Adjustable prosthetic anatomical device holder and handle for the implantation of an annuloplasty ring

• US 10,028,834 B2
• Filed: 01/31/2012
• Issued: 07/24/2018
• Est. Priority Date: 01/31/2011
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Kovach, Melinda K., Clegg, Susan E., Morris, Benjamin E., Furnish, Gregory R., Bielefeld, Eric E., Furnish, Simon McKnight
• Primary Examiner(s): Nguyen, Tuan V
• Application Number:
  US13/982,612
• Publication Number:
  US 20140142690A1
• Time in Patent Office: 2,366 Days
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0065 telescopic
• CPC Class Codes: A61F 2250/0089 coded with symbols, e.g. dots, numbers, letters, words
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: B25B 15/02 operated by rotating the handle
• CPC Class Codes: B25B 23/142 specially adapted for hand operated wrenches or screwdrivers
• CPC Class Codes: B25G 1/046 with free-turning section at end of handle remote from tool
• CPC Class Codes: B25G 3/18 comprising catches or pawls

Abstract

An adjustable prosthetic anatomical holder system may include an adjustable annuloplasty ring, a ring holder, and a positioning handle. The adjustable annuloplasty ring holder facilitates placement and adjustment of the annuloplasty ring during a cardiac surgical procedure. An optional positioning handle holds the adjustable annuloplasty ring during placement and suturing of the ring. The ring holder is constructed from two members that are slidably fit together in telescopic arrangement to accommodate adjustment of the ring size.

Claims

1. An adjustable prosthetic anatomical system, comprising:

an adjustable prosthetic anatomical device including an anterior region and a posterior region, the device being transitionable in a controlled manner from a first diameter to a second diameter and being adapted to remain at the second diameter after such transition;

an adjustment tool including an elongated shaft directly engageable with the device to effect transitioning of the device from the first diameter to the second diameter; and

a holder comprising;

a first member operably attachable to the posterior region of the device;

a neck member extending from the first member, the neck member including a channel in which the elongated shaft of the adjustment tool is receivable; and

a second member operably attachable to the anterior region of the device, wherein the first member and the second member are engageable with one another and slidable telescopically relative to one another in response to adjustment of the device from the first diameter to the second diameter.

2. The system of claim 1, wherein the channel has a generally U-shaped configuration.

3. The system of claim 1, wherein the elongated shaft of the adjustment tool is detachable from the neck member while the adjustment tool is operably engaged with the device.

4. The system of claim 1, wherein the first member defines an elongated slot along a longitudinal axis, and the second member includes a pair of opposing tabs receivable within the elongated slot to secure the second member to the first member, whereby the first and second members are slideable relative to each other along the longitudinal axis.

5. The system of claim 1, wherein the first member and the second member are each securable to the device by a length of suture, and the first and second members each include a cutting block to facilitate cutting of the length of suture.

6. The system of claim 5, wherein the cutting blocks are aligned along a common axis.

7. The system of claim 1, wherein the neck member further comprises a second channel configured and adapted to receive a positioning tool to facilitate positioning of the holder.

8. The system of claim 1, wherein the first member includes a longitudinally extending channel and the second member includes a longitudinally extending bar, the bar being translatable through the channel along a single axis of the first and second members.

9. The system of claim 8, wherein the first member and the second member are operably coupled to one another by a length of suture.

10. The system of claim 1, further comprising a positioning tool including a rod, the neck member including a channel adapted for receiving the rod.

11. The system of claim 10, wherein the rod is formed from a malleable material.

12. The system of claim 1, wherein the neck member further includes a second channel adapted for receiving a positioning tool.

13. The system of claim 12, further comprising a positioning tool assembled to the holder in an assembled position, the positioning tool including an elongated shaft, wherein the elongated shaft of the adjustment tool and the elongated shaft of the positioning tool are substantially parallel to one another in the assembled position.

14. The system of claim 13, wherein the positioning tool includes a handle having a proximal end and a distal end, the handle defining a groove extending between the proximal and distal ends and adapted to rotationally receive the elongated shaft of the adjustment tool therein, the elongated shaft of the positioning tool extending distally from the distal end of the handle.

