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:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     The invention relates to a gastric band. More particularly, the invention relates to a balloon-based gastric band having an “accordion-like” construction allowing for improved expansion and contraction.  
         [0003]     2. Description of the Prior Art  
         [0004]     Morbid obesity is a serious medical condition. In fact, morbid obesity has become highly pervasive in the United States, as well as other countries, and the trend appears to be heading in a negative direction. Complications associated with morbid obesity include hypertension, diabetes, coronary artery disease, stroke, congestive heart failure, multiple orthopedic problems and pulmonary insufficiency with markedly decreased life expectancy. 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 the costs relating to obesity are in excess of 100 billion dollars in the United States alone.  
         [0005]     A variety of surgical procedures have been developed to treat obesity. The most common currently performed procedure is Roux-en-Y gastric bypass (RYGB). This procedure is highly complex and is commonly utilized to treat people exhibiting morbid obesity. Other forms of bariatric surgery include Fobi pouch, bilio-pancreatic diversion, and gastroplastic or “stomach stapling”. In addition, implantable devices are known which limit the passage of food through the stomach and affect satiety.  
         [0006]     In view of the highly invasive nature of many of these procedures, efforts have been made to develop less traumatic and less invasive procedures. Gastric-banding is a type of gastric reduction surgery attempting to limit food intake by reducing the size of the stomach. In contrast to RYGB and other stomach reduction procedures, gastric banding does not require the alteration of the anatomy of the digestive tract in the duodenum or jejunum.  
         [0007]     Since the early 1980s, gastric bands have provided an effective alternative to gastric bypass and other irreversible surgical weight loss treatments for the morbidly obese. Several alternative procedures are performed under the heading of gastric-banding. Some banding techniques employ a gastric ring, others use a band, some use stomach staples and still other procedures use a combination of rings, bands and staples. Among the procedures most commonly performed are lap band, vertical banded gastroplasty (VBG), silastic ring gastroplasty (SRG), and adjustable silastic gastric banding (AGB).  
         [0008]     In general, the gastric band is wrapped around an upper portion of the patient&#39;s stomach, forming a stoma that is less than the normal interior diameter of the stomach that restricts food passing from an upper portion to a 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 fullness that discourages overeating.  
         [0009]     Typically, the gastric band is introduced into a patient&#39;s abdomen by pushing it through a trocar. As such, it is desirable to reduce the diameter of the band to aid in transport through a trocar.  
         [0010]     Gastric bands with balloon constructions have also been developed. Kuzmak et al., in U.S. Pat. No. 4,592,339, teaches a stoma-adjustable gastric band that includes a balloon section that is expandable and deflatable through a remote injection site. The balloon expandable section adjusts the size of the stoma opening both intraoperatively and post-operatively.  
         [0011]     During the last several years, manufacturers of prior art gastric bands have improved the designs of the balloons of these bands. One significant area of further improvement, however, is the development of a gastric band that includes a balloon which overcomes problems associated with expansion and contraction while being inserted through a trocar. The present invention, therefore, provides such a gastric band.  
       SUMMARY OF THE INVENTION  
       [0012]     It is, therefore, an object of the present invention to provide a gastric band including a balloon 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 extends 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.  
         [0013]     It is also an object of the present invention to provide a gastric band including fluid supply tube fluidly communicating with the balloon for controlled inflation thereof.  
         [0014]     It is another object of the present invention to provide a gastric band including a fluid injection port in fluid communication with the fluid supply tube.  
         [0015]     It is a further object of the present invention to provide a gastric band wherein the balloon is composed of silicone.  
         [0016]     It is also another object of the present invention to provide a gastric band including a belt secured to the balloon, wherein the belt is shaped and dimensioned to circumscribe the stomach at a predetermined location.  
         [0017]     It is still another object of the present invention to provide a gastric band including a belt secured to the balloon, wherein the belt is composed of silicone.  
         [0018]     It is yet a further object of the present invention to provide a gastric band wherein the balloon is affixed to an inner surface of the belt.  
