CA2068715A1

CA2068715A1 - Reversible stoma-adjustable gastric band

Info

Publication number: CA2068715A1
Application number: CA002068715A
Authority: CA
Inventors: Lubomyr I. Kuzmak
Original assignee: Inamed Development Co
Current assignee: Inamed Development Co
Priority date: 1990-08-03
Filing date: 1991-07-29
Publication date: 1992-02-04
Also published as: EP0495057A1; AU637960B2; EP0495057A4; AU8318091A; US5074868A; WO1992002182A1

Abstract

A reversible gastric banding device for creating a stoma opening in the stomach (51) for restricting food intake into the lower digestive portion of the stomach (51). The band (20) is operatively placed to encircle the stomach (51). Once in position, it is held securely with sutures (61) on the outside of the stomach (51) thereby prohibiting the encircled stoma opening from expanding. If it becomes necessary or desirable to remove the gastric band (20), a remotely actuated releasing portion permits the removal of the gastric band (20) without major surgery. In one embodiment, the banding device is conveniently removed by means of a retractable blade (25) within the band (20) which blade (25), when retracted by remote activation, severs the retaining sutures (61) and frees the band (20) for removal. Additionally the most preferred embodiment of the device includes a flexible substantially non-extensible band (12) portion having an expandable, balloon-like section (15) that is in fluid communication with a remote injection site.

Description

2 PCI'/US91/0535 REVERSIBLE STOMA-ADJUSTABLE GASTRIC BAND ~5~71 BACKG~OUND OF THE INVENTION
1. Field of the Invention The present invention relates to a device for the treatment of morbid obesity and, in particular, it relates to a reversible gastric banding devicc that encircles and compresses a portion of the stomach to form a stoma opening of reduced diameter, the raversible feature permitting removal of the device without the necessity of major surgery.
2. Definitions "Rever ~le gastric band~ as used herein, shall me~n a gastric band which may be removed from an encircling position around the stomach without major surgery.
"Stoma-Adjustable gastr..c band" as used herein, shall mea~ a gastric band which may be adjusted to vary the diameter of the stoma opening within th~t por~ion of the ~tomach encircled by the band.

3. ~-scri~tion of the_Prior Art Morbid obesi~y is a condition that is associated with a multitude of other hazardE _o health that include soci~-psychologic prreDlems and reduced life expectancy. Dieta y manac ~ent of morbid obesity has not been succe6sful a6 a long term lreatment. Psychiatric or dietary regimens depend upon the willpower o the patent to achieve the desired results.
While weight lnss may occur, ~he lack of willpower in patien~s -oftPn leads to ultimate ~ailure. In response to the failure ,''. ' ' '' ' ".

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of dietary management, various surgical techniques ha-~e been develoDed and used to try to treat morbid obesity.
Methods that have been used in the prior art to treat morbid obesity include gastric bypasses and small-bowel bypasses. Stapling of portions of the stomach has also been used to treat morbid obesity. This includes both vertic:al and horizontal stapling and other variations trying to reduce the size of the stomach or make a small stoma opening. Many problems have been associated with the use of staples. First~
staples are undependable; second, they may cause perforations;
and the pouch or stoma opening formed by the staples becomes enlarged over time making the procedure useles~.
Yet another method that has been developed is the placement of an inflatable bag or balloon into the stomach causing the recipient to feel "full." This procedure has been described in the patent to Garren et al U.S. Patent No.

4,416,267 which discloses a device which displaces volume inside the stomach thereby reducing the size of the gastric compartment and which is easily removed. The balloon is inflated to approximately 80~ of the stomach volume and remains in the stomach for a period of about three months or more. This procedure, although simple, has resulted in intestinal blockage~ gastric ulcers, and even in one instance, death and fails to address the problems of potentially ~deleterious contact with the gastric mucosa which can result WO92/02182 PCT/US91/0~35 3_ ~ 7~

from leaving an inflated bag in the stomach for an extended period of time. Moreover, it also failed to produce significant weight loss for long periods of ime.
A more promising method employs the placement of a band around a portion of the stomach thereby compres6ing the stomach and creating a stoma opening that is :Le6~ than the normal interior diameter of the stomach for restricting food intake into the lower digestive portion of the stomach. Such a band has been described by Kuzmak et al in U.S. Patent 4,592,339. It comprises a substantially no~-extensible belt-like strap which cons~rictively encircles the outside of the stomach thereby p~eventing the stoma opening from expanding.
Kuzmak et al also describe bands which include a balloon-like ssction that is expandable and deflatable through a remote injection site. The balloon like expandable section is used to adjust the size of the stoma opening both intraoperatively and post-operatively. Such a device is referred to as a stoma-adjustable gastric band. Although the banding procedure has great promise due to its simplicity and the fact that it retains the desired diameter of the stoma opening, there have been problems in obtaining a proper sized stoma opening.
Ruzmak, in U.S. Patent 4,696,288, describes a calibrating apparatus and me~hod for using with a gastric banding device. - -The calibrating appara~us ~acilitates controlling the size of the stoma with the gastric band.
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W092tO2182 PCT/US91/0535S

