WO1999044649B1 - Composition and process for manufacturing pbt catheter balloons - Google Patents

Composition and process for manufacturing pbt catheter balloons

Info

Publication number
WO1999044649B1
WO1999044649B1 PCT/US1999/004836 US9904836W WO9944649B1 WO 1999044649 B1 WO1999044649 B1 WO 1999044649B1 US 9904836 W US9904836 W US 9904836W WO 9944649 B1 WO9944649 B1 WO 9944649B1
Authority
WO
WIPO (PCT)
Prior art keywords
polymer
composition
poly
butylene terephthalate
tubing
Prior art date
Application number
PCT/US1999/004836
Other languages
French (fr)
Other versions
WO1999044649A1 (en
Inventor
Lixiao Wang
Jianhua Chen
Original Assignee
Scimed Life Systems Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Scimed Life Systems Inc filed Critical Scimed Life Systems Inc
Priority to EP99909845A priority Critical patent/EP1059948B1/en
Priority to AT99909845T priority patent/ATE259668T1/en
Priority to DE69914882T priority patent/DE69914882T2/en
Publication of WO1999044649A1 publication Critical patent/WO1999044649A1/en
Publication of WO1999044649B1 publication Critical patent/WO1999044649B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08K—Use of inorganic or non-macromolecular organic substances as compounding ingredients
    • C08K3/00—Use of inorganic substances as compounding ingredients
    • C08K3/38—Boron-containing compounds
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L67/00—Compositions of polyesters obtained by reactions forming a carboxylic ester link in the main chain; Compositions of derivatives of such polymers
    • C08L67/02—Polyesters derived from dicarboxylic acids and dihydroxy compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—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
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article

Abstract

A processing technique and a composition which allow compositions of PBT polymers or copolymers to be formed into blow molded articles, especially medical balloons such as dilatation or stent placement balloons, from extruded tubular parisons. The process includes a longitudinal stretch step run at a temperature below the Tg of the polymeric material and a radial expansion step run at a temperature above the Tg of the polymeric material. During the longitudinal stretch step, the tubing is subjected to high internal pressure. In the composition a small amount of boric acid is added to the polybutylene terephthalate in a melt blend to give a formulation which has reduced crystallinity after extrusion and which can more readily be fashioned into high strength blow molded articles than PBT by itself.

