U.S. patent application number 10/755408 was filed with the patent office on 2004-08-05 for gastric band.
Invention is credited to Dudai, Moshe.
Application Number | 20040153106 10/755408 |
Document ID | / |
Family ID | 11072612 |
Filed Date | 2004-08-05 |
United States Patent
Application |
20040153106 |
Kind Code |
A1 |
Dudai, Moshe |
August 5, 2004 |
Gastric band
Abstract
A gastric band of a belt type is presented for attaching around
a circumference of a patient's stomach, so as to define the
diameter of the stomach opening. The band comprises outer and inner
surfaces, wherein the inner surface engages the stomach, and at
least the outer surface is formed by an elongated member
substantially non-extendable along a longitudinal axis thereof. A
through-going opening is made in the elongated member and is
located so as to define an end portion of the band having a
predetermined length. An opposite end portion of the band is shaped
so as to be insertable into the through-going opening for adjusting
a desired inner diameter of the band in its closed operating
position and fastening the opposite end portion to the outer
surface of the band.
Inventors: |
Dudai, Moshe; (Jerusalem,
IL) |
Correspondence
Address: |
Gary M. Nath
NATH & ASSOCIATES PLLC
6th Floor
1030 15th Street, N.W.
Washington
DC
20005
US
|
Family ID: |
11072612 |
Appl. No.: |
10/755408 |
Filed: |
January 13, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10755408 |
Jan 13, 2004 |
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09526757 |
Mar 16, 2000 |
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6676674 |
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Current U.S.
Class: |
606/157 ;
606/15 |
Current CPC
Class: |
A61F 5/0066 20130101;
A61F 5/003 20130101; A61F 5/005 20130101; A61F 5/0089 20130101;
A61B 17/12 20130101 |
Class at
Publication: |
606/157 ;
606/015 |
International
Class: |
A61B 017/08 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 17, 1999 |
IL |
129032 |
Claims
1. A gastric band for attaching around a circumference of a
patient's stomach so as to define the diameter of the stomach
opening, the band comprising: (a) outer and inner surfaces, wherein
the inner surface engages the stomach, and at least the outer
surface is formed by an elongated member substantially
non-extendable along a longitudinal axis thereof; (b) a
through-going opening made in said member and located so as to
define an end portion of the band having a predetermined length;
and (c) an opposite end portion of the band shaped so as to be
insertable into said through-going opening for adjusting a desired
inner diameter of the band in its closed operating position and
fastening the opposite end portion to the outer surface of the
band.
2. The gastric band according to claim 1, and also comprising a
fastening means for fastening said opposite end portion of the band
when in said operating position thereof
3. The gastric band according to claim 1, wherein said fastening
utilizes at least two stitches applied to the band.
4. The gastric band according to claim 2, wherein said fastening
means comprises at least one mushroom-like projection located on
the outer surface of the band, and at least one through-going hole
for receiving said at least one mushroom-like projection, when in
the operating position of the band.
5. The gastric band according to claim 2, wherein said fastening
means comprises a plurality of teeth extending along opposite edges
of said opposite end portion, said opening being shaped in a manner
to define a slot for receiving the teeth-like opposite end portion
so as to allow its movement in a forward direction through said
opening and preventing its sliding in a reverse direction.
6. The gastric band according to claim 1, wherein said end portion
is made of a substantially flexible material.
7. The gastric band according to claim 1, wherein said outer and
inner surfaces are formed of the same material.
8. The gastric band according to claim 1, wherein said outer and
inner surface are formed of different first and second materials,
respectively.
9. The gastric band according to claim 7, wherein said second
material is substantially flexible.
10. The gastric band according to claim 8, wherein said second
material comprises silicone.
11. The gastric band according to claim 7, wherein said first
material comprises poly-tetra-fluoro-ethylene.
12. The gastric band according to claim 4, wherein the material of
said outer and inner surfaces comprises
poly-tetra-fluoro-ethylene.
13. The gastric band according to claim 1, wherein said inner
surface engaging the stomach has substantially circular shape when
in the operating position of the band.
14. The gastric band according to claim 1, wherein said
predetermined length of the end portion is such as to enable the
detection of the gastric band by a laproscopic inspection tool.
