Reduced profile medical balloon element

• US 20040093008A1
• Filed: 10/17/2003
• Published: 05/13/2004
• Est. Priority Date: 10/08/1996
• Status: Active Grant

• Current Assignee: Alan Zamore
• Original Assignee: Alan M. Zamore
• Inventors: Zamore, Alan M.
• Granted Patent: US 7,749,585 B2
• Time in Patent Office: Days
• US Class Current: 606/194
• 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.

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 comprises a crosslinked polymer or a polymer with shrink memory.

6. The catheter balloon of claim 4 wherein the crosslinked polymer is crosslinked with a chemical crosslinker or wherein the crosslinked polymer is crosslinked using radiation.

7. The catheter balloon of claim 4 wherein the polymer with shrink memory comprises a stretch-oriented polymer.

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

9. The catheter balloon of claim 8 wherein the balloon is welded to the tubular element.

10. The catheter balloon of claim 8 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.

35. A catheter comprising the catheter balloon of claim 1 or 11, wherein the catheter has an outer diameter and wherein the catheter balloon has an outer diameter that is equal or less that the catheter outer diameter.

11. A catheter balloon having a predetermined compliance curve that is attained at least in part by axially restrained shrinkage of the balloon.

12. The catheter balloon of claim 11 wherein the balloon has a wall length that remains the same or increases upon axially restrained shrinkage.

13. The catheter balloon of claim 11 wherein the compliance curve is a non-linear compliance curve.

14. The catheter balloon of claim 11 wherein the compliance curve has a reduced increase of diameter in a range of 14 atm to 20 atm as compared to a comparable catheter balloon that is produced without axially restrained shrinkage.

15. The catheter balloon of claim 11 wherein the balloon is a compliant or semi-compliant catheter balloon.

16. The catheter balloon of claim 11 wherein the balloon has an axial front end and an axial back end, and wherein axial restrained shrinkage is achieved by maintaining a distance between the front end and back end relative to each other.

17. The catheter balloon of claim 11 wherein the balloon has an axial front end and an axial back end, and wherein axial restrained shrinkage is achieved by increasing a distance between the front end and back end relative to each other.

18. The catheter balloon of claim 11 wherein the balloon comprises a crosslinked polymer or a polymer with shrink memory.

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

20. A compliant or semi-compliant catheter balloon for inflation to a pressure of between P₁ and P₂, wherein the balloon is formed from a polymer that is crosslinked such that the balloon has a reduced compliance in a pressure range of 70% of P₂ up to P₂.

21. The catheter balloon of claim 20 wherein the balloon is further heat treated under axial restraint to form the compliant or semi-compliant catheter balloon.

22. The catheter balloon of claim 21 wherein the polymer comprises a polyamide/polyether polyester.

24. The catheter balloon of claim 21 wherein the polyamide/polyether polyester is crosslinked using radiation.

25. The catheter balloon of claim 20 wherein P₁ is 1 atm and P₂ is 20 atm.

26. A method of manufacture of a medical device for dilation of a hollow anatomic structure, comprising a step of (1) forming a balloon from a polymer material, and (2) heating the balloon while axially restraining and radially shrinking to form an axially restrained-shrunk balloon.

27. The method of claim 26 further comprising a step of crosslinking the polymer material.

28. The method of claim 27 wherein the step of crosslinking comprises irradiating the polymer material or reacting the polymer material with crosslinking agent.

29. The method of claim 27 wherein the catheter balloon has a predetermined compliance curve that is attained by at least one of the steps of heating the balloon while axially restraining and crosslinking the polymer material.

30. The method of claim 26 wherein the step of forming the balloon comprises (1) heating a tubing comprising the polymeric material to a temperature that is above a glass transition temperature of the polymeric material and that is below a melting temperature of the polymeric material, and (2) longitudinally stretching the heated tubing.

31. The method of claim 26 wherein the polymer material is crosslinked.

32. A stent with a substantially continuous outer surface comprising a polymer material with expansion memory in a configuration that radially expands the stent when the stent is heated from a first to a second temperature, and wherein the configuration is obtained by radial compression.

33. The stent of claim 32 wherein the configuration is obtained by radial compression of the stent under axial restraint at an elevated temperature.

34. The stent of claim 32 wherein the polymer material is crosslinked.