Patent Document

BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The invention relates to a gastric band and related accessories. More specifically, the invention relates to a supply tube check valve for use with a gastric band. 
         [0003]    2. Description of the Related 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 one hundred 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 one of these methods. 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 1980&#39;s, gastric bands have provided an effective alternative to gastric bypass and other irreversible surgical weight loss treatments for the morbidly obese. Several alternate 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 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. This 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]    In practice, the gastric band is inserted behind the stomach and the ends of the gastric band are coupled to latch the device about the stomach. However, when balloon-type gastric bands are used, the balloon must be inflated to ensure proper constriction of the stomach. This is commonly achieved by coupling the balloon to a fluid injection port, for example, a velocity port as is commonly employed within the industry. However, the attachment of the balloon, supply tube and fluid source can sometimes be complicated. In particular, in current low pressure gastric band products, prior to inserting the gastric band into the body the surgeon has to evacuate the gastric band and tie a knot in the supply tube to maintain evacuation of the gastric band during the procedure. After the procedure is complete, the surgeon cuts the knot off of the supply tube. A locking connector is slid onto the supply tube and then the supply tube is pushed onto the barbed fitting on the fluid injection port. The locking connector is then slid up and locked to the fluid injection port to prevent the supply tube and fluid injection port from coming disconnected in the body postoperatively. As those skilled in the art will certainly appreciate, this is a difficult procedure and a need, therefore, exists for improvements in the manner in which a balloon-type gastric band is applied to the stomach and secured to a fluid injection port. The present invention provides a mechanism for overcoming these difficulties. 
       SUMMARY OF THE INVENTION 
       [0010]    It is, therefore, an object of the present invention to provide a balloon-type gastric band. The gastric band includes a balloon shaped and dimensioned to circumscribe the stomach at a predetermined location. The balloon includes a longitudinally extending body. A supply tube is secured to the balloon for fluid communication with an internal cavity of the balloon, wherein the supply tube includes a valve controlling the flow of fluid to and from the balloon. 
         [0011]    It is also another object of the present invention to provide a gastric band wherein the valve is a check valve. 
         [0012]    It is also an object of the present invention to provide a gastric band wherein the check valve is a ball check valve. 
         [0013]    It is a further object of the present invention to provide a gastric band wherein the ball check valve is spring biased. 
         [0014]    It is still another object of the present invention to provide a gastric band including a fluid injection port shaped and dimensioned for selective attachment to the balloon for fluid communication therewith. 
         [0015]    It is yet a further object of the present invention to provide a gastric band wherein the valve may be removed from the supply tube prior to attachment of the supply tube to the fluid injection port. 
         [0016]    It is also another object of the present invention to provide a gastric band wherein the fluid injection port is shaped and dimensioned for selective attachment to the valve. 
         [0017]    It is also an object of the present invention to provide a gastric band wherein the fluid injection port includes a central barb selectively engaging the valve for opening the check valve for the flow of fluid from the fluid injection port to the balloon. 
         [0018]    It is also another object of the present invention to provide a gastric band wherein the valve is spring biased. 
         [0019]    It is a further object of the present invention to provide a gastric band wherein the valve is a spring biased, ball check valve and the central barb selectively engages the ball to open the valve for the flow of fluid from the fluid injection port to the balloon. 
         [0020]    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 
         [0021]      FIG. 1  is a perspective view of a balloon-type gastric band in accordance with the present invention secured about a patient&#39;s stomach. 
           [0022]      FIG. 2  is a perspective view of the distal end of the supply tube secured to a fluid injection port. 
           [0023]      FIG. 3  is a perspective view of the distal end of the supply tube detached from the fluid injection port. 
           [0024]      FIGS. 4 and 5  are cross sectional views of the supply tube/fluid injection port in accordance with the present invention. 
           [0025]      FIG. 6  is a cross sectional view of the supply tube unsecured to the fluid injection port. 
           [0026]      FIG. 7  is a cross sectional view of the supply tube secured to a syringe used in evacuating the balloon of the gastric band. 
       
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0027]    The detailed embodiments of the present invention are disclosed herein. It should be understood, however, that the disclosed embodiments are 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 teaching one skilled in the art how to make and/or use the invention. 
