Dynamic annuloplasty ring sizer

• US 9,351,833 B2
• Filed: 09/28/2015
• Issued: 05/31/2016
• 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:
  US14/867,992
• Publication Number:
  US 20160015518A1
• Time in Patent Office: 246 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 device for sizing a heart valve annulus, comprising:

a proximal handle having an actuator;

a shaft coupled to and extending in a distal direction from the handle;

an annuloplasty ring replica coupled to a distal end of the shaft configured to be adjusted to a plurality of different sizes, the annuloplasty ring replica being elongated and defining a shape of the annulus being sized and being biased to a maximum size; and

at least one elongated member coupled to the actuator in the handle and extending along the shaft to the annuloplasty ring replica, the elongated member being configured, when actuated, to reduce the size of the annuloplasty ring replica to a plurality of different sizes smaller than the maximum size.

2. The device according to claim 1, wherein the annuloplasty ring replica comprises a generally C-shaped ring replica having a first free end and a second free end.

3. The device according to claim 2, wherein the handle couples to a mid-point along the C-shaped ring replica.

4. The device according to claim 1, wherein the handle is malleable and couples to the C-shaped ring replica with a swivel joint.

5. The device according to claim 1, wherein the shaft has a hollow bore and the at least one elongated member comprises a flexible tension member that connects to the actuator, passes through the hollow bore, and extends through aligned channels in a plurality of articulating segments defining an arc of the annuloplasty ring replica, wherein tension on the flexible tension member pivots the articulating segments with respect to one another to reduce the size of the annuloplasty ring replica.

6. The device according to claim 1, wherein the annuloplasty ring replica includes a flexible extension wire extending along its length that biases the annuloplasty ring replica to its maximum size.

7. The device according to claim 1, further comprising a display on the handle configured to provide the size of annuloplasty ring that corresponds to incremental sizes of the annuloplasty ring replica.

8. A device for sizing a heart valve annulus, comprising:

a proximal handle having an actuator;

a shaft coupled to and extending in a distal direction from the handle;

an annuloplasty ring replica coupled to a distal end of the shaft configured to be adjusted to a plurality of different sizes, the annuloplasty ring replica comprising a plurality of articulating segments defining an arc of the annuloplasty ring replica and each segment being pivotable with respect to one or more respective adjacent articulating segment; and

at least one elongated member coupled to the actuator in the handle and extending along the shaft to the annuloplasty ring replica, the elongated member being configured, when actuated, to pivot the articulating segments so as to adjust the size of the annuloplasty ring replica to a plurality of different sizes.

9. The device according to claim 8, wherein the annuloplasty ring replica comprises a generally C-shaped ring replica having a first free end and a second free end.

10. The device according to claim 8, wherein the handle is malleable and couples to the C-shaped ring replica with a swivel joint.

11. The device according to claim 8, further comprising a display on the handle configured to provide the size of annuloplasty ring that corresponds to incremental sizes of the annuloplasty ring replica.

12. The device according to claim 8, wherein the shaft has a hollow bore and the at least one elongated member comprises a flexible tension member that connects to the actuator, passes through the hollow bore, and extends through aligned tension wire channels in the plurality of articulating segments, wherein tension on the flexible tension member pivots the articulating segments with respect to one another to adjust the size of the annuloplasty ring replica.

13. The device according to claim 12, wherein the annuloplasty ring replica further includes a plurality of aligned extension wire channels in the plurality of articulating segments and a flexible extension wire extending therethrough that biases the annuloplasty ring replica to a maximum size, wherein tension on the flexible tension member reduces the size of the annuloplasty ring replica against the bias of the flexible extension wire.

14. The device according to claim 13, wherein the extension wire channels are positioned adjacent an outer surface of the adjustable ring replica, and the tension wire channels are positioned adjacent an inner surface of the adjustable ring replica.

15. The device according to claim 12, wherein the annuloplasty ring replica comprises a backbone segment coupled to the shaft 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.

16. A device for sizing a heart valve annulus, comprising:

a proximal handle having an actuator;

a shaft coupled to and extending in a distal direction from the handle;

an annuloplasty ring replica coupled to a distal end of the shaft configured to be adjusted to a plurality of different sizes, the annuloplasty ring replica being elongated and defining a shape of the annulus being sized, and wherein the annuloplasty ring replica comprises a generally C-shaped ring replica having a first free end and a second free end; and

at least one elongated member coupled to the actuator in the handle and extending along the shaft to the annuloplasty ring replica, the elongated member being configured, when actuated, to adjust the size of the annuloplasty ring replica to a plurality of sizes.

17. The device according to claim 16, wherein the shaft is a malleable shaft comprising a hollow bore configured to receive the at least one elongated member, and wherein the actuator comprises an adjustment trigger on the handle, wherein actuation of the adjustment trigger is configured to expand and contract the annuloplasty ring replica.

18. A device for sizing a heart valve annulus, comprising:

a proximal handle having an actuator;

a shaft coupled to and extending in a distal direction from the handle;

an annuloplasty ring replica coupled to a distal end of the shaft configured to be adjusted to a plurality of different sizes, the annuloplasty ring replica being elongated and defining a shape of the annulus being sized; and

at least one elongated member coupled to the actuator in the handle and extending along the shaft to the annuloplasty ring replica, the elongated member being configured, when actuated, to adjust the size of the annuloplasty ring replica to a plurality of sizes, wherein the shaft has a hollow bore and the at least one elongated member comprises a flexible tension member that connects to the actuator, passes through the hollow bore, and extends through aligned channels in a plurality of articulating segments defining an arc of the annuloplasty ring replica, wherein tension on the flexible tension member pivots the articulating segments with respect to one another to adjust the size of the annuloplasty ring replica.

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

20. The device according to claim 18, wherein the annuloplasty ring replica further includes a plurality of aligned extension wire channels in the plurality of articulating segments and a flexible extension wire extending therethrough that biases the annuloplasty ring replica to a maximum size, wherein tension on the flexible tension member reduces the size of the annuloplasty ring replica against the bias of the flexible extension wire.