Valvuloplasty catheter and methods

• US 9,504,807 B2
• Filed: 11/07/2014
• Issued: 11/29/2016
• 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): Hayman, Imani
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US14/535,724
• Publication Number:
  US 20150066069A1
• Time in Patent Office: 753 Days
• Field of Search: 604/500, 604/509, 604/103.13, 604/100.1, 606/194
• US Class Current: 1/1
• 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
• 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 a balloon assembly comprising:

a plurality of balloons, each having a proximal end, a distal end, and an exterior surface composed of expandable material and each having a length extending axially relative to said balloon catheter;

each of said plurality of balloons being directly attached to said exterior surfaces of adjacent balloons via attachment sites along said length of said plurality of balloons, such that said exterior surfaces of said plurality of balloons are arranged around an axis of said balloon catheter and define a single central flow area that extends linearly along said plurality of balloons;

said single central flow area being accessible to said lumen of said body vessel between said proximal ends and said distal ends of said plurality of balloons so as to allow blood to perfuse between said proximal ends and said distal ends of said plurality of balloons when inflated; and

,

an inflation passage connected to said plurality of balloons, causing inflation or deflation of said plurality of balloons.

2. A balloon catheter for dilating tissue of a lumen of a body vessel, said balloon catheter having an expandable balloon assembly with a central linear axis located at a distal end of said balloon catheter, said balloon assembly comprising:

A. at least three individual balloons aligned axially and surrounding said central linear axis, said at least three individual balloons being in intimate contact with each other and being attached to neighboring balloons along an axial length of each of said at least three individual balloons at attachment sites, each of said at least three individual balloons having an outer surface of expandable material and being attached to a manifold that communicates with an inlet port located at a proximal end of said balloon catheter, said manifold providing access for inflation fluid under pressure to the interiors of said at least three individual balloons to inflate said at least three individual balloons from a smaller diameter to a larger diameter;

B. a single central flow area located collinearly with said central linear axis and formed by said outer surfaces of said at least three individual balloons along an entire length of said at least three individual balloons via direct contact with each of said at least three individual balloons and extending contiguously throughout a cross section of said balloon assembly along said entire length of said at least three individual balloons;

said central linear axis of said balloon assembly extending through said single central flow area of said balloon assembly;

C. said single central flow area having an access between proximal ends of said at least three individual balloons and access between distal ends of said at least three individual balloons so as to allow passage for blood from the lumen of the body vessel, between said proximal ends, through said single central flow area, and out from between said distal ends while each of said at least three individual balloons are inflated to said larger diameter.

3. The balloon catheter of claim 2 wherein said balloon assembly has an external wrap positioned around all of said at least three individual balloons.

4. The balloon catheter of claim 3 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 at least three individual balloons to a larger diameter to dilate the tissue.

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

6. The balloon catheter of claim 2 wherein each of said at least three 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 at least three individual balloons.

7. The balloon catheter of claim 2 wherein said at least three individual balloons are disposed between said single central flow area and the tissue of the body vessel.

8. The balloon catheter of claim 2 wherein said single central flow area enlarges in diameter upon inflation of said at least three individual balloons.

9. The balloon catheter of claim 2 wherein said inlet port and said manifold are located away from said central linear axis.