15. A system for laproscopically attaching a gastric band around a
patient's stomach so as to define a certain diameter of the stomach
opening, the system comprising a calibration device which is
insertable into the stomach at a predetermined depth and a pair of
articulated gripping devices, wherein the calibration device
comprises: an upper portion having variable volume, and a lower
projection-like portion having a diameter substantially equal to
said certain diameter of the stomach opening to be defined by the
band, the location of said projection-like portion when in the
inserted position of the calibration device defining the location
of the band with respect to the stomach; said band comprising:
outer and inner surfaces, wherein the inner surface engages the
stomach, and at least the outer surface is formed by an elongated
member substantially non-extendable along a longitudinal axis
thereof; a through-going opening made in said member and located so
as to define an end portion of the band having a predetermined
length; and an opposite end portion of the band shaped so as to be
insertable into sad through-going opening for adjusting a desired
inner diameter of the band in its closed operating position and
fastening the opposite end portion to the outer surface of the
band.
Description
FIELD OF THE INVENTION
[0001] This invention relates to a gastric banding device that
encircles a portion of the stomach to form a stoma opening of
reduced diameter.
BACKGROUND OF THE INVENTION
[0002] Morbid obesity is associated with medical risks in terms of
the development of additional diseases such as diabetes,
hypertension, cardiac insufficiency and other socio-psychological
problems, overall reducing life expectancy. Dietary management,
psychiatric or dietary regiments are the first choice for treating
morbid obesity, but as they depend on the goodwill of the patient,
especially in the long run, these approaches often fail.
[0003] Various surgical approaches have been developed and used for
treating morbid obesity. These include gastric bypasses, small
bowel bypasses and stapling of portions of the stomach. The
stapling techniques include horizontal and vertical stapling for
reducing the volume of the stomach, as well as narrowing the stoma
opening thus controlling the food intake of the stomach. However
the latter approach, stapling, may not bring the desired results
due to the fact that the staples frequently open or tend to cause
perforations. Furthermore the stomach opening formed by staples
widens over time, thus the effect is reduced or even
eliminated.
[0004] A different approach to the problem specified above is
described in U.S. Pat. No. 4,416,267, which discloses a method for
treating obesity by placing an inflatable balloon into the stomach.
Such a device displaces volume inside the stomach, thereby reducing
the effective free volume of the gastric portion causing the
individual to feel no need for additional food intake. The balloon
is inflated in the stomach to a predetermined volume and is left
there for a certain period of time after which it is easily
removed. However, this procedure although being physically easy to
implement and basically being non-surgical, may lead to harmful
results. The inflated balloon in the stomach is in constant contact
with gastric mucous, and such contact for an extended period of
time may give rise to gastric ulcers and intestinal blockage.
[0005] Recently, another approach has been developed based on
placing a physical means (i.e. a gastric band) outside the stomach.
A gastric band is placed around the upper part of the stomach,
thereby creating an altered stomach opening of a reduced diameter,
resulting in the restriction of food intake into the digestive
portion of the stomach. Such a gastric-banding technique is simple
as compared to the above-mentioned balloon-based technique.
However, this band has no means for adjusting its diameter to
obtain the optimal diameter of the stomach opening.
[0006] Adjustable gastric bands have been developed, and disclosed
for example in U.S. Pat. No. 4,592,339, as well as in "A Gastric
Band with Adjustable Inner Diameter for Obesity Surgery", P.
Forsell et al., Obes Surg., 1993, No. 3, pp. 303-306. According to
this technique, the diameter of a belt-like band, when in a closed
position thereof, may be adjusted. For this purpose, the band
includes an inflatable portion in its interior part. Controllable
inflating and deflating of this portion alters the stomach opening.
Although this gastric band can retain the predetermined diameter of
the stomach opening, obtaining of the proper opening is somewhat
problematic.
[0007] U.S. Pat. No. 4,696,288 discloses a calibrating apparatus
for using with, a gastric band for controlling the diameter of the
stomach opening by regulating the band's diameter. Such a gastric
band is typically mounted with a laproscopic technique, disclosed
for example in U.S. Pat. No. 5,226,429.
SUMMARY OF THE INVENTION
[0008] It is a main object of the present invention to provide a
gastric band of a belt type, which can be attached to a patient's
stomach in a safe manner and without damaging the stomach
circumference.
[0009] It is a further object of the present invention to provide
such a band which can be easily mounted on the stomach utilizing a
laproscopic technique.
[0010] It is a still further object of the present invention to
provide such a band that is easily enables its facile detectable by
any suitable imaging means, thereby facilitating access to the band
when additional surgical/laproscopic intervention is desired.
