Valvuloplasty catheter and methods

• US 8,900,264 B2
• Filed: 05/16/2011
• Issued: 12/02/2014
• Est. Priority Date: 10/10/2008
• Status: Active Grant

• Current Assignee: InterValve Medical, Inc.
• Original Assignee: InterValve, Inc. (Venus Medtech (Hangzhou), Inc.)
• Inventors: Drasler, William, Pedersen, Wes, Ungs, Mark
• Primary Examiner(s): Vu, Quynh-Nhu H
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US13/108,938
• Publication Number:
  US 20110218564A1
• Time in Patent Office: 1,296 Days
• Field of Search: 604/509, 606/193, 606/194
• US Class Current: 606/194
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• 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 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/1088 having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10186 One-way valves
• CPC Class Codes: A61M 25/10188 Inflation or deflation data displays
• 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: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A valvuloplasty catheter has a dog-bone shaped balloon with semi-compliant smaller diameter waist and non-compliant larger diameter bulbous end regions. The balloon centers across the valve with the waist adjacent to the annulus. One bulbous region serves to hyperextend the valve leaflets and the other assists in stabilizing the balloon position to reduce migration. The semi-compliant waist increases in diameter as fluid enters the balloon until it comes into contact with the valve annulus. The pressure within the balloon per unit of volume delivery has a greater slope after contact with the annulus than before resulting in a change in slope for the pressure versus volume curve. The diameter of the balloon and annulus are determined at this inflection point when the balloon contacts the annulus.

Claims

1. A method comprising:

providing a pressure system connectable to a catheter for fluid communication with a balloon disposed on a distal end of said catheter;

dilating valve leaflets with a first region of said balloon;

subsequent to said dilating said valve leaflets, expanding a second region of said balloon into contact with a valve annulus;

said pressure system determining contact between said second region of said balloon and said valve annulus;

wherein said first region of said balloon has a first diameter that is larger than a second diameter of said second region during said contact with said valve annulus.

2. The method of claim 1, wherein said second diameter is measured via fluoroscopy, ultrasound or electromagnetic energy.

3. The method of claim 1, wherein said balloon has a waist having a generally smaller diameter than a proximal and distal ends of said balloon during said dilating said valve leaflets.

4. The method of claim 1, wherein said pressure system further monitors a change in volume.

5. The method of claim 1, wherein said pressure system monitors a change in pressure and a change in volume within said balloon.

6. A method comprising:

providing a catheter;

providing a balloon having a first region and a second region, and being disposed on said catheter;

providing a pressure system communicable with an interior of said balloon;

said pressure system;

expanding said first region of said balloon to achieve a diameter larger than said second region and to dilate valve leaflets;

monitoring a change in pressure within said balloon;

subsequent to said expanding said first region of said balloon, expanding said second region of said balloon into contact with a valve annulus;

determining with said pressure system when said second region of said balloon contacts said valve annulus; and

,

at said contact with said valve annulus, said first region having a first diameter larger than a second diameter of said second region.

7. The method of claim 6, wherein said first region of said balloon comprises noncompliant material and said second region of said balloon comprises semi-compliant material.

8. The method of claim 7, wherein said second diameter is measured via fluoroscopy, ultrasound or electromagnetic energy.

9. The method of claim 8, wherein said balloon has a waist having a generally smaller diameter than a proximal and distal ends of said balloon during said expanding said first region of said balloon.

10. The method of claim 6, further comprising monitoring a change in volume in said balloon.

11. The method of claim 6, further comprising monitoring a change in volume within said balloon and determining said diameter of said second region.

12. The method of claim 6, further comprising determining said diameter of said second region based on determining contact between said second region of said balloon and said valve annulus.

13. The method of claim 6, wherein said first region of said balloon comprises noncompliant material and said second region of said balloon comprises semicompliant material.

14. A method for dilating a valve, the method comprising:

providing a balloon catheter having a balloon and being connectable to a fluid delivery device for inflating the balloon;

advancing the balloon catheter to the valve;

dilating leaflets of the valve to a larger diameter with a non-compliant region of the balloon;

expanding a semi-compliant region of the balloon subsequent to the dilating leaflets of the valve;

monitoring with a pressure system for contact between the semi-compliant region of the balloon with an annulus of the valve.

15. The method of claim 14, wherein said noncompliant region of said balloon is located proximally to said semicompliant region of said balloon.

16. The method of claim 15, wherein said semicompliant region of said balloon has a smaller diameter than said noncompliant region of said balloon during said dilating said leaflets.

17. The method of claim 15, wherein said balloon has a waist having a generally smaller diameter than a proximal and distal ends of said balloon during said dilating said leaflets of said valve.

18. The method of claim 15, further comprising monitoring a change in volume in said balloon.

19. The method of claim 15, further comprising monitoring a change in pressure and a change in volume within said balloon.

20. The method of claim 15, further comprising determining a diameter of said second region based on said monitoring for contact between said second region of said balloon with an annulus of said valve.

21. The method of claim 14, further comprising determining a diameter of said semi-compliant region based on said pressure system determining contact between said semi-compliant region of said balloon and said annulus of said valve.

22. The method of claim 21, wherein said diameter of said semi-compliant region is further determined by monitoring a change in pressure within said balloon.