Catheter assembly with valve crimping accessories

• US 9,414,914 B2
• Filed: 10/25/2010
• Issued: 08/16/2016
• Est. Priority Date: 02/24/2010
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Inventors: Duffy, Niall, Mearns, Paul, Gallagher, John, Miller, Noam
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): LAUER, CHRISTINA C
• Application Number:
  US12/911,458
• Publication Number:
  US 20110208296A1
• Time in Patent Office: 2,122 Days
• Field of Search: 623/2.11, 623/1.23, 623/1.12, 292/82
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/9525 using a funnel
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: Y10T 29/53996 by deforming

Abstract

Catheter assemblies including a handle assembly located on the proximal end of the catheter assembly and a distal tip assembly located on the distal end of the catheter assembly. A crimping funnel is slidably positioned along the catheter. The crimping funnel includes a distal end having a first diameter and a proximal end having a second diameter smaller than the first diameter. An axial split is formed in the proximal end. A first collar is provided encompassing a portion of the proximal end. The first collar is configured to hold the axial split in the proximal end together when the first collar is at a first axial location along the proximal end, and to allow the axial split in the proximal end to open when the first collar is at a second axial location along the proximal end, such that the crimping funnel can be removed from the catheter assembly. Various methods of retaining a prosthetic valve on the catheter assembly during the crimping process are described.

Claims

1. A catheter assembly for crimping an expandable prosthesis, the catheter assembly comprising:

a handle assembly located on the proximal end of the catheter assembly;

a distal tip assembly located on the distal end of the catheter assembly and having a distal tip assembly diameter;

a first elongate member, the first elongate member extending from the handle assembly towards the distal tip assembly; and

a crimping funnel slidably positioned over the first elongate member and the distal tip assembly, the crimping funnel comprising;

a distal end having a first diameter;

a proximal end having a second diameter smaller than the first diameter, the proximal end having an axial split, wherein the second diameter is less than the distal tip assembly diameter; and

a first collar encompassing a portion of the proximal end, wherein the first collar is configured to hold the axial split in the proximal end together when the first collar is at a first axial location along the proximal end, and wherein the first collar is configured to allow the axial split in the proximal end to open when the first collar is at a second axial location along the proximal end,

wherein the axial split allows the second diameter of the proximal end of the crimping funnel to increase to a diameter larger than the distal tip assembly, when the first collar is in the second axial location,

wherein the crimping funnel is positioned over the first elongate member such that the first elongate member is disposed within the proximal end of the crimping funnel and the distal tip assembly is disposed within or distal of the distal end of the crimping funnel such that the distal tip assembly is disposed distal of the first diameter with the first collar at the first axial location.

2. A catheter assembly according to claim 1, further comprising a loading ring with a plurality of loading wires secured thereto, wherein the loading ring is positioned proximally of the crimping funnel over the first elongate member, and wherein the loading wires extend distally from the loading ring through an interior of the funnel.

3. A catheter assembly according to claim 1, further comprising a valve retainer configured to secure a prosthetic valve to the catheter assembly, wherein the prosthetic valve retainer is configured to prevent axial movement of the valve assembly relative to the first elongate member.

4. A catheter assembly according to claim 1, further comprising a second collar encompassing a portion of the distal end, wherein the second collar is separate from the first collar such that the second collar moves independently of the first collar, wherein the axial split extends from the proximal end of the funnel to the distal end of the funnel, and wherein the second collar is configured to hold the axial split together when the second collar is at a first axial location along the distal end, and wherein the second collar is configured to allow the axial split to open when the second collar is at a second axial location along the distal end.

5. A catheter assembly according to claim 1, wherein the first collar is mounted to the crimping funnel.

6. A catheter assembly according to claim 1, wherein the first collar is rotatably mounted to the crimping funnel.

7. A catheter assembly according to claim 6, wherein rotating the first collar causes the first collar to move between the first axial location and the second axial location.

8. A catheter assembly according to claim 1, wherein the crimping funnel is configured to reduce the diameter of a prosthetic valve passing therethrough.

9. A method of crimping a prosthetic valve onto a catheter assembly, the method comprising:

securing a prosthetic valve to a valve retaining assembly of a catheter assembly, the catheter assembly further including;

a first elongate member;

a crimping funnel slidably positioned over the first elongate member; and

a first sleeve positioned over the first elongate member;

wherein the valve retaining assembly is positioned over the first elongate member;

crimping the prosthetic valve by advancing the crimping funnel in a distal direction along the first elongate member and over the first sleeve;

advancing the first sleeve in a distal direction along the first elongate member until at least a proximal portion of the crimped prosthetic valve is encompassed by the first sleeve; and

removing the funnel from the catheter assembly.

10. The method of claim 9, wherein the catheter assembly further includes a second sleeve positioned over the first elongate member distally of the first sleeve, wherein the advancing step further includes retracting the second sleeve in a proximal direction along the first elongate member until the distal end of the crimped prosthetic valve is encompassed by the second sleeve.