Fixation devices, systems and methods for engaging tissue

Patent metadata

Field	Value
Publication number	US-10653427-B2
Application number	US-201916408018-A
Country	US
Kind code	B2
Filing date	May 9, 2019
Priority date	Jun 27, 2001
Publication date	May 19, 2020
Grant date	May 19, 2020

Abstract

System for fixation of leaflets of a heart valve including an implantable fixation device including 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, and a second proximal element moveable relative to the second distal element between a first position and a second position. The system further includes a delivery device including a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion. The delivery device further includes a first proximal element line extending through the at least one lumen, the first proximal element line coupled to the first proximal element and actuatable to move the first proximal element between the first position and second position, and a second proximal element line extending through the at least one lumen, the second proximal element line coupled to the second proximal element and actuatable to move the second proximal element between the first position and second position. The first proximal element line and the second proximal element line are independently actuatable.

First claim

What is claimed is:

1. A system for fixation of leaflets of a heart valve comprising:
an implantable fixation device 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, and
a second proximal element moveable relative to the second distal element between a first position and a second position; and

a delivery device comprising:
a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion,
a first proximal element line extending through the at least one lumen, the first proximal element line coupled to the first proximal element and actuatable to move the first proximal element between the first position and second position, and
a second proximal element line extending through the at least one lumen, the second proximal element line coupled to the second proximal element and actuatable to move the second proximal element between the first position and second position,
wherein the first proximal element line and the second proximal element line are independently actuatable.

2. The system of claim 1 , wherein at least the first proximal element comprises nitinol.

3. The system of claim 1 , wherein the first proximal element is biased toward the first distal element; and the second proximal element is biased toward the second distal element.

4. The system of claim 1 , wherein the first proximal element and the second proximal element each comprises at least one barb extending therefrom.

5. A system for fixation of native leaflets of a heart valve comprising:
an implantable fixation device comprising:
a first distal element configured to engage a ventricular side of a first native leaflet and a second distal element configured to engage a ventricular side of a second native leaflet,
a first proximal element moveable relative to the first distal element between a first position and a second position and configured to grasp the first native leaflet between the first proximal element and the first distal element, and
a second proximal element moveable relative to the second distal element between a first position and a second position and configured to grasp the second native leaflet between the second proximal element and the second distal element; and

a delivery device comprising:
a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion,
a first proximal element line extending through the at least one lumen, the first proximal element line coupled to the first proximal element and actuatable to move the first proximal element between the first position and second position, and
a second proximal element line extending through the at least one lumen, the second proximal element line coupled to the second proximal element and actuatable to move the second proximal element between the first position and second position,
wherein the first proximal element line and the second proximal element line are independently actuatable.

6. The system of claim 5 , wherein at least the first proximal element comprises nitinol.

7. The system of claim 5 , wherein the first proximal element is biased toward the first distal element; and the second proximal element is biased toward the second distal element.

8. The system of claim 5 , wherein the first proximal element and the second proximal element each comprises at least one barb extending therefrom.

9. A system for fixation of leaflets of a heart valve comprising:
an implantable fixation device comprising:
a first distal element and a second distal element, and
a gripping arrangement consisting essentially of:
a first proximal element moveable relative to the first distal element between a first position and a second position, and
a second proximal element moveable relative to the second distal element between a first position and a second position; and

a delivery device comprising:
a catheter having a proximal end portion and a distal end portion, the implantable fixation device releasably coupled to the distal end portion of the catheter, the catheter defining at least one lumen extending between the proximal end portion and the distal end portion,
a first proximal element line extending through the at least one lumen, the first proximal element line coupled to the first proximal element and actuatable to move the first proximal element between the first position and second position, and
a second proximal element line extending through the at least one lumen, the second proximal element line coupled to the second proximal element and actuatable to move the second proximal element between the first position and second position,
wherein the first proximal element line and the second proximal element line are independently actuatable.

10. The system of claim 9 , wherein at least the first proximal element comprises nitinol.

11. The system of claim 9 , wherein the first proximal element is biased toward the first distal element; and the second proximal element is biased toward the second distal element.

12. The system of claim 9 , wherein the first proximal element and the second proximal element each comprises at least one barb extending therefrom.

Assignees

• Evalve Inc

Inventors

• Goldfarb Eric A
• Raschdorf Alfred H
• Erickson Sylvia Wen-Chin
• Dell Kent D
• Powell Ferolyn T
• Thornton Troy L
• Martin Brian B

Classifications

• A61B17/0469

  Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery · CPC title

• A61F2/246

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

• A61B17/122 Primary

  Clamps or clips, e.g. for the umbilical cord {(for the vas deferens A61F6/206)} · CPC title

• A61F2/2442

  Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve · CPC title

• A61B2017/00867

  shape memory effect · CPC title