Delivery system for a prosthetic heart valve

• US 9,907,651 B2
• Filed: 05/05/2015
• Issued: 03/06/2018
• Est. Priority Date: 06/13/2005
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Taylor, David M.
• Primary Examiner(s): Holwerda, Kathleen
• Application Number:
  US14/704,866
• Publication Number:
  US 20150305865A1
• Time in Patent Office: 1,036 Days
• Field of Search: 623 211, 623 111, 623 112, 623 123, 606108, 604528
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

A method of delivering a prosthetic heart valve to a native aortic valve is disclosed. The prosthetic heart valve comprises a radially compressible and expandable metallic stent and a flexible valvular structure. A delivery system comprises a selectively steerable section and a pusher member extending through a central lumen of the steerable section. The prosthetic heart valve is compressed and inserted into a distal end portion of the delivery system. The delivery system and prosthetic heart valve are advanced through a femoral artery and around an aortic arch. A pull wire is actuated for selectively controlling a curvature of the steerable section during advancement around the aortic arch. The pusher member is advanced for ejecting the prosthetic heart valve from the delivery system into the native aortic valve, wherein the prosthetic valve self-expands after ejection.

Claims

1. An assembly comprising:

a self-expanding prosthetic valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent; and

a delivery apparatus comprising;

a delivery sleeve assembly comprising a selectively steerable section, a distal portion distal to the steerable section, and a central lumen defined by the steerable section and the distal portion, wherein the prosthetic valve is retained in a radially compressed state within the distal portion;

a pusher member extending through the central lumen of the delivery sleeve assembly, the pusher member having a distal end located proximal to the prosthetic valve;

a handle coupled to a proximal end of the delivery sleeve assembly; and

a pull wire having a distal end portion fixed to the steerable section of the delivery sleeve assembly and a proximal end portion connected to the handle;

wherein the handle comprises a steering mechanism configured to actuate the pull wire for selectively controlling a curvature of the selectively steerable section during advancement of the delivery apparatus around an aortic arch;

wherein the delivery sleeve assembly is configured to be retracted relative to the pusher member for ejecting the prosthetic valve from the delivery sleeve assembly and into a native aortic valve, wherein the prosthetic valve is configured to self-expand after ejection from the delivery sleeve assembly;

wherein the steerable section comprises a flexible metal tubular portion comprising a plurality of axially spaced-apart, circumferentially extending openings and an exterior polymeric cover extending over an entire outer surface of the tubular portion and covering the openings in the tubular portion, the cover being less flexible than the tubular portion.

2. The assembly of claim 1, wherein each opening in the tubular portion comprises two elongate straight portions connected by a curved portion.

3. The assembly of claim 2, wherein the delivery sleeve assembly comprises an elongated sleeve extending from the handle to the steerable section, the elongated sleeve having a pull wire lumen through which the pull wire extends, wherein the pull wire lumen is circumferentially aligned with the curved portion of the openings of the steerable section.

4. The assembly of claim 2, wherein the openings are formed by laser cutting.

5. The assembly of claim 1, wherein the tubular portion comprises a stainless steel hypo-tube.

6. The assembly of claim 1, wherein the distal end of the pusher member is configured to abut a proximal end of the prosthetic valve for pushing the prosthetic valve out of the delivery system.

7. The assembly of claim 1, wherein the steering mechanism is configured to pull the pull wire proximally to bend the selectively steerable section when actuated by a user.

8. The assembly of claim 7, wherein the steering mechanism comprises a rotatable knob operably coupled to a longitudinally moveable core member disposed inside the handle, the proximal end portion of the pull wire being fixed to the core member, such that manual rotation of the knob in a first rotational direction produces longitudinal movement of the core member in a first longitudinal direction to increase tension in the pull wire and manual rotation of the knob in a second rotational direction produces longitudinal movement of the core member in a second longitudinal direction to decrease tension in the pull wire.

9. The assembly of claim 1, wherein the distal end portion of the pull wire is fixed to the steerable section at a location proximal to the prosthetic valve retained within the distal portion of the delivery sleeve assembly.

10. The assembly of claim 9, wherein the steerable section is relatively more flexible than the distal portion of the delivery sleeve assembly such that the distal portion of the delivery sleeve assembly remains straight when the pull wire is actuated to change the curvature of the steerable section, so that the prosthetic valve retained within the distal portion of the delivery sleeve assembly can be aligned with the native aortic valve.

