U.S. patent number RE36,176 [Application Number 08/927,494] was granted by the patent office on 1999-03-30 for laparoscopic adjustable gastric banding device and method for implantation and removal thereof.
Invention is credited to Lubomyr I. Kuzmak.
United States Patent |
RE36,176 |
Kuzmak |
March 30, 1999 |
Laparoscopic adjustable gastric banding device and method for
implantation and removal thereof
Abstract
An adjustable gastric banding device for regulating the size of
a stoma opening in the stomach of a patient includes an elongate
band portion that encircles the stomach to as to limit the food
intake by the digestive potion of the stomach. The device can be
readily implanted and removed using laparoscopic procedures. A
locking element protruding from a location near the distal end of
the encircling band portion is inserted into a slot formed in a
receiving segment at an intermediate location along the encircling
band portion so as to form a circle or loop of fixed diameter. The
receiving segment has a thickness which is greater than the
thickness of the encircling band portion and of the rear portion of
the band. A moveable bolt secures the locking element in the slot.
The bolt can be displaced remotely, thus releasing the locking
element and allowing easy laparoscopic removal of the banding
device. The entire circumference of the stomach encircling band
portion is covered by an expandable section in contact with the
surface of the stomach. The size of the stoma opening can be
adjusted by injecting into or removing fluid from the expandable
section.
Inventors: |
Kuzmak; Lubomyr I. (Livingston,
NJ) |
Family
ID: |
26692092 |
Appl.
No.: |
08/927,494 |
Filed: |
September 11, 1997 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
19302 |
Feb 18, 1993 |
|
|
|
Reissue of: |
059592 |
May 12, 1993 |
05449368 |
Sep 12, 1995 |
|
|
Current U.S.
Class: |
606/157;
606/228 |
Current CPC
Class: |
A61F
5/0066 (20130101); A61F 5/0056 (20130101); A61B
17/12013 (20130101); A61B 17/135 (20130101) |
Current International
Class: |
A61F
5/00 (20060101); A61B 017/00 () |
Field of
Search: |
;606/151,157,201-203
;600/29-31 ;128/899,DIG.25 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Buiz; Michael
Assistant Examiner: Trinh; Vikki
Attorney, Agent or Firm: Larson & Taylor
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part of my application Ser.
No. 08/019,302, filed on Feb. 18, 1993, .Iadd.now abandoned,
.Iaddend.entitled "Adjustable Gastric Banding Device."
Claims
What is claimed is:
1. A gastric banding device for forming a stoma opening in a
stomach so as to restrict food intake to the lower digestive
portion of the stomach, said device comprising:
an elongate band member including a band portion for, in use,
encircling a stomach to form a stoma opening in the stomach, said
band member including a free end and an intermediate portion having
a thickness greater than the thickness of the remainder of said
band member;
an expandable section secured to said band portion of said band
member for varying the size of the stoma a opening;
a securing member located near said free end of said band member
and protruding outwardly therefrom;
a recess, formed in said intermediate portion of said band member,
for receiving said securing member therein; and
means, including a movable control member separate from said
securing member, for positively retaining said securing member in
aid recess to that said band portion forms a circle of a
predetermined fixed diameter around said stoma opening.
2. A gastric binding device as claimed in claim 1, wherein said
central member comprises a moveable bolt for releasably retaining
said securing member in said recess.
3. A gastric banding device as claimed in claim 2, wherein said
ring member includes a threaded hole therein in which said bolt is
received.
4. A gastric banding device as claimed in claim 2, wherein said
bolt comprises a distal part of an elongate control element located
within said band member and extending longitudinally thereof.
5. A gastric banding device as claimed in claim 2, wherein said
control element includes a proximal end which extends beyond said
band member for allowing remotely controlled release of securing
member from said recess by movement of said bolt.
6. A gastric banding device as claimed in claim 2, further
comprising a guiding plate, located within said band member of on
one side of said recess, for guiding the movement of said bolt, and
a holding plate located within said band member on the other side
of said recess, for retaining the free end of said bolt.
7. A gastric banding device as recited in claim 1, wherein said
expandable section comprises an expandable member extending around
substantially the entire circumference of said band portion that,
in use, encircles the stomach wall.
8. A gastric banding device as claimed in claim 1, wherein said
expandable section includes reinforcement in the sidewall
thereof.
