# US 11,305,098 B2 · Methods of fabricating an inflatable balloon > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,305,098 B2 - Document ID: US11305098B2 - Status: Granted - Kind: B2 - Application number: 16/940,833 - Filed: 2020-07-28 - Published: 2020-11-12 - Granted: 2022-04-19 - Earliest claimed: 2014-11-20 - Assignees: Edwards Lifesciences Corporation - Applicants: Edwards Lifesciences Corporation - Inventors: Pu Zhou; Bin Tian; Yidong M. Zhu - Web page: https://patentgrep.com/patent/US11305098B2 ## 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} - B21D 39/00: Application of procedures in order to connect objects or parts, e.g. coating with sheet metal otherwise than by plating ({joining mitred profiles B21D53/745; } riveting B21J; uniting components by forging or pressing to form integral members B21K25/00; welding B23K; press-fitting, force-fitting, or shrinking in general B23P11/00, B21D19/00; by adhesives F16B11/00 {; Connections as such F16L, F16B}); Tube expanders - B23K 26/0624: {using ultrashort pulses, i.e. pulses of 1 ns or less} - B23K 26/0626: {Energy control of the laser beam (B23K26/0622 takes precedence)} - B23K 26/361: for deburring or mechanical trimming (B23K26/351 takes precedence) - B23K 26/362: Laser etching - B23K 26/402: involving non-metallic material, e.g. isolators - A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface} - A61M 2025/107: {having a longitudinal slit in the balloon} - A61M 2025/1075: {having a balloon composed of several layers, e.g. by coating or embedding} - A61M 2025/1079: {having radio-opaque markers in the region of the balloon} - A61M 2025/1084: {having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands} - A61M 2025/1086: {having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves} - A61M 2025/1088: {having special surface characteristics depending on material properties or added substances, e.g. for reducing friction} - B23K 2103/42: {Plastics other than composite materials} - B23K 2103/50: {Inorganic materials other than metals or composite materials} - 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)} - B21D: WORKING OR PROCESSING OF SHEET METAL OR METAL TUBES, RODS OR PROFILES WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL (working or processing of wire B21F) - B23K: SOLDERING OR UNSOLDERING; WELDING; CLADDING OR PLATING BY SOLDERING OR WELDING; CUTTING BY APPLYING HEAT LOCALLY, e.g. FLAME CUTTING; WORKING BY LASER BEAM ## Abstract Inflatable devices are disclosed including a surface which has a network of polymer chains and is configured to be inflatable into a therapeutically or diagnostically useful shape, and at least one ultrashort laser pulse-formed modification in the surface. The network can, for example, include a network morphology that is substantially unchanged by modification with the ultrashort pulse laser. Ultrashort laser pulses can be laser pulses equal to or less than 1000 picoseconds in duration. Advantageously, the etching process uses a relatively low-heat laser to avoid significant heating of surrounding polymers while modifying the surface (and other structures) of the device. The process is configured so that the polymer chain morphology adjacent the modification is substantially unaffected by the low-heat laser. The resulting inflatable device has customized surface features while still retaining substantially homogenous polymer network morphology. This preserves the elasticity, especially the surface elasticity, of the inflatable device. ## Claims ### Claim 1 A method of fabricating a transcatheter device having an inflatable balloon, the method comprising: obtaining a polymer tube defining a longitudinal axis, the polymer comprising a network of polymer chains with a homogenous network morphology; blow molding the polymer tube into a hollow balloon shape having a wall defined by wall regions including a central body region, a pair of leg regions on opposite ends of the balloon shape that are radially smaller than the central body region and define axial openings therethrough, and a pair of cone regions extending between the body region and the leg regions, the wall in each wall region having an outer surface and an inner surface; and applying low heat laser pulses to portions of either the outer surface or inner surface of at least one wall region to form a laser-formed modification, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged, wherein the low heat laser pulses are applied to the central body region to form a recession that extends parallel to the longitudinal axis and around a circumferential perimeter of the central body region to reduce the wall thickness in a portion thereof. ### Claim 2 (depends on 1) The method of claim 1, wherein the low heat laser pulses are less than 1000 picoseconds in duration. ### Claim 3 (depends on 1) The method of claim 1, wherein the low heat laser pulses are applied to an outer surface of the cone regions to create a constant wall thickness in the cone regions. ### Claim 4 (depends on 1) The method of claim 1, wherein the low heat laser pulses are applied to an outer surface of the cone regions to create a plurality of longitudinal recessions in the cone regions. ### Claim 5 (depends on 1) The method of claim 1, wherein the step of applying is done prior to the step of blow molding. ### Claim 6 (depends on 1) The method of claim 1, wherein the low heat laser pulses are applied to the leg regions and create a diminished wall thickness of the leg region. ### Claim 7 (depends on 1) The method of claim 1, wherein the low heat laser pulses are applied to the leg regions and create a wedge, a taper, or an increase in surface roughness on the inner surface of the leg regions. ### Claim 8 (depends on 1) The method of claim 1, wherein the central body region has an original thickness and an ablated wall thickness, and the ablated wall thickness is between about 1-40% of the original wall thickness. ### Claim 9 (depends on 1) The method of claim 1, further including folding the balloon and crimping a heart valve around the reduced wall thickness portion of the central body region. ### Claim 10 A method of fabricating a transcatheter device having an inflatable balloon, the method comprising: obtaining a polymer tube defining a longitudinal