161 |
Filed: |
August 2, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14859280 |
Sep 19, 2015 |
10376400 |
|
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16530161 |
|
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62062366 |
Oct 10, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/1139 20130101;
A61B 17/1114 20130101; A61B 2017/00876 20130101; A61F 5/0076
20130101; A61F 5/0089 20130101; A61F 2002/045 20130101; A61F 2/04
20130101 |
International
Class: |
A61F 5/00 20060101
A61F005/00; A61B 17/11 20060101 A61B017/11; A61F 2/04 20060101
A61F002/04 |
Claims
1-20. (canceled)
21. A method of treating obesity in a patient, the method
comprising: inserting a first endoscope into the patient's stomach;
inserting a second endoscope into the patient's bowel; inserting an
approximating device into the patient's stomach through the first
endoscope; puncturing the patient's stomach and the patient's bowel
with the approximating device; retracting the approximating device
to thereby approximate the patient's bowel and the patient's
stomach; inserting a first magnet into the patient's stomach
through the first endoscope; inserting a second magnet into the
patient's bowel through the second endoscope such that the second
magnet is magnetically connected to the first magnet through the
patient's stomach and the patient's bowel; inserting a cutting
device through the first endoscope; removing stomach and bowel
tissue between the first magnet and the second magnet to thereby
form an opening between the patient's stomach and the patient's
bowel; inserting a stent through the first endoscope; and
positioning the stent within the opening between the patient's
stomach and the patient's bowel.
22. The method of claim 21, wherein puncturing the patient's
stomach and the patient's bowel includes passing a needle through
the patient's stomach and the patient's bowel.
23. The method of claim 22, wherein puncturing the patient's
stomach and the patient's bowel includes positioning an engagement
member carried by the needle in contact with the patient's
bowel.
24. The method of claim 23, wherein positioning the engagement
member in contact with the patient's bowel includes orienting a
T-bar within the patient's bowel such that the T-bar is positioned
transversely in relation to the needle.
25. The method of claim 23, wherein retracting the approximating
device includes pulling the engagement member proximally into
contact with the patient's bowel.
26. The method of claim 21, wherein inserting the stent through the
first endoscope includes inserting a sheath through the first
endoscope, the stent being positioned within the sheath.
27. The method of claim 26, wherein positioning the stent within
the opening between the patient's stomach and the patient's bowel
includes exposing the stent from the sheath.
28. The method of claim 21, wherein inserting the first magnet into
the patient's stomach includes reconfiguring the first magnet from
a generally linear configuration to curved configuration such that
the first magnet defines an opening.
29. The method of claim 28, wherein inserting the second magnet
into the patient's bowel includes reconfiguring the second magnet
from a generally linear configuration to curved configuration such
that the second magnet defines an opening.
30. The method of claim 29, wherein removing the stomach and bowel
tissue between the first magnet and the second magnet includes
passing the cutting device through the opening in the first magnet
and through the opening in the second magnet.
31. A method of treating obesity comprising: inserting a first
endoscope into a first tissue region; inserting a second endoscope
into a second tissue region; puncturing the first tissue region and
the second tissue region using an approximating device inserted
through one of the first endoscope and the second endoscope;
retracting the approximating device to thereby position the first
tissue region and the second tissue region in adjacent relation;
magnetically connecting the first tissue region and the second
tissue region via insertion of a first magnet into the first tissue
region through the first endoscope and insertion of a second magnet
into the second tissue region through the second endoscope; forming
an opening between the first tissue region and the second tissue
region by removing tissue between the first magnet and the second
magnet using a cutting device inserted through one of the first
endoscope and the second endoscope; and inserting a stent into the
opening between the first tissue region and the second tissue
region through one of the first endoscope and the second
endoscope.
32. The method of claim 31, wherein puncturing the first tissue
region and the second tissue region includes passing a needle from
the first tissue region into the second tissue region.
