MXPA06008069A

MXPA06008069A - Accordion-like gastric band

Info

Publication number: MXPA06008069A
Application number: MXPA/A/2006/008069A
Authority: MX
Inventors: Mark Tsonton
Original assignee: Johnson&Ampjohnson*
Priority date: 2005-07-15
Filing date: 2006-07-14
Publication date: 2008-09-02

Abstract

A gastric band includes a belt and a balloon secured to the belt. The balloon and belt being shaped and dimensioned to circumscribe the stomach at a predetermined location. The balloon includes a longitudinally extending body with at least one crease formed therein, the crease extending along a longitudinal axis of the body for providing the balloon with a reduced noninflated profile without reducing the fill volume of the fully expanded balloon.

Description

GASTRIC BAND OF TYPE ACCORDION 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 an "accordion-like" construction allowing for improved expansion and contraction.

DESCRIPTION OF THE PREVIOUS TECHNIQUE Morbid obesity is a serious medical condition. In fact, morbid obesity has become highly dominant in the United States, as well as in other countries, and the trend seems to be heading in a negative direction. Complications associated with morbid obesity include hypertension, diabetes, coronary artery disease, heart attack, congestive heart failure, multiple orthopedic problems, and pulmonary insufficiency with a marked decrease in life expectancy. With this in mind, and according to those skilled in the art, you will certainly appreciate that the monetary and physical costs associated with morbid obesity are substantial. In fact, it is estimated that the costs related to obesity are over 100 trillion dollars in the United States alone. A variety of surgical procedures have been developed to treat obesity. The most commonly performed procedure is the Roux Y gastric bypass (RYGB). This procedure is highly complex and is commonly used to treat people who exhibit morbid obesity. Other forms of bariatric surgery include biliopancreatic diversion of Fobi's pouch and "stomach stapling" or gastroplastic. In addition, implantable devices are known to 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 procedures. The placement of plastic bands is a type of gastric reduction surgery that attempts to limit the intake of food by reducing the size of the stomach. In contrast to RYBG and other stomach reduction procedures, the placement of gastric banding does not require alteration of the anatomy of the digestive tract in the duodenum or jejunum. Since the early 1980s, gastric banding has provided an effective alternative to gastric bypass and other irreversible surgical weight loss treatments for the morbidly obese. Several alternative procedures were performed under the heading of gastric banding, some techniques for the placement of bands employ rings Gastric, others use a band, some use stomach staples and still other procedures use a combination of rings, bands, and staples. The most commonly performed procedures include folded band, vertical banded gastroplasty (VBG), silastic ring gastroplasty (SRG), and the placement of adjustable silastic gastric banding (AGB). In general, the gastric band wraps around the upper portion of the patient's stomach, forming a stoma that is smaller than the normal inside diameter of the stomach. This restricts the passage of food from the upper portion to the lower digestive portion of the stomach. When the stoma is of an appropriate size, food held in the upper portion of the stomach provides a feeling of satiety that discourages overfeeding. Typically, the gastric band is inserted into the abdomen of the patient by pushing it through a trocar. That is, it is desirable to reduce the diameter of the band to aid in transport through a trocar. Gastric bands with balloon constructions have also been developed. Kuzmak et al., U.S. Patent No. 4,592,339, teaches an adjustable gastric stoma band that includes a balloon section that expands and deflates through a remote injection site. The expandable section of the balloon adjusts the size of the stoma opening both operatively and postoperatively. During the last several years the band manufacturers Gastric devices of the prior art have improved the designs of the balloons of these bands. A significant area of further improvement, however, is the development of a gastric band that includes a balloon that overcomes the problems associated with expansion and contraction while inserting through a trocar. The present invention, therefore, provides said gastric band.

BRIEF DESCRIPTION OF THE INVENTION It is, therefore, an object of the present invention to provide a gastric band that includes a balloon configured and dimensioned to circumscribe the stomach at a predetermined location. The balloon includes a body that extends longitudinally with at least one fold formed therein. The fold extends along a longitudinal axis of the body to provide the balloon with a reduced non-inflated profile without reducing the fill volume of the fully expanded balloon. It is also an 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 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 a further object of the present invention to provide a Gastric band where the ball is made of silicone. It is another object of the present invention to provide a gastric band that includes a belt secured to the balloon, wherein the belt is configured and sized to circumscribe the stomach at a predetermined location. It is yet another object of the present invention to provide a gastric band that includes a belt secured to the balloon, wherein the belt is composed of silicone. It is yet another additional object of the present invention to provide a gastric band wherein the balloon is fixed to an inner surface of the belt. It is also another object of the present invention to provide a gastric band wherein the balloon is integrally formed with the balloon. It is another object of the present invention to provide a gastric band wherein the balloon includes an individual cavity. It is a further object of the present invention to provide a gastric band that includes an assurance mechanism to selectively secure the gastric band in a position enclosed around a portion of the stomach. 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 present wrapped around the stomach. Figure 2 is a perspective view of the preconfigured gastric band. Figure 3 is a top view of the gastric band present in its circular configuration. Figure 4 is a cross-sectional view along line 4-4 in Figure 3.

