Tissue tensioning device for cardiac valve repair

Patent metadata

Field	Value
Publication number	US-2018353182-A1
Application number	US-201715616727-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 tensioning cardiac valve tissue at a targeted gap, the device comprising:
a distal section; a proximal section; and an intermediate section disposed between and joining the distal section and the proximal section,
wherein the intermediate section has a default width, the intermediate section being laterally compressible from the default width to a compressed width sized for fitting within the targeted gap, and
wherein the intermediate section is configured to be biased toward the default width when compressed, the intermediate section thereby providing a tensioning force upon edges of the targeted gap.

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 , wherein the proximal section has a width that is greater than the default width of the intermediate section.

4 . The interventional device of claim 1 , wherein the tissue interventional device is formed as an open wire structure.

5 . The interventional device of claim 4 , wherein the proximal section includes a pair of free ends of the wire structure, the free ends extending distally to form the intermediate section and then closing to form the distal section.

6 . The interventional device of claim 5 , wherein the free ends flare laterally outward relative to the intermediate section.

7 . The interventional device of claim 1 , wherein the interventional device has a substantially flat profile.

8 . The interventional device of claim 1 , wherein the proximal section and the distal section have widths greater than an expanded width of the intermediate section.

9 . The interventional device of claim 1 , further comprising an interior mesh.

10 . The interventional device of claim 1 , wherein the distal section includes a pair of opposing lateral members configured to compress tissue therebetween.

11 . The interventional device of claim 10 , wherein the opposing lateral members each extend to a bend and then extend proximally to form longitudinal members, the longitudinal members defining the intermediate section.

12 . The interventional device of claim 11 , wherein the longitudinal members meet and close to form the proximal section.

13 . The interventional device of claim 10 , wherein the device is formed from a shape-memory material such that free ends, when deployed distally, sweep around proximally to grasp targeted cardiac valve tissue.

14 . An interventional system for tensioning cardiac valve tissue at a targeted gap of a cardiac valve, the system comprising:
an interventional tissue tensioning device, the tensioning device comprising:
a distal section;
a proximal section; and
an intermediate section disposed between and joining the distal section and the proximal section,
wherein the intermediate section has a default width, the intermediate section being laterally compressible from the default width to a compressed width sized for fitting within the targeted gap, and
wherein the intermediate section is configured to be biased toward the default width when compressed, the intermediate section thereby providing a tensioning force upon edges of the targeted gap; 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.

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

16 . The system of claim 15 , 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.

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

18 . A method of reducing regurgitation through a cardiac valve by tensioning leaflet tissue at a targeted gap of the cardiac valve, the method comprising:
delivering an interventional tissue tensioning device to the targeted gap, the tensioning device comprising:
a distal section;
a proximal section; and
an intermediate section disposed between and joining the distal section and the proximal section,
wherein the intermediate section has a default width, the intermediate section being laterally compressible from the default width to a compressed width sized for fitting within the targeted gap, and
wherein the intermediate section is configured to be biased toward the default width when compressed, the intermediate section thereby providing a tensioning force upon edges of the targeted gap; and
deploying the tensioning device at the targeted gap to tension the leaflet tissue and reduce regurgitant flow through the targeted gap.

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

20 . The method of claim 19 , wherein the tensioning device is delivered to the mitral valve from an atrial approach.

Assignees

• Evalve Inc

Inventors

• Wei Michael F

Classifications

• A61B90/17

  for soft tissue, e.g. breast-holding devices · CPC title

• A61B17/00234 Primary

  for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence) · CPC title

• A61B17/08

  Wound clamps {or clips, i.e. not or only partly penetrating the tissue (suture bridges A61B17/0466); Devices for bringing together the edges of a wound} · CPC title

• A61B90/02

  Devices for expanding tissue, e.g. skin tissue (implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00) · CPC title

• A61B2017/081

  Tissue approximator (A61B2017/1103, A61B17/8866 take precedence) · CPC title