Abstract:
A gastric reduction apparatus endoscopically draws stomach walls into apposition. The apparatus includes an applicator body having a proximal end and a distal end. The applicator body also includes a suction slot shaped and dimensioned for housing a corkscrew anchor. A firing mechanism is associated with the corkscrew anchor for rotation of the corkscrew anchor in a manner causing the corkscrew anchor to penetrate and engage tissue brought adjacent the suction slot. A method for gastric reduction is achieved by introducing a gastric reduction apparatus as disclosed above within the stomach of an individual, applying the corkscrew anchor to a stomach wall and drawing stomach walls together to create a cavity within the stomach.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to gastric reduction surgery. More particularly, the invention relates to a method and apparatus for performing gastric reduction surgery endoscopically through the implementation of a corkscrew style wall anchor. 
     2. Description of the Prior Art 
     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. 
     A variety of surgical procedures have been developed to treat obesity. One of the most commonly performed procedures is Roux-en-Y gastric bypass (RYGB). This procedure is highly complex and is utilized to treat people exhibiting morbid obesity. Even though this is a complex operation, greater than 100,000 procedures are performed annually in the United States alone. 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. 
     RYGB involves movement of the jejunum to a high position using a Roux-en-Y loop. The stomach is completely divided into two unequal portions (a smaller upper portion and a larger lower gastric pouch) using an automatic stapling device. The upper pouch typically measures less than about 1 ounce (or 20 cc), while the larger lower pouch remains generally intact and continues to secret stomach juices flowing through the intestinal track. 
     A segment of the small intestine is then brought from the lower abdomen and joined with the upper pouch to form an anastomosis created through a half-inch opening, also called the stoma. This segment of the small intestine is called the “Roux loop” and carries the food from the upper pouch to the remainder of the intestines, where the food is digested. The remaining lower pouch, and the attached segment of duodenum, are then reconnected to form another anastomotic connection to the Roux loop at a location approximately 50 to 150 cm from the stoma, typically using a stapling instrument. It is at this connection that the digestive juices from the bypass stomach, pancreas, and liver, enter the jejunum and ileum to aid in the digestion of food. Due to the small size of the upper pouch, patients are forced to eat at a slower rate and are satiated much more quickly. This results in a reduction in caloric intake. 
     The conventional RYGB procedure requires a great deal of operative time. Because of the degree of invasiveness, post-operative recovery time can be quite lengthy and painful. 
     In view of the highly invasive nature of the current RYGB procedure, other less invasive procedures have been developed. The most common form of gastric reduction surgery involves the application of vertical staples along the stomach to create an appropriate pouch. This procedure is commonly performed laparoscopically and, as such, requires substantial preoperative, operative, postoperative resources. 
     With the foregoing in mind, procedures that allow for the performance of gastric reduction surgery in a time efficient and patient friendly manner are needed. The present invention provides such a method and an associated apparatus. 
     SUMMARY OF THE INVENTION 
     It is, therefore, an object of the present invention to provide a gastric reduction apparatus for endoscopically drawing stomach walls into apposition. The apparatus includes an applicator body including a proximal end and a distal end. The applicator body also includes a suction slot shaped and dimensioned for housing a corkscrew anchor. A firing mechanism is associated with the corkscrew anchor for rotation of the corkscrew anchor in a manner causing the corkscrew anchor to penetrate and engage tissue brought adjacent the suction slot. 
     It is also an object of the present invention to provide a method for gastric reduction. The method is achieved by introducing a gastric reduction apparatus as disclosed above within the stomach of an individual, applying the corkscrew anchor to a stomach wall and drawing stomach walls together to create a cavity within the stomach. 
     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 
         FIG. 1  is a perspective view of the corkscrew anchors of the present invention used in gastric reduction surgery. 
         FIG. 2  is a perspective view of a corkscrew anchor in accordance with the present invention. 
         FIG. 3  is a side view of the present gastric reduction apparatus. 
         FIGS. 4 and 5  are detailed view of the applicator body of the gastric reduction apparatus with and without the corkscrew anchor positioned therein, respectively. 
         FIGS. 6 ,  7 ,  8  and  9  are cross sectional views showing operation of the gastric reduction apparatus. 
         FIG. 10  is a detailed interior view of the gastric reduction apparatus. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT 
     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. 
     Referring to the various figures, an endoscopic gastric reduction apparatus  10  for efficiently performing gastric reduction surgery is disclosed. The gastric reduction apparatus  10  functions by applying respective corkscrew anchors  12  to anterior and posterior gastric walls  14 ,  16  for the creation of a closure generated by pulling the anterior and posterior walls  14 ,  16  together. 
