# US 10,368,963 B2 · Method for selecting implant components

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- Number: US 10,368,963 B2
- Document ID: US10368963B2
- Status: Granted
- Kind: B2
- Application number: 15/865,608
- Filed: 2018-01-09
- Published: 2018-05-10
- Granted: 2019-08-06
- Earliest claimed: 2007-05-18
- Assignees: Biomet 3i, LLC
- Applicants: Biomet 3I, LLC
- Inventors: Zachary B. Suttin; Bruce Berckmans, III; T. Tait Robb
- Web page: https://patentgrep.com/patent/US10368963B2

## CPC

- A61C 8/00: Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools (fastening of peg-teeth in the mouth A61C13/30)
- A61B 6/032: {Transmission computed tomography [CT]}
- A61B 6/505: {for diagnosis of bone}
- A61B 6/51: for dentistry
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- A61C 8/009: {for selecting the right implanting element, e.g. templates}
- A61C 13/0004: {Computer-assisted sizing or machining of dental prostheses}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- A61B 2034/108: {Computer aided selection or customisation of medical implants or cutting guides}
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Methods of selecting or designing an implant to be used in a patient are provided. A CT scan of a patient's mouth is performed. A 3D CAD model of the patient's mouth is created utilizing data generated by the CT scan. Properties of the patient's mouth are determined based upon CT scan data and assigned to the 3D CAD model. A desired location for an implant is selected. A FEA simulation is performed on the 3D CAD model to choose an implant or to design an implant that optimizes a selected variable.

## Claims

### Claim 1

A method of selecting an implant to be used in a patient, the method comprising:
performing a CT scan of the patient's mouth;
creating a 3D CAD model of the patient's mouth utilizing data generated by the CT scan;
determining properties of the patient's mouth based upon data generated by the CT scan;
assigning the determined properties of the patient's mouth to the 3D CAD model;
selecting a desired location for the implant;
assigning at least one variable to be optimized by a FEA simulation, the at least one variable including an initial implant stability relative to a necessary transient torque to seat the implant in the bone;
performing an FEA simulation on a plurality of possible implants and a plurality of osteotomy variables with the 3D CAD model; and
choosing a protocol including a selected implant and a selected osteotomy based upon the results of the FEA simulation of the 3D CAD model including the initial implant stability relative to the necessary transient torque to seat the selected implant.

### Claim 2 (depends on 1)

The method of claim 1, wherein the act of determining properties determines a type of bone present in the patient's jaw.

### Claim 3 (depends on 1)

The method of claim 1, wherein the act of determining properties determines a magnitude of bone density of the patient's jaw.

### Claim 4 (depends on 1)

The method of claim 1, wherein the act of performing an FEA simulation is a real-time simulation of placing the implant into the patient's bone.

### Claim 5 (depends on 1)

The method of claim 1, wherein the chosen protocol includes the selected implant and the selected osteotomy that minimizes the necessary transient torque while maximizing the initial implant stability.

### Claim 6 (depends on 1)

The method of claim 1, wherein the choosing the protocol is based upon verifying that a maximum stress level is not surpassed in the bone surrounding the selected implant.

### Claim 7

A method of selecting an implant to be used in a patient, the method comprising:
performing a CT scan of the patient's mouth;
creating a 3D CAD model of the patient's mouth utilizing data generated by the CT scan;
determining properties of the patient's mouth based upon data generated by the CT scan;
assigning the determined properties of the patient's mouth to the 3D CAD model;
selecting a desired location for the implant;
assigning at least one variable including an initial implant stability to be optimized by a FEA simulation;
performing an FEA simulation in real-time on the 3D CAD model on a plurality of possible implants to optimize the at least one assigned variable;
determining the necessary transient torque to seat each of the plurality of possible implants into the patient's mouth based on the determined properties of the patient's mouth, the plurality of possible implants, and the desired location via the real-time FEA simulation; and
choosing a selected implant from the plurality of possible implants to use in the patient based upon results from performing the FEA simulation.

### Claim 8 (depends on 7)

The method of claim 7, wherein the act of determining properties determines a type of bone present in the patient's jaw.

### Claim 9 (depends on 7)

The method of claim 7, wherein the act of determining properties determines a magnitude of bone density of the patient's jaw.

### Claim 10 (depends on 7)

The method of claim 7, wherein the at least one variable to optimize includes a maximum stress level not to be surpassed in the bone surrounding the implant.

### Claim 11 (depends on 7)

The method of claim 7, wherein the plurality of possible implants are contained in a library of a 3D CAD system to optimize the assigned variable.

### Claim 12

A method of designing an implant to be used in a patient, the method comprising
performing a CT scan of the patient's mouth;
creating a 3D CAD model of the patient's mouth utilizing data generated by the CT scan;
determining properties of the patient's mouth based upon data generated by the CT scan;
assigning the determined properties of the patient's mouth to the 3D CAD model;
selecting an implant to be placed into the patient's mouth;
selecting a desired location for the selected implant;
assigning at least one osteotomy variable to be optimized by a FEA simulation;
performing a real-time FEA simulation on the 3D CAD model to optimize the assigned osteotomy variable;
determining the necessary transient torque to seat the selected implant into the patient based on the determined properties of the patient's mouth, the selected implant, and the desired location via the FEA simulation; and
optimizing the osteotomy for the desired location based upon results from the act of performing the real-time FEA simulation and the necessary transient torque.

### Claim 13 (depends on 12)

The method of claim 12, wherein the act of determining properties determines a type of bone present in the patient's jaw.

### Claim 14 (depends on 12)

The method of claim 12, wherein the act of determining properties determines a magnitude of bone density of the patient's jaw.

### Claim 15 (depends on 12)

The method of claim 12, wherein the optimizing the osteotomy includes determining at least one osteotomy dimension from the real-time FEA simulation.

### Claim 16 (depends on 15)

The method of claim 15, wherein the osteotomy dimension determined is at least one of length, diameter, taper, tap type, and whether a counter sink is present.

### Claim 17 (depends on 15)

The method of claim 15, further including:
performing a FEA calibration, prior to performing the real-time FEA simulation on the 3D CAD model of the patient.

### Claim 18 (depends on 17)

The method of claim 17, wherein the FEA calibration includes:
performing a calibration CT scan on a calibration sample;
creating a calibration 3D CAD model of the calibration sample utilizing data generated by the calibration CT scan;
determining properties of the calibration sample;
assigning the determined properties of the calibration sample to the calibration 3D CAD model;
selecting a calibration location for a calibration implant;
perform a calibration FEA simulation on the calibration 3D CAD model;
place the calibration implant into the calibration sample;
measure data from the placement of the calibration implant into the calibration sample; and
compare the measured data from the placement of the calibration implant into the calibration sample with the calibration FEA simulation.

### Claim 19 (depends on 18)

The method of claim 18, further including:
determining whether the calibration FEA simulation accurately predicts the measured data,
wherein, in response to the calibration FEA simulation accurately predicting the measured data, performing the real-time FEA simulation, and
wherein, in response to the calibration FEA simulation not accurately predicting the measured data, adjusting FEA simulation variables.

### Claim 20 (depends on 1)

The method of claim 1, wherein the plurality of osteotomy variables includes at least at least one of length, diameter, taper, tap type, and whether a counter sink is present.
