Valvuloplasty devices and methods

• US 7,618,432 B2
• Filed: 05/27/2004
• Issued: 11/17/2009
• Est. Priority Date: 07/18/2003
• Status: Active Grant

• Current Assignee: InterValve Medical, Inc.
• Original Assignee: InterValve, Inc. (Venus Medtech (Hangzhou), Inc.)
• Inventors: Brucker, Gregory G., Schwartz, Robert S., Van Tassel, Robert A., Greenhalgh, Skott E., Pedersen, Wesley
• Primary Examiner(s): Bui; Vy Q
• Application Number:
  US10/856,494
• Publication Number:
  US 20050090846A1
• Time in Patent Office: 2,000 Days
• Field of Search: 606/191, 606/194, 606/195, 606/198, 604/96.01
• US Class Current: 606/194
• 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 of performing aortic valvuloplasty comprising:

providing a catheter having a balloon;

advancing said catheter towards an aortic valve;

expanding a first region of said balloon to a first maximum inflated diameter so as to contact a patient'"'"'s ventricular outflow tract to reduce downstream migration of said balloon;

expanding a second region of said balloon to a second maximum inflated diameter so as to hyperextend a patient'"'"'s valve leaflets against an aortic sinus; and

,

expanding a third region of said balloon to a third maximum inflated diameter that is smaller than said first and second maximum inflation diameter and substantially equal to a diameter of a patient'"'"'s valve annulus so as to prevent dissection of said annulus;

wherein said third region is located between said first region and said second region.

2. The method as set forth in claim 1, wherein said first region expands at a first media pressure and said second region expands at a second media pressure.

3. The method as set forth in claim 1, wherein said first region has a first compliancy, said second region has a second compliancy and said third region has a third compliancy.

4. The method as set forth in claim 3, wherein said first region expands prior to expansion by said second region.

5. The method as set forth in claim 1, further comprising, allowing perfusion of blood past said expandable member.

6. The method as set forth in claim 1, further comprising measuring a pressure proximal and distal to said aortic valve.

7. The method as set forth in claim 1, further comprising depositing an anti-restenosis agent in a region of said aortic valve.

8. The method according to claim 1, further comprising:

providing a sheath movable over said catheter such that movement of said sheath controls exposure of said balloon; and

,

stabilizing said balloon with said sheath after expanding said balloon.

9. The method of claim 1, wherein said first and second media pressures are substantially equal.

10. A method of treating a heart valve comprising:

identifying a target heart valve having diseased leaflets;

delivering a balloon an at said diseased leaflets; and

,

expanding a first region of said balloon to a first maximum inflated diameter so as to engage a patient'"'"'s ventricular outflow tract to reduce downstream migration of said balloon;

expanding a second region of said balloon to a second maximum inflated diameter so as to hyperextend a patient'"'"'s valve leaflets against an aortic sinus; and

,

expanding a third region of said balloon to a third maximum inflated diameter that is smaller than said first maximum inflated diameter and second maximum inflated diameter and not greater than a diameter of a patient'"'"'s valve annulus so as to prevent distension of said annulus

wherein said third region is located between said first region and said second region.

11. A method according to claim 10, wherein said first region expands at a first media pressure and said second region expands at a second media pressure.

12. A method according to claim 11, wherein said first region has a first compliancy, said second region has a second compliancy and said third region has a third compliancy.

13. A method according to claim 11, wherein said first region is shared to conform to a share of said ventricular outflow tract when expanded to said first maximum inflated diameter.