Methods and devices for tissue grasping and assessment

Patent metadata

Field	Value
Publication number	US-2020323549-A1
Application number	US-202016912361-A
Country	US
Kind code	A1
Filing date	Jun 25, 2020
Priority date	Sep 27, 2004
Publication date	Oct 15, 2020
Grant date	—

Abstract

Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.

First claim

What is claimed is:

1 . A fixation device for fixation of leaflets of a heart valve, comprising:
a first distal element and a second distal element; a first proximal element moveable relative to the first distal element between a first position and a second position to grasp a first leaflet in a first target area defined by the first proximal element and the first distal element; a second proximal element moveable relative to the second distal element between a first position and a second position to grasp a second leaflet in a second target area defined by the second proximal element and the second distal element; a first indicator associated with the first distal element to indicate a presence of the first leaflet in the first target area, wherein the first indicator extends into the first target area and is configured to at least one of change shape or change orientation by the presence of the first leaflet grasped within the first target area; and a second indicator associated with the second distal element to indicate a presence of the second leaflet in the second target area, wherein the second indicator extends into the second target area and is configured to at least one of change shape or change orientation by the presence of the second leaflet grasped within the second target area.

2 . The method of claim 1 wherein the first indicator is configured to change shape by the presence of the first leaflet grasped within the first target area; and
wherein the second indicator is configured to change shape by the presence of the first leaflet grasped within the first target area.

3 . The method of claim 1 wherein the first indicator is configured to change orientation by the presence of the first leaflet grasped within the first target area; and
wherein the second indicator is configured to change orientation by the presence of the first leaflet grasped within the first target area.

4 . The fixation device of claim 1 , wherein the first indicator comprises an enhanced visibility material viewable using a visualization technique; and
wherein the second indicator comprises an enhanced visibility material viewable using the visualization technique.

5 . The fixation device of claim 4 , wherein the first distal element comprises an enhanced visibility material viewable using the visualization technique; and
wherein the second distal element comprises an enhanced visibility material viewable using the visualization technique.

6 . The fixation device of claim 4 , wherein the visualization technique comprises at least one of fluoroscopy, ultrasound, and echocardiography.

7 . The fixation device of claim 1 , wherein the first the first indicator is configured to be pressed toward the first distal element by the presence of the first leaflet grasped within the first target area; and
wherein the second indicator is configured to be pressed toward the second distal element by the presence of the second leaflet grasped within the second target area.

8 . The fixation device of claim 1 , wherein the first indicator extends from the first distal element to define a first angle θ 1 ; and
wherein the second indicator extends from the second distal element to define a second angle θ 2 .

9 . The fixation device of claim 8 , wherein the first angle θ 1 is configured to be changed by the presence of the first leaflet grasped within the first target area; and
wherein the second angle θ 2 is configured to be changed by the presence of the second leaflet grasped within the second target area

10 . The fixation device of claim 1 , wherein the first indicator comprises one or more wire elements; and
wherein the second indicator comprises one or more wire elements.

11 . The fixation device of claim 10 , wherein the one or more wire elements of the first indicator comprise an enhanced visibility material viewable using a visualization technique; and
wherein the one or more wire elements of the second indicator comprise an enhanced visibility material viewable using the visualization technique.

12 . The fixation device of claim 10 , wherein the one or more wire elements of the first indicator are biased towards the first proximal element; and
wherein the one or more wire elements of the second indicator are biased towards the second proximal element.

13 . The fixation device of claim 10 , where the one or more wire elements of the first indicator are configured to be pressed toward the first distal element by the presence of the first leaflet grasped within the first target area; and
wherein the one or more wire elements of the second indicator are configured to be pressed toward the second distal element by the presence of the second leaflet grasped within the second target area.

14 . A minimally invasive device comprising:
a first proximal element and a first distal element configured for grasping tissue therebetween; and a first indicator configured to indicate a presence of tissue in a first target area between the first proximal element and the first distal element.

15 . The device of claim 14 , wherein the first indicator comprises an enhanced visibility material viewable using a visualization technique.

16 . The device of claim 14 , wherein the first distal element comprises an enhanced visibility material viewable using a visualization technique.

17 . The device of claim 14 , wherein the first indicator is configured to change shape by the presence of tissue within the target area.

18 . The device of claim 17 , wherein the first indicator is configured to extend into the target area in the absence of tissue within the target area.

19 . The device of claim 14 , wherein the first indicator is configured to change orientation by the presence of tissue within the target area.

20 . The device of claim 19 , wherein the first indicator is configured to extend into the target area in the absence of tissue within the target area.

21 . The device of claim 14 , wherein the first indicator comprises a flap.

22 . The device of claim 14 , wherein the first indicator comprises one or more wire loops.

23 . The device of claim 14 , further comprising a second proximal element and a second distal element configured for grasping tissue therebetween; and
a second indicator configured to indicate a presence of tissue in a second target area between the second proximal element and the second distal element.

Assignees

• Evalve Inc

Inventors

• Goldfarb Eric A
• Thornton Troy L
• Raschdorf Alfred H
• Sarabia Jaime E
• Madden John P
• Powell Ferolyn T
• Martin Brian B
• Erickson Sylvia
• Komtebedde Jan
• Liao Yen C

Classifications

• A61F2/2478

  Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2/2487

  Devices within the heart chamber, e.g. splints · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F2230/001

  Figure-8-shaped, e.g. hourglass-shaped · CPC title