Systems and methods for anchoring and restraining gastrointestinal prostheses
Inventors
Belhe, Kedar R. • Schwarz, Werner • Stangenes, Todd
Assignees
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Publication Number
US-11737900-B2
Publication Date
2023-08-29
Expiration Date
Abstract
Systems and methods for anchoring and restraining gastrointestinal prostheses are disclosed. In various examples, the systems and methods include securing a gastrointestinal device within a patient's anatomy by extending an anti-migration anchor through a plurality of portions of the gastrointestinal device to couple together the plurality of portions of the gastrointestinal device. In some examples, the anti-migration anchor extends through tissue situated between the plurality of portions of the gastrointestinal device.
Core Innovation
The disclosed system secures a gastrointestinal implant within a pylorus by combining a braided wire implant with proximal and distal wall flanges and a neck portion spanning a pyloric sphincter. The proximal wall flange and the distal wall flange are each defined by a necked portion that spaces the flanges from tissue of the pyloric sphincter at the necked portion when implanted, so the neck portion spans the pylorus while the wall flanges are positioned away from the pyloric sphincter tissue.
An anti-migration anchor provides retention by using an elongate element with a length greater than the distance between the proximal wall flange and the distal wall flange. The elongate element is inserted partially through the braided wire structure of each of the proximal portion and the distal portion of the implant so that the anti-migration anchor spans the neck portion of the implant, with first and second retention features coupled to the elongate element.
In the described configurations, deployment positions the retention features proximal to and in contact with the proximal portion and distal to and in contact with the distal portion. The anti-migration anchor is deployed after the implant is deployed such that the anti-migration anchor punctures the proximal and distal portions while maintaining the spaced relationship of the flanges at the necked portion.
Claims Coverage
The document provides two independent claims covering a gastrointestinal implant system and a method of securing the implant within a pylorus. Across the independent claims, the inventive concepts center on the implant geometry, the elongate anti-migration anchor length relative to the flange spacing, and the proximal and distal retention feature placement achieved by inserting the elongate element through the braided wire structure spanning the neck portion.
Braided wire pylorus-spanning implant with spaced wall flanges at necked portions
An implant formed of a braided wire structure having a proximal portion including a proximal wall flange, a distal portion including a distal wall flange, and a neck portion situated between the proximal and distal portions, where the neck portion spans a pyloric sphincter when implanted and the proximal and distal wall flanges are each defined by a necked portion so the proximal and distal wall flanges are configured to be spaced from a pyloric sphincter at the necked portion when implanted.
Elongate anti-migration anchor spanning the neck portion with proximal and distal retention features
An anti-migration anchor including an elongate element having a length greater than a distance between the proximal wall flange and the distal wall flange, a first retention feature coupled to the elongate element, and a second retention feature coupled to the elongate element, configured such that the elongate element is operable to be inserted partially through the braided wire structure of each of the proximal portion and the distal portion to span the neck portion, positioning the first retention feature proximal to and in contact with the proximal portion and positioning the second retention feature distal to and in contact with the distal portion.
Deploy implant within pylorus with neck portion spanning and flanges spaced at necked portion
Providing and deploying an implant formed of a braided wire structure having a proximal portion including a proximal wall flange, a distal portion including a distal wall flange, and a neck portion situated between the proximal and distal portions, deploying the implant within the pylorus such that the neck portion spans the pylorus with the proximal portion situated proximal to the pylorus and the distal portion situated distal to the pylorus, and providing the proximal and distal wall flanges each defined by a necked portion such that the proximal and distal wall flanges are spaced from tissue of the pyloric sphincter at the necked portion.
After deploying implant, deploy anti-migration anchor by inserting through braided structure and puncturing portions
After deploying the implant, deploying the anti-migration anchor by inserting the anti-migration anchor into the braided wire structure of the proximal portion and the distal portion such that the anti-migration anchor spans the neck portion of the implant and punctures the proximal and distal portions, with the first retention feature situated proximal to the proximal portion and the second retention feature situated distal to the distal portion.
Across the independent claims, protection is directed to a braided wire implant whose neck spans the pyloric sphincter while proximal and distal wall flanges are spaced at necked portions, and to an anti-migration anchor with an elongate element longer than the flange-to-flange distance that is inserted through the braided wire structure so proximal and distal retention features are positioned in contact with proximal and distal implant portions while spanning the neck portion; the method claim further requires deployment of the anti-migration anchor after implant deployment such that the anti-migration anchor punctures the proximal and distal portions and places the retention features proximal and distal to the implant portions.
Stated Advantages
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