CA2476178A1 - Medical device balloons with improved strength properties and processes for producing same - Google Patents

Medical device balloons with improved strength properties and processes for producing same Download PDF

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Publication number
CA2476178A1
CA2476178A1 CA002476178A CA2476178A CA2476178A1 CA 2476178 A1 CA2476178 A1 CA 2476178A1 CA 002476178 A CA002476178 A CA 002476178A CA 2476178 A CA2476178 A CA 2476178A CA 2476178 A1 CA2476178 A1 CA 2476178A1
Authority
CA
Canada
Prior art keywords
medical device
polymeric material
balloon
parison
elongation
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002476178A
Other languages
French (fr)
Other versions
CA2476178C (en
Inventor
Lixiao Wang
John Jianhua Chen
Jeffrey Lindquist
Nao Pao Lee
Douglas Devens
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
Original Assignee
Individual
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
Family has litigation
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Application filed by Individual filed Critical Individual
Publication of CA2476178A1 publication Critical patent/CA2476178A1/en
Application granted granted Critical
Publication of CA2476178C publication Critical patent/CA2476178C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/125—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • 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
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/022—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the choice of material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • 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
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/03—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor characterised by the shape of the extruded material at extrusion
    • B29C48/09—Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • 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
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/78—Thermal treatment of the extrusion moulding material or of preformed parts or layers, e.g. by heating or cooling
    • B29C48/80—Thermal treatment of the extrusion moulding material or of preformed parts or layers, e.g. by heating or cooling at the plasticising zone, e.g. by heating cylinders
    • B29C48/83—Heating or cooling the cylinders
    • B29C48/832—Heating
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • 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
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/78—Thermal treatment of the extrusion moulding material or of preformed parts or layers, e.g. by heating or cooling
    • B29C48/86—Thermal treatment of the extrusion moulding material or of preformed parts or layers, e.g. by heating or cooling at the nozzle zone
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • 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
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/78—Thermal treatment of the extrusion moulding material or of preformed parts or layers, e.g. by heating or cooling
    • B29C48/86—Thermal treatment of the extrusion moulding material or of preformed parts or layers, e.g. by heating or cooling at the nozzle zone
    • B29C48/865—Heating
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • 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
    • B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
    • B29C48/25—Component parts, details or accessories; Auxiliary operations
    • B29C48/88—Thermal treatment of the stream of extruded material, e.g. cooling
    • B29C48/919—Thermal treatment of the stream of extruded material, e.g. cooling using a bath, e.g. extruding into an open bath to coagulate or cool the material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters
    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09K—MATERIALS FOR MISCELLANEOUS APPLICATIONS, NOT PROVIDED FOR ELSEWHERE
    • C09K2323/00—Functional layers of liquid crystal optical display excluding electroactive liquid crystal layer characterised by chemical composition
    • C09K2323/06—Substrate layer characterised by chemical composition

Abstract

A tubular parison for forming a medical device balloon. The parison is formed of a polymeric material, for instance a thermoplastic elastomer. The parison has an elongation at break which is not more than 80% of the elongation of the bulk polymeric material. The elongation of the parison is controlled by altering extrusion conditions. Balloons prepared from the parisons provide higher wall strength and/or higher inflation durability than balloons prepared from conventional parisons of the same material.

Claims (24)

