Proximal Element Actuator Fixation And Release Mechanisms

Patent metadata

Field	Value
Publication number	US-2024074854-A1
Application number	US-202318507310-A
Country	US
Kind code	A1
Filing date	Nov 13, 2023
Priority date	Jul 15, 2019
Publication date	Mar 7, 2024
Grant date	—

Abstract

Fixation system for engaging tissue of a patient including an implantable fixation device having a first arm and a second arm, a first proximal element, a second proximal element, and a coupling member. The system includes a delivery device having a catheter, a shaft extending through the at least one lumen of the catheter, a first proximal element actuator and a second proximal element actuator. The second end portions of the first proximal element actuator and second proximal element actuator can be coupled to at least one of the shaft and the coupling member.

First claim

1 . A fixation system for engaging tissue of a patient, comprising:
an implantable fixation device comprising:
a first arm and a second arm,
a first proximal element moveable relative to the first arm between a first position and a second position, and
a second proximal element moveable relative to the second arm 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 catheter defining at least one lumen extending between the proximal end portion and the distal end portion,
a first proximal element actuator extending through the at least one lumen, the first proximal element actuator having a first end portion and a second end portion, the first proximal element actuator coupled to the first proximal element at the second end portion of the first proximal element actuator and actuatable to move the first proximal element between the first position and the second position, and
a second proximal element actuator extending through the at least one lumen, the second proximal element actuator having a first end portion and a second end portion, the second proximal element actuator coupled to the second proximal element at the second end portion of the second proximal element actuator and actuatable to move the second proximal element between the first position and the second position.

2 . The fixation system of claim 1 , wherein the second end portion of each of the first proximal element actuator and the second proximal element actuator comprises:
an outer sheath having a first window, an inner mandrel axially moveable relative to the outer sheath, and a suture extending from the outer sheath and defining a loop, wherein the suture is actuatable between a captured position wherein the suture extends into the window of the outer sheath and receives the inner mandrel through the loop, and a released position.

3 . The fixation system of claim 2 , wherein the outer sheath includes a lumen within which the inner mandrel is axially moveable in a proximal direction to the released position and in a distal direction to the captured position.

4 . The fixation system of claim 3 , wherein the first window extends into the outer sheath in a direction transverse to a longitudinal axis of the lumen of the outer sheath, and the mandrel at least partially intersects the first window when in the captured position.

5 . The fixation system of claim 1 , wherein the first proximal element actuator and the second proximal element actuator each comprises an outer sheath axially moveable relative an inner member having a distal pincer, wherein the outer sheath is configured to close the pincer by moving distally relative to the inner member and to open the pincer by moving proximally relative to the inner member.

6 . The fixation system of claim 5 , wherein the first and second proximal elements each include a loop extending therefrom, and the pincer includes first and second pincer prongs configured to couple to the loop when the outer sheath moves distally to close the pincer and to decouple from the line loop when the sheath is moved proximally to open the pincer.

7 . The fixation system of claim 6 , wherein the first and second pincer prongs are formed of a shape memory material such that they are biased outwardly.

8 . The fixation system of claim 1 , wherein the first proximal element actuator and the second proximal element actuator each comprises a weakened region proximal the second end portion.

9 . The fixation system of claim 8 , wherein the second end portion of each of the first and second proximal element actuators is bonded directly to the respective first and second proximal elements.

10 . The fixation system of claim 9 , wherein the bond is one of an adhesive bond and a welded bond.

11 . The fixation system of claim 8 , wherein the weakened region is configured to fracture upon the application of a threshold amount of proximal force applied to each of the first and second proximal element actuators.

12 . The fixation system of claim 8 , wherein the weakened region defines a neck-down portion of the first and second proximal element actuators.

13 . A fixation system for engaging tissue of a patient, comprising:
an implantable fixation device comprising:
a first arm and a second arm,
a first proximal element moveable relative to the first arm between a first position and a second position, and
a second proximal element moveable relative to the second arm 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 catheter defining at least one lumen extending between the proximal end portion and the distal end portion,
a first proximal element actuator extending through the at least one lumen, the first proximal element actuator having a first end portion and a second end portion, the second end portion of the first proximal element actuator being releasably coupled to the first proximal element, and
a second proximal element actuator extending through the at least one lumen, the second proximal element actuator having a first end portion and a second end portion, the second end portion of the second proximal element actuator being releasably coupled to the second proximal element.

14 . The fixation system of claim 13 , wherein the second end portion includes a pincer actuatable between a closed and open configuration to respectively couple and decouple the second end portion from the respective first and second proximal elements.

15 . The fixation system of claim 13 , wherein the second end portion includes a suture loop and a mandrel moveable from a first position in which the mandrel is received within the suture loop and a second position in which the suture loop is released from the mandrel.

16 . The fixation system of claim 15 , wherein each of the first and second proximal element actuators includes an outer sheath having a lumen and a lateral window extending into the lumen of the outer sheath, the mandrel being moveable between the first and second positions within the lumen of the outer sheath.

17 . A fixation system for engaging tissue of a patient, comprising:
an implantable fixation device comprising:
a first arm and a second arm,
a first proximal element moveable relative to the first arm between a first position and a second position, and
a second proximal element moveable relative to the second arm 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 catheter defining at least one lumen extending between the proximal end portion and the distal end portion,
a first proximal element actuator extending through the at least one lumen, the first proximal element actuator having a length extending from a first end of the first proximal element actuator and terminating at a second end of the first proximal element actuator, the first proximal element actuator releasably coupled to the first proximal element at the second end of the first proximal element actuator and actuatable to move the first proximal element between the first position and the second position, and
a second proximal element actuator extending through the at least one lumen, the second proximal element actuator having a length extending from a first end of the second proximal element actuator and terminating at a second end of the second proximal element actuator, the second proxim

Assignees

• Evalve Inc

Inventors

• Childs Richard
• Kizuka Koji
• Gonzales Gabriel
• Hoven Dylan Van
• Mahmoud Tamer
• Abunassar Chad
• Prabhu Santosh

Classifications

• A61F2/2442

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

• A61F2/2427 Primary

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

• A61F2/2466

  Delivery devices therefor · CPC title

• A61F2/246 Primary

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

• A61F2/9522

  Means for mounting a stent or stent-graft onto or into a placement instrument · CPC title