         [0028]    Referring to  FIGS. 1 through 7 , a balloon-type gastric band  10  is disclosed in accordance with a preferred embodiment of the present invention. The gastric band  10  is generally composed of a reinforcing belt  12  to which an elongated balloon  14  is secured. The belt  12  includes a first end  16  and a second end  18  to which first and second latching members  20 ,  22  are respectively secured when attached about a patient&#39;s stomach  24 . In accordance with a preferred embodiment the first and second latching members  20 ,  22  are shaped and dimensioned for selective engagement, and are the same as disclosed in commonly owned U.S. patent application Ser. No. 11/182,072, entitled “Latching Device for Gastric Band”, filed Jul. 15, 2005, which is incorporated herein by reference. 
         [0029]    In accordance with a preferred embodiment, the belt  12  and balloon  14  are constructed as disclosed in commonly owned U.S. patent application Ser. No. 11/364,343, filed Mar. 1, 2006, entitled “Precurved Gastric Band”, which is incorporated herein by reference. In general, the belt  12  and balloon  14  may be respectively coupled by either overmolding or separate molding with subsequent adhesive bonding. In accordance with preferred embodiments, and as those skilled in the art will certainly appreciate, the balloon  14  and belt  12  may be secured together by either adhesive bonding, comolding, overmolding or mechanical connection (for example, coupling sleeves), which secures the balloon  14  and belt  12  in a manner resulting in the coupling of these distinct gastric band components. 
         [0030]    With the foregoing in mind, the balloon  14  employed in accordance with a preferred embodiment of the present application is constructed of an elastomeric material. Due to the design of this balloon  14 , it does not inflate or expand in a manner causing high strain in the balloon  14  when filled during gastric band adjustment. Rather, the balloon  14  is adapted to receive a large volume of fluid under a relatively low pressure. In this way, the balloon  14  receives fluid during application, but does not inflate or expand in a traditional manner creating strain along the walls of the balloon  14 . In other words, when the balloon  14  is filled up to the volume recommended to achieve maximum stomach restriction, there is no expansion of the balloon material. Instead, the balloon  14  fills to some percentage of its total theoretical volume (that is, maximum fill volume). Since the balloon  14  is not filled even close to its maximum fill volume, it remains low pressure, allowing the balloon  14  to conform to the stomach rather than the stomach to a rigid balloon. 
         [0031]    In accordance with a preferred embodiment of the present invention, the balloon  14  is designed with a maximum capacity of between approximately 10 cc and approximately 18 cc, and preferably 12 cc, although it will be fully filled for functioning in accordance with the present invention to achieve the smallest stoma size with approximately 9 cc to approximately 12 cc, and preferably 11 cc. By providing a balloon  14 , which is not at its capacity when properly filled for functioning, the softness and conformance of the balloon  14  is improved. While specific volumes are disclosed in accordance with a preferred embodiment of the present invention, those skilled in the art will appreciate the filling volumes may be varied without departing from the spirit of the present invention. 
         [0032]    As those skilled in the art will certainly appreciate, a supply tube  26  is used to connect the internal cavity  28  of the balloon  14  of the gastric band  10  with a fluid injection port  30 , for example, a velocity port. The utilization of the supply tube  26  with a remote fluid injection port  30  allows for controlled inflation and deflation of the balloon  14  in a predetermined manner. The exact position of the supply tube  26  is important in that the surgeon does not want tubing to be a visual obstruction during locking and/or other manipulation of the gastric band  10 . In addition, once placement of the gastric band  10  is complete, the supply tube  26  should not cause irritation to surrounding tissue (for example, sticking directly into the liver or spleen). Surgeons also do not want to pull the supply tube  26  through a retro-gastric tunnel, since they cannot easily see if the tissue is being damaged. The supply tube  26  should also be able to act as a safe grasping location for manipulation of the gastric band  10 , the supply tube  26  must not kink at the junction to the gastric band  10  and prevent fluid flow, and the supply tube location should facilitate passage of the gastric band  10  through a small trocar. In accordance with a preferred embodiment, the supply tube  26  is connected to the balloon  14  as disclosed in commonly owned U.S. patent application Ser. No. 11/364,362, filed Mar. 1, 2006, entitled “Gastric Band”, which is incorporated herein by reference. 
