# US 2018/0021044 A1 · Method and Apparatus for Clamping Tissue Layers and Occluding Tubular Body Structures > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2018/0021044 A1 - Document ID: US20180021044A1 - Status: Published application - Kind: A1 - Application number: 15/699,975 - Filed: 2017-09-08 - Published: 2018-01-25 - Earliest claimed: 2011-01-11 - Assignees: Amserl Medical Corporation - Applicants: Amsel Medical Corporation - Inventors: Arnold Miller; Raanan Miller; Nir Lilach; William Edelman - Web page: https://patentgrep.com/patent/US20180021044A1 ## CPC - A61B 17/122: Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)} - A61B 17/12031: {complete occlusion} - A61B 17/1285: {for minimally invasive surgery} - A61B 17/12109: {in a blood vessel} - A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)} - A61B 2017/00407: {Ratchet means} - A61B 2017/00477: {Coupling (A61B2017/0046 takes precedence)} - A61B 2017/00867: {shape memory effect} - A61B 2017/00986: {Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts} - A61B 2017/12054: {Details concerning the detachment of the occluding device from the introduction device} - A61B 2090/037: {with a frangible part, e.g. by reduced diameter} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Apparatus and methods for occluding hollow body structures, such as blood vessels, and for attaching tissue layers together by providing implantable elements on opposite sides of the structure or tissue layers and drawing the implants together to occlude the body structure and/or bring the tissue layers together. The implants are deliverable in a low profile configuration and self-expand to an enlarged configuration. The implantable elements are delivered by transfixing the body structure, then releasing the implants on opposite sides of the body structure and drawing the implants together to effect an occlusion or attachment. The implants are configured to apply oppositely directed forces to opposite surfaces of the tissue layers at alternate, circumferentially spaced locations and may constrain the tissue in a serpentine pattern or in a direct clamping pattern. The implants grip the tissue in a manner that defines a pressure zone about the transfixion aperture that prevents leakage from the aperture. ## Claims ### Claim 1 Apparatus for clamping tissue layers together comprising: a proximal implant and a distal implant disposed along a common axis, each implant having a plurality of radially extending legs; a latching element associated with each of the implants to cooperatively secure the implants to each other such that tissue layers disposed between the implants may be gripped between the legs of the proximal and distal implants; the implants, when secured together, being oriented about the axis with legs of one of the implants being interdigitated with legs of the other implant and constrain the tissue in a serpentine configuration that circumscribes the axis. ### Claim 2 (depends on 1) Apparatus as defined in claim 1 further comprising: each implant having a delivery configuration in which its legs are arranged in a low profile by which it can be releasably contained in a delivery tube and an expanded profile in which the legs self-expand to extend radially outward of the axis when released from its delivery tube, the implants being moveable toward each other when released. ### Claim 3 (depends on 2) Apparatus as defined in claim 2 further comprising a proximal delivery tube containing the proximal implant and a distal delivery tube containing the distal implant; a guidewire having a selectively expandable distal tip; a hollow needle adapted to pass through the tissue layers, the needle containing the distal delivery tube and distal implant, whereby the needle can pass through the tissue layers to locate the distal end of the distal delivery tube distally beyond the tissue layers; the guidewire extending through the distal implant delivery tube and the distal implant; a pushing member advanceable through the distal implant delivery tube and engageable with the proximal end of the distal implant to push the distal implant out of the distal end of the delivery tube and enable the legs of the distal implant to expand distally of the tissue layers, the distal implant being retainable on the guidewire by engagement with its expanded tip, the distal delivery tube, pushing member and needle being removable after deployment of the distal implant; the proximal delivery tube being advanceable over the guidewire to place its distal end on the proximal side of the tissue layers, the proximal implant being slidable distally through and out of the distal end of the proximal delivery tube by the pushing member to enable the legs of the proximal implant to expand; the pushing member and guidewire expanded tip enabling the proximal and distal implants to be brought together to enable the latching elements to engage and secure the implants together with tissue layers therebetween. ### Claim 4 (depends on 3) Apparatus as defined in claim 3 further comprising: the proximal implant and pushing member having releasably interlocking elements by which rotation of the pushing member can be transmitted to the proximal implant, to enable the angular position of the proximal legs about the axis to be adjusted. ### Claim 5 (depends on 3) Apparatus as defined in claim 3 wherein each implant has a tubular portion and wherein the tubular portion of one is receivable, telescopically, into the tubular portion of the other implant when the implants are brought together into engagement with each other. ### Claim 6 (depends on 1) Apparatus as defined in claim 1 wherein the tissue layers comprise opposing wall portions of a hollow or tubular body part and the serpentine configuration is such as to occlude the hollow or tubular body part. ### Claim 7 (depends on 1) Apparatus as