FIELD OF THE INVENTION  
       [0001]     This invention relates to a medical device for clamping the stomach in morbid obesity bariatric surgery.  
       BACKGROUND OF THE INVENTION  
       [0002]     One of the most common illnesses is obesity. Many diseases are caused by or exacerbated by obesity, particularly in the western world, and these illnesses may be accompanied by physical and psychological disabilities. Surgical methods for controlling weight initially involved gastric stapling in various forms, which, over a prolonged period, resulted in major weight reduction. Because of the invasiveness of this type of surgery, and the irreversibility of it, the gastric stapling surgical technique was not widely accepted. These surgical procedures required a laparotomy which carried the risk of morbidity and death. Additionally, the gastric stapling technique required that the setting of the gastric restriction be initially set correctly because of the inability of the surgeon to modify the degree of restriction after the operation was performed. To overcome this difficulty, adjustable gastric banding was introduced which utilized an inflatable balloon carried by a band that could be placed around the stomach by an open operation or laparoscopically. The later technique has become the preferred surgical technique because of the reduced invasiveness of the operation. The degree of gastric restriction after placement of the band around the stomach immediately below the oseophagogastric junction was controlled by inflating an encircling balloon which was sealingly carried on the inner surface of the band; however, the bands of the prior art created the gastric restriction by annularly or hoop compressing the stomach. A possible consequence of annular stress is the inducement of erosion that permitted the band to go into the bowel thereby causing bleeding, infection, and even death. Thus, it is desirable to provide a stomach plication device that avoids annular stress, that utilizes inflatable members to prolong the life of the plication device, that is laparoscopically implantable, avoids erosion, and is adjustable to control the gastric restriction stoma after the operation is completed.  
       SUMMARY OF THE INVENTION  
       [0003]     There is, therefore, provided according to the present invention a fluid inflatable clamp device to plicate the stomach for morbid obesity surgery and substantially reduce the risk of band erosion resulting form annular compression of the stomach. The inflatable device is adjustable and can be placed laparoscopically or by open operation.  
         [0004]     The present invention is directed to embodiments that utilize opposing legs carrying an inflatable balloon member in one embodiment or balloons in other embodiments to permit clamping of the stomach below the grastroesphogeal junction. By selectively inflating or aspirating opposing balloons, the life of the clamp may be substantially prolonged and consequently the frequency of replacement surgery greatly reduced. The device is preferably made of silicone where the legs are so constructed and proportioned to have sufficient stiffness to permit limited bending and are so hinged such that the hinged ends of the legs are in fixed lateral spaced relationship.  
         [0005]     In each of the embodiments of the invention, the fluid inflatable device to plicate the stomach is U-shaped and consists of a first leg or plate having a preferably rectangular shape where the first leg has a free first end and a hinged opposite end and an axis of elongation; a second leg having substantially the same configuration as the first leg also has a hinged end and free second end. The hinged ends of the legs are integrally connected to a laterally extending bight portion which has sufficient stiffness to retain the legs in fixed lateral spaced relationship at their hinged ends.  
         [0006]     In the preferred embodiment, the first leg has a first lumen extending at least in part axially therein that communicates with a first inflation port and, likewise, the second leg has a second lumen extending at least in part axially therein that communicates with a second inflation port. However the second leg also has a third lumen extending axially therein that communicates with a bight lumen extending laterally through the bight portion where the bight lumen is in fluid communication with the first lumen. Thus, a flow path is provided that permits fluid flow for inflating or aspirating a first inflatable member that is peripherally sealed and extends axially along the inner surface of the first leg. A separate flow path is provided to permit fluid flow through the second lumen and second inflation port for inflating and aspirating a second inflatable member that is peripherally sealed and extends axially along the inner surface of the second leg; the second inflatable member is oppositely positioned from the first inflatable member when the stomach is clamped.  
         [0007]     The embodiment above described further includes latch means associated with the first and second legs at their free ends to permit the legs to be locked in pre-determined fixed lateral relationship during the clamping of the stomach. Separate fluid flow paths are defined by first and second conduits which are contained within a flexible latch member having at least one serration where the flexible latch member is integrally carried by the second leg member adjacent its free end; the first conduit of the flexible latch member communicates with the second lumen and the second conduit of the flexible latch member communicates with the third lumen. Fluid supply means associated with the latch means permits saline fluid to be selectively supplied or aspirated through the first conduit to inflate or aspirate the first inflatable member to a pre-determined pressure. The second inflatable member may be separately inflated to a pre-determined pressure by the fluid supply means supplying or aspirating fluid through the second conduit of the flexible latch member. To secure the free ends of the first and second legs in substantially fixed lateral spaced relationship, the first leg has a latch cavity adjacent the free end so dimensioned and proportioned to permit locking engagement with a selected serration of the serrated flexible latch member.  