33. The method of claim 32, wherein puncturing the first tissue
region and the second tissue region includes deploying an
engagement member carried by the needle such that the engagement
member contacts the second tissue region.
34. The method of claim 33, wherein retracting the approximating
device includes pulling the engagement member proximally to thereby
pull the second tissue region into contact with the first tissue
region.
35. The method of claim 31, wherein forming the opening between the
first tissue region and the second tissue region includes passing
the cutting device through annular openings in the first magnet and
the second magnet.
36. The method of claim 31, wherein inserting the stent into the
opening between the first tissue region and the second tissue
region includes deploying the stent from a sheath.
37. A system for treating obesity, the system comprising: a) a
first endoscope configured to receive a first magnet; b) a second
endoscope configured to receive a second magnet; c) a tissue
approximating device configured for movement through the first
endoscope, the tissue approximating device including: a needle; and
a tissue engagement member carried by the needle; d) a cutting
device configured for movement through the first endoscope; and e)
a stent delivery device configured for movement through the first
endoscope, the stent delivery device including: a sheath; and a
stent deployable positioned within the sheath, wherein the first
endoscope further includes a plurality of working channels
configured to receive the first magnet, the tissue approximating
device, the cutting device, and the stent delivery device such that
the first magnet, the tissue approximating device, the cutting
device, and the stent delivery device are each insertable into an
internal working space within a patient without removing the first
endoscope from the patient.
38. The system of claim 37, wherein the first magnet and the second
magnet are each reconfigurable between a first configuration, in
which the first magnet and the second magnet are each generally
linear, and a second configuration, in which the first magnet and
the second magnet are each generally annular.
39. The system of claim 37, wherein the plurality of working
channels includes: a first working channel configured to receive
the first magnet; a second working channel configured to receive
the tissue approximating device; a third working channel configured
to receive the cutting device; and a fourth working channel
configured to receive the stent delivery device.
40. The system of claim 37, wherein the tissue engagement member is
repositionable between a first position, in which the tissue
engagement member is oriented in generally parallel relation to the
needle, and a second position, in which the tissue engagement
member is oriented transversely in relation to the needle.
Description
[0001] This application claims priority from provisional
application Ser. No. 62/062,366, filed Oct. 10, 2014, the entire
contents of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The application relates to system and method treating
obesity, and, more particularly, to a system and method for
performing gastric bypass.
2. Background of the Related Art
[0003] The incidence of obesity continues to increase worldwide.
Obesity has been defined in terms of a body mass index greater than
30, with body mass index defined by weight in kilograms divided by
the square of the height in meters. (Overweight is defined as a
body mass index of over 25). Obesity can cause a number of serious
health conditions such as hypertension, diabetes, certain forms of
cancer, coronary artery disease, stroke, congestive heart failure,
and venous disease. Obesity can also cause orthopedic problems,
skin problems and respiratory difficulties.
[0004] A variety of methods are currently being utilized to treat
obesity. In general, these procedures fall into two categories:
procedures which restrict food intake or procedures which alter the
anatomy of the small intestine or divert the peristalsis of a
person's food intake past the small intestine to decrease caloric
absorption.
[0005] Some methods are designed to reduce the stomach by partition
or bypass such as by stapling or tying off portions of the large or
small intestine or stomach to reduce the amount of food desired by
the patient, and the amount absorbed by the intestinal tract. In
gastric banding, an adjustable band is placed externally of the
stomach to constrict a portion of the stomach. Such treatments are
designed to reduce the caloric intake of the individual by more
rapidly triggering the satiety impulse or limiting the amount of
food the individual can ingest. Complications can occur as the
individual, due to the stomach restriction, may not be intaking
sufficient nutrients.
[0006] Laparoscopic methods of banding and vertical banded
gastroplasty have been developed, which although provide the
advantages of minimally invasive surgery compared to open surgery
such as less trauma, less hospital stay and faster recovery, are
complicated to perform.
