Heart and peripheral vascular valve replacement in conjunction with a support ring

• US 11,654,017 B2
• Filed: 10/27/2016
• Issued: 05/23/2023
• Est. Priority Date: 05/24/2013
• Status: Active Grant

• Current Assignee: ValCare Medical, Inc.
• Original Assignee: ValCare, Inc.
• Inventors: Shaolian, Samuel M., Yellin, Nadav, Eftel, Avraham, Dumontelle, Jeffrey
• Primary Examiner(s): Woznicki, Jacqueline
• Application Number:
  US15/336,310
• Publication Number:
  US 20170042670A1
• Time in Patent Office: 2,399 Days
• 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 having an elongate insertion geometry and an annular operable geometry and comprising a first end and a second end opposite the first end; and

wherein the first end is not engaged to the second end in the elongate insertion geometry, and

wherein the first end and second end are engaged in the annular operable geometry,

a plurality of anchors, housed within the body member in both the elongate insertion geometry and the annular operable geometry, wherein the plurality of anchors have a deployment configuration in the annular operable geometry configured to engage the annulus of a cardiovascular valve; and

an implantable valve frame comprising one or more valve leaflets, a portion of the implantable valve frame being in mechanical communication with a portion of the adjustable stabilizing ring,

wherein the implantable valve frame comprises at least one frame anchor configured to couple to the adjustable stabilizing ring and to stabilize the implantable valve frame,

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 adjustable stabilizing ring, the implantable valve frame, or both are coated with a pliable material comprising a polymer.

3. 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.

4. The implantable valve system of claim 3, wherein the one or more valve leaflets are at least partially secured to the first support element, the second support element, the at least one bridging element, or any combination thereof.

5. The implantable valve system of claim 3, 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.

6. The implantable valve system of claim 3, wherein the at least one bridging element is configured to be collapsible.

7. The implantable valve system of claim 3, wherein the at least one bridging element extends radially inwards from at least one of the first support element and the second support element towards a central axis of the implantable valve frame.

8. The implantable valve system of claim 3, 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.

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

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

11. The implantable valve system of claim 10, wherein the implantable valve frame is configured to be delivered via a catheter in an at least partially collapsed state.

12. The implantable valve system of claim 10, wherein the at least partially collapsible implantable valve frame is expandable.

13. The implantable valve system of claim 1, wherein the implantable valve frame comprises a shape memory metal.

14. An implantable valve system comprising:

an adjustable stabilizing ring comprising;

a body member having an elongate insertion geometry and an annular operable geometry and comprising a first end and a second end opposite the first end;

wherein the first end is not engaged to the second end in the elongate insertion geometry, and

wherein the first end and second end are engaged in the annular operable geometry; and

a plurality of anchors, housed within the body member in both the elongate insertion geometry and the annular operable geometry, wherein the plurality of anchors have a deployment configuration in the annular operable geometry configured to engage the annulus of a cardiovascular valve; and

an implantable valve frame comprising one or more valve leaflets, the implantable valve frame being in mechanical communication with the adjustable stabilizing ring,

wherein the implantable valve frame comprises at least one frame anchor configured to couple to the adjustable stabilizing ring and to stabilize the implantable valve frame,

wherein the elongate insertion geometry is configured to allow percutaneous passage of the stabilizing ring, via a catheter, to a position adjacent 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 stabilizing ring and the implantable valve frame are configured to be delivered via a single catheter.