     In general, the gastric reduction apparatus  10  uses suction to respectively draw the anterior and posterior stomach walls  14 ,  16  into contact with the gastric reduction apparatus  10 . Thereafter, retention bars  18 ,  20  are advanced across the access openings of the gastric reduction apparatus  10  and through the tissue held therein to securely hold the anterior and posterior stomach walls  14 ,  16  adjacent the apparatus  10 . The stomach tissue is held in a configuration in which the gaps in the gastric reduction apparatus  10  are spaced at the same pitch as the corkscrew anchors  12  and the gaps will allow for a full thickness tissue penetration. 
     In particular, the corkscrew anchors  12  pass alternately through mucosa, muscular layer and serosa, and then back through the stomach wall in a reverse, rotational direction. This results in full thickness penetration of the stomach wall. The tight hold of the suction on the tissue ensures that the corkscrew anchors  12  never touch adjacent organs. The vacuum is then replaced with light insufflation to remove the anterior and posterior stomach walls  14 ,  16  from the gastric reduction apparatus  10 . 
     Once the corkscrew anchors  12  are installed, the gastric reduction apparatus  10  is extracted to allow the cinching of a pre-woven suture  22  passing through the corkscrew anchors  12  to form the gastric pouch. In particular, this results in the application of two opposing corkscrew anchors  12  that are subsequently pulled together through the utilization of a pre-woven mattress stitch suture  22  cinched down over the two corkscrew anchors  12 . Although a mattress stitch is disclosed in accordance with a preferred embodiment of the present invention, those skilled in the art will appreciate other stitch patterns may be used without departing from the spirit of the present invention. 
     With reference to  FIGS. 3 through 10 , the gastric reduction apparatus  10  includes a longitudinally extending applicator body  24  having a distal end  26  and a proximal end  28 . The applicator body  24  has anterior and posterior suction slots  30 ,  32  shaped and dimensioned for housing respective corkscrew anchors  12 . The suture  22  is pre-woven for access to the suction slots  30 ,  32  and the corkscrew anchors  12  respectively held therein. The suture  22  is held in position within the suction slots  30 ,  32  by retaining member  23  about which the suture  22  is threaded in a predetermined manner alternately attaching the anterior and posterior sides allowing for attachment to the corkscrew anchors  12  and release from the applicator body  24  once the anchor members  12  are secured to the stomach wall. Since the anterior and posterior sides of the applicator body  24  are substantially identical, only the anterior suction side will be described in detail. 
     The anterior suction slot  30  includes a series of suction holes  34  formed within the central wall  36  of the applicator body  24 . The central wall  36  divides the anterior suction slot  30  from the posterior suction slot  32  and is substantially hollow for the creation of a vacuum in accordance with the present invention. The anterior suction slot  30  is shaped and dimensioned for receiving tissue therein. The anterior suction slot  30  extends along the applicator body  24  defining a recess  36  into which the anterior stomach tissue may be respectively drawn during the installation of the corkscrew anchor  12 . 
     The applicator body  24  also includes a storage section  40  adjacent the anterior suction slot  30  in which the corkscrew anchor  12  is stored prior to the installation in accordance with the present invention. The storage section  40  is partially covered and sits directly adjacent the anterior suction slot  30 . In this way, and as will be discussed below in greater detail, the corkscrew anchor  12  will move distally within the applicator body  24  as the corkscrew anchor  12  is rotated and threaded upon the tissue of the stomach wall  14 ,  16 . 
     With regard to the corkscrew anchor  12 , it is formed in the shape of a spiral and includes a pointed first end shaped and dimensioned for penetration through the stomach tissue in the manner discussed below. The corkscrew anchor is preferably manufactured from Nitinol, titanium, stainless steel, plastics, or absorbable PDS or PGA (poly glycolic acid). As for the diameter of the anchor, it should be shaped and dimensioned with a diameter sufficient to pass through the tissue to which it is secured without adversely affecting the tissue. 
     In accordance with a preferred embodiment, the proximal end of the applicator body  24  includes a barbed attachment member  44  shaped and dimensioned for attachment to the distal end of a shaft  46  coupling the applicator body  24  to the handle  48  of the gastric reduction apparatus  10  located at the proximal end of the apparatus  10 . The attachment member  44  brings the applicator body  24  into communication with the suction line of the shaft  46  for creation of a vacuum within the anterior and posterior suction slots  30 ,  32 . 