[0007] The need exists for an improved system and method for
treating obesity.
SUMMARY OF THE INVENTION
[0008] The present invention advantageously provides a minimally
invasive system and method for treating obesity.
[0009] In accordance with a first aspect, the present invention
provides a method for treating obesity comprising the steps of:
[0010] inserting first and second endoscopes, the first endoscope
inserted into a stomach of the patient and the second endoscope
inserted into a bowel of a patient;
[0011] delivering a penetrating device to penetrate a wall of the
stomach and a wall of the bowel;
[0012] approximating the bowel and stomach;
[0013] deploying a first magnet in the stomach and a second magnet
in the bowel;
[0014] creating an opening between the stomach and bowel; and
[0015] positioning a stent into the opening.
[0016] In some embodiments, the step of inserting a first endoscope
into the stomach includes advancing the first endoscope transorally
into the stomach.
[0017] In some embodiments, the method further includes the step of
inserting a T-bar through the wall of the stomach and wall of the
bowel and the step of approximating the bowel and stomach includes
the step of pulling the T-bar proximally.
[0018] In some embodiments, the first magnet is deployed from the
first endoscope and the second magnet is deployed from the second
endoscope. In some embodiments, the first magnet has a first
opening and the second magnet has a second opening, and the step of
creating an opening between the stomach and the bowel includes
inserting a cutting instrument through the first and second
openings of the magnets. In some embodiments, the first magnet is
retained in the first endoscope in a substantially linear position
and/or the second magnet is retained in the second endoscope in a
substantially linear position and the first and/or second magnets
move to a curved placement position after deployment from the
respective endoscope.
[0019] In some embodiments, the first endoscope has a first channel
to receive the first magnet and a second channel to receive a
device for approximating the stomach and bowel, and the step of
deploying the first magnet advances the first magnet from the first
channel. The first endoscope can have in some embodiments a third
channel to receive the stent and the step of positioning the stent
in the opening can include the step of advancing the stent from the
third channel.
[0020] The method can include the step of removing the first and
second endoscopes and closing off a portion of the stomach.
[0021] In accordance with another aspect of the present invention,
a system for treating obesity is provided comprising a first
instrument containing a first magnet therein, the first instrument
insertable into a stomach of a patient and the first magnet
deployable into the stomach of the patient and having a first
space. A second instrument contains a second magnet therein, the
second instrument insertable into a bowel of a patient and the
second magnet deployable into the bowel of the patient and having a
second space. A stent is insertable into the first and second
spaces to maintain an opening formed between the stomach and
bowel.
[0022] In some embodiments, the first magnet is retained in the
first instrument in a substantially linear position in the delivery
configuration and has a curved placement configuration after
deployment from the first instrument. In some embodiments, the
second magnet is retained in the second instrument in a
substantially linear position in the delivery configuration and has
a curved placement configuration after deployment from the second
instrument.
[0023] In some embodiments, the stent has a first collapsed
configuration when positioned in the first instrument and an
expanded second position after exposure from the first
instrument.
