Abstract:
A gastric restrictive device positionable around a human stomach to limit the flow of food therethrough is provided with structure for facilitating suturing of the gastric restrictive device to the stomach and thereby preventing movement of the gastric restrictive device relative to the stomach.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
   Applicant claims priority based on provisional patent application Ser. No. 60/745,584 filed Apr. 25, 2006, the entire content of which is incorporated herein by reference. 

   TECHNICAL FIELD 
   This invention relates generally to the treatment of morbid obesity by means of adjustable gastric bands, and more particularly to a method of and apparatus for preventing gastric band slips during the treatment procedure. 
   BACKGROUND AND SUMMARY OF THE INVENTION 
   Referring to the Drawings, and particularly to  FIG. 1  thereof, there is shown a human stomach  10  having an adjustable gastric band  12  secured therearound. As is well known to those skilled in the art, the adjustable gastric band  12  typically includes an outer flexible, substantially non-extendable layer  14  and an inner expandable layer which is secured to the outer layer  14 . 
   In use, the adjustable gastric band  12  is extended around the stomach  10  at the location shown in  FIG. 1 . The adjustable gastric band  12  is then secured in place by joining the opposite ends of the flexible, substantially non-extendable layer  14  utilizing a latch. When the adjustable gastric band  12  is thus secured in place the stomach is divided into a relatively small upper portion  16  and a relatively larger lower portion  18 . 
   The adjustable gastric band  12  is provided with a tube  20  which extends through an incision made in the abdominal wall of the patient to a location outside of the abdominal cavity. Sterile saline is directed through the tube  20 , through a valve, and into the expandable inner layer of the adjustable gastric band  12  thereby causing the expandable inner layer to balloon inwardly. In this manner the passage of food from the upper portion  16  to the lower portion  18  of the stomach  10  is restricted. 
   It is theorized that the upper portion  16  of the stomach  10  and/or the adjacent lower region of the esophagus contains nerve endings which trigger a “full” feeling when the stomach  10  is full. When the adjustable gastric band  12  is positioned as illustrated in  FIG. 1  and when the flexible inner wall of the adjustable gastric band is inflated, food accumulates in the upper portion  16  and in the adjacent lower region of the esophagus. This causes the patient to experience a “full” feeling even though the lower portion  18  of the stomach  10  is in fact not full. Because the patient experiences a “full” feeling after consuming a relatively small amount of food the patient&#39;s total caloric intake is reduced thereby facilitating control of the patient&#39;s obesity. As is understood by those skilled in the art, the inner flexible layer of the adjustable gastric band  12  is further expanded as the obesity treatment progresses thereby further restricting the passage of food from the upper portion  16  to the lower portion  18  of the stomach  10 . 
   In between about 3% and about 5% of the 40,000+ cases annually in which an adjustable gastric band is used in the treatment of morbid obesity the adjustable gastric band  12  moves downwardly relative to the stomach  10 , an occurrence known as a slip. When an anterior slip occurs the adjustable gastric band moves into the improper vertical orientation illustrated in  FIG. 2  as opposed to the proper angular orientation illustrated in  FIG. 1 . A slip of the type illustrated in  FIG. 2  is dangerous because it results in food accumulating in the upper portion  16  of the stomach  10  rather than flowing smoothly from the upper portion  16  to the lower portion  18  of the stomach  10  albeit at a slower than normal rate. Accumulation of food in the upper portion  16  of the stomach  10  can cause the patient to experienced frequent vomiting. More importantly, a slip directly restricts blood flow to the herniated portion of the stomach which can cause necrosis thereof which can lead to a surgical emergency and possibly death. 
   As is also well known to those skilled in the art a posterior slip of the adjustable gastric band  12  relative to the stomach  10  can also occur. The undesirable results of a posterior slip are substantially the same as those described above in conjunction with the slip illustrated in  FIG. 2 . 
     FIG. 3  illustrates a prior art technique for preventing movement of the adjustable gastric band  12  relative to the stomach  10 . A flap comprising part of the lower portion  18  of the stomach  10  is secured to the upper portion  16  by a plurality of sutures  22 . So long as the flap remains sutured to the upper portion  16  of the stomach  10  the adjustable gastric band  12  is secured against significant movement relative to the stomach. However, as is well known to those skilled in the art, various occurrences can cause the flap to become disengaged from the upper portion  16  of the stomach  10 . For example, the sutures  22  can simply tear loose. It is also possible that the knots which secure the sutures  22  in place will fail either by becoming untied or due to breakage. It is also possible that the sutures will deteriorate under the action of fluids contained within the stomach  10  and/or within the body cavity. 
   The present invention comprises a method of and apparatus for preventing movement of an adjustable gastric band relative to the stomach upon which the adjustable gastric is installed. In accordance with the broader aspects of the invention, an adjustable gastric band is positioned on a stomach in the conventional manner and is thereafter sutured to the stomach thereby eliminating the possibility of movement of the adjustable gastric band relative to the stomach. 