     As discussed above, the anterior and posterior suction slots  30 ,  32  are shaped and dimensioned for allowing stomach tissue to be sucked therein such that the tissue comes into intimate contact with the applicator body  24  for penetration of the corkscrew anchor  12  as the corkscrew anchor  12  is rotated. 
     Tissue retention bars  18 ,  20  are also provided for tracking the corkscrew anchor  12 . It is also contemplated the retention bars  18 ,  20  may be used for securely holding tissue within the anterior and posterior suction slots  30 ,  32  during application of the corkscrew anchors  12 . In particular, first and second tissue retention bars  18 ,  20  are positioned on opposite sides of each of the respective anterior and posterior suction slot  30 , 32 . The retention bars  18 ,  20  move longitudinally within the suction slots  30 ,  32  to allow for engagement with tissue suctioned within the suction slots  30 ,  32 . The tissue retention bars  18 ,  20  are controlled via cables (not shown) extending between the applicator body  24  and the handle  48  at the proximal end of the gastric reduction apparatus  10 . 
     As briefly mentioned above, the gastric reduction apparatus  10  further includes a handle  48  on its proximal end. The handle  48  is generally opposite the applicator body  24  positioned at the distal end of the apparatus  10 . The two ends are connected by the shaft  46 , through which runs a gear shaft  50  for firing of the corkscrew anchor  12 , a suction line  51  for the creation of a vacuum with the suctions slots  30 ,  32 , and cables for controlling the first and second retention bars  18 ,  20 . 
     The gear shaft  50  of the firing mechanism is coupled to the applicator body  24  for rotation of the corkscrew anchors  12  in a manner that will be discussed below in greater detail. With this in mind, the gear shaft  50  includes a proximal end connected to a knob  52  on the handle  48  for manual rotation of the gear shaft  50 . The gear shaft  50  also includes a distal end connected to firing gears  54  (via a central gear  56 ) housed within the applicator body  24  for controlled rotation of the corkscrew anchor  12  during installation. In accordance with a preferred embodiment of the present invention, the central gear  56  drives the series of firing (or planetary) gears  54 . 
     In practice, the gastric reduction apparatus  10  is introduced orally until the distal end of the apparatus  10 , that is, the applicator body  24  reaches the stomach. The gastric reduction apparatus  10  is positioned at the desired location within the stomach for application of the corkscrew anchors  12  into both the posterior or anterior walls  14 ,  16 . 
     Once the applicator body  24  of the gastric reduction apparatus  10  is properly positioned within the stomach (see  FIG. 6 ), suction is drawn within the anterior and posterior suction slots  30 ,  32 , and onto the posterior and anterior walls  14 ,  16  of the stomach, until the stomach tissue is drawn into the suction slots  30 ,  32  (see  FIG. 7 ). 
     The corkscrew anchors  12  are then rotated and advanced longitudinally within the anterior and posterior suction slots  30 ,  32 . The first and second retention bars  18 ,  20  prevent the corkscrew anchors  12  from riding up out of the suction slots  30 ,  32  (see  FIG. 8 ). 
     Firing of the corkscrew anchors  12  is achieved by rotation of the corkscrew firing gears  54  that are releasably coupled to corkscrew anchors  12 . The corkscrew firing gears  54  are caused to rotate by the rotation of the central gear  56  that is driven by the gear shaft  50 . The gear shaft  50  is ultimately connected to the knob  52  in the handle  48  such that the medical practitioner performing the procedure may control rotation of the corkscrew anchors  12  and ultimately the installation of the corkscrew anchors  12 . 
     After the corkscrew anchors  12  are fired, the first and second retention bars  18 ,  20  are retracted and light insufflation is applied. The corkscrew anchors  12  at this point have spiraled through the pre-woven suture  22  held in place by retaining members  23  and the suture  22  may then be utilized to cinch the corkscrew anchors  12  together to form the gastric restriction (see  FIG. 9 ). The suture is fastened with releasable tape or slots. The tips of the respective corkscrew anchors  12 , on spiraling forward, advance through segments of the suture path such that the suture  22  and the corkscrew anchors  12  on each side of the device  10  are operatively coupled on extraction of the device (see  FIGS. 1 ,  4 ,  6 ,  7 ,  8  and  9 ). The suture  22  is then cinched, drawing the anterior and posterior walls  14 ,  16  of the stomach into apposition. A suture clip is placed on a proximal end of the suture to retain the apposition of the anterior and posterior walls. Alternatively, the suture can be tied to retain the apposition. 
     In addition, tissue glue may be used in conjunction with the anchor to improve the seal resulting therefrom. Fibrin based glues such as those available from Ethicon could be used to adhere the tissue together. 
     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.