[0024] In some embodiments, the first instrument has a first
channel to receive the first magnet and a second channel to receive
a device for approximating the stomach and bowel. In some
embodiments, the first instrument has a third channel to receive
the stent.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] So that those having ordinary skill in the art to which the
subject invention appertains will more readily understand how to
make and use the surgical apparatus disclosed herein, preferred
embodiments thereof will be described in detail hereinbelow with
reference to the drawings, wherein:
[0026] FIG. 1 is a perspective view of a first endoscopic
instrument of the present invention configured for transoral
insertion into the stomach of a patient;
[0027] FIG. 2 is a perspective view showing the first endoscopic
instrument of FIG. 1 positioned in the stomach and a second
endoscopic instrument inserted in the bowel;
[0028] FIG. 3A is a front perspective view of the first endoscopic
instrument of FIG. 1;
[0029] FIG. 3B is a front perspective view of an alternate
embodiment of the first endoscopic instrument of the present
invention;
[0030] FIG. 4 is a perspective view of one of the magnets of the
present invention in the elongated delivery configuration;
[0031] FIG. 5A is a perspective view of the magnet of FIG. 4 in a
circular placement configuration;
[0032] FIG. 5B is a perspective view of the magnet of FIG. 4 in an
alternate C-shaped placement configuration;
[0033] FIGS. 6-20 illustrate the method of use of the system of the
present invention wherein
[0034] FIG. 6 illustrates the second endoscopic instrument being
inserted into the bowel;
[0035] FIG. 7 illustrates the first endoscopic instrument being
inserted into the stomach via a transoral approach;
[0036] FIG. 8 illustrates a needle and T-bar delivery sheath being
advanced from the first endoscopic instrument of FIG. 1 and further
showing the second endoscopic instrument positioned in the
bowel;
[0037] FIG. 9 is a view similar to FIG. 8 showing the needle
advanced from the delivery sheath to puncture the stomach wall;
[0038] FIG. 10 is a view similar to FIG. 9 illustrating the needle
and T-bar inserted through the stomach wall and into the bowel;
[0039] FIG. 11 is a view similar to FIG. 10 showing movement of the
T-bar proximally to approximate the stomach and bowel walls, and
further showing initial deployment of the sheath containing the
first magnet;
[0040] FIG. 12 is a view similar to FIG. 11 showing initial
deployment of the first magnet from the sheath;
[0041] FIG. 13 is a view similar to FIG. 12 showing the first
magnet fully released from the first endoscopic instrument and
positioned in the stomach, and further showing initial deployment
from the second endoscopic instrument the second sheath containing
the second magnet;
[0042] FIG. 14 is a view similar to FIG. 13 showing initial
deployment of the second magnet from the sheath;
[0043] FIG. 15 is a view similar to FIG. 14 showing the second
magnet fully released from the second endoscopic instrument and
positioned in the bowel adjacent the bowel wall and the attraction
of the second and first magnets to maintain the approximated
position of the stomach and bowel walls;
[0044] FIG. 16 is a view similar to FIG. 15 illustrating a
puncturing device advanced from the first endoscopic instrument and
being inserted through the space (opening) in the first magnet;
[0045] FIG. 17 is a view similar to FIG. 16 showing initial
deployment of a sheath containing a stent from the first endoscopic
instrument;
[0046] FIG. 18 is a view similar to FIG. 17 illustrating
advancement of the stent sheath through the openings in the
magnets;
[0047] FIG. 19 is a view similar to FIG. 18 illustrating placement
of the stent in the space between the first and second magnets to
maintain the opening between the stomach and bowel, and further
showing the first and second endoscopic instruments being
withdrawn; and
[0048] FIG. 20 illustrates the stent positioned in the stomach and
bowel and the endoscopic instruments removed.
[0049] FIG. 21 is a flow chart showing the procedural steps of the
system of the present invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0050] Referring now to the drawings wherein like reference
numerals identify similar structural features of the apparatus
disclosed herein, there is illustrated in FIG. 1 a first endoscopic
instrument, designated generally by reference numeral 10. The first
endoscopic instrument 10 of the system is configured to be inserted
transorally into the stomach S, as shown in FIG. 2. A second
endoscopic instrument 12 (FIG. 2) of the system is configured to be
inserted into the bowel minimally invasively through a port (not
shown). The two instruments 10, 12 deliver first and second
magnets, respectively, in performance of a gastric bypass procedure
explained in detail below.