         [0033]    As mentioned above, current low pressure gastric band products, prior to insertion into the body, require that the surgeon evacuate the gastric band and tie a knot in the supply tube to maintain evacuation of the gastric band during the procedure. After the procedure is complete, the surgeon cuts the knot off of the supply tube. A locking connector is slid onto the supply tube and then the supply tube is pushed onto the barbed fitting on the fluid injection port. The locking connector is then slid up and locked to the fluid injection port to prevent the supply tube and fluid injection port from becoming disconnected in the body postoperatively. 
         [0034]    The need for knotting and cutting is obviated in accordance with the present invention by incorporating a check valve  32  at the end  62  of the supply tube  26 . Then, instead of having to tie a knot in the end of the supply tube  26 , the surgeon only needs to attach a syringe  58  and evacuate the gastric band  10  via the check valve  32 . The check valve  32  helps the gastric band  10  maintain evacuation throughout the procedure. 
         [0035]    More particularly, and with reference to  FIGS. 2 to 7 , the gastric band  10  includes a check valve  32  integrally formed at the proximal end  44  of the supply tube  26 . The locking connector  46 , in accordance with a preferred embodiment, is a male Luer lock, which is integrated with the check valve  32  for attachment to the fluid injection port  30  in a manner discussed below in greater detail. In practice, the surgeon may, therefore, evacuate the gastric band  10  with a syringe  58  and the check valve  32  ensures that evacuation is maintained throughout the procedure. Once the primary procedure is complete, the surgeon uses the locking connector  46  at the first end (or mating end)  34  of the check valve  32  to lock onto the fluid injection port  30 . This function requires the fluid injection port  30  to have the same geometry as the syringe  58  so the male Luer lock, that is, the locking connector  46 , on the check valve  32  is compatible with both the syringe  58  and the fluid injection port  30 . In addition, and with reference to  FIG. 4 , the fluid injection port  30  is provided with a barb  60 , which, when the check valve  32  is locked in place on the fluid injection port  30 , keeps the check valve  32  open and allows the fluid to flow freely (in both directions) to and from the fluid injection port  30 . This ensures that during a postoperative gastric band adjustment, the supply tube  26  patency is ensured. 
         [0036]    More particularly, and with reference to  FIG. 4 and 5  where the gastric band  10  is shown connected to the fluid injection port  30  via the supply tube  26 , the supply tube  26  is connected to the fluid injection port  30  that provides a controlled supply of fluid to the balloon  14  of the gastric band  10 . Improved filling is achieved by incorporating the check valve  32  between the supply tube  26  and the fluid injection port  30 . In accordance with a preferred embodiment, the check valve  32  includes a first end  34  and second end  36 . The first end  34  of the check valve  32  includes the input end  38  and the second end  36  of the check valve  32  includes the output end  40  (as referenced based upon the flow of fluid from the fluid injection port  30  to the balloon  14 ). The first end  34  is adapted for connection with the outlet  42  of the fluid injection port  30  and the second end  36  is adapted for connection with a proximal end  44  of the supply tube  26 . 
         [0037]    The check valve  32  is constructed to prevent the flow of fluid therethrough in the direction from the first end  34  to the second end  36  to prevent the flow of fluid to the gastric band  10  while it is being evacuated before the supply tube  26  is secured to the pressurized fluid injection port  30 , while permitting the flow of fluid from the second end  36  to the first end  34  in a manner which allows for the evacuation of a gastric band  10  attached thereto. Ultimately, the check valve  32  is structured to prevent the flow of fluid into the balloon  14  while the gastric band  10  is being secured about the stomach and the supply tube  26  has yet to be secured to the fluid injection port  30 . 
         [0038]    However, and as discussed above, once the balloon  14  of the gastric band  10  is evacuated, the proximal end  44  of the supply tube  26 , in particular, the first end  34  of the check valve  32 , is coupled to fluid injection port  30  and the balloon  14  is ready for inflation. In order to provide for the flow of fluid from the fluid injection port  30  through the check valve  32  and to the balloon  14 , the check valve  32  must be opened. A central barb  60  is, therefore, provided at the outlet  42  of the fluid injection port  30 . The barb  60  is shaped and dimensioned to engage the check valve  32  and open it in a manner permitting the flow of fluid from the fluid injection port  30  to the balloon  14 . 
