# US 11,443,846 B2 · Integrated orthopedic planning and management process

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- Number: US 11,443,846 B2
- Document ID: US11443846B2
- Status: Granted
- Kind: B2
- Application number: 16/005,055
- Filed: 2018-06-11
- Published: 2018-12-13
- Granted: 2022-09-13
- Earliest claimed: 2013-04-05
- Assignees: Biomet Manufacturing, LLC
- Applicants: Biomet Manufacturing Corp.
- Inventors: Ryan John Schoenefeld; Troy W. Hershberger; Bryan Morrison; Joshua B. Catanzarite
- Web page: https://patentgrep.com/patent/US11443846B2

## CPC

- G16H 30/40: for processing medical images, e.g. editing
- A61B 34/10: Computer-aided planning, simulation or modelling of surgical operations
- G16H 15/00: ICT specially adapted for medical reports, e.g. generation or transmission thereof
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 50/50: for simulation or modelling of medical disorders
- A61B 2034/102: {Modelling of surgical devices, implants or prosthesis}
- A61B 2034/105: {Modelling of the patient, e.g. for ligaments or bones}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A method can include receiving, at a server, preoperative image data of a patient's bone, and accessing, at the server, a database of three-dimensional model data. A patient specific three-dimensional model of the patient's bone can be generated, at the server. A preoperative surgical plan can be generated at the server, which can include comparing aspects of the preoperative surgical plan with predetermined reliability criteria. An interactive user interface for use by a surgeon to review the preoperative surgical plan can be provided, from the server, to a user device. Approval of the preoperative surgical plan can be received, at the server, via the interactive user interface. Postoperative image data of the patient's bone can be received at the server. A postoperative outcome study report can be generated, at the server, and can include a comparison of the preoperative surgical plan with the postoperative image data.

## Claims

### Claim 1

A system for generating a preoperative plan for an orthopedic surgical procedure, the system comprising:
one or more processors;
memory including instructions, which when executed by the one or more processors, cause the one or more processors to:
retrieve, from a database, generalized data of previous bone models generated for orthopedic surgical procedures and surgical outcome information for the orthopedic surgical procedure;
retrieve, from the database, patient-specific information related to the orthopedic surgical procedure, including range of motion data;
automatically generate the preoperative plan for the orthopedic surgical procedure using the generalized data, the surgical outcome information, and the patient-specific information related to the orthopedic surgical procedure, operations to generate the preoperative plan including:
select, with the one or more processors automatically, an implant based on the range of motion data;
generate a patient-specific 3D model based on the patient-specific information and the generalized data of previous bone models; and
render a visual depiction of the implant with the patient-specific 3D model; and
output the preoperative plan for display on a user interface;
receive postoperative image data; and
generate a postoperative outcome study report including a comparison of the preoperative plan with the postoperative image data, wherein the comparison includes comparison of the 3D model to the postoperative image data, and wherein the outcome information includes range of motion data.

### Claim 2 (depends on 1)

The system of claim 1, wherein the outcome information includes range of motion data.

### Claim 3 (depends on 1)

The system of claim 1, wherein the patient-specific information includes an image of the patient.

### Claim 4 (depends on 1)

The system of claim 1, wherein the instructions further cause the one or more processors to output a data file including instrumentation to be included with a surgical kit based on the preoperative plan.

### Claim 5 (depends on 1)

The system of claim 1, wherein the user interface is presented on a heads-up display.

### Claim 6 (depends on 1)

The system of claim 1, wherein the patient-specific information includes data generated or captured during a previous orthopedic surgical procedure for the patient.

### Claim 7 (depends on 1)

The system of claim 1, wherein the orthopedic surgical procedure is a knee arthroplasty, and wherein the instructions further cause the one or more processors to:
obtain knee kinematic data intraoperatively;
analyze the knee kinematic data; and
provide real-time feedback via the user interface based on the analyzed knee kinematic data.

### Claim 8 (depends on 7)

The system of claim 7, wherein the feedback includes a validation of implant positioning or an analysis of kinematic data as compared to predetermined data or a threshold.

