Generating patient specific instruments for use as surgical aids

• US 10,130,378 B2
• Filed: 05/10/2012
• Issued: 11/20/2018
• Est. Priority Date: 05/11/2011
• Status: Active Grant

• Current Assignee: Cleveland Clinic Foundation
• Original Assignee: Cleveland Clinic Foundation
• Inventors: Bryan, Jason A.
• Primary Examiner(s): Cook, Brian S
• Application Number:
  US13/468,272
• Publication Number:
  US 20120290272A1
• Time in Patent Office: 2,385 Days
• Field of Search: 600407, 700186, 606 88, 606 87, 606 8887, 703 1, 703 2, 703 6, 345419, 382128, 701 6
• CPC Class Codes: A61B 17/1684 for the shoulder
• 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 2034/102 Modelling of surgical devices, implants or prosthesis
• 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: A61F 2/4081 Glenoid components, e.g. cups
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Systems and methods are provided for generating patient specific instruments for use as surgical guides. A region of interest within a body of a patient is scanned to provide a three-dimensional model of the region of interest. A first user is allowed to position a model of a selected implant with the three-dimensional model of the region of interest via a graphical user interface. A patient specific instrument model is generated from a generic patient specific instrument model according to the position of the model of the selected implant within the three-dimensional model of the region of interest and the position of at least one extension of the model that is not visible to the first user. A patient specific instrument is fabricated according to the patient specific instrument model.

Claims

1. A combination of a non-transitory computer readable medium storing machine readable instructions for fabricating a patient specific instrument (PSI) for use as a surgical guide for a surgical implant and of a model of the PSI in a digital format for use in fabricating the PSI, and the PSI, the combination comprising:

the machine readable instructions comprising;

a region modeling component configured to provide a three-dimensional model of a region of interest within a body from at least one imaging scan of the region of interest,

a surgical planning component configured to display a visible portion of a model of the implant and the three-dimensional model of the region of interest to a first user and allow the first user to select a preoperative surgical plan including a position of the implant within the three-dimensional model of the region of interest in a desired orientation, the implant having at least one hidden attribute that is not visible to the first user, the at least one hidden attribute of the implant being an implant extension configured to extend into a bone in the region of interest for maintaining the implant in the desired orientation relative to the region of interest, and

a PSI design component configured to prohibit alterations to the preoperative surgical plan selected by the first user, the PSI design component configured to display the at least one hidden attribute that is not visible to the first user, to generate at least one guide structure as extending from the implant extension and out of bone in the region of interest when the implant is in the desired orientation, the PSI design component configured to generate a model of the PSI incorporating at least one guide hole, the PSI design component configured to generate the at least one guide hole by subtracting the at least one guide structure from a generic PSI model, the PSI design component configured to display the at least one guide structure relative to the region of interest while excluding the visible portion of the implant;

the model of the PSI in a digital format for use in fabricating the PSI; and

the PSI fabricated from the model of the PSI in the digital format to implement the preoperative surgical plan, the PSI fabricated using data related to the model of the PSI in the digital format to control a manufacturing apparatus.

2. The combination of claim 1, each of the implant, the model of the region of interest, and the generic PSI model comprising a model, and the PSI design component being configured to provide the patient specific instrument model as a series of geometry processing operations on the implant, the model of the region of interest, and the generic PSI model.

3. The combination of claim 1, each of the implant and the generic PSI model comprising a model and the at least one hidden attribute comprising an extension on the implant, the PSI design component being configured to provide the patient specific instrument model as a series of geometry processing operations on the at least one hidden attribute and the generic PSI model.

4. The combination of claim 1, wherein the PSI design component prohibits displacement of the guide structure extending from the implant extension.

5. The combination of claim 1, the PSI design component further configured to select a portion of a surface within the region of interest and extrude the surface in a determined direction to provide the generic PSI model.

6. The combination of claim 1, wherein the region of interest is a shoulder joint and the region modeling component is configured to provide a three-dimensional model of at least one bone within the shoulder joint.

7. The combination of claim 1, wherein the region modeling component is configured to modify the three-dimensional model of the region of interest to eliminate any underhanging features on a portion of the three-dimensional model of the region of interest representing a bone.

8. The combination of claim 1, wherein the at least one hidden attribute comprises a first attribute that is visible to a second user.

9. The combination of claim 8, wherein the at least one hidden attribute comprises a second attribute that is not visible to either of the first user and the second user.

22. The non-transitory computer readable medium of claim 1, wherein the at least one hidden attribute of the model of the implant is not present in the surgical implant.

24. The non-transitory computer readable medium of claim 1, wherein the PSI is fabricated using at least one of selective laser sintering, fused deposition modeling, stereolithography, laminated object manufacturing, electron beam melting, three-dimensional printing, contour milling and computer numeric control.