[0051] As shown in FIG. 1, endoscopic instrument 10 is in the form
of an endoscope having visualization capabilities. Endoscopic
instrument 10 has a flexible outer tube 14 and a handle 16 with
optional access ports 16a, 16b for insertion of instruments,
insertion of fluid, and/or aspiration. Instruments inserted through
the instrument 10 exit the distal end 15. The flexible tube 14 is
dimensioned for insertion through the natural opening of the mouth
of the patient and through the esophagus into the patient's stomach
to provide a minimally invasive entry into the stomach. In
alternate embodiments, the endoscopic instrument 10 can be
configured for insertion through an access port for minimally
invasive entry into the stomach through a small surgeon-created
opening.
[0052] The second endoscopic instrument 12, as shown in FIG. 8, has
a distal end 13, imaging lens 17a, an illumination lens or window
17b for the light delivery system, and a lumen 19 to receive a
magnet delivery device 49 (FIG. 13) which contains a second magnet
described below. The second endoscopic instrument 12 can have
flexible tube, handle and access ports as in the first endoscopic
instrument 10.
[0053] Note the designations of "first" and "second" for the
various components and instruments, e.g., endoscopic instruments
and magnets, as used herein are merely to identify the separate
instruments and components and are not necessarily designated in
the order of insertion. For example, the first endoscopic
instrument can be inserted before or after the second endoscopic
instrument, and the first magnet can be inserted before or after
the second magnet.
[0054] As used herein, the term "proximal" denotes the portion of
the instrument closer to the user and the term "distal" denotes the
portion of the instrument further from the user.
[0055] In the embodiment of FIG. 3A (and FIG. 8), the first
endoscopic instrument 10 has four working channels (lumens), an
imaging lens 18a for visualization of the surgical site and an
illumination lens or window 18b for the light delivery system for
illuminating the surgical site. The four working channels or lumens
are for the various components of the system which are deployable
from the instrument 10 for performing the gastric bypass procedure.
More specifically, lumen 22 receives a magnet delivery device 40
for delivering a magnet 42 adjacent the inner stomach wall, lumen
24 receives a sheath 30 for delivering a needle 32 and T-bar 34 for
approximating the wall of the stomach and the wall of the bowel,
lumen 26 receives a cutting instrument (device) 36 for cutting an
opening between the deployed magnet 42 and a second magnet which is
deployed in the bowel, and lumen 28 receives a stent sheath 50 for
delivery of a stent 52 in the openings in the magnets and through
the approximated walls of the stomach and bowel to maintain the
opening between the approximated stomach and bowel. The lumens 22,
24, 26, 28 can be of various sizes and the instruments can be
inserted through lumens other than the particular lumen designated
in FIG. 8, e.g., sheath 30 can be inserted through lumen 28 and
stent sheath 50 inserted through lumen 24.
[0056] In the alternate embodiment of FIG. 3B, the endoscopic
instrument 60 has fewer working channels (lumens), thereby reducing
the overall diameter of the instrument 10. In this embodiment, the
same channel can be used to deploy several components of the
system. For example, endoscopic instrument 60 of this alternate
embodiment has an imaging lens 62 and an illumination lens or
window 64 for visualizing and illuminating the surgical site as in
the endoscopic instrument 10 of FIG. 3A. However, endoscopic
instrument 60 has a lumen 66 for the needle 32 and T-bar 34 and a
lumen 68 for the magnet delivery device 40 and magnet 42. In this
embodiment, the lumen 68 used for magnet delivery can also be used
for the cutting device 36, inserted after the magnet delivery
device 40 is withdrawn from the lumen after delivery of the magnet
42. The stent delivery device (stent sheath 50) can then be
inserted through the lumen 68 after withdrawal of the cutting
instrument 36. Note that lumen 66 can alternatively be used for the
cutting device and/or stent delivery. As can be appreciated, the
embodiment of FIG. 3B enables a smaller diameter endoscope to be
utilized since a single lumen can be used for multiple purposes.
However, the embodiment of FIG. 3A has the advantages of quicker
procedure time and ease of use as the various devices/components
can be preloaded in the endoscope working channels so the user does
not need to fully withdraw one device and then insert another
device through the endoscope working channel as in the embodiment
of FIG. 3B. Even if not preloaded, the instrument of FIG. 3A still
saves procedural time because one device does not have to be fully
removed from the instrument before another device is inserted.
