Valvuloplasty catheter

• US 9,375,555 B2
• Filed: 06/25/2013
• Issued: 06/28/2016
• Est. Priority Date: 07/18/2003
• Status: Active Grant

• Current Assignee: InterValve Medical, Inc.
• Original Assignee: InterValve, Inc. (Venus Medtech (Hangzhou), Inc.)
• Inventors: Pedersen, Wesley, Van Tassel, Robert A., Schwartz, Robert S., Brucker, Gregory G., Greenhalgh, Skott E.
• Primary Examiner(s): BUI, VY Q
• Application Number:
  US13/926,924
• Publication Number:
  US 20130289607A1
• Time in Patent Office: 1,099 Days
• Field of Search: 606/191, 606/194, 606/195, 606/198, 604/96.01
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2433 using balloon catheter
• 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 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

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

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.

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

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.

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.