System of preoperative planning and provision of patient-specific surgical aids

• US 9,717,508 B2
• Filed: 10/27/2011
• Issued: 08/01/2017
• Est. Priority Date: 10/29/2010
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Iannotti, Joseph P., Barsoum, Wael K., Bryan, Jason A., O'Neill, Peter D.
• Primary Examiner(s): Fernandez Rivas, Omar
• Assistant Examiner(s): KHAN, IFTEKHAR A
• Application Number:
  US13/282,550
• Publication Number:
  US 20120141034A1
• Time in Patent Office: 2,105 Days
• Field of Search: 703 1, 703 6
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1778 for the shoulder
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/25 User interfaces for surgical systems
• CPC Class Codes: A61F 2/4081 Glenoid components, e.g. cups
• CPC Class Codes: A61F 2002/4633 for selection of endoprosthetic joints or for pre-operative planning

Abstract

A method of preoperative planning and provision of patient-specific surgical aids includes creating a virtual model of a native patient tissue. A virtual device is placed into a predetermined device orientation relative to the virtual model of the native patient tissue. At least one predetermined landmark orientation is specified for placement of at least one virtual landmark relative to the native patient tissue. A virtual patient-specific template containing the predetermined landmark orientation and having a landmark guiding feature is generated. At least one virtual patient-specific placement guide configured to interact simultaneously with at least one previously placed virtual landmark and the virtual device when the virtual device is in the predetermined device orientation is generated. A physical patient-specific template is created as a tangible representation of the virtual patient-specific template. A physical patient-specific placement guide is created as a tangible representation of the virtual patient-specific placement guide.

Claims

1. A method of preoperative planning and provision of patient-specific surgical aids, the method comprising the steps of:

creating a virtual model of a native patient tissue;

placing a virtual device into a predetermined device orientation relative to the virtual model of the native patient tissue;

specifying at least one predetermined landmark orientation for placement of at least one virtual landmark relative to the native patient tissue, the at least one virtual landmark being representative of a non-tissue landmark;

generating a virtual patient-specific template positioned on said virtual model, the virtual patient-specific template containing the predetermined landmark orientation and having a landmark guiding feature for placement of the non tissue landmark in said predetermined landmark orientation relative to the native patient tissue;

generating at least one virtual patient-specific placement guide configured to interact simultaneously with the at least one virtual landmark in said predetermined landmark orientation, with the virtual model of the native patient tissue after removal of the virtual patient-specific template, and

with the virtual device when the virtual device is in the predetermined device orientation;

creating a physical patient-specific template as a tangible representation of the virtual patient specific template for placing the non-tissue landmark in the native patient tissue; and

creating a physical patient-specific placement guide as a tangible representation of the virtual patient-specific placement guide separate from the physical patient-specific template, the physical patient-specific placement guide for interacting with the non-tissue landmark sequentially after removal of the patient-specific template after use of the patient-specific template to install the non-tissue landmark.

2. The method of claim 1, including the steps of:

specifying at least one structural change to the native patient tissue to facilitate placement of the device in the predetermined device orientation; and

creating a virtual model of an altered patient tissue responsive to the step of specifying at least one structural change to the native patient tissue.

3. The method of claim 2 wherein the step of specifying at least one structural change to the native patient tissue includes the step of comparing the native patient tissue with a reference patient tissue model, the reference patient tissue model being at least one of a contralateral patient tissue model, a standard reference patient tissue value, a standard reference patient tissue value range, and a predetermined average patient tissue model.

4. The method of claim 1, including the step of creating a physical model of the native patient tissue as a tangible representation of the virtual model of the native patient tissue, the physical model of the native patient tissue including at least one information feature providing clinically useful information to the user.

5. The method of claim 2, including the step of creating a physical model of the altered patient tissue as a tangible representation of the virtual model of the altered patient tissue, the physical model of the altered patient tissue including at least one information feature providing clinically useful information to the user.

6. The method of claim 1, including the steps of:

specifying at least one target trajectory and at least one penetration location for the insertion of a penetrating structure into the patient tissue in a predetermined penetration orientation;

generating at least one penetration-guiding feature embodying the specified target trajectory and penetration location; and

providing the penetration-guiding feature to at least one of the virtual patient-specific template and the virtual patient-specific placement guide.

