Non-symmetrical insert sensing system and method therefor

• US 10,893,955 B2
• Filed: 09/05/2018
• Issued: 01/19/2021
• Est. Priority Date: 09/14/2017
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: OrthoSensor, Inc (Stryker Corporation)
• Inventors: Goodchild, Gordon, Ortiz, Ryan, Chase, Andrew
• Primary Examiner(s): Waggle, Jr., Larry E
• Application Number:
  US16/122,628
• Publication Number:
  US 20190076272A1
• Time in Patent Office: 867 Days
• CPC Class Codes: A61B 17/025 Joint distractors
• CPC Class Codes: A61B 2017/0268 for the knee
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 2562/0252 Load cells
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61B 5/1036 Measuring load distribution, e.g. podologic studies
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4585 Evaluating the knee
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/6847 mounted on an invasive device
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6878 Bone
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/38 : for elbows or knees
• CPC Class Codes: A61F 2/389 : Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/4657 : Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/468 : Testing instruments for artificial joints for testing non-implantable prostheses A61F2/76
• CPC Class Codes: A61F 2/4684 : Trial or dummy prostheses
• CPC Class Codes: A61F 2002/3067 : for data transfer
• CPC Class Codes: A61F 2002/4632 : using computer-controlled surgery, e.g. robotic surgery
• CPC Class Codes: A61F 2002/4666 : for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2002/4672 : for measuring temperature
• CPC Class Codes: A61F 2002/4674 : for measuring the pH

Abstract

An orthopedic system to monitor a parameter related to the muscular-skeletal system is disclosed. The orthopedic system includes electronic circuitry, at least one sensor, and a computer to receive measurement data in real-time. The orthopedic system comprises a first plurality of shims of a first type, a second plurality of a second type, a measurement module, and the computer. The measurement module houses the electronic circuitry and at least one sensor. The measurement module is adapted to be used with the first plurality of shims and the second plurality of shims. The measurement module has a medial surface that differs from a lateral surface by shape, size, or contour.

Claims

1. A knee measurement system comprising:

a first shim of a first type having a medial articular surface and a lateral articular surface wherein the first shim is non-symmetrical about the anterior-posterior axis;

a second shim of a second type having a medial articular surface and a lateral articular surface wherein the second shim is non-symmetrical about an anterior-posterior axis;

a measurement module having a first medial surface and a first lateral surface on a first side of the measurement module and a second medial surface and a second lateral surface on a second side of the measurement module wherein the measurement module is configured to measure loading applied to the first shim or the second shim when installed in a knee joint, wherein the first side of the measurement module is configured to couple to the first shim, and wherein the second side of the measurement module is configured to couple to the second shim; and

a tibial prosthetic component wherein a handle is configured to couple to the tibial prosthetic component to support movement of the tibial prosthetic component and wherein the handle is configured to couple to the first or second shim.

2. The knee measurement system of claim 1 further including a first plurality of shims of the first type wherein each of the first plurality of shims have a different height.

3. The knee measurement system of claim 1 further including a second plurality of shims of the second type wherein each of the second plurality of shims have a different height.

4. The knee measurement system of claim 1 wherein the first medial surface and first lateral surface of the measurement module are non-symmetrical about the anterior-posterior axis.

5. The knee measurement system of claim 1 wherein the first medial surface of the measurement module differs in area or contour from the first lateral surface of the measurement module.

6. The knee measurement system of claim 1 wherein the measurement module includes:

at least three load sensors coupled between the first medial surface and the second medial surface of the measurement module;

at least three load sensors coupled between the first lateral surface and the second lateral surface of the measurement module; and

electronic circuitry coupled to the at least three load sensors coupled between the first medial surface and the second medial surface of the measurement module and the at least three load sensors coupled between the first lateral surface and the second lateral surface of the measurement module.

7. The knee measurement system of claim 6 wherein the at least three load sensors coupled to the first and second medial surfaces are placed at vertexes of a first polygon, wherein the at least three load sensors coupled to the first lateral surface or the second lateral surface are placed at vertexes of a second polygon, and wherein the first polygon differs in area from the second polygon.

8. The knee measurement system of claim 6 further including a computer wherein the electronic circuitry of the measurement module is configured to control a measurement process and transmit measurement data to the computer.