9. A gastric banding device as recited in claim 1, further
comprising a remotely disposed fluid injection unit in fluid
connection with said expandable section through said band member
such that the size of the stoma opening can be altered by adding or
withdrawing fluid to cause expansion and retraction of said
expandable section.
10. A gastric banding device as claimed in claim 1, further
comprising barrier means for preventing tissue from growing around
said securing member.
11. A gastric banding device as claimed in claim 10, wherein sad
barrier means comprises a soft sponge-like silicone barrier
element.
12. A gastric banding device a claimed in claim 1, further
comprising a thin loop extending around a peripheral surface of
said securing member which is received in said recess for ensuring
a secure fit between said securing member and said recess.
13. A method for removing a gastric band device including an
encircling band portion encircling a stomach so as to form a
restricted stoma opening for limiting food intake to the lower
digestive portion of the stomach, said gastric band device
including an expandable section secured to said encircling band
portion for varying the size of the stomach opening, an elongate
band portion incorporating a remotely operable securing means for
retaining a locking element projecting from said gastric band
device at a location near the distal end of said encircling band
portion in a locking position wherein said locking element is
received in a recess formed at an intermediate location along said
gastric banding device so that said encircling band portion forms a
circle of a predetermined fixed diameter around said stoma opening,
and expansion control means, located in the abdominal muscle wall
at the proximal end of said gastric band device, for controlling
expansion and contraction of said expandable section, said method
comprising the steps of:
providing an incision in the abdominal muscle wall at the location
of said expansion control means;
retracting said securing means so as to release said locking
element from said recess;
cutting said elongate band portion close to said recess on a side
of said recess opposite said expandable section, with said securing
means sufficiently retracted such that the securing means is not
severed by said cutting, so as to produce a cut portion of said
elongate band portion;
removing both said expansion control means and said cut portion of
said elongate band portion through said incision; and
laparoscopically removing the remainder of said gastric band device
containing said recess and said expandable section at the location
of said stoma opening.
14. A method for removing a gastric band device including an
encircling band portion encircling a stomach so as to form a
restricted stoma opening for limiting food intake to the lower
digestive portion of the stomach, said gastric band device
including an expandable section secured to said encircling band
portion for varying the size of the stomach opening, an elongate
band portion incorporating a remotely operable securing means for
retaining an outwardly projecting locking element formed integral
with and projecting from said gastric band device at a location at
least near the distal end of said encircling band portion in a
locking position wherein said locking element is received in a
recess formed at in intermediate fixed distance along said gastric
banding device from said locking element so that said encircling
band portion forms a circle of a predetermined fixed diameter
around said stoma opening, and expansion control means, located in
the abdominal muscle wall at the proximal end of said gastric band
device, for controlling expansion and contraction of said
expandable section, said method comprising the steps of:
providing an incision in the abdominal muscle wall at the location
of said expansion control means;
removing said expansion control means through said incision;
releasing said outwardly projecting locking element from said
recess and completely removing said securing means from said
gastric band device through said incision; and
laparoscopically removing said gastric band device at the location
of said stoma opening.
15. A method for laparoscopically implanting a gastric band device
including an encircling band portion which, in use, encircles a
stomach so as to form a restricted stoma opening for limiting food
intake to the lower digestive portion of the stomach, said gastric
band device including an expandable section secured to said
encircling band portion for varying the size of the stomach opening
an elongate band portion incorporating a remotely operable securing
means for, when the device is implanted, retaining an outwardly
projecting locking element formed integral with and projecting from
said gastric band device at a location at least near the distal end
of said encircling band portion in a locking position wherein aid
locking element is received in a recess formed at an intermediate
fixed distance along said gastric banding device from said locking
element so that, when the band is implanted, said encircling band
portion forms a circle of a predetermined fixed diameter around
said stoma opening, and expansion control means, communicating with
said expandable section through a channel formed in said elongate
band portion, for controlling expansion said contraction of said
expandable section, said method comprising the steps of:
using an endoscope introduced into an cannula to dissect tissue
surrounding the stomach to provide a path for the elongate band
portion of the gastric band device;
laparoscopically introducing the gastric band into the abdominal
cavity such that said encircling band portion encircles the stomach
and said locking element is in inserted in said recess so that said
encircling band portion forms a circle of a fixed diameter around
said stoma opening of the stomach which is predetermined prior to
insertion of the locking element into the recess by said fixed
distance between the locking element and the recess;
operating said securing means to lock said locking element in said
recess; and
implanting said expansion control means in the abdominal muscle
wall.
