Kinetic assessment and alignment of the muscular-skeletal system and method therefor

• US 9,820,678 B2
• Filed: 09/13/2013
• Issued: 11/21/2017
• Est. Priority Date: 03/18/2013
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: OrthoSensor, Inc (Stryker Corporation)
• Inventors: Stein, Marc, Roche, Martin
• Primary Examiner(s): GIBSON, ERIC SHANE
• Application Number:
  US14/026,544
• Publication Number:
  US 20140277526A1
• Time in Patent Office: 1,530 Days
• CPC Class Codes: A61B 17/154 for preparing bone for knee prosthesis
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 17/157 Cutting tibia
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/104 Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• 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 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/1036 Measuring load distribution, e.g. podologic studies
• CPC Class Codes: A61B 5/1072 measuring distances on the body, e.g. measuring length, height or thickness A61B5/1076 takes precedence
• CPC Class Codes: A61B 5/1121 Determining geometric values, e.g. centre of rotation or angular range of movement
• CPC Class Codes: A61B 5/45 For evaluating or diagnosing the musculoskeletal system or teeth A61B5/1036, A61B5/1074, A61B7/006 take precedence
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4571 Evaluating the hip
• CPC Class Codes: A61B 5/4585 Evaluating the knee
• CPC Class Codes: A61B 5/4851 Prosthesis assessment or monitoring
• CPC Class Codes: A61B 5/4887 Locating particular structures in or on the body
• CPC Class Codes: A61B 5/686 : Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61F 2/38 : for elbows or knees
• CPC Class Codes: A61F 2/3836 : Special connection between upper and lower leg, e.g. constrained
• CPC Class Codes: A61F 2/461 : of knees
• CPC Class Codes: A61F 2/4657 : Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/4684 : Trial or dummy prostheses
• CPC Class Codes: A61F 2002/4658 : for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4668 : for measuring angles
• CPC Class Codes: G06F 3/0481 : based on specific properties of the displayed interaction object or a metaphor-based environment, e.g. interaction with desktop elements like windows or icons, or assisted by a cursor's changing behaviour or appearance

Abstract

A system is disclosed herein for providing a kinetic assessment and preparation of a prosthetic joint comprising one or more prosthetic components. The system comprises a prosthetic component including sensors and circuitry configured to measure load, position of load, and joint alignment. The system further includes a remote system for receiving, processing, and displaying quantitative measurements from the sensors. The kinetic assessment measures joint alignment under loading that will be similar to that of a final joint installation. The kinetic assessment can use trial or permanent prosthetic components. Furthermore, adjustments can be made to the applied load magnitude, position of load, and joint alignment by various means to fine-tune an installation. The kinetic assessment increases both performance and reliability of the installed joint by reducing error that is introduced by elements that load or modify the joint dynamics not taken into account by prior assessment methods.

Claims

1. A system to support kinetic assessment, joint modification, and installation of a final prosthetic joint comprising:

a device configured to couple to a joint of a first bone and a second bone to measure load, position of load, and joint alignment, wherein the device includes one or more sensors;

a computer configured to receive measurement data from the one or more sensors of the device, wherein kinetic assessment results in at least one change performed under musculoskeletal loading that affects alignment, whereby a final joint installation has similar loading, position of load, or alignment; and

a display coupled to the computer, wherein the computer is configured to calculate alignment from the measurement data, and wherein the display is configured to display one of a bone offset relative to a mechanical axis or a total offset relative to the mechanical axis generated from the measurement data.

2. The system of claim 1, wherein the prosthetic component comprises:

at least one articular surface;

a plurality of load sensors underlying the at least one articular surface configured to measure load and position of load; and

at least one inertial sensor configured to measure a movement of the muscular-skeletal system under loading, wherein the measurement data corresponds to and is converted to an alignment measurement.

3. The system of claim 2, wherein the computer is configured to calculate an offset of the first bone relative to the mechanical axis from the measurement data generated by a first movement of the joint.

4. The system of claim 2, wherein the computer is configured to calculate an offset of the second bone relative to the mechanical axis from the measurement data generated by a second movement of the joint.

5. The system of claim 2, wherein the display is configured to display a portion of a surgical field in an operating room.

6. The system of claim 5, wherein the computer and the display are configured to indicate if the total offset is outside a predetermined range.

7. The system of claim 5, wherein the display is configured to display a contact point on the device from the measurement data.

8. The system of claim 2, wherein the display is configured to display contact point rotation using the measurement data.

9. The system of claim 1, wherein the display is configured to display at least a portion of the first bone relative to a portion of the second bone.

10. The system of claim 9, wherein the display is configured to display a flexion angle corresponding to an angle formed by the first bone relative to the second bone.

11. The system of claim 9, wherein the computer and the display is configured to display a anterior-posterior slope of a bone cut on the first bone or the second bone measured by the one or more sensors.

12. The system of claim 1, wherein the computer and the display are configured to provide real-time feedback corresponding to the at least one change as it is being made using the measurement data.

13. The system of claim 1, wherein the computer and the display are configured to provide visual, audible, or haptic feedback related to the at least one change as it is being made.

14. The system of claim 1, wherein the display is configured to display a major surface of a prosthetic component and wherein the computer and the display is configured to display a position of applied load to the major surface.

15. The system of claim 1, wherein the device is configured to be referenced to a first plane and wherein the device is configured to be referenced to a second plane that is perpendicular to the first plane.

16. The system of claim 1, wherein the device is configured to be referenced to a bone landmark and wherein a reference position of the device corresponds to zero degrees of rotation.

17. They system of claim 1, wherein the computer and the display is configured to display a hip knee angle calculated from the measurement data or a needle point graphic to monitor movement of the joint.

18. The system of claim 1, wherein the display is configured to display video of a surgery in real-time.

19. The system of claim 1, wherein the at least one change that is performed under musculoskeletal loading is soft tissue tensioning and wherein the display is configured to display a change in the bone offset or a change in the total offset relative to the mechanical axis.