Complications have been observed with bot~ infla~able and non-inflatable gastric bands. In particular, obstruction of the stoma from edema and migration of the band has been observed. Such edema-caused obstruction o~ the stoma may be due to excessive vomiting. In these cases, the stoma must be enlarged either by deflating the expandable portion of a band or by removing the band altogether.
Until now, following implantation, the only way to remove a gastric banding device is by major surgery. Thus, while it is possible to vary the pressure on the exterior wall of the stomach by injec~ion or removal of fluid into or out of a r~mote injection port, it is neces6ary to perform major surgery to remove prior art gastric bands. It is desirable to provide a ga6tric banding device with means thereon for removal of the band without the neces~ity for major surgery.
A gastric band with such means for removal is referred to hereinafter as a reversible gastric band.
SU~5A:RY OF THE I~VENTXON
The present .invention is a reversible gastric band for creating a stoma opening in the stomach. The essential and novel feature of the invention is the means thereon for the removal of the band without the need for major surgery. Such a reversible gastric band may further include means thereon permitting remo~e adjustment of the stoma opening after implantation by adding or removing fluid from the expandable .. ~: .. ....... . ....... .. , - . . ........................... .

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W092/0~182 P~T/US91/05355 2 ~

portion of a stoma-adjustable gastric band. For example, in a preferred lbodiment, the reversible gastric band includes, in addition t~ means for nonsurgical removal, a flexible substantially non-extensible band portion ~ h encircles the stomach, and has, in addition, a balloon-like expandable section that is expandable and deflatable through a remote injectio site. The expand~.,e section is used to adjust the size of the stoma opening by percutaneous injection of a fluid into, or removal of fluid from an implantable injection port, ~.
the interior chamber of which port is in fluid communlcation with the expandable sectl . h this preferred embodiment, if the patient is not losing weight as expect.sd, the expanda le section may be further expanded by injecting a .
fluid into the injection pork thereby increasing the size of .le expand~b . section which, in turn, compres~es the stomach thereby ~urther decreasing the size of the stoma opening. ~he :.
decrease in the 6ize of the stoma opening further restricts . . .
the flow of foo~ ~.nto the lower digestive portion of the stomach. If the patient is receiving inadequate nutrition and the weight 1066 is ~oo great, the expandable section is incrementally def`:~ed by withdrawing fluid from the injection site, thereby increasing the size of the stoma opening and _ncreasing ~he ~low of food into the lower ~tomach portion.

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', ' ~ . ' ., . ~ , ~ ~ ~ ob~ec~ of the invention is to provide a reversible gastric band suitable for the adjustable formation of a stoma within the s~omach.
BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a perspective view of a prior art stoma-adjustable band.
Figure 2 is a perspective view of the reversible ga~txic banding device of the present invention.
Figure 3 A-C are exploded views of two embodiments of ~uture cutting means taken along line 3-3 of Figure 2.
Figure 4 A and B are perspective views of a preferred em~odiment of the reversible gastric band showing the :
~elation6hip of parts before being placed around the stomach.
Figure 5 is a perspective view of the rev~rsible ga6tric banding device bein~ initially placed in po6ition around a ~tomach.
Figure 6 is a perspective view of the reversible gastric banding device in place after suturing of the greater curvature to retain the device and removal of the buckle.
DETAILED DESCRIPTION OF TH~ PREFERRED EMBODIMENTS