defined in claim 1 wherein the latching elements comprise a ratchet mechanism by which the proximity of the implants, when secured, can be varied. ### Claim 8 (depends on 1) Apparatus as defined in claim 1 in which the latching elements comprise; one of the implants having a locking tube extending axially in a proximal direction; the other implant having a tubular body portion with an axial lumen receptive to the locking tube when the implants are brought together; the locking tube and tubular body portion having cooperative detents that lock the implants together. ### Claim 9 (depends on 8) Apparatus as defined in claim 8 wherein the cooperative detents are arranged so that the implants can be locked together only when their legs are in an interdigitated orientation. ### Claim 10 (depends on 2) Apparatus as defined in claim 2 wherein both of the implants are contained within a single delivery tube in tandem relation, the legs of the implants being constrained in a low profile by engagement with the lumen of the delivery tube; the distal implant having a locking shaft secured thereto, the locking shaft having a first connector element at its proximal end; a retention shaft extending through the delivery tube and having a second connector element at its distal end, the first and second connector elements being cooperatively engageable to releasably lock the locking shaft to the retention shaft; the proximal implant being mounted within the delivery tube and about the one of the retention shaft or locking shaft; the delivery tube being advanceable through the tissue layers to locate the distal implant on the distal side of the tissue layers, the distal implant being exposable by retraction of the delivery tube while maintaining the position of the retention shaft; and a pushing member advanceable within the delivery tube for engaging the proximal implant and urging it along the retention shaft and locking shaft into locking engagement with the distal implant. ### Claim 11 (depends on 10) Apparatus as defined in claim 10 further comprising a locking pin removably extending through the locking shaft and retention shaft to secure the connection therebetween. ### Claim 12 (depends on 10) Apparatus as defined in claim 10 wherein each implant has a tubular portion and wherein the tubular portion of one is receivable, telescopically, into the tubular portion of the other implant when the implants are brought together into engagement with each other. ### Claim 13 (depends on 10) Apparatus as defined in claim 10 wherein the latching elements provide a ratchet by which the proximity of the implants, when secured, can be varied. ### Claim 14 (depends on 10) Apparatus as defined in claim 10 wherein the tissue layers comprise opposing wall portions of a hollow or tubular body part and the serpentine configuration is such as to occlude the hollow or tubular body part. ### Claim 15 (depends on 10) Apparatus as defined in claim 10 in which the latching elements comprise; one of the implants having a locking tube extending axially in a proximal direction; the other implant having a tubular body portion with an axial lumen receptive to the locking tube when the implants are brought together; the locking tube and tubular body portion having cooperative detents that lock the implants together. ### Claim 16 (depends on 2) Apparatus as defined in claim 2 wherein the legs of the implants, when in their expanded configurations, are at an acute angle to the axis and define, generally, a conical locus. ### Claim 17 (depends on 16) Apparatus as defined in claim 16 wherein the conical loci both face in the same proximal or distal direction. ### Claim 18 (depends on 16) Apparatus as defined in claim 16 wherein the conical loci face each other. ### Claim 19 Apparatus for clamping tissue layers together comprising: a proximal implant and a distal implant disposed along a common axis, each implant having a plurality of radially extending legs; a latching element associated with each of the implants to cooperatively secure the implants to each other such that tissue layers disposed between the implants may be gripped between the proximal and distal implants; the implants, when secured together, being configured to alternately apply oppositely directed forces to the tissue layers at circumferentially spaced locations about the axis of the implants. ### Claim 20 (depends on 19) The apparatus as defined in claim 19 wherein the oppositely directed forces constrain the tissue layers between the implants in a serpentine configuration. ### Claim 21 A method for clamping tissue layers together comprising: constraining the tissue layers together by applying oppositely directed forces to opposite surfaces of the tissue layers, the forces being applied alternately at circumferentially spaced locations about a central location. ### Claim 22 A method for clamping tissue layers together comprising: constraining the tissue layers together in a serpentine configuration between at least three clamping segments and having at least three sequentially reversing bends, the serpentine configuration circumscribing an axis that is approximately perpendicular to the tissue layers. ### Claim 23 (depends on 23) The method as defined in claim 23 wherein the tissue layers comprise opposing portions of a tubular or hollow body part and where the clamping occludes the lumen of the body part. ### Claim 24 (depends on 1) Apparatus for clamping tissue layers together as defined in claim 1 further comprising: the implants having axially disposed members by which they can be connected together, at least one of the axially disposed members extending through a transfixion aperture in the tissue; the implants, when secured together, defining a zone of occlusion surrounding the transfixion aperture, thereby substantially preventing leakage from the transfixion aperture.