Combined holder tool and rotator for a prosthetic heart valve

• US 5,776,187 A
• Filed: 08/05/1996
• Issued: 07/07/1998
• Est. Priority Date: 02/09/1995
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: DeLeon, Averdon M., Anderson, Kimberly A., Girard, Michael J., Krueger, Kurt D., Nettekoven, William S.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/692,396
• Time in Patent Office: 701 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation

Abstract

The invention relates to a holder/rotator device which may be used to hold and then rotate a heart valve prosthesis during implantation of the heart valve prosthesis. The device comprises holder/rotator which includes a post and a rotator head, and a handle. The rotator head comprises a gripping surface of a material which engages and grips the surface of the heart valve prosthesis and facilitates the smooth rotation of the valve.

Claims

1. A device for engaging and gripping during implantation a heart valve prosthesis having two leaflets in an annulus with a substantially annular aperture therein, the prosthesis having a first perimeter and a second perimeter disposed on opposite sides of the annular aperture with the leaflets positioned therebetween, the device comprising:

an elongated handle having a proximal end and a keyed distal end;

an upstanding post extending in an axial direction having a proximal end and a distal end, the post comprising a substantially rigid material, the upstanding post having a keyed bore formed therein extending in the axial direction from the proximal end, the keyed bore adapted for receiving the elongated handle keyed distal end, the keyed bore shaped to substantially conform to the keyed distal end such that the keyed distal end of the elongated handle is moveable in the axial direction relative to the keyed bore and the keyed bore prevents rotation of the keyed distal end relative to the bore in a plane substantially perpendicular to the axial direction such that a torque applied to the handle is transferred to the post, and the handle is selectively removeable from the upstanding post; and

a head integral with the distal end of the post, the head having a gripping surface configured to couple with the first perimeter and extend into the annulus a distance less than a distance to the second perimeter and generally conform to the leaflets, the gripping surface spaced apart from and not contacting the second perimeter, whereby the gripping surface of head may engage and grip the first perimeter of the heart valve prosthesis to facilitate rotation of the valve prosthesis relative to a sewing cuff during implantation.

2. The device of claim 1 wherein the leaflets meet at an angle along a diametral line of the annulus when in a closed position, and wherein the head has angled surfaces and substantially vertical sidewalls, the angled surfaces adapted for parallel relation with the leaflets of the heart valve prosthesis in the closed position.

3. The device of claim 2 adapted for use with a heart valve prosthesis having at least two pivot guards, the substantially vertical sidewalls adapted to be disposed substantially adjacent the pivot guards.

4. The device of claim 1 including at least one suture shoulder adapted for coupling the heart valve prosthesis to the device.

5. The device of claim 4 further comprising sutures for coupling the heart valve prosthesis to the suture shoulder.

6. The device of claim 5 adapted for use with a rotatable heart valve prosthesis having a sewing cuff rotatable relative to the annulus, wherein the sewing cuff may be coupled to the suture shoulder by the suture such that the suture may be cut to decouple the heart valve prosthesis from the suture shoulder and the device may be used to rotate the annulus relative to the sewing cuff during implantation.

7. The device of claim 1 wherein the keyed bore includes a key way passageway which extends substantially radially from an axis of the bore, and the keyed distal end of the handle includes a pin which extends substantially radially from an axis of the handle, the pin being engageable with the key way passageway.

8. The device of claim 1 wherein the post includes splines extending outward from the distal end of the post, the head being molded about the splines.

9. The device of claim 1 wherein the gripping surface comprises a soft elastomeric material.

10. The device of claim 9, wherein the head includes a stiffening core, the stiffening core comprising a rigid material covered by a soft elastomeric material.

11. The device of claim 10 wherein the distal end of the post comprises at least one axially extending stud, and the stiffening core comprises at least one bore, the at least one stud engaging the at least one bore to couple the stiffening core to the post.

12. The device of claim 1 wherein the gripping surface is formed of a rigid material.

13. A holder/rotator device for engaging and gripping during implantation of a heart valve prosthesis having two leaflets in an annulus with a substantially annular aperture therein, the prosthesis having a first perimeter and a second perimeter disposed on opposite sides of the annular aperture with the leaflets positioned therebetween, the device comprising:

an elongated handle having a proximal end and a keyed distal end;

an upstanding post extending in an axial direction to be substantially coaxial with an axis of the heart valve prosthesis, the upstanding post having a keyed bore formed therein extending in the axial direction from a proximal end, the bore adapted for receiving the elongated handle keyed distal end and shaped to substantially conform to the keyed distal end such that the keyed distal end of the elongated handle is moveable in the axial direction relative to the keyed bore and the keyed bore prevents rotation of the keyed distal end relative to the bore in a plane substantially perpendicular to the axial direction such that a torque applied to the handle is transferred to the post and the handle is selectively removeable from the upstanding post;

a head integral with a distal end of the post, the head having a gripping surface sized to couple with the first perimeter and extend into the annulus a distance less than a distance to the second perimeter, the gripping surface spaced apart from and not contacting the second perimeter, such that the head is configured to generally conform to the leaflets and couple to the first perimeter, the gripping surface adapted to engage and grip the first perimeter of the heart valve prosthesis to facilitate rotation of the valve prosthesis during implantation, such that a torque may be applied along the axis to the heart valve prosthesis to rotate the prosthesis in a sewing cuff relative to a natural tissue annulus of the heart following implantation;

a suture adapted to operably couple to the heart valve prosthesis; and

a suture shoulder on the head for attaching the suture to the head and thereby adapted to attach the heart valve prosthesis to the head, whereby the head may be selectively withdrawn from the heart valve prosthesis by cutting the suture.

14. The device of claim 13 wherein the leaflets meet at an angle along a diametral line of the annulus when in a closed position, and wherein the head has angled surfaces and substantially vertical sidewalls, the angled surfaces adapted for parallel relation with the leaflets of the heart valve prosthesis in the closed position.

15. The device of claim 14 adapted for use with a heart valve prosthesis having at least two pivot guards, the substantially vertical sidewalls adapted to be disposed substantially adjacent the pivot guards.

16. The device of claim 13 wherein the head comprises a soft material.

17. The device of claim 16 wherein the head further comprises a stiffening core encompassed by the soft material, the stiffening core comprising a rigid material.

18. The device of claim 13 wherein the post further comprises a key way passageway which extends substantially radially from the keyed bore, and the handle comprises a pin which extends substantially radially from a rod, the pin being engageable with the key way passageway.

19. The device of claim 13 wherein the gripping surface is formed of a rigid material.