Patient-specific craniofacial implants

• US 10,639,158 B2
• Filed: 04/08/2019
• Issued: 05/05/2020
• Est. Priority Date: 08/09/2013
• Status: Active Grant

• Current Assignee: Plastic Surgery, LLC
• Original Assignee: Plastic Surgery, LLC
• Inventors: Gordon, Chad
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US16/377,455
• Publication Number:
  US 20190231531A1
• Time in Patent Office: 393 Days
• 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 facial or craniofacial implants structured for filling bone voids in the cranium and face as well as for simultaneously providing soft tissue reconstruction and/or augmentation for improved aesthetic symmetry and appearance of face and skull. Pterional or temporal voids or defects generally result from a chronic skull or lateral facial deformity along with a compromised temporalis muscle or soft tissue distortion from previous surgery. When muscle atrophy occurs in the pterion or temporal face, temporal hollowing deformity generally results where there would be soft tissue but for the atrophy. The patient-specific temporal implants with dual-purpose herein are configured to have an augmented region adjacent the temporal region of the face and cranium in order to prevent and/or correct any such temporal hollowing deformity.

Claims

1. A method of designing a facial or craniofacial implant for filling an existing bony void in a cranial and/or facial region of a patient and for replacing facial soft tissue comprising:

creating a three-dimensional model of the cranial and/or facial region providing regions of intact skull including a zygomatic process of temporal bone and zygomatic-frontal suture, temporal fossa, and lateral orbital rim and having the bony void; and

creating an implant model configured to replace the bony void in the cranial and/or facial region of the three-dimensional model, the implant model comprising material for replacing the bony void and an extension of material that goes from the bony void to above an intact skull region of the three-dimensional model corresponding to an area of the cranial and/or facial region of the patient expected to suffer soft tissue atrophy as an onlay extension around the zygomatico-frontal suture along the temporal fossa abutting the lateral orbital rim of the three-dimensional model; and

trimming the implant model using a vector spanning between the zygomatic process of the temporal bone and the zygomatic-frontal suture of the lateral orbital rim of the three-dimensional model so that the implant model is configured to be positioned over an area of the three-dimensional model corresponding to a location of a scarred down temporalis muscle attached to the brain and dura of the patient so that the facial or craniofacial implant based on the implant model leaves the temporalis muscle undisturbed and restores aesthetic symmetry and camouflages missing muscle and/or fat volume to the cranial and/or facial region.

2. The method of claim 1, wherein creating the three-dimensional model comprises:

making a tomographic scan of the cranial and/or facial region of the patient to provide two-dimensional cross-section images, and

combining the two-dimensional cross-section images using segmentation software to create the three-dimensional model.

3. The method of claim 1, wherein creating the three-dimensional model comprises taking two-dimensional or three-dimensional photographs from various views for confirmation of aesthetic deformity size and/or shape of the bony void.

4. The method of claim 1, wherein creating the implant model comprises:

creating a preliminary implant model configured to replace the bony void in the cranial and/or facial region of the three-dimensional model, and

creating an updated implant model by augmenting an outer contour of the preliminary implant model corresponding to the area of the cranial and/or facial region of the patient expected to suffer soft tissue atrophy as an onlay extension around the zygomatico-frontal suture along the temporal fossa abutting the lateral orbital rim.

5. The method of claim 4, wherein augmenting the outer contour of the preliminary implant model comprises:

providing a first cross-sectional view of the preliminary implant model in a coronal plane, 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 tangent to the most lateral portion of the zygomatic arch in the first cross-sectional view, 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 in a coronal plane, the coronal plane of the first cross-section view being more posterior than the coronal plane of the second cross sectional view,

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 tangent to the most lateral portion of the zygomatic arch in the second cross-sectional view, the contour line representing a second portion of the augmented outer contour of the preliminary implant model.

7. The method of claim 5, wherein augmenting the outer contour of the preliminary implant model is carried out in a plurality of cross-sectional views in the coronal plane.

8. The method of claim 5, wherein augmenting the outer contour of the preliminary implant is carried out in a plurality of cross-sectional views in an axial plane.

9. The method of claim 5, wherein augmenting the outer contour of the preliminary implant is carried out in a plurality of cross-sectional views in a sagittal plane.