A prior art 6toma-adjustable gastric banding device is generally indicated at 10 in Figure 1. The device includes a longi~udinal substantially non-extensible band portion (12), an expandable ~ection tlS), a buckle portion (13~, a guide tab portion (11), and an injection site (16) in fluid ; . .
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W092/02182 PCT/US91/0~355 communication with the expandable section by means of tubing (17). The band portion (12) preferably inclucles two central layers made of a Dacron mesh material (not shown) embedded in a medical grade silicone polymer. The expandable section (15) includes an inflatable balloon made o~ a silic:one polymer interposed between the layers. The balloon is pre~er~bly at least partially filled with a physiologically compatible fluid such as a saline solution~ The balloon is inflated and deflated by piercing the injection site (16) with a hypodermic needle and either adding or withdrawing fluid. In prac~ice, the band is wrapped around the stomach and the guide tab (11) pas~ed through the slot (14) in buckle (13) and cinched down ``~
snugly. The loose end of the band, that is, the tab end which has passed through the ~lot (14), is sutured to the encircling band portion in the general area denoted as (18) thus securing the band about the stomach. Once ~he su~ure(s) are in place, :.:
the buckle may be removed. After the prior art gastric banding device (10) is in place, and the stoma adjusted, the injection site ~16) may be anchored between the rectus sheaths at a convenient location and the patient allowed to recover. :
In fiummary, the prior ar~ device (10) provid~s a permanent implant that controls the amount of fovd ingested by ;~
a morbidly obese patient. The size of the ._oma opening may be adjusted by means of percutaneous injection or withdrawal . .

of fluid from an expandable balloon-like section without need ,'''~'' '', ~ ' ::, for further surgery to regulate the flow of food within the stomach of the patient. If it is necessary, however, to remove the prior art gastric bands, major surgery is necessary.
Turning now to Figure 2, we see the reversible gastric band of the present invention is generally indicated at 20 in Figure 2. The device, although similar to the prior art device (10), includes a ~u~ure-cutting blade portion (25) and a remote blade pull-cord (26) which facilitates removal of the gastric banding device following implantation without the need for major surgery thereby endowing the prior art ga~tric band with reversibility.
Directing attention now to Figure 3A which shows a partially cutaway view of Figure 2 taken along line 3-3, showing one preferred embodiment of the reversible gastric band in which the suture-cutting blade portion i6 an annular rin~ t25), the inner circumferential border of which i~ honed to a sharp cutting edge (30). The suture-cutting portion is positioned within a slot (31) to encircle a suture guide hole (18). A pull cord (26) which is attached ~o the blade (25~
extends out of the s}ot (31) to emerge from the band ~12) and preferably extend collinearly with the tubing used to inflate the balloon-like portion of the band, preferably and conveniently thrsugh a second lumen in double lumen tubing, to terminate adjacent the injection reservoir.

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Figure 3B shows a cutaway view of Figure 3A along line 3B-3~ in which a suture (32) is passed through the 6uture hole (18) to ,e~ure overlapping portions (12) of the reversibl~:
gastric band ~o each other. The suture (32) is ~ied off thereby preventi the gastric band from becoming loose following implantation.
Figure 3C shows yet c.o~her preferred embodiment of a suture-cut ing blade device in which the suture hole (18) is in the path of a guillotine blade (35) with a sharp edge (36) which blade slides in the blade 810t ( 31) in response to i~
tensi n on t~ pull wire (26).
The functional relationship of the various portions of the reversible gastric band ma~ be understood b~ turniny now to Figure 4A which is a per~pective view of the aversible ga6tric band '20) of Figure 2 with the balloon-like portion ~15) inflated for clarity. A pull cord (26) extends from an ;~
i~jection port (not shown) collinearly with the balloon fill ;;
tube (17) through a double lumen tubing (41) to termi~ate at ;, .
the suture-cutting portion where i~ is attached to the cutting blade (25). In Figure 4B, the reversible band (~0~ efld tab ~ '~
(11) is brought through the buckle slot (14) to overlap the band upon itself. A suture (32) is passed ~hrough the suture hole (18) the~ through ~e overlapping port~on of the band (12) and tied off thereby securing the band in a circle. : ;