         [0008]     In another embodiment of this invention, the inflatable device has as in the preferred embodiment a first leg, preferably of plate shape, an axis of elongation, a first end and a hinged end, a first inflation port, and a first lumen extending at least in part axially therein; a second leg having substantially the same rectangular plate configuration as the first leg, an axis of elongation, a hinged end, a free end, and a second lumen extending at least in part axially therein where the second lumen communicates with a second inflation port. The hinged ends of the legs are self hinged and integrally associated with a laterally extending bight portion where the bight portion has sufficient stiffness to retain the legs in fixed lateral spaced relationship at their hinged ends. The bight portion contains a laterally extending bight lumen that communicates with the first and second lumens thereby providing a fluid flow path to the first inflation port. The first inflatable member which is sealingly carried by the first leg extends at least in part axially on the inner surface of the first leg where the first inflatable member communicates with the first inflatable port. The second leg sealingly carries a second inflatable member which is oppositely positioned from the first inflatable member when the stomach is clamped between the first and second legs. As in the preferred embodiment above described, in this embodiment the serrated flexible latch member is carried by the second leg adjacent its free end and the flexible latch member contains a first conduit therein in fluid communication with the second lumen. To secure the free ends of the first and second legs in fixed space relationship, the first leg has a latch cavity adjacent to the free end that is so dimensioned and proportioned to permit locking engagement with a selected serration of the serrated flexible latch member. A fluid supply and aspiration means is associated with the serrated flexible latch member and communicates with the first conduit to selectively permit inflation or aspiration of both the first and second inflatable members.  
         [0009]     In yet still another embodiment, the plication device is of similar construction as in the previous embodiments. As in the above described embodiments, the plication device is preferably U-shaped and has a first leg and a second leg which are preferably of a rectangular plate shape and self-hinged to the bight portion so as to permit the legs to articulate with respect to the bight portion. An axis of elongation extends through the first leg, bight portion, and second leg and a single inflatable member is sealingly carried and extends axially and continuously on the inner side of the first and second legs and bight portion. The first leg has a first lumen that communicates with an inflation port that is in fluid communication with the single inflatable member. As in the above described embodiments, a flexible latch member is associated with the first and second legs for spacing the legs in substantially fixed spatial relationship where the flexible latch member contains at least one serration. The flexible latch member has a first conduit therein that is in fluid communication with the first lumen. A fluid supply means, as described in the above embodiments, is associated with the flexible latch member for selectively supplying and aspirating fluid through the first conduit to inflate or aspirate the inflatable member to a pre-determined pressure or lateral distance from the inner surfaces of the first and second legs  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0010]     These and other features and advantages will become appreciated as the same become better understood with reference to the following specification, claims and drawings wherein:  
         [0011]      FIG. 1  is a perspective view of the preferred embodiment of the stomach plication device of this invention for morbid obesity surgery illustrating the device open and latched configurations.  
         [0012]      FIG. 2  is a side view of  FIG. 1  illustrating the preferred embodiment in the unlatched open configuration.  
         [0013]      FIG. 3  is a side view of  FIG. 1  illustrating the preferred embodiment of this invention in a latched configuration with the stomach plicated.  
         [0014]      FIG. 4  is a front view of  FIG. 3 .  
         [0015]      FIG. 5  is a rear view of  FIG. 3 .  
         [0016]      FIG. 6  is a top view of  FIG. 3 .  
         [0017]      FIG. 7  is a perspective view of the preferred embodiment illustrating the device in latched configuration with the stomach plicated.  
         [0018]      FIG. 8  is a side view of another embodiment of this invention.  
         [0019]      FIG. 9  is a front view of  FIG. 8 .  
         [0020]      FIG. 10  is a rear view of  FIG. 8 .  
         [0021]      FIG. 11  is a top view of  FIG. 8 .  
