Delivery apparatus and methods for implanting prosthetic devices

Patent metadata

Field	Value
Publication number	US-2026000511-A1
Application number	US-202519320010-A
Country	US
Kind code	A1
Filing date	Sep 5, 2025
Priority date	Mar 6, 2023
Publication date	Jan 1, 2026
Grant date	—

Abstract

A shaft assembly to facilitate delivery of an implant to an implantation location within a patient's anatomy may comprise an outer shaft that is movable between an extended position to encapsulate the implant loaded onto a delivery apparatus and a retracted position to expose the implant for deployment at the implantation location at a distal end of the outer shaft. The outer shaft may be movable from the retracted position to the extended position to encapsulate the implant at least partially within the distal end of the outer shaft, the outer shaft comprising one or more flaring openings at the distal end of the outer shaft.

First claim

What is claimed is:

1 . A shaft assembly to facilitate delivery of an implant to an implantation location within a patient's anatomy, the shaft assembly comprising:
an outer shaft that is movable between an extended position to encapsulate the implant loaded onto a delivery apparatus and a retracted position to expose the implant for deployment at the implantation location at a distal end of the outer shaft, the outer shaft movable from the retracted position to the extended position to encapsulate the implant at least partially within the distal end of the outer shaft, the outer shaft comprising one or more flaring openings at the distal end of the outer shaft.

2 . The shaft assembly of claim 1 , wherein the flaring openings include one or more slits originating at the distal end of the outer shaft.

3 . The shaft assembly of claim 2 , wherein the flaring openings include between three and six slits.

4 . The shaft assembly of claim 2 , wherein the one or more slits include a first slit of a first length and a second slit of a second length different from the first length.

5 . The shaft assembly of claim 2 , wherein at least one of the one or more slits progresses in a generally longitudinal direction relative to the outer shaft when extending away from the distal end of the outer shaft.

6 . The shaft assembly of claim 2 , wherein at least one of the one or more slits progresses in both a longitudinal direction and a circumferential direction relative to the outer shaft when extending away from the distal end of the outer shaft.

7 . The shaft assembly of claim 1 , wherein the flaring openings include a wedge-shaped opening.

8 . The shaft assembly of claim 7 , wherein at least one side of the wedge-shaped opening is curved.

9 . The shaft assembly of claim 1 , wherein the flaring openings include a box-shaped opening.

10 . The shaft assembly of claim 9 , wherein at least one side of the box-shaped opening is curved.

11 . The shaft assembly of claim 9 , wherein at least one side of the box-shaped opening is angled inward such that as the box-shaped opening progresses in a longitudinal direction along the outer shaft and originating at the distal end of the outer shaft, the box-shaped opening becomes more narrow.

12 . The shaft assembly of claim 1 , wherein the flaring openings include at least one slit and at least one wedge-shaped opening.

13 . The shaft assembly of claim 1 , wherein the flaring openings include at least one slit and at least one box-shaped opening.

14 . The shaft assembly of claim 1 , wherein the flaring openings include at least one wedge-shaped opening and at least one box-shaped opening.

15 . The shaft assembly of claim 1 , wherein the flaring openings include at least one slit, at least one wedge-shaped opening, and at least one box-shaped opening.

16 . A delivery assembly comprising:
a delivery apparatus comprising:
a handle body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, and a cavity disposed between the proximal end and the distal end;
a carriage member disposed within the cavity and axially movable relative to the handle body in a direction parallel to the longitudinal axis of the handle body, the carriage member having an internal surface defining an internal bore;
an outer shaft having a proximal end positioned within the internal bore of the carriage member and one or more flaring openings at a distal end of the outer shaft; and
an inner shaft extending through a lumen of the outer shaft and fixed relative to the handle body; and
an implant removably loaded onto the delivery apparatus.

17 . The delivery assembly of claim 16 , wherein the outer shaft is movable between an extended position to at least partially encapsulate the implant and a retracted position to expose the implant for deployment at an implantation location at a distal end of the outer shaft.

18 . The delivery assembly of claim 17 , wherein the flaring openings are configured to permit outward displacement of at least a portion of an outer circumference of the distal end of the outer shaft as the outer shaft is extended to at least partially encapsulate the implant within the outer shaft.

19 . A method, comprising:
providing a delivery apparatus comprising
a handle body having a proximal end, a distal end, a longitudinal axis extending between the proximal end and the distal end, and a cavity disposed between the proximal end and the distal end,
a carriage member disposed within the cavity and axially movable relative to the handle body in a direction parallel to the longitudinal axis of the handle body, the carriage member having an internal surface defining an internal bore,
an outer shaft having a proximal end positioned within the internal bore of the carriage member and one or more flaring openings at a distal end of the outer shaft,
an inner shaft extending through a lumen of the outer shaft and fixed relative to the handle body, and
an implant removably loaded onto the delivery apparatus;
inserting a distal end of the delivery assembly into a vasculature of a patient; advancing the delivery assembly through the vasculature of the patient to position the implant at a select implantation location; moving the carriage member relative to the handle in a first direction to retract the outer shaft and expose the implant; and moving the carriage member relative to the handle in a second direction different from the first direction to extend the outer shaft to at least partially encapsulate the implant within the outer shaft.

20 . The method of claim 19 , wherein the flaring openings facilitate outward displacement of at least a portion of an outer circumference of the distal end of the outer shaft as the outer shaft is extended to at least partially encapsulate the implant within the outer shaft.

Assignees

• Edwards Lifesciences Corp

Inventors

• Desrosiers John J

Classifications

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2002/9665

  with additional retaining means · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2/97

  the outer sleeve being splittable · CPC title

• A61F2/966 Primary

  with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod · CPC title