Claims

-20- AMENDED CLAIMS[received by the International Bureau on 10 September 1999 (10.09.99); original claims 1-39 replaced by new claims 1 -24 (3 pages)]
1. A balloon for a medical device formed from a polymer material composition, wherein the composition comprises a high butylene terephthalate content polymer and 0.01-5.0% by weight of said composition of boric acid.
2. An article prepared by radial expansion of a hollow parison of a polymer material composition at elevated temperature and pressure, wherein the polymer material composition comprises a high butylene terephthalate content polymer and 0.01 -5.0% by weight of said composition of boric acid.
3. A polymer material composition consisting essentially of a single high butylene terephthalate content polymer and 0.01-5.0% by weight of said composition of boric acid.
4. A process for forming an article from a polymer composition consisting essentially of a polymer material having a high crystallization rate, the process comprising: extruding a hollow parison of the composition; stressing the extruded hollow parison at a temperature at or below the Tg of the polymer while subjecting the parison to internal pressure under conditions which produce a propagating necking of at least a portion of the extruded parison; and then radially expanding the necked portion of the parison under pressure at a temperature above the Tg of the polymer material to form the article.
5. A process for forming a balloon for a medical device, comprising: a) providing a length of tubing comprising at least one polymer layer of PBT or PBT block copolymer, optionally in mixture with up to 5% boric acid; b) longitudinally stressing the length of tubing at a temperature where necking occurs so as to neck down at least a portion of the tubing length, while subjecting the tubing to a first internal pressure; and c) radially expanding a necked down portion of the tubing at a temperature between 85 °C and 200° under a second internal pressure.
6. The invention of any of claims 1 -4 wherein the polybutylene terephthalate -21-
content of the polymer is sufficient to cause opacification of extruded material in the absence of boric acid.
7. The invention of any of claims 1 -6 wherein said polymer is poly (butylene terephthalate) homopolymer. 5
8. The invention of any of claims 1 -6 wherein said polymer is poly(butylene terephthalate)- Wøc£-poly(tetramethylene oxide) .
9. The invention of any of claims 1-8 wherein the polymer composition has a boric acid content of 0.05 to 0.5 % by weight.
10. A process as in claim 1-2 wherein the polymer material is a member 10 selected from the group consisting of a) poly(butylene terephthalate) homopolymer, b) random polyester copolymers having above 80% butylene terephthalate repeat units, c) block copolymers comprising about 60% or more by weight of 15 poly(butylene terephthalate), d) mixtures of at least two of a), b) and/or c); and e) mixtures of one or more of a), b) and/or c) with no more than 10% by weight of another polymer.
11. The invention of any of claims 3-4 wherein the polymer is a poly (butylene 20 terephthalate) homopolymer, a random polyester copolymers having above 80% butylene terephthalate repeat units, or a block copolymer comprising about 60% or more by weight of poly(butylene terephthalate).
10. A balloon for a medical device produced by the method of claim 4 or claim 5. 25 11. A balloon as in claim 10 wherein the medical catheter device is a dilatation catheter.
12. A process as in claim 4 or claim 5 wherein the radially expanding step is performed in a mold.
13. A process as in claim 5 wherein in step b) the temperature at which the 30 tubing is necked down is in the range 15°C to 35°C and the first internal pressure is in the range of 50 to 800 psi (345-5516 kPa), and in step c), the radial expansion -22-
temperature is in the range of 85 °C to 140°C, and the second internal pressure is in the range of from about 250 psi (1724 kPa) to about 500 psi (3447 kPa).
14. A process as in claim 13 wherein said first internal pressure is in the range of from about 300 psi (2068 kPa) to about 500 psi (3447 kPa). 5
15. A process as in claim 4 or claim 5 further comprising heat setting the balloon after said radially expanding step.
16. A process as in claim 4 or claim 5 further comprising subjecting the balloon to a shrink step after said radially expanding step.
17. A process as in claim 5 wherein said length of tubing comprises at least 10 two layers of polymer material.
18. A process as in claim 17 wherein said length of tubing comprises a layer of PBT homopolymer and a layer of a PBT block copolymer.
19. A process as in claim 18 wherein the PBT block copolymer material is poly(butylene terephthalate)-δ/oc£-poly(tetramethylene oxide).
15 20. A method as in claim 23 wherein said length of tubing has a single layer construction.
21. A process as in claim 20 wherein said single layer is made of PBT homopolymer.
22. A process for forming an article from poly(butylene terephthalate) 20 optionally mixed with up to 5% by weight of boric acid, the process comprising: extruding a hollow parison of the composition; and, without axially stretching the extruded parison, radially expanding the extruded parison under pressure at a temperature above the Tg of the polymer material to form the article. 25
23. A process as in claim 4 wherein the polymer composition is poly(butylene terephthalate) optionally mixed with up to 5% boric acid, polypropylene, nylon 12, nylon 11, nylon 6 or injection grade poly(ethylene terephthalate).
24. A process as in claim 23 wherein the article is a balloon for a medical catheter.
PCT/US1999/004836 1998-03-04 1999-03-04 Composition and process for manufacturing pbt catheter balloons WO1999044649A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP99909845A EP1059948B1 (en) 1998-03-04 1999-03-04 Composition and process for manufacturing pbt catheter balloons
AT99909845T ATE259668T1 (en) 1998-03-04 1999-03-04 COMPOSITION AND METHOD FOR PRODUCING PBT CATHETER BALLOONS
DE69914882T DE69914882T2 (en) 1998-03-04 1999-03-04 COMPOSITION AND METHOD FOR PRODUCING PBT CATHETER BALLOONS

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US3443198A 1998-03-04 1998-03-04
US09/034,431 1998-03-04

Publications (2)

Publication Number Publication Date
WO1999044649A1 WO1999044649A1 (en) 1999-09-10
WO1999044649B1 true WO1999044649B1 (en) 1999-11-04

Family

ID=21876375

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1999/004836 WO1999044649A1 (en) 1998-03-04 1999-03-04 Composition and process for manufacturing pbt catheter balloons

Country Status (5)

Country Link
US (3) US6465067B1 (en)
EP (1) EP1059948B1 (en)
AT (1) ATE259668T1 (en)
DE (1) DE69914882T2 (en)
WO (1) WO1999044649A1 (en)

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Also Published As

Publication number Publication date
DE69914882D1 (en) 2004-03-25
WO1999044649A1 (en) 1999-09-10
US6787095B2 (en) 2004-09-07
DE69914882T2 (en) 2004-12-16
ATE259668T1 (en) 2004-03-15
US20030030189A1 (en) 2003-02-13
US20050043459A1 (en) 2005-02-24
EP1059948A1 (en) 2000-12-20
US6465067B1 (en) 2002-10-15
EP1059948B1 (en) 2004-02-18

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