Valvuloplasty catheter

• US 7,744,620 B2
• Filed: 05/14/2004
• Issued: 06/29/2010
• Est. Priority Date: 07/18/2003
• Status: Active Grant

• Current Assignee: InterValve Medical, Inc.
• Original Assignee: InterValve, Inc. (Venus Medtech (Hangzhou), Inc.)
• Inventors: Greenhalgh, Skott E., Pedersen, Wesley, Brucker, Gregory G., Schwartz, Robert S., Van Tassel, Robert A.
• Primary Examiner(s): Bui; Vy Q
• Application Number:
  US10/846,613
• Publication Number:
  US 20050075662A1
• Time in Patent Office: 2,237 Days
• Field of Search: 606/194, 606/195, 606/198, 623/1.11, 604/103.08, 604/101.05
• 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 with different compartments A61M2025/1072
• 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; and

,

a balloon disposed towards a distal end of said catheter;

said balloon in fluid communication with said lumen;

said balloon having a proximal region, a middle region and a distal region; and

,

said proximal region having a first maximum inflated diameter between about 24-30 mm;

sized to hyperextend valve leaflets against an aortic sinus said distal region having a second maximum inflated diameter sized to contact a ventricular outflow tract to reduce downstream migration of said balloon; and

said middle region having a third maximum inflated diameter smaller than said first maximum inflated diameter and said second maximum inflated diameter; and

substantially equal to a diameter of a patient'"'"'s valve annulus to ensure said annulus is not dissected.

2. The device of claim 1, wherein said proximal region expands at a first media pressure, and said distal region expands at a second media pressure.

3. The device of claim 2, wherein said proximal region having a first compliancy;

said distal region having a second compliancy and said middle region having a third compliancy.

4. The device of claim 1, wherein said is comprised of a variably compliant material so as to ensure expansion of said proximal region 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 balloon.

8. The device of claim 1 wherein said distal region is 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 according to claim 8, wherein said balloon includes at least one perfusion channel.

10. The device according to claim 9, 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.

11. The device of claim 1, wherein at least one perfusion channel is disposed within said balloon.

12. The device according to claim 11, wherein said at least one perfusion channel is disposed at a side of said balloon.

13. The device according to claim 12, wherein said at least one perfusion channel is comprised of two channels disposed at opposite sides of said balloon.

14. The device according to claim 11, wherein said perfusion passageway extends off-axis through said first expandable member.

15. The device according to claim 14, 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.

16. The device according to claim 15, wherein said perfusion passageway includes a tubular channel above said open channel.

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

18. The device according to claim 11, wherein said at least one perfusion channel extends through a longitudinal length of said balloon.

19. The device according to claim 18, wherein said perfusion channel includes a valve to control perfusion through said perfusion channel.

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

21. The device of claim 1, wherein said second maximum inflated diameter of said distal region is between about 20-28 mm.

22. The device of claim 1, wherein said distal region has a fusiform shape.

23. The device of claim 1, wherein said middle region includes a diameter restriction mechanism.

24. The device of claim 1, wherein said proximal region is about 18 mm in length.

25. The device of claim 1, wherein said distal region is about 15-20 mm in length.

26. A device for treating a heart valve comprising:

a tube;

a balloon disposed on said tube;

a first expandable region of said balloon disposed toward a distal end of said tube and having a first maximum inflated diameter sized to hyperextend valve leaflets against an aortic sinus;

a second expandable region of said balloon disposed toward said distal end of said tube and having a second maximum inflated diameter sized at about 20-28 mm to contact a ventricular outflow tract to reduce downstream migration of said balloon;

a third expandable region of said balloon disposed toward said distal end of said tube and being laterally adjacent said first expandable region and said second expandable region, said third expandable region having a third maximum inflated diameter smaller than said first maximum inflated diameter and said second maximum inflated diameter said third maximum inflated diameter being no greater than a diameter of a patient'"'"'s valve annulus to ensure said annulus is not dissected;

a first inflation media port disposed within said tube and communicating with said balloon.

27. A device according to claim 26, wherein said first expandable region has a first compliancy;

said second expandable region has a second compliancy; and

said third expandable region has a first compliancy.

28. The device of claim 26, wherein said second region has a fusiform shape.

29. The device of claim 26, wherein said first maximum inflated diameter of said first expandable region is sized between about 24-30 mm.

30. The device of claim 26, wherein said first expandable region is about 18 mm in length.

31. The device of claim 26, wherein said second expandable region is about 15-20 mm in length.

32. A device for performing valvuloplasty in a heart valve comprising:

a catheter having a lumen for transferring a media therethrough;

a balloon disposed towards a distal end of said catheter;

said balloon in fluid communication with said lumen and having a first region, a second region and a third region; and

said first region having a first maximum inflated diameter sized between about 24-30 mm to hyperextend valve leaflets against an aortic sinus;

said second region having a second maximum inflated diameter sized and shaped to be expandable to a diameter between 20-28 mm; and

a third region having a third maximum inflated diameter smaller than said first maximum inflated diameter and said second maximum inflated diameter, said third maximum inflated diameter being less than said first maximum inflated diameter and said second maximum inflated diameter, and being at most a diameter of a patient'"'"'s valve annulus to prevent said annulus from dissection.

33. A device according to claim 32, wherein said first region has a first compliancy;

said second region has a second compliance and said middle region has a third compliancy.

34. A device according to claim 33, wherein said first region expands at a first media pressure and said second region expands at a second media pressure.

35. A device according to claim 33, wherein first region and said second region simultaneously expand.

36. A device according to claim 33, wherein said balloon is a variably compliant balloon such that expansion of said first region occurs before expansion of said second region.

37. The device of claim 32, wherein said second region has a fusiform shape.

38. The device of claim 32, wherein said first region is about 18 mm in length and said second region is about 15-20 mm in length.

39. A device for performing valvuloplasty comprising:

a catheter having a lumen for transferring a media therethrough; and

,

a balloon disposed towards a distal end of said catheter;

said balloon in fluid communication with said lumen;

said balloon having a proximal region, a middle region and a distal region; and

, said proximal region having a first maximum inflated diameter;

said distal region having a second maximum inflated diameter and a fusiform shape to contact a ventricular outflow tract to reduce downstream migration of said balloon;

and said middle region having a third maximum inflated diameter smaller than said first maximum inflated diameter and said second maximum inflated diameter;

said third maximum inflated diameter being less than said first and second maximum inflated diameter wherein said first maximum inflated diameter of said proximal region is between about 24-30 mm and said second maximum inflated diameter of said distal region is between about 20-28 mm.

40. The device of claim 39, wherein said distal region is sized and shaped to expand into a profile that substantially matches a profile of a left ventricular outflow tract of said heart.

41. The device of claim 39, wherein said proximal region has a fusiform shape in said first maximum inflated diameter, shaped to hyperextend valve leaflets against an aortic sinus.