15. The system of claim 14, wherein the handle includes at least one aperture adapted to receive suture therethrough to inhibit separation of the elongated shaft of the adjustment tool from the groove of the handle.

16. The system of claim 1, further comprising a locking mechanism including a cylindrical section that is securable within the channel, the locking mechanism releasably engaging the elongated shaft of the adjustment tool.

17. The system of claim 16, wherein the locking mechanism selectively inhibits rotation of the elongated shaft of the adjustment tool.

18. An adjustable prosthetic anatomical device holder, comprising:

a first member operably attachable to a posterior region of an adjustable prosthetic anatomical device;

a second member operably attachable to an anterior region of the device, the first member and the second member being engageable with one another and slidable telescopically relative to one another in response to adjustment of the device from a first diameter to a second diameter larger than the first diameter;

a neck member on the first member, the neck member defining a first channel and a second channel;

an adjustment tool received in the first channel, the adjustment tool being effective to transition the device from the first diameter to the second diameter; and

a positioning tool received in the second channel, the positioning tool facilitating positioning of the holder.

19. The holder of claim 18, wherein the first channel has a generally U-shaped configuration.

20. The holder of claim 18, wherein the first member defines an elongated slot along a longitudinal axis, and the second member includes a pair of opposing tabs receivable within the elongated slot to secure the second member to the first member, whereby the first and second members are slideable relative to each other along the longitudinal axis.

21. The holder of claim 18, wherein the first member and the second member each include an opening for receiving a length of suture for securing the first and second members to the device.

22. The holder of claim 21, wherein the first and second members each include a cutting block to facilitate cutting of the length of suture.

23. The holder of claim 18, wherein the first member includes a longitudinally extending channel and the second member includes a longitudinally extending bar, the bar being translatable within the channel along a single axis of the first and second members.

24. The holder of claim 23, further including a length of suture tethering the first member to the second member.

25. The holder of claim 18, wherein the first member includes sections adapted to be snap fitted together with the second member.

26. The holder of claim 18, wherein the first and second members move relative to one another along a common plane.

27. The holder of claim 18, wherein the first and second members move relative to one another along a single axis of the holder.

28. The holder of claim 18, wherein the second member includes a bar having a projection adapted to be received within a groove provided in the first member.

29. An adjustable prosthetic anatomical system, comprising:

an adjustable prosthetic anatomical device including an anterior region and a posterior region, the device being transitionable from an initial diameter to a second diameter larger than the initial diameter;

an adjustment tool directly engageable with the device to effect transitioning of the device from the first diameter to the second diameter; and

a holder comprising;

a first member operably attachable to the posterior region of the device; and

a neck member extending from the first member, the neck member including a channel in which the elongated shaft of the adjustment tool is receivable; and

a second member operably attachable to the anterior region of the device, wherein the first member and the second member are engageable with one another and slidable telescopically relative to one another in response to the transition of the device from the initial diameter to the second diameter.

30. An adjustable prosthetic anatomical system, comprising:

an adjustable prosthetic anatomical device including an anterior region and a posterior region, the device being transitionable in a controlled manner from a first diameter to a second diameter and being adapted to remain at the second diameter after such transition;

an adjustment tool including an elongated shaft directly engageable with the device to effect transitioning of the device from the first diameter to the second diameter; and

a holder comprising;

a first member operably attachable to the posterior region of the device; and

a second member operably attachable to the anterior region of the device, wherein the first member and the second member are engageable with one another and slidable telescopically relative to one another in response to adjustment of the device from the first diameter to the second diameter.

31. An adjustable prosthetic anatomical system, comprising:

an adjustable prosthetic anatomical device including an anterior region and a posterior region, the device being transitionable from an initial diameter to a second diameter larger than the initial diameter;

an adjustment tool directly engageable with the device to effect transitioning of the device from the first diameter to the second diameter; and

a holder comprising;

a first member operably attachable to the posterior region of the device; and

a second member operably attachable to the anterior region of the device, wherein the first member and the second member are engageable with one another and slidable telescopically relative to one another in response to the transition of the device from the initial diameter to the second diameter.