MXPA06008068A - Gastric band with mating end profiles - Google Patents

Abstract

A gastric band includes a belt and a balloon secured to the belt. The balloon and belt are shaped and dimensioned to circumscribe the stomach at a predetermined location. The balloon includes a longitudinally extending body having a first end and a second end, the first end and the second end respectively including mating profiles which align to create generally continuous surfaces along an outer surface of the gastric band and an inner surface of the gastric band as the outer surface and the inner surface transition between the first and second ends of the balloon.

Description

GASTRIC BAND WITH COUPLING END PROFILES BACKGROUND OF THE INVENTION FIELD OF THE INVENTION The invention relates to a gastric band. More particularly, the invention relates to a gastric band based on a balloon having coupling ends that ensure a complete loop around the stomach wall.

DESCRIPTION OF THE RELATED TECHNIQUE Morbid obesity is a serious medical condition. In fact, morbid obesity has become highly pervasive in the United States, as well as in other countries, and the trend appears to be steered in a negative direction. Complications related to morbid obesity include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems, and pulmonary insufficiency with markedly diminished life expectancies. With this in mind, and as those skilled in the art will certainly appreciate, the monetary and physical costs associated with morbid obesity are substantial. In fact, it is estimated that the costs related to obesity are greater than 100,000 million dollars in the United States alone. A variety of surgical procedures have been developed to treat obesity. The most commonly performed procedure in Roux gastric bypass in Y RYGB). This procedure is highly complex and is commonly used to treat people who are morbidly obese. Other forms of bariatric surgery include biliopancreatic diversion of the Fobi bag, and gastroplasty or "Stapled stomach". In addition, implantable devices are known which limit the passage of food through the stomach and affect satiety. In view of the highly invasive nature of many of these procedures, efforts have been made to develop less traumatic and less invasive invasive procedures. Gastric banding is a type of gastric reduction surgery that attempts to limit the consumption of food by reducing the size of the stomach. In contrast to RYGB and other stomach reduction procedures, gastric banding does not require altering the anatomy of the digestive tract in the duodenum or jejunum. In the early 1980s, gastric banding provided an effective alternative for gastric bypass and other irreversible surgical weight loss treatments for morbid obesity. Said alternative procedures are performed under the direction of gastric banding.

Some banding techniques employ a gastric ring, others use a band, some use staples for the stomach and other procedures use a combination of rings, bands and staples. Among the most commonly performed procedures are those of gastric band or lap band, vertical band gastroplasty (VBG), silastic ring gastroplasty (SRG), and adjustable silastic gastric banding (AGB). In general, the gastric band wraps around an upper portion of the patient's stomach, forming a stoma that has less than the normal interior diameter of the stomach that restricts the passage of food from a superior portion to a lower digestive portion of the stomach. When the stoma is appropriately sized, food held in the upper portion of the stomach provides a feeling of fullness that discourages overeating. Gastric bands with balloon constructions have also been developed. Kuzmak et al., In the patent of E.U.A. No. 4,592,339, teaches a gastric band with adjustable stoma that includes a balloon section that expands and deflates through a remote injection site. The expandable balloon section adjusts the size of the stoma opening both operatively and postoperatively. During the last years, the manufacturers of the bands of the prior art have improved the designs of the balloons of these bands. Some balloon-based gastric bands create a circumference of almost 360 degrees when closed. When they are filled and expanded, these balloon-based gastric bands provide a pressure interface of almost 360 degrees with the stomach tissue. Although these gastric bands create a circumference of almost 360 degrees, there still remains a space or compression point where the first and second ends of the balloon meet. As such, there is a need for a gastric band to relieve this separation or compression point to ensure a complete 360 degree interface with the exterior stomach wall and thus significantly reduce or eliminate the space or compression point found in the stomachs. current gastric banding. The present invention, therefore, provides a gastric band.

BRIEF DESCRIPTION OF THE INVENTION Therefore, it is an object of the present invention to provide a gastric band that includes a balloon formed and sized to circumscribe the stomach at a predetermined location. The balloon includes a longitudinally extending body having a first end and a second end, the first end and the second end respectively including coupling profiles that align to create generally continuous surfaces along an outer surface of the gastric band. and an inner surface of the gastric band as the outer surface and inner surface move between the first and second balloon ends.

