Systems and methods for joint replacement

• US 9,271,756 B2
• Filed: 02/16/2012
• Issued: 03/01/2016
• Est. Priority Date: 07/24/2009
• Status: Active Grant

• Current Assignee: Orthalign, Inc.
• Original Assignee: Orthalign, Inc.
• Inventors: van der Walt, Nicholas, Shapiro, Charles, Lane, Richard, Ryan, Matt
• Primary Examiner(s): SEVILLA, CHRISTIAN ANTHONY
• Application Number:
  US13/398,712
• Publication Number:
  US 20120316567A1
• Time in Patent Office: 1,475 Days
• Field of Search: 606 87- 89, 606/102, 606/130
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2034/2048 using an accelerometer or inertia sensor
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• 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 5/1121 Determining geometric values, e.g. centre of rotation or angular range of movement
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06

Abstract

Systems and methods for joint replacement are provided. The systems and methods include a surgical orientation device, a reference sensor device, and at least one orthopedic fixture. The surgical orientation device, reference sensor device, and orthopedic fixtures can be used to locate the orientation of an axis in the body, to adjust an orientation of a cutting plane or planes along a bony surface, or otherwise to assist in an orthopedic procedure(s).

Claims

1. A method for performing total knee arthroplasty on a knee joint of a leg of a patient, comprising:

preparing a distal portion of a femur for receiving a knee implant, comprising;

placing the knee joint in flexion and exposing a distal end of the femur;

coupling a first orthopedic fixture to a distal portion of the femur, the first orthopedic fixture comprising a surgical orientation device, the surgical orientation device comprising an orientation sensor and an interactive user interface configured to display an indication of a change in one or more angle measurements corresponding to a flexion-extension angle or a varus-valgus angle of a mechanical axis of the femur, the first orthopedic fixture further comprising a reference device, the reference device comprising a reference sensor;

monitoring an orientation of the reference sensor while swinging the leg to obtain information regarding a location of the mechanical axis;

adjusting a varus/valgus and flexion/extension angle of a portion of the first orthopedic fixture by monitoring the first surgical orientation device and moving the reference device relative to the surgical orientation device;

attaching a cutting block to the first orthopedic fixture, the cutting block being oriented relative an adjusted varus/valgus and flexion/extension angle; and

resecting the distal end of the femur.

2. The method of claim 1, wherein the knee joint is placed in extension during the step of swinging the leg.

3. The method of claim 1, wherein the step of swinging the leg comprises swinging the leg in at least one of an abduction-adduction plane and in an anterior-posterior plane.

4. The method of claim 1, wherein the step of swinging the leg comprises swinging the leg up to about 30 degrees and returning the leg to a home position, and raising the leg about up to about 45 degrees and returning the leg to the home position.

5. The method of claim 1, wherein the step of swinging the leg comprises swinging the leg from a starting position in a loop-like manner and returning the leg generally to the starting position.

6. The method of claim 1, further comprising preparing a proximal portion of a tibia for receiving a knee implant, the preparation of the proximal portion comprising:

coupling a second orthopedic fixture with the proximal portion of the tibia, the second orthopedic fixture comprising a second surgical orientation device, a second reference device, and a moveable portion;

moving the moveable portion of the second orthopedic fixture to adjust a position of the second surgical orientation device in response to a prompt from the second surgical orientation device to orient a cutting guide at an intended orientation relative to the mechanical axis; and

resecting the tibia.

7. The method of claim 1, further comprising obtaining and entering an AP offset of the first orthopedic fixture into the surgical orientation device prior to swinging the leg.

8. The method of claim 1, wherein the first orthopedic fixture comprises:

a distal guide assembly configured to be positioned adjacent to at least one distal condyle of the femur

a microblock assembly releasably attached to the distal guide assembly, the microblock assembly comprising a microblock member and a translating member configured to be moved relative the microblock member; and

a cutting block assembly releasably attached to the microblock assembly.

9. The method of claim 6, wherein the second orthopedic fixture comprises:

a base member attachable to a proximal aspect of the tibia;

at least one adjustment device connected to and moveable relative to the base member;

at least one probe for referencing a plurality of anatomical landmarks, the anatomical landmarks referencing the mechanical axis;

wherein the at least one adjustment device is moveable in at least one degree of freedom to orient a cutting guide relative to a proximal feature of the tibia, such that the cutting guide is oriented at a selected angle relative to the mechanical axis.

