# US 2014/0194856 A1 · Introducer sheath > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0194856 A1 - Document ID: US20140194856A1 - Status: Published application - Kind: A1 - Application number: 14/208,746 - Filed: 2014-03-13 - Published: 2014-07-10 - Earliest claimed: 2000-03-23 - Assignees: Cook Medical Technologies LLC - Applicants: Cook Medical Technologies LLC - Inventors: Fred T. Parker - Web page: https://patentgrep.com/patent/US20140194856A1 ## CPC - A61M 25/005: {with embedded materials for reinforcement, e.g. wires, coils, braids} - A61M 25/0662: {Guide tubes} - A61M 25/0053: {having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid} - A61M 25/0054: {with regions for increasing flexibility} - 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 Introducer sheath (10,30,40) having a flexible kink-resistant distal tip portion (26,32,42). A multilayer sheath structure is used, with an inner tube (12) such as PTFE having a coil (14) of wire wound therearound. A first length of outer tubing (20) such as of nylon is inserted over most of the coil-wound inner tube (12) in a manner exposing a distal length of coil-wound inner tube. A second length of outer tubing (22) with a softer durometer than first outer tubing length (20), is inserted over the exposed coil-wound inner tube and extends for a slight distance beyond the end of the coil. During heat application, the outer tubing lengths (20, 22) are melted to bond to each other and to flow between the spacings of the coil turns to bond to the roughened outer surface of the inner tube (12). The distal tip region corresponding to the second tubing length is flexible and is kink-resistant due to the coil (14). ## Claims ### Claim 1 A flexible kink-resistant introducer sheath comprising: an inner tube extending to a distal end; a wire coil disposed around said inner tube extending to an end spaced proximally from said inner tube distal end, said wire coil comprising a plurality of uniformly spaced coil turns, each coil turn being free from crossing by another coil turn; a first outer tube disposed around said wire coil and said inner tube to a first outer tube distal end spaced proximally from said wire coil distal end such that a distal end portion of said wire coil extends beyond the first outer tube distal end; a radiopaque marker band positioned on the introducer sheath at the distal end of the coil; at least a second outer tube disposed around said wire coil and said inner tube therewithin extending distally from said first outer tube distal end and covering said distal end portion of said wire coil and extending beyond said distal end of said inner tube; and an atraumatic flexible, kink-resistant distal tip; said first outer tube being of a material having a first durometer of between 50 D and 60 D, and said second outer tube having a second durometer that is softer than said material of said first outer tube and being between 35 D and 45 D; wherein the second outer tube is polymeric and contains radiopaque filler particles; wherein the first outer tube is substantially free of radiopaque filler; and wherein the coil extends only partly within the length of the second outer tube. ### Claim 2 (depends on 1) The flexible kink-resistant introducer sheath of claim 1, wherein said outer tube and said inner tube are bonded to each other and to said wire coil and to said inner tube between windings of said wire coil. ### Claim 3 (depends on 2) The flexible kink-resistant introducer sheath of claim 2, wherein an outwardly facing surface of said inner tube has been roughened to enhance bonding thereto of said first and second outer tubes. ### Claim 4 (depends on 1) The flexible kink-resistant introducer sheath of claim 1, wherein said second outer tube comprises a material having a durometer of at least 5 D lower than that of the first outer tubing length. ### Claim 5 (depends on 1) The flexible kink-resistant introducer sheath of claim 1, wherein said first outer tube comprises a material having a durometer of between 56 D to 58 D. ### Claim 6 (depends on 1) The flexible kink-resistant introducer sheath of claim 1, wherein said wire coil comprises flat wire. ### Claim 7 (depends on 1) The flexible kink-resistant introducer sheath of claim 1, wherein a distal tip region of the sheath is arcuate. ### Claim 8 The flexible kink-resistant introducer sheath 7, wherein said arcuate distal tip region has a length of about 1 cm or more. ### Claim 9 (depends on 7) The flexible kink-resistant introducer sheath of claim 7, wherein said arcuate distal tip region extends about an angle of about 90 degrees. ### Claim 10 (depends on 1) The flexible kink-resistant introducer sheath of claim 1, wherein said second outer tube comprises a material having a durometer of about 45 D. ### Claim 11 (depends on 1) The flexible kink-resistant introducer sheath of claim 1, wherein said wire coil extends for a length of about five millimeters to about 1 centimeter beyond said distal end of said first outer tube. ### Claim 12 (depends on 1) The flexible kink-resistant introducer sheath of claim 1, wherein the inner and outer tubes comprise nylon. ### Claim 13 A flexible kink-resistant introducer sheath comprising: an inner tube extending to a distal end; a wire coil disposed around said inner tube extending to an end spaced proximally from said inner tube distal end, said wire coil comprising a plurality of uniformly spaced coil turns, each coil turn being free from crossing by another coil turn; a first outer tube disposed around said wire coil and said inner tube to a first outer tube distal end spaced proximally from said wire coil distal end such that a distal end portion of said wire coil extends beyond the first outer tube distal end; at least a second outer tube disposed around said wire coil and said inner tube therewithin extending distally from said first outer tube distal end and covering said distal end portion of said wire coil and extending beyond said distal end of said inner tube; and an atraumatic flexible, kink-resistant distal tip; said first outer tube being of a material having a first durometer of between 50 D and 60 D, and said second outer tube having a second durometer that is softer than said material of said first outer tube and being between 35 D and 45 D; wherein the second outer tube is polymeric and contains radiopaque filler particles; wherein the first outer tube is substantially free of radiopaque filler; and wherein the coil extends only partly within the length of the second outer tube. ### Claim 14 (depends on 13) The flexible kink-resistant introducer sheath of claim 13 further comprising at least one intermediate outer tube between the first and second outer tubes and having a respective durometer between that of the first and second outer tubes. ### Claim 15 (depends on 13) The flexible kink-resistant introducer sheath of claim 13 wherein the second outer tube comprises a hydrophilic coating. ### Claim 16 (depends on 13) The flexible kink-resistant introducer sheath of claim 13, where both the first and second outer tubes comprise nylon. ### Claim 17 (depends on 13) The flexible kink-resistant introducer sheath of claim 13 where the coil extends for almost the entire length of the second outer tube. ### Claim 18 (depends on 13) The flexible kink-resistant introducer sheath of claim 13 where the coil does not extend for any length into the atraumatic distal tip. ### Claim 19 (depends on 13) The flexible kink-resistant introducer sheath of claim 13, wherein said second outer tube comprises a material having a durometer of about 45 D. ### Claim 20 (depends on 13) The flexible kink-resistant introducer sheath of claim 13, further comprising a radiopaque marker band embedded in the second outer tubing at a position about the distal end of the coil.