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W092/02182 PCT/US9l/0535 Since the suture(s) (32) secure ~he band in a circle, the buckle (13) may then be cut off as it is not needed.
The use of a reversihle gastric band may be best understood by turning now to Figure (5). ~he reversible gastric band (20) is firs~ wrapped around the stomach (51) and the guide tab (11) pas~ed through the slot (14) in the buckle (13) and cinched tight until a calibrating apparatus in the stomach (not shown), ~uch as that described in U.S. Patent 4,696,288, indicates the stoma opening, that i8, the opening inside the stomach in the por~ion of the stomach encircled by the band, is the correct size. The loose end of the band (the end of the band that has been passed through the slot in the bùckle) is then sutured (61) (Figure 6) to the band di.stal to the buckle through the suture gu.ide hole (18) thereby anchoring the band around the stomach. Preferably the suture is 00 Ethabond applied with a non-cutting needle. A ~mall amount of fluid is normally present in the expandable portion of the band ~Figure 2(1S)) to facilitate non-~urgical enlargement of the stoma opening should it be necessary. The protruding portions of the buckle (13) may then be cut off and removed. The suture (Figure 6)(61)) should be non-absorbable and of 6ufficient strength to hold the band securely about the stomach and capable of resisting expansion a~ food moYes through the stoma opening. Figure 6 shows the band (20) in .
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place with the buckle (13) removed and secured by a suture (61)-To prevent th~ reversible gas~ric band (20) from moving `~
out of position by slippinq along the greater curvature of the ;
stomach, the reversible gastric band (20) is retained in position by su~uring the greater curvature ~51) of the stomach on both sides of the band portion (20) to itself with s~veral ,~ -sutures (62). The retaining of the banding device (20) i~
position is important ~ince the size of the upper portion (63) of the stomach determines the amount of food that the patient will consume to achieve satiety. Movement of the band will change the size o~ the upper portion t63). The stoma oper.ing regulates the flow of food from the upper portion of the . . . .
stomach to the lower portion of the stomach and consequently controls the rate of ingestion by the patient.
If the patient is ingesting to~ much food, the expandable balloon-like section of the band (Figure 4A)(15)~ may be expanded to decrease the size of the stoma opening via percutaneous injection of fluid in o the expandable portio~ by means of the implanted injection port (1~). Withdrawal of fluid will deflate the device thereby increa~ing the 6toma ; ;
opening.
The band retaining suture(s) t61) lie directly in the path of the cutting blade ~25). The blade pull-cord (26) i~
conven~iently implan~ed collinearly with the injection port :

Wo92/02182 PCT/US9l/OS355 tubing (17) to terminate subcutaneously adjacent the inj~ction port (16). To remove the band from the stom~ch, the distal end of the pull-cord is located via an incision exposing the injection port. The distal end of the pull-cord ii then retracted causing the suture cutting blade (25) to slide in the 610t ( 1) in the direction of tension thereby severing the retaining suture(s) ~5) lying in the blade path. The band may ~
then be removsd by pulling i~ out with the injection port. : :
In practice, it i6 important to design the reversible ::
ga~tric band ~o that the fill tube and the remotely actuated :
releasing pull-cord are (a) collinear or nearly col}inear; and :
~b) eme~ge from the gastric band at or near the buckle. The collinearity is conveniently achieved by housiing the fill tub~
a~d pull-cord in double-lumen tubing. The latter ~eature is readily achieved by having the ~ill tube and the pull cord ~:
emerge from the band on either side of the slot in the buckle. : -Thls is easily accomplished by narrowing the guide tab end o~ ~
the ga6tric band distal to the suture-cutting means so that ~ .
the buckle ~lot may be narrowed to accommodate the narrower guide tab end.
There are i~numerable possible embodimen~s which are capable o~ being remotely actuated to release a reversible gast~ic ba~d. The suture-cut~ing devices of Figure 3A and Figure 3C are presen~ed as examples only. It is clear that a ~ .
cotter-type of pin could be used (instead of suture6) to -.

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secure the band to itself. The pin could be retracted by remote actuation of a pull wire to free t~.e ban~. The essence of this invention is not the means used to -emotely release a gastric band. The essence of the invention is making the gastric band reversible. Spe~ -ic embodiments for endowing the gastric band with reversibllity as presented herein, are exemplary and are not to limit the scope of the invention.
Although the present invention has been described ~ith .' reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing frGm the spirit and scope of the invention.
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Claims

What I claim is:

1. A reversible gastric band.

2. A gastric banding device having means thereon for removal of the gastric band from an encircling position around the stomach without the need for major surgery.

3. A reversible gastric banding device for forming a stoma opening in a stomach comprising:
a) a longitudinal flexible substantially non-extensible band portion for encircling the stomach and for partitioning the stomach into a smaller upper portion and a larger lower portion; and b) means for securing said band in an encircling position around the stomach; and c) means for remotely releasing said means for securing said band from its said encircling position around the stomach.

4. The device of claim 3 further comprising an expandable section located on the band portion adapted for positioning against a stomach wall; and injection site means in fluid communication with the expandable section wherein the expandable section is expandable or deflatable to decrease or increase the size of the stoma opening by addition or withdrawal of fluid through the injection site means.