Dynamic annuloplasty ring sizer

• US 9,149,360 B2
• Filed: 02/21/2014
• Issued: 10/06/2015
• Est. Priority Date: 03/12/2013
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US14/187,084
• Publication Number:
  US 20140277421A1
• Time in Patent Office: 592 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/0807 Indication means
• CPC Class Codes: A61B 5/107 Measuring physical dimensions, e.g. size of the entire body or parts thereof
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2472 Devices for testing
• 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 2250/0097 Visible markings, e.g. indicia

Abstract

A dynamic, adjustable annuloplasty ring sizer can include an adjustable ring replica, which can be adjusted through a range of sizes corresponding to available prosthetic annuloplasty repair ring sizes. Actuation of an adjustment trigger on a handle portion of the ring sizer can displace tension wires that extend through a malleable shaft and through a plurality of articulating segments that form the ring replica. Displacement of the tension wires causes flexion of the joints between adjacent articulating segments, thereby reducing the overall size of the ring replica. Releasing the tension wires can allow an elastic extension wire to act on the ring replica, enlarging the ring replica to its maximum, at-rest size. In this manner, the appropriate size of annuloplasty ring prosthesis can be determined with a single device, without requiring a plurality of static ring sizers that require individual insertion and placement for the conventional trial-and-error sizing methods.

Claims

1. A sizing device, comprising:

a device body having a proximal end and a distal end;

a handle portion positioned adjacent the proximal end of the device body;

an adjustable annuloplasty ring replica positioned adjacent the distal end of the device body, wherein the adjustable annuloplasty ring replica is configured to be adjusted to a plurality of different sizes, and wherein the adjustable annuloplasty ring replica comprises a generally C-shaped ring replica having a first free end and a second free end, as well as an inner surface and an outer surface; and

a shaft that couples the adjustable annuloplasty ring replica to the handle portion.

2. The device according to claim 1, wherein the shaft is a malleable shaft comprising a hollow bore configured to receive at least one elongated member configured to adjust the adjustable annuloplasty ring replica to a plurality of different sizes.

3. The device according to claim 2, wherein the handle portion comprises an adjustment trigger, wherein actuation of the adjustment trigger is configured to expand and contract the adjustable annuloplasty ring replica.

4. The device according to claim 3, wherein actuation of the adjustment trigger displaces the at least one elongated member.

5. The device according to claim 2, wherein the at least one elongated member comprises at least one selected from the following:

suture, wire rope, and wire cable.

6. The device according to claim 1, wherein the adjustable annuloplasty ring replica comprises an extension wire channel and a tension wire channel.

7. The device according to claim 6, wherein the extension wire channel is positioned adjacent the outer surface of the adjustable ring replica, and the tension wire channel is positioned adjacent the inner surface of the adjustable ring replica.

8. The device according to claim 7, wherein the extension wire channel is configured to receive at least one elongated member.

9. The device according to claim 8, wherein the at least one elongated member comprises an elastically deformable material and extends from the first free end of the adjustable ring replica to the second free end of the adjustable ring replica.

19. The device according to claim 1, wherein the adjustable annuloplasty ring replica comprises a plurality of articulating segments serially arranged and hinged with respect to one or more respective adjacent articulating segment, and the sizing device further includes at least one tension wire extending along the shaft from the handle portion to the adjustable annuloplasty ring replica and configured to contract and/or expand the adjustable C-shaped annuloplasty ring replica by pivoting the articulating segments respect to the adjacent articulating segments.

10. A device comprising:

a handle portion positioned adjacent a proximal end of the device;

an adjustable C-shaped annuloplasty ring replica positioned adjacent a distal end of the device, wherein the adjustable C-shaped annuloplasty ring replica comprises a first free end and a second free end;

a malleable shaft coupling the handle portion to the adjustable C-shaped annuloplasty ring replica via an articulating joint, the malleable shaft being configured to receive at least one tension wire; and

an adjustment trigger positioned adjacent the handle portion, wherein actuation of the adjustment trigger is configured to displace the at least one tension wire, and wherein displacement of the at least one tension wire is configured to contract and/or expand the adjustable C-shaped annuloplasty ring replica;

wherein the C-shaped adjustable annuloplasty ring replica comprises a backbone segment coupled to the malleable shaft, wherein the backbone segment comprises a first backbone end and a second backbone end opposite the first backbone end, wherein a first plurality of articulating segments serially coupled to one another extend in an elongated manner from the first backbone end to the first free end of the ring replica, and wherein a second plurality of articulating segments serially coupled to one another extend in an elongated manner from the second backbone end to the second free end of the ring replica, wherein the C-shaped adjustable annuloplasty ring replica comprises an extension wire channel adjacent an outer ring surface and a tension wire channel adjacent an inner ring surface, and wherein displacement of the at least one tension wire is configured to move each respective articulating segment with respect to each adjacent articulating segment and/or the backbone segment.

11. The device according to claim 10, further comprising a display on the handle portion of the device, wherein the display is configured to provide the size of annuloplasty ring that corresponds to each respective size of the adjustable annuloplasty ring replica.

12. The device according to claim 11, further comprising an extension wire that extends through the extension wire channel from the first free end to the second free end of the C-shaped annuloplasty ring replica.

13. A sizing device, comprising:

a device body having a proximal end and a distal end;

a handle portion positioned adjacent the proximal end of the device body;

an adjustable annuloplasty ring replica positioned adjacent the distal end of the device body, wherein the adjustable annuloplasty ring replica is configured to be adjusted to a plurality of different sizes, wherein the adjustable annuloplasty ring replica comprises a plurality of articulating segments each moveable with respect to one or more respective adjacent articulating segment, wherein the adjustable annuloplasty ring replica comprises an elongated backbone segment having a first backbone end and a second backbone end, wherein a first plurality of articulating segments are serially arranged and coupled to the first backbone end and extend to the first free end of the adjustable ring replica, and a second plurality of articulating segments are serially arranged and coupled to the second backbone end and extend to the second free end of the adjustable ring replica; and

a shaft that couples the adjustable annuloplasty ring replica to the handle portion.

14. The device according to claim 13, wherein the elongated backbone segment is coupled to the shaft.

15. The device according to claim 14, wherein the elongated backbone segment is coupled to the shaft via an articulating joint.

16. The device according to claim 13, wherein the adjustable ring replica comprises an extension wire channel and a tension wire channel.

17. The device according to claim 16, wherein the tension wire channel is configured to receive at least one elongated member.

18. The device according to claim 13, wherein the adjustable annuloplasty ring replica comprises a generally C-shaped ring replica.