1. A method of making a parison for forming a medical device balloon, the method comprising extruding a tube of polymeric material to form the tube, wherein the extrusion is controlled to provide the extruded tube with an elongation at break which is not more than 80% of the elongation at break of the bulk polymeric material.
2 A method as in claim 1 wherein the elongation at break of the extruded tube is not more than about 70% of the elongation at break of the bulk polymeric material.
3. A method of making a parison for forming a medical device balloon, the method comprising extruding a tube of polymeric material to form the tube, the extrusion having a draw down ratio of about 8 or higher.
4. A method of making a parison for forming a medical device balloon, the method comprising extruding a tube of polymeric material from an extruder having a barrel where the mixture is kept in molten state at a barrel temperature and a die zone where the molten material is pushed through a die to form the tube, wherein the die zone is kept at a temperature at least 5°F below the barrel temperature.
5. A method as in claim 4 wherein said die zone temperature is 10-40°F
below the barrel temperature.
6. A method as in claim 4 wherein said die zone temperature is 20-30°F
below the barrel temperature.
7. A tubular parison for forming a medical device balloon, the parison being formed of a polymeric material, the parison having an elongation at break which is not more than 80% of the elongation at break of the bulk polymeric material.
8. A tubular parison as in claim 7, wherein the elongation at break of the extruded tube is not more than about 70% of the elongation at break of the bulk polymeric material.
9. A medical device balloon formed from a parison as in claim 7.
10. A medical device balloon as in claim 9 wherein the polymeric material comprises a polyamide/polyether/polyester, a polyester/polyether block copolymer, a polyurethane block copolymer or a mixture thereof.
11. A medical device balloon as in claim 10 wherein the polymeric material is a polyamide/polyether/polyester.
12. A medical device balloon as in claim 9 formed with a single layer of said polymeric material.
13. A medical device balloon as in claim 9 comprising of a plurality of layers of said polymeric material.
14. A medical device comprising a balloon as in claim 9 mounted on a catheter.
15. A medical device as in claim 14 further comprising a stent mounted on the catheter.
16. A medical device balloon formed of a thermoplastic elastomer polymeric material and having a tensile wall strength in excess of 34,000 psi in pre-sterilized condition.
17. A medical device balloon as in claim 16 wherein said tensile wall strength in excess of 37,000 psi in pre-sterilized condition.
18. A medical device balloon as in claim 16 wherein the polymeric material comprises a polyamide/polyether/polyester, a polyester/polyether block copolymer, a polyurethane block copolymer or a mixture thereof.
19. A medical device balloon as in claim 16 wherein the polymeric material is a polyamide/polyether/polyester.
20. A medical device balloon as in claim 16 formed with a single layer of said polymeric material.
21. A medical device balloon as in claim 16 comprising of a plurality of layers of said polymeric material.
22. A medical device comprising a balloon as in claim 16 mounted on a catheter.
23. A medical device as in claim 22 further comprising a stent mounted on the catheter.
24. A medical device balloon formed of a thermoplastic elastomer polymeric material and having a tensile wall strength, in post-sterilized condition, of 32,000 psi or more.
CA2476178A 2002-02-28 2003-01-21 Medical device balloons with improved strength properties and processes for producing same Expired - Fee Related CA2476178C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/087,653 2002-02-28
US10/087,653 US7029732B2 (en) 2002-02-28 2002-02-28 Medical device balloons with improved strength properties and processes for producing same
PCT/US2003/001899 WO2003074115A1 (en) 2002-02-28 2003-01-21 Medical device balloons with improved strength properties and processes for producing same

Publications (2)

Publication Number Publication Date
CA2476178A1 true CA2476178A1 (en) 2003-09-12
CA2476178C CA2476178C (en) 2011-01-18

Family

ID=27787552

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2476178A Expired - Fee Related CA2476178C (en) 2002-02-28 2003-01-21 Medical device balloons with improved strength properties and processes for producing same

Country Status (7)

Country Link
US (5) US7029732B2 (en)
EP (1) EP1478426B1 (en)
JP (1) JP4339128B2 (en)
AT (1) ATE524209T1 (en)
AU (1) AU2003216086A1 (en)
CA (1) CA2476178C (en)
WO (1) WO2003074115A1 (en)

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US20030167067A1 (en) 2003-09-04
JP4339128B2 (en) 2009-10-07
US20180085499A1 (en) 2018-03-29
AU2003216086A1 (en) 2003-09-16
WO2003074115A1 (en) 2003-09-12
US20140330202A1 (en) 2014-11-06
CA2476178C (en) 2011-01-18
ATE524209T1 (en) 2011-09-15
US20060151921A1 (en) 2006-07-13
US9956321B2 (en) 2018-05-01
US9801981B2 (en) 2017-10-31
US20120323301A1 (en) 2012-12-20
US7029732B2 (en) 2006-04-18
EP1478426B1 (en) 2011-09-14
EP1478426A1 (en) 2004-11-24
JP2005518879A (en) 2005-06-30

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