AU781942B2 - Removable gastric band - Google Patents

Removable gastric band Download PDF

Info

Publication number
AU781942B2
AU781942B2 AU20705/01A AU2070501A AU781942B2 AU 781942 B2 AU781942 B2 AU 781942B2 AU 20705/01 A AU20705/01 A AU 20705/01A AU 2070501 A AU2070501 A AU 2070501A AU 781942 B2 AU781942 B2 AU 781942B2
Authority
AU
Australia
Prior art keywords
stomach
gastric band
elongated body
section
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
AU20705/01A
Other versions
AU2070501A (en
Inventor
Valerio Cigaina
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medtronic Transneuronix Inc
Original Assignee
Medtronic Transneuronix Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to ITMI992641 priority Critical patent/IT1315260B1/en
Priority to ITMI99A002641 priority
Application filed by Medtronic Transneuronix Inc filed Critical Medtronic Transneuronix Inc
Priority to PCT/US2000/033236 priority patent/WO2001041671A2/en
Publication of AU2070501A publication Critical patent/AU2070501A/en
Application granted granted Critical
Publication of AU781942B2 publication Critical patent/AU781942B2/en
Application status is Ceased legal-status Critical
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/005Gastric bands
    • A61F5/0066Closing devices for gastric bands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/0026Anti-eating devices using electrical stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/0003Apparatus for the treatment of obesity; Anti-eating devices
    • A61F5/0013Implantable devices or invasive measures
    • A61F5/005Gastric bands
    • A61F5/0053Gastric bands remotely adjustable
    • A61F5/0056Gastric bands remotely adjustable using injection ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/132Tourniquets
    • A61B17/135Tourniquets inflatable

Description

WO 01/41671 PCT/US00/33236 REMOVABLE GASTRIC BAND Related Application This application claims priority from Italian Patent Application Number M199A002641, filed December 7,1999.

Field of the Invention The present invention relates to a removable gastric band which can be used to control obesity by allowing control and/or modification of the diameter of a patient's stomach.

Background of the Invention Laparoscopic banding systems are available which provide for the use of an elongated main part that is placed around the stomach and closed over the stomach so as to reduce the diameter of the stomach to be able to treat the patient's obesity. Such currently available bands, however, present some drawbacks essentially due to the difficulty of application and/or removal of the gastric band. In fact, normally, the current bands' means of closing the elongated main part are almost always hard to manipulate; moreover, their connection entails the use of additional instruments and/or devices that further complicate the application and/or later removal of the gastric band for the surgeon.

Furthermore, to be able to remove the known bands, which must necessarily be done after a more or less long time interval, it is necessary to execute an additional surgical intervention and, consequently, to administer more anesthesia to the patient. The application and/or removal of the known bands also require the application of suture stitches, in addition to another intervention and more anesthesia. In particular, the bands used today are also hard to remove because they present little resistance to tissue adhesions and lack sufficient mechanical integrity to withstand tensile forces, both of which hinder their removal unless the patient is undergoing surgery.

-2- It is desirable, therefore, to provide an improved gastric band which is both easier to implant within the patient and, when necessary, to remove from the patient.

Summary of the Invention Disclosed herein is a removable gastric band which can be used to control obesity by allowing control and/or modification of the diameter of a patient's stomach. More specifically, there is disclosed herein a removable gastric band comprising an elongated body having a first or distal zone, a second or middle zone, a third or proximal zone and a closure mechanism, wherein the closure mechanism allows the elongated body to close around a portion of the stomach, preferably the proximal tract of the stomach, wherein the closure 1o mechanism comprises a button in the first zone and at least one aperture in the second zone, such that the button can be inserted into the aperture to close the elongated body around, and hold it to, the portion of the stomach.

There is further disclosed herein a removable gastric band comprising an elongated body having a first zone, a second zone, a third zone, and a closure mechanism, wherein the closure mechanism allows a portion of the elongated body to close around a section of the stomach, wherein the closure mechanism comprises a button in the first zone and at least one aperture in the second zone, such that the button can be inserted into the aperture to close the portion of the elongated body around, and hold it to, the section of the stomach, and wherein the portion of the elongated body is essentially planar in cross section.

According to a first embodiment the present invention provides a removable gastric band comprising an elongated body having a first zone, a second zone, and a closure mechanism, wherein the closure mechanism allows a portion of the elongated body to close Saround a section of the stomach, wherein the closure mechanism comprises a button in the •first zone and a plurality of apertures in the second zone, such that the button can be inserted S 25 into one of the apertures to close the portion of the elongated body around, and hold it to, the section of the stomach, and wherein the portion of the elongated body is essentially planar in cross section.

According to a second embodiment the present invention provides a method for the *oo• treatment of obesity in a patient, said method comprising: 30 positioning a removable gastric band around a section of the patient's •stomach; locking the removable gastric band around the section of the patient's sm ha stomach; and o*oo•* [R:\LIBVV]03598-speciamend.doc:THR 2aadjusting the removable gastric band to control the stomach's diameter in the section of the patient's stomach, wherein-the removable gastric-band comprises an elongated body having a first zone, s a second zone, and a closure mechanism, wherein the closure mechanism allows a portion of the elongated body to close around the section of the patient's stomach, wherein the closure mechanism comprises a button in the first zone and a plurality of apertures in the second zone, such that the button can be inserted into one of the apertures to close the portion of the elongated body around, and hold it to, the section of the stomach, and wherein the portion of the elongated body is essentially planar in cross section.