DESCRIPTION OF THE PREFERRED MODALITY The detailed embodiment of the present invention is described herein. It should be understood, however, that the described mode is merely illustrative of the invention, which can be exemplified in various ways. Accordingly, the details described herein will not be construed as limiting, but merely as the basis for the claims and as the basis for teaching a person skilled in the art how to make and / or use the invention. With reference to Figures 1 to 4, a gastric band based on a balloon 10 according to the present invention is described. The Gastric band 10 is configured and sized to circumscribe the stomach at a predetermined location by reducing the size of the stomach. A fluid supply tube 14 in fluid communication 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 transport belt 18 having a balloon. inflatable 20 fixed to the internal 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 transported to the balloon 20 through 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 fixing the first and second ends 24, 26 of the band 10 together and extending over a portion of the stomach 12 over the gastric band 10 through the suture of a portion to the stomach 12. Referring now to Figures 2 to 4, the gastric band 10 according to the present invention is described in greater detail. As mentioned briefly above, the gastric band 10 includes a tension transport belt 18, a fluid supply tube 14 in fluid communication with a balloon 20 and a fluid injection port. remotely located 16. The inflatable balloon 20 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 even made of a unitary construction with the belt 18 , although the belt 18 is typically formed separately. A distal end 28 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 is preferably a length of approximately 11 cm. However, those skilled in the art will appreciate that the balloon 20 can be of any length that can provide sufficient compression to the stomach 12. The balloon 20 is preferably comprised of material with a thickness between about 0.3 mm and 0.7 mm and more preferably around 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 of medical grade silicone, although other known materials, for example, implantable polyurethane, can be used without departing from the spirit of the present invention. According to a preferred embodiment of the present invention, the balloon 20 is an elongated body with an individual cavity. However, various balloon designs could be used within the spirit of the present invention. For example, a multiple segmented balloon as described in U.S. Patent Application Publication No. 2005/0070937, entitled "SEGMENTED GASTRIC BAND", which is incorporated herein by reference, could be used without departing from the spirit of the present invention. . As best shown in Figures 2 to 4, the balloon 20 is formed with first and second folded sections 36, 38. The first and second folded sections 36, 38 are formed in diametrically opposite locations along the circumference of the balloon. 20. As will be explained below in greater detail, the folded sections 36, 38 allow the reduction of the size of the balloon 20 in a way that improves the insertion of the balloon 20 through a trocar. The folded sections 36, 38 extend along the length of the balloon 20 and, therefore, allow compression of the balloon 20 at a low profile configuration during insertion without adjusting the fill volume of the fully expanded balloon 20. The folded sections 36, 38 provide a controlled compression point along the length of the balloon 20, allowing the balloon 20 to be compressed in a controlled and reliable manner along the length of the balloon. Each of the folded sections 36, 38 is composed of opposed walls 36a, 36b, 38a, 38b linked through an articulated section 36c, 38c. In this way, the Folded sections 36, 38 open and close in the same way as an accordion. By providing increased compression of the balloon 20 in a controlled manner, the potential damage of the balloon 20 is decreased during the gastric-gastric suture step of the application procedure. In addition, the design of the lower profile allows the use of a gastric band present with small diameter trocars (for example, 12 mm), which previously had difficulty in distributing said balloon, based on the gastric bands in a reliable and controlled manner . As those skilled in the art will certainly appreciate, the folds can be formed in a variety of configurations without departing from the spirit of the present invention. For example, more than two folds could be used and the folds could be configured to overlap in a uniform configuration, such as, with folds of pants. The tension transport belt 18 is slightly larger than the balloon 20 and can be of any suitable length sufficient to accommodate the type of retaining mechanism 40 used. As with the balloon itself, the transport belt 18 is composed of a 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 more particularly, the belt of Tension transport 18 is provided with a retention mechanism 40 so that the gastric band 10 can be releasably secured in a position enclosed around a portion of the stomach 12. Various retention mechanisms can be used within the spirit of the present invention. Some of these retention mechanisms are described in the published US patent applications Nos. 2005/0002984, entitled "IMPLANTABLE BAND WITH ATTACHMENT MECHANISM HAVING DISSIMALR MATERIAL PRORPERTIES", 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 inlet connections 42 that provide access to the internal cavity 30 of the balloon 20. The remote injection port 16 includes a silicone compartment. At the time when 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 sheaths of the rectus muscle, for transcutaneous access through of a Huber needle. Examples of structures of injection port which may be used in accordance with the present invention is described in US Patent Application Publication 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 here 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 supplied with physiologically compatible fluids, such as a saline or radio-opaque solution during post-operative adjustment. The post-operative adjustment of the perimeter enclosed by the balloon 20, and therefore the size of the stoma is achieved through the addition or removal of fluid from the internal cavity 30 of the balloon 20 through the insertion of a Huber needle, percutaneously within the silicone compartment of the injection port 16. The installation of the gastric band 10 is achieved 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 then clamped through an instrument, such as a blunt dissection catcher or device, and wrapped around the stomach of patient 12 through the created tunnel. The retention mechanism 40 after it connects. The injection port 16 is then fixed 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, is then injected into the injection port 16 while the solution is transported to the internal cavity 30 of the balloon by means of the inlet connections 42 in the fluid supply tube 14. If necessary either at the time when the gastric band 10 is installed or at some time afterwards in the future, a predetermined amount of the filling solution of the balloon 20 can be extracted through the insertion of a syringe into the injection port 16. and the solution is extracted. Although the present invention is described for use in conjunction with gastric bands, those skilled in the art will appreciate that the above invention also has applicability to other types of implantable bands. For example, the bands are used for the treatment of fecal incontinence. One of said bands is described in the patent of E. U. A. No. 6,461, 292. The bands can also be used to treat urinary incontinence. One of said bands is described in the patent application publication of E. U. A. No. 2003/0105385. The bands can also be used to treat gastric acidity and / or acid reflux. One of said bands is described in the patent of E. U. A. No. 6,470,892. The bands can also be used to treat impotence. One such band is described in the patent application publication of E. U. A. No. 2003/0114729.