16. A gastric banding device for forming a stoma opening in a
stomach so as to restrict food intake to the lower digestive
portion of the stomach, said device comprising:
a band member including encircling band means for, in use,
encircling a stomach in a single loop so as to form a stoma opening
in the stomach;
an expandable section ending completely around the entire length of
said encircling band means so that, in use, the expandable section
fully encircles the stoma opening; and
means for controlling expansion and contraction of said expandable
section so as to control the size of the stoma opening;
said band means having a free end and said device further
comprising a first interlocking securing means disposed at a first
predetermined fixed position at least close to said free end and a
second interlocking securing means, disposed at a second
predetermined fixed position located at an intermediate portion
along said band, for interlocking with said first interlocking
securing means to provide securing of said free end of said band
means to said intermediate portion of said band means at said
second position so that the band means forms a single loop circle
of predetermined fixed diameter around the stoma opening.
17. A gastric banding device as claimed in claim 16, wherein said
expandable section comprises an elongate inflatable element having
reinforced walls.
18. A gastric banding device as recited in claim 16, further
comprising releasing means for remotely releasing said securing
means.
19. A gastric banding device for forming a stoma opening in a
stomach so as to restrict food intake to the lower digestive
portion of the stomach, said device comprising:
an elongate band member including a band portion for, in use,
encircling a stomach to form a stoma opening in the stomach, said
band member including a free end, and securing means for securing
the free end of said band member to an intermediate portion of said
band member so that said band portion forms a circle of a
predetermined fixed diameter around said stoma opening said
securing means comprising first had second fixed interlocking means
formed integrally with the band member for, when interlocked,
forming said band portion into said circle of predetermined
diameter; and an expandable section secured to said band portion of
said band member for varying the size of the stoma opening; said
first interlocking means comprising a securing member located near
the free end of said band member and protruding outwardly therefrom
and said second interlocking means comprising a recess formed in
said band member at said intermediate portion thereof for receiving
said securing member therein.
20. A gastric banding device as claimed in claim 19, wherein said
securing means further comprises retaining means separate from said
securing member for positively retaining said securing member in
said recess.
21. A gastric banding device as claimed in claim 20, wherein said
retaining means comprises a moveable bolt.
22. A gastric banding device as claimed in claim 20, wherein said
retaining means comprises a distal part of an elongate control
element located within said band member and extending
longitudinally thereof.
23. A gastric banding devices as claimed in claim 22, wherein said
control element includes a proximal end which extends beyond said
band member for allowing remotely controlled release of securing
member from said recess by movement of said retaining means.
24. A gastric banding device as claimed in claim 21, wherein said
bolt has a free end, said device further comprising a guiding
plate, located within said band member of on one side of said
recess, for guiding the movement of said bolt, and a holding plate
located within said band member on the other side of the recess,
for retaining the free end of said bolt.
25. A gastric banding device as recited in claim 19, wherein
expandable section comprises an expandable member extending around
the entire circumference of said band portion that, in use,
encircles the stomach wall in a single loop.
26. A gastric banding device as claimed in claim 19, wherein said
band portion of said band member is of a first thickness and the
remainder of the band member is of a second, greater thickness.
27. A gastric banding device as claimed in claim 19, wherein said
expandable section includes reinforcement in the sidewalls
thereof.
28. A gastric banding device as recited in claim 19, further
comprising a remotely disposed fluid injection unit in fluid
connection with Aid expandable section through said band member
such that the size of the stoma opening can be altered by adding or
withdrawing fluid to cause expansion and retraction of said
expandable section.
29. A gastric banding device as claimed in claim 19, further
comprising barrier means on said band member for preventing tissue
from growing around said securing member.
30. A gastric banding device as claimed in claim 29 wherein said
barrier means comprises a soft sponge-like silicone barrier
element.
31. A gastric banding device as claimed in claim 19, further
comprising a thin loop formed around the securing member for
ensuring a secure fit between said securing member and said
recess.
32. A device as claimed in claim 19, wherein said securing means
further comprises retaining means separate from said securing
member for positively retaining said securing member in said
recess.