10. The method of claim 6, wherein the surgical orientation device and the second surgical orientation device are the same device, the reference device and second reference device are the same device, and wherein the surgical orientation device and the reference device are each releasably attachable to the first orthopedic fixture and the second orthopedic fixture.

11. A method for performing total knee arthroplasty on a knee joint of a patient, comprising:

attaching a base member of an orthopedic fixture to a proximal aspect of a tibia such that movement of the tibia produces corresponding movement of the base member, the orthopedic fixture comprising at least one movable member moveable relative the base member, the at least one moveable member comprising a probe for referencing a plurality of anatomical landmarks;

attaching a portable surgical orientation device to the at least one moveable member, the portable surgical orientation device comprising an interactive user interface, the portable surgical orientation device having a first sensor;

attaching a reference device to the base member, the reference device having a second sensor;

moving the at least one moveable member and the probe to contact anatomical locations on a leg;

directing the portable surgical orientation device to determine a spatial location or orientation of a mechanical axis based on the anatomical locations; and

moving the at least one moveable member such that a cutting guide is oriented at a selected angle relative to the mechanical axis.

12. The method of claim 11, wherein each of the first and second sensors have at least one of a three-axis accelerometer and a three-axis gyroscope, at least one of the first and second sensors being configured to monitor orientation of the portable surgical orientation device in a three-dimensional coordinate reference system and to generate orientation data corresponding to the monitored orientation of the surgical orientation device.

13. The method of claim 11, wherein the portable surgical orientation device comprises an electronic control unit, and the reference device comprises a wireless communication device that is configured to relay information from the second sensor to the electronic control unit of the surgical orientation device.

14. The method of claim 11, wherein the at least one moveable member comprises a pivot arm.

15. The method of claim 14, further comprising attaching the base member of the orthopedic fixture to an anterior face of the tibia.

16. The method of claim 14, further comprising attaching the base member of the orthopedic fixture to a tibial plateau of the tibia.

17. A method of preparing for orthopedic surgery, comprising:

determining an orientation of a mechanical axis of a bone or joint;

coupling an orthopedic orientation assembly with an extremity of a patient, the orthopedic orientation assembly having a positioning device, a reference device and a surgical orientation device coupled with the positioning device; and

constraining at least one degree of freedom between the reference device and the surgical orientation device while moving at least one of the surgical orientation device and the reference device to collect data indicative of orientation;

wherein determining the orientation includes contacting a plurality of anatomical landmarks of a tibia and recording an orientation of at least one of the surgical orientation device and the reference device to determine the mechanical axis.

18. The method of claim 17, wherein determining the orientation involves moving a femur about its center of rotation in order to determine the mechanical axis.

19. A method of preparing orthopedic surgery, comprising:

determining an orientation of a mechanical axis of a bone or joint;

coupling an orthopedic orientation assembly with an extremity of a patient, the orthopedic orientation assembly having a positioning device, a reference device and a surgical orientation device coupled with the positioning device;

constraining at least one degree of freedom between the reference device and the surgical orientation device while moving at least one of the surgical orientation device and the reference device to collect data indicative of orientation;

positioning, based upon a determined angle, a cutting guide coupled with the orthopedic orientation assembly; and

cutting a portion of a femur or a tibia at an angle corresponding to a position of the cutting guide.

20. A method of preparing for orthopedic surgery, comprising:

determining a reference frame of a bone or joint;

coupling an orthopedic orientation assembly with the patient on or adjacent to the bone or joint, the orthopedic orientation assembly having a positioning device, a reference device and a surgical orientation device coupled with the positioning device; and

constraining at least one degree of freedom between the reference device and the surgical orientation device while moving at least one of the surgical orientation device and the reference device to collect data indicative of orientation;

wherein determining the reference frame includes contacting a plurality of anatomical landmarks of or adjacent to the bone or joint and recording an orientation of the surgical orientation device to determine the reference frame of the bone or joint of the patient.

21. The method of claim 20, wherein contacting further comprises contacting anatomical landmarks on or adjacent to the distal tibia.

22. The method of claim 20, wherein the reference frame includes a mechanical axis.

23. The method of claim 20, wherein the reference frame includes a line or plane.

24. The method of claim 23, further comprising displaying an orientation of a cutting block relative to the line or plane.

25. The method of claim 20, wherein the reference frame includes a line or plane, and further comprising orienting an instrument relative to the line or plane and adapting the bone adjacent to the joint based on the position of the instrument relative to the line or plane.

26. The method of claim 25, further comprising confirming alignment of the instrument with the line or plane prior to or while adapting the bone.