# US 11,304,831 B2 · Systems and methods for making encapsulated hourglass shaped stents > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,304,831 B2 - Document ID: US11304831B2 - Status: Granted - Kind: B2 - Application number: 17/095,615 - Filed: 2020-11-11 - Published: 2021-04-08 - Granted: 2022-04-19 - Earliest claimed: 2016-05-31 - Assignees: V-Wave Ltd. - Applicants: V-Wave Ltd. - Inventors: Nir Nae; Lior Rosen; Neal Eigler; Erez Rozenfeld; Werner Hafelfinger; Yeela Scop - Web page: https://patentgrep.com/patent/US11304831B2 ## CPC - A61F 2/07: Stent-grafts - A61B 2017/00252: {for by-pass connections, i.e. connections from heart chamber to blood vessel or from blood vessel to blood vessel} - A61B 2017/00575: {for closure at remote site, e.g. closing atrial septum defects} - A61F 2/2415: {Manufacturing methods} - A61F 2/844: folded prior to deployment - A61F 2/91: made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes - A61F 2/915: with bands having a meander structure, adjacent bands being connected to each other - A61F 2/958: Inflatable balloons for placing stents or stent-grafts - A61F 2002/072: {Encapsulated stents, e.g. wire or whole stent embedded in lining} - A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol - A61F 2210/0076: multilayered, e.g. laminated structures - A61F 2220/0041: using additional screws, bolts, dowels or rivets, e.g. connecting screws - A61F 2220/0058: soldered or brazed or welded - A61F 2230/001: Figure-8-shaped, e.g. hourglass-shaped - A61F 2230/0067: conical - A61F 2230/0078: hyperboloidal - A61F 2240/00: Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof - A61F 2240/001: Designing or manufacturing processes - A61F 2240/004: Using a positive or negative model, e.g. moulds - A61F 2250/0039: differing in diameter - A61F 2250/0082: specially designed for children, e.g. having means for adjusting to their growth - A61M 27/002: {Implant devices for drainage of body fluids from one part of the body to another (intraocular A61F9/00781; middle ear A61F11/202)} - A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} ## Abstract Systems and methods for the manufacture of an hourglass shaped stent-graft assembly having an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension. ## Claims ### Claim 1 A stent-graft assembly comprising: an expandable stent comprising a first flared region, a neck region, and a second flared region, the neck region positioned between the first flared region and the second flared region; and a continuous biocompatible graft-tube covering the expandable stent, the continuous biocompatible graft tube comprising a first end and a second end, and first, second, and third portions, the first end of the biocompatible graft tube being an end of the first graft portion and the second end of the biocompatible graft tube being an end of the third graft portion, the first graft portion deposited on the neck region and the second flared region of the expandable stent, the second graft portion deposited along an interior surface of the expandable stent and adjacent to the first graft portion and the third graft portion, and the third graft portion deposited along the first flared region and the neck region of the expandable stent, such that: the first flared region is covered by two layers of biocompatible material comprising the second graft portion and the third graft portion, the neck region is covered by three layers of biocompatible material comprising the first graft portion, the second graft portion, and the third graft portion, and the second flared region is covered by two layers of biocompatible material comprising the second graft portion and the first graft portion. ### Claim 2 (depends on 1) The stent-graft assembly of claim 1, wherein the first, second, and third portions of biocompatible graft tube become sintered together into a monolithic layer of graft material upon application of heat, thereby forming an encapsulated stent-graft. ### Claim 3 (depends on 2) The stent-graft assembly of claim 2, wherein the expandable stent comprises through-wall openings such that the application of heat causes the first, second, and third portions to bond to one another through the through-wall openings. ### Claim 4 (depends on 2) The stent-graft assembly of claim 2, wherein the encapsulated stent-graft is configured to transition from a compressed state to an expanded state. ### Claim 5 (depends on 4) The stent-graft assembly of claim 4, wherein the encapsulated stent-graft is configured to transition from the compressed state to an expanded state using an inflatable balloon. ### Claim 6 A stent-graft assembly comprising: an expandable stent having an exterior, a lumen and a first length that includes a first region and first end, a second region and a