33. A method for controlling the size of a stoma opening in a
stomach as to provide the restriction of food intake to the
digestive portion of the stomach, said method comprising the steps
of:
placing elongate band around an exterior surface of a stomach that
a portion of the band encircles the stomach;
inserting a locking element formed integrally with and projecting
outwardly from said band at a location near the distal end of the
band into a recess formed at an intermediate location along the
said band so as to form said band into a complete circle of fixed
diameter around the stomach; and
positively securing said locking element in said recess using a
retaining member separate from said locking element.
34. The method as recited in claim 33, further comprising varying
the amount of fluid contained in an expandable section located on a
surface of said band in contact with the exterior surface of the
stomach so as to vary the size of the stoma opening.
35. The method as claimed in claim 33 wherein securing of said
locking element in said recess comprises using a remotely located
control member connected to said retaining member by a connector
element extending along the length of said band to move said
retaining member so as to lock said locking element in said
recess.
36. The method as claimed in claim 33 further comprising using a
remotely located control member connected to said retaining member
by a connector element extending along the length of said band to
move said retaining member so as to release said locking member
from said recess.
37. A gastric banding device for forming a stoma opening in a
stomach so as to restrict food intake to the lower digestive
portion of the stomach, said device comprising:
an elongate band member including a band portion for, in use,
encircling a stomach to form a stoma opening in the stomach, said
band member including a free end, and securing means for securing
the free end of said band member to an intermediate portion of said
band member so that said band portion forms a circle of a
predetermined fixed diameter around said stoma opening, said
securing means comprising first and second fixed interlocking means
formed integrally with the band member for, when interlocked,
forming said band portion into said circle of predetermined
diameter; and a retaining member separate from said first and
second interlocking means for positively securing said first and
second interlocking means together so as to prevent unlocking
thereof; and an expandable section secured to said band portion of
said band member for varying the size of the stoma opening.
38. A device as claimed in claim 37 further comprising a control
member located at the proximal end of said band member and
connected to said retaining member by a connector element extending
along the length of said band member for controlling movement of
said retaining member.
39. A device as claimed in claim 37 wherein one of said first and
second interlocking means comprises a projection and the other of
said first and second interlocking means comprises a recess and
wherein said retaining member engages said projection in said
recess to provide locking of said projection in said recess.
40. The device as claimed in claim 39 wherein said retaining member
comprises a movable bolt. .Iadd.
41. A gastric banding device for forming a stoma opening in a
stomach so as to restrict food intake to the lower digestive
portion of the stomach, said device being adapted for laparoscopic
placement around the stomach and comprising:
an elongate band member including a band portion for use, in use,
encircling a stomach to form a stoma opening in the stomach, said
band member including a free end, and securing means for securing
the free end of said band member to an intermediate portion of said
band member so that said band portion forms a circle of a
predetermined fixed diameter around said stoma opening, said
securing means comprising first and second fixed interlocking
means, formed integrally with the band member and defining said
band portion therebetween, for, when interlocked, forming said band
portion into said circle of predetermined diameter; and an
expandable section, secured to an inner stomach facing surface of
said band portion of said band member and extending substantially
coextensively with said band portion, for varying the size of the
stoma opening, said expandable section being connected by means of
a fluid tight connection through an elongate tubular member to an
injection reservoir so that said expandable section is in fluid
communication with said injection reservoir. .Iaddend.
Description
FIELD OF THE INVENTION
The present invention relates to a device for the treatment of
morbid obesity, and, in particular, relates to gastric banding
devices which encircle a portion of the stomach to form a stoma
opening of reduced diameter so as to restrict food intake.
DESCRIPTION OF THE PRIOR ART
In the previously known stoma adjustable silicone gastric banding
(SASGB), disclosed in U.S. Pat. No. 4,592,339 (Kuzmak et al.),
which is hereby incorporated by reference, an inflatable or
expandable section of a gastric band covers a portion of the circle
defined by the band. The expandable section of the device permits
some adjustment of the size of the stoma opening both
intraoperatively and postoperatively. This device is simple in
construction and enables the desired diameter of the stoma opening
to be maintained U.S. Pat. No. 4,696,288 (Kuzmak et al.), which is
also hereby incorporated by reference discloses a calibrating
apparatus which facilitates controlling the size of the stoma with
a gastric band.
Even with the ability to adjust the stoma size, it may still be
desirable in given situations, e.g., obstruction of the stoma from
edema and migration of the band to remove the band entirely when
deflation is insufficient to relieve the condition. A scheme for
enabling gastric bands to be removed is discussed in U.S. Pat. No.
