The present invention relates to a system and method for treating a patient having a disorder related to the patient's intestine. Such disorder may be caused by injury, birth defect, cancer or other diseases, such as constipation or incontinence. More specifically the invention relates to a system and method of regulating the flow through an intestinal reservoir.
In an attempt to overcome such disorders, many different solutions have been proposed. These solutions often include surgery, in particular where a portion of the intestine has to be removed. The reason for such operation may be colorectal cancer, perforated diverticulitis or other kinds of diseases, such as ulceros colitis or Crohns disease. For instance, in the case of ileostoma, jejunostoma, colostoma and rectostoma operations the small intestine (jejunum or ileum) or the large intestine (colon or rectum) is cut and the open end of the healthy portion of the intestine is reattached either to a surgically created stoma in the patient's abdominal wall or, where possible, to the patient's rectum or anus or to tissue adjacent the patient's anus.
The problem then arises to control the intestinal contents flow and, more particularly, to prevent feces from exiting the patient's body uncontrolled. The patient is typically required to excrete into a colostoma bag. This is obviously inconvenient and, in addition, may cause skin irritation since such a bag arrangement requires an adhesive plate to be attached to the patient's skin in order to render the bag liquid tight.
U.S. Pat. No. 4,222,377 suggests the use of an inflatable artificial sphincter comprising a cuff around the anal or urethral canal. A manually operated pump is implanted in the patient's scrotum for inflating and deflating the artificial sphincter.
Similarly, U.S. Pat. No. 5,593,443 discloses an artificial hydraulic anal sphincter under voluntary control. More specifically, the patient may actuate a mechanical or electrical pump for inflating and deflating a cuff. The cuff consists of two parts positioned on opposite sides of the intestine and pressing the intestinal walls together when inflated.
U.S. Pat. No. 6,752,754 B1 discloses an artificial rectum for replacing a portion of a patient's rectum. An inlet of the artificial rectum is operatively connected to the distal end of the patient's large intestine and communicates fecal matter to a macerator-type pump that discharges the feces through an outlet of the artificial rectum connected to the patient's anus. The pump includes a helical screw-type impeller, which when rotated creates shearing effects on the feces, causing it to move down the thread of the screw impeller and discharge through the patient's anus.
An improved system has been described in WO2009/046995 comprising a reservoir in the patient's body for receiving and temporarily collecting therein intestinal contents. In one embodiment the reservoir is surgically created and formed from a plurality of bent portions of the patient's intestine. Laterally adjacent sections of the intestine are cut open along their mutual contact line and the resulting upper halves and lower halves thereof are interconnected so as to form the reservoir. The intestinal reservoir remains within the patient's body when emptying the reservoir. The intestine exits the patients abdominal wall through a surgically created stoma. An exit valve is implanted within the intestine between the intestinal reservoir and the stoma. The exit valve is normally closed by resilient means. An external manually driven suction pump comprising a piston-cylinder-arrangement is used to be temporarily applied from outside the patient's body for emptying the intestinal reservoir, wherein a conduit on the front end of the suction pump is inserted into the intestine, thereby mechanically urging the exit valve to open.
This way of emptying the surgically created intestinal reservoir has been proven unsatisfactory. In particular, although the reservoir remains within the patient's body, an external collecting device has still to be attached, removed and cleaned, similar to the previously described prior art systems.
Other embodiments described in WO2009/046995 overcome this problem by implanting an all artificial reservoir along with a pump acting on the reservoir for emptying the reservoir. Entry and exit valves may be provided in addition to the pump to control the flow of intestinal contents into and from the artificial reservoir. The artificial reservoir with implantable pump substantially improves the patient's living circumstances, because an external collecting device is no longer needed when emptying the reservoir.
Incorporating an artificial reservoir within the patient's natural intestine or at the end thereof is critical. The interconnection between the artificial piece and the intestine's natural tissue will always be subject to the intestine's peristaltic contractions and may therefore fail over time.
USPTO Backgrounds
USPTO Backgrounds