7. The method of claim 1 wherein the step of placing a virtual device into a predetermined device orientation relative to the virtual model of the native patient tissue includes the steps of:

providing at least two optional device orientations;

comparing the optional device orientations;

choosing an optional device orientation; and

designating the chosen optional device orientation as the predetermined device orientation.

8. The method of claim 7 wherein the step of choosing an optional device orientation includes the step of comparing at least one device property at each optional device orientation, the device properties including at least one of device size, device shape, device material, number of fasteners, type of fasteners, size of fasteners, shape of fasteners, amount of patient tissue alteration, type of patient tissue alteration, orientation of the device relative to another device, and physical quality of the native patient tissue.

9. The method of claim 1, including the step of choosing the virtual device from a library of available virtual devices.

10. A method of preoperative planning and provision of patient-specific surgical aids,

the method comprising the steps of:

choosing a device for placement in engagement with a native patient tissue;

virtually specifying a predetermined device orientation for the device with respect to the native patient tissue;

virtually placing at least one landmark in a predetermined landmark orientation with respect to the predetermined device orientation, the at least one landmark being representative of a non-tissue landmark;

virtually modeling a patient-specific template, the patient-specific template being configured to mate with the native patient tissue, the patient-specific template having a landmark guiding feature configured to place the non-tissue landmark in the predetermined landmark orientation when the patient-specific template is mated with the native patient tissue;

virtually modeling a patient-specific placement guide, the patient-specific placement guide being configured to simultaneously mate with the device and the native patient tissue after removal of the virtual patient-specific template, and registered with the at least one landmark when the device is in the predetermined device orientation;

creating a physical version of the patient-specific template for placing the non-tissue landmark in the native patient tissue; and

creating a physical version of the patient-specific placement guide separate from the physical version of the patient-specific template, the physical patient-specific placement guide for interacting with the non-tissue landmark sequentially after removal of the patient-specific template after use of the physical patient-specific template to install the non-tissue landmark.

11. The method of claim 10, including the steps of:

specifying at least one structural change to the native patient tissue to facilitate placement of the device in the predetermined device orientation; and

creating a model of an altered patient tissue responsive to the step of specifying at least one structural change to the native patient tissue.

12. The method of claim 11 wherein the step of specifying at least one structural change to the native patient tissue includes the step of comparing the native patient tissue with a reference patient tissue model, the reference patient tissue model being at least one of a contralateral patient tissue model, a standard reference patient tissue value, a standard reference patient tissue value range, and a predetermined average patient tissue model.

13. The method of claim 10, including the step of creating a physical version of the native patient tissue, the physical version of the native patient tissue including at least one information feature providing clinically useful information to the user.

14. The method of claim 10, including the steps of:

specifying at least one target trajectory and at least one penetration location for the insertion of a penetrating structure into the patient tissue in a predetermined penetration orientation;

generating at least one penetration-guiding feature embodying the specified target trajectory and penetration location; and

providing the penetration-guiding feature to at least one of the patient-specific template and the patient-specific placement guide.

15. The method of claim 10 wherein the step of virtually specifying a predetermined device orientation for the device with the native patient tissue includes the steps of:

providing at least two optional device orientations;

comparing the optional device orientations;

choosing an optional device orientation; and

designating the chosen optional device orientation as the predetermined device orientation.

16. The method of claim 15 wherein the step of choosing an optional device orientation includes the step of comparing at least one device property at each optional device orientation, the device properties including at least one of device size, device shape, device material, number of fasteners, type of fasteners, size of fasteners, shape of fasteners, amount of patient tissue alteration, type of patient tissue alteration, orientation of the device relative to another device, and physical quality of the native patient tissue.

17. The method of claim 10, including the step of choosing the device from a library of available devices.

18. The method of claim 10 wherein the step of virtually modeling a patient-specific template includes the steps of:

virtually placing a template blank into a desired template position with respect to the native patient tissue;

virtually overlapping at least a portion of the native patient tissue with the template blank to create a superposed volume of the template blank upon the native patient tissue; and

virtually removing the superposed volume from the template blank to create a mating surface of the template blank adjacent the native patient tissue.