         [0039]    The check valve  32  of the present invention may employ a variety of known valve structures. It is contemplated the valve structure may be a ball check valve, a butterfly valve, gate valve, vacuum relief valve, etc., although other known valve structures could certainly be implemented without departing from the spirit of the present invention. As shown in  FIGS. 4 ,  5 ,  6  and  7 , the check valve  32  is a ball type check valve and, therefore, includes a central ball  52  which is guided along a plurality of rails  54  between the first end  34  of the check valve  32  and the second end  36  of the check valve  32 . The ball  52  is biased toward the first end  34  by a spring  64 . When fully biased toward the first end  34 , the ball  52  engages the valve seat  56  in a manner preventing the flow of fluid from the first end  34  toward the second end  36 . When the ball  52  is positioned away from the valve seat  56  due to the central barb  60  or the needle  70  of the syringe  58  pushing the ball  52  in a direction toward the second end  36  of the check valve, the rails  54  permit fluid to flow about the central ball  52  as it is forced from the fluid injection port  30  to the supply tube  26  with the central ball  52  supported by the rails  54  moved toward the second end  36  of the check valve  32  or as the fluid is drawn from the balloon  14  by the action of the syringe  58  in evacuating the balloon  14 . While a preferred check valve structure has been disclosed herein, those skilled in the art will appreciate a variety of structures may be employed without departing form the spirit of the present invention. 
         [0040]    In accordance with a preferred embodiment of the present invention, the first end  34  of the check valve  32  is provided with a male Luer lock  46  shaped and dimensioned for selective connection with a female Luer lock  48  formed at the outlet  42  of the fluid injection port  30 . Although a Luer lock construction is disclosed in accordance with a preferred embodiment of the present invention, those skilled in the art will appreciate other connection structures may be employed without departing from the spirit of the present invention. Similarly, the syringe  58  is provided with a female Luer lock  66  for attachment during the evacuation stage. 
         [0041]    With regard to the second end  36  of the check valve  32 , it is provided with a barbed projection (not shown) shaped and dimensioned for frictional engagement within the proximal end  44  of the supply tube  26  leading to the internal cavity  28  of the balloon  14 . As with the first end  34  of the check valve  32 , a variety of connection structures are known to those skilled in the art and various connection structures may be applied in connecting the proximal end of the supply tube to the second end of the check valve without departing from the spirit of the present invention. 
         [0042]    By incorporating a check valve  32  as described above into the line feeding fluid to the balloon  14  of the gastric band  10 , the balloon  14  may be readily evacuated without requiring the surgeon to clamp the supply tube  26  prior to attachment of the supply tube  26  to the fluid injection port  30 . This improves efficiency and minimizes the steps that must be taken during a gastric band application procedure. In addition, the check valve  32  is provided with a pressure sensor  50  to measure the amount of pressure in the gastric band  10 . 
         [0043]    The present gastric band  10  is utilized in the following manner. First, the balloon  14  of the gastric band  10  is evacuated by securing a syringe  58  to the first end  34  of the check valve  32 , with the needle  70  of the syringe  58  moving the ball  52  away from the valve seat  56  and toward the second end  36  of the check valve  52 , and all of the fluid from the balloon  14  is drawn out of the balloon  14 , through the check valve  32  and into the syringe  58  as plunger  72  is moved. Once the evacuation of the balloon is completed, the gastric band  10  is secured about the stomach of a patient in a traditional manner. Thereafter, the proximal end  44  of the supply tube  26 , in particular, the first end  34  of the check valve  32 , is secured to the fluid injection port  30 . Upon attachment of the outlet  42  of the fluid injection port  30  to the first end  34  of the check valve  32 , the central barb  60  engages the ball  52  to move it off of the valve seat  56  and toward the second end  36  of the check valve  32 . In this position, fluid may freely flow from the fluid injection port  30  to the balloon  14  and through the check valve  32 . 
         [0044]    In accordance with an alternate embodiment, the check valve may be cut from the supply tube after evacuation of the fluid from the balloon such that the supply tube may be directly connected to the fluid injection port. 
         [0045]    In accordance with various preferred embodiments of the present invention, different tube placements may be employed as disclosed in commonly owned U.S. patent application Ser. No. 11/364,362, entitled “Gastric Band”, filed Mar. 1, 2006, which is incorporated herein by reference. 
         [0046]    Although the present invention is described for use in conjunction with gastric bands, those skilled in the art will appreciate the above invention has equal 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. 
         [0047]    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.

Technology Category: 1