Stented prosthesis delivery system having a bumper

Patent metadata

Field	Value
Publication number	US-11806236-B2
Application number	US-202017121903-A
Country	US
Kind code	B2
Filing date	Dec 15, 2020
Priority date	Mar 3, 2016
Publication date	Nov 7, 2023
Grant date	Nov 7, 2023

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 method of delivering a stented prosthesis to a target site, the method comprising:
providing an expandable stented prosthesis loaded onto a delivery device in a collapsed, loaded state, the stented prosthesis having a distal end and a proximal end, wherein the stented prosthesis is a prosthetic heart valve and the target site is a heart valve; the delivery device including:
an inner shaft assembly having a distal portion retaining the stented prosthesis,
a distal bumper engaged with and covering the distal end of the stented prosthesis, the distal bumper comprising a cavity comprising a tapered inner surface against which the distal end of the stented prosthesis is compressed, with the distal end of the stented prosthesis in contact with the tapered inner surface that comprises a decreasing inner diameter from a proximal end of the distal bumper toward a distal end of the distal bumper, and wherein the distal end of the distal bumper has a smaller outer diameter as compared to an outer diameter of the proximal end of the distal bumper with a ramped surface comprising a decreasing outer diameter from a midpoint of the distal bumper to the distal end of the distal bumper,

percutaneously delivering the stented prosthesis in the collapsed, loaded state to the target site with the distal bumper and a portion of the stented prosthesis between the distal bumper and the proximal end being unsheathed; and
once the loaded stented prosthesis is at the target site, transitioning the stented prosthesis from the collapsed, loaded state to an expanded arrangement.

2. The method of claim 1 , wherein the stented prosthesis is delivered via a transapical approach.

3. The method of claim 1 , wherein a maximum outer diameter of the distal bumper is less than or equal to a maximum outer diameter of the stented prosthesis in the collapsed, loaded state.

4. The method of claim 1 , further comprising a proximal bumper compressing the proximal end of the stented prosthesis.

5. The method of claim 4 , wherein a maximum outer diameter of the proximal bumper is less than or equal to a maximum outer diameter of the stented prosthesis in the collapsed, loaded state.

6. The method of claim 1 , wherein the distal bumper is connected to the inner shaft assembly so that the inner shaft assembly extends through the cavity defined by the distal bumper.

7. The method of claim 1 , wherein the stented prosthesis is mechanically expandable.

8. The method of claim 1 , wherein the proximal end of the stented prosthesis is compressed with an elongated tension member.

9. The method of claim 8 , further comprising a second elongate tension member circumferentially secured around the stented prosthesis between the proximal end and the distal end.

10. The method of claim 8 , wherein the proximal end of the stented prosthesis includes a plurality of crowns through which the elongated tension member is routed.

11. The method of claim 8 , wherein the proximal end of the stented prosthesis includes a plurality of eyelets through which the elongated tension member is routed.

12. A loaded delivery device comprising:
an expandable stented prosthesis in a collapsed, loaded state, the stented prosthesis having a proximal end and a distal end, the proximal end including a plurality of features comprising crowns or eyelets;
a first elongate tension member circumferentially wrapped through the plurality of features and compressing the proximal end;
an inner shaft assembly on which the stented prosthesis is positioned; and
a distal bumper assembled to and projecting radially from the inner shaft assembly, the distal bumper having a cavity in which the distal end of the stented prosthesis is positioned, wherein the distal bumper is engaged with and covers the distal end of the stented prosthesis, the cavity comprising a tapered inner surface against which the distal end of the stented prosthesis is compressed, with the distal end of the stented prosthesis in contact with the tapered inner surface that comprises a decreasing inner diameter from a proximal end of the distal bumper toward a distal end of the distal bumper, and wherein the distal end of the distal bumper has a smaller outer diameter as compared to an outer diameter of the proximal end of the distal bumper with a ramped surface comprising a decreasing outer diameter from a midpoint of the distal bumper to the distal end of the distal bumper;
wherein a portion of the stented prosthesis between the distal bumper and the proximal end is unsheathed.

13. The device of claim 12 , further comprising a second elongate tension member circumferentially secured around the stented prosthesis between the proximal end and the distal end.

14. The device of claim 12 , wherein a maximum outer diameter of the distal bumper is less than or equal to a maximum outer diameter of the stented prosthesis in the collapsed, loaded state.

15. The method of claim 4 , wherein the distal bumper is spaced apart from the proximal bumper to define a longitudinal spacing between the distal bumper and the proximal bumper as the stented prosthesis is in the collapsed, loaded state.

16. A method of delivering a stented prosthesis to a target site, the method comprising:
providing an expandable stented prosthesis loaded onto a delivery device in a collapsed, loaded state, the stented prosthesis having a distal end and a proximal end, wherein the stented prosthesis is a prosthetic heart valve and the target site is a heart valve; the delivery device including:
an inner shaft assembly having a distal portion retaining the stented prosthesis,
a distal bumper engaged with and covering the distal end of the stented prosthesis, the distal bumper comprising a tapered inner surface with a gradually decreasing inner diameter from a proximal end of the distal bumper,
a proximal bumper engaged with and covering the proximal end of the stented prosthesis,

percutaneously delivering the stented prosthesis in the collapsed, loaded state to the target site with the distal bumper and a central portion of the stented prosthesis between the distal bumper and the proximal bumper being unsheathed with a longitudinal spacing between the distal bumper and the proximal bumper as the stented prosthesis is in the collapsed, loaded state and wherein a maximum outer diameter of the distal bumper is less than or equal to a maximum outer diameter of the central portion of the stented prosthesis in the collapsed, loaded state; and
once the loaded stented prosthesis is at the target site, transitioning the stented prosthesis from the collapsed, loaded state to an expanded arrangement.

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

• A61F2/2418

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

• A61F2/966

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

• A61F2002/9665

  with additional retaining means · CPC title

• A61F2230/0067

  conical · CPC title