Devices and methods for knee arthroplasty

• US 10,716,580 B2
• Filed: 12/22/2016
• Issued: 07/21/2020
• Est. Priority Date: 05/18/2012
• Status: Active Grant

• Current Assignee: Orthalign, Inc.
• Original Assignee: Orthalign, Inc.
• Inventors: Berend, Michael, Nielsen, Jonathan, van der Walt, Nicholas, Small, Scott Richard
• Primary Examiner(s): Boles, Sameh R
• Application Number:
  US15/388,096
• Publication Number:
  US 20170196571A1
• Time in Patent Office: 1,307 Days
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 17/157 Cutting tibia
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses

Abstract

The present invention provides, in certain embodiments, a device for positioning and orienting the femoral cutting block. The present invention also provides a device for setting rotation of sagittal resection for unicompartmental knee arthroplasty. The present invention further provides methods for setting the rotation of the tibial implant by kinematic measurements.

Claims

1. A system comprising:

a plurality of implants or trial implants, wherein each implant or trial implant is configured to be positioned between a femur and a tibia;

a reference device configured to be coupled with the femur or the tibia when an implant or trial implant of the plurality of implants or trial implants is positioned between the femur and the tibia, the reference device comprising an accelerometer or a gyroscope;

a surgical orientation device configured to be coupled with the femur or the tibia when the implant or trial implant is positioned between the femur and the tibia, the surgical orientation device comprising an accelerometer or a gyroscope;

a processor configured to;

gather measurements from the accelerometer or the gyroscope of the surgical orientation device or the reference device while positioning the tibia in a plurality of positions differing in flexion, axial rotation, and/or varus-valgus relative to the femur when the implant or trial implant is positioned between the femur and the tibia; and

perform calculations to convert the measurements from the accelerometer or the gyroscope of the reference device or the surgical orientation device to an output indicative of motion of the tibia and femur in one or more directions corresponding to a flexion direction, an axial rotation direction, and/or a varus-valgus direction to facilitate adjustment of the rotational alignment of the implant or trial implant positioned between the femur and the tibia.

2. The system of claim 1, wherein the processor is configured to perform one or more of the following functions:

compare the output indicative of motion of the tibia and femur to target values; and

transmit to a display one or both of the output indicative of motion of the tibia and femur and the target values.

3. The system of claim 1, wherein the surgical orientation device or the reference device is configured to guide the placement of a cutting block.

4. The system of claim 1, wherein the tibial component alignment that provides the best fit with the soft tissue kinematic envelope will be identified as the configuration that produces the minimum tibia femoral contact force.

5. The system of claim 1, wherein a user output provides information to quantitatively compare laxity.

6. The system of claim 1, wherein the surgical orientation device or the reference device comprises a user interface.

7. The system of claim 1, wherein the surgical orientation device or the reference device is configured to graphically display rotation when the surgeon applies alternating torque to the knee in order to gauge the tibio-femoral rotation allowed in each direction.

8. The system of claim 1, wherein the surgical orientation device or the reference device is configured to graphically display rotation when a force is applied to the knee.

9. The system of claim 1, wherein the surgical orientation device or the reference device is configured to display the output indicative of motion of the tibia and femur.

10. The system of claim 1, wherein the processor is configured to perform the function of a transfer alignment.

11. The system of claim 1, wherein the system comprises a set of target values based on values for healthy knees and the processor is configured to compare the target values of the set to the output indicative of motion of the tibia and femur.

12. The system of claim 1, wherein the system comprises a set of target values based on kinematic measurements taken from a patient and the processor is configured to compare the target values of the set to the output indicative of motion of the tibia and femur.

13. The system of claim 1, wherein the processor is configured to perform a function of comparing laxity in a first direction of rotation of a knee joint with laxity in a second direction of rotation of the knee joint.

14. The system of claim 1, wherein the processor is configured to perform the function of quantifying the laxity of the knee joint in full extension or in any other angle to which the knee can be flexed.

15. The system of claim 1, wherein the processor is configured to compare values based on the output indicative of motion of the tibia and femur with target values for one or more of flexion, axial rotation, and/or varus-valgus.

16. The system of claim 1, wherein the processor is configured to compare the output indicative of motion of the tibia and femur with a target value of tibio-femoral kinematics.

17. A system comprising:

a reference device configured to be coupled with a femur or a tibia, the reference device comprising an inertial sensor, wherein the inertial sensor of the reference device comprises an accelerometer and/or a gyroscope, wherein a mechanical axis of the femur or the tibia is calculated based at least in part from data from the inertial sensor of the reference device;

a surgical orientation device configured to be coupled with a cutting block, the surgical orientation device comprising an inertial sensor, wherein the inertial sensor of the surgical orientation device comprises an accelerometer and/or a gyroscope, the surgical orientation device configured to display an angle of the surgical orientation device relative to the calculated mechanical axis;

a processor configured to;

gather measurements from one or more inertial sensors of the surgical orientation device or the reference device while positioning the tibia in a plurality of positions differing in flexion, axial rotation, and/or varus-valgus relative to the femur; and

perform calculations to convert the measurements from the one or more inertial sensors to an output indicative of motion of the tibia and femur in one or more directions corresponding to a flexion direction, an axial rotation direction, and/or a varus-valgus direction;

wherein the surgical orientation device or reference device is configured to guide the placement of the cutting block.

18. A system comprising:

a plurality of implants or trial implants, wherein each implant or trial implant is configured to be positioned between a femur and a tibia;

a reference device configured to be coupled with the femur or the tibia when an implant or trial implant of the plurality of implants or trial implants is positioned between the femur and the tibia, the reference device comprising an accelerometer or a gyroscope;

a surgical orientation device configured to be coupled with the femur or the tibia when the implant or trial implant is positioned between the femur and the tibia, the surgical orientation device comprising an accelerometer or a gyroscope;

a processor configured to;

gather measurements from the accelerometer or the gyroscope of the surgical orientation device or the reference device while positioning the tibia in a plurality of positions differing in flexion, axial rotation, and/or varus-valgus relative to the femur when the implant or trial implant is positioned between the femur and the tibia; and

perform calculations to convert the measurements from the accelerometer or the gyroscope of the reference device or the surgical orientation device to an output indicative of motion of the tibia and femur in one or more directions corresponding to a flexion direction, an axial rotation direction, and/or a varus-valgus direction to facilitate implant selection by quantifying aspects of the knee joint when the implant or trial implant is positioned between the femur and the tibia.

19. The system of claim 18, wherein the processor is configured to perform calculations to facilitate adjustment of the rotational alignment of the implant or trial implant positioned between the femur and the tibia.

20. The system of claim 18, wherein the processor is configured to perform calculations to facilitate soft tissue release when the implant or trial implant positioned between the femur and the tibia.

21. The system of claim 18, wherein the surgical orientation device displays graphical plots representing a pre-operative data set and superimposes additional data on the graphical plots.