Conformable balloon devices

Patent metadata

Field	Value
Publication number	US-10076642-B2
Application number	US-201615231494-A
Country	US
Kind code	B2
Filing date	Aug 8, 2016
Priority date	Mar 14, 2013
Publication date	Sep 18, 2018
Grant date	Sep 18, 2018

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 comprising
a balloon comprising a polymeric material,
wherein the balloon is configured to have a nominal diameter between 13 mm to 14 mm and a nominal inflation pressure at or below 6 atm,
wherein the balloon is configured to be inflated to a curved conformation requiring 16% total strain at a pressure of 6 atm to 8 atm such that the balloon exhibits less than a 4N increase in mean straightening force,
wherein the balloon is configured to remain kink-free when inflated in the curved conformation, and
wherein the balloon is capable of perfusion.

2. The medical balloon of claim 1 , wherein the balloon is configured to inflate to the nominal diameter in response to introduction of a fluid at a first pressure, wherein the fluid begins to perfuse through the balloon at a second pressure, the second pressure being greater than the first pressure,
wherein the balloon wall is configured such that it can be inflated by an inflation to a curved configuration having a neutral axis requiring 20% total strain, the medical balloon in the curved configuration having a working length including an inner arc, a center axis, an outer arc where a portion of balloon wall extending along the inner arc undergoes at least 5% compressive strain,
wherein the center axis of the balloon and the neutral axis of the curved configuration are co-radial.

3. The medical balloon of claim 1 , where the balloon exhibits less than a 3.5 N increase in mean straightening force when inflated from a pressure of 6 atm to 8 atm while in the curved conformation requiring 16% total strain.

4. The medical balloon of claim 1 , where the balloon exhibits a mean straightening force less than 12 N at a pressure of 8 atm while in the curved conformation requiring 16% total strain.

5. The medical balloon of claim 1 , where the mean straightening force is determined with a 3-point bend fixture.

6. The medical balloon of claim 1 , wherein the polymeric material comprises a porous microstructure.

7. The medical balloon of claim 6 , wherein the porous microstructure comprises a node and fibril microstructure.

8. The medical balloon of claim 6 , wherein the porous microstructure is highly fibrillated.

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

10. The medical balloon of claim 6 , wherein the porous microstructure is expanded polyethylene.

11. The medical balloon of claim 1 , wherein the nominal inflation pressure is greater than 4 atm and at or below 6 atm.

12. The medical balloon of claim 1 , wherein an outer surface of the medical balloon is coated with a therapeutic agent.

13. The medical balloon of claim 1 , further comprising an endovascular medical device disposed about the balloon in a delivery configuration.

14. The medical balloon of claim 13 , wherein the endovascular medical device comprises at least one of a stent and a stent graft.

15. The medical balloon of claim 14 , wherein the endovascular medical device comprises said stent and said stent comprises a plurality of discrete annular stent members.

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