HK1098330B - Releasably-securable one-piece adjustable gastric band - Google Patents

Description

Releasably-fixed integrated adjustable gastric band

Background

1. Field of the invention

The present invention generally relates to a surgically implanted gastric band having a releasable fixation attachment for encircling the stomach. Also disclosed is a method of treating morbid obesity using a releasably secured gastric band device.

2. Description of the related Art

Vincent, in U.S. Pat. No. 5,601,604, which is incorporated herein by reference, discloses a band-shaped gastric band for encircling the stomach to control morbid obesity. The band comprises a band that can be wrapped around the stomach and locked into a wrapped position to form a stoma opening in the stomach. The adjustable portion of the strap includes an inflatable member that allows for fine adjustment of the aperture opening after the aperture is created by locking the strap in place. The orifice opening may be adjusted by injecting fluid into the inflatable member or withdrawing fluid from the inflatable member. The means for injecting fluid into the inflatable member typically comprises an injection port located subcutaneously that can be used from outside the body by percutaneous injection. Thus, after implantation, the gastric band may be adjusted to enlarge or reduce the stoma as desired.

The gastric band is implanted surgically, by laparoscopy or laparotomy, and may include placement of a calibration device in the stomach to locate the stoma and determine the size of the pocket (pouch) formed over the stoma. The gastric band is typically lapped around the stomach in place to prevent slippage, usually by gastrogastric suturing (i.e., tissue is wrapped around the gastric band and sutured to itself).

As disclosed by Vincent, the inflatable member or shell is preferably substantially coextensive with the inner stomach-facing surface of the gastric band. Moreover, it has been noted that the inflatable member is not capable of being corrugated or folded upon adjustment to present a substantially smooth profile along the inner circumference. This not only ensures that the inflatable member does not compress against stomach tissue, which could cause discomfort or necrosis, but also protects the shell from the well-known phenomenon of crease failure that occurs when the inflation exceeds a predetermined adjustment range or the shell is not formed in a circular or rounded shape.

In use, it has been noted that current gastric bands cannot be easily loosened once they are locked in place around the stomach to form the stoma. This can be a significant impediment to a surgeon attempting to move the gastric band after implantation. In particular, the patient's physiology or changes in physiology also require the gastric band to be moved after initial placement. Other factors that may require the gastric band to be moved or loosened include the inability of the patient to control food intake.

In the event that the gastric band slips off, is improperly placed, or the patient's physiology changes requiring movement of the gastric band, currently known gastric bands do not allow for release of the closure device that holds the band securely around the patient's stomach. Although some devices may eventually be released, such devices typically require the application of substantial external forces that can cause damage or failure of the strap. Moreover, when the gastric band is manipulated laparoscopically, the amount of force that can be applied during the procedure is very limited.

A gastric band with certain locking and unlocking abilities is described as HELIOGASTThe name of (1) is sold. The Heliogast band is an inflatable gastric band having an inflatable closure device attached to the distal end and inserted into a loop attached to the head end of the gastric band. After implantation, the gastric band must be inflated to lock the gastric band in place. Ideally, such gastric bands could be reopened after placement to allow a medical professional to change the position of the gastric band. However, it suffers from the disadvantage that it must be inflated to lock it in place and therefore deflated before opening and moving it. The necessity that the gastric band must be inflated when tightened also limits the range of stoma openings obtained with such gastric bands, which must require a certain liquid pressure within the band in order to be tightened. Therefore, the range of adjustment of the Heliogast band is limited compared to the gastric band of the present invention that is locked regardless of the degree of expansion. In addition, it can be opened with less force than prior art gastric bands. The ability to overcome the locking mechanism with less force increases the likelihood of accidentally unlocking the gastric band, such as when the patient vomits.

Thus, there is a need for a releasable gastric band that can be releasably locked in place around a patient's stomach, released or unfastened to reposition the gastric band on the patient's stomach (or to remove the entire gastric band), and then re-secured in place around the patient's stomach. There is also a need for such a releasably securable gastric band that does not require deflation before being released and which can be locked in place without subsequent inflation of the locking device. In addition, there is a need for a gastric band that is resistant to unraveling by forces of normal physiology.

There is a need for an adjustable gastric band that also provides improved ease of use, particularly one that has high tensile properties along the direction of the band while being able to open with less force, as compared to gastric bands popular in the international market.

Various other objects, advantages and features of the present invention will become more readily apparent from the following description and the novel features will be particularly pointed out in the appended claims.