[0011] There is thus provided according to one aspect of the
present invention, a gastric band for attaching around a
circumference of a patient's stomach so as to define the diameter
of the stomach opening, the band comprising:
[0012] (a) outer and inner surfaces, wherein the inner surface
engages the stomach, and at least the outer surface is formed by an
elongated member substantially non-extendable along a longitudinal
axis thereof;
[0013] (b) a through-going opening made in said member and located
so as to define an end portion of the band having a predetermined
length; and
[0014] (c) an opposite end portion of the band shaped so as to be
insertable into said through-going opening for adjusting a desired
inner diameter of the band in its closed operating position and
fastening the opposite end portion to the outer surface of the
band.
[0015] The gastric band is of a belt type, and also comprises a
suitable fastening means, which may utilize a required number of
stitches or the provision of bolt-and-nut arrangements on the band.
The fastening means may also be in the form of teeth-like edges of
the opposite end portion and a correspondingly shaped through-going
opening.
[0016] The outer and inner surface may be formed either of the same
material, or of different materials, provided that the material of
the outer surface is substantially not-extendable.
[0017] Preferably, at least the outer surface of the band is made
of poly-tetra-fluoro-ethylene, known as Gortex. The material of the
inner surface of the band engaging the stomach may be silicone. The
band, when in the operation position thereof is such that its inner
surface engaging the stomach has a substantially circular
shape.
[0018] The predetermined length of the end portion is such as to
enable the detection of the gastric band by a laproscopic
inspection tool.
[0019] According to another aspect of the present invention, there
is provided a system for laproscipically attaching a gastric band
around a patient's stomach so as to define a certain diameter of
the stomach opening,
[0020] the system comprising a calibration device which is
insertable into the stomach at a predetermined depth and
comprises:
[0021] an upper portion having variable volume, and
[0022] a lower projection-like portion having a diameter
substantially equal to said certain diameter of the stomach opening
to be defined by the band, the location of said projection-like
portion when in the inserted position of the calibration device
defining the location of the band with respect to the stomach;
[0023] said band comprising:
[0024] outer and inner surfaces, wherein the inner surface engages
the stomach, and at least the outer surface is formed by an
elongated member substantially non-extendable along a longitudinal
axis thereof;
[0025] a through-going opening made in said member and located so
as to define an end portion of the band having a predetermined
length; and
[0026] an opposite end portion of the band shaped so as to be
insertable into said through-going opening for adjusting a desired
inner diameter of the band in its closed operating position and
fastening the opposite end portion to the outer surface of the
band.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] In order to understand the invention and to see how it may
be carried out in practice, a preferred embodiment will now be
described, by way of non-limiting example only, with reference to
the accompanying drawings, in which:
[0028] FIGS. 1a and 1b are schematic illustrations of a gastric
band in its open and closed positions, respectively, constructed
according to one embodiment of the invention;
[0029] FIG. 2 schematically illustrates the band of FIGS. 1a and 1b
in its operation position being attached to the patient's
stomach;
[0030] FIGS. 3a and 3b are schematic illustrations of a gastric
band in its open and closed positions, respectively, constructed
according to another embodiment of the invention;
[0031] FIGS. 4a and 4b are schematic illustrations of a gastric
band in its open and closed positions, respectively, constructed
according to yet another embodiment of the invention;
[0032] FIGS. 5a and 5b are schematic illustrations of a gastric
band in its open and closed positions, respectively, constructed
according to yet another embodiment of the invention;
[0033] FIGS. 6a and 6b schematically illustrate two steps of a
calibration procedure carried out prior to mounting the band on the
stomach; and
[0034] FIGS. 7a to 7f illustrates five sequential steps,
respectively, of mounting the band of FIGS. 3a-3b onto the
patient's stomach.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
[0035] Referring to FIGS. 1a and 1b there is illustrated a gastric
band, generally designated 1, constructed according to one
embodiment of the invention. The band is typically an elongated
strap having two opposite end portions 1a and 1b. The portion 1b is
substantially cone shaped, while the end portion 1a is formed with
a through-going, substantially elliptically-shaped opening 4
displaced from the corresponding butt-end of the band 1 by a
certain length L.sub.0, the purpose of which will be described
further below. For example, the band's dimensions may be as
follows:
[0036] 1) the length L.sub.1 of the entire band is about 15 cm;
[0037] 2) the length L.sub.0 is about 3 cm;
[0038] 3) the width h.sub.0 of the band is 2 cm;
[0039] 4) the thickness h.sub.1 of the band is 2 mm; and
[0040] 5) the long axis L.sub.2 of the opening 4 is about 1-7
mm.