19. The method of claim 10 wherein the step of virtually modeling a patient-specific placement guide includes the steps of:

virtually selecting a placement guide blank in response to the step of choosing a device; and

virtually altering the placement guide blank to register with at least one landmark when the patient-specific placement guide is mated with the device.

20. A non-transitory computer storage medium having computer executable instructions for performing the method comprising:

receiving scanned image data based on an imaging scan of a native patient tissue;

displaying an image of the native patient tissue based on the received scanned image data;

displaying placement of an image of a selected device over the image of the native patient tissue;

reorienting the image of the selected device over the image of the native patient tissue into a predetermined device orientation;

displaying placement of an image of at least one selected landmark in a predetermined landmark orientation over the image of the native patient tissue, the at least one selected landmark being representative of a non-tissue landmark;

displaying placement of an image of a selected guide blank in a predetermined guide orientation over the image of the native patient tissue and the image of the selected device, when the image of the selected device is in the predetermined device orientation;

providing the selected guide blank with at least one orienting feature, the provided orienting feature being registered with the at least one selected landmark when the image of a selected guide blank is in the predetermined guide orientation and the image of the selected device is in the predetermined device orientation;

displaying placement of an image of a selected template blank in a desired final template position over the image of the native patient tissue;

adjusting dimensions of a bottom template surface of the selected template blank to mate with a surface of the native patient tissue;

placing an image of a landmark guiding feature on the image of the selected template blank, the landmark guiding feature being configured to guide the non-tissue landmark into the landmark orientation with respect to the native patient tissue; and

fabricating a physical template from the selected template blank having the adjusted bottom surface dimensions for placing the non-tissue landmark in the native patient tissue; and

fabricating a physical guide from the selected guide blank having the provided orienting feature and the landmark guiding feature separate from the physical template, the physical guide for interacting with the non-tissue landmark sequentially after removal of the physical template after use of the physical template to install the non-tissue landmark.

21. The non-transitory computer storage medium of claim 20, wherein the method includes removing the displayed placement of the image of the selected device over the image of the native patient tissue.

22. The non-transitory computer storage medium of claim 20, wherein the selected template blank is selected one of automatically and manually from a selected template blank library.

23. The non-transitory computer storage medium of claim 20, wherein the selected guide blank is selected one of automatically and manually from a selected guide blank library.

24. The non-transitory computer storage medium of claim 20, wherein the selected device is selected one of automatically and manually from a selected device library.

25. The non-transitory computer storage medium of claim 20, including:

displaying placement of an image of a selected penetrator in a predetermined penetrator orientation over the image of the native patient tissue and the image of the selected device; and

placing an image of a penetration guiding feature on the image of the selected guide blank, the penetration guiding feature being configured to guide a penetrator into the predetermined penetrator orientation with respect to the native patient tissue; and

wherein fabricating a physical guide from the selected guide blank having the provided orienting feature includes fabricating a physical guide from the selected guide blank having the provided orienting feature and the penetration guiding feature.

26. The non-transitory computer storage medium of claim 20, including:

displaying placement of an image of a selected penetrator in a predetermined penetrator orientation over the image of the native patient tissue and the image of the selected device; and

placing an image of a penetration guiding feature on the image of the selected guide blank, the penetration guiding feature being configured to guide a penetrator into the predetermined penetrator orientation with respect to the native patient tissue; and

wherein fabricating a physical template from the selected template blank having the adjusted bottom surface dimensions and the landmark guiding feature includes fabricating a physical template from the selected template blank having the adjusted bottom surface dimensions, the landmark guiding feature, and the penetration guiding feature.

27. The non-transitory computer storage medium of claim 20, including:

comparing at least a portion of the image of the native patient tissue with a reference patient tissue, the reference patient tissue being at least one of an image of a contralateral patient tissue, a value taken from a standard reference patient tissue, a value range taken from a standard reference patient tissue, and an image of a predetermined average patient tissue; and

adjusting the predetermined device orientation responsive to the comparison of at least a portion of the image of the native patient tissue with the reference patient tissue.

28. The non-transitory computer storage medium of claim 20, including fabricating a physical native patient tissue model based upon the image of the native patient tissue, the physical native patient tissue model including at least one information feature providing clinically useful information to the user.