Disclosure of Invention

The present invention relates to a releasably securable inflatable gastric band having a distal end and a head end for receiving the distal end. The gastric band also includes a releasable locking mechanism that releasably secures the head and tail ends together. The tail end may comprise a tooth and the head end may comprise a notch for engaging the tooth. Upon insertion of the tail end into the head end, the tooth engages the notch and releasably locks the tail end in the head end. The releasably securable gastric band also contains a release tab. When a force is applied to the release tab in a direction perpendicular to the central axis of the gastric band, the release tab acts on the teeth and the teeth disengage from the notches. This movement of the teeth out of the notches allows the gastric band to be opened.

The various features of novelty which characterize the invention are pointed out with particularity in the claims annexed to and forming a part of this disclosure. For a better understanding of the invention, its operating advantages and specific objects attained by its uses, reference is made to the accompanying descriptive matter in which preferred embodiments of the invention are illustrated.

Brief Description of Drawings

FIG. 1 is a side view of the distal end of a gastric band in accordance with the present invention;

FIG. 2 is a side view of a head end of a gastric band according to the present invention;

FIG. 3 shows a gastric band having a smooth inflatable member according to the present invention;

FIG. 4 shows a fatigue resistant inflatable member of the gastric band;

FIG. 5 shows a prior art gastric band according to U.S. Pat. No. 5,601,604 to Vincent;

FIG. 6 is a perspective view of a gastric band according to the present invention showing the head end in the prominent position; and

FIG. 7 is a perspective view of a gastric band according to the present invention, showing the tip at a prominent location.

Detailed Description

The present invention relates to a laparoscopic implantable adjustable gastric band designed to be opened or released laparoscopically for ease of repositioning or removal as needed. Once locked in place, previously known laparoscopic gastric BANDs, such as LAP-BANDOpening it is difficult due to the external force required and risks damaging the components. While particularly suited for laparoscopic implantation, release and/or removal, the gastric band of the present invention is also suited for standard laparotomy procedures.

Figures 1 and 7 show the distal end 10a of a releasably securable gastric band 12. In fig. 2 and 6, the head end 10b of the gastric band 12 is shown. The tip 10a includes an elongated tip 18 that may be coupled to an expansion tube 30 and angled teeth 14. The inflation tube 30 has a lumen therethrough that allows fluid to be added to or removed from the inflatable portion of the gastric band 32 to hydraulically adjust the diameter of the band when the band is in an encircling position with the stomach or desired organ. As is well known in the art, a small hole of a desired size may be formed by adjusting the diameter of the gastric band. The adjustment may be performed mechanically or hydraulically. In a hydraulically adjustable gastric band, inflation tube 30 need not be bonded to tip 10 a. Instead, it may be coupled to the head end 10b or any point therebetween. Alternatively, the gastric band 12 may be adjusted by a variety of known mechanical means. Whether hydraulic or mechanical, the gastric band 12 is preferably adjusted by means of a remote control from outside the body. Such a remotely adjustable restriction device may be an active device, i.e. powered by an implantable source of energy such as a battery, capacitor, etc., or a passive device, powered from outside the body by energy transfer via radio frequency, induction, electromagnetic energy, etc.

Turning now to the releasable locking feature of the present invention, the tooth 14 is defined on one side by the notch 16 and may include a visual indicator 38, which will be described below in connection with the head end 10 b. Figure 1 also shows the adjustable portion 32 of the belt. The head end 10a of the gastric band 12 is formed with a gripping land 34 that allows a surgeon or other medical professional to grip the gastric band without fear of damaging the fluid support portion of the band. The gripping land 34 is particularly useful when releasing a previously secured gastric band.

As shown in FIG. 2, the head end 10b includes a clasp (buckle)20 that receives and locks the tip end 10a to form a band that is positioned around the stomach. The clasp 20 includes a notch 22 for receiving the tooth 14 of the tip 10 a. The head end 10b also includes a release tab 24. On the other side of the head end 10b is an indicator window 36 which allows the surgeon or other medical professional to view an indicator portion 38 of the distal end 10a, preferably brightly colored by a contrasting color or texture, which when inserted into the head end 10b provides a positive visual and/or tactile indication that the gastric band has been releasably locked in place.

In practice, the gastric band is implanted around the patient's stomach using currently standard laparoscopic or laparotomy procedures using techniques well known to those of ordinary skill in the gastric band art. Once the gastric band 12 is looped around the stomach and positioned at a desired location along the length of the stomach, the tail end 10a is inserted into the clasp 20 of the head end 10 b. A closure tool, such as that described in U.S. patent No. 5,658,298 to Vincent and Coe, the disclosure of which is incorporated herein by reference, may be used to secure the tail end 10a and head end 10b together. For example, the tip 10a is pulled through the clasp 20 until the teeth 14 and notches 22 engage or interlock and prevent the gastric band 12 from opening. When the ends of the gastric band are properly locked together, the indicator 38 on the distal end 10a is visible through the window 36 on the head end 10 b.