10. A computer-implemented method for fabricating a patient specific instrument (PSI) for use as a surgical guide for a surgical implant, comprising:

scanning a region of interest within a body of a patient to provide a three-dimensional model of the region of interest;

allowing a first user to select a preoperative surgical plan by positioning a model of the implant to a desired orientation with respect to the three-dimensional model of the region of interest via a graphical user interface by displaying a visible portion of the implant relative to the three-dimensional model of the region of interest, the implant having at least one hidden attribute that is not visible to the first user, the at least one hidden attribute of the implant being an implant extension configured to extend into a bone in the region of interest configured for maintaining the implant in the desired orientation relative to the region of interest;

prohibiting alterations by a second user to the preoperative surgical plan selected by the first user,

displaying to the second user the at least one hidden attribute that is not visible to the first user, a model of the PSI relative to the region of interest while excluding the visible portion of the implant, for the second user to alter parameters of the model of the PSI;

generating the model of the PSI incorporating at least one guide hole, the at least one guide hole resulting from a subtraction of a guide structure from a generic PSI model, the guide structure configured to extend from the implant extension and out of bone in the region of interest when the implant is in the desired orientation; and

fabricating the PSI according to the model of the PSI configured for implementing the preoperative surgical plan, fabricating the PSI comprises using data related to the model of the PSI in the digital format to control a manufacturing apparatus.

11. The method of claim 10, wherein generating a model of the PSI from a generic PSI model comprises performing a series of geometry processing operations on the implant, an at least one extension of the implant, the three-dimensional model of the region of interest, and the generic PSI model.

12. The method of claim 11, wherein performing the series of geometry processing operations comprises subtracting a portion of intersection between the three-dimensional model of the region of interest and the generic PSI model from the generic PSI model such that a first surface of the generic PSI model is contoured to a portion of a surface of the three-dimensional model of the region of interest.

13. The method of claim 11, further comprising prohibiting displacement of the guide structure extending from the implant extension after allowing the first user to position the model of the implant.

14. The method of claim 11, wherein performing the series of geometry processing operations comprises taking the union of an extension of the at least one extension and the generic PSI model as to add the at least one guide structure to the generic PSI model.

15. The method of claim 11, applying a parameterized transform operation to at least a portion of the generic PSI model to produce a desired deformation in the generic PSI model.

16. The method of claim 10, further comprising generating one of the model of a selected implant and the generic PSI model as a specific instance, represented by an appropriate set of parameters, of an implicitly defined model.

17. The method of claim 10, further comprising modifying the three-dimensional model of the region of interest to eliminate features on a portion of the three-dimensional model of the region of interest expected to interfere with the engagement of the model with the region of interest.

18. The method of claim 10, further comprising allowing a second user to configure the generic PSI model to alter at least one of the size and the shape of the generic PSI model.

19. The method of claim 10, further comprising allowing a second user to configure the model of the selected implant to alter one of the size and position of a first extension of the implant.

20. The method of claim 10, wherein generating a patient specific instrument model from a generic PSI model comprises executing a script in an associated script language.

21. A system for fabricating a patient specific instrument (PSI) for use as a surgical guide for a surgical implant, the system comprising a non-transitory computer readable medium storing machine readable instructions for performing a method comprising the steps of:

allowing a first user to select a preoperative surgical plan by positioning a model of the implant in a desired orientation relative to a three-dimensional model of a region of interest by displaying a visible portion of the implant relative to the three-dimensional model of the region of interest, the implant having at least one hidden attribute that is not visible to the first user, the at least one hidden attribute of the implant being an implant extension configured to extend into a bone in the region of interest for maintaining the implant in the desired orientation relative to the region of interest;

allowing a second user to alter a first attribute of the implant by displaying the at least one hidden attribute that is not visible to the first user, and at least one guide structure relative to the region of interest to the second user, while excluding the visible portion of the implant from being viewed by the second user, the at least one guide structure extending from the implant extension and out of bone in the region of interest when the implant is in the desired orientation;

concurrently prohibiting alterations by the second user to the preoperative surgical plan selected by the first user,

generating a model of the PSI from a generic PSI model according to the preoperative surgical plan of the implant by the first user, the alteration of the first attribute by the second user, the model of the PSI incorporating at least one guide hole, the at least one guide hole resulting from a subtraction of the guide structure extending from the implant extension from the generic PSI model;

outputting the model of the PSI in a digital format for use in fabricating the PSI;

fabricating the PSI using data related to the model of the PSI in the digital format to control a manufacturing apparatus; and

a processor configured to execute the machine readable instructions.

23. The system of claim 21, further comprising prohibiting displacement of the guide structure extending from the implant extension in the desired orientation of the model of the implant after allowing the first user to position the model of the implant in the desired orientation.