There is further disclosed herein a method for treatment of obesity or for reducing weight in a patient, said method comprising: positioning a removable gastric band around a section of the patient's stomach; locking the removable gastric band around the section of the patient's stomach; and **oo* [R:\LIBVV]3598_speciamend.doc:THR WO 01/41671 PCTUSO0/33236 adjusting the removable gastric band to control the stomach's diameter in the section of the patient's stomach, wherein the removable gastric band comprises an elongated body having a first zone, a second zone, a third zone, and a closure mechanism, wherein the closure mechanism allows a portion of the elongated body to close-around the section-of-the patient's stomrnach, wherein the closure mechanism comprises a button in the first zone and at least one aperture in the second zone, such that the button can be inserted into the aperture to close the portion of the elongated body around, and hold it to, the section of the stomach, and wherein the portion of the elongated body is essentially planar in cross section.

The task proposed by the present invention is the realization of a removable gastric band that eliminates the above-noted drawbacks of the known gastric bands. Within the scope of this task, one important purpose of the invention is to realize a removable gastric band that can be removed without having to subject the patient to further intervention and, consequently, to additional general anesthesia.

Yet another purpose of the invention is to realize a removable gastric band that is easy to remove because it is highly resistant to adhesion to the tissue and has sufficient mechanical integrity to withstand tensile forces during removal. Yet another purpose of the invention is to realize a removable gastric band that can be applied without necessarily having to use suture stitches.

Yet another purpose of the invention is to realize a removable gastric band that can be applied and/or removed by the surgeon very simply and without having to use additional instruments or devices for that purpose.

Another purpose of the invention is to realize a removable gastric band that is extremely easy to manipulate, so that it can be easily placed in and/or removed from the patient.

WO 01/41671 PCTUS00O/33236 Brief Description of the Drawings Figure 1 illustrates the gastric band according to the invention.

Figure 2 shows schematically the gastric band according to the invention being applied to the proximal tract of a patient's stomach; Figure 3 shows the gastric band according to the invention applied to the proximai tract of the patient's stomach; Figure 4 shows the gastric band according to the invention inflated so as to compress a portion of the patient's stomach; Figure 5A shows in cross-sectional view (along line A-A in Figure 1) the inner surface of the gastric band compressing the patient's stomach before the gastric band has been inflated; Figure 5B shows in cross-sectional view (along line A-A in Figure 1) the inner surface of the gastric band in relation to the patient's stomach after the gastric band has been inflated; Figure 5C shows in cross-section sectional view a reinforcing member or element located within the elongated perimeter the rib connecting the inner and outer surfaces, thereby forming an inflatable chamber or cavity) of the gastric band which reduces the tendency of the gastric band to twist around its longitudinal axis; Figure 6A is a view of the gastric band attached to the patient's stomach with the inflation mechanism positioned to allow for inflation; and Figure 6B is an expanded view of the inflation mechanism.

Detailed Description of the Invention With reference to the figures described above, the removable gastric band according to the invention, indicated as a whole with reference number 1, comprises an elongated body 3 having a first or distal zone 30, a second or middle zone 32, a third or proximal zone 34, and a closure mechanism 2 for closing the elongated body 3 back upon itself so as to surround a portion, preferably the proximal tract, of the patient's stomach 4. The closure mechanism 2 preferably comprises a button 6 in the first zone 30 and a corresponding aperture 5 in the second zone 32 whereby the button 6 can fit WO 01/41671 PCT/US00/33236 through the aperture 5 and fix or lock the elongated body 3 back onto to itself.

Once locked into place, the gastric band 1 completely encircles and compresses a portion of the patient's stomach (see, Figures 3 and 4).

Although only one aperture 5 is shown within the second zone 32, a plurality of such apertures can be provided if desired; using such a plurality of apertures allows the surgeon to more closely adjust the diameter of the encircling portion of the gastric band to the particular patient's situation and needs.

Appropriately, button 6 is suitably shaped and sized to allow it to be internally introduced into aperture 5, as well as to close, in an extremely simple but secure manner, the elongated main part 3 around stomach 4 and keep it in place. Although the button 6 and aperture 5 are preferably circular as shown in Figure 1, other shapes can be used so long as they provide the desired closing/locking action. Elongated body 3 presents at least an inner surface 7 and an outer surface 8 as more clearly'shown in Figure 5A (deflated state) and Figure 5B (inflated state). Preferably, the elongated body 3 has an inflatable portion or internal cavity 9 formed by inner surface 7, outer surface 8, and ribs, welds, or closures 22 at the edges of the elongated body 3. Ribs 22 essentially form a closed space or internal cavity 9 in combination with the inner and outer surfaces 7 and 8 (see, Figure 58). Such an inflatable member allows the elongated body 3 to be expanded when a physiological inflation medium liquid or gas) 9 is introduced between inner surface 7 and outer surface 8. (Both the inflatable portion or internal cavity and the inflation medium, which effectively defines the size of the internal cavity, are referred to by common reference number 9 in the figures.) Preferably, button 6 is fluid-dynamically connected to inner surface 7 of elongated body 3 in such a way that, as the latter inflates, button 6 also inflates, as can be seen, for example, in Figure 3; this provides a more secure locking of the elongated body back upon itself. Preferably, the inner surface 7 is more easily expandable relative to outer surface 8 so that inflation of the elongated body 3 allows further compression, and thus more control of the compression, of the stomach. Generally, therefore, it is preferred that outer surface 8 WO 01/41671 PCT/US00/33236 undergoes little, if any, expansion when the physiological inflation liquid or gas 9 is introduced between inner surface 7 and outer surface 8.

