Valvuloplasty Catheter

• US 20100228277A1
• Filed: 05/19/2010
• Published: 09/09/2010
• Est. Priority Date: 07/18/2003
• Status: Active Grant

• Current Assignee: InterValve Medical, Inc.
• Original Assignee: InterValve, Inc. (Venus Medtech (Hangzhou), Inc.)
• Inventors: Tassel, Robert A. Van, Brucker, Gregory G., Schwartz, Robert S., Greenhalgh, Skott E., Pedersen, Wesley
• Granted Patent: US 8,486,102 B2
• Time in Patent Office: Days
• 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 device for performing valvuloplasty comprising:

a catheter having a lumen for transferring a media therethrough;

a first expandable member disposed towards a distal end of said catheter;

said expandable member in fluid communication with said lumen; and

,

said first expandable member having at least a first portion sized and shaped to be expandable to a profile substantially matching a profile of aortic root sinuses of an aorta connected to a heart.

2. The device of claim 1, wherein said first expandable member further includes a second portion located distal to said first portion, said second portion being sized and shaped to expand to a profile substantially matching a profile of a left ventricular outflow tract of said heart, and wherein said second portion expands at a first media pressure, and said first portion expands at a second media pressure.

3. The device of claim 2, wherein said first expandable member is sized and shaped such that said first media pressure is lower than said second media pressure such that said second portion expands prior to said first portion.

4. The device of claim 1, wherein said first expandable member is comprised of a variably compliant material so as to ensure expansion of said first portion into said profile substantially matching a profile of said aortic root sinuses.

5. The device of claim 1, wherein said catheter includes radiopaque markers.

6. The device of claim 1, wherein said lumen includes a port opening within said first expandable member.

7. The device of claim 1, wherein said catheter includes a screen deployable proximal to said first expandable member.

8. The device of claim 1 wherein said catheter includes a second expandable member disposed distal to said first expandable member, said second expandable member being sized and shaped to expand into a profile that substantially matches a profile of a left ventricular outflow tract of said heart.

9. The device of claim 1, wherein a perfusion passageway is disposed within said first expandable member.

10. The device of claim 1, wherein said expandable member includes axially aligned perfusion grooves.

11. The device according to claim 9, wherein said perfusion passageway extends through a longitudinal length of said first expandable member.

12. The device according to claim 11, wherein said perfusion channel includes a valve to control perfusion through said perfusion channel.

13. The device according to claim 9, wherein said perfusion passageway is comprised of at least one channel disposed at a side of said first expandable member.

14. The device according to claim 13, wherein said perfusion passageway is comprised of two channels disposed at opposite sides of said first expandable member.

15. The device according to claim 8, wherein said first expandable member includes at least one perfusion channel.

16. The device according to claim 15, wherein said at least one perfusion channel is comprised of two walls of said first expandable member spanned by a membrane connecting said two walls.

17. The device according to claim 9, wherein said perfusion passageway extends off-axis through said first expandable member.

18. The device according to claim 17, wherein said perfusion passageway includes an open channel disposed in a second portion of said expandable member, said second portion being distal to said at least a first portion.

19. The device according to claim 18, wherein said perfusion passageway includes a tubular channel above said open channel.

20. A method of performing aortic valvuloplasty comprising:

providing a catheter having an expandable member;

advancing said catheter towards an aortic valve;

securing said catheter in place; and

,

urging leaflets of said aortic valve into an open state by expanding at least a first portion of said expandable member to a profile that substantially matches a profile of the aortic root sinuses of an aorta.