Pre-operative planning and manufacturing method for orthopedic procedure

• US 8,903,530 B2
• Filed: 09/06/2013
• Issued: 12/02/2014
• 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:
  US14/020,378
• Publication Number:
  US 20140018948A1
• Time in Patent Office: 452 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 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 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

when there is insufficient data to construct the patient-specific alignment guide therefrom;

determining, from the image data, a size of a non-custom implant to be implanted in the patient;

selecting the non-custom implant from a group of non-custom implants of different sizes; and

assembling a surgical kit containing the non-custom implant and a trial implant that corresponds to the non-custom implant.

2. The method of claim 1, further comprising manufacturing the non-custom implant.

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

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 the trial implant.

8. The method of claim 1, further comprising including in the surgical kit a non-custom surgical instrument configured for use during surgery for implanting 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;

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 relative to the joint portion, the non-custom implant chosen from a group of non-custom implants of different sizes; and

assembling a surgical kit including the non-custom implant and a surgical instrument for use with the non-custom implant.

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, wherein the surgical instrument is a non-custom surgical instrument, the method further comprising determining, from the medical image data, a dimension of the 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 including in the surgical 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. The method of claim 18, wherein the non-custom implant is selected from one of full knee replacement implant and partial knee replacement implant.

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; and

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