Trans-aortic delivery system with containment capsule centering device

Patent metadata

Field	Value
Publication number	US-11291543-B2
Application number	US-201715632546-A
Country	US
Kind code	B2
Filing date	Jun 26, 2017
Priority date	Sep 5, 2012
Publication date	Apr 5, 2022
Grant date	Apr 5, 2022

Abstract

Heart valve delivery systems and methods of delivering and implanting heart valves using delivery catheters are disclosed. The delivery systems can include a handle assembly which can include a first control mechanism, a second control mechanism, and a decoupling mechanism. The delivery systems can also include a delivery catheter extending from the handle assembly. The delivery catheter can include an outer shaft, which can be controlled by the first control mechanism; a prosthesis containing capsule comprising a proximal capsule portion connected to the outer shaft, and a distal capsule portion releasably coupled to the proximal capsule portion. After deploying a valve prosthesis, the capsule can be closed by activating the decoupling mechanism in the handle to rapidly close the distal and proximal capsule portions together. The delivery system can also include a centering element to guide the distal and proximal capsule portions together.

First claim

What is claimed is:

1. A catheter tip comprising:
a proximal capsule portion;
a distal capsule portion releasably coupled to the proximal capsule portion, the distal capsule portion including a cavity configured to contain a valve prosthesis within the cavity;
a distal tip connected to an inner shaft of a delivery catheter;
an intermediate shaft having a prosthesis retainer located at a distal end; and
a centering element attached to the intermediate shaft, located proximally from the prosthesis retainer, wherein the centering element includes a radially compressed configuration wherein the centering element is disposed within at least one of the proximal capsule portion or the distal capsule portion, and a radially expanded configuration wherein the centering element is configured to guide the distal capsule portion and the proximal capsule portion together when closing distal and proximal capsule portions, wherein in the radially expanded configuration, a maximum outer diameter of the centering element is less than or equal to a first capsule diameter of the proximal capsule portion and a second capsule diameter of the distal capsule portion.

2. The catheter tip of claim 1 , wherein the centering element comprises a self-expanding frame attached to the intermediate shaft at either a proximal end or a distal end of the frame.

3. The catheter tip of claim 2 , wherein the self-expanding frame comprises a shape memory alloy.

4. The catheter tip of claim 1 , wherein the centering element comprises a plurality of nitinol wires.

5. The catheter tip of claim 1 , wherein the proximal capsule includes a distally facing opening and the distal capsule includes a proximally facing opening, wherein the distally facing opening and the proximally facing opening are configured to meet to contain a heart valve prosthesis within the proximal capsule portion and the distal capsule portion.

6. A catheter tip comprising:
a proximal capsule portion;
a distal capsule portion releasably coupled to the proximal capsule portion, the distal capsule portion including a cavity configured to contain a valve prosthesis within the cavity;
a distal tip connected to an inner shaft of a delivery catheter;
an intermediate shaft having a prosthesis retainer located at a distal end; and
a centering element attached to the intermediate shaft, located proximally from the prosthesis retainer, wherein the centering element includes a radially compressed configuration wherein the centering element is disposed within at least one of the proximal capsule portion or the distal capsule portion, and a radially expanded configuration wherein the centering element is configured to guide the distal capsule portion and the proximal capsule portion together when closing distal and proximal capsule portions, wherein in the radially expanded configuration, a maximum outer diameter of the centering element is less than or equal to a first capsule diameter of the proximal capsule portion and a second capsule diameter of the distal capsule portion, and wherein the centering element comprises a radially expandable funnel attached to the intermediate shaft at a proximal end or a distal end of the funnel.

7. The catheter tip of claim 6 , wherein the funnel is constrained within an elastomeric sleeve configured to expand with the funnel.

8. The catheter tip of claim 6 , further comprising an attachment ring attaching the proximal end or the distal end of the funnel to the intermediate shaft.

9. The catheter tip of claim 6 , wherein the funnel is self-expanding.

10. The catheter tip of claim 9 , wherein the funnel comprises a sheet of a self-expanding material rolled into a funnel shape.

11. The catheter tip of claim 10 , wherein the self-expanding material is Nitinol.

12. The catheter tip of claim 6 , wherein the funnel is balloon expandable.

13. The catheter tip of claim 1 , further comprising a valve containment sleeve extending proximally from the distal capsule portion, the valve containment sleeve including a sleeve cavity configured to contain a heart valve prosthesis in the sleeve cavity.

14. The catheter tip of claim 13 , wherein the valve containment sleeve is configured to extend into the proximal capsule portion when the distal capsule portion and the proximal capsule portion are mated together.

15. The catheter tip of claim 13 , wherein the valve containment sleeve is a cylindrical polymer sleeve.

Assignees

• Medtronic Vascular Galway Ltd

Inventors

• Costello Declan
• Griffin Patrick
• Gallagher John
• Kenny Gavin
• Sheahan Edmond

Classifications

• A61F2/2436 Primary

  Deployment by retracting a sheath · CPC title

• A61F2/9517

  handle assemblies therefor · CPC title

• A61F2002/9665

  with additional retaining means · CPC title