Valvuloplasty Catheter And Methods

• US 20150066069A1
• Filed: 11/07/2014
• Published: 03/05/2015
• 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 9,504,807 B2
• Time in Patent Office: Days
• 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 balloon catheter for dilating tissue of a lumen of a body vessel, said balloon catheter having an expandable balloon located at its distal end, said balloon comprising;

A. at least 3 individual balloons aligned axially along an axis and in intimate contact with each other forming attachment sites, each of said individual balloons being attached to a manifold that communicates with an inlet port located at the proximal end of the catheter, said manifold providing access for inflation fluid under pressure to the interiors of said individual balloons to inflate said individual balloons from a smaller diameter to a larger diameter;

B. A central flow area located along said axis and in direct contact with a portion of each of said individual balloons;

said central flow area not making fluid communication with said interiors of said individual balloons;

C. Said central flow area providing passage for a fluid from the lumen of the body vessel at a proximal end of said balloon to the lumen of the body vessel at a distal end of said balloon while each of said individual balloons are inflated to said larger diameter and into contact with the tissue during tissue dilation.

2. The balloon catheter of claim 1 wherein said balloon has an external wrap positioned around said individual balloons.

3. The balloon catheter of claim 2 wherein said external wrap forms a separate passage for an external inflation fluid, said external inflation fluid providing for expansion of said external wrap during expansion of said balloon to a larger diameter to dilate the tissue.

4. The balloon catheter of claim 3 wherein said external wrap has a bulbous shape with a smaller diameter waist located between two larger diameter bulbs.

5. The balloon catheter of claim 3 further comprising an internal passage that provides a confined flow space for fluid flow through said central flow area.

6. The balloon catheter of claim 1 wherein said individual balloons are formed an inner balloon half and an outer balloon half, said inner balloon half being bonded to said outer balloon half to form balloon-type cylindrical shapes that form said individual balloons.