Abstract:
A gastroenterologic sleeve is anchored within the digestive tract, without tissue-puncturing mechanisms, by providing anchoring mechanisms that utilize the inherent shape of the stomach to prevent sleeve migration. In at least two embodiments, the anchoring mechanism expands to conform to the interior stomach walls. In other embodiments, internal pessary rings are held in place at the gastroesophageal junction by an external band. A delivery device is provided for implanting the various device transesophageally.

Description:
CLAIM OF PRIORITY 
       [0001]    This application claims priority to U.S. Provisional Patent Application Ser. No. 61/025,500, filed Feb. 1, 2008 by Gagner et al., entitled Methods And Devices For Anchoring A Gastroenterologic Sleeve, the contents of which are incorporated in their entirety herein. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates generally to improved methods and devices for anchoring a gastroenterologic sleeve within the stomach without reliance on sutures, staples, or other mechanisms that puncture the stomach wall. In addition to leaving the stomach walls free of punctures, the anchoring system of the present invention prevents movement of the sleeve in both directions, thereby preventing the sleeve from being passed through the digestive system but also from refluxing up the esophagus. 
         [0003]    According to the Center for Disease Control (CDC), sixty six percent of American are overweight, and thirty two percent are obese, presenting an overwhelming health problem. From an economic standpoint, it is estimated that more than 100 billion dollars are spent on obesity and treating its major co-morbidities. This figure does not include psychological and social costs. Many health care experts consider obesity the largest health problem facing westernized societies and considered obesity an epidemic. From a medical standpoint, obesity is the primary risk factor for type 2 diabetes and obstructive sleep apnea. It increases the chances for heart disease, pulmonary disease, infertility, osteoarthritis, cholecystitis and several major cancers, including breast and colon cancers. Despite these alarming facts, treatment options for obesity remain limited. 
         [0004]    Treatment options include dietary modification, very low-calorie liquid diets, pharmaceutical agents, counseling, exercise programs and surgery. Diet and exercise plans often fail because most individuals do not have the discipline to adhere to such plans. When diet and exercise fail, many try dietary supplements and drugs or other ingestible preparations promoted as being capable of suppressing appetite or inducing satiety. In general, these techniques for treating compulsive overeating/obesity have tended to produce only a temporary effect. The individual usually becomes discouraged and/or depressed after the initial rate of weight loss plateaus and further weight loss becomes harder to achieve. The individual then typically reverts to the previous behavior of compulsive overeating. 
         [0005]    Surgical procedures that restrict the size of the stomach and/or bypass parts of the intestine are the only remedies that provide lasting weight loss for the majority of morbidly obese individuals. Surgical procedures for morbid obesity are becoming more common based on long-term successful weight loss result. 
         [0006]    Bariatric surgery is a treatment for morbid obesity that involves alteration of a patient&#39;s digestive tract to encourage weight loss and to help maintain normal weight. Known bariatric surgery procedures include jejuno-ileal bypass, jejuno-colic shunt, biliopancreatic diversion, gastric bypass, Roux-en-Y gastric bypass, gastroplasty, gastric banding, vertical banded gastroplasty, and silastic ring gastroplasty. A more complete history of bariatric surgery can be found on the website of the American Society for Bariatric Surgery at http://www.asbs.orq, the contents of which are incorporated by reference herein in their entirety. 
         [0007]    Most of the surgeries which create malabsorption, such as the by-pass operations, although effective in weight reduction, involve permanent modification of the GI tract and have a risk of short and long term complication and even death. By implanting a gastroenterologic sleeve, which is essentially a prosthetic liner for the stomach and/or duodenum, malabsorption can be induced without permanently modifying the GI tract. The sleeve simply provides a physical barrier between the food eaten and the absorptive stomach and duodenic walls. 
         [0008]    Unfortunately, present gastroenterologic sleeve designs require fastening the sleeve to the tissue of the stomach or duodenum. Typically, this is accomplished through sutures, staples, or the like. Because the interior lining of the GI tract is incredibly slippery, it is very difficult to mechanically fasten anything to them. Additionally, anytime the walls of the GI tract are punctured, there is a risk of infection and other complications. 
