Heart valve holder assembly for use in valve implantation procedures

• US 8,273,118 B2
• Filed: 09/16/2008
• Issued: 09/25/2012
• Est. Priority Date: 09/17/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bergin, Cathleen A.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): Anderson, Gregory
• Application Number:
  US12/283,890
• Publication Number:
  US 20090076599A1
• Time in Patent Office: 1,470 Days
• Field of Search: 623/2.11, 623 238- 241, 606/139, 606/151
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion

Abstract

A valve holder assembly for delivering a prosthetic heart valve having a stent base an multiple extending commissure posts. The valve holder assembly includes a holder and a rotor that is rotatable relative to the holder.

Claims

1. A valve holder assembly for a prosthetic valve having a stent comprising a stent ring and multiple commissure posts extending from the stent ring, the valve holder assembly comprising:

a holder comprising;

a base ring having a central opening;

a plurality of legs extending in a generally downward direction from the base ring, each of the plurality of legs comprising a proximal end and a distal end; and

at least one flexible finger extending in a generally downward direction from the base ring,

wherein the distal end of each of the legs is engageable with the stent ring between adjacent commissure posts;

a rotor positioned within the central opening of the base ring, the rotor comprising a proximal end, a distal end, a circumferential groove adjacent to the distal end of the rotor, and at least one ratchet arm at the proximal end of the rotor, wherein a portion of the at least one finger of the holder is engaged with the circumferential groove of the rotor; and

a handle extending from the proximal end of the rotor for rotation of the rotor relative to the holder.

2. The valve holder assembly of claim 1, further comprising a recessed portion in a top side of the base ring, wherein the top side of the base ring faces in a direction that is generally opposite the downward direction that the plurality of legs extend, and wherein the at least one ratchet arm of the rotor is positioned in the recessed portion of the base ring.

3. The valve holder assembly of claim 2, wherein the recessed portion of the base ring comprises a plurality of ratchet teeth that are engageable with the at least one ratchet arm of the rotor.

4. The valve holder assembly of claim 1, wherein each of the at least one ratchet arms is spaced from a central body portion of the rotor by a gap having a width.

5. The valve holder assembly of claim 4, wherein each of the at least one ratchet arms is flexibly moveable toward and away from the central body portion of the rotor when the rotor is rotated relative to the holder to thereby change the width of the gap.

6. The valve holder assembly of claim 5, wherein the recessed portion of the base ring further comprises a stop element that is positioned to contact one of the at least one ratchet arms of the rotor for limiting rotation of the rotor relative to the holder to less than one full rotation of the rotor.

7. The valve holder assembly of claim 1, further comprising three ratchet arms at the proximal end of the rotor.

8. The valve holder assembly of claim 7, wherein the proximal end of the rotor further comprises three slots, wherein each slot is circumferentially positioned between two ratchet arms.

9. The valve holder assembly of claim 8, wherein each of the slots comprises a first aperture, a second aperture spaced from the first aperture, and a recessed channel portion between the first and second apertures.

10. The valve holder assembly of claim 1, wherein each leg of the holder comprises at least one upper aperture and at least one lower aperture at its proximal end, and wherein each leg of the holder comprises at least one leg attachment aperture at its distal end.

11. The valve holder assembly of claim 1, wherein each of the at least one flexible fingers is moveable relative to a longitudinal axis that extends through the central opening of the base ring for engagement with the circumferential groove of the rotor during assembly of the rotor within the central opening of the base ring.

12. A valve holder assembly for a prosthetic valve having a stent comprising a stent ring and multiple commissure posts extending from the stent ring, the valve holder assembly comprising:

a holder comprising;

a base ring having a central opening;

a plurality of legs extending in a generally downward direction from the base ring, each of the plurality of legs comprising a proximal end and a distal end; and

at least one flexible finger extending in a generally downward direction from the base ring,

wherein the distal end of each of the legs is engageable with the stent ring between adjacent commissure posts;

a rotor positioned within the central opening of the base ring, the rotor comprising a proximal end, a distal end, a circumferential groove adjacent to the distal end of the rotor and comprising a plurality of ratchet teeth spaced from each other around at least a portion of the groove, wherein the at least one finger of the holder is engaged with the circumferential groove of the rotor; and

a handle extending from the proximal end of the rotor for rotation of the rotor relative to the holder.