Compression of the stomach using the gastric band of the present invention allows for a reduction of the stomach volume as desired. The degree of compression can be modified as desired throughout the course of treatment by adding or removing inflation medium 9.

Furthermore, button 6 and aperture 5 are preferably sized relative to one another that once button 6 is passed through aperture 5 and inflated, the closure mechanism is securely activated but, once button 6 is deflated, the closure mechanism can easily be deactivated by simply pulling on one end of the gastric band (preferably by pulling on tube 20) to remove the gastric band from the abdomen. Furthermore, button 6 is preferably located outside of elongated main part 3 by a distance that can allow a substantial alignment of the first and second zones of elongated body 3, when the latter is closed around the stomach. Thus, when the elongated body 3 is inflated (and preferably button 6 is also inflated), there is no unsuitable and/or harmful superposition of two parts of the elongated body 3 that would provide an undesired enlargement at the zone where they are superposed. In other words, the inflatable portions of the gastric band do not overlap; such overlapping might result in undesirable and/or additional stomach compression in the area of overlap.

Preferably, button 6 is equipped with flap 10 that makes it easier to catch and insert the button 6 into aperture 5 using appropriate instruments.

Flap 10 is appropriately made with no internal cavity and, therefore, is not inflatable. Flap 10 can be grasped quickly and simply by surgical endoscopic forceps 11 that is passed first through aperture 5 (see Figure Once grasped, flap 10 and button 6 are pulled back through aperture 5 to lock the gastric band in place (see Figure 3).

As noted above, it is preferred that the button 6 expands at the same time as inner surface 7 of the elongated body 3. The expansion of button 6 should, however, be limited so that, once the gastric band 1 is locked firmly in place, the button 6 does not under go significant further expansion. For WO 01/41671 PCT/US00/33236 example, the relative thicknesses of the walls of the button 6 and inner surface 7 can be controlled such that the inflation of the button will reach a definite value without expanding any further, independently of the inflation of inner surface 7 of elongated body 3. Thus, preferably the button 6 expands to a size sufficient to lock the closure mechanism 2 in place but not significantly larger.

The elongated body 3 is preferably designed so as to prevent or reduce the tendency of the elongated body 3 to rotate around its long axis as it is being placed in the proper position around the patient's stomach. For example, one or both of the ribs 22 at the edges of the elongated body 3 can contain stiffening elements 12 (see Figure 5C) which will reduce the tendency of the elongated body 3 to rotate or twist about its long axis without effecting the ability of the elongated body to fold back on itself and encircle the patient's stomach. Such stiffening elements 12 will reduce the tendency to twist as the gastric band is being positioned within the patient. Such stiffening or antirotation elements 12 will tend to stabilize the prosthesis and make the insertion easier. The ribs 22 at the edges of the elongated body 3 are preferably gently curved so as not to create problems either at the time of the implant or during removal by pulling of elongated body 3 from the outside; in other words, the ribs, as well as other portions of the gastric band, preferably present smooth and gently curved surfaces to allow the gastric band to slide easily around organs during implantation and removal.

The gastric band preferably has an inflation mechanism 15 comprising a reservoir 16 for receiving the inflation medium, preferably a physiological liquid or gas, for inflating both elongated body 3 and button 6. Preferably, the reservoir 16 has several concentric layers 17 to allow it to be pierced, for example with needle 18, without the inflation medium 9 being able to escape from the perforation. Preferably, reservoir 16 is constructed with multiple layers of material (preferably elastomeric or plastic materials) that. when pricked with needle 18, allows the hole to be made without skewing or leakage between the different layers 17. Such skewing or leakage would generally be mainly noticeable or chiefly accentuated during the expansion of WO 01/41671 PCT/US00/33236 reservoir 16 when the inflation medium 9 would tend to leak. The external layer of reservoir 16, preferably constructed of biocompatible materials, is generally thicker than the other, internal layers and can even be rigid, since it preferably remains adjacent to the abdominal wall, more preferably within the subcutis, and presents such dimensions as to permit easy introduction through-a surgical laparoscopic trocar. By maintaining the reservoir 16 near the abdominal wall, the compression of the stomach can more easily be modified as desired by addition or removal of the inflation medium 9. In some instances, it may be desired for the reservoir 16 to remain outside the abdominal wall.

The elongated body 3 can be inflated using the inflation medium introduced into the reservoir 16 using, for example, a syringe 18 as shown in Figures 6A and 6B. The elongated body is inflated until the desired degree of compression of the stomach occurs. The inflation of the gastric band is generally performed under the control of the endoscopist, who can observe, preferably using an endoscope from inside the stomach, the diameter of the gastric restriction induced by the inflation of the gastric band, particularly by inner surface 7. Preferably, essentially the entire length of the gastric band 3 encircling the stomach can be inflated using the inflation medium 9.

Reservoir 16 is preferably located in the third or proximal zone 34 of elongated body 3 and is connected to the second or middle zone 32 containing aperture 5 is present via tube 20. The length of tube 20 can be varied as needed for particular patients; preferably, tube 20 does not significantly expand when inflation medium 9 is added to the gastric band. In operation, the reservoir 16 is preferably not secured and remains in the subcutis of the abdominal wall. It may be located, using, for example, feel or ultrasound, for introduction of the inflation medium in order to inflate or deflate the gastric band. Using such a technique, the diameter of the gastric constriction provided by the gastric band can be modified or adjusted as desired. Preferably, reservoir 16 has a flap 21 which can be grasped using appropriate instruments to assist in the inflation or deflation operation.