       OBJECTS AND SUMMARY OF THE INVENTION 
       [0009]    The methods and devices of the present invention are directed to methods and devices for implanting a gastroenterologic sleeve into the stomach and/or duodenum without using puncturing fasteners such as staples or sutures. 
         [0010]    In one embodiment, a plurality of pessary rings is incorporated into a sleeve such that the rings expand until they contact the stomach walls. This embodiment takes advantage of the fact that the inlet and outlet of the stomach are much smaller than the interior of the stomach. Hence, once the rings have expanded, they are too large to migrate out of the stomach. 
         [0011]    Another embodiment involves the use of a loose, yet expandable matrix implanted in the stomach. The matrix allows interaction between the stomach and food yet provides an anchor to which a sleeve lining the duodenum is attached. Hence, the matrix eliminates the possibility of the sleeve migrating through the intestinal tract. 
         [0012]    Another embodiment employs two pessary rings and a band or other constrictor, such as a lap band. The pessary rings are installed inside the esophageal-stomach junction and have an inherent expansive force. A lap band is placed around the outside of the stomach, between the pessary rings, and has a squeezing force. Hence, the pessary rings and the lap band interact to lock each other in place. A sheath, tube or sleeve is attached to the pessary rings and extends into the stomach to cause food to bypass some or all of the stomach. The sheath may also extend into the duodenum such that a portion of the small intestine is also bypassed. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0013]      FIG. 1  is an elevation of an embodiment of the present invention installed within a stomach; 
           [0014]      FIG. 2  is an elevation of an embodiment of the present invention installed within a stomach; 
           [0015]      FIG. 3  is an elevation of an embodiment of the present invention installed within a stomach; 
           [0016]      FIG. 4  is an elevation of an embodiment of the present invention installed within a stomach; and 
           [0017]      FIG. 5  is a perspective view of a delivery device that may be used to delivery the devices of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0018]    Referring now to the figures and first to  FIG. 1  there is shown an embodiment of the present invention that includes a device  10  for creating a malabsorption condition in the stomach and/or duodenum. The device  10  generally includes an absorption-limiting or preventing sheath or tube  20  that is attached at a proximal end  22  to an anchoring device  40 . 
         [0019]    The anchoring device  40  includes a plurality of rings  42 , such as pessary rings for example, connected together by thin connectors  44 . The rings  42  are resilient and collapsible such that they may be compressed into elongate members for introduction into the stomach via the esophagus with a catheter or endoscope. Upon release from the delivery device, the rings  42  expand and orient themselves in a spaced-apart fashion. The rings are sized and arranged according to the shape of the stomach and it is envisioned that each device will be sized proportionately to the size of the patient, if necessary. 
         [0020]    The connectors  44  are thin, thread-like connectors that prevent the rings  42  from twisting. The connectors  44  also function to combine the rings  42  into a single anchor and further create large gaps through which food may contact the stomach walls for digestion. In the event that it is desired to prevent the food from contacting the stomach walls, the thin connectors  42  may be replaced by a sleeve-like material. It is further envisioned that a combination of thin connectors  42  and connectors made of sleeve-like material may be used to control the area of the stomach that participates in the digestive process. It is further contemplated that the thin connectors  42  may be replaced by a semi-permeable sleeve material that allows some of the food to come into contact with stomach acid for digestion. 
         [0021]      FIG. 2  shows another embodiment of a device  50  of the present invention. The device  50  also includes an absorption-limiting or preventing sheath or tube  20  that is attached at a proximal end  22  to an anchoring device  60 . The anchoring device  60  is constructed of a loose, expandable matrix  62 . The matrix  62  is constructed such that some or all of the food entering the stomach is permitted to interact with the stomach in the digestive process. The matrix may be constructed of a self-expanding material such as Nitinol, or any suitable, digestive-resistant material. The anchoring device  60  is sized to substantially fill the stomach cavity when expanded and also to conform to the shape of the stomach, thereby providing a stable anchor for the tube  20 . 
         [0022]      FIG. 3  shows an embodiment of a device  70  that includes sheath  80  connected to an anchoring device  90 . The sheath  80  is sized and constructed to prevent food from contacting the upper stomach, thereby limiting digestion. At its upper end, the sheath  80  is connected to the anchoring device  90 , which includes components that are internal and external to the gastroesophageal junction. 
