Conformable balloon devices and methods

Patent metadata

Field	Value
Publication number	US-9669194-B2
Application number	US-201414209711-A
Country	US
Kind code	B2
Filing date	Mar 13, 2014
Priority date	Mar 14, 2013
Publication date	Jun 6, 2017
Grant date	Jun 6, 2017

Abstract

The present disclosure is directed toward a semi-compliant to non-compliant, conformable balloon useful in medical applications. Conformable balloons of the present disclosure exhibit a low or insignificant straightening force when in a curved configuration and at inflation pressures greater than 4 atm. Balloons of the present disclosure are constructed of material that can compress along an inner length when the balloon is in a curved configuration. In further embodiments, balloons of the present disclosure can be constructed of material that sufficiently elongates along an outer arc when the balloon is in a curved configuration. As a result, medical balloons, in accordance with the present disclosure, when inflated in a curved configuration, exhibit kink-free configurations and do not cause a significant degree of vessel straightening.

First claim

What is claimed is:

1. A medical balloon having a working length and comprising
a balloon wall defining a chamber, wherein at least a portion of the balloon wall comprises a material that is longitudinally compressed;
wherein the medical balloon is configured to be inflated to a pressure of at least 4 atm and is semi-compliant to non-compliant when inflated to a pressure of at least 4 atm;
wherein the longitudinally compressed material allows the balloon wall to be bent to an orientation imparting at least 20% total strain to the balloon wall, and when the medical balloon is inflated to a pressure of at least 4 atm and not subjected to a bending force, the medical balloon will assume an essentially straight configuration, and further when the medical balloon is inflated to a pressure of at least 4 atm and is subjected to a bending force of 20% total strain, the medical balloon, along a portion of the working length, defines an inner arc and an outer arc and a portion of balloon wall extending along the inner arc undergoes at least 5% compressive strain.

2. The medical balloon of claim 1 , wherein the balloon wall is configured to remain kink-free when inflated in the curved configuration.

3. The medical balloon of claim 1 , wherein the portion of the balloon wall extending along the inner arc has a length of at least 5 mm.

4. The medical balloon of claim 1 , wherein the balloon wall material comprises a porous microstructure.

5. The medical balloon of claim 4 , wherein the porous microstructure is highly fibrillated.

6. The medical balloon of claim 4 , wherein the porous microstructure is expanded polytetrafluoroethylene.

7. The medical balloon of claim 1 , wherein the portion of balloon wall extending along the inner arc undergoes at least 10% compressive strain.

8. The medical balloon of claim 1 ,
wherein the longitudinally compressed material allows the balloon wall to be bent to an orientation imparting at least 25% total strain to the balloon wall; and
wherein when the medical balloon is inflated to a pressure of at least 4 atm and is subjected to a bending force of 25% total strain, the portion of balloon wall extending along the inner arc undergoes at least 10% compressive strain.

9. The medical balloon of claim 1 , wherein the working length of the balloon lengthens less than 10% during inflation to at least an angioplasty pressure.

10. The medical balloon of claim 1 , wherein the balloon wall material is configured to remain kink-free when a ratio of a balloon diameter within the working length to a bend radius is at least 1:3.

11. The medical balloon of claim 1 , further comprising a compliant bladder.

12. The medical balloon of claim 1 , wherein the medical balloon is inflatable to a pressure greater than 8 atm.

13. The medical balloon of claim 1 , wherein the balloon wall material comprises a circumferential stiffness greater than 200 gf/mm/mm.

14. The medical balloon of claim 1 , wherein the balloon wall material comprises a circumferential stiffness and a longitudinal stiffness and wherein the circumferential stiffness is at least 5 times greater than the longitudinal stiffness.

15. The medical balloon of claim 14 , wherein the medical balloon has an inflated diameter of 4 mm and a longitudinal stiffness less than 30 gf/mm/mm.

