Pre-operative planning and manufacturing method for orthopedic procedure

• US 8,532,807 B2
• Filed: 06/06/2011
• Issued: 09/10/2013
• 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 JOY
• Application Number:
  US13/153,760
• Publication Number:
  US 20120310399A1
• Time in Patent Office: 827 Days
• Field of Search: 700/95, 700/97, 700/98, 345418-420, 345/619, 345/629, 345/630, 345/634, 606/53, 606/60, 606/86.A, 606/86.B, 606/86.R, 606 87- 90, 606/96, 606/280, 606/281, 623/11.11, 623/13.11, 623/13.12, 623/16.11, 623/18.11, 623/20.11, 623/20.14, 623/20.21, 623/20.32, 623/20.35, 623/22.11, 623/23.39
• US Class Current: 700/98
• 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 manufacturing the non-custom implant when there is insufficient image data to construct the patient-specific alignment guide therefrom.

Claims

1. A pre-operative planning and manufacturing method for orthopedic surgery comprising:

obtaining pre-operative medical image data representing a joint portion of a patient;

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 having 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; and

determining, from the image data, a size of a non-custom implant to be implanted in the patient and manufacturing the non-custom implant when there is insufficient image data to construct the patient-specific alignment guide therefrom.

2. The method of claim 1, further comprising manufacturing a patient-specific implant after constructing the three-dimensional digital model of the joint portion.

3. The method of claim 1, wherein determining the size of the non-custom implant includes selecting the non-custom implant from a group of non-custom implants of different sizes.

4. The method of claim 1, further comprising determining, from the image data, a dimension of a non-custom surgical instrument configured for use during surgery for implanting the non-custom implant.

5. The method of claim 4, 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.

6. The method of claim 4, further comprising selecting the non-custom surgical instrument from a plurality of non-custom surgical instruments of different dimensions.

7. The method of claim 1, further comprising manufacturing a trial implant that corresponds to the non-custom implant.

8. The method of claim 1, further comprising assembling a kit containing the non-custom implant, a non-custom surgical instrument configured for use during surgery for implanting the non-custom implant, and a trial implant that corresponds to the non-custom implant.

9. The method of claim 1, 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.

10. A pre-operative planning and manufacturing method for orthopedic surgery comprising:

pre-operatively obtaining medical image data that is readable on a computer, the medical image data containing a plurality of two-dimensional medical images of a joint portion of a patient;

pre-operatively constructing a three-dimensional digital model of the joint portion from the plurality of two-dimensional medical images and displaying the three-dimensional digital model on a display of the computer when the plurality of two-dimensional medical images are sufficient to construct the three-dimensional digital model of the joint portion and a corresponding a patient-specific alignment guide; and

selecting, based on the image data, a non-custom implant to be implanted in the patient and providing the non-custom implant when the plurality of two-dimensional medical images are insufficient for use in constructing a patient-specific alignment guide having a three-dimensional patient-specific surface 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 non-custom implant chosen from a group of non-custom implants of different sizes.

11. The method of claim 10, further comprising manufacturing the patient-specific alignment guide when the plurality of two-dimensional medical images are sufficient, 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 joint portion of the patient in only one position relative to the joint portion, and further comprising manufacturing the selected non-custom implant when the plurality of two-dimensional medical images are insufficient to construct the patient-specific alignment guide therefrom.

12. The method of claim 10, further comprising manufacturing a patient-specific implant after constructing the three-dimensional digital model of the joint portion.

13. The method of claim 10, further comprising determining, from the medical image data, a dimension of a non-custom surgical instrument configured for use during surgery for implanting the non-custom implant.

14. The method of claim 13, 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.

15. The method of claim 13, further comprising selecting the non-custom surgical instrument from a plurality of non-custom surgical instruments of different dimensions.

16. The method of claim 10, further comprising manufacturing a trial implant that corresponds to the non-custom implant.

17. The method of claim 10, further comprising assembling a kit containing the non-custom implant, a non-custom surgical instrument configured for use during surgery for implanting the non-custom implant, and a trial implant that corresponds to the non-custom implant.

18. The method of claim 10, 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.

19. A computerized pre-operative planning tool for planning an orthopedic surgical procedure comprising:

a receiver device that receives medical image data containing a plurality of two-dimensional medical images of a joint portion of a patient;

a processor that determines whether the medical image data is sufficient for constructing a three-dimensional digital model of the joint portion from the plurality of two-dimensional medical images, the processor also configured to construct the three-dimensional digital model when the medical image data is sufficient to construct the three-dimensional digital model, the processor further configured to construct a patient-specific digital model of a patient-specific alignment guide when the medical image data is sufficient to construct the three-dimensional digital model, the patient-specific alignment guide having a three-dimensional surface that nests against a corresponding surface of the three-dimensional digital model of the joint portion; and

a display that displays the three-dimensional digital model of the joint portion and the patient specific digital model of the patient-specific alignment guide when the processor determines that the medical image data is sufficient for constructing the three-dimensional digital model of the joint portion, the display also displaying at least one of the two-dimensional medical images of the joint portion for selection of a non-custom implant when the processor determines that the medical image data is insufficient for constructing the patient-specific alignment guide therefrom.

20. A pre-operative planning and manufacturing method for orthopedic surgery of a knee joint of a patient comprising:

obtaining pre-operative medical image data representing the knee joint, the medical image data including a plurality of two-dimensional images of the knee joint;

constructing a three-dimensional digital model of the knee joint and 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;

determining, 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;

determining 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;

manufacturing at least one of the non-custom implant and the non-custom surgical instrument when there is insufficient image data to construct the patient-specific alignment guide therefrom; and

assembling a kit containing the non-custom implant and the non-custom surgical instrument when there is insufficient image data to construct the patient-specific alignment guide therefrom.