# US 11,992,635 B2 · Medical balloon assembly > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,992,635 B2 - Document ID: US11992635B2 - Status: Granted - Kind: B2 - Application number: 16/794,766 - Filed: 2020-02-19 - Published: 2020-08-27 - Granted: 2024-05-28 - Earliest claimed: 2019-02-25 - Assignees: Medtronic Vascular, Inc. - Applicants: Medtronic Vascular, Inc. - Inventors: Risa Tom Egerter - Web page: https://patentgrep.com/patent/US11992635B2 ## CPC - A61M 25/1029: {Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril} - A61M 25/104: {used for angioplasty} - A61L 29/049: {Mixtures of macromolecular compounds} - A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)} - A61M 25/1006: {Balloons formed between concentric tubes} - A61M 25/1025: {Connections between catheter tubes and inflation tubes} - A61M 25/1034: {Joining of shaft and balloon} - A61M 25/1036: {Making parts for balloon catheter systems, e.g. shafts or distal ends (A61M25/1029 takes precedence)} - B29C 48/00: Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor (extrusion blow-moulding B29C49/04) - A61F 2/958: Inflatable balloons for placing stents or stent-grafts - A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface} - A61M 2025/1056: {having guide wire lumens outside the main shaft, i.e. the guide wire lumen is within or on the surface of the balloon} - A61M 2025/1061: {having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube} - A61M 2025/1075: {having a balloon composed of several layers, e.g. by coating or embedding} - A61M 2025/1093: {having particular tip characteristics} - 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)} - 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) - B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00) - 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) ## Abstract In one aspect, a medical balloon assembly includes a tip sleeve secured to the distal end portion of a balloon catheter that includes the distal neck of a balloon. The tip sleeve has at least an inner layer and an outer layer. The inner layer is formed from a bondable material that is directly bondable to the exterior of the distal neck portion of the balloon. The tip sleeve is bonded directly to the distal neck of the balloon. The outer layer is formed from a lubricious polymer. Such a medical balloon assembly is made by receiving the distal neck inside the proximal end portion of the tip sleeve and directly bonding the distal neck of the balloon to the inner layer of the tip sleeve. ## Claims ### Claim 1 A medical balloon assembly, the medical balloon assembly comprising: a balloon comprising a distal end, a proximal end, and a length extending from the distal end of the balloon to the proximal end of the balloon, the balloon comprising a distal neck defining the distal end of the balloon and an inflatable portion proximal of the distal neck, at least an exterior portion of the distal neck being formed from a first bondable material; a tip sleeve having a proximal end, a distal end, and a length extending from the distal end of the tip sleeve to the proximal end of the tip sleeve, at least a first non-tapering longitudinal portion of the tip sleeve receiving at least a segment of the distal neck of the balloon therein such that the tip sleeve radially overlaps the distal neck, the tip sleeve comprising at least an inner layer and an outer layer, the inner layer comprising a second bondable material that is directly bondable to the first bondable material, the outer layer comprising a lubricious polymer, wherein the first non-tapering longitudinal portion of the tip sleeve is bonded directly to the distal neck of the balloon; and a guidewire tube defining a guidewire lumen, the guidewire tube being received in the distal neck of the balloon such that the distal neck radially overlaps the guidewire tube, the guidewire tube comprising a protruding distal end portion that protrudes distally from the distal neck of the balloon, wherein the protruding distal end portion of the guidewire tube is received inside the tip sleeve such that the tip sleeve radially overlaps the protruding distal end portion; wherein the tip sleeve has a second non-tapering longitudinal portion directly bonded to the protruding distal end portion of the guidewire tube, wherein the tip sleeve has a first tapered portion tapering from the first non-tapering longitudinal portion to the second non-tapering longitudinal portion of the tip sleeve, the first tapered portion being free from direct attachment to the protruding distal end portion of the guidewire tube, and wherein the tip sleeve has a second tapered portion tapering from the second non-tapering longitudinal portion toward the distal end of the tip sleeve, the second tapered portion being free from direct attachment to the protruding distal end portion of the guidewire tube. ### Claim 2 (depends on 1) A medical balloon assembly as set forth in claim 1, wherein the first bondable material comprises a polymer of a polymer type and the second bondable material comprises a polymer of the polymer type. ### Claim 3 (depends on 2) A medical balloon assembly as set forth in claim 2, wherein the polymer type is one of a polyether block amide and a nylon. ### Claim 4 (depends on 1) A medical balloon assembly as set forth in claim 1, wherein the first bondable material and the second bondable material are the same material. ### Claim 5 (depends on 1) A medical balloon assembly as set forth in claim 1, wherein the lubricious polymer comprises a high density polyethylene. ### Claim 6 (depends on 1) A medical balloon assembly as set forth in claim 1, wherein the tip sleeve further comprises an intermediate tie layer radially between the inner layer and the outer layer. ### Claim 7 (depends on 6) A medical balloon assembly as set forth in claim 6, wherein the intermediate tie layer is formed from a different material than either of the inner layer and the outer layer. ### Claim 8 (depends on 6) A medical balloon assembly as set forth in claim 6, wherein the intermediate tie layer is formed from a material that is directly bondable to the second bondable material and the lubricious polymer. ### Claim 9 (depends on 6) A medical balloon assembly as set forth in claim 6, wherein the inner layer, the intermediate tie layer, and the outer layer are coextruded. ### Claim 10 (depends on 6) A medical balloon assembly as set forth in claim 6, wherein the intermediate tie layer comprises one of an acid-modified polyolefin resin and an anhydride-modified polyolefin resin. ### Claim 11 (depends on 1) A medical balloon assembly as set forth in claim 1, wherein the inner layer and the outer layer of the tip sleeve are coextruded. ### Claim 12 (depends on 1) A medical balloon assembly as set forth in claim 1, wherein the distal end of the tip sleeve protrudes distally of the protruding distal end portion of the guidewire tube. ### Claim 13 (depends on 1) A method of making a medical balloon assembly as set forth in claim 1, the method comprising: receiving the distal neck of the balloon inside the proximal end of the tip sleeve; and directly bonding the distal neck of the balloon to the inner layer of the tip sleeve. ### Claim 14 (depends on 13) A method as set forth in claim 13, further comprising coextruding the inner layer and the outer layer of the tip sleeve in a single extrusion. ### Claim 15 (depends on 13) A method as set forth in claim 13, further comprising: after performing the step of receiving the distal neck of the balloon inside the proximal end of the tip sleeve, placing a heat shrink tube over the tip sleeve such that the heat shrink tube radially overlaps the tip sleeve and the distal neck of the balloon; and before performing the step of directly bonding the distal neck to the inner layer of the tip sleeve, heating the heat shrink tube to radially compress the proximal end of the tip sleeve against the distal neck of the balloon. ### Claim 16 (depends on 13) A method as set forth in claim 13, further comprising: receiving the protruding distal end portion of the guidewire tube that protrudes distally from the distal neck of the balloon inside the tip sleeve; and directly bonding the protruding distal end portion to the inner layer of the tip sleeve.