DEVICES AND METHODS FOR POSITIONING AND MONITORING TETHER LOAD FOR PROSTHETIC MITRAL VALVE

• US 20160367368A1
• Filed: 08/30/2016
• Published: 12/22/2016
• Est. Priority Date: 03/10/2014
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: VIDLUND, Robert M., EKVALL, Craig A.
• Granted Patent: US 10,517,728 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

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.

Claims

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, 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.

2. The apparatus of claim 1, further comprising:

a tether securing device coupled to the handle assembly proximal to the force sensor device, the tether securing device configured to secure the tether extending through the elongate member and handle assembly at a fixed position relative to the handle assembly.

3. The apparatus of claim 1, further comprising:

a tether securing device coupled to the handle assembly proximal to the force sensor device, the tether securing device configured to secure a tether extending through the elongate member and handle assembly at a fixed position relative to the handle assembly,

the tether securing device configured to contact the force sensor device and exert the force on the force sensor device as the tether is pulled proximally to a desired tension.

4. The apparatus of claim 1, 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, the fluid chamber containing a volume of fluid, the volume of fluid being displaced when the force is exerted on the force sensor device.

5. The apparatus of claim 1, wherein the force sensor device includes a sensor housing and a load cell disposed within an interior of the sensor housing, the load cell being coupled to a transducer, the load cell configured to detect the force exerted on the force sensor device and communicate the detected force to the transducer.

6. 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 a tether extending through the elongate member and handle assembly.

7. 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 a tether extending through the elongate member and handle assembly.

8. The apparatus of claim 1, further comprising:

a rod member coupled to the handle assembly, the rod member having an indicator disposed at a distal end of the rod member,

the handle assembly including a transparent segment with indications, the indicator disposed at the distal end of the rod member being viewable through the transparent segment, a tether extending through the apparatus having a marker disposed thereon,

a location of the indicator relative to the indications on the transparent segment corresponding to a distance between a surface of the epicardial anchor device contacting the heart and an annulus of the heart when the marker on the tether is disposed proximal to a proximal end of the apparatus.

9. A method, comprising:

inserting a tether through an epicardial anchor device, the tether extending from a prosthetic heart valve implanted within the heart, the tether extending outside of the heart,

inserting the tether through a positioning device such that a proximal end of the tether extends outside a proximal end of the positioning device;

coupling the epicardial anchor device to a docking member disposed at a distal end of the positioning device;

pulling the tether proximally until a desired tension on the tether is achieved;

positioning the epicardial anchor device at a desired location on an outside wall of the heart;

after the positioning, securing the tether to the epicardial anchor device; and

releasing the epicardial anchor device from the docking member.

10. The method of claim 9, further comprising:

prior to the to the securing the tether to the epicardial anchor device, securing a proximal end portion of the tether to a tether securing device disposed at a proximal end of the positioning device;

increasing the tension on the tether by moving the epicardial anchor device distally while holding the tether securing device in a fixed position; and

releasing the tether from the tether securing device.

11. The method of claim 9, further comprising:

prior to the securing the tether to the epicardial anchor device, securing a proximal end portion of the tether to tether securing device disposed at a proximal end of the positioning device;

increasing the tension on the tether by moving the tether securing device with the tether secured thereto proximally relative to the epicardial anchor device; and

releasing the tether from the tether securing device.

12. The method of claim 10, wherein the moving the epicardial anchor device distally includes moving distally a tension member coupled to a rod member of the positioning device, the moving of the tension member configured to move distally a handle assembly, elongate member and the docking member of the positioning device.

13. The method of claim 11, wherein the positioning device includes a tension member coupled to a rod member, the tether securing device coupled to the rod member,

the increasing the tension on the tether includes rotating the tension member such that the rod member and tether securing device are both moved proximally relative to the epicardial anchor device.

14. The method of claim 9, wherein the positioning device includes a force sensor device, the method further comprising:

prior to the securing the tether to the epicardial anchor device, measuring a force exerted on the force sensor device, the force associated with a tension of the tether extending through the positioning device.

15. The method of claim 14, 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,

the measuring the force includes measuring a displacement of a volume of fluid disposed within the fluid chamber when a force exerted on the load washer.

16. The method of claim 14, wherein the force sensor device includes a sensor housing and a load cell disposed within an interior of the sensor housing,

the measuring the force includes measuring a deflection on the load cell caused by a force being exerted on the load cell.

17. 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 with a heart at a location on an exterior of a ventricular wall of the heart; and

a tether securing device coupled to the handle assembly proximal to the handle assembly, the tether securing device configured to secure the tether extending through the elongate member and handle assembly at a fixed position relative to the handle assembly.

18. The apparatus of claim 17, 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 a tether extending through the elongate member and handle assembly when the tether is secured to the tether securing device.

19. The apparatus of claim 17, 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 a tether extending through the elongate member and handle assembly.

20. The apparatus of claim 17, further comprising:

a rod member coupled to the handle assembly, the rod member having an indicator disposed at a distal end of the rod member,

the handle assembly including a transparent segment with indications, the indicator disposed at the distal end of the rod member being viewable through the transparent segment, a tether extending through the elongate member and handle assembly having a marker disposed thereon,

a location of the indicator relative to the indications on the transparent segment corresponding to a distance between a surface of the epicardial anchor device contacting the heart and an annulus of the heart when the marker on the tether is disposed proximal to a proximal end of the apparatus.

21. An apparatus comprising:

a tether release tool including a handle coupled to an elongate member, the elongate member including a shaped distal tip, the shaped distal tip having a shape corresponding to a shape of an opening in an epicardial anchor device configured to secure a tether extending from a prosthetic heart valve implanted within a heart to an outer wall the heart,

the distal tip of the elongate member configured to be received within the corresponding opening in the epicardial anchor device and used to unlock a tether pinning mechanism of the epicardial anchor device such that a tension on a tether secured to the epicardial anchor device can be adjusted.

22. The apparatus of claim 21, wherein the elongate member defines a distal opening in fluid communication with an access port, the distal opening of the elongate member configured to receive a portion of the unlocked tether therethrough and out through the access port such that the tether can be pulled proximally relative to the epicardial anchor device to adjust the tension on the tether.

23. A method, comprising:

inserting a distal tip of a tether release tool into an opening defined by an epicardial anchor device, the tether release tool including a handle coupled to an elongate member, the elongate member including the distal tip, the distal tip having a shape corresponding to a shape of the opening in the epicardial anchor device,

after the inserting, rotating the tether release tool to unlock a locking mechanism of the epicardial anchor device and release a tether coupled thereto;

removing the distal tip of the elongate member from the opening of the epicardial anchor device;

pulling the tether proximally relative to the epicardial anchor device to adjust a tension on the tether.

24. The method of claim 23, further comprising:

when a desired tension on the tether is achieved, inserting the distal tip of the elongate member into the opening of the epicardial anchor device; and

rotating the tether release tool to lock the locking mechanism of the epicardial anchor device and secure the tether to the epicardial anchor device.

25. The method of claim 23, further comprising:

prior to the pulling the tether, inserting a proximal end portion of the tether through a distal opening defined in the elongate member and out through an access port defined by the elongate member, the access port being in fluid communication with the distal opening.