IP Library Granted Patent US 9,375,555
Granted Patent B2
US 9,375,555 · App. 13/926,924 · Granted Jun 28, 2016

Valvuloplasty catheter

Inventors: Wesley Pedersen (Minneapolis, MN); Robert A. Van Tassel (Excelsior, MN); Robert S. Schwartz (Inver Grove Heights, MN); Gregory G. Brucker (Minneapolis, MN); Skott E. Greenhalgh (Glenside, PA)
Assignee: InterValve, Inc.
A61M29/02A61B17/22A61B17/3207A61M25/104A61B17/320725A61B2017/00783A61B2017/22051A61B2017/22061A61B2017/22098A61M25/1002A61M2025/1059
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Quick Facts
Patent No.
US 9,375,555
App. No.
13/926,924
Granted
Jun 28, 2016
Kind
B2
Abstract

The present invention provides an aortic valvuloplasty catheter which, in one preferred embodiment, has a tapered distal balloon segment that anchors within the left ventricle outflow track of the patient's heart and a rounded proximal segment which conforms to the aortic sinuses forcing the valve leaflets open. In addition, this embodiment of the valvuloplasty catheter includes a fiber-based balloon membrane, a distal pigtail end hole catheter tip, and a catheter sheath.

Claims (40)

1. A method for dilating heart valve leaflets comprising:

providing a catheter having a balloon; said balloon having a proximal section and a distal section;

inflating said proximal and distal sections to a first pressure in which said distal section engages a ventricular outflow tract via direct, circumferential contact, while maintaining said proximal section in a non-fully expanded configuration;

positioning said distal section upstream and adjacent a valve annulus; said distal section having a larger diameter than a diameter of said valve annulus and said proximal section having a smaller diameter than said diameter of said valve annulus;

positioning said proximal section downstream and adjacent to said valve leaflets;

dilating said heart valve leaflets with said proximal section by further inflating said balloon to a second pressure higher than said first pressure.

2. The method of claim 1 , wherein said balloon further comprises a middle section located between said proximal section and said distal section;

and wherein said middle section expands to a fully inflated middle section diameter that is less than a distal section diameter of said distal section at said second pressure.

3. The method of claim 2 , wherein said middle section diameter is less than a proximal section diameter at said second pressure.

4. A method of dilating valve leaflets, comprising:

advancing a balloon to a valve;

inflating a distal section and a proximal section of said balloon to a first pressure lower than about 1 atmosphere so as to expand a diameter of said distal section of said balloon larger than a diameter of said proximal section of said balloon; said distal section of said balloon expanding into direct, circumferential contact with a ventricular outflow tract;

positioning said distal section of said balloon upstream of an annulus of said valve;

further inflating said balloon to a second pressure higher than about 1 atmosphere so as to expand said proximal section of said balloon against said leaflets of said valve.

5. The method of claim 4 , further comprising a waist section of said balloon, located between said proximal section and said distal section; wherein said waist section is positioned at said annulus of said valve prior to inflating said balloon to said second pressure.

6. The method of claim 5 , wherein said waist section is restrained from dilating said annulus of said valve.

7. The method of claim 5 , wherein said waist section expands to a size smaller than said distal section at said first pressure.

8. The method of claim 5 , wherein said waist section expands to a size smaller than said proximal section at said second pressure.

9. A method of dilating valve leaflets or a valve with a balloon having a proximal region, a middle region, and a distal region, comprising:

positioning said middle region of a balloon upstream of a valve annulus;

exposing said proximal region, said middle region, and said distal region to an inflation pressure and expanding said distal region of said balloon via said inflation pressure to a radial size larger than a diameter of said valve annulus and into direct circumferential contact with a ventricular outflow tract;

positioning said balloon such that said middle region is located at said valve annulus and said distal region is located upstream of said valve annulus;

expanding a proximal region of said balloon via further inflation of said balloon, so as to expand said valve leaflets.

10. The method of claim 9 , wherein material of said distal region is more compliant than said proximal region.

11. The method of claim 9 , further comprising restricting with a fiber reinforcement the diametric growth of said proximal region larger than an aortic root sinus of said valve.

12. The method of claim 9 , further comprising restricting with a fiber reinforcement the diametric growth of said middle region to be less than said valve annulus.

13. The method of claim 9 , wherein said distal region comprises a wall thickness less than said proximal region, so as to provide increased compliance of said distal region as compared with said proximal region.

14. The method of claim 1 , wherein said balloon is constructed of a membrane material comprising silicone, polyurethane, or a highly elastic polymer.

15. The method of claim 11 , wherein said fiber reinforcement comprises a woven, braided, or knit structure.

16. The method of claim 12 , wherein said fiber reinforcement comprises a woven, braided, or knit structure.

17. The method of claim 11 , wherein said fiber reinforcement comprises partially oriented yarns.

18. The method of claim 12 , wherein said fiber reinforcement comprises partially oriented yarns.

19. The method of claim 11 , wherein said fiber reinforcement comprises non-compliant yarns.

20. The method of claim 12 , wherein said fiber reinforcement comprises non-compliant yarns.

21. The method of claim 11 , wherein said fiber reinforcement comprises polyethylene terephthalate or nylon yarn.

22. The method of claim 12 , wherein said fiber reinforcement comprises polyethylene terephthalate or nylon yarn.

23. The method of claim 11 , wherein said fiber reinforcement is formed from elastic filaments that restrain expansion at low pressure and expand in a compliant manner thereafter.

24. The method of claim 12 , wherein said fiber reinforcement is formed from elastic filaments that restrain expansion at low pressure and expand in a compliant manner thereafter.

25. The method of claim 11 , wherein said fiber reinforcement is formed from a wrapped yarn comprising an elastic filament wrapped by a noncompliant yarn.

26. The method of claim 12 , wherein said fiber reinforcement is formed from a wrapped yarn comprising an elastic filament wrapped by a noncompliant yarn.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 13, 2018
From: PEDERSEN, WESLEY; VAN TASSEL, ROBERT A.; SCHWARTZ, ROBERT S.; BRUCKER, GREGORY G.; GREENHALGH, SKOTT E.
To: INTERVALVE, INC.
Reel/Frame 046870/0682 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 12, 2018
From: INTERVALVE, INC.
To: INTERVALVE MEDICAL, INC.
Reel/Frame 046855/0290 →
RELEASE OF SECURITY INTEREST Recorded Oct 25, 2017
From: OXFORD FINANCE LLC
To: INTERVALVE, INC.
Reel/Frame 043946/0420 →
SECURITY INTEREST Recorded Jan 15, 2016
From: INTERVALVE, INC.
To: OXFORD FINANCE LLC
Reel/Frame 037500/0429 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 29, 2015
From: PEDERSEN, WESLEY; VAN TASSEL, ROBERT A.; SCHWARTZ, ROBERT S.; BRUCKER, GREGORY G.; GREENHALGH, SKOTT E.
To: INTERVALVE, INC.
Reel/Frame 034848/0928 →
Continuity (5)
Continuation 12783438 · May 19, 2010
Continuation 10846613 · May 14, 2004
Provisional Application 60488635 · Jul 18, 2003
Provisional Application 60547896 · Feb 25, 2004
Related Publication 20130289607A1 · Oct 31, 2013