Valvuloplasty Catheter And Methods

• US 20100094209A1
• Filed: 10/09/2009
• Published: 04/15/2010
• 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
• Granted Patent: US 7,951,111 B2
• Time in Patent Office: Days
• US Class Current: 604/95.04
• 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 medical device comprising:

an elongated tubular member having a proximal end connectable to a fluid delivery device and a distal end; and

,

a balloon disposed on a distal end of said elongated tubular member and in communication with the fluid delivery device;

said balloon having a distal region formed of a non-compliant material, a middle region formed of a semi-compliant material and a proximal region formed of a non-compliant material.

2. The medical device of claim 1, wherein at a first inflation pressure, a diameter of said middle region is less than a diameter of said distal region or proximal region.

3. The medical device of claim 2, wherein at a second inflation pressure larger than said first inflation pressure, said diameter of said middle region increases relative to said diameters of said proximal region and said distal region.

8. The medical device of claim 3, further comprising a support structure that limits the enlargement of said middle region.

9. The medical device of claim 8, wherein said support structure comprises a plurality of braided members bonded to said waist.

10. The medical device of claim 1, wherein said middle region comprises a support structure that restricts its axial length from enlargement as fluid volume is delivered to said balloon.

4. The medical device of claim 4, further comprising a pressure sensor in communication with an internal lumen of said balloon.

5. The medical device of claim 4, further comprising a display arranged to display a graph of pressure data versus time sensed with said pressure sensor.

6. The medical device of claim 5, further comprising a computer circuit configured to determine an inflection point of said pressure versus time data.

7. The medical device of claim 6, wherein said computer circuit is further configured to determine an annulus size based on said pressure data.

11. A medical device for dilating stenotic valve leaflets, comprising:

an elongated member sized for advancing within the vascular system of a patient;

a balloon disposed on a distal end of said elongated member and in communication with said lumen of said elongated member;

said balloon having a middle region comprising a semi-compliant material, a first end comprising a non-compliant material; and

a second end comprising a non-compliant material;

wherein when said balloon is brought to an equilibrium pressure, said middle portion forms a waist having a smaller diameter than said first end and said second end.

12. The medical device of claim 11, further comprising a pressure system configured to monitor a pressure within said balloon and determine a size of said middle portion of said balloon.

13. The medical device of claim 12, wherein said pressure system determines said size of said middle portion of said balloon.

14. The medical device of claim 13, wherein said pressure system monitors said pressure within said balloon for a pressure inflection point and wherein said inflection point indicates contact of said middle region with an annulus of a patient.

15. The medical device of claim 12, wherein said pressure system monitors said middle portion of said balloon for contact with a valve annulus of a patient.

16. A medical device for treatment of a patient, comprising:

an elongated member sized for advancing within the vascular system of a patient;

a fluid delivery device connected to a lumen of said elongated member;

a balloon disposed on a distal end of said elongated member and in communication with said lumen of said elongated member;

said balloon having a middle region, a distal region; and

a proximal region; and

a pressure system in communication with said balloon;

wherein said proximal region and said distal region are limited from expansion at a first inflation pressure and wherein said middle region is unrestricted from expansion at said first inflation pressure;

wherein said pressure system determines contact with said middle portion and said vasculature system at a pressure higher than said first inflation pressure.

17. The medical device of claim 16, wherein said pressure system and said volume sensor send signals to a computer chip that determines contact with said middle portion by detecting a change in a rate of pressure increase versus volume within said balloon.

18. The medical device of claim 17, wherein said computer chip determines a diameter of a valve annulus of a patient based on said change in said rate of pressure increase versus relative volume within said balloon.

19. The medical device of claim 18, wherein said distal region and said proximal region comprise non-compliant material and wherein said middle region comprises semi-compliant material.

20. The medical device of claim 19, wherein said middle region is smaller in diameter than said distal region and said proximal region when said balloon is inflated to an equilibrium pressure.

21-53. -53. (canceled)