9. The knee measurement system of claim 6 further including:

a first power source underlying the first medial surface of the measurement module; and

a second power source underlying the first lateral surface of the measurement module wherein the first and second power source couple to the electronic circuitry and wherein the first and second power source are configured to power the measurement module during a knee joint installation.

10. The knee measurement system of claim 1 wherein the measurement module is non-symmetrical about the anterior-posterior axis.

11. A knee measurement system comprising:

a first plurality of shims of a first type each having a medial articular surface and a lateral articular surface wherein each of the first plurality of shims is non-symmetrical about an anterior-posterior axis;

a second plurality of shims of a second type each having a medial articular surface and a lateral articular surface wherein each of the second plurality of shims is non-symmetrical about the anterior-posterior axis;

a measurement module having a first medial surface and a first lateral surface on a first side of the measurement module and a second medial surface and a second lateral surface on a second side of the measurement module wherein the measurement module is configured to measure loading applied to a first shim of the first plurality of shims when the first shim is coupled to the first side of the measurement module, or wherein the measurement module is configured to measure loading applied to a second shim of the second plurality of shims when the second shim is coupled to the second side of the measurement module;

electronic circuitry configured to control a measurement process and transmit measurement data wherein the electronic circuitry couples to three or more sensors coupled between the first medial surface and the second medial surface of the measurement module and wherein the electronic circuitry couples to three or more sensors coupled between the first lateral surface and the second lateral surface of the measurement module;

a first power source coupled to the electronic circuitry wherein at least a portion of the first power source resides between the first medial surface and the second medial surface; and

a second power source coupled to the electronic circuitry wherein at least a portion of the second power source resides between the first lateral surface and the second lateral surface.

12. The knee measurement system of claim 11 wherein the three or more sensors between the first medial surface and the second medial surface of the measurement module are placed at vertexes of a first polygon and wherein the three or more sensors between the first lateral surface and the second lateral surface of the measurement module are placed at vertexes of a second polygon.

13. The knee measurement system of claim 12 further including a computer and a display wherein the computer is configured to receive measurement data from the measurement module and wherein the display is configured to display the measurement data.

14. The knee measurement system of claim 11 wherein the measurement module is non-symmetrical about the anterior-posterior axis.

15. The knee measurement system of claim 11 further including a tibial prosthetic component configured to couple to a tibia wherein the measurement module couples to the tibial prosthetic component, wherein a handle is configured to couple to the tibial prosthetic component to rotate the tibial prosthetic component from a reference position, and wherein the handle is configured to couple to the first plurality of shims or the second plurality of shims.

16. A knee measurement system comprising:

a shim of a first plurality of shims wherein the shim has a medial surface and a lateral surface and wherein at least one column couples to the medial surface or the lateral surface at a predetermined location of the shim;

a measurement module having a first medial surface and a first lateral surface on a first side of the measurement module and a second medial surface and a second lateral surface on a second side of the measurement module, wherein the shim couples to the first side of the measurement module, wherein the measurement module is configured to measure loading applied to the shim when installed in a knee joint, and wherein the at least one column of the shim couples the predetermined location on the medial surface or the lateral surface of the shim to a load sensor in the measurement module;

and

a computer configured to receive measurement data from the measurement module wherein the computer is coupled to a display configured to display the measurement data, and wherein the computer uses the predetermined location on the medial or lateral surface of the shim to calculate a position of applied load on the medial surface or the lateral surface of the shim.

17. The knee measurement system of claim 16 wherein the computer uses the predetermined location of the medial or lateral surface of the shim in a calculation of a position of applied load to the medial or lateral surface of the shim.

18. The knee measurement system of claim 17 wherein the computer uses the predetermined location of the medial or lateral surface of the shim in a calculation of a load magnitude at the position of applied load to the medial or lateral surface of the shim.

19. The knee measurement system of claim 16 wherein the measurement module includes electronic circuitry configured to control a measurement process and transmit measurement data wherein the load sensor in the measurement module is a strain gauge.

20. The knee measurement system of claim 16 further including a shim of a second type from a second plurality of shims wherein the shim of the second type has a medial surface and a lateral surface, wherein at least one column of the shim of the second type couples to the medial surface or the lateral surface at a predetermined location of the shim of the second type, wherein the shim of the second type is configured to couple to the second side of the measurement module, and wherein the at least one column of the shim of the second type couples the predetermined location on the medial surface or the lateral surface of the shim of the second type to the load sensor in the measurement module.