Reduced profile medical balloon element

• US 7,749,585 B2
• Filed: 10/17/2003
• Issued: 07/06/2010
• Est. Priority Date: 10/08/1996
• Status: Expired due to Fees

• Current Assignee: Alan Zamore
• Original Assignee: Alan Zamore
• Inventors: Zamore, Alan
• Primary Examiner(s): Jackson; Monique R
• Application Number:
  US10/688,292
• Publication Number:
  US 20040093008A1
• Time in Patent Office: 2,454 Days
• Field of Search: None
• US Class Current: 428/35.1
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 29/04 Macromolecular materials
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• 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: B29C 55/00 Shaping by stretching, e.g. drawing through a die; Apparatus therefor B29C61/08 takes precedence
• CPC Class Codes: B29L 2031/7543 Balloon catheters
• CPC Class Codes: C08F 218/18 Diallyl phthalate
• CPC Class Codes: C08F 226/06 by a heterocyclic ring containing nitrogen
• CPC Class Codes: C08F 283/00 Macromolecular compounds obtained by polymerising monomers on to polymers provided for in subclass C08G
• CPC Class Codes: C08F 291/00 Macromolecular compounds obtained by polymerising monomers on to macromolecular compounds according to more than one of the groups C08F251/00 - C08F289/00
• CPC Class Codes: C08L 75/04 Polyurethanes
• CPC Class Codes: C08L 77/12 Polyester-amides
• CPC Class Codes: C09D 4/06 Organic non-macromolecular compounds having at least one polymerisable carbon-to-carbon unsaturated bond in combination with a macromolecular compound other than an unsaturated polymer of groups C09D159/00 - C09D187/00
• CPC Class Codes: Y10T 428/1328 Shrinkable or shrunk [e.g., due to heat, solvent, volatile agent, restraint removal, etc.]
• CPC Class Codes: Y10T 428/1331 Single layer [continuous layer]
• CPC Class Codes: Y10T 428/139 Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/1397 : Single layer [continuous layer]
• CPC Class Codes: Y10T 428/18 : Longitudinally sectional layer of three or more sections
• CPC Class Codes: Y10T 428/24752 : Laterally noncoextensive components
• CPC Class Codes: Y10T 428/31504 : Composite [nonstructural laminate]

Abstract

Medical dilatation balloons comprise a polymer that has the attribute of memory, and/or is crosslinked to impart memory. Such balloons exhibit a reduced tendency to overinflate at high inflation pressures. Furthermore, such balloons when shrunk radially by the application of heat while restraining axial shrinkage, exhibit customizable linear or non-linear compliance curves and lower crosslinking profile relative to the same balloon when unshrunk. Also disclosed is an expansive element within a tube whose outer diameter is equal to the outer diameter of the tube from which it was made. In addition, disclosed are (a) processes for preparing crosslinkable polymers, (b) joining crosslinked balloons to catheter systems, (c) forming shrunk balloon elements, and (d) forming an expansive element within a tube whose outer diameter is equal to the outer diameter of the tube from which it was made.

Claims

1. An axially restrained-shrunk catheter balloon comprising an axially stretched polymer wherein the catheter balloon is continuous and radially re-expandable.

2. The catheter balloon of claim 1 wherein the balloon is a compliant or semi-compliant catheter balloon.

3. The catheter balloon of claim 1 having a predetermined compliance curve that is attained at least in part by the axially restrained shrinkage of the balloon.

4. The catheter balloon of claim 3 wherein the predetermined compliance is a non-linear compliance curve.

5. The catheter balloon of claim 1 wherein the balloon is further coupled to a tubular element.

6. The catheter balloon of claim 5 wherein the balloon is welded to the tubular element.

7. The catheter balloon of claim 5 wherein the balloon has a balloon outer diameter and wherein the tubular element has a tubular element outer diameter, and wherein the balloon outer diameter and the tubular element outer diameter are the same.

8. The catheter balloon of claim 1 having a wall thickness that is less than a wall thickness of a polymer tube from which the catheter balloon is formed.

9. The shrunk catheter balloon of claim 1 having a non-linear compliance curve.

10. The shrunk catheter balloon of claim 1 comprising a crosslinked polymer or a polymer with shrink memory.

11. The shrunk catheter balloon of claim 1 wherein the shrunk catheter balloon is coupled to a wire-guided catheter.

12. A catheter comprising the catheter balloon of claim 1, wherein the catheter has an outer lumen diameter and wherein the catheter balloon has an outer diameter that is equal to or less than the catheter outer lumen diameter.

13. A catheter comprising the catheter balloon of claim 1, wherein the catheter has an outer lumen of a given diameter and wherein the catheter balloon has an outer diameter that is equal to or greater than the catheter outer lumen diameter.

14. A catheter comprising a catheter balloon according to claim 1, wherein the restrained-shrunk balloon has a reduced profile and the reduced profile is obtained without requiring the wrapping of the shrunk catheter balloon element about itself.

15. The catheter balloon of claim 1, having a reduced profile and comprising an expandable portion and a less expandable portion.

16. The catheter balloon of claim 15, wherein the expandable portion is between two less expandable portions.

17. The catheter balloon of claim 15, joined to a catheter to comprise a medical dilatation device.

18. The catheter balloon of claim 1, wherein an outer diameter of an expandable portion is a value between an outer diameter of a corresponding shrunken balloon and an outer diameter of the tube from which it is formed.

21. The catheter balloon of claim 1 or 19 wherein the balloon comprises a stretch-oriented polymer.

19. An axially restrained-shrunk catheter balloon comprising an axially stretched polymer wherein the catheter balloon is radially re-expandable and wherein the balloon comprises a crosslinked polymer.

20. The catheter balloon of claim 19 wherein the crosslinked polymer is crosslinked with a chemical crosslinker or wherein the crosslinked polymer is crosslinked using radiation.

22. A shrunk continuous catheter balloon produced by a process comprising:

providing a polymer material formed into a tube;

axially stretching the tube;

forming a continuous balloon from the polymer material, and

heating the balloon while restraining axial contraction in a controlled manner and thereby radially shrinking the axially stretched balloon.

23. A catheter comprising the shrunk catheter balloon of claim 22, wherein the catheter has an outer lumen diameter and wherein the shrunk catheter balloon has an outer diameter that is equal to or less than the catheter outer lumen diameter.

24. A catheter comprising the shrunk catheter balloon of claim 22, wherein the catheter has an outer lumen diameter and wherein the shrunk catheter balloon has an outer diameter that is equal to or greater than the catheter outer lumen diameter.

25. A catheter comprising a shrunk catheter balloon according to claim 22, wherein the shrunk catheter balloon has a reduced profile and the reduced profile is obtained without requiring the wrapping of the shrunk catheter balloon element about itself.