[0041] As clearly seen in FIG. 1b, the band 1 has outer and inner
surfaces 2a and 2b, respectively. To attach the band 1 around a
stomach (not shown here), the cone shaped end portion 1b passes
through the opening 4, and is fastened along a corresponding
location on the band by a suitable fastening means, for example by
stitches 6. Thereafter, the free part of the end portion 1b is cut
off by any suitable means, as shown in a dashed line. The opposite
end portion 1a, whilst being optionally partly stitched to the band
1, extends away therefrom. The band 1 is made of a polymer
material, which is substantially non-extendable along its
longitudinal axis. For example, poly-tetra-fluoro-ethylene (i.e.
Gortex) can be used for manufacturing the band 1.
[0042] Turning now to FIG. 2, there is illustrated that, when in
the operative position of the band 1 being attached around a
stomach 10, the free end portion 1a protrudes from the band. It
will be readily understood that such a protrusion would be easily
detected by any suitable imaging means. This is a very important
feature facilitating the access to the band when additional
surgical/laproscopic intervention is desired
[0043] As further seen in FIG. 2, the band 1 actually defines two
portions 10a and 10b of the stomach 10, and defines the diameter of
a so-called stomach opening (not seen here) underneath the band 1.
The portions 10a and 10b are fastened to each other by stitches 12
or the like within the vicinity of the band 1, thereby fixing its
relative location on the stomach. It should be noted that stitches
6, as well as the stitches 12, may be replaced by any other
suitable fastening means.
[0044] Reference is made to FIGS. 3a and 3b, illustrating a gastric
band 14 in its opened and closed positions, respectively. The band
14 has somewhat different construction as compared to the band 1.
To facilitate understanding, same reference numbers are used for
identifying those components, which are identical in the bands 1
and 14. Here, at least one so-called "bolt-and-nut" arrangement is
provided serving as the fastening means. To this end, as shown in
the figures in a self-explanatory manner, spaced-apart
mushroom-like bolts, generally at 16, project upwardly from the
upper surface 2a. Consequently, holes 18 (four in the present
example) are aligned along the longitudinal axis of the band in a
spaced-apart parallel relationship. The diameter of the hole 18
corresponds to that of the head portion of the mushroom-like bolt
16 to put the bolt-and-nut arrangement into its engaged position,
thereby closing the band.
[0045] In this specific example, the bolts 16 project from a
plate-like support 20, forming together an integral assembly,
generally designated 22. The assembly 22 is attached to the upper
surface 2a of the band 14 by stamping. The entire band, except for
the assembly 22, may be made of a polymer material like Gortex,
while the assembly 22 may be made of a substantially rigid
silicone. The bolts 16 (and consequently two locally adjacent holes
18) are spaced from each other by the length L.sub.4 of about 7 mm,
the dimensions of the plate 20 being as follows: the length
L.sub.3=2 cm, and the width h.sub.3=12 mm. As shown in FIG. 3b,
after closing the band on the patient's stomach, two stitches 24
(or the like) are provided to ensure the fixed diameter of the
band, and thereby of the stomach opening. Similarly to the
previously described embodiments, the corresponding part of the end
portion 1b is cut off, while the opposite part 1a protrudes from
the band to be detectable.
[0046] FIGS. 4a and 4b illustrate a gastric band, generally at 26,
according to yet another embodiment of the invention. Similarly,
same reference numbers are used for identifying those components,
which are identical in the bands 1, 14 and 26. The band 26, in
distinction to the bands 1 and 14, has its inner surface 2b formed
of a relatively flexible material relative to that of the outer
surface. For example, this may be implemented by coating a center
part of the inner surface of the band 26 with silicone. As for the
outer surface 2a of the band 26, as well as the inner surface
thereof within the end portions, they are made of a substantially
non-extendable material. The end portion 1a should be made of such
a non-extendable material which is not too rigid in order not to
harm the stomach, e.g. Gortex.
