Adjustable annuloplasty ring replica sizer

• US 10,729,545 B2
• Filed: 10/02/2017
• Issued: 08/04/2020
• Est. Priority Date: 03/12/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Conklin, Brian S.
• Primary Examiner(s): Hindenburg, Max F
• Application Number:
  US15/722,939
• Publication Number:
  US 20180021135A1
• Time in Patent Office: 1,037 Days
• 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. An annuloplasty ring replica sizer for sizing a heart valve annulus to inform selection of a size of an annuloplasty ring for subsequent implant, comprising:

an elongated annuloplasty ring replica configured to be adjusted to a plurality of different size arc shapes, the ring replica having a plurality of articulating segments serially coupled to one another that define an arc shape and are biased to a maximum size arc shape that is C-shaped; and

at least one flexible tension member that engages the articulating segments which, when placed in tension, reduces the arc shape size of the ring replica to a plurality of different size arc shapes smaller than the maximum size arc shape.

2. The ring replica sizer of claim 1, wherein the ring replica comprises a central arcuate backbone segment including a first backbone end and a second backbone end opposite the first backbone end, wherein a first plurality of the articulating segments serially coupled to one another extend in an elongated manner from the first backbone end to a first free end of the ring replica, and wherein a second plurality of the articulating segments serially coupled to one another extend in an elongated manner from the second backbone end to a second free end of the ring replica, and wherein there are two flexible tension members one for each of the first and second plurality of articulating segments.

3. The ring replica sizer of claim 2, wherein the ring replica includes a flexible extension member extending along its length from the first free end to the second free end that has sufficient stiffness to bias the ring replica to its maximum size arc shape.

4. The ring replica sizer of claim 1, further comprising a proximal handle having an actuator, a shaft coupled to and extending in a distal direction from the handle and coupled to the ring replica, wherein the at least one flexible tension member extends from the actuator in the handle through the shaft to the ring replica, and including a display on the handle configured to indicate the arc shape size of the heart valve annulus.

5. The ring replica sizer of claim 4, wherein the actuator is moveable through a series of incremental positions to adjust the ring replica incrementally through a series of different sized arc shapes corresponding to annuloplasty ring sizes from 24 to 40 mm, and the display on the handle incrementally changes through a plurality of corresponding annuloplasty ring sizes as the arc shape size of the ring replica is adjusted.

6. The ring replica sizer of claim 1, wherein the at least one flexible tension member extends through aligned channels in the plurality of articulating segments defining an arc shape of the ring replica, wherein tension in the flexible tension member pivots the articulating segments with respect to one another to reduce the arc shape size of the ring replica.

7. An annuloplasty ring replica sizer for sizing a heart valve annulus to inform selection of a size of an annuloplasty ring for subsequent implant, comprising:

an elongated annuloplasty ring replica configured to be adjusted to a plurality of different size arc shapes, the ring replica having;

a central arcuate backbone segment including a first backbone end and a second backbone end opposite the first backbone end;

a first plurality of articulating segments serially coupled to one another extending in an elongated manner from the first backbone end to a first free end of the ring replica;

a second plurality of articulating segments serially coupled to one another extending in an elongated manner from the second backbone end to a second free end of the ring replica; and

a flexible extension member extending from the first free end to the second free end and passing through the backbone segment and the first and second plurality of articulating segments that has sufficient stiffness to bias the ring replica to a maximum size arc shape that is C-shaped.

8. The ring replica sizer of claim 7, further including two flexible tension members that extend from a mid-point of the ring replica to the first and second free ends, respectively, and which, when placed in tension, reduce the arc shape size of the ring replica to a plurality of different size arc shapes smaller than the maximum size arc shape.

9. The ring replica sizer of claim 8, wherein the first and second plurality of articulating segments each have a male end and a female end with adjacent articulating segments having a pair of male and female ends that are in pivoting contact with one another and resist misalignment from the different size arc shapes, and wherein an articulating segment in each of the first and second plurality of articulating segments pivotably mates with the first backbone end and the second backbone end.

10. The ring replica sizer of claim 8, wherein the backbone segment and the first and second plurality of articulating segments have aligned channels adjacent an outer surface of the ring replica through which the flexible extension member extends and aligned channels adjacent an inner surface of the ring replica through which the two flexible tension members extend.

11. The ring replica sizer of claim 8, further comprising a proximal handle having an actuator, a shaft coupled to and extending in a distal direction from the handle and coupled to the ring replica, wherein the flexible tension members extend from the actuator in the handle through the shaft to the ring replica, and including a display on the handle configured to indicate the arc shape size of the heart valve annulus.

12. The ring replica sizer of claim 11, wherein the actuator is moveable through a series of incremental positions to adjust the ring replica incrementally through a series of different sized arc shapes corresponding to annuloplasty ring sizes from 24 to 40 mm, and the display on the handle incrementally changes through a plurality of corresponding annuloplasty ring sizes as the arc shape size of the ring replica is adjusted.

13. The ring replica sizer of claim 11, wherein the handle is malleable and couples to the ring replica with a swivel joint.

14. An annuloplasty ring replica sizer for sizing a heart valve annulus to inform selection of a size of an annuloplasty ring for subsequent implant, comprising:

an elongated annuloplasty ring replica configured to be adjusted to a plurality of different size arc shapes between a minimum size arc shape to a maximum size arc shape that is C-shaped, the ring replica having a plurality of articulating segments pivotably coupled to one another in series to define the different size arc shapes, the elongated ring replica having a first free end and a second free end and channels that are continuous therebetween through the series of articulating segments;

two flexible tension members that extend through the channels from a mid-point of the ring replica to the first and second free ends, respectively, and which, when placed in tension, reduce the arc shape size of the ring replica to a plurality of different size arc shapes smaller than the maximum size arc shape.

15. The ring replica sizer of claim 14, wherein the ring replica comprises a central arcuate backbone segment including a first backbone end and a second backbone end opposite the first backbone end, wherein a first plurality of the 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 the 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, and wherein there is one of the two flexible tension members for each of the first and second plurality of articulating segments.

16. The ring replica sizer of claim 15, wherein the ring replica includes a flexible extension member extending along its length from the first free end to the second free end that has sufficient stiffness to bias the ring replica to its maximum size arc shape.

17. The ring replica sizer of claim 16, wherein the first and second plurality of articulating segments have continuous channels adjacent an outer surface of the ring replica through which the flexible extension member extends and continuous channels adjacent an inner surface of the ring replica through which the two flexible tension members extend.

18. The ring replica sizer of claim 17, wherein the continuous channels in adjacent articulating segments are in different locations relative to a pivot point such that the shape of the ring replica is more D-shaped for smaller arc shape sizes and more circular for larger arc shape sizes.

19. The ring replica sizer of claim 16, wherein the flexible extension member is a Nitinol wire, the flexible tension members are selected from the group consisting of a flexible wire rope, a wire cable, a braided wire cable, sutures, and strings, and the articulating segments are selected from the group consisting of polycarbonate or acrylonitrile butadiene styrene (ABS).

20. The ring replica sizer of claim 14, further comprising a proximal handle having an actuator, a shaft coupled to and extending in a distal direction from the handle and coupled to the ring replica, wherein the two flexible tension members extend from the actuator in the handle through the shaft to the ring replica, and including a display on the handle configured to indicate the arc shape size of the heart valve annulus.