16. The medical balloon of claim 14 , wherein the medical balloon has an inflated diameter of 8 mm and a longitudinal stiffness less than 70 gf/mm/mm.

17. The medical balloon of claim 1 , wherein the balloon wall material comprises a helically wrapped film at an angle greater than 80 degrees relative to the longitudinal axis and wherein the helically wrapped film comprises a balance ratio of at least 10:1.

18. The medical balloon of claim 1 , further comprising an endovascular medical device disposed about the balloon.

19. The medical balloon of claim 1 , wherein the balloon wall comprises a material having a porous microstructure, wherein at least a portion of the porous microstructure comprises a plurality of voids defined by the porous microstructure.

20. The medical balloon of claim 1 , further comprising a therapeutic agent attached to the balloon.

21. A medical balloon having a length along a longitudinal axis comprising
a polymeric balloon wall material, wherein at least a portion of the balloon wall comprises a material that is longitudinally compressed;
wherein the medical balloon is configured to be inflated to a pressure of at least 4 atm and is semi-compliant to non-compliant when inflated to a pressure of at least 4 atm;
wherein when the medical balloon is inflated to a pressure of at least 4 atm and not subjected to a bending force, the medical balloon will assume an essentially straight configuration;
wherein the balloon wall material comprises a circumferential stiffness and a longitudinal stiffness; and
wherein the longitudinally compressed material allows the medical balloon to readily bend when inflated to at least 4 atm and subjected to a bending force of 20% total strain, imparting the medical balloon with a circumferential stiffness at least 5 times greater than the longitudinal stiffness.

22. The balloon of claim 21 , wherein the circumferential stiffness is at least 8 times greater than the longitudinal stiffness.

23. The medical balloon of claim 21 , wherein the balloon wall material remains kink-free when inflated in a curved configuration.

24. The medical balloon of claim 21 , wherein the balloon wall material comprises a material with a porous microstructure.

25. The medical balloon of claim 24 , wherein the porous microstructure is highly fibrillated.

26. The medical balloon of claim 24 , wherein the porous microstructure is expanded polytetrafluoroethylene.

27. The medical balloon of claim 21 , wherein a working length of the balloon lengthens less than 10% during inflation to at least an angioplasty pressure.

28. The medical balloon of claim 21 , wherein the balloon wall material is configured to remain kink free when a ratio of a balloon diameter within a working length to a bend radius is at least 1:3.

29. The medical balloon of claim 21 , further comprising a compliant bladder.

30. The medical balloon of claim 21 , wherein the medical balloon is inflatable to a pressure greater than 8 atm.

31. The medical balloon of claim 21 , wherein the balloon wall material comprises a circumferential stiffness greater than 200 gf/mm/mm.

32. The medical balloon of claim 21 , wherein the medical balloon has an inflated diameter of 8 mm and a longitudinal stiffness is less than 70 gf/mm/mm.

33. The medical balloon of claim 21 , wherein the medical balloon has an inflated diameter of 4 mm and a longitudinal stiffness is less than 30 gf/mm/mm.

34. The medical balloon of claim 21 , wherein the balloon wall material comprises a helically wrapped film at an angle greater than 80 degrees relative to the longitudinal axis and wherein the helically wrapped film comprises a balance ratio of at least 10:1.

35. The balloon of claim 21 , wherein the circumferential stiffness is at least 10 times greater than the longitudinal stiffness.

Assignees

• Gore & Ass

Inventors

• Campbell Carey V
• Maulding Matthew E
• Trapp Benjamin M

Classifications

• A61M2025/1088

  having special surface characteristics depending on material properties or added substances, e.g. for reducing friction · CPC title

• A61M2025/1084

  having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands · CPC title

• A61M25/1027

  Making of balloon catheters · CPC title

• A61M25/1002

  characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence) · CPC title

• A61F2/958

  Inflatable balloons for placing stents or stent-grafts · CPC title