WO 01/41671 PCTUSOO/33236 Preferably, both the main portion of the elongated body 3 and the tube have stiffening or antirotation elements 12 within the ribs 22 as shown in Figure 5C. For example, the stiffening elements 12 could be a thin steel, other metal, or other type wire that is fused into the plastic material of the rib 22. Such a stiffening element 12 reduces the tendency of the gastric band to rotate about-its-long axis before the closure mechanism is activated.

Additionally, it makes the gastric band considerably stronger acting as a reinforcing element); this added strength may be especially important when the gastric band is removed from the patient by pulling on the proximal end 34 from the outside. The stiffening element 12, when formed using a steel or other suitable metal wire, can also be observed using X-rays, thereby determining the exact position of the band inside the patient's abdomen.

Preferably, such stiffening element 12 extends essentially the entire length of the elongated body 3 through the first, second, and third zones, including tube When it is desired to remove the gastric band from the abdomen, it is generally preferred to remove at least a portion of the inflation medium 9 so that the closure mechanism 2 can more easily be disengaged. A significant portion of the inflation medium 9 can be removed using, for example, a syringe using essentially the same procedures as used for the initial inflation process. Altemrnatively, tube 20 can be cut using cutting device 1 la to separate reservoir 16, as represented in Figure 3, to release inflation medium 9. Preferably, at least a portion of inflation medium 9 is removed prior to cutting tube 20 so as to minimize release of inflation medium 9 into the abdominal cavity. For this purpose, under local anesthesia, a small cutaneous incision is made in the abdominal wall to access reservoir 16, at which time tube 20 is cut and the reservoir 16 is removed from the abdominal cavity. After the closure mechanism 2 is disengaged, the gastric band 3 can be removed from the abdominal cavity by pulling on the tube 20 through the small cutaneous incision.

Preferably, the limit of expandability of inner surface 7 is linked to the limit of compressibility of the gastric walls and the two ends of the elongated WO 01/41671 PCT/US00/33236 body must be blunted enough to allow sliding between the patient's tissues in the phase of removal from the abdomen. In the removal phase, the gastric band will behave as an abdominal drainage tube. Preferably, the materials of construction and the surface smoothness are such that they will impede the production of fibrotic scar adhesions, as normally occurs with drainage tubes or prostheses of silicone materials. Such a smooth surface helps to prevent tissue adhesion to the gastric band. Thus, once deflated and unbuttoned, the gastric band can be removed easily by pulling on one end through a small incision. Preferably, the gastric band will have sufficient strength to withstand the forces associated with removal by this technique.

The gastric band of the present invention can be easily paired with the use of a gastric electrostimulator 100 and may be useful, therefore, for inducing forced slimming in the initial phase of treatment for morbigenous obesity. The electrostimulator 100 may be incorporated into the design of the gastric band as shown in Figure 1 attached to the inner surface 7) such that the electrostimulator 100 is in contact with the stomach when the gastric band is properly positioned. Alternatively, it may be separately implanted elsewhere within the abdominal cavity as shown in Figure 2 attached to the antrum). If incorporated into the gastric band design, the electrostimulator 100 is implanted at the same time as, and held in place by, the gastric band, thereby eliminating separate attachment of the electrostimulator 100. In such a unitary design, however, the electrostimulator 100 must be removed at the same time as the gastric band. If such an electrostimulator 100 is separately placed at a distance from the gastric band, it may remain within the abdominal cavity after removal of the gastric band. The selection of the preferred location of such an electrostimulator 100 relative to the gastric band will depend largely on the particular patient's requirements and planed treatment regime. Both the electrostimulator 100 and the gastric band are preferably installed and/or removed at the same time, thereby reducing the extent of surgical intervention and anesthesia.

Conventional electrostimulation devices 100 may be used in the practice of this invention in combination with the gastric band 3. Such -11 devices include, for example, those described in U.S. Patent 5,423,872 (June 3, 1995) (an implantable gastric electrical stimulator at the antrum area of the stomach which generates sequential electrical pulses to stimulate the entire stomach, thereby artificially altering the natural gastric motility to prevent emptying or to slow down food transit hr"ough the stomach);- U.S. Patent 5,690,691- (November 25, 1997) (a portable or implantable gastric pacemaker employing a number of electrodes along the greater curvature of the stomach for delivering phased electrical stimulation at different locations to accelerate or attenuate peristaltic movement in the gastrointestinal tract); U.S. Patent 5,836,994 (November 17,1998) (an implantable gastric stimulator which incorporates 0o direct sensing of the intrinsic gastric electrical activity by one or more sensors of predetermined frequency bandwidth for application or cessation of stimulation based on the amount of sensed activity); U.S. Patent 5,861,014 (January 19, 1999) (an implantable gastric stimulator for sensing abnormal electrical activity of the gastrointestinal tract so as to provide electrical stimulation for a preset time period or for the duration of the abnormal electrical activity to treat gastric rhythm abnormalities); U.S. Patent 6, 041,258 (March 21, 2000) (electrostimulation device with improved handle for laparoscopic surgery); U.S. Patent Application Serial Number 09/640, 201 (US 6,510,332, filed August 16, 2000) (eletrostimulation device attachable to enteric or endo-abdominal tissue or viscera which is resistance to detachment); PCT Application Serial Number PCT/US00/09910 (WO 00/61224, filed April 14, 2000; Attorney Docket No. 3581/006 PCT) entitled "Gastric Stimulator Apparatus and Method for Installing" based on United States Provisional Application Serial Numbers 60/129,198 and 60/129,199 (both filed April 14, 1999); PCT Application Serial Number PCT/US00/10154 (WO 00/61223, filed April 14, 2000; Attorney Docket No. 3581/004 PCT) entitled "Gastric Stimulator 25 Apparatus and Method for Use" based on United States Provisional Application Serial Numbers 60/129,209 (filed April 14, 1999) and 60/466,387 (filed December 17, 1999); and U.S. Provisional Patent Application Serial Number 60/235,660 (WO 02/26317, filed o September 26, 2000) entitled "Method and Apparatus for Intentional Impairment of Gastric Motility and/or R:\LIBH15035doc:M