Since the preferred embodiments have been shown and described, it will be understood that it is not intended to limit the invention to said description, but rather, it is intended to cover all modifications and alternative constructions that fall within the spirit and scope of the invention.

Claims

NOVELTY OF THE INVENTION CLAIMS

1. - A gastric band, comprising: a balloon configured and sized to circumscribe the stomach at a predetermined location; the balloon includes a longitudinally extending body with at least one fold formed therein, the fold extending along the longitudinal axis of the body to provide the balloon with a reduced non-inflated profile without reducing the fill volume of the fully extended balloon.

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

3. The gastric band according to claim 2, further characterized in that it includes a fluid injection port in fluid communication with the fluid supply tube.

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

5. The gastric band according to claim 1, further characterized in that it includes a belt secured to the balloon, wherein the belt is configured and sized to circumscribe the stomach at a predetermined location.

6. The gastric band according to claim 1, 1 further characterized in that it includes a belt secured to the balloon, wherein the belt is composed of silicone.

7. The gastric band according to claim 5, further characterized in that the balloon is fixed to an internal surface of the belt.

8. The gastric band according to claim 5, further characterized in that the belt is integrally formed with the balloon.

9. The gastric band according to claim 1, further characterized in that the balloon includes a single cavity.

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

11. A gastric band, comprising: a belt, a ball secured to the belt, the balloon and the belt configured and sized to circumscribe the stomach in a predetermined location; The balloon includes a longitudinally extending body with at least one fold formed therein, the fold extending along the longitudinal axis of the body to provide the balloon with a reduced non-inflated profile without reducing the filling volume of the fully expanded balloon.

12. The gastric band according to claim 11, further characterized in that additionally the supply tube of fluid in fluid communication with the balloon for controlled inflation of the same.

13. The gastric band according to claim 12, further characterized in that it additionally includes a fluid injection port in fluid communication with the fluid supply tube.

14. The gastric band according to claim 11, further characterized in that the balloon and the belt are made of silicone.

15. The gastric band in accordance with the claim 11, further characterized in that the balloon is fixed to an inner surface of the belt.

16. The gastric band according to claim 11, further characterized in that the balloon includes a single cavity.

17. The gastric band in accordance with the claim 11, further characterized in that it includes a retention mechanism to selectively secure the gastric band in a position enclosed around a portion of the stomach.