     
    
     DETAILED DESCRIPTION  
       [0022]      FIG. 1  is a perspective of the preferred embodiment illustrating the stomach plication device  1  of this invention in both latched and unlatched configurations. As can be seen in  FIG. 1 , the first leg  2  is shown in phantom to depict the unlatched configuration; and the latched, closed configuration, is shown in solid lines. In the preferred embodiment the frame  5  of plication device  1  is U-shaped having a pair of opposing legs or rectangular plates interconnected by a bight and made of a silicone material. The frame consists of first leg or rectangular plate  2  which has a free-end  3  and a hinged-end  4 . Hinged-end  4  is integrally connected and self-hinged to bight portion  6 . First leg  2  is so constructed and proportioned to have sufficient stiffness to permit limited bending and to have sufficient flexibility at the juncture of the first leg and bight portion to rotate with respect to bight portion  6  at its hinged end  4 . Bight portion  6  is also shaped rectangularly and is preferably made of a stiff silicone material with sufficient flexibility at the juncture of second leg  7  and bight portion  6  so as to form self-hinging joint  8 ; bight portion  6  is of sufficient stiffness such that the lateral distance between the hinged end  4  of first leg  2  and hinged end  9  of second leg  7  is essentially constant.  
         [0023]     Referring to  FIGS. 1 and 2 , it can be seen that second leg  7  has a free-end portion  11  that contains flexible latch member  12  which is bendable with respect to second leg  7  and consists of a multiplicity of serrations  13  to permit the forming of an adjustable latch lock with first leg  2 . To form the latch lock, the serrations  13  are sequentially advanced through latch cavity  14  until a desired lateral separation between first leg  2  and second leg  7  is achieved. Each of the serrations  13  and latch cavity  14  are so dimensioned and constructed such that when a serration sufficiently engages latch cavity  14 , the serration cannot be withdrawn back through the latch cavity.  
         [0024]     Referring again to  FIGS. 1 and 2 , it can be seen that, first leg  2  has an axis of elongation  16  and second leg  7  has an axis of elongation  17 . First inflatable member  18  is carried by first leg  2  and extends axially along inner surface  19  of the first leg. First inflatable member  18  is peripherally sealed to inner surface  19  and is selectively inflatable, preferably with saline fluid, to a desired lateral distance from inner surface  19  such as that illustrated in  FIG. 2  by phantom line  21 . In a like manner, second inflatable member  22  is peripherally sealed to inner surface  23  and extends axially along inner surface  23  of second leg  7  and is selectively inflatable with a saline fluid to a desired lateral dimension as illustrated in  FIG. 2  by phantom line  24 . In the preferred embodiment, first and second inflatable members are separately inflatable as hereafter described by reference to  FIGS. 3, 4 ,  5 , and  6 .  
         [0025]     As can be seen is  FIG. 3 , the stomach  36  is plicated between first leg  2  and second leg  7  by inflation of second inflatable member  22 . First inflatable member  18  as shown in  FIG. 3  has not been inflated while second inflatable member  22  is inflated to illustrate that either inflatable member or both can be used to further plicate the stomach  36  between the first and second legs.  
         [0026]     The flow paths for inflating and aspirating inflatable members  18  and  22 , and the corresponding inflation ports, can be seen by reference to  FIG. 3 . First leg  2  has a first inflation port  26  that communicates with first inflation member  18 . Saline fluid for inflating first inflation member  18  is supplied from reservoir  40  through first conduit  27  that extends axially within flexible latch member  12  and communicates with third lumen  28 . A fluid flow path is provided to first inflation port  26  by third lumen  28  which extends axially within and through second leg  7  and communicates with bight lumen  29 . Bight lumen  29  extends laterally through bight portion  6  and in turn communicates with first lumen  31 ; first lumen  31  extends in part axially within first leg  2  completing the flow path to first inflation port  26 . To inflate second inflatable member  22 , a separate flow path is provided through second conduit  32  which extends axially through flexible latch member  12  and communicates with second lumen  33 ; second lumen  33  extends at least in part axially within second leg  7  and communicates with second inflation port  34 . Thus, saline fluid may be separately supplied to inflate or aspirate second inflatable member  22  to a desired lateral dimension.  
