# US 12,004,978 B2 · Stent and method of manufacture > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,004,978 B2 - Document ID: US12004978B2 - Status: Granted - Kind: B2 - Application number: 17/954,805 - Filed: 2022-09-28 - Published: 2023-01-19 - Granted: 2024-06-11 - Earliest claimed: 2019-11-22 - Applicants: Tre Raymond Welch - Inventors: Tre Raymond Welch - Web page: https://patentgrep.com/patent/US12004978B2 ## CPC - A61F 2/88: the wire-like elements formed as helical or spiral coils - A61F 2/885: {comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis} - A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07) - A61F 2/90: characterised by a net-like or mesh-like structure - A61L 31/041: {Mixtures of macromolecular compounds} - A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - A61L 31/18: Materials at least partially X-ray or laser opaque - A61F 2002/825: {having longitudinal struts} - A61F 2250/001: for adjusting a diameter - A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body - A61F 2250/0098: radio-opaque, e.g. radio-opaque markers - 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) - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) ## Abstract A dual opposing helical stent having a furled, small-diameter state and an expanded, large-diameter state. In the furled, small-diameter state, the stent includes a plurality of central lobes arranged at spaced-apart intervals and extending longitudinally defining a stent axis. The stent also includes peripheral lobes formed on the plurality of central lobes. The terminal ends of the stent are welded in a middle section of the stent. A method and technique for manufacturing the stent is also disclosed. ## Claims ### Claim 1 A method for forming a stent having a furled, small-diameter state and an expanded, large-diameter state, the method for forming the stent in the furled, small-diameter state comprising: winding a polymer element in a first rotational direction to form a first plurality of central lobes arranged longitudinally along a stent axis from a first stent end to a second stent end, wherein each of the first plurality of central lobes is spaced along the stent axis, and wherein the polymer element has a first terminal end and a second terminal end and a reserve portion of the polymer element at the first terminal end is reserved; winding the polymer element in the first rotational direction to form a second plurality of central lobes, wherein the polymer element is wound from the second stent end until the second terminal end is in a middle section of the stent, winding the reserve portion of the polymer element in a second rotational direction to form a third plurality of central lobes, wherein the polymer element is wound from the first stent end until the first terminal end is in the middle section of the stent, wherein during the winding of the first plurality of central lobes, the second plurality of central lobes and the third plurality of central lobes, at least one peripheral lobe is wound in each of the first plurality of central lobes, the second plurality of central lobes and the third plurality of central lobes; and wherein the second plurality of central lobes and the third plurality of central lobes form an opposing winding pattern to the first plurality of central lobes along the stent axis. ### Claim 2 (depends on 1) The method of claim 1, wherein the at least one peripheral lobe comprises a plurality of peripheral lobes disposed about each of the first plurality of central lobes, the second plurality of central lobes and the third plurality of central lobes. ### Claim 3 (depends on 1) The method of claim 1, wherein the polymer element comprises at least one of a Poly-L-Lactic Acid fiber, a Poly-D,L-Lactide, a polycaprolactone fiber, a Poly-lactide-co-glycolide fiber, a Polyglycolide fiber or a polydioxanone fiber. ### Claim 4 (depends on 1) The method of claim 1, wherein the polymer element comprises a polymer fiber loaded with a material. ### Claim 5 (depends on 4) The method of claim 4, wherein the material is radio-opaque. ### Claim 6 (depends on 4) The method of claim 4, wherein the material is at least one of a drug or a therapeutic agent. ### Claim 7 (depends on 4) The method of claim 4, wherein the material is at least one of curcumin, niacin, an anti-inflammatory material or anti-proliferative material. ### Claim 8 (depends on 1) The method of claim 1, wherein the polymer element is wound on a mandrel. ### Claim 9 A stent having a furled, small-diameter state and an expanded, large-diameter state, the stent comprising, in the furled, small-diameter state: a polymer element coiled to form: a first plurality of central lobes arranged longitudinally along a stent axis from a first end to a second end of the stent, a second plurality of central lobes extending from a middle section of the stent to the first end of the stent, a third plurality of central lobes extending from the middle section of the stent to the second end of the stent, and at least one peripheral lobe on each of the first plurality of central lobes, the second plurality of central lobes and the third plurality of central lobes; wherein the terminal ends of the polymer element are in the middle section. ### Claim 10 (depends on 9) The stent of claim 9, wherein the at least one peripheral lobe comprises a plurality of peripheral lobes disposed about each of the first plurality of central lobes, the second plurality of central lobes and the third plurality of central lobes. ### Claim 11 (depends on 9) The stent of claim 9, wherein the polymer element comprises at least one of a Poly-L-Lactic Acid fiber, a Poly-D,L-Lactide, a polycaprolactone fiber, a Poly-lactide-co-glycolide fiber, a Polyglycolide fiber or a polydioxanone fiber. ### Claim 12 (depends on 9) The stent of claim 9, wherein the polymer element comprises a polymer fiber loaded with a material. ### Claim 13 (depends on 12) The stent of claim 12, wherein the material is radio-opaque. ### Claim 14 (depends on 12) The stent of claim 12, wherein the material is a drug or therapeutic agent. ### Claim 15 (depends on 12) The stent of claim 12, wherein the material is at least one of curcumin, niacin, an anti-inflammatory material or anti-proliferative material. ### Claim 16 (depends on 9) The stent of claim 9, further comprising a longitudinal rod attached to the first plurality of central lobes and second plurality of central lobes. ### Claim 17 (depends on 9) The stent of claim 9, wherein the polymer element is wound on a mandrel. ### Claim 18 A method for forming a stent having a furled, small-diameter state and an expanded, large-diameter state, the method for forming the stent in the furled, small-diameter state comprising: winding a polymer element in a first rotational direction to form a first plurality of central lobes arranged longitudinally along a stent axis from a middle section of the stent to a first stent end; winding the polymer element in the first rotational direction to form a second plurality of central lobes arranged longitudinally along a stent axis from the first stent end to a second stent end; winding the polymer element in the first rotational direction to form a third plurality of central lobes, wherein the polymer element is wound from the second stent end to the middle section of the stent, wherein the polymer element has a first terminal end and a second terminal end that are in the middle section, wherein during the winding of the first plurality of central lobes, the second plurality of central lobes and the third plurality of central lobes, at least one peripheral lobe is wound in each of the first plurality of central lobes, the second plurality of central lobes and the third plurality of central lobes; and wherein the first plurality of central lobes and the third plurality of central lobes form an opposing winding pattern to the second plurality of central lobes along the stent axis. ### Claim 19 (depends on 18) The method of claim 18, wherein the polymer element is wound on a mandrel.