second end, and a middle region positioned between the first region and the second region; and a biocompatible graft-tube having a second length greater than twice the first length, the second length having first, second, and third portions, wherein the first portion extends from the first end of the first region, through the middle region and to the second end of the second region, the second portion is continuously joined to the first portion at the first end and extends from the first end and into the middle region, and the third portion is continuously joined to the second portion at the second end and extends along the second region and into the middle region, such that the second and third portions overlap and are joined to one another. ### Claim 7 (depends on 6) The stent-graft assembly of claim 6, wherein the second and third portions of the biocompatible graft tube are sintered together upon application of heat. ### Claim 8 (depends on 7) The stent-graft assembly of claim 7, wherein the expandable stent comprises through-wall openings such that the first, second, and third portions bond to one another through the through-wall openings upon application of heat to form an encapsulated stent-graft. ### Claim 9 (depends on 8) The stent-graft assembly of claim 8, wherein the encapsulated stent-graft is configured to transition from a compressed state to an expanded state. ### Claim 10 (depends on 8) The stent-graft assembly of claim 8, wherein the encapsulated stent-graft is configured to transition from the compressed state to an expanded state using an inflatable balloon. ### Claim 11 (depends on 6) The stent-graft assembly of claim 6, wherein at least one of the first region and the second region flares outwardly at the first end or the second end, respectively, in an expanded state. ### Claim 12 (depends on 11) The stent-graft assembly of claim 11, wherein both the first region and the second region flare outwardly in the expanded state. ### Claim 13 (depends on 12) The stent-graft assembly of claim 12, wherein the stent-graft assembly forms an hourglass shape in the expanded state. ### Claim 14 (depends on 6) The stent-graft assembly of claim 6, wherein the second and third portions of the biocompatible graft-tube overlap and are joined to one another in the middle region. ### Claim 15 A stent-graft assembly comprising: an expandable stent having a first region having a first end, a second region having a second end, and a middle region disposed between the first region and the second region; and a biocompatible graft-tube having a first portion, a second portion, and a middle portion disposed between the first portion and the second portion, wherein the first portion extends along the expandable stent from the middle region to the first end, the middle portion extends along the expandable stent from the first end to the second end, and the second portion extends along the expandable stent from the second end to the middle region. ### Claim 16 (depends on 15) The stent-graft assembly of claim 15, wherein at least one of the first region and the second region flares outwardly at the first end or the second end, respectively, in an expanded state. ### Claim 17 (depends on 16) The stent-graft assembly of claim 16, wherein both the first region and the second region flare outwardly in the expanded state. ### Claim 18 (depends on 17) The stent-graft assembly of claim 17, wherein the stent-graft assembly forms an hourglass shape in the expanded state. ### Claim 19 (depends on 15) The stent-graft assembly of claim 15, wherein the first portion and the second portion of the biocompatible graft-tube overlap. ### Claim 20 (depends on 19) The stent-graft assembly of claim 19, wherein the first portion and the second portion of the biocompatible graft-tube overlap at the middle region of the expandable stent. ### Claim 21 (depends on 15) The stent-graft assembly of claim 15, wherein the first, second, and middle portions of biocompatible graft-tube become sintered together into a monolithic layer of graft material upon application of heat, thereby forming an encapsulated stent-graft. ### Claim 22 (depends on 21) The stent-graft assembly of claim 21, wherein the expandable stent comprises through-wall openings such that the application of heat causes the first, second, and middle portions to bond to one another through the through-wall openings. ### Claim 23 (depends on 21) The stent-graft assembly of claim 21, wherein the encapsulated stent-graft is configured to transition from a compressed state to an expanded state. ### Claim 24 (depends on 23) The stent-graft assembly of claim 23, wherein the encapsulated stent-graft is configured to transition from the compressed state to an expanded state using an inflatable balloon.