C

C

[R:\LIBH15035.doc:MOT WO 01/41671 PCT/US00/33236 Efficiency by Triggered Electrical Stimulation of the Gastric Tract with Respect to the Intrinsic Gastric Electrical Activity." All of these patents, patent applications, provisional patent applications, and/or publications are hereby incorporated by reference.

ro Moreover, the gastric band of the invention is of great clinical interest, especiaiiy in relation to problems inherent to prolonged permanence in the abdomen, that is, intragastric decubitus, perforation, strangulation, and the like. In practice it has been confirmed that the removable gastric band according to the invention is particularly advantageous because it can be removed without having to perform an additional surgical intervention and additional anesthesia on the patient, thanks especially to its qualities of resistance to pulling.

The invention thus conceived is susceptible to numerous modifications and variations, all falling within the scope of the inventive concept; furthermore, all of the details can be substituted with technically equivalent elements. In practice, other materials and dimensions can be used, depending on the demands and on the state of the technique.

-12-

Claims (19)

1. A removable gastric band comprising an elongated body having a first zone, a second zone, and a closure mechanism, wherein the closure mechanism allows a portion of the eio ngate-d- bodyto close around a section of the stomach, wherein the closure mechanism comprises a button in the first zone and a plurality of apertures in the second zone, such that the button can be inserted into one of the apertures to close the portion of the elongated body around, and hold it to, the section of the stomach, and wherein the portion of the elongated body is essentially planar in cross section.
2. The removable gastric band of claim 1, wherein at least the portion of the ijo elongated body encircling the section of the stomach comprises an essentially planar inner surface, an essentially planar outer surface, and ribs running along the elongated body and connecting the inner and outer surfaces to form an internal cavity, such that the cavity can be inflated whereby the inner surface can controllably compress the section of the stomach.
3. The removable gastric band of claim 2, wherein the button is fluid- dynamically connected to the cavity and is inflatable, whereby the elongated body can be more securely closed around the section of the stomach when the cavity is inflated.
4. The removable gastric band of claim 3, wherein the button is located along the elongated body by a distance from the apertures to allow substantial alignment of the first and second zones of the elongated body when closed around said stomach, whereby the inflated cavity does not overlap with itself when closed around said stomach. The removable gastric band of claim 3, wherein the button has a flap for catching and easy introduction into the apertures.
6. The removable gastric band of claim 5, wherein the ribs have reinforcing elements to reduce the tendency of the elongated body to rotate around its long axis. i. 25 7. The removable gastric band of claim 6, wherein the elongated body further has a third zone, wherein the second and third zones are connected by a tube and the third °zone has a reservoir for receiving an inflation medium, and wherein the reservoir is fluid- dynamically connected to the cavity, whereby the cavity can be inflated or deflated by adding oO*o or removing, respectively, inflation medium from the reservoir. 30 8. The removable gastric band of claim 7, wherein the reservoir comprises a sphere having a plurality of concentric layers to allow the reservoir to be pierced with a needle without allowing the inflation medium to escape. Oo°° o [R:\LBVV]03598_speciamend.doc:THR
14- 9. The removable gastric band of claim 8, wherein the reinforcing elements are radiopaque. The removable gastric band of claim 7, wherein the reservoir has a flap for easy holding. 11. The removable gastric band of claim 8, wherein the reservoir has a flap for easy holding. 12. The removable gastric band of claim 2, wherein essentially planar inner surface of the portion of the elongated body encircling the section of the stomach has an electrostimulator that contacts the stomach when the gastric band is in place around the stomach. 13. The removable gastric band of claim 7, wherein the essentially planar inner surface of the portion of the elongated body encircling the section of the stomach has an electrostimulator that contacts the stomach when the gastric band is in place around the stomach. 14. A method for the treatment of obesity in a patient, said method comprising: positioning a removable gastric band around a section of the patient's stomach; locking the removable gastric band around the section of the patient's stomach; and adjusting the removable gastric band to control the stomach's diameter in the section of the patient's stomach, wherein the removable gastric band comprises an elongated body having a first zone, a second zone, and a closure mechanism, wherein the closure mechanism allows a portion of the elongated body to close around the section of the patient's stomach, wherein the closure mechanism comprises a button in the first zone and a plurality of apertures in the second zone, such that the button can be inserted into one of the apertures to close the portion of the elongated body around, and hold it to, the section of the stomach, and wherein the portion of the elongated body is essentially planar in cross section.
15. The method of claim 14, wherein at least the portion of the elongated body 30 encircling the section of the stomach comprises an essentially planar inner surface, an essentially planar outer surface, and ribs running along the elongated body and connecting the inner and outer surfaces to form an internal cavity, such that the cavity can be inflated whereby the inner surface can controllably compress the section of the stomach. C CCC C C C C.r C 6* C S C. C C S S ScC* S C C C C C [R:\LIBVV]03598_speciamend.doc:THR
16. The method of claim 15, wherein the button is fluid-dynamically connected to the cavity and is inflatable, whereby the elongated body can be more securely closed around the section of the stomach when the cavity is inflated.
17. The removable gastric band-of claim 16, wherein the button is located along the elongated body by a distance from the apertures to allow substantial alignment of the first and second zones of the elongated body when closed around said stomach, whereby the inflated cavity does not overlap with itself when closed around said stomach.
18. The method of claim 16, wherein the button has a flap for catching and easy introduction into the apertures.
19. The method of claim 18, wherein the ribs have reinforcing elements to reduce the tendency of the elongated body to rotate around its long axis. The method of claim 19, wherein the elongated body further has a third zone, wherein the second and third zones are connected by a tube and the third zone has a reservoir for receiving an inflation medium and wherein the reservoir is fluid-dynamically connected to the cavity, whereby the cavity can be inflated or deflated by adding or removing, respectively, inflation medium from the reservoir.
21. The method of claim 20, wherein the reservoir comprises a sphere having a plurality of concentric layers to allow the reservoir to be pierced with a needle without allowing the inflation medium to escape.
22. The method of claim 21, wherein the reinforcing elements are radiopaque.
23. The method of claim 20, wherein the reservoir has a flap for easy holding.
24. The method of claim 21, wherein the reservoir has a flap for easy holding.
25. The method of claim 15 further comprising implanting an electrostimulator near or adjacent to the patient's stomach and providing electrostimulation to the patient's 25 stomach in combination with the gastric band.
26. The method of claim 25, wherein the electrostimulator is located on the essentially planar inner surface of the portion of the elongated body encircling the section of the patient's stomach such that the electrostimulator contacts the patient's stomach when the Sgastric band is in place around the patient's stomach. S 30 27. The method of claim 25, wherein the electrostimulator is located separately from the gastric band. a S S [R:\LIBVV]03598_speciamend.doc:THR 16-
28. The method of claim 20 further comprising implanting an electrostimulator near or adjacent to the patient's stomach and providing electrostimulation to the patient's stomach in combination with the gastric band.
29. The method of claim 28, wherein -the electrostimulator is located on the essentially planar inner surface of the portion of the elongated body encircling the section of the patient's stomach such that the electrostimulator contacts the patient's stomach when the gastric band is in place around the patient's stomach. The method of claim 28, wherein the electrostimulator is located separately from the gastric band. 1o 31. A removable gastric band substantially as hereinbefore described with reference to the accompanying drawings. Dated 24 September, 2004 Transneuronix, Inc. Patent Attorneys for the Applicant/Nominated Person SPRUSON FERGUSON S 9 S 5* S [R\LIBVV]03598_speciamend.doc:THR
AU20705/01A 1999-12-07 2000-12-07 Removable gastric band Ceased AU781942B2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
ITMI992641 IT1315260B1 (en) 1999-12-07 1999-12-07 Gastric banding removable
ITMI99A002641 1999-12-07
PCT/US2000/033236 WO2001041671A2 (en) 1999-12-07 2000-12-07 Removable gastric band

