HEART AND PERIPHERAL VASCULAR VALVE REPLACEMENT IN CONJUNCTION WITH A SUPPORT RING

• US 20160120642A1
• Filed: 05/23/2014
• Published: 05/05/2016
• Est. Priority Date: 05/24/2013
• Status: Abandoned Application

• Current Assignee: ValCare Medical, Inc.
• Original Assignee: ValCare, Inc.
• Inventors: SHAOLIAN, SAMUEL M., YELLIN, NADAV, EFTEL, AVI, DUMONTELLE, JEFFREY
• Application Number:
  US14/893,131
• Publication Number:
  US 20160120642A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval

Abstract

An implantable valve replacement system for a cardiovascular valve may include an adjustable stabilizing ring. The stabilizing ring may be composed of a body member that is transitionable from an elongate insertion geometry to an annular operable geometry. The stabilizing ring may further include a plurality of anchors deployable in the annular operable geometry to engage the annulus of the cardiovascular valve. The ring may be used in conjunction with an implantable valve frame. The valve frame may be located within the ring and the ring, in turn, may be stabilized through the anchors engaging the valve annulus. The valve replacement system may be applied by engaging the ring in its annular operable geometry with the valve annulus through the anchors. The valve frame may be inserted through the opening of the ring, thereby forming a stabilizing mechanical contact between the frame and the annulus.

Claims

1. An implantable valve system comprising:

an adjustable stabilizing ring comprising;

a body member that is transitionable from an elongate insertion geometry to an annular operable geometry, and

a plurality of anchors deployable in the annular operable geometry to engage the annulus of a cardiovascular valve; and

an implantable valve frame in mechanical communication with the adjustable stabilizing ring,

wherein the elongate insertion geometry is configured to allow percutaneous passage of the stabilizing ring, via a catheter, to a position adjacent to an annulus of the cardiovascular valve, and

wherein the annular operable geometry has a closed state to conform to the annulus of the cardiovascular valve.

2. The implantable valve system of claim 1, wherein the implantable valve frame comprises one, two, or three valve leaflets.

3. The implantable valve system of claim 1, wherein the adjustable stabilizing ring, the implantable valve frame, or both are coated with a pliable material comprising a polymer.

6. The implantable valve system of claim 1, wherein the implantable valve frame comprises a first support element, a second support element, and at least one bridging element extending from the first support element to the second support element.

7. The implantable valve system of claim 6, wherein the implantable valve frame further comprises one, two, or three valve leaflets at least partially secured to the first support element, the second support element, the at least one bridging element, or any combination thereof.

8. The implantable valve system of claim 6, wherein the at least one bridging element comprises a continuous surface having a first end and a second end, wherein the first end is in physical contact with an entirety of the first support element and the second end is in physical contact with an entirety of the second support element.

9. The implantable valve system of claim 6, wherein the at least one bridging element comprises a collapsible material.

12. The implantable valve system of claim 6, wherein the at least one bridging element extends radially inwards towards a central axis of the implantable valve frame.

13. The implantable valve system of claim 6, wherein at least a portion of an exterior surface of the at least one bridging element is in mechanical communication with the adjustable stabilizing ring.

14. The implantable valve system of claim 6, wherein the implantable valve frame comprises at least one ring anchor configured to stabilize the implantable valve frame in mechanical communication with the adjustable stabilizing ring.

17. The implantable valve system of claim 1, wherein the implantable valve frame comprises a plurality of elements disposed in a criss-cross arrangement.

18. The implantable valve system of claim 1, wherein the implantable valve frame comprises at least a portion of a stent.

20. The implantable valve system of claim 1, wherein the implantable valve frame is at least partially collapsible.

21. The implantable valve system of claim 20, wherein the implantable valve frame is configured to be delivered via a catheter in an at least partially collapsed state.

22. The implantable valve system of claim 20, wherein the at least partially collapsible implantable valve frame is expandable.

25. The implantable valve system of claim 1, wherein the implantable valve frame comprises one or more of a memory metal, a nickel titanium alloy, a stainless steel alloy, and a cobalt-chrome alloy.

26. The implantable valve system of claim 1, wherein the adjustable stabilizing ring in the annular operable geometry is rigid or semi-rigid in the closed state.

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27. A platform to stabilize an implantable valve frame, the platform comprising:

an adjustable stabilizing ring comprising;

a body member that is transitionable from an elongate insertion geometry to an annular operable geometry, and

a plurality of anchors deployable in the annular operable geometry to engage the annulus of a cardiovascular valve,

wherein the elongate insertion geometry is configured to allow percutaneous passage of the stabilizing ring, via a catheter, to a position adjacent to an annulus of the cardiovascular valve,

wherein the annular operable geometry has a closed state to conform to the annulus of the cardiovascular valve, and

wherein the adjustable stabilizing ring in the closed state of the annular operable geometry is configured to receive and stabilize the implantable valve frame at a position proximal to the annulus of the cardiovascular valve.

29. The platform of claim 27, wherein the body member in the annular operable geometry has an anterior-posterior diameter of about 17 mm to about 23 mm and a commissure-commissure diameter of about 28 mm to about 36 mm.

30. The platform of claim 27, wherein the adjustable stabilizing ring is rigid or semi-rigid.

31. The platform of claim 27, wherein the adjustable stabilizing ring has one of a D-shape, a circular shape, or an oval shape.

33. The platform of claim 27, wherein the adjustable stabilizing ring is radiopaque.

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34. A method of stabilizing a replacement of a cardiovascular valve, the method comprising:

inserting a distal end of a catheter comprising a delivery system into the cardiovascular valve;

guiding, via the delivery system, an adjustable stabilizing ring in an elongate geometry from a proximal end of the catheter to the distal end such that the adjustable stabilizing ring transitions to an annular operable geometry upon exiting the distal end of the catheter;

deploying a plurality of anchors from the adjustable stabilizing ring to engage an annulus of the cardiovascular valve;

guiding an implantable valve frame comprising the replacement of the cardiovascular valve through the cardiovascular valve and through a center of the adjustable stabilizing ring; and

engaging at least a portion of the implantable valve frame with the adjustable stabilizing ring, thereby stabilizing a position of the implantable valve frame with respect to the cardiovascular valve.

35. The method of claim 34, wherein engaging at least a portion of the implantable valve frame with the adjustable stabilizing ring comprises expanding the implantable valve frame thereby forming a mechanical contact between the implantable valve frame and the adjustable stabilizing ring.

37. The method of claim 35, wherein expanding the implantable valve frame comprises expanding the implantable valve frame with an expansion device.

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