Stomach lining patch with central fixation

Abstract

A stomach lining patch includes a collapsible frame, a membrane covering the collapsible frame, collapsible frame and the membrane providing a collapsed configuration suitable for endoluminal delivery to a stomach of a patient and an expanded configuration suitable for lining an internal surface of a gastric wall of the stomach, and a set of anchoring arms extending from the collapsible frame and being configured to pass through a puncture in the gastric wall and lay flat against an outer surface of the gastric wall when the collapsible frame and the membrane are in an expanded configuration lining the internal surface of the gastric wall.

What is claimed is: 
     
         1 . A stomach lining patch comprising:
 a collapsible frame comprising one or more elongated elements shaped to form a set of interwoven or interconnected undulating rings;   a membrane covering the one or more elongated elements of the collapsible frame, the one or more elongated elements of the collapsible frame and the membrane providing a collapsed configuration suitable for endoluminal delivery to a stomach of a patient and an expanded configuration suitable for lining an internal surface of a gastric wall of the stomach; and   a set of anchoring arms extending from the one or more elongated elements of the collapsible frame and being configured to pass through a puncture in the gastric wall and lay flat against an outer surface of the gastric wall when the one or more elongated elements of the collapsible frame and the membrane are in an expanded configuration lining the internal surface of the gastric wall.   
     
     
         2 . The stomach lining patch of  claim 1 , wherein the membrane covers the set of anchoring arms. 
     
     
         3 . The stomach lining patch of  claim 1 , wherein the one or more elongated elements of the collapsible frame and the set of anchoring arms include a monolithic frame element forming at least a portion of the one or more elongated elements of the collapsible frame and the set of anchoring arms. 
     
     
         4 . The stomach lining patch of  claim 1 , wherein the one or more elongated elements of the collapsible frame and the set of anchoring arms are formed from a cut tube structure. 
     
     
         5 . The stomach lining patch of  claim 1 , wherein the one or more elongated elements of the collapsible frame, when in the expanded configuration, are compliant to remain in contact with the internal surface of the gastric wall during peristalsis. 
     
     
         6 . The stomach lining patch of  claim 1 , wherein the one or more elongated elements of the collapsible frame, when in the expanded configuration, are configured to lay flat against the internal surface of the gastric wall and limit nutrient contact from lined portions of the internal surface of the gastric wall. 
     
     
         7 . The stomach lining patch of  claim 1 , wherein the membrane includes expanded polytetrafluoroethylene (ePTFE). 
     
     
         8 . The stomach lining patch of  claim 1 , wherein the one or more elongated elements of the collapsible frame are formed from Nitinol. 
     
     
         9 . The stomach lining patch of  claim 1 , wherein the set of anchoring arms are covered in a material that resists ingrowth and adhesion. 
     
     
         10 . The stomach lining patch of  claim 1 , wherein the set of anchoring arms are radially offset relative to the one or more elongated elements of the collapsible frame. 
     
     
         11 . The stomach lining patch of  claim 1 , wherein the set of anchoring arms comprise a plurality of petal-shaped wire frames. 
     
     
         12 . The stomach lining patch of  claim 1 , wherein the set of anchoring arms comprise a plurality of solid petals. 
     
     
         13 . The stomach lining patch of  claim 1 , wherein the one or more elongated elements of the collapsible frame and the set of anchoring arms are formed from a single woven wire. 
     
     
         14 . The stomach lining patch of  claim 1 , wherein the one or more elongated elements of the collapsible frame and the set of anchoring arms are formed from a combination of one or more wire elements and one or more cut tube elements. 
     
     
         15 . The stomach lining patch of  claim 1 , wherein the one or more elongated elements of the collapsible frame comprise an outer layer formed of Nitinol and an internal core formed of a radiopaque material. 
     
     
         16 . The stomach lining patch of  claim 1 , wherein the interwoven or interconnected undulating rings are concentric. 
     
     
         17 . An assembly comprising:
 an endoscopic delivery catheter; and   a stomach lining patch including:
 a collapsible frame comprising one or more elongated elements shaped to form a set of interwoven or interconnected undulating rings; 
 a membrane covering the one or more elongated elements of the collapsible frame, the one or more elongated elements of the collapsible frame and the membrane providing a collapsed configuration suitable for endoluminal delivery to a stomach of a patient and an expanded configuration suitable for lining an internal surface of a gastric wall of the stomach; and 
 a set of anchoring arms extending from the one or more elongated elements of the collapsible frame and being configured to pass through a puncture in the gastric wall and lay flat against an outer surface of the gastric wall when the one or more elongated elements of the collapsible frame and the membrane are in an expanded configuration lining the internal surface of the gastric wall, wherein the stomach lining patch is in a collapsed configuration within the endoscopic delivery catheter. 
   
     
     
         18 . The assembly of  claim 17 , further comprising a plunger configured to push the stomach lining patch out a distal end of the endoscopic delivery catheter to facilitate deployment of the stomach lining patch within a patient. 
     
     
         19 . A method of implanting a stomach lining patch within the stomach of a patient, the method comprising:
 inserting an endoscopic delivery catheter through an esophagus of the patient to locate a distal end of the endoscopic delivery catheter within a stomach of the patient;   forming a puncture in a gastric wall of the stomach;   delivering a stomach lining patch in a collapsed configuration to the stomach via the endoscopic delivery catheter, the stomach lining patch including a collapsible frame comprising one or more elongated elements shaped to form a set of interwoven or interconnected undulating rings, a membrane covering the one or more elongated elements of the collapsible frame, the one or more elongated elements of the collapsible frame and the membrane providing a collapsed configuration suitable for endoluminal delivery to a stomach of a patient and an expanded configuration suitable for lining an internal surface of a gastric wall of the stomach, and a set of anchoring arms extending from the one or more elongated elements of the collapsible frame;   inserting the set of anchoring arms through the puncture the gastric wall;   deploying the stomach lining patch from the distal end of the endoscopic delivery catheter to expand the stomach lining patch from the collapsed configuration to an expanded configuration,   wherein, once deployed, the set of anchoring arms lay flat against an outer surface of the gastric wall, and the one or more elongated elements of the collapsible frame and the membrane line an internal surface of the gastric wall.   
     
     
         20 . The method of  claim 19 , wherein the stomach lining patch is a first stomach lining patch, the method further comprising deploying a second stomach lining patch from the distal end of the endoscopic delivery catheter to line more of the internal surface of the gastric wall.