Positionable valvuloplasty catheter

• US 9,242,081 B2
• Filed: 09/13/2011
• Issued: 01/26/2016
• Est. Priority Date: 09/13/2010
• Status: Active Grant

• Current Assignee: InterValve Medical, Inc.
• Original Assignee: InterValve, Inc. (Venus Medtech (Hangzhou), Inc.)
• Inventors: Drasler, William, Pedersen, Wesley, Ungs, Mark
• Primary Examiner(s): Miles, Jonathan W
• Assistant Examiner(s): Scherbel, Todd J
• Application Number:
  US13/231,807
• Publication Number:
  US 20120083809A1
• Time in Patent Office: 1,596 Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2025/1059 having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties with different compartments A61M2025/1072
• CPC Class Codes: A61M 2025/1072 having balloons with two or more compartments
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

In one embodiment, a balloon catheter is provided for use during annuloplasty. Preferably, the balloon includes a distal, noncompliant portion and a proximal semi-compliant portion which allows for sequential inflation, reliable positioning, and compliance measurement.

Claims

1. A balloon valvuloplasty catheter comprising:

a balloon disposed at a distal end of an elongated shaft;

a non-compliant distal bulb of said balloon having a fully inflated distal bulb diameter at a fully inflated distal bulb pressure of zero to 0.5 atm;

said non-compliant distal bulb consisting solely of non-compliant material;

a semi-compliant proximal bulb having a smaller diameter than said distal bulb diameter at said fully inflated distal bulb pressure;

a waist portion of said balloon positioned between said distal bulb and said proximal bulb;

said waist portion having a fully inflated waist diameter that is smaller than said fully inflated distal bulb diameter at said fully inflated distal bulb pressure;

said proximal bulb having a fully inflated proximal bulb diameter at a pressure higher than said fully inflated distal bulb pressure;

said fully inflated waist diameter is smaller than said fully inflated proximal bulb diameter at a pressure higher than said fully inflated distal bulb pressure.

2. The balloon catheter of claim 1, wherein said waist portion is between 4-10 mm in length.

3. The balloon catheter of claim 1, wherein said proximal bulb has a diameter that is smaller than a diameter of said waist portion and a diameter of said distal bulb at a pressure of 0.1 to 1.0 atm.

4. The balloon catheter of claim 1, wherein said balloon forms a dogbone structure wherein said fully inflated waist diameter is smaller than said fully inflated proximal bulb diameter of said proximal bulb.

5. The balloon catheter of claim 1, for dilation of valve leaflets attached at their base to an annulus wherein said fully inflated waist diameter is from 1 to 3 mm smaller than the diameter of the annulus.

6. The balloon catheter of claim 1, wherein said semi-compliant proximal bulb is formed from a polymer including the material of polyurethane, silicone copolymers, or high compliance Nylon.

7. The balloon catheter of claim 1, wherein said non-compliant distal bulb is formed from a non-compliant polymer having less compliance than said semi-compliant proximal bulb, said non-compliant distal bulb formed from a non-compliant polymer including polyethylene therephthalate, low compliance Nylon, low compliance Pebax, and other low compliance polymer materials used in low compliance medical device balloons.

8. The balloon catheter of claim 1, wherein said proximal bulb further comprises non-compliant fibers attached to said semi-compliant material to provide a limit said fully inflated proximal diameter.

9. The balloon catheter of claim 1, wherein said waist portion comprises a non-compliant material.

10. The balloon catheter of claim 1, wherein said waist portion comprises a semi-compliant material.

11. The balloon catheter of claim 10, wherein said waist portion further comprises non-compliant fibers attached to said waist semi-compliant material.

12. The balloon catheter of claim 10 wherein said semi-compliant material of said waist portion is able to expand under increasing pressure and volume into contact with a valve annulus resulting in an inflection point in a plot of pressure versus volume.

13. The balloon catheter of claim 1, wherein said fully inflated waist diameter is 1-8 mm smaller than said fully inflated distal bulb diameter and said fully inflated proximal bulb diameter.

14. The balloon catheter of claim 1, wherein at least a portion of said balloon is formed from a coextrusion of a non-compliant polymer layer over a semi-compliant polymer layer, and said non-compliant polymer layer has been removed from the semi-compliant proximal portion.

15. The balloon catheter of claim 1, wherein said waist has a fully inflated waist diameter range of 16-26 mm.

16. The balloon catheter of claim 1, wherein said distal bulb has a fully inflated distal bulb diameter range of 20-30 mm.

17. The balloon catheter of claim 1, wherein said proximal bulb has a proximal bulb diameter range of 5-18 mm at a pressure of 0.2-0.5 atm.

18. A balloon valvuloplasty catheter comprising:

a balloon disposed at a distal end of an elongated shaft;

a proximal portion of said balloon comprising a semi-compliant material that unfolds to form a first diameter at zero pressure and is capable of expansion to a larger second diameter under increasing pressure;

a non-compliant distal portion of said balloon;

said non-compliant distal portion adapted to form a fully inflated distal diameter at a pressure of zero atm and comprising a non-compliant material, said distal portion being less compliant than said proximal portion, said distal portion having a larger diameter than said first diameter of said proximal portion at said zero pressure said distal portion consisting solely of non-compliant material;

a waist portion located between said proximal portion and said distal portion of said balloon comprising a semi-compliant material and having a fully inflated waist diameter that is smaller than said fully inflated distal diameter and smaller than said second larger diameter of said proximal portion;

wherein said proximal portion expands to a fully inflated proximal diameter at a higher pressure than said non-compliant distal portion expands to said fully inflated distal diameter.

19. The balloon catheter of claim 18, wherein said waist portion further comprises a plurality of fibers braided to restrict expansion of said waist portion to said fully inflated diameter.