IP Library Granted Patent US 11,890,189
Granted Patent B2
US 11,890,189 · App. 17/228,184 · Granted Feb 6, 2024

Delivery apparatus for a prosthetic heart valve

Inventors: Oren Cohen (Kadima, IL); Ofir Witzman (Kfar Saba, IL)
Assignee: EDWARDS LIFESCIENCES CORPORATION
A61F2/2427A61F2/2418A61F2/2439A61F2/2436A61F2/844A61F2/9517A61F2220/0091
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Quick Facts
Patent No.
US 11,890,189
App. No.
17/228,184
Granted
Feb 6, 2024
Kind
B2
Abstract

In one embodiment, a delivery apparatus handle, such as for a mechanical heart valve frame can comprise an actuation knob with a toggle mechanism that can toggle the actuation knob from a first state in which the actuation knob is operable to cause the linear or rotational movement of multiple elements or sets of elements, such as tubes that are attached to, e.g., a mechanical heart valve frame to cause expansion or collapsing of the frame, to a second state in which only a single element or set of elements is moved, allowing for additional operations, such as, e.g., locking the frame and/or releasing it from the delivery apparatus.

Claims (59)

1. A delivery apparatus for implanting a medical device in a patient's body, the delivery apparatus comprising:

a handle;

plurality of elongate elements extending from the handle;

an actuation knob configured to actuate at least one of the plurality of elongate elements; and

a toggle configured to move axially along a longitudinal axis relative to the actuation knob from a first toggle position to a second toggle position to toggle the actuation knob between a first state and a second state, wherein when the actuation knob is in the first state, rotation of the actuation knob moves at least two of the plurality of elongate elements axially, and wherein when the actuation knob is in the second state, rotation of the actuation knob moves only a single one of the plurality of elongate elements axially;

wherein:

the medical device comprises a radially expandable and compressible frame that is expandable from a radially compressed, delivery state to a radially expanded state; and

rotation of the actuation knob when in the first state is effective to radially expand the frame to the expanded state.

2. The delivery apparatus of claim 1 , wherein the toggle comprises a toggle knob which can be rotated in a first direction to move from the first toggle position to the second toggle position.

3. The delivery apparatus of claim 1 , wherein:

rotation of the actuation knob when in the first state is effective to radially expand the frame to the expanded state; and

rotation of the actuation knob when in the second state is effective to lock the frame.

4. The delivery apparatus of claim 3 , wherein further rotation of the actuation knob when in the second state is effective to release the frame from the delivery apparatus.

5. A delivery apparatus for implanting a medical device in a patient's body, the delivery apparatus comprising:

a handle;

a plurality of elongate elements extending from the handle;

an actuation knob configured to actuate at least one of the plurality of elongate elements;

a toggle configured to toggle the actuation knob between a first state and a second state, wherein when the actuation knob is in the first state, rotation of the actuation knob moves at least two of the plurality of elongate elements axially, and wherein when the actuation knob is in the second state, rotation of the actuation knob moves only one of the plurality of elongate elements axially;

a rotatable component disposed in the handle, wherein the rotatable component is operatively coupled to a selected one of the plurality of elongate elements, such that when the actuation knob is in the first state, rotation of the actuation knob causes corresponding rotation of the rotatable component, the rotation of the rotatable component causing axial movement of the selected one of the plurality of elongate elements; and

one or more plungers disposed between the toggle and the actuation knob, wherein the toggle is configured to move the plungers between a first plunger position and a second plunger position upon movement of the toggle toward and away from the actuation knob, wherein:

when the plungers are in the first plunger position, the plungers extend through the actuation knob and into the rotatable component such that rotation of the actuation knob causes rotation of the rotatable component, and

when the plungers are in the second position, the plungers are withdrawn from the rotatable component such that rotation of the actuation knob does not cause corresponding rotation of the rotatable component.

6. The delivery apparatus of claim 5 , wherein when the actuation knob is in the second state, rotation of the actuation knob does not cause corresponding rotation of the rotatable component and axial movement of the selected one of the plurality of elongate elements.

