Apparatus and method for treating a regurgitant valve

• US 20070185571A1
• Filed: 01/31/2007
• Published: 08/09/2007
• Est. Priority Date: 02/06/2006
• Status: Abandoned Application

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Yadav, Jay, Kapadia, Samir
• Application Number:
  US11/700,295
• Publication Number:
  US 20070185571A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

An apparatus for treating regurgitation of blood through a diseased valve having at least one leaflet includes a valve member having a support structure with a diameter and at least one valvular leaflet attached to the support structure. The valve member is dimensioned so that at least one leaflet of the diseased valve abuts at least one surface of the valve member to mitigate regurgitation of blood through the diseased valve. The apparatus further includes a suspending mechanism operatively coupled to the valve member. The suspending mechanism is configured so that the valve member is freely suspended within the diseased valve.

Claims

1. An apparatus for treating regurgitation of blood through a diseased valve having at least one leaflet, said apparatus comprising:

a valve member comprising a support structure with a diameter and at least one valvular leaflet attached to said support structure, said valve member being dimensioned so that at least one leaflet of the diseased valve abuts at least one surface of said valve member to mitigate regurgitation of blood through the diseased valve; and

a suspending mechanism operatively coupled to said valve member, said suspending mechanism configured so that said valve member is freely suspended within the diseased valve.

2. The apparatus of claim 1, wherein said suspending mechanism is operatively securable to a vascular wall surrounding the diseased valve, said suspending mechanism positioned so that said valve member is freely suspended by said suspending mechanism within the diseased valve and at least a portion of said valve member is positioned adjacent to the at least one leaflet of the diseased valve, said portion contacting at least one surface of the at least one leaflet.

3. The apparatus of claim 1, wherein at least a portion of said valve member is configured to be positioned between the valve leaflets.

4. The apparatus of claim 1, wherein at least a portion of said valve member is configured to be positioned below the free ends of the valve leaflets.

5. The apparatus of claim 1, wherein at least a portion of said valve member is configured to be positioned approximately at a level of the annulus of the valve.

6. The apparatus of claim 1, wherein said valve member comprises a mechanical valve.

7. The apparatus of claim 1, wherein said valve member comprises a bioprosthetic valve.

8. The apparatus of claim 1, wherein said support structure is collapsible to a smaller diameter.

9. The apparatus of claim 1, wherein said support structure further comprises an adjustable sizing member for adjusting the diameter of said valve member within the diseased valve.

10. The apparatus of claim 9, wherein said adjustable sizing member further comprises an inflatable balloon encircling at least a portion of said support structure.

11. The apparatus of claim 1, wherein the diseased valve is located in the arterial vasculature.

12. The apparatus of claim 1, wherein the diseased valve is located in the venous vasculature.

13. The apparatus of claim 1, wherein the diseased valve is a heart valve.

14. A method for treating regurgitation of blood through a diseased valve, said method comprising the steps of:

providing an apparatus comprising a valve member and a suspending mechanism operatively coupled to the valve member, the valve member comprising a support structure with a diameter and at least one valvular leaflet attached to the support structure;

positioning a balloon in the diseased valve to determine the size and shape of the diseased valve;

selecting a valve member having a size and shape that corresponds to the size and shape of the diseased valve so that at least one leaflet of the diseased valve coapts with the valve member;

introducing the apparatus into a patient'"'"'s vasculature; and

positioning the apparatus in the diseased valve.

15. The method of claim 14, wherein the balloon comprises a first layer and second layer.

16. The method of claim 14, wherein the second layer encapsulates at least one portion of the first layer.

17. The method of claim 16, wherein the at least one portion of the second layer has a non-uniform thickness.

18. The method of claim 14, wherein said step of positioning the balloon in the diseased valve further comprises the steps of:

positioning the balloon in a deflated configuration in a regurgitant orifice of the diseased valve;

inflating the balloon so that blood flow through the regurgitant orifice is substantially hindered; and

measuring the geometry of the balloon in at least one of a plurality of dimensions.

19. The method of claim 14, wherein said step of positioning the apparatus in the diseased valve comprises the steps of:

extending the apparatus into a portion of the diseased valve; and

suspending the apparatus in the diseased valve so that at least one leaflet of the diseased valve coapts with the valve member to substantially hinder regurgitant bloodflow through the valve.

20. The method of claim 14, wherein said step of positioning the apparatus in the diseased valve further comprises the step of adjusting the diameter of the valve member by altering the diameter of the support structure.