It is also an object of the present invention to provide a gastric band wherein the first and second ends are respectively formed with skewed surfaces which engage when the first and second ends meet. It is another object of the present invention to provide a gastric band wherein the first and second ends are respectively formed with tongue-and-groove profiles which engage when the first and second ends meet. It is a further object of the present invention to provide a gastric band that includes a fluid supply tube in fluid communication with the balloon for controlled inflation thereof. It is also another object of the present invention to provide a gastric band that includes a fluid injection port in fluid communication with the fluid supply tube. It is even another object of the present invention to provide a gastric band wherein the balloon is composed of silicone. It is also an object of the present invention to provide a gastric band that includes a band that is composed of silicone. It is a further object of the present invention to provide a gastric band wherein the balloon is fixed to an inner surface of the band. It is still a further object of the present invention to provide a gastric band that includes a clamping mechanism for selectively securing the gastric band in a position encircled about a portion of the stomach. It is also an object of the present invention to provide a gastric band that includes a band and a balloon secured to the band. The balloon and the band are formed and sized to circumscribe the stomach at a predetermined location. The balloon includes a longitudinally extending body having a first end and a second end, the first end and the second end respectively include coupling profiles. It is another object of the present invention to provide a gastric band that includes a balloon forming and dimensioning to circumscribe the stomach at a predetermined location. The balloon includes a longitudinally extending body having a first end and a second end, which when aligned create generally continuous surfaces along an outer surface of the gastric band and an inner surface of the gastric band as the outer surface and inner surface move between the first and second ends of the balloon. Other objects and advantages of the present invention will be apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which establish certain embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of the gastric band of the present wrap around a stomach. Figure 2 is a perspective view of the gastric band of the present. Figure 3 is a top view of the gastric band of the present in its circular cguration. Figures 4 and 5 are respectively a side view and a top view of an alternative embodiment in accordance with the present invention. Figures 6 and 7 are respectively a side view and a top view of another alternative embodiment in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED MODALITY The detailed embodiment of the present invention is described herein. However, it will be understood that the described modality is simply exemplary of the invention, which can be modalized in various forms. Therefore, the details described herein will not be construed as limiting, but simply as the basis for the claims and as a basis for instructing one skilled in the art on how to make and / or use the invention. Referring to Figures 1 to 3, a balloon-based gastric band 10 according to the present invention is described. The gastric band 10 is configured and sized to circumscribe the stomach 12 at a predetermined location by reducing the size of the stomach. A fluid supply tube 14 that communicates fluidly with the gastric band 10 is in fluid communication with a remotely located fluid injection port 16. The gastric band 10 generally comprises an external tension conveyor belt 18 having a inflatable balloon 20 fixed to the inner surface 22 thereof. When the gastric band 10 is in place, the balloon 20 is inflated, restricting the volume of the stomach. To inflate the balloon 20, a filling solution is injected into the injection port 16 and the filling solution is conveyed to the balloon 20 via the delivery tube 14. Referring to Figure 1, the gastric band 10 is shown wrapped around an upper portion of a stomach 12. The gastric band 10 is held in place by joining the first and second ends 24, 26 of the band 10 and extending a portion of the stomach 12 over the gastric band 10 by suturing a portion to the stomach. stomach 12. Referring now to Figures 2 and 3, gastric band 10 according to the present invention is described in more detail. As briefly mentioned above, the gastric band 10 includes a tension conveyor belt 18, a fluid supply tube 14 in fluid communication with a balloon 20 and a remotely located fluid injection port 16. The inflatable balloon 20 it is carried along the inner surface 22 of the belt 18. The balloon 20 is secured to the inner surface 22 of the belt 18 in any known manner or is even made of a unitary construction with the belt 18, although the belt 18 it is usually formed separately. A distal end 18 of the fluid supply tube 14 is in fluid communication with the internal cavity 30 of the balloon 20 and the proximal end 27 is in fluid communication with an internal cavity (not shown) of the remote injection port 16. balloon 20 is an elongated structure with a first end 32 and a second end 34. The balloon 20 preferably has a length of approximately 11 cm. However, those skilled in the art will appreciate that the balloon 20 may have any length which provides sufficient compression of the stomach 12. The balloon 20 is preferably comprised of a material with a thickness between about 0.3 mm and 0.7 mm and preferably of approximately 0.64 mm. The thickness of the material depends on the material of the ball and it should be appreciated that the thickness of the ball may vary depending on the composition of the ball. According to a preferred embodiment of the present invention, the balloon 20 is made from medical grade silicone, although other known materials can be used, without departing from the spirit of the present invention, for example, implantable polyurethane. According to a preferred embodiment of the present invention, the balloon 20 is an elongated body with a single cavity. However, various balloon designs can be used within the spirit of the present invention. For example, it can be employed without departing from the spirit of the present invention, a multiple segmented balloon as described in the patent application publication of E.U.A. No. 2005/00770937, entitled "SEGMENTED GASTRIC BAND", which is incorporated herein by reference. The balloon 20 is formed with respective coupling profiles, 36, 38 along the first and second ends 32, 34 thereof. Coupling profiles 36, 38 are designed to ensure a complete 360 degree