11. An assembly comprising:

a self-expanding prosthetic valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent; and

a delivery apparatus comprising;

a delivery sleeve assembly comprising a selectively steerable section, a distal valve-retaining portion distal to a distal end portion of the steerable section, and a central lumen defined by the steerable section and the distal valve-retaining portion, wherein the prosthetic valve is retained in a radially compressed state within the distal valve-retaining portion;

a pusher member extending through the central lumen of the delivery sleeve assembly, the pusher member having a distal end located proximal to the prosthetic valve;

a handle mechanism; and

a pull wire having a distal end portion fixed to the distal end portion of the steerable section of the delivery sleeve assembly at a location proximal to the distal valve-retaining portion and a proximal end portion connected to the handle mechanism;

wherein the handle mechanism is configured to actuate the pull wire for selectively controlling a curvature of the selectively steerable section during advancement of the delivery apparatus through a patient'"'"'s vasculature;

wherein the distal valve-retaining portion remains straight for aligning with the native aortic valve upon actuation of the pull wire to bend the steerable section;

wherein the delivery sleeve assembly is configured to eject the prosthetic valve from the distal valve-retaining portion of the delivery sleeve assembly, wherein the prosthetic valve is configured to self-expand after ejection from the distal valve-retaining portion of the delivery sleeve assembly;

wherein the steerable section comprises a flexible tubular portion and an exterior cover extending over the entire length of the tubular portion, the cover being less flexible than the tubular portion.

12. The assembly of claim 11, wherein the distal end of the pusher member is configured to abut a proximal end of the prosthetic valve for pushing the prosthetic valve out of the distal valve-retaining portion of the delivery sleeve assembly.

13. The assembly of claim 11, wherein the handle mechanism comprises a rotatable knob operably coupled to a longitudinally moveable core member disposed inside the handle mechanism, the proximal end portion of the pull wire being fixed to the core member, such that manual rotation of the knob in a first rotational direction produces longitudinal movement of the core member in a first longitudinal direction to increase tension in the pull wire and manual rotation of the knob in a second rotational direction produces longitudinal movement of the core member in a second longitudinal direction to decrease tension in the pull wire.

14. The assembly of claim 11, wherein the flexible tubular portion of the steerable section comprises a plurality of axially spaced-apart, circumferentially extending elongate openings, wherein each elongate opening comprises two elongate straight portions connected by a curved portion.

15. The assembly of claim 11, wherein the delivery sleeve assembly ejects the valve from the distal valve-retaining portion when the distal valve-retaining portion is retracted relative to the pusher member.

16. An assembly comprising:

a self-expanding prosthetic valve comprising a radially compressible and expandable metallic stent and a flexible valvular structure mounted within the stent; and

a delivery apparatus comprising;

a delivery sleeve assembly comprising a selectively steerable section, a distal valve-retaining portion distal to the steerable section, and a central lumen defined by the steerable section and the distal valve-retaining portion, wherein the prosthetic valve is retained in a radially compressed state within the distal valve-retaining portion;

a pusher member extending through the central lumen of the delivery sleeve assembly, the pusher member having a distal end located proximal to the prosthetic valve;

a handle coupled to a proximal end of the delivery sleeve assembly; and

a pull wire having a distal end portion fixed to the steerable section of the delivery sleeve assembly and a proximal end portion connected to the handle;

wherein the handle comprises a steering mechanism configured to actuate the pull wire for selectively controlling a curvature of the selectively steerable section during advancement of the delivery apparatus around an aortic arch;

wherein the steering mechanism comprises a rotatable knob operably coupled to a longitudinally moveable core member disposed inside the handle, the proximal end portion of the pull wire being fixed to the core member, such that manual rotation of the knob in a first rotational direction produces longitudinal movement of the core member in a first longitudinal direction to increase tension in the pull wire and manual rotation of the knob in a second rotational direction produces longitudinal movement of the core member in a second longitudinal direction to decrease tension in the pull wire;

wherein the delivery sleeve assembly is configured to be retracted relative to the pusher member for ejecting the prosthetic valve from the delivery sleeve assembly and into a native aortic valve, wherein the prosthetic valve is configured to self-expand after ejection from the delivery sleeve assembly;

wherein the steerable section comprises a flexible metal hypo-tube and an exterior cover extending over the entire length of the hypo-tube, the cover being less flexible than the hypo-tube.

17. The assembly of claim 16, wherein the distal end portion of the pull wire is fixed to a distal end portion of the steerable section at a location proximal to the distal-valve retaining portion, and the distal valve-retaining portion remains straight for aligning with the native aortic valve upon bending of the steerable section.

18. The assembly of claim 16, wherein the metal hypo-tube of the steerable section comprises a flexible metal tubular portion comprising a plurality of axially spaced apart, circumferentially extending openings, each opening comprising two elongate straight portions connected by a curved portion.