# US 11,478,573 B2 · Catheter tubing with tailored modulus response

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- Number: US 11,478,573 B2
- Document ID: US11478573B2
- Status: Granted
- Kind: B2
- Application number: 16/788,937
- Filed: 2020-02-12
- Published: 2020-06-11
- Granted: 2022-10-25
- 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/US11478573B2

## 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 method of making a medical device including a catheter tubing comprising:
producing 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, wherein the first elastic modulus is at least 1300 MPa, wherein the producing 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;
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 elastic modulus.

### Claim 2 (depends on 1)

The method of claim 1 further comprising combining the catheter tubing with one or more components to form the medical device.

### Claim 3 (depends on 2)

The method of claim 2, wherein the one or more components includes a needle and the medical device is a vascular access device.

### Claim 4 (depends on 3)

The method of claim 3, 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 5

A method of delivering a medical fluid to a patient comprising:
obtaining 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, and at least one polyglycol, and optionally further, 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;
inserting the catheter tubing into a patient under first conditions when the catheter tubing comprises a first elastic modulus of at least 1300 MPa; 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 elastic modulus.

### Claim 6 (depends on 5)

The method of claim 5, wherein the first conditions comprise: a temperature in a range of 20 to 30° C. and a relative humidity in a range of 0 to 90% and the two or more in vivo stimuli of the second conditions comprise a temperature in a 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 7 (depends on 5)

The method of claim 5, wherein the first elastic modulus is in a range of 1300 to 2200 MPa and the second elastic modulus is in a range of 10 to 650 MPa.

### Claim 8 (depends on 5)

The method of claim 5, wherein the second elastic modulus is reached after exposure to the second conditions for about 5 to about 10 minutes.