Valvuloplasty catheter

• US 8,486,102 B2
• Filed: 05/19/2010
• Issued: 07/16/2013
• 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., Brucker, Gregory G., Greenhalgh, Skott E., Schwartz, Robert S.
• Primary Examiner(s): Bui, Vy Q
• Application Number:
  US12/783,438
• Publication Number:
  US 20100228277A1
• Time in Patent Office: 1,154 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 valvuloplasty device comprising:

a balloon forming only a single chamber shaped for dilating aortic valve leaflets and having a proximal region, a distal region, and a middle region;

said proximal region being composed of a semi-compliant material;

at a first pressure throughout said single chamber, said distal region forms a first diameter that is larger than a second diameter of said proximal region;

at a second pressure throughout said single chamber and being higher than said first pressure, said distal region forms a third diameter that is greater than a fourth diameter of said middle region;

at said second pressure, said proximal region having a fifth diameter that is larger than said fourth diameter of said middle region.

2. The valvuloplasty device of claim 1, wherein said semi-compliant material of said proximal region further comprises a variably compliant material that is expandable at different rates to sequentially lock said balloon from movement and expand the aortic valve leaflets.

3. The valvuloplasty device of claim 1, wherein said distal region comprises a non-compliant material.

4. The valvuloplasty device of claim 1, wherein said middle region comprises a non-compliant material.

5. The valvuloplasty device of claim 1, wherein said middle region is contiguous with said distal region.

6. The valvuloplasty device of claim 1, wherein said middle region is contiguous with said proximal region.

7. The valvuloplasty device of claim 1, wherein said semi-compliant proximal region is formed of an elastomeric material.

8. The valvuloplasty device of claim 1, wherein said proximal region comprises a fabric.

9. The valvuloplasty device of claim 8, wherein said fabric comprises a braided fabric, a woven fabric, or a knitted fabric.

10. The valvuloplasty device of claim 8, wherein said fabric comprises yarn, and wherein said yarn comprises partially oriented yarns, oriented yarns, or stretchable yarns.

11. The valvuloplasty device of claim 8, wherein said distal region has a fabric contained therein.

12. The valvuloplasty device of claim 11, wherein said fabric comprises braided fabric, woven fabric, or knitted fabric.

13. The valvuloplasty device of claim 11, wherein said fabric comprises yarn and wherein said yarn comprises partially oriented yarns, oriented yarns, or stretchable yarns.

14. The valvuloplasty device of claim 1, wherein an external fabric placed around a portion of said balloon limits the opening of said balloon under pressure such that said distal region expands first.

15. The valvuloplasty device of claim 14, wherein said fabric comprises a braided fabric, woven fabric, or knitted fabric.

16. The valvuloplasty device of claim 14, wherein said fabric comprises yarn and wherein said yarn comprises partially oriented yarns, oriented yarns, or stretchable yarns.

17. The valvuloplasty device of claim 1, wherein said fifth diameter of said proximal region is larger than a sixth diameter of said proximal region at said second pressure, such that said aortic valve leaflets can be adjustably dilated.

18. A valvuloplasty balloon for dilating valve leaflets comprising:

only a single chamber formed by said valvuloplasty balloon;

a proximal segment and a distal segment;

at a first lower pressure throughout said single chamber, said distal segment having a first portion with a larger diameter than a second portion of said distal segment and said proximal segment;

at a second higher pressure throughout said single chamber, said proximal segment having a larger diameter than said second portion of said distal segment.

19. A valvuloplasty device for dilating aortic valve leaflets comprising:

a balloon comprising a proximal region having a first compliance, a distal region having a second compliance, and a middle region having a third compliance;

said balloon forming only a single chamber;

at a first pressure throughout said single chamber, said distal region having a first diameter that is greater than a second diameter of said proximal region and a third diameter of said middle region;

at a second pressure throughout said single chamber and being higher than said first pressure, said proximal region having a fourth diameter that is greater than a fifth diameter of said middle region;

at said second pressure throughout said single chamber, said distal region having a sixth diameter that is greater than said fifth diameter of said middle region.

20. A valvuloplasty balloon for dilating aortic valve leaflets forming a proximal region, a distal region, and a middle region;

said valvuloplasty balloon forming only a single balloon chamber;

said distal region having a first maximum inflated diameter greater than a second maximum inflated diameter of said middle region;

said first maximum inflated diameter being greater than a second diameter of said proximal region at a first lower pressure throughout said balloon chamber;

said proximal region being formed of a semi-compliant material and having a fourth diameter greater than said second maximum inflated diameter at a second higher pressure throughout said balloon chamber.