Tissue compression device for cardiac valve repair

Patent metadata

Field	Value
Publication number	US-2018353181-A1
Application number	US-201715616723-A
Country	US
Kind code	A1
Filing date	Jun 7, 2017
Priority date	Jun 7, 2017
Publication date	Dec 13, 2018
Grant date	—

Abstract

The present disclosure describes interventional devices, systems, and methods for closing a regurgitant gap in a cardiac valve. Interventional devices are configured to be deployed between two previously placed implants or between a previously placed implant and a valve commissure. The interventional devices compress captured leaflet tissue and/or apply a tensioning force along the line of coaptation to assist in closing the gap and reducing regurgitant flow through the gap.

First claim

1 . An interventional device for compressing cardiac valve tissue at a targeted gap, the device comprising:
a distal member; and a pair of opposing arms flexibly joined to the distal member, each arm extending proximally from the distal member to a free end, the pair of opposing arms defining an interior space between the arms for holding cardiac valve tissue,
wherein the arms have a default position, the arms being flexibly moveable apart from one another away from the default position to increase the interior space and to enable receiving cardiac valve tissue within the interior space, and
wherein the arms are configured to be biased toward the default position when moved apart from one another, the arms thereby providing a compressive force upon cardiac valve tissue held within the interior space.

2 . The interventional device of claim 1 , wherein the device is configured in size and shape for deployment at a targeted gap measuring about 2 to 8 mm.

3 . The interventional device of claim 1 , further comprising a plurality of frictional elements configured to engage with the cardiac valve tissue held within the interior space, the frictional elements being disposed on an interior side of one or both of the arms.

4 . The interventional device of claim 1 , wherein one or both of the free ends flare outwardly.

5 . The interventional device of claim 1 , further comprising a neck section joining the distal member to the arms, the neck section being configured as a flexible living hinge from which the arms can flex.

6 . The interventional device of claim 1 , further comprising an attachment point at the distal member for attaching to a delivery device.

7 . The interventional device of claim 1 , further comprising an anchor configured to couple to the distal member, the anchor extending through the interior space, and the anchor having a width greater than a width of the distal member or the arms.

8 . The interventional device of claim 7 , wherein the anchor includes a textured surface configured to encourage tissue ingrowth.

9 . The interventional device of claim 7 , wherein the anchor has a width of about 5 to 8 mm.

10 . The interventional device of claim 1 , wherein a first arm extends proximally from the distal member to form an inner member, and wherein a second arm extends proximally from the distal member and loops back distally to form a pair of outer members, the inner member being laterally offset from each of the outer members.

11 . The interventional device of claim 1 , wherein the device is formed from a shape-memory material such that the free ends, when deployed distally, sweep around proximally to grasp targeted cardiac valve tissue.

12 . The interventional device of claim 1 , wherein one or both of the arms include a force-distributing wire pattern.

13 . An interventional system for compressing cardiac valve leaflet tissue at a targeted gap of a cardiac valve, the system comprising:
an interventional tissue compression device, the compression device comprising:
a distal member; and
a pair of opposing arms flexibly joined to the distal member, each arm extending proximally from the distal member to a free end, the pair of opposing arms defining an interior space between the arms for holding leaflet tissue,
wherein the arms have a default position, the arms being flexibly moveable apart from one another away from the default position to increase the interior space and to enable receiving leaflet tissue within the interior space, and
wherein the arms are configured to be biased toward the default position when moved apart from one another, the arms thereby providing a compressive force upon leaflet tissue held within the interior space; and
a self-centering delivery catheter, the delivery catheter including a pair of laterally extending fins extending from a distal section of the delivery catheter, the fins enabling alignment of the delivery catheter with a line of coaptation at the targeted gap.

14 . The system of claim 13 , wherein the fins are configured to be intra-procedurally adjustable in width.

15 . The system of claim 14 , wherein the distal section of the delivery catheter includes a pair of skives and a corresponding pair of wires laterally extendable through the skives to form the fins.

16 . The system of claim 15 , wherein the wires extend through a lumen of the delivery catheter such that width of the fins is controllable via translation of the wires.

17 . A method of reducing regurgitation through a cardiac valve by compressing leaflet tissue at a targeted gap of the cardiac valve, the method comprising:
delivering an interventional tissue compression device to the targeted gap, the compression device comprising:
a distal member; and
a pair of opposing arms flexibly joined to the distal member, each arm extending proximally from the distal member to a free end, the pair of opposing arms defining an interior space between the arms for holding leaflet tissue,
wherein the arms have a default position, the arms being flexibly moveable apart from one another away from the default position to increase the interior space and to enable receiving leaflet tissue within the interior space, and
wherein the arms are configured to be biased toward the default position when moved apart from one another, the arms thereby providing a compressive force upon leaflet tissue held within the interior space; and
deploying the compression device at the targeted gap to compress the leaflet tissue and reduce regurgitant flow through the targeted gap.

18 . The method of claim 17 , wherein the targeted gap is at a mitral valve.

19 . The method of claim 18 , wherein the targeted gap is disposed between two previously deployed implants or between a previously deployed implant and a valve commissure.

20 . The method of claim 18 , wherein the compression device is delivered to the ventricular side of the mitral valve, and then is retracted proximally to enable the arms to grasp the leaflet tissue at the ventricular side of the mitral valve.

Assignees

• Evalve Inc

Inventors

• Wei Michael F

Classifications

• A61B2017/00243

  cardiac · CPC title

• A61B17/1227

  Spring clips · CPC title

• A61F2/246

  Devices for obstructing a leak through a native valve in a closed condition · CPC title

• A61B17/083 Primary

  Clips, e.g. resilient · CPC title

• A61B2017/00783

  Valvuloplasty · CPC title