# US 11,439,396 B2 · Occluder and anastomosis devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,439,396 B2 - Document ID: US11439396B2 - Status: Granted - Kind: B2 - Application number: 14/926,330 - Filed: 2015-10-29 - Published: 2016-05-19 - Granted: 2022-09-13 - Earliest claimed: 2014-05-02 - Assignees: W. L. Gore & Associates, Inc. - Applicants: W. L. Gore & Associates, Inc. - Inventors: Matthew A. Johnson; Nathan K. Mooney; Lindsey Rappleyea - Web page: https://patentgrep.com/patent/US11439396B2 ## CPC - A61B 17/11: for performing anastomosis; Buttons for anastomosis - A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)} - A61B 17/12022: {Occluding by internal devices, e.g. balloons or releasable wires (plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20)} - A61B 17/1114: {of the digestive tract, e.g. bowels or oesophagus} - A61B 17/12145: {having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526)} - A61B 2017/00592: {Elastic or resilient implements} - A61B 2017/00597: {Implements comprising a membrane} - A61B 2017/00615: {Implements with an occluder on one side of the opening and holding means therefor on the other} - A61B 2017/00623: {Introducing or retrieving devices therefor} - A61B 2017/00818: {Treatment of the gastro-intestinal system} - A61B 2017/1107: {for blood vessels} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract An implantable medical device for sealing and repairing defects in a body tissue or for creating an anastomosis includes a frame and a covering material. In some embodiments, the frame includes a single continuously wound wire that defines an apposition portion, a defect-occupying portion, and a sealing portion. In some embodiments, the tissue-sealing and anastomosis devices provided herein are well-suited for use in the GI tract including the small bowel and colon. In some embodiments, a two-part frame construct facilitates independent tailoring of apposition forces and radial forces exerted on tissues by the two-part frame. ## Claims ### Claim 1 A medical device comprising: a frame comprising at least one elongate member, said at least one elongate member defining: an apposition portion; a sealing portion; and a defect-occupying portion defined by a plurality of discrete sections of the at least one elongate member disposed between said apposition portion and said sealing portion defining a passage between the apposition portion and the sealing portion unobstructed by the frame on either side of the passage, the defect-occupying portion defining an outwardly tapered profile at each of the apposition and sealing portions to define curved transitions between the apposition portion and the sealing portion, and a covering material disposed on at least a portion of said sealing portion, wherein said apposition portion contains a plurality of apposition petals, wherein said sealing portion contains a plurality of sealing petals abutting each other along a length of the apposition petals extending radially outward from the defect-occupying portion, and wherein said apposition petals and said sealing petals have a pre-strained geometry such that an apposition force exists in the absence of a tissue layer, and wherein the axes of the apposition petals are parallel with the axes of the sealing petals such that the apposition petals are symmetrical with the sealing petals. ### Claim 2 (depends on 1) The medical device of claim 1, wherein a geometry of said apposition petals is substantially the same as a geometry of said sealing petals. ### Claim 3 (depends on 1) The medical device of claim 1, wherein an appositional force for sealing and migration resistance of said medical device is substantially provided by said apposition portion and said sealing portion. ### Claim 4 (depends on 1) The medical device of claim 1, wherein said apposition petals are configured to move independently of each other. ### Claim 5 (depends on 1) The medical device of claim 1, wherein said apposition petals are configured to be separated from or to abut at least portions of adjacent apposition petals. ### Claim 6 (depends on 1) The medical device of claim 1, wherein said elongate member is a nitinol wire. ### Claim 7 (depends on 1) The medical device of claim 1, further comprising one or more radiopaque markers disposed on said medical device. ### Claim 8 (depends on 1) The medical device of claim 1, wherein said covering material is configured to promote tissue ingrowth or endothelialization into said covering material. ### Claim 9 (depends on 1) The medical device of claim 1, wherein said covering material is configured to inhibit tissue ingrowth or endothelialization into said covering material. ### Claim 10 (depends on 1) The medical device of claim 1, wherein said frame comprises one or more tissue anchorage features. ### Claim 11 (depends on 1) The medical device of claim 1, wherein said apposition portion is free of said covering material. ### Claim 12 (depends on 1) The medical device of claim 1, wherein said apposition portion is configured to conform to a geometry of a first tissue surface and to provide an apposition force against the first tissue surface, and wherein said sealing petals are configured to bear a load associated with said first tissue surface without imparting a substantial force on any other sealing petal. ### Claim 13 (depends on 1) The medical device of claim 1, wherein the apposition petals and the sealing petals project outward from the defect-occupying portion in a direction of the radial axes of the petals. ### Claim 14 A medical device comprising: a frame comprising an elongate member, said elongate member defining: an apposition portion; a sealing portion; and a defect-occupying portion defined by a plurality of discrete sections of the elongate member disposed between said apposition portion and said sealing portion forming a passage between the apposition portion and the sealing portion unobstructed by the frame on either side of the passage, the defect-occupying portion defining an outwardly tapered profile at each of the apposition and sealing portions to define curved transitions between the apposition portion and the sealing portion, and a covering material disposed on at least a portion of said sealing portion, wherein said apposition portion contains a plurality of apposition petals, wherein said sealing portion contains a plurality of sealing petals abutting each other along a length of the apposition petals extending radially outward from the defect-occupying portion, wherein said apposition petals are configured to move independently of each other, wherein said sealing petals abut each other and create a sealing edge, and wherein said apposition petals and said sealing petals have a pre-strained geometry such that an apposition force exists in the absence of a tissue layer, and wherein the apposition petals are aligned over the sealing petals such that the apposition petals are symmetrical with the sealing petals. ### Claim 15 (depends on 14) The medical device of claim 14, wherein a geometry of said apposition petals is substantially the same as a geometry of said sealing petals. ### Claim 16 (depends on 14) The medical device of claim 14, wherein said apposition petals and said sealing petals have a linear portion extending radially from said defect-occupying portion and a substantially diamond-shaped outer portion extending from said linear portion. ### Claim 17 (depends on 14) The medical device of claim 14, wherein an appositional force for sealing and migration resistance of said medical device is substantially provided by said apposition portion and said sealing portion. ### Claim 18 (depends on 14) The medical device of claim 14, wherein said apposition portion is free of said covering material. ### Claim 19 (depends on 14) The medical device of claim 14, wherein said apposition petals are configured to be separated from or to abut at least portions of adjacent apposition petals. ### Claim 20 (depends on 14) The medical device of claim 14, wherein said elongate member is a nitinol wire. ### Claim 21 (depends on 14) The medical device of claim 14, further comprising one or more radiopaque markers disposed on said medical device. ### Claim 22 (depends on 14) The medical device of claim 14, wherein said covering material is configured to promote tissue ingrowth or endothelialization into said covering material. ### Claim 23 (depends on 14) The medical device of claim 14, wherein said covering material is configured to inhibit tissue ingrowth or endothelialization into said covering material. ### Claim 24 (depends on 14) The medical device of claim 14, wherein said frame comprises one or more tissue anchorage features. ### Claim 25 (depends on 14) The medical device of claim 14, wherein said apposition portion is configured to conform to a geometry of a first tissue surface and to provide an apposition force against the first tissue surface, and wherein said sealing petals are configured to bear a load associated with said first tissue surface without imparting a substantial force on any other sealing petal.