Publications (2)

Publication Number Publication Date
AU2070501A AU2070501A (en) 2001-06-18
AU781942B2 true AU781942B2 (en) 2005-06-23

Family

ID=11384141

Family Applications (1)

Application Number Title Priority Date Filing Date
AU20705/01A Ceased AU781942B2 (en) 1999-12-07 2000-12-07 Removable gastric band

Country Status (10)

Country Link
EP (1) EP1237486A4 (en)
JP (1) JP2003526410A (en)
CN (1) CN1230126C (en)
AU (1) AU781942B2 (en)
CA (1) CA2390666A1 (en)
HK (1) HK1059873A1 (en)
IL (2) IL149852D0 (en)
IT (1) IT1315260B1 (en)
NO (1) NO20022660D0 (en)
WO (1) WO2001041671A2 (en)

Families Citing this family (60)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9101765B2 (en) 1999-03-05 2015-08-11 Metacure Limited Non-immediate effects of therapy
FR2808674B1 (en) * 2000-05-12 2002-08-02 Cie Euro Etude Rech Paroscopie gastroplasty ring has tabs prehension
AU2002255245A1 (en) 2001-04-18 2002-10-28 Impulse Dynamics Nv Analysis of eating habits
US7146984B2 (en) * 2002-04-08 2006-12-12 Synecor, Llc Method and apparatus for modifying the exit orifice of a satiation pouch
US6845776B2 (en) * 2001-08-27 2005-01-25 Richard S. Stack Satiation devices and methods
US6675809B2 (en) 2001-08-27 2004-01-13 Richard S. Stack Satiation devices and methods
CN101810521B (en) 2001-08-27 2015-05-13 辛尼科有限责任公司 Satiation devices and methods
DE10158940C2 (en) * 2001-12-03 2003-10-30 Goetz Alois H gastric Banding
US7338433B2 (en) 2002-08-13 2008-03-04 Allergan, Inc. Remotely adjustable gastric banding method
US7097665B2 (en) 2003-01-16 2006-08-29 Synecor, Llc Positioning tools and methods for implanting medical devices
US20040172084A1 (en) 2003-02-03 2004-09-02 Knudson Mark B. Method and apparatus for treatment of gastro-esophageal reflux disease (GERD)
US7444183B2 (en) 2003-02-03 2008-10-28 Enteromedics, Inc. Intraluminal electrode apparatus and method
US7844338B2 (en) 2003-02-03 2010-11-30 Enteromedics Inc. High frequency obesity treatment
EP1603634B1 (en) * 2003-02-03 2011-12-21 Enteromedics Inc. Electrode band
US7201757B2 (en) * 2003-06-20 2007-04-10 Enteromedics Inc. Gastro-esophageal reflux disease (GERD) treatment method and apparatus
CN1748659B (en) * 2003-06-27 2010-05-26 伊西康内外科公司 Implantable band with attachment mechanism having dissimilar material properties
US7951067B2 (en) 2003-06-27 2011-05-31 Ethicon Endo-Surgery, Inc. Implantable band having improved attachment mechanism
US7500944B2 (en) 2003-06-27 2009-03-10 Ethicon Endo-Surgery, Inc. Implantable band with attachment mechanism
AT412525B (en) 2003-07-25 2005-04-25 Wolfgang Dr Lechner Controllable gastric band
US20050059583A1 (en) 2003-09-15 2005-03-17 Allergan, Inc. Methods of providing therapeutic effects using cyclosporin components
US8206456B2 (en) 2003-10-10 2012-06-26 Barosense, Inc. Restrictive and/or obstructive implant system for inducing weight loss
US20050247320A1 (en) 2003-10-10 2005-11-10 Stack Richard S Devices and methods for retaining a gastro-esophageal implant
CA2567161C (en) 2004-01-23 2012-03-13 Allergan, Inc. Releasably-securable one-piece adjustable gastric band
US9821158B2 (en) 2005-02-17 2017-11-21 Metacure Limited Non-immediate effects of therapy
WO2005105003A1 (en) 2004-04-26 2005-11-10 Synecor, Llc Restrictive and/or obstructive implant for inducing weight loss
WO2005120363A1 (en) 2004-06-03 2005-12-22 Mayo Foundation For Medical Education And Research Obesity treatment and device
US7833279B2 (en) 2004-11-12 2010-11-16 Enteromedics Inc. Pancreatic exocrine secretion diversion apparatus and method
US7416528B2 (en) 2005-07-15 2008-08-26 Ethicon Endo-Surgery, Inc. Latching device for gastric band