Other elements of the gastric band 12 are mating recesses 26 and 28 at the head end 10b and the tail end 10a, respectively. These substantially mirror-inverted (negative image) grooves butt together and prevent the two ends of the inner stomach-facing surface 32 of the gastric band from overlapping when the gastric band is in the closed position. Grooves 26 and 28 are machined into the head and tail ends, respectively, to ensure a substantially smooth continuous surface that contacts the patient's stomach.

The releasably securable gastric band in accordance with the present invention requires two steps to release the locked head and tail ends thereof. First, the interlocked teeth 14 and notches 20 are disengaged by pulling the release tab 24 in a direction substantially perpendicular to the central axis of the now-closed gastric band 12. To assist in pulling the release tab 24, the surgeon or other medical professional may also grasp the gripping land 34 with a second medical implement. This helps to hold the gastric band 12 in place so that force can be effectively applied to the release sheet 24. The trailing end 10a may then be removed from the leading end 10b if the band is moved or loosened sufficiently to allow the gastric band 12 to be repositioned along the length of the patient's stomach.

LAP-BAND with prior artIn contrast to U.S. patent No. 5,601,604, by using a slightly elongated head end 10b, pulling release tab 24 causes a translation force toward the central axis of gastric band 12, thereby loosening and releasing the head and tail ends of the gastric band of the present invention to allow repositioning or removal of gastric band 12 without fear of damaging the gastric band. The fit of the teeth 14 and grooves 20, as well as the elasticity of the material from which the gastric band is made, may both be optimized to ensure adequate secure closure of the gastric band, which requires less force on the release tab 24 to open.

Of course, geometries other than teeth 14 and notches 22 may be used to achieve the ability to releasably secure a gastric band in accordance with the present invention. One such geometry includes several smaller interlocking elements. Additionally, the interlock may be shaped to snap-fit in order to provide a tactile indication that the strap is secured in place or if greater resistance to separation is desired.

As shown in fig. 3, the present invention may be used in conjunction with a substantially smooth adjustable member 32 as is known in the art. Alternatively, as shown in FIG. 4, the present invention may be used in conjunction with the newer fatigue resistant inflatable members 32 a. Fatigue resistant bands are described in detail in PCT/US03/26678 and are incorporated herein by reference. As described therein, the fatigue resistant inflatable portion 32a is multi-chambered and resists wrinkling or folding over its range of adjustment. As with the adjustable portion 32 shown in FIG. 3, the fatigue resistant inflatable portion 32a presents a substantially smooth profile along the inner circumference to improve wearer comfort and avoid gastric contractions which can lead to necrosis. To better illustrate its novel features, the fatigue resistant inflatable member is shown in cross-section in FIG. 4 separated from the intact gastric band. As with prior bands, the gastric band containing the fatigue resistant inflatable portion 32a may be preformed into a circle, may be locked in place by a surgeon or medical professional, and in a preferred embodiment is inflated by passing through an inflation lumen in the end 10a of the gastric band.

The gastric band according to the present invention may be constructed through successive molding steps, resulting in fully automated assembly and high accuracy. In addition, the materials used to make the gastric band include silicone and other materials known to those of ordinary skill in the art to be suitable for implantation into the body.

It will be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained and, since certain changes may be made in carrying out the above method and in the construction(s) set forth without departing from the spirit and scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

Claims (11)

1. An adjustable, releasably securable gastric band comprising:

a terminal end;

a head end for receiving the tail end;

a releasable locking mechanism for releasably securing said head and tail ends of said gastric band in a circumferential position;

a tooth formed on a portion of the tip;

a notch at said head end for engaging said tooth;

a release tab on the head end;

upon insertion of said tail end into said head end, said teeth engage said notches and releasably latch said tail end in said head end; and

applying a force to the release tab in a direction substantially perpendicular to a central axis of the gastric band causes the teeth to disengage from the notches, thereby allowing the tail end to be released from the head end.

2. The releasably securable gastric band of claim 1, further comprising a visual securement indicator.

3. The releasably securable gastric band of claim 2, further comprising a window providing a clear visual indication when said head and tail ends are releasably secured together.

4. The releasably securable gastric band of claim 3, wherein said gastric band is releasably secured in position when said indicator is present at said window after insertion of said distal end into said head end.

5. The releasably securable gastric band of claim 1, further comprising a tactile securement indicator.

6. The releasably securable gastric band of claim 1, wherein said band is adjustable by hydraulic expansion.

7. The releasably securable gastric band of claim 6, further comprising an inflation tube.

8. The releasably securable gastric band of claim 7, wherein said distal end includes said inflation tube.

9. The releasably securable gastric band of claim 7, wherein said head end includes said inflation tube.

10. The releasably securable gastric band of claim 1, wherein said band is mechanically adjustable.

11. The releasably securable gastric band of claim 1, wherein said band is remotely adjustable.