### Claim 9 (depends on 1)

The system of claim 1, wherein the instructions further cause the one or more processors to scan a machine readable code on a surgical kit, an instrument, or an implant selected based on the preoperative plan, and wherein the preoperative plan is automatically output for display on the user interface in response to scanning the machine readable code.

### Claim 10 (depends on 1)

The system of claim 1, further including instructions, which when executed by the one or more processors, cause the one or more processors to:
receive postoperative image data;
generate a postoperative outcome study report including a comparison of the preoperative plan with the postoperative image data, wherein the comparison includes comparison of the 3D model to the postoperative image data.

### Claim 11

A method for generating a preoperative plan for an orthopedic surgical procedure, the method comprising:
retrieving, from a database; generalized data of previous bone models generated for orthopedic surgical procedures and surgical outcome information for the orthopedic surgical procedure;
retrieving, from the database, patient-specific information related to the orthopedic surgical procedure, including range of motion data;
automatically generating the preoperative plan for the orthopedic surgical procedure using the generalized data, the surgical outcome information, and the patient-specific information related to the orthopedic surgical procedure, the generating the preoperative plan including:
selecting, automatically using a processor, an implant based on the range of motion data;
generating, using the processor, a patient-specific 3D model based on the patient-specific information and the generalized data of previous bone models; and
rendering a visual depiction of the implant with the patient-specific 3D model; and
outputting the preoperative plan for display on a user interface,
receiving postoperative image data; and
generating a postoperative outcome study report including a comparison of the preoperative plan with the postoperative image data, wherein the comparison includes comparison of the 3D model to the postoperative image data, and wherein the outcome information includes range of motion data.

### Claim 12 (depends on 11)

The method of claim 11, wherein retrieving the surgical outcome information includes retrieving range of motion data.

### Claim 13 (depends on 11)

The method of claim 11, wherein retrieving the patient-specific information includes retrieving an image of the patient.

### Claim 14 (depends on 11)

The method of claim 11, further comprising outputting a data file including instrumentation to be included with a surgical kit based on the preoperative plan.

### Claim 15 (depends on 11)

The method of claim 11, wherein the user interface is presented on a heads-up display.

### Claim 16 (depends on 11)

The method of claim 11, wherein the patient-specific information includes data generated or captured during a previous orthopedic surgical procedure for the patient.

### Claim 17 (depends on 11)

The method of claim 11, wherein the orthopedic surgical procedure is a knee arthroplasty, and further comprising:
obtaining knee kinematic data intraoperatively;
analyzing the knee kinematic data; and
providing real-time feedback via the user interface based on the analyzed knee kinematic data.

### Claim 18 (depends on 17)

The method of claim 17, wherein the feedback includes a validation of implant positioning or an analysis of kinematic data as compared to predetermined data or a threshold.

### Claim 19 (depends on 11)

The method of claim 11, further comprising scanning a machine readable code on a surgical kit, an instrument, or an implant selected based on the preoperative plan, and wherein the preoperative plan is automatically output for display on the user interface in response to scanning the machine readable code.

### Claim 20

At least one machine readable medium including instructions for generating a preoperative plan for an orthopedic surgical procedure, which when executed by one or more processors, cause the one or more processors to:
retrieve; from a database, generalized data of previous bone models generated for orthopedic surgical procedures and surgical outcome information for the orthopedic surgical procedure;
retrieve, from the database; patient-specific information related to the orthopedic surgical procedure, including range of motion data;
automatically generate the preoperative plan for the orthopedic surgical procedure using the generalized data, the surgical outcome information, and the patient-specific information related to the orthopedic surgical procedure, operations to generate the preoperative plan include:
select, via the one or more processors, an implant based on the range of motion data;
generate a patient-specific 3D model based on the patient-specific information and the generalized data of previous bone models; and
render a visual depiction of the implant with the patient-specific 3D model; and
output the preoperative plan for display on a user interface,
receive postoperative image data; and
generate a postoperative outcome study report including a comparison of the preoperative plan with the postoperative image data, wherein the comparison includes comparison of the 3D model to the postoperative image data, and wherein the outcome information includes range of motion data.

### Claim 21 (depends on 20)

The at least one machine readable medium of claim 20, wherein the outcome information includes range of motion data.