[0057] The first magnet 42 is illustrated in FIG. 4. Preferably the
magnet 42 is delivered in a substantially linear configuration,
maintained in this delivery configuration (position) by a magnet
delivery device (sheath) 40 (see FIG. 11). When deployed from the
delivery device 40, the magnet 42 returns to a curved
placement/configuration for placement at the stomach wall. In the
embodiment of FIG. 5A, the magnet 42 returns to a circular, 360
degree shape. In the alternate embodiment of FIG. 5B, the magnet
42' returns from its substantially linear delivery configuration to
a C-shaped configuration so that ends 42a and 42b are spaced apart.
In either embodiment, the magnet 42, 42' has an opening or space
45, 45' respectively, to receive a cutting device and then a stent
as described in more detail below in conjunction with the method of
use. Note the magnet 42, 42', can be composed of a shape memory
material such as a nickel titanium alloy, e.g., Nitinol, with a
curved memorized configuration to which it returns upon deployment,
e.g., a memorized position of FIG. 5A or 5B. Other materials are
also contemplated.
[0058] The second magnet 48 can be the same as the first magnet 42
(or 42') and its variations described above, and made of the same
or alternate material as magnet 42 (or 42'). It is contained in the
magnet delivery device (sheath) 49 (FIG. 13) in a substantially
linear delivery configuration (position) and delivered into the
bowel for placement at the bowel wall as described below where it
returns to a curved configuration in a similar manner as magnet 42
or 42' shown in FIG. 5A or FIG. 5B.
[0059] The method of use of the system of the present invention for
performing gastric bypass will now be discussed in conjunction with
FIGS. 6-20. It should be noted that the system can alternatively be
used for other surgical procedures. The first endoscope or
endoscopic instrument 10 is inserted transorally into the stomach S
so that its distal end 15 is adjacent the stomach wall X as shown
in FIG. 7. The second endoscope or endoscopic instrument 12 is
inserted through a trocar port into the bowel B with its distal end
13 adjacent the bowel wall Z (FIG. 7). Note the first endoscope 10
does not necessarily need to be inserted before the second
endoscope 12, e.g., it could alternatively be inserted after the
second endoscope 12 is inserted into the bowel B. Additionally, the
first and second endoscopes 10, 12 can be inserted via other ways
into the stomach and bowel, respectively.
[0060] Once positioned in the stomach S, a needle and T-bar
delivery sheath 30 is advanced from lumen 24 of the endoscope 10 as
shown in FIG. 8. The needle 32, which carries the T-bar 34, is
advanced from sheath 30 by a pusher (not shown) to form a puncture
through the wall X of the stomach S and the wall Z of the bowel to
advance the T-bar 34 into the bowel B as shown in FIGS. 9 and 10.
Sheath 30 can then be retracted or a flexible T-bar connector 33
pulled proximally to pull T-bar 34 proximally to engage the inner
side of wall Z of the bowel B and to move the wall Z toward the
stomach wall X to approximate the bowel B and stomach S (FIG. 11).
The sheath 30 can be retracted within lumen 24. Magnet delivery
sheath 40 is then advanced from the lumen 22 of the endoscope 10
(FIG. 11), and a pusher (not shown) within the delivery sheath 40
advances the magnet 42 from the sheath 40. The magnet 42 as shown
is retained in a substantially linear delivery position along a
longitudinal axis of the delivery sheath 40 for insertion. When the
magnet 42 is exposed, it resumes its shape memory position as shown
in FIGS. 12 and 13, and when fully exposed assumes the curved
circular configuration of FIGS. 13 and 5A (or alternatively the
C-shape as in FIG. 5B), placed to rest against the internal side of
the stomach wall X. As shown, the circular shape of the magnet 42
has an opening 43.
