Devices And Methods For Positioning And Monitoring Tether Load For Prosthetic Mitral Valve

Patent metadata

Field	Value
Publication number	US-2020113696-A1
Application number	US-201916681282-A
Country	US
Kind code	A1
Filing date	Nov 12, 2019
Priority date	Mar 10, 2014
Publication date	Apr 16, 2020
Grant date	—

Abstract

Apparatus and methods are described herein for positioning an epicardial anchor device and measuring the load of a tether extending from a prosthetic heart valve and coupled to the epicardial anchor device. In some embodiments, an apparatus includes a handle assembly coupled to an elongate member and a docking member coupled to a distal end of the elongate member. The docking member can be releasably coupled to an epicardial anchor device configured to secure a tether extending from a prosthetic heart valve implanted with a heart at a location on an exterior of a ventricular wall of the heart. A force sensor device is coupled to the handle assembly and can measure a force exerted on the force sensor device. The force is associated with a tension of the tether extending through the elongate member and handle assembly.

First claim

What is claimed is:

1 . An apparatus, comprising:
a handle assembly coupled to an elongate member; a docking member coupled to a distal end of the elongate member, the docking member configured to be releasably coupled to an epicardial anchor device configured to secure a tether extending from a prosthetic heart valve implanted within a heart at a location on an exterior of a ventricular wall of the heart; and a force sensor device coupled to the handle assembly and including a pinning mechanism, the force sensor device configured to measure a force exerted on the force sensor device, the force associated with a tension of the tether extending through the elongate member and handle assembly, the pinning mechanism configured to secure the tether to the force sensor device.

2 . The apparatus of claim 1 , wherein the docking member further includes a plurality of arms configured to be releasably coupled to the epicardial anchor device.

3 . The apparatus of claim 1 , further comprising:
a rod member coupled to the handle assembly; and a tension member coupled to the rod member, the tension member configured to be moved distally relative to the rod member to adjust the tension on the tether extending through the elongate member and handle assembly.

4 . The apparatus of claim 1 , further comprising:
a rod member coupled to the handle assembly; and a tension member coupled to the rod member, the rod member configured to be moved proximally when the tension member is rotated to adjust the tension on the tether extending through the elongate member and handle assembly.

5 . The apparatus of claim 1 , wherein the pinning mechanism includes a pin and a pin holder for receiving at least a portion of the pin, the pin configured to pierce and secure the tether to the force sensor device.

6 . The apparatus of claim 5 , wherein the force sensor device includes a load washer, a first portion of the pin holder being received within the load washer and a second portion of the pin holder extending from the load washer.

7 . The apparatus of claim 6 , wherein the load washer defines an opening configured to receive the tether, wherein, in a first position, the pin holder is at a first distance from the opening of the load washer and, in a second position, the pin holder is at a second distance from the opening of the load washer, the first distance being greater than the second distance.

8 . The apparatus of claim 7 , wherein, in the first position, a second portion of the pin is outside of the opening of the load washer and, in the second position, the second portion of the pin is received within the opening of the load washer.

9 . The apparatus of claim 8 , wherein the force sensor device includes a housing coupled to the elongate member, the housing defining an opening in communication with a lumen of the elongate member.

10 . The apparatus of claim 9 , wherein the housing receives a screw and a spring, the screw and spring configured to tune a pressure reading at a fixed load.

11 . A method comprising:
inserting a tether through an epicardial anchor device, the tether extending from a prosthetic heart valve implanted within a heart, the tether extending outside of the heart, coupling the epicardial anchor device to a docking member disposed at a first end of a positioning device; inserting the tether through the positioning device; actuating a pinning mechanism disposed at a second end of the positioning device to secure the tether to the positioning device; while the tether is secured to the positioning device, tensioning the tether until a desired tension on the tether is achieved; and releasing the epicardial anchor device from the docking member.

12 . The method of claim 11 , further comprising measuring a force exerted on the force sensor device, the force associated with a tension of the tether extending through the positioning device.

13 . The method of claim 12 , wherein the force sensor device includes a sensor housing, a fluid chamber disposed within the sensor housing and a load washer coupled to the sensor housing such that the fluid chamber is disposed between the sensor housing and the load washer, and measuring the force includes measuring a displacement of a volume of fluid disposed within the fluid chamber when a force is exerted on the load washer.

14 . The method of claim 11 , wherein the pinning mechanism includes a pin and a pin holder for receiving at least a portion of the pin, and wherein a first portion of the pin holder is received within the force sensor device and a second portion of the pin holder extends from the force sensor device, and actuating the pinning mechanism includes moving the second portion of the pin holder.

15 . The method of claim 14 , wherein the force sensor device defines an opening, and moving the second portion of the pin holder includes moving the pin holder towards the opening.

16 . The method of claim 15 , further comprising receiving the tether within the opening of the force sensor device and wherein moving the second portion of the pin holder includes securing the tether to the force sensor device.

17 . The method of claim 16 , wherein moving the second portion of the pin holder includes piercing, with the pin, the tether received in the opening of the force sensor device.

18 . The method of claim 15 , further comprising moving the second portion of the pin holder away from the opening of the force sensor device to release the tether.

19 . A system comprising:
an epicardial anchor device; a flexible member; a positioning device comprising:
a handle assembly coupled to an elongate member;
a docking member coupled to a distal end of the elongate member, the docking member releasably coupled to the epicardial anchor device and configured to secure the flexible member extending from a prosthetic heart valve implanted within a heart at a location on an exterior of a ventricular wall of the heart; and
a force sensor device coupled to the handle assembly and including a pinning mechanism, the force sensor device configured to measure a force exerted on the force sensor device, the force associated with a tension of the flexible member extending through the elongate member and handle assembly, the pinning mechanism configured to secure the flexible member to the force sensor device.

20 . The apparatus of claim 19 , wherein the pinning mechanism includes a pin and a pin holder for receiving at least a portion of the pin, the pin configured to pierce and secure the tether to the force sensor device.

Assignees

• Tendyne Holdings Inc

Inventors

• Ekvall Craig A
• Vidlund Robert M

Classifications

• A61F2220/0008

  Fixation appliances for connecting prostheses to the body · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2487 Primary

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

• A61F2/2457

  Chordae tendineae prostheses · CPC title

• A61F2/2427

  Devices for manipulating or deploying heart valves during implantation · CPC title