5,074,868 (Kuzmak), which is hereby incorporated by reference. When
a remotely situated pull cord is retracted, a suture cutting blade
severs sutures securing overlapping portions of the band which
encircle the stomach. Another removable gastric band device is
disclosed in U.S. Pat. No. 5,160,338 (Vincent).
A laparoscopic gastric band and a method for using such a band is
disclosed in U.S. Ser. No 07/719,123, filed Jun. 20, 1991, in the
name of Lubomyr I. Kuzmak. Reference is also made to Lubomyr I.
Kuzmak, "Stoma Adjustable Silicone Gastric Banding," Problems in
General Surgery, Volume 9, No 2, J. B. Lippincott Co., April/June
1992.
Although the devices disclosed in the Kuzmak and Kuzmak et al
patents and patent application referred to above have proven to be
successful in practice, some potential disadvantages remain. For
example, the belt-like band construction of the devices wherein one
end of the band fits through a buckle at the other end can be
difficult to tighten, and bulges are created at the ends of the
inflated or expanded section (caused by the fact that the expanded
section only partially extends around the circumference of the
band), thereby resulting in localized compression of the stomach
wall. Further, the parts of the band must be sutured together when
the band is placed at a desired position around the stomach and
this suturing can be difficult to carry out.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a laparoscopic
SASGB which is more effective in providing uniform modification of
the stoma size, is less invasive to the stomach wall, and is also
easily reversible.
It is a further object of the present invention to provide a
laparoscopic gastric band positioned around the stomach which
includes a locking element secured by a remotely removable device
which eliminates or substantially reduces the discomfort caused to
some patients by related devices.
It is another object of the present invention to eliminate bulging
associated with SASGB devices of the prior art and thus eliminate
localized compression of the stomach wall.
It is a further object of the present invention to eliminate the
need for suturing of the band together in order to secure the band
at a desired position around the stomach.
It is a further object of the present invention to provide a SASGB
having an increased range of stoma adjustment.
In accordance with a one aspect of the invention, a gastric banding
device is provided for forming a stoma opening in a stomach so as
to restrict food intake to the lower digestive portion of the
stomach and which is particularly adapted for use in, but not
limited to, laparoscopic implantation and removal of the device.
According to a preferred embodiment thereof, the device comprises:
an elongate band member including a band portion for, in use,
encircling a stomach to form a stoma opening in the stomach, the
band member including a free end; an expandable section secured to
the band portion of the band member for varying the size of the
stoma opening; a securing member located near the free end of the
band member and protruding outwardly therefrom; a recess, formed in
an intermediate portion of the band member segment having a
thickness greater than the thickness of the remainder of the band
member, for receiving the securing member therein; and means for
retaining the securing member in the recess so that the band
portion forms a circle of a predetermined fixed diameter around the
stoma opening.
Advantageously, the retaining means comprises a moveable threaded
bolt, and in a preferred embodiment, the securing member includes a
threaded hole therein in which the bolt is received. The bolt
preferably comprises a distal part of an elongate control element
located within the band member and extending longitudinally
thereof. The control element includes a proximal end which extends
beyond the band member for allowing remotely controlled release of
the securing member from the recess by movement of the bolt.
Advantageously, the device further includes a guiding plate,
located within the band member of on one side of the recess, for
guiding the movement of the bolt, and a holding plate located
within the band member on the other side of the recess, for
retaining the free end of the bolt.
The expandable section preferably comprises an expandable member
corresponding to that discussed above, i.e., one extending around
substantially the entire circumference of the band portion, i.e.,
the portion that, in use encircles the stomach wall.
A remotely disposed fluid injection unit is preferably provided
which is in fluid connection with the expandable section through
the band member such that the size of the stomach opening can be
altered by adding or withdrawing fluid to cause expansion and
retraction of the expandable section.
Advantageously, a barrier means is provided for preventing tissue
from growing around the securing member. The barrier means
preferably comprises a soft sponge-like silicone barrier
element.
Preferably, a thin loop is formed around the securing member for
ensuring a secure fit between the securing member and the
recess.
