Patient-matched surgical component and methods of use

• US 10,136,950 B2
• Filed: 08/28/2017
• Issued: 11/27/2018
• Est. Priority Date: 06/19/2007
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Schoenefeld, Ryan John
• Primary Examiner(s): Ramana, Anu
• Application Number:
  US15/688,433
• Publication Number:
  US 20180008351A1
• Time in Patent Office: 456 Days
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2074 Interface software
• CPC Class Codes: A61B 2034/254 being adapted depending on the stage of the surgical procedure
• CPC Class Codes: A61B 2090/3983 Reference marker arrangements for use with image guided surgery
• 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 90/36 Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation

Abstract

A method of automatically registering a surgical navigation system to a patient'"'"'s anatomy is provided. The method comprises programming a surgical navigation system with a first spatial relationship between a surgical component and a reference array connected to the surgical component, programming the surgical navigation system with a second spatial relationship between an anatomical feature of a patient and the surgical component, installing the surgical component on the patient such that the surgical component engages the anatomical feature in the second spatial relationship, and locating the reference array with the surgical navigation system. The navigation system automatically recognizes the position of the reference array relative to the patient'"'"'s anatomy.

Claims

1. A method of performing a surgical procedure aided by a surgical navigation system, comprising:

generating a representative model of an anatomical feature from an image of a patient'"'"'s anatomy;

using the model to make a virtual surgical component;

installing the virtual surgical component on the representative model of the anatomical feature by mating the surface of the component with the anatomical feature in the predefined spatial relationship;

tracking movement of the anatomical feature with a tracking system when a physical surgical component corresponding to the virtual surgical component is moved within a measurement field of the tracking system;

tracking movement of a surgical cutting instrument with the tracking system;

displaying the representative model and the surgical cutting instrument on a display of the surgical navigation system; and

guiding the surgical cutting instrument on the display to verify a cutting plane of the surgical cutting instrument relative to the anatomical feature.

2. The method of claim 1, wherein tracking movement of the anatomical feature with the tracking system comprises tracking movement of a reference array attached to the physical surgical component.

3. The method of claim 1, further comprising identifying a finite number of predefined points on the anatomical feature, the predefined points being shown on the model to assist in cutting the anatomical feature.

4. The method of claim 3, wherein at least one of the predefined points is a bony anatomical landmark selected from at least one of a femoral head landmark, a central knee landmark, a medial femoral condyle landmark, a lateral femoral condyle landmark, a medial epicondyle landmark, a lateral epicondyle landmark, a medial posterior condyle landmark, a lateral posterior condyle landmark and an anterior cortex point landmark.

5. The method of claim 1, further comprising:

generating a surgical plan from the representative model and the virtual surgical component; and

wherein displaying the representative model and the surgical cutting instrument includes displaying a cut plane of the surgical plan on the representative model on the display.

6. The method of claim 5, wherein displaying the representative model and the surgical cutting instrument includes displaying a cutting blade of the surgical cutting instrument in the cutting plane on the representative model in the display relative to the cut plane.

7. A method of conducting navigated knee arthroplasty on a patient, comprising:

acquiring a representation of a knee joint of the patient;

creating a three-dimensional virtual model of the knee joint of the patient from the representation;

identifying bony landmarks on a femur within the three-dimensional virtual model of the knee joint;

developing a surgical protocol for the patient including anatomic orientation information of the femur from an analysis of the bony landmarks;

tracking with an optical locator a retro-reflective marker array affixed to a handheld surgical saw; and

displaying a current cut plane of the handheld surgical saw on a surgical display during surgery in reference to a planned cut plane from the surgical protocol, wherein the surgical display is located outside of a sterile field in which the handheld surgical saw is located, the current cut plane comprising a cutting path of the handheld surgical saw determined from the surgical plan.

8. The method of claim 7, further comprising using a surgical navigation system to calculate a bone cut in the current cut plane at least in part by analyzing the predefined points on the three-dimensional virtual model.

9. The method of claim 7, wherein developing the surgical protocol comprises:

displaying a rotatable and manipulable visual representation of the three-dimensional virtual model of the knee joint of the patient on at least one display; and

displaying a rotatable and resizable representation of a femoral knee implant on the visual representation of the three-dimensional virtual model on the at least one display.

10. The method of claim 7, wherein displaying the current cut plane includes:

displaying the three-dimensional virtual model on the surgical display; and

displaying the current cut plane on the three-dimensional virtual model displayed on the surgical display, the current cut plane including a representation of a saw blade of the handheld surgical saw on the surgical display.

11. The method of claim 10, further comprising confirming positioning of the handheld surgical saw by viewing the representation of the saw blade relative to the displayed current cut plane.

12. The method of claim 7, further comprising:

creating a virtual representation of a patient-matched surgical component;

manufacturing the patient-matched surgical component; and

affixing the patient-matched surgical component to the knee of the patient.

13. The method of claim 12, wherein displaying the current cut plane includes displaying the patient-matched surgical component on the surgical display.

14. The method of claim 13, further comprising:

tracking with an optical locator a retro-reflective marker array affixed to the patient-matched surgical component attached to the patient in the sterile field.

15. The method of claim 14, further comprising:

pre-registering a first spatial relationship between the patient-matched surgical component and the retro-reflective marker array connected to the handheld surgical saw; and

pre-registering a second spatial relationship between an anatomical feature of the knee joint of the patient and the patient-matched surgical component.

16. The method of claim 13, wherein the patient-matched surgical component comprises a cutting guide.

17. A method of performing a surgical procedure aided by a surgical navigation system, comprising:

generating a representative model of an anatomical feature from an image of anatomy of a patient;

creating a virtual representation of a patient-matched surgical component based on the representative model;

displaying the virtual representation on the representative model;

manipulating the representative model of the anatomical feature and the virtual representation of the patient-matched surgical component to gather surgical information using a computer-operated planning program;

planning a surgical protocol from the gathered surgical information, the surgical protocol including a cutting plane disposed relative to the anatomical feature;

displaying a surgical plan image from the surgical protocol and the patient-matched surgical component on a computer display, the surgical plan image including a representation of the cutting plane relative to the anatomical feature;

tracking a resection plane of a surgical instrument on the computer display while displaying the patient-matched surgical component and the representative model; and

performing the surgical procedure on the bone guided by at least a portion of the resection plane of the surgical instrument relative to the cutting plane of the surgical protocol displayed on the computer display including the surgical instrument and the representative model.

18. The method of claim 17, wherein the patient-matched surgical component comprises a prosthetic implant device.

19. The method of claim 18, further comprising:

creating a virtual representation of a patient-matched surgical instrument based on the representative model.

20. The method of claim 19, further comprising:

tracking the patient-matched surgical instrument; and

displaying the patient-matched surgical instrument in the computer display.

21. The method of claim 19, wherein the patient-matched surgical instrument comprises a guide.

22. The method of claim 17, wherein the surgical instrument comprises a drill.