   In accordance with a first embodiment of the invention a plurality of tabs are formed integrally with the flexible, substantially non-extendable layer of an adjustable gastric band and are provided with suture receiving holes to facilitate suturing of the adjustable gastric band to the stomach. In accordance with a second embodiment of the invention, lengths of suture material secured to the flexible, substantially non-extendable outer layer of an adjustable gastric band to facilitate suturing of the adjustable gastric band to the stomach. 
   In accordance with a third embodiment of the invention, the flexible, substantially non-extendable layer of an adjustable gastric band is provided with a plurality of tabs each having a suture receiving hole formed therein and with a plurality of loops formed from suture material for facilitating suturing of the adjustable gastric band to the stomach. In accordance with a fourth embodiment of the invention a plurality of tabs are secured to the flexible, substantially non-extendable layer of an adjustable gastric band and are provided with suture receiving apertures thereby facilitating suturing of the adjustable gastric band to the stomach. In accordance with a fifth embodiment of the invention a length of fabric is secured to the flexible, substantially non-extendable layer of an adjustable gastric band and is provided with a plurality of apertures extending therethrough for facilitating suturing of the adjustable gastric band to the stomach. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     A more complete understanding of the present invention may be had by reference to the following Detailed Description when taken in connection with the accompanying Drawings, wherein: 
       FIG. 1  is an illustration of an adjustable gastric band properly installed on a stomach; 
       FIG. 2  is an illustration of an adjustable gastric band slip; 
       FIG. 3  is an illustration of the use of a stomach flap to secure an adjustable gastric band against movement relative to the stomach; 
       FIG. 4  is a perspective view illustrating a first embodiment of the invention; 
       FIG. 5  is a perspective view illustrating a second embodiment of the invention; 
       FIG. 6  is a perspective view illustrating a third embodiment of the invention; 
       FIG. 7  is perspective view illustrating a fourth embodiment of the invention; 
       FIG. 8  is perspective view illustrating the use of the first, second, third, and fourth embodiments of the invention in conjunction with a stomach; 
       FIG. 9  is perspective view illustrating a fifth embodiment of the invention; and 
       FIG. 10  is perspective view illustrating the use of a fifth embodiment of the invention in conjunction with a stomach. 
   

   DETAILED DESCRIPTION 
   Referring now to the drawings, and particularly to  FIG. 4  thereof, there is shown an adjustable gastric band  30  comprising a first embodiment of the invention. Although a particular gastric band construction is illustrated in the drawings, those skilled in the art will appreciate that the present invention is applicable to all gastric restrictive devices including but not limited to the Lap Band® adjustable gastric band distributed by INAMDED®, the Swedish Adjustable Gastric Band (SAGB) distributed by Obtech, the MIDBAND adjustable gastric band distributed by Médical Innovation Développement, and the AMI Soft Gastric Band distributed by C.J. Medical. 
   The adjustable gastric band  30  comprises a flexible, substantially non-extendable outer layer  32  and an inner flexible layer  34 . A tube  36  is connected to the inner flexible layer  34  of the adjustable gastric band  30  through a one way valve for use in inflating the flexible layer  34  thereby causing the layer  34  to balloon inwardly. The adjustable gastric band  30  further includes a latching mechanism  38  which is employed to initially secure the adjustable gastric band  30  around the stomach of a patient. 
   In accordance with the present invention, the flexible, substantially non-extendable layer  32  has a plurality of tabs  40  formed integrally therewith. Each of the tabs  40  has a suture receiving aperture  42  formed therethrough. After the adjustable gastric band  30  has been properly positioned on a stomach and secured in place by the locking mechanism  38 , the tabs  40  are utilized to prevent movement of the adjustable gastric band  30  relative to the stomach. This is accomplished by suturing the adjustable gastric band  30  to the stomach utilizing the apertures  42  extending through the tabs  40 . 
   Referring to  FIG. 5 , there is shown an adjustable gastric band  50  comprising a second embodiment of the invention. The adjustable gastric band  50  comprises a flexible, substantially non-extendable outer layer  52  and an inner flexible layer  54 . A tube  56  is connected to the inner flexible layer  54  of the adjustable gastric band  50  through a one way valve for use in inflating the flexible layer  54  thereby causing the layer  54  to balloon inwardly. The adjustable gastric band  50  further includes a latching mechanism  58  which is employed to initially secure the adjustable gastric band  50  around the stomach of a patient. 
   In accordance with the present invention, the flexible, substantially non-extendable layer  52  has a plurality of loops  60  secured thereto. Each of the loops  60  comprises a length of suture material which is secured to the outer layer  52  by conventional means such as the use of a suitable adhesive, welding, sewing, stapling, etc. After the adjustable gastric band  50  has been properly positioned on a stomach and secured in place by the locking mechanism  58 , the loops  60  are utilized to prevent movement of the adjustable gastric band  50  relative to the stomach. This is accomplished by suturing the adjustable gastric band  50  to the stomach utilizing the loop  60 . 
