IP Library Granted Patent US 10,820,994
Granted Patent B2
US 10,820,994 · App. 15/954,193 · Granted Nov 3, 2020

Methods for delivering a prosthetic valve

Inventors: David Alon (Zichron Yaacov, IL); Netanel Benichou (D.N. Hof HaCarmel, IL); Oded Meiri (Moshav Ram-On, IL)
Assignee: Edwards Lifesciences Corporation
A61F2/2436A61F2/2418A61F2/2439A61F2/9517A61F2/9522A61F2002/9528A61F2002/9534A61F2210/0076A61F2220/005A61F2220/0075A61F2230/001A61F2230/0054A61F2230/0076A61F2250/0039
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Quick Facts
Patent No.
US 10,820,994
App. No.
15/954,193
Granted
Nov 3, 2020
Kind
B2
Abstract

Methods for delivering a prosthetic valve comprise introducing the prosthetic heart valve into a body of a patient. The prosthetic valve is mounted within a delivery sheath of a delivery apparatus in a radially compressed state. The prosthetic valve is advanced through the body to a delivery location. A motor is actuated to cause the delivery sheath to retract to expose the prosthetic valve and the prosthetic valve expands to a radially expanded state at the delivery location. The methods can also include releasing the prosthetic valve from the delivery apparatus and removing the delivery apparatus from the patient.

Claims (38)

1. A method for delivering a prosthetic valve, the method comprising:

percutaneously introducing a prosthetic valve mounted within a delivery sheath of a delivery apparatus into a body, the prosthetic valve mounted within the delivery sheath in a radially compressed state and connected to a valve retaining mechanism at a distal end of the delivery apparatus;

advancing the prosthetic valve through the body to a delivery location;

actuating a motor to cause the delivery sheath to retract to expose the prosthetic valve;

expanding the prosthetic valve to a radially expanded state at the delivery location, thereby deploying the prosthetic valve; and

removing the delivery apparatus from the patient;

wherein the motor is operatively coupled to a torque shaft within the delivery apparatus and the torque shaft is operatively coupled to the delivery sheath, and wherein actuating the motor rotates the torque shaft and thereby causes the delivery sheath to retract.

2. The method of claim 1 , wherein percutaneously introducing the prosthetic heart valve comprises inserting all of the delivery sheath into a blood vessel of the body.

3. The method of claim 1 , wherein the torque shaft is configured to rotate in a first direction to cause the delivery sheath to retract, and wherein activating the motor to cause the delivery sheath to retract includes actuating the motor such that the motor causes the torque shaft to rotate in the first direction to cause the delivery sheath to retract.

4. The method of claim 3 , further comprising actuating the motor such that the motor causes the torque shaft to rotate in a second direction opposite the first direction to cause the delivery sheath to advance over the prosthetic valve; and repositioning the prosthetic valve proximate the delivery location.

5. The method of claim 1 , wherein the torque shaft is a first shaft and the delivery apparatus further comprises a second shaft through which the torque shaft extends, wherein a distal end portion of the second shaft is coupled to a proximal end portion of the delivery sheath.

6. The method of claim 1 , wherein a distal end portion of the torque shaft is connected to the valve retaining mechanism.

7. The method of claim 1 , wherein the prosthetic valve is held in the radially compressed state within the delivery sheath at a location distal to a distal end of the torque shaft.

8. A method for delivering a prosthetic heart valve, the method comprising:

disposing a prosthetic heart valve mounted within a delivery sheath of a delivery apparatus in a patient, wherein the prosthetic heart valve is mounted within the delivery sheath in a radially compressed state and is radially expandable to a radially expanded state, wherein the prosthetic heart valve is connected to a valve retaining mechanism;

positioning the prosthetic heart valve at a native heart valve annulus;

activating a motor to cause the delivery sheath to retract to expose the prosthetic heart valve; and

allowing the prosthetic heart valve to radially self-expand at the native heart valve annulus, thereby delivering the prosthetic heart valve;

wherein the motor is operatively coupled to a torque shaft of the delivery apparatus and the torque shaft is operatively coupled to the delivery sheath, and wherein activating the motor to cause the delivery sheath to retract includes actuating the motor such that the motor causes the torque shaft to rotate and thereby causes the delivery sheath to retract.