         [0023]    The interior components of the anchoring device  90  include two pessary rings  92 , each connected to the sheath  80 . The pessary rings  92  are self-expanding and, when in place, place a mild pressure on the inside of the esophagus. 
         [0024]    The exterior components of the anchoring device  90  include a lap band  94  and an inflation device  96 . The lap band  94  is fastened around the outside of the gastroesophageal junction between the locations of the pessary rings  92 . The anchoring device  90  also includes a pump  98 , such as a hand pump, connected to the lap band  94  via a tube  100 . Once the lap band  94  is fastened around the outside of the gastroesophageal junction between the locations of the pessary rings  92 , the lap band  94  is inflated with an acceptable fluid, such that the lap band places an inward pressure on the gastroesophageal junction between the external pressure points of the pessary rings  92 . In this way, the lap band  94  and the pessary rings  92  cooperate to prevent movement of the anchoring device  90 . It is further contemplated that the lap band  94  can be controlled using the pump  98  to control the amount and rate that food can enter the stomach, as well as preventing gastroesophageal reflux disease (GERD). 
         [0025]      FIG. 4  depicts another embodiment of the device  70  in which a sheath  110  is attached to the anchoring device  90  is longer and extends well into the duodenum. This embodiment provides a solution for completely bypassing the stomach and some or all of the duodenum. However, it is envisioned that the sheath  110  could be constructed, partly or entirely, of a semi-permeable material that allows some gastric interaction between the food and the digestive system. Doing so may prevent some of the undesirable effects of malabsorption, such as the various forms of malabsorption syndrome. 
       Implantation 
       [0026]    The devices of  FIGS. 1 and 2  may be implanted completely endoscopically, without the use of a general anesthesia.  FIG. 5  shows one example of a delivery device  120  for use in implanting devices  10  and  50 . The delivery device  120  includes a endoscopic catheter  130  surrounded by a sheath catheter  150 . A space  152  exists between the endoscopic catheter  130  and the sheath catheter  150  that is sized to allow the device  10  or  50  to be tubularly loaded therein. 
         [0027]    The endoscopic catheter  130  includes a pulling wire  132  with an attachment mechanism  134  at a distal end thereof. The endoscopic catheter  130  also includes an endoscope  136  and a steering device (not shown). Preferably, a portion of the endoscopic catheter  130 , such as the pulling wire  132 , is radiopaque. Alternatively, radiopaque bands may be incorporated into the distal end of the delivery device  120 . 
         [0028]    In operation, a device  10  or  50  is loaded into the delivery device  150  such that the endoscopic catheter  130  passes through the interior lumen of the device  10  or  50  and the sheath catheter  150  surrounds the exterior of the device  10  or  50 . The device  10  or  50  is loaded such that the distal end of the device  10  or  50  is at the distal end of the delivery device  120 . The attachment mechanism  134  is attached to the distal end of the device  10  or  50 . 
         [0029]    The delivery device is then navigated transesophageally into and through the stomach and into the duodenum to a desired depth. The device  120  is then retracted while the pulling wire is advanced through the endoscopic catheter  130  such that the distal end of the pulling wire  132  remains somewhat stationary with respect to the duodenum. Hence, as the delivery device  120  is retracted, the pulling wire  132  pulls the device  10  or  50  from the distal end of the delivery device via the attachment mechanism  134 . 
         [0030]    As the delivery device  120  is retracted, the endoscope  136  provides an interior view of the device being deployed. Hence, verification that the device is not twisted or otherwise fouled is provided. 
         [0031]    Once the delivery device  120  is retracted through the stomach, and the entire device  10  or  50  is deployed, the attachment device  134  is released from the distal end of the device  10  or  50  and the pulling wire  132  is retracted into the endoscopic catheter  130 . Then the entire delivery device  120  is removed from the body. 
         [0032]    The delivery device  120  may be similarly used to deploy the device  70  of  FIGS. 3 and 4 . However, laparoscopic installation of the lap band  94  is also required. 
         [0033]    Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proffered by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.