# US 11,660,420 B2 · Catheters and related devices and methods of manufacture > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,660,420 B2 - Document ID: US11660420B2 - Status: Granted - Kind: B2 - Application number: 17/584,627 - Filed: 2022-01-26 - Published: 2022-05-12 - Granted: 2023-05-30 - Earliest claimed: 2018-09-17 - Assignees: Seigla Medical, Inc. - Applicants: Seigla Medical, Inc. - Inventors: Chad J. Kugler; Ross A. Olson - Web page: https://patentgrep.com/patent/US11660420B2 ## CPC - A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)} - A61M 25/0012: {with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils} - A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids} - A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)} - A61M 25/0108: {using radio-opaque or ultrasound markers} - A61M 2025/0042: {Microcatheters, cannula or the like having outside diameters around 1 mm or less} - A61M 2025/0048: {with an outer layer made from silicon} - A61M 2025/1079: {having radio-opaque markers in the region of the balloon} - 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 Catheters incorporating a thin film polymeric layer or layers. The thin film may have a wall thickness of about 0.00025″ +/− less than 0.0001″ to about 0.0015″ +/−0.0002″, for example. The thin film may be formed by extruding a sheet and cutting the sheet into elongate ribbons, each having two opposing long edges. The ribbon may be rolled or wrapped to define a tubular shape with a gap between the long edges. Heat and pressure may be applied to close the gap, abut the edges and form a longitudinal joint. The joint may extend along a portion of the length of the tubular shaft or most of the length of the tubular shaft. The tubular-shaped thin film layer may have a uniform wall thickness around the circumference, and the uniform wall thickness may extend across the joint. ## Claims ### Claim 1 A catheter, comprising: an elongate tubular shaft having a proximal end, a distal end, a length, a longitudinal axis and a lumen extending therethrough, wherein the tubular shaft includes a saddle portion having a distal facing, terminal trailing edge disposed proximal of the distal end of the elongate tubular shaft, a lubricious polymeric inner liner extending through the saddle portion, a reinforcement coil disposed about the lubricious polymeric inner liner, and a thin film polymeric layer disposed about the saddle portion, wherein the distal facing, terminal trailing edge of the saddle portion includes a plurality of peninsular members defining a plurality of embayments, and wherein the thin film polymeric layer extends through the embayments to the lubricious polymeric inner liner in the saddle portion such that the thin film polymeric layer is connected to and extends from the distal-facing trailing edge. ### Claim 2 (depends on 1) A catheter as in claim 1, wherein the reinforcement coil is metallic. ### Claim 3 (depends on 1) A catheter as in claim 1, wherein the thin film has a thickness less than 0.0015″+/−0.0002″. ### Claim 4 (depends on 1) A catheter as in claim 1, wherein the thin film has a thickness less than 0.0010″+/−0.00013″. ### Claim 5 (depends on 1) A catheter as in claim 1, wherein the thin film has a thickness less than 0.00075″+/−0.0001″. ### Claim 6 (depends on 1) A catheter as in claim 1, wherein the thin film has a thickness less than 0.0005″+/− less than 0.0001″. ### Claim 7 (depends on 1) A catheter as in claim 1, wherein the saddle portion includes a proximal-facing leading edge configured at an acute angle relative to the longitudinal axis and having a plurality of notches, and wherein the thin film polymeric layer extends through the notches to the lubricious polymeric inner liner in the saddle portion. ### Claim 8 (depends on 1) A catheter as in claim 1, wherein the reinforcement coil and the saddle portion are separate components joined together. ### Claim 9 (depends on 1) A catheter as in claim 1, wherein the embayments form a saddle interlocking portion and the thin film polymeric layer forms a complementary interlocking portion engaged with the saddle interlocking portion to form a mechanically interlocking connection between the saddle portion and the thin film polymeric layer. ### Claim 10 A catheter, comprising: an elongate rod, a saddle member connected to a distal end of the rod, and an elongate tubular shaft extending from a distal end of the saddle member, a lubricious polymeric inner liner extending through the tubular shaft and the saddle member, a reinforcement coil disposed about the lubricious polymeric inner liner, a thin film polymeric layer extending over the tubular shaft and saddle member, wherein the saddle member includes a distal facing, terminal trailing edge having a plurality of peninsular members defining a plurality of embayments, and wherein the thin film polymeric layer extends through the embayments to the lubricious polymeric inner liner in the saddle member such that the thin film polymeric layer is connected to, and extends from, the distal-facing, terminal trailing edge. ### Claim 11 (depends on 10) A catheter as in claim 10, wherein the reinforcement coil and the saddle member are separate components joined together. ### Claim 12 (depends on 10) A catheter as in claim 10, wherein the embayments form a saddle interlocking portion and the thin film polymeric layer forms a complementary interlocking portion engaged with the saddle interlocking portion to form a mechanically interlocking connection between the saddle member and the thin film polymeric layer. ### Claim 13 A catheter, comprising: an elongate rod, a saddle member connected to a distal end of the rod, and an elongate tubular shaft extending from a distal end of the saddle member, a lubricious polymeric inner liner extending through the tubular shaft and the saddle member, a coil disposed about the inner liner, and a thin film polymeric layer extending over the coil and saddle member, wherein the coil has a proximal end and a distal end and wherein the coil comprises a core and a jacket, wherein the core has a first attenuation coefficient when radiated by a first X-ray radiation, and the jacket has a second attenuation coefficient when radiated by the first X-ray radiation, the first attenuation coefficient being greater than the second attenuation coefficient, and wherein adjacent turns of the coil at the proximal and distal ends thereof contact each other and are welded together, and wherein the saddle member includes a distal-facing, terminal trailing edge that includes a plurality of peninsular members defining a plurality of embayments, and wherein the thin film polymeric layer extends through the embayments to the lubricious polymeric inner liner in the saddle member such that the thin film polymeric layer is connected to, and extends from, the distal-facing, terminal trailing edge. ### Claim 14 (depends on 13) A catheter as in claim 13, wherein the core comprises tantalum. ### Claim 15 (depends on 13) A catheter as in claim 13, wherein the jacket comprises a spring-tempered metal alloy. ### Claim 16 (depends on 13) A catheter as in claim 13, wherein the jacket comprises stainless steel. ### Claim 17 (depends on 13) A catheter as in claim 13, wherein the coil and the saddle member are separate components joined together. ### Claim 18 (depends on 13) A catheter as in claim 13, wherein the embayments form a saddle interlocking portion and the thin film polymeric layer forms a complementary interlocking portion engaged with the saddle interlocking portion to form a mechanically interlocking connection between the saddle member and the thin film polymeric layer.