         [0019]     It is also an object of the present invention to provide a gastric band wherein the belt is intregrally formed with the balloon.  
         [0020]     It is another object of the present invention to provide a gastric band wherein the balloon includes a single cavity.  
         [0021]     It is a further object of the present invention to provide a gastric band including a fastening mechanism for selectively securing the gastric band in an encircled position around a portion of the stomach.  
         [0022]     Other objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0023]      FIG. 1  is a perspective view of the present gastric band wrapped about a stomach.  
         [0024]      FIG. 2  is a perspective view of the preset gastric band.  
         [0025]      FIG. 3  is a top view of the present gastric band in its circular configuration.  
         [0026]      FIG. 4  is a cross sectional view along the line  4 - 4  in  FIG. 3 .  
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0027]     The detailed embodiment of the present invention is disclosed herein. It should be understood, however, that the disclosed embodiment is merely exemplary of the invention, which may be embodied in various forms. Therefore, the details disclosed herein are not to be interpreted as limiting, but merely as the basis for the claims and as a basis for teaching one skilled in the art how to make and/or use the invention.  
         [0028]     With reference to FIGS.  1  to  4 , a balloon based gastric band  10  in accordance with the present invention is disclosed. The gastric band  10  is shaped and dimensioned to circumscribe the stomach  12  at a predetermined location reducing the size of the stomach.  
         [0029]     A fluid supply tube  14  fluidly communicating with gastric band  10  is in fluid communication with a remotely located fluid injection port  16 . The gastric band  10  generally comprises an outer tension carrying belt  18  having an inflatable balloon  20  affixed to the inner surface  22  thereof. When the gastric band  10  is in place, the balloon  20  is inflated, restricting the volume of 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  by way of the supply tube  14 .  
         [0030]     Referring to  FIG. 1 , the gastric band  10  is shown wrapped around an upper portion of a stomach  12 . The gastric band  10  is kept in place by attaching the first and second ends  24 ,  26  of the band  10  together and extending a portion of the stomach  12  over the gastric band  10  by suturing a portion to the stomach  12 .  
         [0031]     Referring now to FIGS.  2  to  4 , the gastric band  10  in accordance with the present invention is disclosed in greater detail. As briefly mentioned above, the gastric band  10  includes a tension carrying 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  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 well known manner, or even made of unitary construction with the belt  18 , although the belt  18  is typically formed separately.  
         [0032]     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 .  
         [0033]     The balloon  20  is an elongated structure with a first end  32  and a second end  34 . The balloon  20  is preferably of a length of about 11 cm. However, those skilled in the art will appreciate the balloon  20  may be of any length which would provide sufficient compression of 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 about 0.64 mm. The thickness of the material is dependent on the balloon material and it should be appreciated the thickness of the balloon may vary depending on the balloon composition. In accordance with a preferred embodiment of the present invention, the balloon  20  is manufactured from medical grade silicone, although other known materials, for example, implantable polyurethane, may be used without departing from the spirit of the present invention.  
         [0034]     In accordance with a preferred embodiment of the present invention, the balloon  20  is an elongated body with a single cavity. However, various balloon designs could be used within the spirit of the present invention. For example, a multiple segmented balloon as disclosed in U.S. Patent Application Publication No. 2005/0070937, entitled “SEGMENTED GASTRIC BAND”, which is incorporated herein by reference, could be employed without departing from the spirit of the present invention.  
         [0035]     As best shown in FIGS.  2  to  4 , the balloon  20  is formed with first and second creased sections  36 ,  38 . The first and second creased sections  36 ,  38  are formed at diametrically opposed locations along the circumference of the balloon  20 . As will be discussed below in greater detail, the creased sections  36 ,  38  allow for a reduction in the size of the balloon  20  in a manner improving the insertion of the balloon  20  through a trocar.  
