# US 11,304,808 B2 · Patient-specific craniofacial implants

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- Number: US 11,304,808 B2
- Document ID: US11304808B2
- Status: Granted
- Kind: B2
- Application number: 16/830,748
- Filed: 2020-03-26
- Published: 2020-09-10
- Granted: 2022-04-19
- Earliest claimed: 2013-08-09
- Assignees: Plastic Surgery LLC
- Applicants: Plastic Surgery LLC
- Inventors: Chad Gordon
- Web page: https://patentgrep.com/patent/US11304808B2

## CPC

- A61F 2/2875: {Skull or cranium (A61F2/2803 takes precedence; joints for temporo-mandibular [TM] joints [TMJ] A61F2/3099)}
- A61F 2/0059: {Cosmetic or alloplastic implants (A61F2/10 - A61F2/16, A61F2/28 take precedence)}
- A61F 2/28: Bones
- A61F 2/30942: {for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques}
- A61F 2002/30948: {using computerized tomography, i.e. CT scans}
- A61F 2002/30952: {using CAD-CAM techniques or NC-techniques}
- A61F 2240/002: Designing or making customized prostheses
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Patient-specific craniofacial implants structured for filling bone voids or planned 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 and fat 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 craniofacial 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 and to utilize this newfound space to strategically embed implantable neurotechnologies for improved outcomes.

## Claims

### Claim 1

A method of designing a facial or craniofacial implant for filling a 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 having the bony void;
based on the three-dimensional model, creating an implant model configured to fill the bony void and replace facial soft tissue in the cranial and/or facial region, the implant model comprising an extension of material that goes above an intact skull region to fill in an area suffering nearby soft tissue atrophy as an onlay extension around the zygomatico-frontal suture along the temporal fossa abutting the lateral orbital rim; and
forming a temporal trim window on the implant model that prevents temporalis muscle impingement with an inferior limit designed based on an anatomical vector line between a zygomatic process of a temporal bone and a zygomatic-frontal suture line along the lateral orbital rim.

### Claim 2 (depends on 1)

The method of claim 1, wherein the implant model further comprises an implant over a scarred down temporalis muscle attached to a brain and dura so that the temporalis muscle is left undisturbed by a final implant placement and that a missing muscle and/or fat volume is reliably restored and camouflaged.

### Claim 3

A method of designing a facial or craniofacial implant for filling a 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 having the bony void;
based on the three-dimensional model, creating an implant model configured to fill the bony void and replace facial soft tissue in the cranial and/or facial region, the implant model comprising an extension of material that goes above an intact skull region to fill in an area suffering nearby soft tissue atrophy as an onlay extension around the zygomatico-frontal suture along the temporal fossa abutting the lateral orbital rim; and
flaring out an inferior portion of the extension of material of the implant model to prevent temporal hollowing deformities and ignoring consistency with a contralateral temporal bone shape so as to allow positioning above a temporalis muscle at time of insertion and to prevent a need for plate fixation inferiorly and undesired manipulation of a muscle off of a brain and dura.