interface with the exterior wall of the stomach and reduce or eliminate the space or point of contraction that exists between the first and second ends 32, 34 of the balloon 20 when it is wrapped around the wall of the stomach and it expands. Referring to Figures 1, 2 and 3, the first and second ends 32, 34 are respectively formed with angled surfaces 36, 38 which engage as shown in Figure 3 when the first and second ends 32, 34 come together forming the balloon 20 in a loop around the outer wall of the stomach. Figures 4 to 7 show the first and second ends 132, 232, 134, 234 respectively formed with tongue and groove profiles 136, 236, 138, 238 which engage as shown in Figures 5 and 7 when the first and second ends 132, 232, 134, 234 are joined by forming the balloon 120, 220 in a loop around the exterior wall of the stomach. As will be appreciated by those skilled in the art, a wide variety of possible designs related to end profiles that may be employed in accordance with the present invention are possible within the spirit of the present invention. As mentioned above, the ends of the balloon 20, 120, 220 are formed to create a coupling relationship between the first and second ends 32, 132, 232, 34, 134, 234 thereof. This coupling relationship generally creates continuous surfaces along the outer surface 50, 150, 250 of the gastric band 10, 110, 210 and the inner surface 52, 152, 252 of the gastric band 10, 110, 210. By providing the first and second ends 32, 132, 232, 34, 134, 234 of the balloon 20, 120, 220 with coupling profiles, the external and internal surfaces 50, 150, 250, 52, 152, 252 of the gastric band 10, 110, 210 are substantially continuous as they move between the first and second ends 32, 132, 232, 34, 134, 234 of the balloon 20, 120, 220 and form a continuous ring. The tension conveyor belt 18 is slightly larger than the balloon 20 and can have any suitable length sufficient to accommodate the type of latching mechanism 40 employed. As with the balloon 20 itself, the conveyor belt 18 is composed of medical grade silicone polymer but can be composed of any flexible biocompatible material, for example, implantable polyurethane, without departing from the spirit of the present invention. The gastric band 10, and in particular, the tension conveyor belt 18 is provided with a latching mechanism 40 so that the gastric band 10 can be releasably secured in a position enclosed around a portion of the stomach 12. They can be used various latching mechanisms within the spirit of the present invention. Some of these latching mechanisms are described in the published patent applications of E.U.A. Nos. 2005/002984, entitled "IMPLANTABLE BAND WITH ATTACHMENT MECHANISM HAVING DISSIMALR MATERIAL PROPERTIES", 2004/0267291, entitled "IMPLANTABLE BAND WITH NON-MECHANICAL ATTACHMENT MECHANISM", 2004/0267292, entitled "IMPLANTABLE BAND WITH TRANSVERSE ATTACHMENT MECHANISM", 2004 / 0267288, entitled "IMPLANTABLE BAND HAVING IMPROVED ATTACHMENT MECHANISM", and 2004/0267293, entitled "IMPLANTABLE BAND WITH ATTACHMENT MECHANISM", which are incorporated herein by reference. As mentioned above, the balloon 20 is provided with a fluid supply tube 14 coupled to a remote injection port 16. The fluid supply tube 14 includes inlets 42 that provide access to the internal cavity 30 of the balloon 20. Remote injection port 16 includes a silica gel septum. At the moment the adjustable gastric band 10 is implanted around a portion of the stomach 12, the remote injection port 16 is also implanted in a suitable location, usually within the rectal covers, for transcutaneous access through a Huber needle. Examples of injection port structures that may be employed in accordance with the present invention are described in the patent application publications of E.U.A. Nos. 2004/0254536, entitled "SUBCUTANEOUS SELF ATTACHING INJECTION PORT WITH INTEGRAL FASTENERS", and 2004/0254537, entitled "SUBCUTANEOUS SELF ATTACHING INJECTION PORT WITH INTEGRAL MOVEABLE RETENTION MEMBERS", which are incorporated herein by reference. The internal cavity 30 of the balloon 20 is evacuated before installation. The fluid supply tube 14 and the internal cavity of the remote injection port 16 are preferably provided with physiologically compatible fluids, such as a saline solution or radiopaque solutions, during postoperative adjustment. The postoperative adjustment of the perimeter enclosed by the balloon 20, and therefore the size of the stoma, is achieved through the addition or withdrawal of fluid from the internal cavity 30 of the balloon 20 by inserting a Huber needle percutaneously into the septum silicone of the injection port 16. The installation of the gastric band 10 is performed by first inserting the band 10 into the abdomen of the patient through a trocar. Next, a tunnel is created behind the stomach 12 near the esophagogastric junction using a blunt dissection device. The gastric band 10 is subsequently clamped with an instrument, such as a blunt dissection device or fastener and is wrapped around the stomach of the patient 12 through the created tunnel. The latching mechanism 40 is then engaged. The injection port 16 is then attached to the gastric band 10 and the injection port 16 is secured subcutaneously in the abdomen or other suitable location. A suitable filling solution, such as saline solution, is subsequently injected into the injection port 16 whereupon the solution is transported to the internal cavity 30 of the balloon via the inlets 42 in the fluid supply tube 14. If it is necessary either at the time that the gastric band 10 is installed or at some later time, a predetermined amount of the filling solution can be removed from the balloon 20 by inserting a syringe into the injection port 26 and withdrawing the solution. Although the present invention is described for use in conjunction with gastric bands, those skilled in the art will appreciate that the above invention has equal applicability to other types of implantable bands. For example, bands are used for the treatment of fecal incontinence. A band of that type is described in the U.S. patent. No, 6,461, 292 Bands can also be used to treat urinary incontinence. A band of that type is described in the patent application publication of E.U.A. No. 2003/0105385. Bands can also be used to treat acidity and / or acid reflux. A band of that type is described in the U.S. patent. No. 6,470,892. The bands can also be used to treat impotence. Such a band is described in the patent application publication of E.U.A. No. 2003/0114729. Although the preferred embodiments have been shown and described, it is understood that it is not intended to limit the invention by such a description but rather to cover all modifications and alternative constructions that fall within the essence and scope of the invention.