In accordance with a further aspect of the invention, a method is
provided for removing a band having an expandable section
encircling a stomach which forms a circle of a predetermined fixed
diameter by employing a securing means to retain a locking element
projecting from said band at a location near the distal end of said
band into a recess formed at an intermediate location along said
band, the method comprising the steps of: retracting the securing
means so as to release the locking element from the recess cutting
the band close to the recess on a side of the recess opposite the
expandable section, the securing means being sufficiently retracted
such that it is not severed by the cutting; removing the cut
portion not containing the recess and the expandable section
through a small incision; and laparoscopically removing the
remainder of the band containing the recess and the expandable
section.
In accordance with an additional aspect the invention, a method is
provided for removing a band encircling a stomach which forms a
circle of a predetermined fixed diameter by employing a securing
means to retain a locking element projecting from said band at a
location near the distal end of said band into a recess formed at
an intermediate location along said band, the method comprising the
steps of: completely removing the securing means through a small
incision, thus also releasing the locking element from the recess;
and laparoscopically removing the band.
Preferably, for either method described above, the further step of
removing an injection port in communication with the expandable
section through the small incision prior to the laparoscopically
removing step is also performed.
In accordance with yet another aspect of the invention a method is
provided for laparoscopically implanting a gastric band device
including an encircling band portion which, in use, encircles a
stomach so as to form a restricted stoma opening for limiting food
intake to the lower digestive portion of the stomach, the gastric
band device including an expandable section secured to the
encircling band portion for varying the size of the stomach
opening, an elongate band port incorporating a remotely operable
securing means for, when the device is implanted, retaining a
locking element projecting from the gastric band device at a
location near the distal end of the encircling band portion in a
locking position wherein the locking element is received in a
recess formed at an intermediate location along the gastric banding
device so that, when the band is implanted, the encircling band
portion forms a circle of a predetermined fixed diameter around the
stoma opening, and expansion control means, communicating with the
expandable section through a channel formed in the elongate band
portion, for controlling expansion and contraction of said
expandable section, said method comprising the steps of:
using an endoscope introduced into an cannula to dissect tissue
surrounding the stomach to provide a path for the elongate band
portion of the gastric band device;
laparoscopically introducing the gastric band into the abdominal
cavity such that said encircling band portion encircles the stomach
and said locking element is inserted in said recess so that said
encircling band portion forms a circle of predetermined fixed
diameter around said stoma opening of the stomach;
operating said securing means to lock said locking element in said
recess; and
implanting said expansion control means in the abdominal muscle
wall.
Other features and advantages of the invention will be set forth
in, or apparent from, the following detailed description of
preferred embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will now be describe in further detail with reference
to the accompanying drawings, wherein:
FIG. 1 is a perspective view of the modified laparoscopic SASGB
device of the present invention as placed in position around a
stomach;
FIG. 2(a) is a side view of the SASGB device constructed in
accordance with a preferred embodiment of the present invention,
showing the device in an extended rest state.
FIG. 2(b) is a cross sectional view of a detail of FIG. 2(a)
showing the locking recess or slot;
FIG. 3(a) is a top plan view of the device of FIG. 2(a);
FIG. 3(b) is a side view of the locking element of the device of
FIG. 2(a);
FIG. 4 is a side view of the device of FIG. 2(a) with the band
locked in place to form a circle or loop;
FIG. 5(a) is a side view of the device shown in FIG. 2(a) with the
band unlocked; and
FIG. 5(b) is a side view of the device shown in FIG. 2(a) with the
band unlocked and the locking bolt and associated control member
completely remove.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIG. 1, a SASGB device, generally denoted 10, is shown
in place around a stomach S. More particularly, the device 10
comprises a band 12 which includes a loop or encircling portion
(which is not fully visible in FIG. 1) that, in use, fully
encircles the stomach S so as to form stoma opening at the loop
portion, thereby restricting food intake to the lower digestive
portion of the stomach S. As described in more detail below, a
channel 14 allows fluid to be transmitted to or removed from an
expandable section or portion of the device 10 which is not visible
in FIG. 1, while a further channel 16 contains an elongate control
member 18 for a securing or locking mechanism for encircling
loop.