9. The method of claim 8 , wherein the prosthetic heart valve is mounted on a distal end portion of the delivery apparatus, and further comprising percutaneously introducing the prosthetic heart valve mounted on the distal end portion of the delivery apparatus into a blood vessel of the patient.

10. The method of claim 9 , wherein percutaneously introducing the prosthetic heart valve comprises percutaneously introducing the prosthetic heart valve through a femoral artery.

11. The method of claim 9 , wherein percutaneously introducing the prosthetic heart valve comprises introducing the prosthetic heart valve through an introducer comprising an elongate tubular sleeve having a lumen, the sleeve comprising a metallic layer comprising a plurality of bands spaced along a length of the metallic layer and circumferentially extending openings interposed between adjacent bands.

12. The method of claim 8 , wherein the prosthetic valve is connected to the delivery apparatus by the retaining mechanism, and further comprising releasing the prosthetic heart valve from the delivery apparatus and removing the delivery apparatus from the patient after allowing the prosthetic heart valve to radially self-expand.

13. The method of claim 12 , wherein the retaining mechanism comprises a tether, and wherein releasing the prosthetic heart valve comprises releasing the tether from the prosthetic heart valve.

14. The method of claim 8 , wherein the torque shaft is configured to rotate in a first direction to cause the delivery sheath to retract, and wherein activating the motor to cause the delivery sheath to retract includes actuating the motor such that the motor causes the torque shaft to rotate in the first direction to cause the delivery sheath to retract.

15. The method of claim 14 , further comprising actuating the motor such that the motor causes the torque shaft to rotate in a second direction opposite the first direction to cause the delivery sheath to advance over the prosthetic valve; and repositioning the prosthetic valve at the native heart valve annulus.

16. The method of claim 14 , wherein rotating the torque shaft in a first direction to retract the delivery sheath comprises rotating a threaded portion of the torque shaft to cause axial motion of the delivery sheath.

17. The method of claim 8 , wherein the motor is disposed in a handle portion of the delivery apparatus, and the handle is disposed at a proximal end of the delivery apparatus.

18. A method for delivering a prosthetic valve, the method comprising:

percutaneously introducing into a body a prosthetic valve mounted at a distal end of a delivery apparatus within a delivery sheath of the delivery apparatus, wherein the delivery sheath is operatively coupled to a torque shaft, and wherein the prosthetic valve mounted within the delivery sheath is in a radially compressed state and the prosthetic valve is connected to a retaining mechanism;

advancing the prosthetic valve through the body to a delivery location;

positioning the prosthetic valve at the delivery location;

activating a motor such that the motor causes rotation of the torque shaft in a first direction to retract the delivery sheath;

expanding the prosthetic valve at the delivery location, thereby deploying the prosthetic valve;

releasing the prosthetic heart valve from the delivery apparatus; and

removing the delivery apparatus from the patient.

19. The method of claim 18 , wherein releasing the prosthetic valve from the delivery apparatus comprises releasing the prosthetic valve from the retaining mechanism.

20. The method of claim 19 , wherein the retaining mechanism comprises a tether, and wherein releasing the prosthetic valve from the delivery apparatus comprises releasing the tether from the prosthetic valve.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2018
From: ALON, DAVID; BENICHOU, NETANEL; MEIRI, ODED
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 046530/0741 →
Continuity (5)
Continuation 15181243 · Jun 13, 2016
Continuation 14182169 · Feb 17, 2014
Continuation 12429040 · Apr 23, 2009
Provisional Application 61091293 · Aug 22, 2008
Related Publication 20180228607A1 · Aug 16, 2018