Apparatus and method for creating a lumen of a desired shape and size in a hollow viscus organ from tissue of the organ

Abstract

An apparatus is positioned in a hollow viscus organ and functions as a template for creating a lumen of a desired shape and size in the organ from the tissue of the organ. The apparatus is comprised of an elongate, flexible tube having opposite proximal and distal ends. The tube has several lumens or pathways that extend through the interior of the tube between the proximal and distal ends of the tube. A directional, steerable feature extends through one of the lumens of the tube. An anchor feature is provided at the tube distal end and is manually operable from the tube proximal end. An exterior surface dimension adjustable feature is provided adjacent the tube distal end. A suction communication feature is provided along at least a portion of

1 . A method of creating a lumen of a desired shape and size in a hollow viscus organ of a patient from tissue of the organ, the method comprising:
 providing a template having a flexible tube length with opposite proximal and distal ends;   inserting the template distal end first into the patient's hollow viscus organ;   positioning a portion of the template length against an interior wall of the organ;   demarcating the template's configuration so as to make it easily discernable from outside the organ;   affixing together opposing portions of the organ wall, along a side of the portion of the template length that is opposite the portion of the template length positioned against the organ interior wall, thereby creating a lumen of a desired shape and size in the organ from the tissue of the organ, the lumen having an interior configuration that conforms to the portion of the template length with in the portion of the organ wall;   removing the template from the lumen whereby the lumen has an interior configuration that is without any significant, limiting constriction in the lumen interior configuration or other tenuous area of the lumen interior after the template has been removed.   
     
     
         2 . The method of  claim 1 , further comprising:
 creating the lumen as a tubular gastric sleeve from the patient's stomach.   
     
     
         3 . The method of  claim 2 , further comprising:
 inserting the template distal end first through the esophagus of the patient and then into the patient's stomach.   
     
     
         4 . The method of  claim 3 , further comprising:
 positioning the portion of the template length against the patient's stomach wall, along the stomach lesser curvature.   
     
     
         5 . The method of  claim 4 , further comprising:
 affixing together opposing portions of the stomach wall, along a side of the portion of the template length that is opposite the stomach lesser curvature, thereby creating the lumen as a tubular sleeve of the stomach having an interior configuration that conforms to the portion of the template length within the portion of the stomach wall.   
     
     
         6 . The method of  claim 5 , further comprising:
 removing the template from the gastric sleeve whereby the sleeve will function as a new gastric reservoir with an interior configuration that is without any significant, limiting constriction in the sleeve interior configuration in the area of the stomach incisura or other tenuous area of the reservoir after the template has been removed.   
     
     
         7 . The method of  claim 1 , further comprising:
 enlarging a portion of an exterior surface of the template before demarcating the template's configuration.   
     
     
         8 . The method of  claim 7 , further comprising:
 enlarging the portion of the exterior surface of the template with the enlarged portion of the exterior surface having a larger circumferential dimension adjacent the template distal end and the circumferential dimension of the enlarged portion of the exterior surface becoming smaller as it extends toward the template proximal end.   
     
     
         9 . An apparatus for creating a lumen of a desired shape and size in a hollow viscus organ from tissue of the organ, the apparatus comprising:
 an elongate, flexible tube with opposite proximal and distal ends;   an anchor feature at the tube distal end that is selectively operable at the tube proximal end to selectively anchor the tube distal end to tissue of the hollow viscus organ; and   an exterior surface dimension adjustable feature positioned on the tube between the anchor feature and the tube proximal end, the exterior surface dimension adjustable feature being operable to selectively enlarge and reduce a shape configuration of the adjustable feature and circumferential dimensions of the adjustable feature.   
     
     
         10 . The apparatus of  claim 9 , further comprising:
 a directional, steerable feature along the tube length that is operable at the tube proximal end to direct and steer the tube distal end in different directions relative to the tube length.   
     
     
         11 . The apparatus of  claim 9 , further comprising:
 a suction communication feature along at least a portion of the tube length, the suction communication feature being operable at the tube proximal end to supply suction pressure along at least the portion of the tube length.   
     
     
         12 . The apparatus of  claim 9 , further comprising:
 the anchor feature being operable at the tube proximal end to selectively anchor the tube distal end to stomach tissue.   
     
     
         13 . The apparatus of  claim 9 , further comprising:
 the circumferential dimension of the exterior surface dimension adjustable feature adjacent the tube distal end when enlarged being larger than the circumferential dimension of the exterior surface dimension adjustable feature adjacent the tube proximal end.   
     
     
         14 . The apparatus of  claim 9 , further comprising:
 the circumferential dimension of the exterior surface dimension adjustable feature when enlarged gradually becomes smaller as the enlarged exterior surface dimension adjustable feature extends from adjacent the distal end toward the tube proximal end.   
     
     
         15 . The apparatus of  claim 9 , further comprising:
 the tube having a plurality of lumens extending through an interior of the tube from the tube proximal end toward the tube distal end.   
     
     
         16 . The apparatus of  claim 15 , further comprising:
 the circumferential dimension of the exterior surface dimension adjustable feature adjacent the tube distal end when enlarged being larger than the circumferential dimension of the exterior surface dimension adjustable feature adjacent the tube proximal end.   
     
     
         17 . The apparatus of  claim 16 , further comprising:
 a suction communication feature along at least a portion of the tube length, the suction communication feature being operable at the tube proximal end to supply suction pressure along at least the portion of the tube length.   
     
     
         18 . The apparatus of  claim 17 , further comprising:
 the suction communication feature having suction openings on the tube on opposite sides of the exterior surface dimension adjustable feature.   
     
     
         19 . The apparatus of  claim 18 , further comprising:
 the anchor feature and the exterior surface dimension adjustable feature being separated by a portion of the tube.   
     
     
         20 . The apparatus of  claim 19 , further comprising:
 a directional, steerable feature along the tube length that is operable at the tube proximal end to direct and steer the tube distal end in different directions relative to the tube length.