Dimensionally stable balloons

• US 6,905,743 B1
• Filed: 10/25/2000
• Issued: 06/14/2005
• Est. Priority Date: 02/25/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Wang, Lixiao, Chen, John Jianhua, Wang, Yiqun, Chin, Albert C. C.
• Primary Examiner(s): Pyon, Harold
• Assistant Examiner(s): HON, SOW FUN
• Application Number:
  US09/696,378
• Time in Patent Office: 1,693 Days
• Field of Search: 428/35.7, 604/96.01, 604/103.09, 604/103.11, 264/108, 264/172.13, 264/209.5, 264/173.15, 525/314
• US Class Current: 428/35.7
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: B29L 2031/7542 Catheters
• CPC Class Codes: Y10T 428/1352 Polymer or resin containing [i.e., natural or synthetic]

Abstract

A medical balloon composed of a micro-composite material which provides for radial expansion of a balloon to a predetermined extent, but which has minimal longitudinal growing during balloon inflation. The micro-composite material includes a fibril component, a matrix component, and optionally, a compatibilizer. The fibril component may preferably be liquid crystal polymer fibers randomly scattered through out the balloon material. The liquid crystal polymers are created by extrusion at high speed. An alternative fibril component may be a PET fibers which are uniformly spaced about the balloon material and extend through out the length of the balloon material tube.

Claims

1. An inflatable medical balloon which is mounted on a catheter, and has a determined preinflation length, restricted longitudinal and radial characteristics, a circumference and a longitudinal axis, composed of a micro-composite material comprising a polymer matrix component with a polymer fibril component distributed in the polymer matrix component, the polymer fibril component having micro-fibers oriented substantially parallel or diagonally to the longitudinal axis of the balloon, the polymer fibril component composed of one or more members selected from the group consisting of rigid-rod thermoplastic, semi-rigid rod thermoplastic, liquid crystal polymer, which are stronger than the matrix material and have bulk elongation between 50% and 150%, which is less than the matrix material and the fibril component and the matrix component operatively adhere to one another.

2. The inflatable medical balloon of claim 1, wherein said micro-composite material comprises about 0.1 wt-% to about 20 wt-% of said fibril component.

3. The inflatable medical balloon of claim 1, wherein said micro-composite material comprises about 0.5 wt-% to about 8 wt-% of said fibril component.

4. The inflatable medical balloon of claim 1, wherein said micro-composite material comprises about 0.5 wt-% to about 15 wt-% of said fibril component.

5. The inflatable medical balloon of claim 1, wherein said micro-composite material comprises about 50 wt-% to about 99.9 wt-% of said polymer matrix component.

6. The inflatable medical balloon of claim 1, wherein said micro-composite material comprises about 85 wt-% to about 99.5 wt-% of said polymer matrix component.

7. The inflatable medical balloon of claim 1, wherein the micro-composite material further comprises a compatibilizer component.

8. The inflatable medical balloon of claim 7 wherein said compatibilizer is a block copolymer.

9. The inflatable medical balloon of claim 7 wherein said compatibilizer is selected from the group consisting to copolyester elastomers, ethylene unsaturated ester copolymers, copolymers of ethylene and a carboxylic acid or derivative thereof, polyolefins or ethylene-unsaturated ester copolymers grafted with functional monomers, copolymers of ethylene and a carboxylic acid or derivative thereof, terpolymers of ethylene, copolymers of unsaturated esters and carboxylic acids or derivatives thereof, maleic acid grafted styrene/ethylene-butadiene-styrene block copolymers, acrylic elastomers, glycidyl(meth)acrylates, ionomeric copolymers, polyester-polyether block copolymers, and mixtures thereof.

10. The inflatable medical balloon of claim 7, wherein said compatibilizer is selected from the group consisting of ethylene-maleic anhydride copolymers, ethylene-methyl acrylate copolymers, ethylene-methyl acrylate-maleic anhydride terpolymers, ethylene-methyl acrylate-methacrylic acid terpolymers, alkyl(meth)acrylate-ethylene-glycidyl(meth)acrylate terpolymers, and mixtures thereof.

11. The inflatable medical balloon of claim 1, wherein the fibril component has a melting point of about 275°

C. or less.

12. The inflatable medical balloon of claim 1, wherein the fibril component has a melting point of about 250°

C. or less.

13. The inflatable medical balloon of claim 1, wherein the fibril component has a melting point of about 150°

C. to about 249°

C.

14. The inflatable medical balloon of claim 1, wherein the fibril component has a melting point of about 230°

C. or less.

15. The inflatable medical balloon of claim 1, wherein the matrix component comprises a semi-compliant thermoplastic polymer.

16. The inflatable medical balloon of claim 1, wherein the matrix component has a melting point of about 140°

C. to about 265°

C.

17. The inflatable medical balloon of claim 1, wherein the matrix component has a melting point of about 150°

C. to about 230°

C.

18. The inflatable medical balloon of claim 1, wherein the matrix component has a melting point of about 220°

C. or less.

19. The inflatable medical balloon of claim 1, wherein the orientation of the micro-fibers relative to the longitudinal axis of the balloon changes through the balloon material in a direction transverse to said longitudinal axis.