US20070027466A1 (en) 2005-07-28 2007-02-01 Ethicon Endo-Surgery, Inc. Electroactive polymer-based tissue apposition device and methods of use
US7766815B2 (en) 2005-07-28 2010-08-03 Ethicon Endo-Surgery, Inc. Electroactive polymer actuated gastric band
US7822486B2 (en) 2005-08-17 2010-10-26 Enteromedics Inc. Custom sized neural electrodes
US7672727B2 (en) 2005-08-17 2010-03-02 Enteromedics Inc. Neural electrode treatment
US9055942B2 (en) 2005-10-03 2015-06-16 Boston Scienctific Scimed, Inc. Endoscopic plication devices and methods
US8043206B2 (en) 2006-01-04 2011-10-25 Allergan, Inc. Self-regulating gastric band with pressure data processing
US7763039B2 (en) * 2006-06-09 2010-07-27 Ethicon Endo-Surgery, Inc. Articulating blunt dissector/gastric band application device
EP2572673B1 (en) 2006-09-02 2015-08-19 Boston Scientific Scimed, Inc. Intestinal sleeves and associated deployment systems and methods
WO2008033474A2 (en) 2006-09-15 2008-03-20 Synecor, Llc System for anchoring stomach implant
WO2008139463A2 (en) 2007-05-09 2008-11-20 Metacure Ltd. Analysis and regulation of food intake
US20090030284A1 (en) 2007-07-18 2009-01-29 David Cole Overtube introducer for use in endoscopic bariatric surgery
US20090171383A1 (en) 2007-12-31 2009-07-02 David Cole Gastric space occupier systems and methods of use
US8020741B2 (en) 2008-03-18 2011-09-20 Barosense, Inc. Endoscopic stapling devices and methods
WO2010040528A1 (en) * 2008-10-10 2010-04-15 Universitaetsklinikum Heidelberg Arrangement for implanting and method for implanting
US20100185049A1 (en) 2008-10-22 2010-07-22 Allergan, Inc. Dome and screw valves for remotely adjustable gastric banding systems
US7934631B2 (en) 2008-11-10 2011-05-03 Barosense, Inc. Multi-fire stapling systems and methods for delivering arrays of staples
US8357081B2 (en) 2008-12-05 2013-01-22 Onciomed, Inc. Method and apparatus for gastric restriction of the stomach to treat obesity
US8911346B2 (en) 2008-12-05 2014-12-16 Onclomed, Inc. Gastric restriction devices with fillable chambers and ablation means for treating obesity
US8100932B2 (en) 2009-03-31 2012-01-24 Onciomed, Inc. Method and apparatus for treating obesity and controlling weight gain using self-expanding intragastric devices
US8961539B2 (en) 2009-05-04 2015-02-24 Boston Scientific Scimed, Inc. Endoscopic implant system and method
US8934975B2 (en) 2010-02-01 2015-01-13 Metacure Limited Gastrointestinal electrical therapy
US8840541B2 (en) 2010-02-25 2014-09-23 Apollo Endosurgery, Inc. Pressure sensing gastric banding system
US9028394B2 (en) 2010-04-29 2015-05-12 Apollo Endosurgery, Inc. Self-adjusting mechanical gastric band
US9044298B2 (en) 2010-04-29 2015-06-02 Apollo Endosurgery, Inc. Self-adjusting gastric band
US20110270024A1 (en) 2010-04-29 2011-11-03 Allergan, Inc. Self-adjusting gastric band having various compliant components
US20110270025A1 (en) 2010-04-30 2011-11-03 Allergan, Inc. Remotely powered remotely adjustable gastric band system
US8825164B2 (en) 2010-06-11 2014-09-02 Enteromedics Inc. Neural modulation devices and methods
US20120059216A1 (en) 2010-09-07 2012-03-08 Allergan, Inc. Remotely adjustable gastric banding system
US8961393B2 (en) 2010-11-15 2015-02-24 Apollo Endosurgery, Inc. Gastric band devices and drive systems
US8876694B2 (en) 2011-12-07 2014-11-04 Apollo Endosurgery, Inc. Tube connector with a guiding tip
US8961394B2 (en) 2011-12-20 2015-02-24 Apollo Endosurgery, Inc. Self-sealing fluid joint for use with a gastric band
WO2015134747A1 (en) 2014-03-06 2015-09-11 Mayo Foundation For Medical Education And Research Apparatus and methods of inducing weight loss using blood flow control