Claims (20)

NOVELTY OF THE INVENTION CLAIMS

1. - A gastric band comprising: a balloon configured and sized to encircle the stomach at a predetermined location, the balloon includes a longitudinally extending body having a first end and a second end, the first end and the second end respectively include profiles of coupling which align to create a generally continuous surface along an inner surface of the gastric band as the inner surface makes the transition between the first and second ends of the balloon.

2. The gastric band according to claim 1, further characterized in that the first and second ends are respectively formed with angled surfaces that engage when the first and second ends approach.

3. The gastric band according to claim 1, further characterized in that the first and second ends are respectively formed with tongue and groove profiles that engage when the first and second end approach.

4. The gastric band according to claim 1, further characterized in that it also includes a fluid supply tube that communicates fluidly with the balloon for controlled inflation thereof.

5. The gastric band according to claim 4, further characterized in that it also includes a fluid injection port in fluid communication with the fluid supply tube.

6. The gastric band according to claim 1, further characterized in that the balloon is composed of silicone.

7. The gastric band according to claim 6, further characterized in that it also includes a conveyor belt fixed to an inner surface of a conveyor belt.

8. The gastric band according to claim 7, further characterized in that the balloon and conveyor belt are composed of a silica gel.

9. The gastric band according to claim 1, further characterized in that it also includes a clamping mechanism to selectively secure the gastric band in a position enclosed around a portion of the stomach.

10. A gastric band comprising: a conveyor belt; a ball secured to the conveyor belt, the balloon and conveyor belt being configured and sized to encircle the stomach at a predetermined location; the balloon includes a longitudinally extending body having a first end and a second end, the first end and the second end respectively include coupling profiles that align to create a generally continuous surface along an inner surface of the band gastric according to the interior surface makes the transition between the first and second ends of the balloon.

11. The gastric band according to claim 10, further characterized in that the first and second ends are respectively formed with angled surfaces that engage when the first and second end approach.

12. The gastric band according to claim 10, further characterized in that the first and second ends are respectively formed with tongue and groove profiles that engage when the first and second ends are close.

13. The gastric band according to claim 10, further characterized in that it also includes a fluid supply tube that communicates fluidly with the balloon for controlled inflation thereof.

14. A gastric band comprising: a balloon shaped and sized to surround the stomach in a predetermined location; the balloon includes a longitudinally extending body having a first end and a second end, which when aligned create a generally continuous surface along an inner surface of the gastric band as the inner surface makes the transition between the first and second ends of the ball.

15. The gastric band according to claim 14, further characterized in that the first and second ends are respectively formed with angled surfaces which engage when the first and second ends come close.

16. The gastric band according to claim 14, further characterized in that the first and second ends are respectively formed with tongue and groove profiles that engage when the first and second ends are close.

17. The gastric band according to claim 14, further characterized in that it also includes a fluid supply tube that communicates fluidly with the balloon for controlled inflation thereof.

18. The gastric band according to claim 14, further characterized in that the balloon is composed of silicone.

19. The gastric band according to claim 14, further characterized in that it also includes a clamping mechanism for selectively securing the gastric band in a position enclosed around a portion of the stomach.

20. The gastric band according to claim 14, further characterized in that it also includes a conveyor belt fixed to an inner surface of a conveyor belt.