         [0027]     Referring now to  FIG. 7 , which is a perspective view of the preferred embodiment, stomach  36  is shown to be plicated between first leg  2  and second leg  7  with second inflatable member  22  sufficiently inflated to define a gastric restriction stoma. Although not shown in the drawings, a reservoir  40  is implanted in the patient and contains saline. Reservoir  40  communicates with conduits  27  and  32  which are contained within silicon tubing  37 . Reservoir  40  is implanted during the operation within the left rectal muscle bed. The use of a silicone implanted reservoir to supply saline to inflate or aspirate a balloon is well known in the prior art and widely used in lap band gastric surgical procedures. The reservoir is attached to the anterior rectal sheath by absorbable sutures. After the operation is completed, the gastric restriction stoma can be modified according to a patient&#39;s need. This is accomplished by use of a needle selectively inserted into injection ports carried by the reservoir. The reservoir has two injection ports located under the skin which can be localized radioscopically; the needle is then introduced into a respective port to inflate or aspirate the inflatable member communicating with that port. The preferred embodiment permits the surgeon after the plicating device has plicated the stomach to selectively inflate or aspirate either or both inflatable members to modify the gastric restriction stoma.  
         [0028]     Another embodiment of this invention is illustrated in  FIGS. 8, 9 ,  10 , and  11 . The basic distinction between this embodiment and the preferred embodiment described above is that a single inflatable member  38 , shown in  FIG. 8 , is utilized rather than two separately inflatable members. By referring to  FIG. 8 , it can be seen that inflatable member  38  extends axially along the inner surface  19 ′ of first leg  2 ′, laterally along the inner surface  39  of bight portion  6 ′, and axially along the inner surface  23 ′ of second leg  7 ′. Single inflatable member  38  is peripherally sealed to the inner surfaces of first leg  2 ′, bight portion  6 ′, and second leg  7 ′; the expansion of single inflatable member  38  upon inflation is shown in  FIG. 8  by phantom line  41 . Inflation and aspiration of single inflatable member  38  is illustrated by reference to  FIGS. 8, 9 , and  11 . As can be seen in  FIG. 11 , a single conduit  42  extends within and through flexible latch member  12 ′ and as shown in  FIG. 8  communicates with lumen  43  which extends at least in part axially within second leg  7 ′ and communicates with inflation port  34 ′. Although not shown, a saline reservoir is implanted in the patient and communicates with conduit  42  to supply and aspirate saline to and from single inflatable member  38 . As described above in the description of the preferred embodiment, the use of a silicone implanted reservoir  40  to supply saline to inflate or aspirate a balloon in lap band gastric surgery is well known. The reservoir is implanted during the operation within the left rectal muscle bed. After the operation is completed, the gastric restriction stoma can be modified by locating a reservoir injection port radioscopically and introducing a needle into the port to inflate or aspirate the inflatable member.  
         [0029]     In yet another embodiment of this invention, not shown, the plication device is U-shaped and utilizes first and second inflatable members which are peripherally sealed and carried on the inner surface of the first and second legs, respectively as in the preferred embodiment; however, the device in this embodiment has a single fluid flow path to inflate the first and second inflatable members. The flow path consists of a conduit within the flexible latch member that communicates with reservoir  40 , a first lumen that extends at least in part axially within the first leg, a bight lumen that extends laterally within the bight portion, and a second lumen extending axially within the second leg. The first and second inflatable members communicate with a respective inflation port and the inflation ports are in fluid communication with the first and second lumens. And as above described, the use of a silicone implanted reservoir  40  which is well known in the prior art permits inflation and aspiration of the first and second inflatable members. The gastric restriction stoma may be modified after the stomach is plicated and one of the flexible latch member serrations locked with respect to the first and second legs. As in the above described embodiments, reservoir  40  has an injection port that can be located radioscopically and accessed by a needle to supply or aspirate saline to inflate or aspirate the inflatable members.  
         [0030]     While I have shown and described embodiments of a stomach plication device for morbid obesity surgery, it is to be understood that the invention is subject to many modifications without departing from the scope and spirit of the claims recited herein.
A medical device for clamping the stomach in morbid obesity surgery consists of a silicone frame that is essentially U-shaped, having opposing legs self-hinged to a bight portion interconnecting the legs. The opposing legs have sufficient stiffness to permit limited bending and have inner surfaces that sealingly carry an inflatable balloon which can be selectively inflated or aspirated after the device has been clamped to the stomach to adjust the gastric restriction stoma. A flexible latch member carried by one of the legs has at least one serration which is inserted into a latch cavity of the opposing leg to lock the opposing legs in fixed spaced relationship. Lumens within the legs communicate with a fluid supply source and respective inflatable balloon for selective inflation or aspiration of the inflatable balloons.