13. The valve holder assembly of claim 12, wherein the proximal end of the rotor comprises a first suture hole, a second suture hole spaced from the first suture hole, and a recessed channel between the first and second suture holes.

14. A method of implanting a prosthetic valve in a patient, the prosthetic valve including a stent comprising a stent ring and multiple commissure posts extending from the stent ring, the method comprising the steps of:

providing a valve holder assembly comprising;

a holder comprising a base ring having a central opening, a plurality of legs extending in a generally downward direction from the base ring, each of the plurality of legs comprising a proximal end and a distal end, wherein the distal end of each of the legs is engageable with the stent ring between adjacent commissure posts, and at least one flexible finger extending in a generally downward direction from the base ring;

a rotor positioned within the central opening of the base ring, the rotor comprising a proximal end, a distal end, and at least one ratchet arm at the proximal end of the rotor, wherein a portion of the at least one finger of the holder is engaged with the circumferential groove of the rotor; and

a handle extending from the proximal end of the rotor for rotation of the rotor relative to the holder;

attaching the valve holder assembly to the stent of the prosthetic valve using a plurality of suture members;

rotating the rotor relative to the holder to generally simultaneously deflect the multiple commissure posts of the stent inwardly;

positioning the valve holder assembly with the attached prosthetic valve in an implantation site of a patient;

attaching the prosthetic valve to the tissue of the patient;

detaching the prosthetic valve from the valve holder assembly; and

removing the valve holder assembly from the patient.

15. The method of claim 14, wherein the number of commissure posts is the same as the number of suture members used for attaching the valve holder assembly to the stent, wherein each suture member is attached to the rotor, at least a portion of two adjacent legs of the plurality of legs, and one of the multiple commissure posts.

16. The method of claim 14, wherein a first suture member comprises a first end attached to the rotor, a second end attached to a first leg of the holder adjacent the proximal end of the first leg, and an elongated suture portion between the first and second suture ends, wherein the elongated suture portion follows a suture path that extends from the rotor to the proximal end of a second leg of the holder, to a first commissure post that is positioned between the first and second legs, to the proximal end of the first leg, to the distal end of the first leg, and to the second suture end at the proximal end of the first leg.

17. A valve holder assembly for a prosthetic valve having a stent comprising a stent ring and multiple commissure posts extending from the stent ring, the valve holder assembly comprising:

a holder comprising;

a base ring having a central opening, a top side that faces in a direction that is generally opposite the downward direction that the plurality of legs extend, and a recessed portion on the top side; and

a plurality of legs extending in a generally downward direction from the base ring, each of the plurality of legs comprising a proximal end and a distal end;

wherein the distal end of each of the legs is engageable with the stent ring between adjacent commissure posts;

a rotor positioned within the central opening of the base ring, the rotor comprising a proximal end, a distal end, and at least one ratchet arm at the proximal end of the rotor; and

a handle extending from the proximal end of the rotor for rotation of the rotor relative to the holder;

wherein the at least one ratchet arm of the rotor is positioned in the recessed portion of the base ring.

18. The valve holder of claim 17, wherein the recessed portion of the base ring further comprises a stop element that is positioned to contact one ratchet arm of the rotor for limiting rotation of the rotor to less than one full rotation of the rotor.

19. The valve holder assembly of claim 17, wherein the recessed portion of the base ring comprises a plurality of ratchet teeth that are engageable with the at least one ratchet arm of the rotor.

20. The valve holder assembly of claim 17, further comprising a first suture member that comprises a first end attached to the rotor, a second end attached to a first leg of the holder adjacent the proximal end of the first leg, and an elongated suture portion between the first and second suture ends, wherein the elongated suture portion follows a suture path that extends from the rotor to the proximal end of a second leg of the holder, to a first commissure post that is positioned between the first and second legs, to the proximal end of the first leg, to the distal end of the first leg, and to the second suture end at the proximal end of the first leg.