# US 11,896,273 B2 · Orthognathic surgical implant assembly having pre-osteotomy and post-osteotomy alignment members

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- Number: US 11,896,273 B2
- Document ID: US11896273B2
- Status: Granted
- Kind: B2
- Application number: 17/082,908
- Filed: 2020-10-28
- Published: 2021-04-29
- Granted: 2024-02-13
- Earliest claimed: 2019-10-28
- Assignees: KLS-Martin, L.P.
- Applicants: Travis Simpson; Tirth Patel
- Inventors: Travis Simpson; Tirth Patel
- Web page: https://patentgrep.com/patent/US11896273B2

## CPC

- A61B 17/151: {for corrective osteotomy}
- A61B 17/8071: {for the jaw}
- A61B 17/176: {for the jaw}
- A61B 17/8052: {immobilised relative to screws by interlocking form of the heads and plate holes, e.g. conical or threaded}
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61B 2017/564: {Methods for bone or joint treatment}
- A61B 2017/568: {produced with shape and dimensions specific for an individual patient}
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2090/037: {with a frangible part, e.g. by reduced diameter}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

An implant assembly and its method of use, used in computer-aided orthognathic surgery for properly repositioning a mobile bone segment separated by osteotomy from a malformed mandible, maxilla or chin, the implant assembly comprising fixation bone plates, at least one removable alignment plate for proper pre-osteotomy placement of the implant assembly onto the mandible, maxilla or chin, at least one removable post-osteotomy alignment plate for proper positioning of the mobile bone segment relative to the mandible, maxilla or chin, and a removable cutting guide for guiding the osteotomy saw during separation of the mobile bone segment from the mandible, maxilla or chin.

## Claims

### Claim 1

A customized, patient-specific implant assembly configured to fixedly position a first bone segment relative to a second bone segment across an osteotomy gap, the first and second bone segments having surface topographies, the implant assembly comprising:
one or more fixation bone plates each comprising a pre-osteotomy conforming portion and a post-osteotomy conforming portion joined by a transition portion, the transition portion of the one or more fixation bone plates configured to span the osteotomy gap;
wherein the pre-osteotomy conforming portion is configured to conform to a portion of the first bone segment surface topography, and wherein the post-osteotomy conforming portion is configured to conform to a portion of the second bone segment surface topography;
bone screws configured to affix the one or more fixation bone plates to bone across the osteotomy gap;
bone screw apertures configured to receive the bone screws, the bone screw apertures disposed in the pre-osteotomy conforming portions and the post-osteotomy conforming portions of the one or more fixation bone plates;
one or more removable pre-osteotomy conforming alignment plates connected to the pre-osteotomy conforming portions of the one or more fixation bone plates by severable bridging members; wherein the one or more removable pre-osteotomy conforming alignment plates are configured to conform to a portion of the surface topography of the first bone segment different from the portion of the first bone segment surface topology conformed to by the pre-osteotomy conforming portion of the one or more fixation bone plates;
one or more removable post-osteotomy conforming alignment plates connected to the post-osteotomy conforming portions of the one or more fixation bone plates by severable bridging members; wherein the one or more removable post-osteotomy conforming alignment plates are configured to conform to a portion of the surface topography of the second bone segment different from the portion of the second bone segment surface topology conformed to by the post-osteotomy conforming portion of the one or more fixation bone plates;
wherein the assembly is configured such that, with the one or more fixation plates affixed across the osteotomy gap with the bone screws, the one or more removable pre-osteotomy conforming alignment plates and the one or more removable post-osteotomy conforming alignment plates are removable from the one or more fixation plates by severing the bridging members.

### Claim 2 (depends on 1)

The implant assembly of claim 1, further comprising a removable cutting guide connected to the one or more fixation bone plates.

### Claim 3 (depends on 1)

The implant assembly of claim 1, wherein the pre-osteotomy conforming portion and the post-osteotomy conforming portion of each of the one or more fixation bone plates comprises a surface contact area, and wherein the one or more removable pre-osteotomy conforming alignment plates and the one or more post-osteotomy conforming alignment plates each comprise a contact surface area greater than the contact surface area of the pre-osteotomy conforming portion and the post-osteotomy conforming portion of each of the one or more fixation bone plates.

