Prosthetic heart valve delivery system and method

• US 9,364,325 B2
• Filed: 02/17/2014
• Issued: 06/14/2016
• Est. Priority Date: 08/22/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Alon, David, Benichou, Netanel, Meiri, Oded
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US14/182,169
• Publication Number:
  US 20140163670A1
• Time in Patent Office: 848 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A method for delivering a self-expanding prosthetic heart valve comprises positioning the prosthetic heart valve in an annulus of a native heart valve while mounted in a radially compressed state in a delivery cylinder, the delivery cylinder coupled to a distal end portion of the torque shaft, and rotating a torque shaft coupled to the delivery cylinder. Rotating the torque shaft retracts the delivery cylinder, thereby exposing the prosthetic heart valve, allowing the prosthetic heart valve to self-expand in the native valve annulus. In some embodiments, the torque shaft is rotated by a motor disposed in a handle at a proximal end of the delivery device.

Claims

1. A method for delivering a self-expanding prosthetic heart valve in a native valve annulus, the method comprising:

percutaneously introducing a prosthetic heart valve mounted on a distal end portion of a delivery apparatus into a patient'"'"'s vasculature, the distal end portion of the delivery apparatus comprising a delivery sheath having a proximal end coupled to a distal end portion of an elongate, flexible torque shaft which extends into the vasculature, a second shaft extending between the torque shaft and the delivery sheath, the prosthetic heart valve mounted within the delivery sheath in a radially compressed state;

advancing the prosthetic heart valve through the vasculature to a proximity of a native valve;

positioning the prosthetic heart valve within a native valve annulus;

rotating the torque shaft in a first direction to retract the delivery sheath relative to the second shaft to expose the prosthetic heart valve;

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

releasing the expanded prosthetic heart valve from the delivery apparatus; and

removing the delivery apparatus from the patient.

2. The method of claim 1, further comprising rotating the torque shaft in the first direction to retract the delivery sheath, rotating the torque shaft in a second direction opposite the first direction to advance the delivery sheath over the prosthetic heart valve;

and repositioning the prosthetic heart valve in the native valve annulus.

3. The method of claim 1, wherein percutaneously introducing the prosthetic heart valve into the patient'"'"'s vasculature comprises inserting the entire length of the delivery sheath into the patient'"'"'s vasculature.

4. A method for delivering a self-expanding prosthetic heart valve in a native valve annulus, the method comprising:

disposing a self-expanding prosthetic heart valve mounted on a distal end portion of a delivery device in a vasculature of a patient, the distal end portion of the delivery device comprising a delivery sheath, a proximal end portion of the delivery sheath coupled to a distal end portion of an elongate, flexible torque shaft which extends into the vasculature, the prosthetic heart valve within the delivery sheath in a radially compressed state, wherein the delivery device further comprises a second shaft through which the torque shaft extends, the proximal end of the delivery sheath being coupled to a distal end portion of the second shaft;

positioning the prosthetic heart valve within a native valve annulus;

rotating the torque shaft in a first direction relative to the second shaft and the delivery sheath to retract the delivery sheath relative to the second shaft to expose the prosthetic heart valve; and

allowing the prosthetic heart valve to radially self-expand in the native valve annulus, thereby delivering the self-expanding prosthetic heart valve.

5. The method of claim 4, further comprising percutaneously introducing the prosthetic heart valve mounted on the distal end portion of the delivery device into a patient'"'"'s vasculature.

6. The method of claim 5, wherein percutaneously introducing the prosthetic heart valve comprises percutaneously introducing the prosthetic heart valve through a femoral artery.

7. The method of claim 5, 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.

8. The method of claim 4, further comprising releasing the expanded prosthetic heart valve from the delivery device, and removing the delivery device from the patient.

9. The method of claim 8, wherein releasing the prosthetic heart valve comprises releasing retaining arms of the prosthetic heart valve from a first fork and a second fork of the delivery device.

10. The method of claim 4, further comprising rotating the torque shaft in the first direction to retract the delivery sheath, rotating the torque shaft in a second direction opposite the first direction to advance the delivery sheath over the prosthetic heart valve;

and

repositioning the prosthetic heart valve in the native valve annulus.

11. The method of claim 4, wherein rotating the torque shaft comprises rotating a control knob coupled to the torque shaft, the control knob disposed on a handle portion at a proximal end of the delivery device.

12. The method of claim 4, wherein rotating the torque shaft comprises activating a motor disposed in a handle portion of the delivery device, the motor coupled to the torque shaft, the handle disposed at a proximal end of the delivery device.

13. The method of claim 4, wherein rotating the torque shaft in a first direction to retract the delivery sheath comprises rotating a threaded portion of the torque shaft relative to a threaded portion of the delivery sheath engaged thereto.

14. The method of claim 4, wherein the entire length of the delivery sheath is within the patient'"'"'s vasculature during the acts of positioning, rotating, and allowing.