# US 2018/0296731 A1 · Catheter Tubing With Tailored Modulus Response > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2018/0296731 A1 - Document ID: US20180296731A1 - Status: Published application - Kind: A1 - Application number: 15/489,109 - Filed: 2017-04-17 - Published: 2018-10-18 - Earliest claimed: 2017-04-17 - Assignees: Becton, Dickinson and Company - Applicants: Becton, Dickinson and Company - Inventors: Lisa Lim; Theresa Hermel-Davidock; Marc W. Weimer; Jonathan Karl Burkholz - Web page: https://patentgrep.com/patent/US20180296731A1 ## CPC - A61L 29/049: {Mixtures of macromolecular compounds} - A61L 29/02: Inorganic materials - A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions} - A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} - A61L 29/18: Materials at least partially X-ray or laser opaque - A61M 25/0012: {with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils} - A61M 25/0017: {specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections} - A61M 25/0021: {characterised by the form of the tubing (A61M25/0054 takes precedence)} - A61M 25/0054: {with regions for increasing flexibility} - C08G 18/3206: {aliphatic} - C08G 18/4854: {Polyethers containing oxyalkylene groups having four carbon atoms in the alkylene group} - C08G 18/6674: {with compounds of group C08G18/3203} - C08G 18/7671: {containing only one alkylene bisphenyl group} - C08L 75/04: Polyurethanes - A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents - A61L 2300/42: Anti-thrombotic agents, anticoagulants, anti-platelet agents - A61M 2025/0059: {having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking} - A61M 2025/006: {having a special surface topography or special surface properties, e.g. roughened or knurled surface} - A61M 2025/0064: {which become stiffer or softer when heated} - A61M 2025/0065: {which become stiffer or softer when becoming wet or humid, e.g. immersed within a liquid} - 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) - 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)} - C08G: MACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS - C08L: COMPOSITIONS OF MACROMOLECULAR COMPOUNDS (compositions based on polymerisable monomers C08F, C08G; artificial filaments or fibres D01F; textile treating compositions D06) ## Abstract Catheter tubing comprises: an elongate body comprising a base thermoplastic polyurethane; and a compounded thermoplastic polyurethane co-extruded with the base thermoplastic polyurethane to provide a section of catheter tubing discrete from the elongate body, the compounded thermoplastic polyurethane comprising a thermoplastic polyurethane and a radiopaque material, wherein the catheter tubing comprises a first elastic modulus under first conditions prior to entry into a patient; and wherein when exposed to second conditions comprising two or more in vivo stimuli for a duration of time the catheter tubing comprises a second elastic modulus that is not more than fifty percent of the first modulus. ## Claims ### Claim 1 A catheter tubing comprising: an elongate body comprising a base thermoplastic polyurethane; and a compounded thermoplastic polyurethane co-extruded with the base thermoplastic polyurethane to provide a section of catheter tubing discrete from the elongate body, the compounded thermoplastic polyurethane comprising a thermoplastic polyurethane and a radiopaque material; wherein the catheter tubing comprises a first elastic modulus under first conditions prior to entry into a patient; and wherein when exposed to second conditions comprising two or more in vivo stimuli for a time, the catheter tubing comprises a second elastic modulus that is not more than fifty percent of the first modulus. ### Claim 2 (depends on 1) The catheter tubing of claim 1, wherein the thermoplastic polyurethane of the compounded thermoplastic polyurethane is a different formulation from the base thermoplastic polyurethane. ### Claim 3 (depends on 1) The catheter tubing of claim 1, wherein the section discrete from the elongate body comprises one or more elongate stripes comprising the compounded thermoplastic polyurethane, integrally formed with the elongate body. ### Claim 4 (depends on 1) The catheter tubing of claim 1 having a cross-sectional area that comprises the base thermoplastic polyurethane in an amount in the range of 60% to 80% and the compounded thermoplastic polyurethane in an amount in the range of 20% to 40%. ### Claim 5 (depends on 1) The catheter tubing of claim 1, wherein the first conditions comprise: a temperature in the range of 20 to 30° C. and a relative humidity in the range of 0 to 90%. ### Claim 6 (depends on 1) The catheter tubing of claim 1, wherein the first elastic modulus is at least 1300 MPa. ### Claim 7 (depends on 1) The catheter tubing of claim 1, wherein the first elastic modulus is the range of 1300 to 2200 MPa. ### Claim 8 (depends on 1) The catheter tubing of claim 1, wherein the two or more in vivo stimuli of the second conditions comprise a temperature in the range of about 36 to about 40° C., and one or more of: saline, plasma, white blood cells, platelets, red blood cells, water, absence of light, antibodies, and enzymes. ### Claim 9 (depends on 1) The catheter tubing of claim 1, wherein the second elastic modulus is at most 650 MPa. ### Claim 10 (depends on 1) The catheter tubing of claim 1, wherein the second elastic modulus is the range of 10 to 650 MPa. ### Claim 11 (depends on 1) The catheter tubing of claim 1, wherein the second elastic modulus is reached after exposure to the second conditions for about 30 minutes or less. ### Claim 12 (depends on 11) The catheter tubing of claim 11, wherein the second elastic modulus is reached after exposure to the second conditions for about 5 to about 10 minutes. ### Claim 13 (depends on 1) The catheter tubing of claim 1, wherein the radiopaque material of the compounded thermoplastic polyurethane comprises bismuth oxychloride (BiOCl), bismuth trioxide (Bi2O3), bismuth subcarbonate (Bi2O2CO3), barium sulfate (BaSO4), tungsten (W), or combinations thereof. ### Claim 14 (depends on 1) The catheter tubing of claim 1, wherein the base thermoplastic polyurethane, the compounded thermoplastic polyurethane, or both further comprise an antithrombogenic agent, an antimicrobial agent, a lubricant, a colorant, an active pharmaceutical, or combinations thereof. ### Claim 15 A catheter tubing comprising: an elongate body comprising a base thermoplastic polyurethane that is a product from a reaction of: a diisocyanate, a diol chain extender, at least one polyglycol, and optionally, an amine-terminated polyether, the base thermoplastic polyurethane optionally further comprising an antithrombogenic agent, an antimicrobial agent, a lubricant, a colorant, an active pharmaceutical, or combinations thereof; and one or more elongate stripes co-extruded with the base thermoplastic polyurethane, the elongate stripes comprising a compounded thermoplastic polyurethane comprising a thermoplastic polyurethane and a radiopaque material; wherein the catheter tubing comprises a first elastic modulus under first conditions prior to entry into a patient; and wherein when exposed to second conditions comprising two or more in vivo stimuli for a time, the catheter tubing comprises a second elastic modulus that is not more than fifty percent of the first modulus. ### Claim 16 (depends on 15) The catheter tubing of claim 15, wherein the first conditions comprise: a temperature in the range of 20 to 30° C. and a relative humidity in the range of 0 to 90% and the two or more in vivo stimuli of the second conditions comprise a temperature in the range of about 36 to about 40° C., and one or more of: saline, plasma, white blood cells, platelets, red blood cells, water, absence of light, antibodies, and enzymes. ### Claim 17 (depends on 15) The catheter tubing of claim 15, wherein the first elastic modulus is the range of 1300 to 2200 MPa and the second elastic modulus is the range of 10 to 650 MPa. ### Claim 18 (depends on 15) The catheter tubing of claim 15, wherein the second elastic modulus is reached after exposure to the second conditions for about 30 minutes or less. ### Claim 19 (depends on 18) The catheter tubing of claim 18, wherein the second elastic modulus is reached after exposure to the second conditions from about 5 to about 10 minutes. ### Claim 20 (depends on 1) A vascular access device comprising the catheter tubing of claim 1 in combination with one or more components, wherein the vascular access device is selected from the group consisting of: a central venous catheter, a peripherally-inserted central catheter, a midline catheter midline catheter and a peripheral intravenous catheter. ### Claim 21 A method of making a medical device including a catheter tubing comprising: designing an elongate body having a section of catheter tubing discrete from the elongate body to form the catheter tubing such that the catheter tubing comprises a first elastic modulus under first conditions prior to entry into a patient; and wherein when exposed to second conditions comprising two or more in vivo stimuli for a time, the catheter tubing comprises a second elastic modulus that is not more than fifty percent of the first modulus. ### Claim 22 (depends on 21) The method of claim 21 wherein the designing of the elongate body having the section of catheter tubing discrete from the elongate body comprises: providing a base polyurethane; providing a compounded polyurethane comprising a thermoplastic polyurethane and a radiopaque material; and co-extruding the base polyurethane and the compounded polyurethane to form the elongate body of the base polyurethane and the section discrete from the elongate body of the compounded thermoplastic polyurethane. ### Claim 23 (depends on 21) The method of claim 21 further comprising combining the catheter tubing with one or more components to form the medical device. ### Claim 24 (depends on 23) The method of claim 23, wherein the one or more components includes a needle and the medical device is a vascular access device. ### Claim 25 (depends on 24) The method of claim 24, wherein the vascular access device is selected from the group consisting of: a central venous catheter, a peripherally-inserted central catheter, a midline catheter, and a peripheral intravenous catheter. ### Claim 26 A method of delivering a medical fluid to a patient comprising: obtaining a catheter tubing; inserting the catheter tubing into a patient under first conditions when the catheter tubing comprises a first elastic modulus; and indwelling the catheter tubing for a time under second conditions when the catheter tubing is exposed to two or more in vivo stimuli and the catheter tubing comprises a second elastic modulus that is not more than fifty percent of the first modulus. ### Claim 27 (depends on 26) The method of claim 26, wherein the catheter tubing comprises: an elongate body comprising a base thermoplastic polyurethane; and one or more sections discrete from the elongate body comprising a compounded polyurethane comprising a thermoplastic polyurethane and a radiopaque material. ### Claim 28 (depends on 26) The method of claim 26, wherein the first conditions comprise: a temperature in the range of 20 to 30° C. and a relative humidity in the range of 0 to 90% and the two or more in vivo stimuli of the second conditions comprise a temperature in the range of about 36 to about 40° C., and one or more of: saline, plasma, white blood cells, platelets, red blood cells, water, absence of light, antibodies, and enzymes. ### Claim 29 (depends on 26) The method of claim 26, wherein the first elastic modulus is the range of 1300 to 2200 MPa and the second elastic modulus is the range of 10 to 650 MPa. ### Claim 30 (depends on 26) The method of claim 26, wherein the second elastic modulus is reached after exposure to the second conditions for about 5 to about 10 minutes.