Prosthetic heart valve delivery apparatus

Patent metadata

Field	Value
Publication number	US-11737868-B2
Application number	US-202016783005-A
Country	US
Kind code	B2
Filing date	Feb 5, 2020
Priority date	Feb 25, 2011
Publication date	Aug 29, 2023
Grant date	Aug 29, 2023

Abstract

A handle for a prosthetic heart valve delivery apparatus includes a housing, a motorized mechanism, and a holding mechanism. The housing is configured to be hand-held by a user and includes a distal opening. The motorized mechanism is disposed within the housing and is configured to be releasably coupled to a proximal end portion of a first shaft of the prosthetic heart valve delivery apparatus. When actuated, the motorized mechanism is configured to rotate the first shaft relative to the housing. The holding mechanism is disposed inside the housing and is configured to engage a proximal end portion of a second shaft of the prosthetic heart valve delivery apparatus such that the second shaft is axially and rotationally fixed relative to the housing, and the first shaft extends through the second shaft.

First claim

We claim:

1. A motorized handle for a transvascular prosthetic heart valve delivery apparatus, the motorized handle configured to be releasably coupled to a proximal end of a catheter assembly of the transvascular prosthetic heart valve delivery apparatus, the catheter assembly having an outer shaft and an inner torque shaft within the outer shaft, the motorized handle comprising:
a housing configured to be hand-held by a user and comprising a distal opening;
a motorized mechanism mounted within the housing for rotating the inner torque shaft of the catheter assembly; and
a holding mechanism inside the housing and configured for engaging with the catheter assembly,
wherein the distal opening of the housing is configured to receive the proximal end of the catheter assembly such that a proximal end of the inner torque shaft can be positioned within the housing and releasably connected to the motorized mechanism, and such that the holding mechanism can releasably couple a proximal end of the outer shaft to the motorized handle so as to hold the outer shaft in an axially fixed position and a rotationally fixed position, and
wherein when the motorized handle is coupled to the catheter assembly, the motorized mechanism, when actuated, is configured to rotate the inner torque shaft relative to the outer shaft.

2. The motorized handle of claim 1 , wherein the motorized mechanism comprises a motor, a drive cylinder, and a plurality of gears, and wherein the drive cylinder is operatively coupled to the motor through the plurality of gears, and wherein the inner torque shaft can be releasably connected to the drive cylinder of the motorized mechanism.

3. The motorized handle of claim 2 , wherein the plurality of gears comprise a first gear fixed to the motor and a second gear fixed to the drive cylinder, and wherein the first gear is engaged with the second gear so as to transfer rotation from the motor to the drive cylinder.

4. The motorized handle of claim 2 , wherein the drive cylinder is configured to engage the proximal end of the inner torque shaft of the catheter assembly such that actuating the motor rotates the drive cylinder and the inner torque shaft.

5. The motorized handle of claim 2 , wherein the motor has a first rotation axis, wherein the drive cylinder has a second rotation axis, and wherein the first rotation axis is parallel to and offset radially from the second rotation axis.

6. The motorized handle of claim 2 , wherein the drive cylinder has a through opening, and wherein the through opening of the drive cylinder is configured to receive the proximal end of the inner torque shaft such that rotation of the drive cylinder results in rotation of the inner torque shaft.

7. The motorized handle of claim 6 , wherein the through opening of the drive cylinder is shaped to correspond to flats on the proximal end of the inner torque shaft.

8. The motorized handle of claim 6 , wherein the motorized handle is configured such that when the motorized handle is coupled to the catheter assembly, the proximal end of the inner torque shaft extends through the distal opening in the housing and into the through opening in the drive cylinder, wherein the holding mechanism holds the catheter assembly in an axial position relative to the motorized handle, and wherein the proximal end of the inner torque shaft is retained within the through opening of the drive cylinder when the drive cylinder is rotated.

9. The motorized handle of claim 1 , wherein the motorized mechanism comprises a motor with a shaft, and wherein the inner torque shaft can be connected directly to an end of the shaft of the motorized mechanism.

10. The motorized handle of claim 1 , wherein the holding mechanism comprises a latch configured to extend into a groove in the outer shaft to prevent the outer shaft from moving axially relative to the motorized handle.

11. The motorized handle of claim 1 , wherein the holding mechanism comprises a spring that biases the holding mechanism to a position configured for engaging the catheter assembly.

12. The motorized handle of claim 1 , further comprising a release button coupled to the holding mechanism, wherein depressing the release button is configured to disengage the holding mechanism from the catheter assembly.

13. The motorized handle of claim 1 , further comprising an operator button configured to activate the motorized mechanism.

14. A transvascular prosthetic heart valve delivery apparatus, comprising the motorized handle of claim 1 and the catheter assembly having the outer shaft and the inner torque shaft within the outer shaft, wherein the motorized handle is releasably coupled to a proximal end of the catheter assembly.

15. The transvascular prosthetic heart valve delivery apparatus of claim 14 , wherein the catheter assembly further comprises a delivery sheath, and wherein rotation of the inner torque shaft within the catheter assembly results in the delivery sheath of the catheter assembly moving axially off of or onto a prosthetic heart valve positioned at a distal end of the catheter assembly.

16. The transvascular prosthetic heart valve delivery apparatus of claim 15 , wherein rotation of the inner torque shaft within the catheter assembly in one direction results in the delivery sheath retracting and uncovering the prosthetic heart valve, and wherein rotation of the inner torque shaft within the catheter assembly in a second opposite direction results in the delivery sheath moving distally over the prosthetic heart valve.

17. A handle for a prosthetic heart valve delivery apparatus, the handle comprising:
a housing configured to be hand-held by a user and comprising a distal opening;
a motorized mechanism disposed within the housing and configured to be releasably coupled to a proximal end portion of a first shaft of the prosthetic heart valve delivery apparatus, wherein when actuated, the motorized mechanism is configured to rotate the first shaft relative to the housing; and
a holding mechanism disposed inside the housing and configured to engage a proximal end portion of a second shaft of the prosthetic heart valve delivery apparatus such that the second shaft is axially and rotationally fixed relative to the housing, wherein the first shaft extends through the second shaft.

18. The handle of claim 17 , wherein the motorized mechanism comprises a motor, a drive cylinder, and a plurality of gears, and wherein the drive cylinder is operatively coupled to the motor through the plurality of gears, and wherein the drive cylinder is configured to be releasably coupled to the first shaft.

19. A prosthetic heart valve delivery apparatus comprising:
a catheter assembly that includes a first shaft, a second shaft, and a delivery sheath, wherein the first shaft extends through the second shaft, wherein the delivery sheath is disposed at a distal portion of the second shaft, and wherein a proximal end portion of the second shaft includes a groove; and
a handle that includes a housing a motorized mechanism, and a latch having an engaging surface, wherein the housing comprising a distal opening, wherein the first and second shafts extend through the distal opening such that a proximal end portion of the first shaft and the proximal end portion of the second shaft are disposed within the housing, wherein the motorized mechanism is disposed within the housing and is releasably coupled to the proximal end portion of the first shaft, wherein the latch is at least partially disposed within the housing and movable between an engaged state and

Assignees

• Edwards Lifesciences Corp

Inventors

• Popp Michael J
• Alon David
• Liu Jun
• Pesce Luca
• Jafari Mohammad

Classifications

• A61F2250/0036

  differing in thickness · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title