The SASGB device 10 of FIG. 1 is shown in more detail in FIGS. 2 to
5. As shown in these figures, the band locking device referred to
above includes an outwardly projecting securing or locking member
20 located towards the tip or free (distal) end of the band 12 and
a recess or slot 22 in which locking member 20 is received, as
described hereinafter. The abovementioned expandable or inflatable
section of the band 12 is denoted 24, and extends along the entire
band portion 12a which, in use, encircles the stomach, as is
perhaps best seen in FIG. 4. The channel 14 itself forms a passage,
or accommodates a separate tube 26, which connects the expandable
or inflatable section 24 of the band 12 with an injection unit 28
for injecting or removing solution in order to adjust the size of
the stoma opening. This solution is a physiologically compatible
fluid, such as saline.
Considering the securing or locking mechanism in more detail, the
recess or slot 22 located in an intermediate band portion 12b is
shaped to accommodate locking member or element 20 therein when the
distal end of band 12 is formed into a loop as shown in FIG. 4. The
locking element 20 has a hole 20a therein through which screw
threaded locking bolt 30 formed at the end of the control member 18
introduced through channel 16 (and best seen in FIG. 4) is
inserted, thus securing the locking member 20 in the recess or slot
22. As can best be seen in FIG. 2(b), a first, holding or retaining
plate 32 having an opening 32a therein is provided near the free or
distal end of channel 16 adjacent to recess 22 to hold the tip of
the threaded screw bolt 30. Plate 32 is bonded into the band 12.
The opening 32a in the plate 32 is sized to fit or match the shape
of the tip of the screw bolt 30 and is not threaded. A second,
guiding plate 34 has an opening 34a therein the diameter of which
equals the diameter of the bolt 30 without the screw thread. Plate
34 is bonded into band 12 on the other side of the slot 22. The
control member 18, which terminates at the distal end thereof in
the threaded locking bolt 30, extends at the opposite proximal end
thereof beyond the length of the band 12, thus enabling movement of
bolt 30, and hence locking of the distal end of the band 12 in
recess 22, to be controlled remotely.
As is shown in FIGS. 2(a) and 3(a), the band thickness of the
receiving segment or portion of the band 12b is greater than the
thickness of the remainder of the band. This increased thickness is
necessary in order to accommodate the thickness of the locking
element or projection 20 formed near the distal end of the band,
while still allowing channel 14 to reach the inflatable portion
24.
In a specific, non-limiting but advantageous embodiment, the band
locking element 20 and the band 12 itself are preferably made of
silicone and, as described above, the former has an opening 20a
with a screw type thread for locking the band 12 in place around
the stomach. The proximal edge of the band locking element 20 is
preferably 11/2 centimeters from the tip or free end of the band.
Further, the band locking element 20 is preferably of the truncated
polygonal shape shown in the drawings and has a height of 4
millimeters and a length at its base of 6 millimeters. The
inflatable section or part 24 is preferably reinforced and in the
exemplary embodiment under consideration, the section 24 is 8
centimeters in length. Reinforcement of the sides of the inflatable
part 24 is important in order to eliminate side bulging and to
increase the circular inflation which is important in providing
stoma calibration. The silicone covering the band 12 may be used
for reinforcement. The tube 26 located within channel 14 is also
preferably made of silicone. The retaining plate 32 and the guiding
plate 34 are preferably made of silicone and are located 11/2
centimeters from the recess or slot 22 on opposite sides thereof.
Bolt 30 is advantageously made of silicone or plastic as is control
element 18.
The band 12 is, as stated, preferably made of silicone and is wider
than previously used bands, advantageously 13 mm. The band
thickness of the portion of the band 12a covered by the inflatable
section 24, i.e., that which encircles the stomach, is similar in
thickness to previous bands, preferably 2 mm. The band thickness of
the receiving segment is preferably between 4 to 6 mm. The band
thickness of the elongate band portion 12c is preferably between 2
to 4 mm, and is roughly one-half to two-thirds of the thickness of
the receiving segment. The front part of the band 12, i.e., band
portions 12a and 12b, indicated by bracket 36, is preferably
reinforced with a mesh of Dacron polyethylene terephthalate. The
remaining elongate band portion 12c is preferably not reinforced so
that it is soft and flexible.
