Stented prosthesis delivery system having a bumper

Patent metadata

Field	Value
Publication number	US-2024016605-A1
Application number	US-202318374845-A
Country	US
Kind code	A1
Filing date	Sep 29, 2023
Priority date	Mar 3, 2016
Publication date	Jan 18, 2024
Grant date	—

Abstract

Numerous delivery devices for delivery of a stented prosthesis, such as a stented prosthetic heart valve. Various delivery devices include a capsule that is advanced proximally to retain the stented prosthesis, which is secured over an inner shaft assembly of the delivery device. The delivery device further includes a bumper or bumper assembly to provide a smooth transition of the capsule over the stented prosthesis. In some alternate disclosed embodiments, the bumper further serves to connect various elements of the inner shaft assembly. Additional embodiments include a bumper assembly arranged and configured to longitudinally expand and contract to substantially fill any open space as the capsule is retracted from the stented prosthesis, which prevents kinking in the capsule. Additional embodiments include proximal and/or distal bumpers for temporarily covering and smoothing the ends of the stented prosthesis as part of a delivery device that does not include a capsule.

First claim

What is claimed is:

1 . A delivery device for delivering a stented prosthesis to a target site, the delivery device comprising:
an inner shaft assembly comprising a distal portion configured to receive the stented prosthesis; a middle tube defining a recess within which the inner shaft assembly is received such that the middle tube is configured to be slidable relative to the inner shaft assembly; and a bumper attached to an end of the middle tube and defining a cavity within which the inner shaft assembly is received such that the bumper is configured to be slidable relative to the inner shaft assembly, the bumper extending between a distal end and a proximal end, the distal end of the bumper configured to receive a proximal end of the stented prosthesis within the cavity such that the stented prosthesis is maintained in a radially-compressed configuration.

2 . The delivery device of claim 1 , wherein the bumper comprises a ramped surface with an increasing diameter from the proximal end of the bumper toward the distal end of the bumper.

3 . The delivery device of claim 1 , wherein a first segment of the stented prosthesis is received within the cavity such that the bumper circumferentially surrounds the first segment, and wherein a second segment of the stented prosthesis is located outside of the bumper such that the second segment is not circumferentially surrounded by the bumper.

4 . The delivery device of claim 1 , wherein the inner shaft member comprises a plurality of apertures extending radially through the inner shaft member.

5 . The delivery device of claim 4 , further comprising one or more tension members extending through the plurality of apertures, the one or more tension members circumferentially surrounding the stented prosthesis and configured to maintain the stented prosthesis in the radially-compressed configuration.

6 . The delivery device of claim 1 , the bumper comprising a distal outer diameter that is greater than a compressed diameter of the stented prosthesis in the radially-compressed configuration.

7 . The delivery device of claim 1 , further comprising a capsule comprising an elongated channel within which the bumper and the stented prosthesis are received.

8 . A delivery device for delivering a stented prosthesis to a target site, the delivery device comprising:
an inner shaft assembly comprising a distal portion configured to receive the stented prosthesis; a middle tube defining a recess within which the inner shaft assembly is received such that the middle tube is configured to be slidable relative to the inner shaft assembly; a bumper attached to an end of the middle tube and defining a cavity within which the inner shaft assembly is received such that the bumper is configured to be slidable relative to the inner shaft assembly, the bumper extending between a distal end and a proximal end, and comprising a ramped surface with an increasing diameter from the proximal end toward the distal end with the distal end comprising a distal outer diameter, the bumper configured to receive a proximal end of the stented prosthesis within the cavity such that the stented prosthesis is maintained in a radially-compressed configuration; and a capsule comprising an elongated channel within which the middle tube is received such that the capsule is configured to be slidable relative to the middle tube, the inner shaft assembly, and the bumper, the elongated channel comprising an inner diameter that is greater than the distal outer diameter of the bumper such that the capsule receives the bumper and the stented prosthesis when the capsule moves in a distal direction.

9 . The delivery device of claim 8 , wherein a first segment of the stented prosthesis is received within the cavity such that the bumper circumferentially surrounds the first segment, and wherein a second segment of the stented prosthesis is located outside of the bumper such that the second segment is not circumferentially surrounded by the bumper.

10 . The delivery device of claim 9 , wherein the distal outer diameter of the bumper is greater than a compressed diameter of the stented prosthesis in the radially-compressed configuration.

11 . The delivery device of claim 8 , wherein the inner shaft member comprises a plurality of apertures extending radially through the inner shaft member.

12 . The delivery device of claim 11 , further comprising one or more tension members extending through the plurality of apertures, the one or more tension members circumferentially surrounding the stented prosthesis and configured to maintain the stented prosthesis in the radially-compressed configuration.

13 . The delivery device of claim 8 , wherein the capsule is configured to move between a first position, in which the bumper and the stented prosthesis are received within the elongated channel, and a second position, in which the bumper and the stented prosthesis are outside of the elongated channel.

14 . A method for delivering a stented prosthesis to a target site, the method comprising:
providing a delivery device comprising:
an inner shaft assembly;
a middle tube defining a recess within which the inner shaft assembly is received;
a bumper attached to an end of the middle tube and defining a cavity within which the inner shaft assembly is received; and
a capsule comprising an elongated channel within which the middle tube is received;
loading a stented prosthesis over the inner shaft assembly; radially-compressing the stented prosthesis; moving the bumper in a distal direction toward the stented prosthesis such that a proximal end of the stented prosthesis is received within the cavity and the stented prosthesis is maintained in the radially-compressed configuration; and moving the capsule in the distal direction toward the stented prosthesis such that the bumper and the stented prosthesis are received within the elongated channel.

15 . The method of claim 14 , further comprising, after the bumper and the stented prosthesis are received within the elongated channel, moving the delivery device to the target site while the bumper and the stented prosthesis are maintained within the elongated channel.

16 . The method of claim 15 , further comprising, after moving the delivery device to the target site, moving the capsule in a proximal direction, opposite the distal direction, such that the bumper and the stented prosthesis are not received within the elongated channel.

17 . The method of claim 14 , further comprising extending one or more tension members through a plurality of apertures of the inner shaft member such that the one or more tension members circumferentially surround the stented prosthesis.

18 . The method of claim 17 , wherein radially-compressing the stented prosthesis comprises tightening the one or more tension members around the stented prosthesis to radially-compress the stented prosthesis.

19 . The method of claim 14 , wherein the bumper comprises a ramped surface with an increasing diameter from a proximal end of the bumper toward a distal end of the bumper, the capsule guided by the ramped surface as the capsule moves in the distal direction.

20 . The method of claim 19 , wherein moving the capsule in the distal direction comprises moving the capsule relative to the inner shaft assembly, the middle tube, and the bumper.

Assignees

• Medtronic Vascular Inc

Inventors

• Tran Don
• Barajas-Torres Martha
• Lally Marian
• Gloss Michael
• Groen Timothy
• Mendoza Leonel
• Som Siyan
• Silver Michele
• Brown Nathan
• Mendelson Jill

Classifications

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/966

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

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2002/9665

  with additional retaining means · CPC title

• A61F2250/0039

  differing in diameter · CPC title