[0061] Magnet delivery sheath 49 is then advanced from the lumen 19
of the endoscope 12 (FIG. 13), and a pusher (not shown) within the
delivery sheath 49 advances the magnet 48 from the sheath 49. The
magnet 42 is retained in a substantially linear delivery position
along a longitudinal axis of the delivery sheath 49. When the
magnet 48 is exposed, it resumes its shape memory position as shown
in FIGS. 14 and 15, and when fully exposed assumes the curved
circular configuration of FIGS. 15 and 5A (or alternatively the
C-shape like magnet 42' of FIG. 5B), placed to rest against the
internal side of the bowel wall Z. As shown, the circular shape of
the magnet 48 has an opening 47. The attraction forces of the two
magnets 42 and 48 maintain the stomach and bowel walls in
approximation. Note the T-bar 34 can be removed once the magnets 42
and 48 are in position to maintain the stomach and bowel walls in
approximation due to the magnetic attraction forces.
[0062] Once the magnets 42, 48 are in position, cutting instrument
36 is advanced from the lumen 26 of the endoscope 10 (FIG. 16). The
cutting instrument 36 is advanced through the openings 43 and 47 of
magnets 42, 48, respectively, to make an incision through the
stomach wall X and bowel wall Z. The cutting instrument 36 is then
withdrawn, and stent sheath 50 (FIGS. 17 and 18) is advanced from
lumen 28 of endoscope 10. A stent 52 is contained within the stent
sheath 50 in a reduced diameter collapsed position. The sheath 50
is inserted through the incision through the stomach wall X, bowel
wall Z and into the bowel B. The sheath 50 is then withdrawn, or
the stent 52 exposed from the sheath 50, allowing the stent 52 to
expand to a larger diameter expanded second position within
openings 43, 47 of magnets 42, 48, and leaving the stent 52 in
position to maintain the opening between the stomach S and bowel B
as shown in FIG. 19. The endoscopic instruments (or endoscopes) 10,
12 can then be withdrawn. FIG. 20 shows the stent 52 in position
with the endoscopes 10 and 12 removed from the body. A portion of
the stomach is then closed off such as by a stapling instrument
(not shown) or suturing. With the stent 52 in the position of FIG.
20, contents pass from the stomach into the bowel B through the
openings in the stomach wall X and bowel Z.
[0063] The procedure provides immediate results as the bypass
opening is formed during the procedure. The surgeon can also see
the opening before the patient is released due to the visualization
provided by the endoscopes, thereby increasing efficacy of the
procedure.
[0064] FIG. 21 provides a flow chart setting forth the method steps
of the present invention. The steps are as follows: insert a first
endoscope (or endoscopic instrument) into the stomach, insert a
second endoscope (or endoscopic instrument) into a bowel (although
the second endoscope could alternatively be inserted before the
first endoscope), deliver a needle and T-bar from the first
endoscope to advance the needle and T-bar though the stomach and
bowel, pull the T-bar proximally to approximate the bowel and
stomach, deploy a first magnet from the first endoscope into the
stomach against the lower wall, deploy a second magnet from the
second endoscope against a wall of the jejunum (although the second
magnet could alternatively be placed (deployed) before the first
magnet), deploy a cutting instrument from the first endoscope to
cut through the opening in the magnets to create an opening between
the stomach and bowel, deliver (insert) a stent from the first
endoscope into the opening between the stomach and bowel (through
the openings in the magnets), remove the first and second
endoscopes from the patient, and close off a portion of the
stomach. Note the T-bar can be removed after placement of the first
and second magnets.
[0065] Note the magnets can be removed after a period of time if
desired.
[0066] Although the apparatus and method of the subject invention
have been described with respect to preferred embodiments, those
skilled in the art will readily appreciate that changes and
modifications may be made thereto without departing from the spirit
and scope of the present invention as defined by the appended
claims.
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