Patient-matched surgical component and methods of use

• US 9,775,625 B2
• Filed: 04/23/2015
• Issued: 10/03/2017
• 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 J.
• Primary Examiner(s): Ramana, Anu
• Application Number:
  US14/694,389
• Publication Number:
  US 20150327947A1
• Time in Patent Office: 894 Days
• Field of Search: 606 86 R
• 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 patient matched surgical component including a body having a surface that is preoperatively shaped to substantially mate with the shape of an anatomical feature of a patient in a predefined spatial relationship, the surface being shaped by preoperatively identifying a finite number of bony anatomical landmarks on a representative model of the anatomical feature, and a reference array preoperatively integrated with a surgical navigation tracking system in a predefined spatial orientation relative to the anatomical feature, the reference array being couplable to the body such that when the surgical component is installed onto the anatomical feature intraoperatively, the position of the anatomical feature relative to the reference array is automatically recognized by the surgical navigation system.

Claims

1. A method of automatically registering a surgical navigation system to a patient'"'"'s anatomy, comprising:

using the surgical navigation system to pre-register a first spatial relationship between a surgical component and a reference array connected to the surgical component;

using the surgical navigation system to pre-register 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 to automatically register the position of the reference array relative to the patient'"'"'s anatomy wherein the navigation system automatically registers the position of the reference array relative to the patient'"'"'s anatomy when the reference array is within a measurement field of the navigation system.

2. The method of claim 1, wherein installing the surgical component onto the patient comprises mating a surface of the surgical component with a corresponding surface on the anatomical feature, the corresponding surface on the anatomical feature being shaped to substantially correspond to the shape of the surgical component'"'"'s surface.

3. The method of claim 2, wherein installing the surgical component on the patient comprises adjusting the position of the surgical component relative to the anatomical feature until a tactile sensation of correct placement is achieved.

4. The method of claim 2, wherein mating the surface of the surgical component with the corresponding surface on the anatomical feature comprises attaching the surgical component to the anatomical feature with at least one of pins and screws.

5. The method of claim 1, further comprising identifying a finite number of predefined points on a representative model of the anatomical feature, the model being generated from a preoperative image of the patient'"'"'s anatomy.

6. The method of claim 5, 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.

7. The method of claim 5, further comprising using the surgical navigation system to calculate a bone cut by analyzing the predefined points on the model.

8. The method of claim 1, further comprising removing a portion of the anatomical feature and a portion of the installed surgical component.

9. The method of claim 8, further comprising tracking a remaining portion of the anatomical feature with the surgical navigation system, the remaining portion of the anatomical feature including a portion of the installed surgical component, the remaining portion of the installed surgical component including the reference array.

10. The method of claim 1, wherein the navigation system automatically registers the position of the reference array relative to the patient'"'"'s anatomy when the surgical component is attached to the anatomical feature of the patient.

11. The method of claim 1, further comprising using the surgical navigation system to simultaneously track movement of the anatomical feature and the surgical component with the reference array while the surgical component is installed on the patient and moved within a measurement field of the tracking system.

12. 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 surgical component, the surgical component having a surface that is shaped to substantially mate with the anatomical feature in a predefined spatial relationship;

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

tracking movement of the anatomical feature with a tracking system when the installed surgical component is moved within a measurement field of the tracking system by tracking movement of the surgical component within the measurement field of the tracking system.

13. The method of claim 12, wherein installing the surgical component on the anatomical feature comprises adjusting the position of the surgical component relative to the anatomical feature until a tactile sensation of correct placement is achieved.

14. The method of claim 12, wherein tracking movement of the anatomical feature with the tracking system comprises tracking movement of a reference array attached to the surgical component.

15. The method of claim 12, further comprising identifying a finite number of predefined points on the anatomical feature, the predefined points being shown on the model to assist in making the surgical component.

16. The method of claim 15, 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.

17. The method of claim 12, further comprising removing a portion of the anatomical feature and a portion of the installed surgical component.

18. The method of claim 17, further comprising tracking a remaining portion of the anatomical feature with the surgical navigation system, the remaining portion of the anatomical feature including a portion of the installed surgical component, the remaining portion of the installed surgical component including the reference array.

19. 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 surgical component, the surgical component having a reference array associated therewith and a surface that is shaped to substantially mate with an anatomical feature in a predefined spatial relationship;

installing the surgical component on 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 the tracking system when the installed surgical component is moved within a measurement field of the tracking system;

removing a portion of the anatomical feature, the removed portion also including a portion of the installed surgical component; and

tracking a remaining portion of the anatomical feature with the tracking system, the remaining portion of the anatomical feature including a portion of the installed surgical component, the remaining portion of the installed surgical component including the reference array.

20. The method of claim 19, wherein installing the surgical component on the anatomical feature comprises adjusting the position of the surgical component relative to the anatomical feature until a tactile sensation of correct placement is achieved.

21. The method of claim 19, further comprising identifying a finite number of predefined points on the anatomical feature, the predefined points being shown on the model to assist in making the surgical component.

22. The method of claim 21, 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.

23. The method of claim 19, wherein removing a portion of the anatomical feature comprises resecting bone with a saw blade through a cut slot of the surgical component.

24. The method of claim 19, wherein mating the surface of the component with the anatomical feature in the predefined spatial relationship comprises attaching the surgical component to the anatomical feature with at least one of pins and screws.