7. The delivery apparatus of claim 5 , further comprising one or more springs configured to bias the one or more plungers to the second plunger position.

8. The delivery apparatus of claim 5 , wherein each of the plungers extends through an aperture in the actuation knob and into a corresponding opening in the rotatable component when the plungers are in the first plunger position, and each of the plungers is withdrawn from the corresponding opening in the rotatable component when the plungers are in the second plunger position.

9. The delivery apparatus of claim 5 , further comprising:

a first nut threadably engaging a corresponding threaded portion of the actuation knob and coupled to a proximal end portion of a first one of the plurality of elongate elements; and

a second nut threadably engaging a corresponding threaded portion of the rotatable component and coupled to a proximal end portion of a second one of the plurality of elongate elements;

wherein rotation of the actuation knob causes corresponding axial movement of the first nut and the first one of the plurality of elongate elements and rotation of the rotatable component causes corresponding axial movement of the second nut and the second one of the plurality of elongate elements.

10. The delivery apparatus of claim 9 , wherein the first one of the plurality of elongate elements extends axially through an aperture in the second nut.

11. The delivery apparatus of claim 5 , wherein when the actuation knob is in the second state, rotation of the actuation knob:

causes axial movement of the selected one of the plurality of elongate elements;

does not cause corresponding rotation of the rotatable component; and

does not cause axial movement of a second one of the plurality of elongate elements.

12. An assembly comprising:

a prosthetic heart valve comprising a radially expandable and compressible frame; and

a delivery apparatus for implanting the prosthetic heart valve in a patient's body, wherein the delivery apparatus comprises:

a handle;

a plurality of elongate elements extending from the handle;

an actuation knob configured to actuate at least one of the elongate elements; and

a toggle configured to toggle the actuation knob between a first state and a second state, wherein:

when the actuation knob is in the first state, rotation of the actuation knob moves at least two of the elongate elements axially, and

when the actuation knob is in the second state, rotation of the actuation knob moves only one of the plurality of elongate elements axially; and

wherein:

the frame is expandable from a radially compressed, delivery state to a radially expanded state;

each of the plurality of elongate elements has a distal end portion releasably coupled to the frame;

rotation of the actuation knob when in the first state is effective to radially expand the frame from the delivery state to the expanded state; and

rotation of the actuation knob when in the second state is effective to release the frame from the plurality of elongate elements.

13. The assembly of claim 12 , wherein:

the frame comprises at least one expansion and locking unit comprising first and second members, the first member being configured to apply a proximally directed force to the frame and the second member being configured to apply a distally directed force to the frame such that relative axial movement between first and second members is effective to radially expand or compress the frame;

the first and second members comprise respective, matable locking features configured to retain the frame in the expanded state when the locking feature of the first member engages the locking feature of the second member;

the distal end portion of a first one of the plurality of elongate elements is releasably connected to the first member;

the distal end portion of a second one of the plurality of elongate elements is releasably connected to the second member;

rotation of the actuation knob when in the first state is effective to move the first member relative to the second member to radially expand the frame to the expanded state; and

rotation of the actuation knob when in the second state is effective to allow the locking features to engage each other.

14. The assembly of claim 13 , wherein a third one of the plurality of elongate elements extends between the first and second members.

15. The assembly of claim 14 , wherein rotation of the actuation knob when in the second state is effective to retract the distal end portion of the third one of the plurality of elongate elements from between the first and second members to allow the locking features to engage each other.

16. The assembly of claim 15 , wherein further rotation of the actuation knob when in the second state is effective to release the frame from the plurality of elongate elements.

17. The assembly of claim 13 , wherein further rotation of the actuation knob when in the second state is effective to release the frame from the plurality of elongate elements.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 11, 2021
From: COHEN, OREN; WITZMAN, OFIR
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 056206/0839 →
Continuity (3)
Continuation 15959623 · Apr 23, 2018
Provisional Application 62490210 · Apr 26, 2017
Related Publication 20210228352A1 · Jul 29, 2021