[0047] FIGS. 5a and 5b illustrate yet another construction of a
gastric band 27 using the same reference numbers for identifying
the common elements in the bands 1, 14, 26 and 27. In the band 27,
similar to the band 26, the center part of its inner surface is
formed with a substantially flexible material, e.g. flexible
silicone, while the end portions are made of a non-extendable
material. As for the fastening means, in the band 27 the end
portion 1b is formed with teeth-like edges 16'. Consequently, a
through-going opening 4' is shaped in a manner to define a slot 18'
allowing a forward movement of the portion 1b through the opening
4', but preventing its sliding back out of the opening 4' in the
operating (closed) position of the band 27. To this end, the center
part of the outer surface 2a, as well as the end portion 1b, are
made of a substantially rigid material, e.g. rigid silicone. As
indicated above, the opposite end portion 1a should be made of a
substantially flexible material.
[0048] Reference is now made to FIGS. 6a and 6b illustrating two
steps of a typically performed calibration stage for determining
the desired diameter of the stomach opening and defining its
location to mount a gastric band there. To this end, a calibrating
device, generally designated 28, is used. The construction and
operation of such a calibration device are known per se, and
therefore need not be described in detail, except to note the
following. The device 28 comprises an upper, balloon-like portion
28a associated with a suitable pump, which is not specifically
shown, and a lower projection 28bb having a substantially circular
cross-section of the desired diameter D.sub.0.
[0049] Upon inserting the device 28 inside the stomach 10 through a
stomach inlet 29, the balloon-like portion 28a is inflated up to
the volume V.sub.1 corresponding to the diameter D.sub.1 of the
portion 28a, so as to substantially engage the inner circumference
of the stomach 10. This maximum diameter D.sub.1 of the portion 28a
is determined in accordance with the inflating pressure.
[0050] Thereafter, the device is partially deflated to such a
volume V.sub.2 that corresponds to the diameter D.sub.2 of the
portion 28a, and pulled upwardly up to the inlet 29. Such a
position of the device 28 having the known diameter D.sub.2 of its
balloon-like portion 28a actually allows for locating the
projection 28b, thereby defining the location for mounting the
gastric band. The calibrating device 28 also comprises a pipe 30
installed thereinside, serving for aspirating the stomach contents
and checking whether the mounting of the band caused any damage to
the stomach itself, as will be described more specifically further
below with reference to FIG. 7f.
[0051] Referring to FIGS. 7a to 7f, there are illustrated the main
operational steps for laproscopic mounting of the gastric band, for
example constructed as described above with reference to FIGS. 3a
and 3b, on the patient's stomach. As indicated above, the position
of the projection 28b defines the exact location for mounting the
band. Hence, it defines the convenient locations for cuttings 32a
and 32b to be made in the stomach connecting tissue 32 at opposite
sides of the stomach 10. An articulated gripping device 34 is
typically used for mounting the gastric band on the stomach 10.
FIG. 7a illustrates that the articulated gripping device 34 is
sequentially pushed through the openings 32b and 32a, to clamp the
cone shaped end portion 1b of the band 14. Then, by pulling the
device 34, the band is threaded through the openings 32a and 32b,
thereby engaging the back-side of the stomach (FIG. 7b).
[0052] This having been done, a pair of gripping devices 36 and 37
are used for supporting the end portion 1a of the band, while the
device 34 passes through the opening 4 and proceeds towards the
cone shaped portion 1b (FIG. 7c). As shown in FIGS. 7d and 7e, by
manipulating the gripping devices 36 and 37, the cone shaped end
portion 1b is threaded through the opening 4 and pulled to close
the band in a manner described above with reference to FIGS. 3a and
3b. The closed operating position of the band is illustrated in
FIG. 7f.
[0053] After completing the mounting of the gastric band 14, a pair
of stitches 24 are provided and, optionally, depending on the
desired diameter, the end portion 1b is partly cut off. To check
whether the entire operation did not damage the stomach and did not
completely block the stomach opening, the following procedure is
carried out. After the total deflation of the balloon 28a (through
a suitable pump-valve assembly 38) and pulling of the calibrating
device 28 upwardly towards the upper part of the paunch, a colored
liquid is injected into the pipe 30 through an upper opening 39 of
the device 28. It will be readily understood that the non-passage
of this liquid into the stomach through the lower end of the pipe
30 indicates of the blockage of the stomach opening. Likewise, any
dripping of the colored liquid out of the stomach would indicate of
the dangerous condition of stomach perforation, which should
immediately be treated.
[0054] Those skilled in the art will readily appreciate that
various modifications and changes can be applied to the invention
as hereinbefore exemplified without departing from its scope
defined in and by the appended claims. For example, the gastric
band may have any appropriate dimensions, providing it is capable
of providing the desired diameter of the stomach opening and its
free end portion is detectable by a suitable imaging system.
* * * * *