# US 10,245,352 B2 · Catheter shaft having high strength and flexibility

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- Number: US 10,245,352 B2
- Document ID: US10245352B2
- Status: Granted
- Kind: B2
- Application number: 14/935,568
- Filed: 2015-11-09
- Published: 2016-03-10
- Granted: 2019-04-02
- Earliest claimed: 2006-06-30
- Assignees: Abbott Cardiovascular Systems Inc.
- Applicants: Abbott Cardiovascular Systems Inc.
- Inventors: Bruce M. Wilson; Jonathan P. Durcan; John A. Simpson
- Web page: https://patentgrep.com/patent/US10245352B2

## CPC

- A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00})
- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- A61M 25/0021: {characterised by the form of the tubing (A61M25/0054 takes precedence)}
- A61M 25/10: Balloon catheters ({A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02;} inflatable balloons for placing stents or stent-grafts A61F2/958 {; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00})
- 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}
- A61M 25/1034: {Joining of shaft and balloon}
- A61M 25/1036: {Making parts for balloon catheter systems, e.g. shafts or distal ends (A61M25/1029 takes precedence)}
- A61M 25/104: {used for angioplasty}
- B29C 48/001: {Combinations of extrusion moulding with other shaping operations}
- B29C 48/11: comprising two or more partially or fully enclosed cavities, e.g. honeycomb-shaped
- B29C 49/04114: {for keeping constant thickness}
- B29C 49/08: Biaxial stretching during blow-moulding
- B29C 49/642: {and shrinking of the preform}
- B29C 55/26: biaxial
- B29C 65/02: by heating, with or without pressure
- B29C 66/1122: {Single lap to lap joints, i.e. overlap joints (B29C66/45, B29C66/472, B29C66/52272 take precedence)}
- B29C 66/24221: {being circular (B29C66/51 takes precedence)}
- B29C 66/53241: {said articles being tubular and said substantially annular single elements being of finite length relative to the infinite length of said tubular articles (making T-shaped pieces by joining tubular articles B29C66/52241)}
- B29C 66/73711: {oriented}
- B29C 66/73713: {bi-axially or multi-axially}
- B29D 23/001: {Pipes; Pipe joints (pleated hoses B29D23/18)}
- A61M 25/0054: {with regions for increasing flexibility}
- A61M 25/1006: {Balloons formed between concentric tubes}
- A61M 2025/018: {Catheters having a lateral opening for guiding elongated means lateral to the catheter}
- A61M 2025/0183: {Rapid exchange or monorail catheters}
- A61M 2025/1031: {Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface}
- B29C 48/0018: {combined with shaping by orienting, stretching or shrinking, e.g. film blowing (B29C48/0017 takes precedence)}
- B29C 48/09: Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
- B29C 48/10: flexible, e.g. blown foils
- B29C 48/13: Articles with a cross-section varying in the longitudinal direction, e.g. corrugated pipes
- B29C 49/087: {Means for providing controlled or limited stretch ratio}
- B29C 65/48: using adhesives {, i.e. using supplementary joining material; solvent bonding}
- B29C 66/534: {Joining single elements to open ends of tubular or hollow articles or to the ends of bars}
- B29C 2049/7831: {characterised by pressure values or ranges}
- B29C 2049/7879: {Stretching, e.g. stretch rod}
- B29C 2791/001: Shaping in several steps
- B29C 2949/08: Preforms made of several individual parts, e.g. by welding or gluing parts together
- B29K 2105/258: {Tubular}
- B29L 2022/022: {Balloons}
- B29L 2031/7542: {Catheters}
- 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)}
- B29C: SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING (making preforms B29B11/00; making laminated products by combining previously unconnected layers which become one product whose layers will remain together B32B37/00 - B32B41/00)
- B29D: PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE (making granules B29B9/00; making preforms B29B11/00)
- B29K: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR {MOULDS, } REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29L: INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES

## Abstract

Elongated shaft for a catheter including a single layer biaxially oriented nonporous thermoplastic polymer tubular member having a Shore durometer hardness of less than about 75D is provided. Elongated shaft for a catheter prepared by a process is also provided.

## Claims

### Claim 1

An elongated shaft for a catheter, comprising a single layer biaxially oriented nonporous thermoplastic polymer tubular member having a Shore durometer hardness of less than about 75D.