axis, the tube having at least two polymer wall layers including an outer layer farthest from the longitudinal axis and an inner layer, the polymers in each respective outer or inner layer comprising a network of polymer chains with a homogenous network morphology; blow molding the polymer tube into a hollow balloon shape having a wall defined by wall regions including a central body region, a pair of leg regions on opposite ends of the balloon shape that are radially smaller than the central body region and define axial openings therethrough, and a pair of cone regions extending between the body region and the leg regions, the wall in each wall region having an outer surface formed by the outer layer and an inner surface formed by the inner layer; and applying low heat laser pulses to portions of either the outer surface or inner surface of at least one wall region to form a laser-formed modification, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged, wherein there are more than two polymer wall layers. ### Claim 11 (depends on 10) The method of claim 10, wherein the outer layer is radiopaque. ### Claim 12 (depends on 10) The method of claim 10, wherein the outer layer is removed in a pattern that indicates an orientation of the balloon on radiological instruments. ### Claim 13 (depends on 10) The method of claim 10, wherein the outer layer is radiopaque. ### Claim 14 (depends on 10) The method of claim 10, wherein the polymer of the outer layer is inherently rougher than the polymer of the inner layer, and the low heat laser pulses are applied to the cone regions to facilitate passage of the balloon through body lumens. ### Claim 15 (depends on 10) The method of claim 10, wherein the low heat laser pulses are applied to the central body region wherein the outer layer is removed to expose the inner layer, wherein a remaining portion of the outer layer extends as a circumferential, tubular shaped layer around the perimeter of the inflatable device. ### Claim 16 (depends on 10) The method of claim 10, further including folding the balloon and crimping a heart valve around the central body region, wherein a length of the remaining portion of the outer layer substantially matches a length of the heart valve. ### Claim 17 A method of fabricating a transcatheter device having an inflatable balloon, the method comprising: obtaining a polymer tube defining a longitudinal axis, the polymer comprising a network of polymer chains with a homogenous network morphology; blow molding the polymer tube into a hollow balloon shape having a wall defined by wall regions including a central body region, a pair of leg regions on opposite ends of the balloon shape that are radially smaller than the central body region and define axial openings therethrough, and a pair of cone regions extending between the body region and the leg regions, the wall in each wall region having an outer surface and an inner surface; and applying low heat laser pulses to portions of either the outer surface or inner surface of at least one wall region to form a laser-formed modification, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged, wherein the low heat laser pulses are applied to the central body region and form recessions that enhance a frictional capacity of the central body region. ### Claim 18 (depends on 17) The method of claim 17, further including folding the balloon and crimping a heart valve around the central body region. ### Claim 19 A method of fabricating a transcatheter device having an inflatable balloon, the method comprising: obtaining a polymer tube defining a longitudinal axis, the tube having at least two polymer wall layers including an outer layer farthest from the longitudinal axis and an inner layer, the polymers in each respective outer or inner layer comprising a network of polymer chains with a homogenous network morphology; blow molding the polymer tube into a hollow balloon shape having a wall defined by wall regions including a central body region, a pair of leg regions on opposite ends of the balloon shape that are radially smaller than the central body region and define axial openings therethrough, and a pair of cone regions extending between the body region and the leg regions, the wall in each wall region having an outer surface formed by the outer layer and an inner surface formed by the inner layer; and applying low heat laser pulses to portions of either the outer surface or inner surface of at least one wall region to form a laser-formed modification, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged, wherein the low heat laser pulses are applied to the central body region wherein the outer layer is removed to expose the inner layer, wherein a remaining portion of the outer layer extends as a circumferential, tubular shaped layer around the perimeter of the inflatable device. ### Claim 20 A method of fabricating a transcatheter device having an inflatable balloon, the method comprising: obtaining a polymer tube defining a longitudinal axis, the tube having at least two polymer wall layers including an outer layer farthest from the longitudinal axis and an inner layer, the polymers in each respective outer or inner layer comprising a network of polymer chains with a homogenous network morphology; blow molding the polymer tube into a hollow balloon shape having a wall defined by wall regions including a central body region, a pair of leg regions on opposite ends of the balloon shape that are radially smaller than the central body region and define axial openings therethrough, and a pair of cone regions extending between the body region and the leg regions, the wall in each wall region having an outer surface formed by the outer layer and an inner surface formed by the inner layer; and applying low heat laser pulses to portions of either the outer surface or inner surface of at least one wall region to form a laser-formed modification, the low heat laser pulses being configured so as to leave the polymer network morphology surrounding the laser-formed modification substantially unchanged, further including folding the balloon and crimping a heart valve around the central body region, wherein a length of the remaining portion of the outer layer substantially matches a length the heart valve.