Patient-specific craniofacial implants

• US 9,216,084 B2
• Filed: 08/09/2013
• Issued: 12/22/2015
• Est. Priority Date: 08/09/2013
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Inventors: Gordon, Chad, Bryndza, John Rocco, Bisic, Tahir
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): BARIA, DINAH N
• Application Number:
  US13/963,225
• Publication Number:
  US 20150045897A1
• Time in Patent Office: 865 Days
• Field of Search: 623/17.18, 623/17.19
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/2875 Skull or cranium A61F2/2803 and A61F2/3099 take precedence
• CPC Class Codes: A61F 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2002/30948 using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses

Abstract

Disclosed herein are patient-specific craniofacial implants structured for filling bone voids in the cranium as well as for simultaneously providing soft tissue reconstruction and/or augmentation for improved aesthetic symmetry and appearance. Pterional voids or defects generally result from a chromic skull deformity along with a compromised temporalis muscle or soft tissue distortion from previous surgery. When muscle atrophy occurs in the pterion, temporal hollowing generally results where there would be soft tissue but for the atrophy. The patient-specific temporal implants herein are configured to have an augmented region adjacent the temporal region of the cranium in order to account for and correct any such temporal hollowing.

Claims

1. A method of designing a craniofacial implant for filling a void in a skull of a patient and for replacing soft tissue comprising:

creating a three dimensional model of the skull having the void;

creating a preliminary implant model configured to replace the void in the skull, the preliminary implant model having a first volume; and

creating an updated implant model by augmenting an outer contour of the preliminary implant model to account for soft tissue loss overlying at least a portion of the void such that the updated implant model has a second volume greater than the first volume.

2. The method of claim 1, further comprising:

obtaining tomographic images of the skull of the patient in order to create the three dimensional model of the skull including the void.

3. The method of claim 1, wherein the preliminary model is created by mirroring contralateral bone of the void.

4. The method of claim 3, wherein mirroring contralateral bone of the void occurs about a sagittal plane of the patient.

5. The method of claim 1, wherein augmenting the outer contour of the preliminary implant model comprises:

providing a first cross-sectional view of the preliminary implant model;

providing on the first cross-sectional view a vertical line tangent to a most lateral portion of a zygomatic arch of the skull of the patient; and

providing on the first cross-sectional view a contour line from a temporal crest of the skull until the contour line intersects the vertical line, the contour line representing a first portion of the augmented outer contour of the preliminary implant model.

6. The method of claim 5, wherein augmenting the outer contour of the preliminary implant model further comprises:

providing a second cross-sectional view of the preliminary implant model;

providing on the second cross-sectional view a vertical line tangent to a most lateral portion of a zygomatic arch of the skull of the patient; and

providing on the second cross-sectional view a contour line from a temporal crest of the skull until the contour line intersects the vertical line, the contour line representing a second portion of the augmented outer contour of the preliminary implant model.

7. The method of claim 6, wherein the first and second cross-sectional views of the preliminary implant model are provided in a coronal plane.

8. The method of claim 7, wherein the coronal plane of the first cross-sectional view is more posterior with respect to the skull of the patient than is the coronal plane of the second cross-sectional view.

9. The method of claim 6, wherein the first and second cross-sectional views of the preliminary implant model are provided in an axial plane, and wherein the axial plane of the first cross-sectional view is more superior with respect to the skull of the patient than is the axial plane of the second cross-sectional view.

10. The method of claim 1, wherein the craniofacial implant is manufactured from alloplastic materials selected from one member of a group consisting of polymethylmethacrylate, polyetheretherketone, and porous high-density polyethylene.

11. A method of manufacturing a craniofacial implant for filling a void in a skull of a patient and for replacing soft tissue comprising:

creating a three dimensional model of the skull having the void;

creating a preliminary implant model configured to replace the void in the skull, the preliminary implant model having a first volume;

creating an updated implant model by augmenting an outer contour of the preliminary implant model to account for soft tissue loss overlying at least a portion of the void such that the updated implant model has a second volume greater than the first volume; and

fabricating the updated implant model.

12. The method of claim 11, further comprising:

obtaining tomographic images of the skull of the patient in order to create the three dimensional model of the skull including the void.

13. The method of claim 11, wherein the preliminary model is created by mirroring contralateral bone of the void.

14. The method of claim 13, wherein mirroring contralateral bone of the void occurs about a sagittal plane of the patient.

15. The method of claim 11, wherein augmenting the outer contour of the preliminary implant model comprises:

providing a first cross-sectional view of the preliminary implant model;

providing on the first cross-sectional view a vertical line tangent to a most lateral portion of a zygomatic arch of the skull of the patient; and

providing on the first cross-sectional view a contour line from a temporal crest of the skull until the contour line intersects the vertical line, the contour line representing a first portion of the augmented outer contour of the preliminary implant model.

16. The method of claim 15, wherein augmenting the outer contour of the preliminary implant model further comprises:

providing a second cross-sectional view of the preliminary implant model;

providing on the second cross-sectional view a vertical line tangent to a most lateral portion of a zygomatic arch of the skull of the patient; and

providing on the second cross-sectional view a contour line from a temporal crest of the skull until the contour line intersects the vertical line, the contour line representing a second portion of the augmented outer contour of the preliminary implant model.

17. The method of claim 16, wherein the first and second cross-sectional views of the preliminary implant model are provided in a coronal plane.

18. The method of claim 17, wherein the coronal plane of the first cross-sectional view is more posterior with respect to the skull of the patient than is the coronal plane of the second cross-sectional view.

19. The method of claim 16, wherein the first and second cross-sectional views of the preliminary implant model are provided in an axial plane, and wherein the axial plane of the first cross-sectional view is more superior with respect to the skull of the patient than is the axial plane of the second cross-sectional view.

20. The method of claim 11, wherein the craniofacial implant is manufactured from alloplastic materials selected from one member of a group consisting of polymethylmethacrylate, polyetheretherketone, and porous high-density polyethylene.