Pre-operative planning and manufacturing method for orthopedic procedure

• US 9,757,238 B2
• Filed: 12/01/2014
• Issued: 09/12/2017
• Est. Priority Date: 06/06/2011
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Metzger, Robert
• Primary Examiner(s): Barnes-Bullock, Crystal J
• Application Number:
  US14/556,785
• Publication Number:
  US 20150088293A1
• Time in Patent Office: 1,016 Days
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• CPC Class Codes: A61B 2034/102 Modelling of surgical devices, implants or prosthesis
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• 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 2/3859 Femoral components
• CPC Class Codes: A61F 2/46 Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
• CPC Class Codes: A61F 2/5046 for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2002/30952 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/4633 for selection of endoprosthetic joints or for pre-operative planning
• CPC Class Codes: G06F 30/00 Computer-aided design [CAD]
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A pre-operative planning and manufacturing method for orthopedic surgery includes obtaining pre-operative medical image data representing a joint portion of a patient. The method also includes constructing a three-dimensional digital model of the joint portion and manufacturing a patient-specific alignment guide for the joint portion from the three-dimensional digital model of the joint portion when the image data is sufficient to construct the three-dimensional digital model of the joint portion. The patient-specific alignment guide has a three-dimensional patient-specific surface pre-operatively configured to nest and closely conform to a corresponding surface of the joint portion of the patient in only one position relative to the joint portion. The method further includes determining, from the image data, a size of a non-custom implant to be implanted in the patient and assembling a surgical kit including the non-custom implant when there is insufficient image data to construct the patient-specific alignment guide therefrom.

Claims

1. A pre-operative system for planning a method for orthopedic surgery, comprising:

a receiving device configured to receive pre-operative image data of an anatomic joint portion of a patient;

a processor in communication with the receiving device and configured to analyze the pre-operative image data and generate a three-dimensional digital model of the anatomic joint portion based on the pre-operative image data; and

a display device configured to display the pre-operative image data and the three-dimensional digital model;

wherein the processor is configured to determine whether the pre-operative image data is sufficient to construct the three-dimensional digital model of the anatomic joint portion, and if pre-operative image data is sufficient to generate the three-dimensional mode of the anatomic joint portion, the processor is configured to generate a first surgical plan including a patient-specific alignment guide having a three-dimensional patient-specific surface pre-operatively configured to nest and closely conform to a corresponding surface of the anatomic joint portion of the patient in only one position relative to the anatomic joint portion; and

if the processor determines that the pre-operative image data is insufficient to generate the three-dimensional digital mode of the anatomic joint portion, the processor is configured generate a second surgical plan including a non-patient-specific surgical implant.

2. The system of claim 1, wherein the processor is configured to determine a size of a non-patient-specific implant to be implanted in the patient based on the pre-operative image data.

3. The system of claim 2, wherein the processor is configured to select the non-patient-specific implant from a group of non-custom implants of different sizes.

4. The system of claim 1, wherein the processor is configured to determine a dimension of a non-patient-specific surgical instrument configured for use during surgery for implanting the non-patient-specific implant.

5. The system of claim 4, wherein the non-patient-specific surgical instrument is a resection tool with a guide surface configured for guiding a cutting tool during resection of a bone of the anatomic joint portion.

6. The system of claim 4, wherein the processor is configured to select the non-patient-specific surgical instrument from a plurality of non-custom surgical instruments of different dimensions.

7. The system of claim 1, wherein non-custom implant is at least one of a femoral implant and a tibial implant.

8. The system of claim 1, further comprising a memory configured to store the pre-operative image data.

9. A pre-operative system for planning a method for orthopedic surgery comprising:

a receiver configured to receive pre-operative medical image data containing a plurality of two-dimensional medical images of a joint portion of a patient;

a processor in communication with the receiver and configured to construct a three-dimensional digital model of the joint portion from the plurality of two-dimensional medical images; and

a display configured to display the three-dimensional digital model;

wherein the processor is configured to determine whether the plurality of two-dimensional digital medical images are sufficient to construct a three-dimensional digital model of the joint portion,

if the processor determines that the two-dimensional digital medical images are sufficient, the processor is configured to pre-operatively construct a first surgical plan including the three-dimensional digital model of the joint portion and a corresponding patient-specific alignment guide, and

if the processor determines that the two-dimensional digital medical images are insufficient, the processor is configured to pre-operatively construct, based on the pre-operative medical image data, a second surgical plan including a non-custom implant to be implanted in the patient.

10. The system of claim 9, wherein the second surgical plan constructed by the processor includes determining a non-custom implant chosen from a group of non-custom implants of different sizes.

11. The system of claim 9, wherein the second surgical plan constructed by the processor includes determining a non-custom surgical instrument, and the processor is configured to determine, from the pre-operative medical image data, a dimension of the non-custom surgical instrument configured for use during the second surgical plan for implanting the non-custom implant.

12. The system of claim 11, wherein the non-custom surgical instrument is a resection tool with a guide surface configured for guiding a cutting tool during resection of a bone of the joint portion.

13. The system of claim 11, wherein the processor is configured to select the non-custom surgical instrument from a plurality of non-custom surgical instruments of different dimensions.

14. The system of claim 9, wherein the joint portion is a knee joint and the non-custom implant is at least one of a femoral implant and a tibial implant.

15. The system of claim 9, wherein the non-custom implant is selected from one of full knee replacement implant and partial knee replacement implant.

16. The system of claim 9, further comprising a memory configured to store the pre-operative medical image data.

17. A pre-operative system for planning a method for orthopedic surgery, comprising:

a receiver configured to obtain pre-operative medical image data representing a knee joint, the medical image data including a plurality of two-dimensional images of the knee joint; and

a processor in communication with the receiver, and configured to construct a three-dimensional digital model of the knee joint for manufacturing a patient-specific alignment guide for the knee joint from the three-dimensional digital model of the knee joint when the plurality of two-dimensional images of the knee joint is sufficient to construct the three-dimensional digital model of the knee joint, the patient-specific alignment guide having a three-dimensional patient-specific surface pre-operatively configured to nest and closely conform to a corresponding surface of the knee joint of the patient in only one position relative to the knee joint;

wherein the processor is configured to determine, based on at least one of the two-dimensional images of the knee joint, a size of a non-custom implant to be implanted in the knee joint of the patient when there is insufficient image data to construct the patient-specific alignment guide therefrom; and

the processor is configured to determine a dimension for a non-custom surgical instrument configured for implanting the non-custom implant when there is insufficient image data to construct the patient-specific alignment guide therefrom.

18. The system according to claim 17, further comprising a display configured to display the three-dimensional digital model.

19. The system according to claim 17, further comprising a memory configured to store the pre-operative medical image data.

20. The system according to claim 17, wherein the processor is configured to select the non-patient-specific implant from a group of non-custom implants of different sizes.