   Referring to  FIG. 6 , there is shown an adjustable gastric band  70  comprising a third embodiment of the invention. The adjustable gastric band  70  comprises a flexible, substantially non-extendable outer layer  72  and an inner flexible layer  74 . A tube  76  is connected to the inner flexible layer  74  of the adjustable gastric band  70  through a one way valve for use in inflating the flexible layer  74  thereby causing the layer  34  to balloon inwardly. The adjustable gastric band  70  further includes a latching mechanism  78  which is employed to initially secure the adjustable gastric band  70  around the stomach of a patient. 
   The adjustable gastric band  70  comprises the tabs  40  of the adjustable gastric band  30  of  FIG. 4  and the loops  60  of the adjustable gastric band  50  of  FIG. 5 . It is theorized that the use of the loops  60  on the posterior side of the adjustable gastric band  70  will lessen the drag that would otherwise be experienced in positioning the band  70  around the stomach of a patient. 
   Referring to  FIG. 7  thereof, there is shown an adjustable gastric band  80  comprising a fourth embodiment of the invention. The adjustable gastric band  80  comprises a flexible, substantially non-extendable outer layer  82  and an inner flexible layer  84 . A tube  86  is connected to the inner flexible layer  84  of the adjustable gastric band  80  through a one way valve for use in inflating the flexible layer  84  thereby causing the layer  84  to balloon inwardly. The adjustable gastric band  80  further includes a latching mechanism  88  which is employed to initially secure the adjustable gastric band  80  around the stomach of a patient. 
   In accordance with the present invention the flexible, substantially non-extendable layer  32  is provided with a plurality of tabs  90 . The tabs  90  are secured to the flexible, substantially non-extendable outer layer of the adjustable gastric band  80  by means of a suitable adhesive, welding, sewing, stapling, etc. Each of the tabs  90  has a suture receiving aperture  92  formed therethrough. After the adjustable gastric band  80  has been properly positioned on a stomach and secured in place by a locking mechanism  88 , the tabs  90  are utilized to prevent movement of the adjustable gastric band  80  relative to the stomach. This is accomplished by suturing the adjustable gastric band  80  to the stomach utilizing the apertures  92  extending through the tabs  90 . 
     FIG. 8  illustrates the utilization of the embodiments of the invention shown in  FIGS. 4 ,  5 ,  6 , and  7  and described hereinabove in conjunction therewith. After the adjustable gastric band  100  is secured around the stomach  10 , it is secured in place by means of tabs or loops  102  secured to the flexible, substantially non-extendable outer layer  104  of the adjustable gastric band  100  and sutures  106  which secure the bands or loops  102  to the wall of the stomach  10 . Subsequently a flap comprising part of the lower portion  18  of the stomach  10  may be secured to the upper portion  16  thereof utilizing sutures  108 . Use of the present invention provides an added safeguard against slippage of the adjustable gastric band  100  in the event that the flap becomes disengaged from the upper portion  16  of the stomach  10  for any reason. 
   Referring to  FIG. 9 , there is shown an adjustable gastric band  110  comprising a fifth embodiment of the invention. The adjustable gastric band  110  comprises a flexible, substantially non-extendable outer layer  112  and an inner flexible layer  114 . A tube  116  is connected to the inner flexible layer  114  of the adjustable gastric band  110  through a valve for use in inflating the flexible layer  114  thereby causing the layer  114  to balloon outwardly. The adjustable gastric band  110  further includes a latching mechanism  118  which is employed to initially secure the adjustable gastric band  110  around the stomach of a patient. 
   In accordance with the present invention a fabric layer  120  is secured to the flexible, substantially non-extendable layer  112  of the adjustable gastric band  110 . The layer  120  is preferably pleated as illustrated in  FIG. 9 . The layer  120  may be secured to the flexible, substantially non-extendable layer  112  by any of a variety of conventional techniques such as utilizing a suitable adhesive, welding, sewing, stapling, etc. A plurality of suture receiving aperture  122  extend through the layer  120  adjacent the lower edge thereof. 
     FIG. 10  illustrates the utilization of the embodiment of the invention shown in  FIG. 9  and described hereinabove in conjunction therewith. After the adjustable gastric band is secured around the stomach  10  it is secured in place by means of the layer  120  and sutures  124  and into engagement with the stomach wall to secure the adjustable gastric band  110  against movement relative to the stomach  10 . 
   Although preferred embodiments of the invention have been illustrated in the accompanying Drawings and described in the foregoing Detailed Description, it will be understood that the invention is not limited to the embodiments disclosed, but is capable of numerous rearrangements, modifications, and substitutions of parts and elements without departing from the spirit of the invention.