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5152770A (en) * 1990-03-22 1992-10-06 Ab Hepar Implantable device for occluding a duct in the body of a living being
US5449368A (en) * 1993-02-18 1995-09-12 Kuzmak; Lubomyr I. Laparoscopic adjustable gastric banding device and method for implantation and removal thereof

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE448812B (en) * 1985-02-01 1987-03-23 Astra Meditec Ab Surgical device for rebinding of magsecken of a patient
US4592339A (en) * 1985-06-12 1986-06-03 Mentor Corporation Gastric banding device
US5074868A (en) * 1990-08-03 1991-12-24 Inamed Development Company Reversible stoma-adjustable gastric band
ES2125310T3 (en) * 1993-02-18 1999-03-01 Lubomyr Ihor Kuzmak Laparoscopic Adjustable Gastric Banding.
US6102922A (en) * 1995-09-22 2000-08-15 Kirk Promotions Limited Surgical method and device for reducing the food intake of patient
US5938669A (en) * 1997-05-07 1999-08-17 Klasamed S.A. Adjustable gastric banding device for contracting a patient's stomach
IL129032A (en) * 1999-03-17 2006-12-31 Moshe Dudai Gastric band

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5152770A (en) * 1990-03-22 1992-10-06 Ab Hepar Implantable device for occluding a duct in the body of a living being
US5449368A (en) * 1993-02-18 1995-09-12 Kuzmak; Lubomyr I. Laparoscopic adjustable gastric banding device and method for implantation and removal thereof

Also Published As

Publication number Publication date
CN1450879A (en) 2003-10-22
EP1237486A4 (en) 2003-06-25
CN1230126C (en) 2005-12-07
CA2390666A1 (en) 2001-06-14
WO2001041671A2 (en) 2001-06-14
HK1059873A1 (en) 2006-08-11
WO2001041671A3 (en) 2002-03-07
JP2003526410A (en) 2003-09-09
EP1237486A2 (en) 2002-09-11
IL149852A (en) 2006-12-10
IL149852D0 (en) 2002-11-10
IT1315260B1 (en) 2003-02-03
ITMI992641A1 (en) 2001-06-20
ITMI992641D0 (en) 1999-12-20
AU2070501A (en) 2001-06-18
NO20022660D0 (en) 2002-06-05

Similar Documents

Publication Publication Date Title
US9060844B2 (en) Apparatus and methods for treatment of morbid obesity
US5259399A (en) Device and method of causing weight loss using removable variable volume intragastric bladder
US7033384B2 (en) Stented anchoring of gastric space-occupying devices
US9526649B2 (en) Method and instrument for treating obesity
CA2483243C (en) Implantable band with transverse attachment mechanism
US8882789B2 (en) Methods and systems for tissue manipulation
US6746460B2 (en) Intra-gastric fastening devices
US6916326B2 (en) Gastroplasty ring that can be loosened
EP1804888B1 (en) Bariatric device
JP3313112B2 (en) Surgical apparatus and method
US7211094B2 (en) Magnetic anchoring devices
EP1778098B1 (en) Gastric bypass band
AU2004266574B2 (en) Compressive device for percutaneous treatment of obesity
US7946976B2 (en) Methods and devices for the surgical creation of satiety and biofeedback pathways
AU2008202358B2 (en) Fatigue-resistant gastric banding device
JP5068489B2 (en) Gastric band with a matching end structure
US20070203507A1 (en) Suturing apparatus and methods
JP5252806B2 (en) Device and method for holding the gastroesophageal implant
US7077821B2 (en) Implant system and method for bulking tissue
EP2311388A1 (en) Implantable band with attachment mechanism
AU2002241715B2 (en) Improved process for electrostimulation treatment of morbid obesity
US20100204723A1 (en) Obesity Systems Placed Between the Abdominal Wall and Stomach
US8001976B2 (en) Management systems for the surgically treated obese patient
EP1205148B1 (en) Universal gastric band
US20070276293A1 (en) Closed Loop Gastric Restriction Devices and Methods