         [0036]     The creased sections  36 ,  38  extend along the length of the balloon  20  and, thereby, allow for the compression of the balloon  20  to a low profile configuration during insertion without adjusting the fill volume of the fully expanded balloon  20 . The creased 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 creased sections  36 ,  38  is composed of opposed walls  36   a ,  36   b ,  38   a ,  38   b  linked by a hinged section  36   c ,  38   c . In this way, the creased sections  36 ,  38  open and close in the same manner as an accordion.  
         [0037]     By providing for the increased compression of the balloon  20  in a controlled manner, potential damage to the balloon  20  is decreased during the gastro-gastric suturing step of the application procedure. In addition, the lower profile design allows for use of the present gastric band with small diameter trocars (for example, 12 mm), which previously had difficulty in delivering such balloon, based gastric bands in a reliable and controlled manner.  
         [0038]     As those skilled in the art will certainly appreciate, the creases may be formed in a variety of configurations without departing from the spirit of the present invention. For example, more than 2 creases could be employed and the creases could be configured to overlap in a mating configuration, such as, with pleats on pants.  
         [0039]     The tension-carrying belt  18  is slightly longer than the balloon  20  and may be of any suitable length sufficient to accommodate the type of latching mechanism  40  employed. As with the balloon  20  itself, the carrying belt  18  is composed of medical grade silicone polymer but may be composed of any flexible biocompatible material, for example, implantable polyurethane, without departing from the spirit of the present invention.  
         [0040]     The gastric band  10 , and more particularly, the tension carrying belt  18 , is provided with a latching mechanism  40  so that the gastric band  10  may be releasably secured in an encircled position around a portion of the stomach  12 . Various latching mechanism may be used within the spirit of the present invention. Some of these latching mechanisms are disclosed in U.S. Published Patent Application 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.  
         [0041]     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  providing access to the internal cavity  30  of the balloon  20 . The remote injection port  16  includes a silicone septum. At the time the adjustable gastric band  10  is implanted around a portion of the stomach  12 , the remote injection port  16  is also implanted at a suitable location, usually within the rectus sheaths, for transcutaneous access via a Huber needle. Examples of injection port structures which may employed in accordance with the present invention are disclosed in U.S. 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 by reference.  
         [0042]     The internal cavity  30  of the balloon  20  is evacuated prior to 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 radiopaque solutions, during postoperative adjustment. Postoperative adjustment of the perimeter enclosed by the balloon  20 , and therefore the size of the stoma, is accomplished by the addition or removal of fluid from the internal cavity  30  of the balloon  20  by inserting a Huber needle percutaneously into the silicone septum of the injection port  16 .  
         [0043]     Installation of the gastric band  10  is accomplished by first inserting the band  10  into the patient&#39;s abdomen 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 grasped by an instrument, such as a grasper or blunt dissection device, and wrapped around the patient&#39;s stomach  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, is then injected into injection port  16  whereby the solution is conveyed to the internal cavity  30  of the balloon by way of inlets  42  in fluid supply tube  14 . If necessary either at the time the gastric band  10  is installed or at some time in the future, a predetermined quantity of the filling solution may be withdrawn for the balloon  20  by inserting a syringe into the injection port  16  and withdrawing the solution.  
         [0044]     Although the present invention is described for use in conjunction with gastric bands, those skilled in the art will appreciate the above invention has equally applicability to other types of implantable bands. For example, bands are used for the treatment of fecal incontinence. One such band is described in U.S. Pat. No. 6,461,292. Bands can also be used to treat urinary incontinence. One such band is described in U.S. Patent Application Publication No. 2003/0105385. Bands can also be used to treat heartburn and/or acid reflux. One such band is described in U.S. Pat. No. 6,470,892. Bands can also be used to treat impotence. One such band is described in U.S. Patent Application Publication No. 2003/0114729.  
         [0045]     While the preferred embodiments have been shown and described, it will be understood that there is no intent to limit the invention by such disclosure, but rather, is intended to cover all modifications and alternate constructions falling within the spirit and scope of the invention.