### Claim 2 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the thermoplastic polymer has a Shore durometer hardness of between about 55D and about 75D.

### Claim 3 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the thermoplastic polymer has a Shore durometer hardness of about 63D.

### Claim 4 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the thermoplastic polymer is a polyether block amide.

### Claim 5 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the tubular member has a first outer diameter of about 0.0325 to about 0.0335 inches and a first inner diameter of about 0.028 to about 0.029 inches.

### Claim 6 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the tubular member has a Gurley bending stiffness of less than about 150 mg.

### Claim 7 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the tubular member has a tensile strength of at least about 1 to about 5 lbf.

### Claim 8 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the tubular member has a maximum blow-up-ratio and the tubular member is at least 80% of the maximum blow-up-ratio.

### Claim 9 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the tubular member has a uniform outer diameter along the entire length of the tubular member.

### Claim 10 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the biaxial orientation of the polymer of the tubular member is substantially uniform along the entire length of the tubular member.

### Claim 11 (depends on 1)

The elongated shaft for a catheter of claim 1, wherein the tubular member has a rupture pressure of at least about 20 to about 50 atm.

### Claim 12

An elongated shaft for a catheter prepared by a process comprising:
melt-extruding a thermoplastic polymeric material having a Shore durometer hardness of less than about 75D to form a tube having a lumen, a first inner diameter and a first outer diameter, and cooling the extruded tube to a temperature less than an elevated temperature of the melt-extrusion;
placing the extruded tube within a capture member and biaxially orienting the polymeric material of the extruded tube by radially expanding the extruded tube with pressurized media in the tube lumen and axially expanding the extruded tube with a load applied on at least one end of the tube; and
cooling the expanded tube to room temperature, the cooled, expanded tube being a single layer biaxially oriented nonporous thermoplastic polymer tubular member.

### Claim 13 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the extruded tube is heated to the expansion elevated temperature with a heating nozzle traversing along a length of the extruded tube.

### Claim 14 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the capture member comprises a metallic tube having a lubricious polymeric inner liner, and the pressurized media is a gas at an elevated pressure sufficient to radially expand the extruded tube into contact with an inner surface of the capture member without increasing an outer diameter of the capture member.

### Claim 15 (depends on 14)

The elongated shaft for a catheter of claim 14, wherein the capture member has a uniform inner diameter configured to radially restrain the expanding extruded tube at a second outer diameter, such that the second outer diameter is uniform along the length of the expanded tube.

### Claim 16 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the extruded tube is cooled to room temperature after extrusion and before the radial and axial expansion of the extruded tube.

### Claim 17 (depends on 12)

The elongated shaft for a catheter of claim 12, including heat stabilizing the extruded tube before cooling by heating the extruded tube to an elevated temperature sufficient to stabilize the polymeric material of the extruded tube.

### Claim 18 (depends on 17)

The elongated shaft for a catheter of claim 17, wherein the extruded tube is heat stabilized on a mandrel.

### Claim 19 (depends on 17)

The elongated shaft for a catheter of claim 17, wherein the polymeric material is a polyether block amide, and the heat stabilization comprises heating the expanded tube at about 100 to about 140° C., for about 10 to about 15 minutes.

### Claim 20 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the tubular member is extruded to the first outer diameter of about 0.021 to about 0.023 inches, and the first inner diameter of about 0.004 to about 0.006 inches.

### Claim 21 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the tubular member has a Gurley bending stiffness of not greater than about 50 to about 150 mg, a rupture pressure of at least about 20 to about 50 atm, and a tensile strength of at least about 1 to about 5 lbf.

### Claim 22 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the thermoplastic polymeric material has a Shore durometer hardness of between about 55D and about 75D.

### Claim 23 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the thermoplastic polymeric material has a Shore durometer hardness of about 63D.

### Claim 24 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the extruded tube has a maximum blow-up-ratio and the extruded tube is radially expanded to at least 80% of the maximum blow-up-ratio.

### Claim 25 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the extruded tube is radially expanded such that the expanded tube has a second inner diameter which is at least about 5 times greater than the first inner diameter of the extruded tube.

### Claim 26 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the extruded tube is simultaneously radially and axially expanded.

### Claim 27 (depends on 12)

The elongated shaft for a catheter of claim 12, wherein the extruded tube is sequentially radially and axially expanded.