Delivery system for prosthetic heart valve

• US 10,517,722 B2
• Filed: 03/24/2017
• Issued: 12/31/2019
• Est. Priority Date: 03/24/2016
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Passman, Joseph Arthur, Thai, Linda, Murad, Michael
• Primary Examiner(s): Rosen, Eric J
• Assistant Examiner(s): Restaino, Andrew P.
• Application Number:
  US15/469,294
• Publication Number:
  US 20170273787A1
• Time in Patent Office: 1,012 Days
• Field of Search: 623 211
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

A delivery apparatus for implanting a prosthetic implant in a native lumen of the body includes a handle portion, and a first shaft extending from and movable relative to the handle portion. The first shaft has a proximal end portion coupled to the handle portion and a distal end portion. The delivery apparatus further includes a second shaft extending from the handle portion and coaxially disposed within the first shaft. The second shaft has a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic implant in a radially compressed state. The handle portion of the delivery apparatus also includes a steering assembly configured to move the first shaft longitudinally relative to the second shaft while concurrently flexing the second shaft.

Claims

1. A delivery apparatus for implanting a prosthetic implant in a native lumen of the body, the apparatus comprising:

a handle portion;

a first shaft extending from and movable relative to the handle portion, the first shaft comprising a proximal end portion coupled to the handle portion and a distal end portion;

a second shaft extending from the handle portion and coaxially disposed within the first shaft, the second shaft comprising a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic implant in a radially compressed state;

the handle portion comprising a steering assembly configured to move the first shaft longitudinally relative to the second shaft while concurrently flexing the second shaft;

wherein the steering assembly further comprises a rotatable member coupled to the proximal end portion of the first shaft such that rotation of the rotatable member causes corresponding proximal and distal motion of the first shaft relative to the second shaft;

wherein the rotatable member is coupled to the distal end portion of the second shaft by a pull wire such that rotation of the rotatable member causes corresponding flexing and unflexing of the distal end portion of the second shaft.

2. The delivery apparatus of claim 1 wherein the rotatable member is coupled to the proximal end portion of the first shaft by a threaded shaft movably coupled to the rotatable member and a coupling member disposed on the threaded shaft and coupled to the first shaft.

3. The delivery apparatus of claim 2, wherein the rotatable member includes a threaded tubular portion configured to receive and engage the threaded shaft such that rotation of the rotatable member causes proximal and distal motion of the threaded shaft relative to the rotatable member.

4. The delivery apparatus of claim 1, wherein the pull wire is coupled to a pull wire coupling member movably disposed on a threaded shaft coupled to the rotatable member such that rotation of the rotatable member causes corresponding longitudinal motion of the pull wire coupling member along the threaded shaft.

5. The delivery apparatus of claim 4, wherein the steering assembly further comprises a pull wire guide member positioned to guide the pull wire radially away from the second shaft to the pull wire coupling member.

6. The delivery apparatus of claim 5, wherein the pull wire extends proximally from the pull wire guide member to the pull wire coupling member, and proximal motion of the pull wire coupling member along the threaded shaft causes flexing of the second shaft.

7. The delivery apparatus of claim 5, wherein the pull wire guide member is coupled to a side portion of the handle portion and extends perpendicular to a longitudinal axis of the handle portion.

8. The delivery apparatus of claim 4, wherein the handle portion further comprises at least one guide member extending parallel to the threaded shaft and operatively connected to the pull wire coupling member to prevent rotation of the pull wire coupling member as it moves along the threaded shaft.

9. The delivery apparatus of claim 1, wherein the first shaft comprises a tubular member defined by a plurality helically wound filaments.

10. The delivery apparatus of claim 9, wherein the tubular member further comprises a retaining portion located proximally of a distal end portion of the tubular member, and the filaments are independently movable relative to one another along at least a portion of the tubular member extending between the retaining portion and the distal end portion.

11. The delivery apparatus of claim 9, wherein the distal end portion of the tubular member is shape-set to have predetermined curvature.

12. The delivery apparatus of claim 1, wherein:

the second shaft comprises a braided layer; and

the pull wires extend at least partially within the braided layer.