In order to better accommodate the positioning of the band parts in
the locking position, a thin loop of silicone, indicated at 38 in
FIG. 3(a), is bonded around the projecting barrier or locking
element 20. Additionally, a soft sponge-like silicone guard
portion, indicated at 40 in FIG. 3(a) and FIG. 3(b), is
advantageously placed around the projecting locking element 20 in
order to prevent the capsule tissue, i.e., tissue forming a capsule
around the band, from growing into that space. Such capsule tissue
may cause some limited resistance when the band is removed without
major surgery. Linear markings (not shown) may be placed on both
parts of the band 12 that are joined together as shown in FIGS. 4,
5(a) and 5(b) so that when the markings are matched with each
other, an indication is provided that the locking parts are in
correct position. As noted above, FIG. 4 shows the device in the
fully locked position with the bolt 30 fury extended through the
projection locking element 20 and into the holding or retaining
plate 32. The diameter of the "locked" band, i.e., the band in the
closed position shown in FIG. 4, is preferably 4 cm, although a
diameter between about 4 to 6 cm could be acceptable.
As set forth above, the band device 10 is particularly adapted to
be laparoscopically implanted. In this regard, although the device
disclosed in application Ser. No. 08/019,302 filed on Feb. 18,
1993, can also be laparoscopy implanted and, in this regard, is not
limited to any particular method of implantation, the differences
between the device of the present application and that of the
earlier application, and more specifically, the increased
flexibility and the thinner, more streamlined shape of the gastric
band device of the invention facilitate laparoscopic implantation
thereof. In general, the laparoscopic procedure used to implant the
device is that disclosed in Ser. No. 07/179,123, filed on Jun. 20,
1991, the content of which is hereby incorporated by reference. In
fact, the only differences in the procedure flow from the
differences in the two band devices. In this regard, the band 12 of
the invention would be placed around the stomach in the same
general way after using an endoscope introduced into a cannula to
dissect tissue surrounding the stomach so as to provide a path for
the gastric band 12. However, in contrast to the earlier device,
the remotely controlled movement of the control member 10 would be
used to provide locking of the locking mechanism (comprising
locking element or projection 20 and slot or recess 22), thus
fixing band 12 in place in an encircling relation around the
stomach. The injection unit 28, located at the end of the band 12,
would be implanted in the abdominal wall muscles, as in the prior
application, and the overall laparoscopic procedure would likewise
be similar.
Considering methods of removal of the band 12 after implantation,
as indicated above, the living body in which the device of the
invention is inserted creates a thin capsule around the implanted
silicone band 12 that is not adhered to the band 12. By exposing
the site of the injection unit implantation, i.e., the site at
which unit 28 is disposed within the abdominal wall muscles, the
proximal end of the band 12 is exposed as well. Through
displacement of the threaded bolt 30 by remotely controlled
movement of control member 18, the band locking mechanism
(comprising locking element 20 and slot or recess 22) can be
released.
In accordance with one method of removing the band, the control
member 18 and the locking bolt 30, which are stiff and difficult to
cut relative to elongate band portion 12c, are removed sufficiently
from the band 12, as shown in FIG. 5(a), so that the elongate
portion 12c, i.e., the portion not containing the recess 22 or the
expandable section 24, may be easily cut close to recess 22,
without cutting the control member 18. This allows the relatively
thin band portion 12c to be removed with the injection unit 28
through the site of the injection unit implantation, preferably in
the abdominal muscles near the skin. The remainder of the SASGB,
i.e., portion 12b containing the recess 22 and portion 12a
containing the expandable section 24, can then be removed
laparoscopically at the site of the these portions of the band 12,
i.e. at the stoma opening.
Alternatively, referring to FIG. 5(b), the SASGB of the present
invention can also be removed by completely removing the control
member 18 from within the band 12 and by removing the injection
port 28 through a small superficial incision. With these components
removed, the entire SASGB, including the relatively thin elongate
portion 12c, is then removed laparoscopically at the site of the
stoma. One advantage of removing the band or a part thereof at the
stoma is that the surgeon may wish to gain access to this area in
any event in order to remove suturing at the stoma.
As should be evident from the foregoing, the band device 10 of the
present invention is more effective than the prior art in uniformly
controlling the size of stoma opening and, among other advantages,
is less invasive to the stomach wall because of the use of the
inflatable part 24 which covers the entire portion of band 12a that
encircles the stomach. The use of the thinner elongate portion 12
also helps to relieve the discomfort felt by some patients when the
elongate portion 12C is of a greater thickness.
Although the present invention has been described relative to
specific exemplary embodiments thereof, it will be understood by
those skilled in the art that variations and modifications can be
effected in these exemplary embodiments without departing from the
scope and spirit of the invention.
* * * * *