### Claim 4 (depends on 2)

The implant assembly of claim 2, wherein the pre-osteotomy conforming portion and the post-osteotomy conforming portion of each of the one or more fixation bone plates comprises a surface contact area, and wherein the one or more removable pre-osteotomy conforming alignment plates and the one or more post-osteotomy conforming alignment plates each comprise a contact surface area greater than the contact surface area of the pre-osteotomy conforming portion and the post-osteotomy conforming portion of each of the one or more fixation bone plates.

### Claim 5 (depends on 1)

The implant assembly of claim 1, wherein the one or more removable pre-osteotomy conforming alignment plates and the one or more post-osteotomy conforming alignment plates are non-planar.

### Claim 6 (depends on 2)

The implant assembly of claim 2, wherein the one or more removable pre-osteotomy conforming alignment plates and the one or more post-osteotomy conforming alignment plates are non-planar.

### Claim 7 (depends on 3)

The implant assembly of claim 3, wherein the one or more removable pre-osteotomy conforming alignment plates and the one or more post-osteotomy conforming alignment plates are non-planar.

### Claim 8

A customized, patient-specific implant assembly configured to fixedly position a mobile bone segment relative to a non-mobile bone segment, the mobile and non-mobile bone segments having surface topographies, the implant assembly comprising:
one or more fixation bone plates each comprising a pre-osteotomy conforming portion and a post-osteotomy conforming portion joined by a transition portion, wherein the pre-osteotomy conforming portion is configured to conform to a portion of the surface topography of the non-mobile bone segment, and wherein the post-osteotomy conforming portion is configured to conform to a portion of the surface topography of the mobile bone segment;
bone screws configured to affix the one or more fixation bone plates to the bone segments;
bone screw apertures configured to receive the bone screws, the bone screw apertures disposed in the pre-osteotomy conforming portions and the post-osteotomy conforming portions of the one or more fixation bone plates;
one or more removable pre-osteotomy conforming alignment plates connected to the pre-osteotomy conforming portions of the one or more fixation bone plates by severable bridging members; and
one or more removable post-osteotomy conforming alignment plates connected to the post-osteotomy conforming portions of the one or more fixation bone plates by severable bridging members,
wherein the one or more removable pre-osteotomy conforming alignment plates are configured to conform to other portions of the surface topography of the non-mobile bone segment, and wherein the one or more removable post-osteotomy conforming alignment plates are configured to conform to other portions of the surface topography of the mobile bone segment;
wherein the assembly is configured such that, with the one or more fixation plates affixed to the bone segments by the bone screws, the one or more removable pre-osteotomy conforming alignment plates and the one or more removable post-osteotomy conforming alignment plates are removable from the one or more fixation plates by severing the bridging members.

### Claim 9 (depends on 8)

The implant assembly of claim 8, further comprising a removable cutting guide connected to the one or more fixation bone plates.

### Claim 10 (depends on 8)

The implant assembly of claim 8, wherein the pre-osteotomy conforming portion and the post-osteotomy conforming portion of each of the one or more fixation bone plates comprises a surface contact area, and wherein the one or more removable pre-osteotomy conforming alignment plates and the one or more post-osteotomy conforming alignment plates each comprise a contact surface area greater than the contact surface area of the pre-osteotomy conforming portion and the post-osteotomy conforming portion of each of the one or more fixation bone plates.

### Claim 11 (depends on 9)

The implant assembly of claim 9, wherein the pre-osteotomy conforming portion and the post-osteotomy conforming portion of each of the one or more fixation bone plates comprises a surface contact area, and wherein the one or more removable pre-osteotomy conforming alignment plates and the one or more post-osteotomy conforming alignment plates each comprise a contact surface area greater than the contact surface area of the pre-osteotomy conforming portion and the post-osteotomy conforming portion of each of the one or more fixation bone plates.