CA2451189A1 - Dimensionally stable balloons with fibers distributed in a matrix polymer - Google Patents

Dimensionally stable balloons with fibers distributed in a matrix polymer Download PDF

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Publication number
CA2451189A1
CA2451189A1 CA002451189A CA2451189A CA2451189A1 CA 2451189 A1 CA2451189 A1 CA 2451189A1 CA 002451189 A CA002451189 A CA 002451189A CA 2451189 A CA2451189 A CA 2451189A CA 2451189 A1 CA2451189 A1 CA 2451189A1
Authority
CA
Canada
Prior art keywords
balloon
fibers
polymer
matrix
layers
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
CA002451189A
Other languages
French (fr)
Other versions
CA2451189C (en
Inventor
John Jianhua Chen
Lixiao Wang
Yiqun Wang
Albert C. C. Chin
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
Application filed by Individual filed Critical Individual
Publication of CA2451189A1 publication Critical patent/CA2451189A1/en
Application granted granted Critical
Publication of CA2451189C publication Critical patent/CA2451189C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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
    • A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L29/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • 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
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
    • 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
    • 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
    • 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
    • B29K2077/00—Use of PA, i.e. polyamides, e.g. polyesteramides or derivatives thereof, as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • 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
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/06—Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • 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
    • B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
    • B29K2105/06—Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts
    • B29K2105/12—Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts of short lengths, e.g. chopped filaments, staple fibres or bristles
    • B29K2105/14—Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts of short lengths, e.g. chopped filaments, staple fibres or bristles oriented
    • 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
    • B29L2022/00—Hollow articles
    • 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
    • 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]

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Composite Materials (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Materials Engineering (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Compounds Of Alkaline-Earth Elements, Aluminum Or Rare-Earth Metals (AREA)
  • Toys (AREA)

Abstract

An inflatable medical balloon comprises a polymer matrix material and a plurality of fibers distributed in the matrix material. The plurality of fibers operatively adhere to the matrix material and provide reinforcement thereof. The fibers may be parallel or angularly oriented relative to the longitudinal balloon axis, and may be helically disposed thereabout. The fibers may be composed of material which has a greater tensile strength than the matrix material. The fibers may be microfibers formed by phase separation of a melt blend material during extrusion or polymer cores coextruded with the matrix material and surrounded thereby. The balloon may be formed of alternating layers of fiber-free polymer and layers of fiber-containing polymer.

Claims (22)

1. A balloon for a medical device comprising:
a polymer matrix material; and a plurality of fibers distributed in the matrix material to provide reinforcement thereof, the fibers being distributed in a selected direction relative to the balloon axis and composed of material which has a greater tensile strength than the matrix material.
2. A balloon as in claim 1 wherein the fibers are distributed in the matrix material helically relative to the balloon axis.
3. A balloon as in claim 2 wherein said fibers are cores of polymeric material coextruded with the matrix polymer material.
4. A balloon as in claim 2 wherein the bulk elongation core polymeric material is 150% or less.
5. A balloon as in claim 2 wherein the core polymeric material has a bulk elongation less than the matrix material when oriented in the direction of the longitudinal axis.
6. A balloon as in claim 1, the balloon having a wall composed of a plurality of laminate layers, at least one layer of which comprises said polymer matrix material and said fibers.
7. A balloon as in claim 6 wherein said laminate layers comprise an alternating series of fiber-containing and fiber-free layers.
8. A balloon as in claim 7 having at least 7 of said laminate layers.
9. A balloon as in claim 6 wherein the fibers are distributed in the matrix material helically relative to the balloon axis.
10. A balloon as in claim 9 wherein said fibers are cores of polymeric material coextruded with the matrix polymer material.
11 A balloon as in claim 9 wherein said fibers are LCP fibers having a diameter of from 0.01 to about 10 microns.
12. A balloon as in claim 6 having a body portion wherein the fibers are oriented substantially parallel to the longitudinal axis of the balloon.
13. A balloon as in claim 12 wherein the fibers are LCP fibers having a
14 diameter of from 0.01 to about 10 microns.

14. A balloon for a medical device comprising from 7 to 50 laminate layers of polymer material.
15 A balloon as in claim 14 comprising an alternating series of (A) layers composed of a single polymer material and (B) layers composed of a blend of a matrix polymer material and an LCP polymer.
16. A balloon as in claim 15 wherein the single polymer material and the matrix polymer material are the same.
17. A balloon as in claim 15 wherein the single polymer material is a compliant or semi-compliant polymer material.
18 A balloon as in claim 15 wherein the ratio A/B of the total thickness of the two types of layers, (A )and (B) respectively, is from about 5 to about 15.
19. A balloon as in claim 18 wherein said ratio is from 8 to 10.
20. A balloon as in claim 15 wherein in the layers (B) the LCP polymer is present in the blend in an amount of from about 5 to about 25 % by weight.
21. A balloon as in claim 14, wherein the balloon has a longitudinal axis, at least some of said laminate layers are formed from an extruded blend of a matrix polymer material and an LCP polymer material, and the LCP polymer forming fibers within the matrix polymer with the fibers oriented substantially in a longitudinal or helical direction relative to the balloon axis.

21. A balloon as in claim 14 comprising alternating laminate layers of (A) a material selected from the group consisting of compliant and semi-compliant polymers and (B) a material formed from a blend of an LCP polymer with a material selected from the group consisting of compliant and semi-compliant polymers.
22. A balloon as in claim 21 wherein in said layers (A) and (B) said material selected from the group consisting of compliant and semi-compliant polymers is a member of the group consisting of polyamides and block copolymers comprising polyamide blocks and polyether blocks.
CA2451189A 2001-06-20 2002-06-06 Dimensionally stable balloons with fibers distributed in a matrix polymer Expired - Fee Related CA2451189C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/885,568 2001-06-20
US09/885,568 US6977103B2 (en) 1999-10-25 2001-06-20 Dimensionally stable balloons
PCT/US2002/018248 WO2003000307A1 (en) 2001-06-20 2002-06-06 Dimensionally stable balloons

Publications (2)

Publication Number Publication Date
CA2451189A1 true CA2451189A1 (en) 2003-01-03
CA2451189C CA2451189C (en) 2011-06-14

Family

ID=25387207

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2451189A Expired - Fee Related CA2451189C (en) 2001-06-20 2002-06-06 Dimensionally stable balloons with fibers distributed in a matrix polymer

Country Status (8)

Country Link
US (1) US6977103B2 (en)
EP (1) EP1397169B1 (en)
JP (1) JP2004531330A (en)
AT (1) ATE407711T1 (en)
CA (1) CA2451189C (en)
DE (1) DE60228835D1 (en)
ES (1) ES2314070T3 (en)
WO (1) WO2003000307A1 (en)

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CA2451189C (en) 2011-06-14
US6977103B2 (en) 2005-12-20
WO2003000307A1 (en) 2003-01-03
JP2004531330A (en) 2004-10-14
EP1397169B1 (en) 2008-09-10
US20010043998A1 (en) 2001-11-22
EP1397169A1 (en) 2004-03-17
ES2314070T3 (en) 2009-03-16
ATE407711T1 (en) 2008-09-15
DE60228835D1 (en) 2008-10-23

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