Total joint arthroplasty system

• US 8,801,720 B2
• Filed: 12/18/2006
• Issued: 08/12/2014
• Est. Priority Date: 05/15/2002
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: Otismed Corporation (Stryker Corporation)
• Inventors: Park, Ilwhan, Pearson, Lacerial, Samuel, Stephen M.
• Primary Examiner(s): BATES, DAVID W
• Application Number:
  US11/641,569
• Publication Number:
  US 20090131941A1
• Time in Patent Office: 2,794 Days
• Field of Search: 606 87- 89
• US Class Current: 606/88
• CPC Class Codes: A61B 17/154 for preparing bone for knee prosthesis
• CPC Class Codes: A61B 17/155 Cutting femur
• CPC Class Codes: A61B 17/157 Cutting tibia
• CPC Class Codes: A61B 17/1668 for the upper femur A61B17/164 takes precedence
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/171 for external fixation
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• 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 2034/104 Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2090/3762 using computed tomography systems [CT]
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61F 2/30 Joints
• CPC Class Codes: B29C 64/386 : Data acquisition or data processing for additive manufacturing
• CPC Class Codes: B29C 64/393 : for controlling or regulating additive manufacturing processes
• CPC Class Codes: B33Y 50/00 : Data acquisition or data processing for additive manufacturing
• CPC Class Codes: B33Y 50/02 : for controlling or regulating additive manufacturing processes
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: G05B 19/4099 : Surface or curve machining, making 3D objects, e.g. desktop manufacturing
• CPC Class Codes: G05B 2219/35134 : 3-D cad-cam
• CPC Class Codes: G06F 30/20 : Design optimisation, verification or simulation optimisation, verification or simulation of circuit designs G06F30/30
• 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 method and system for performing a total joint arthroplasty procedure on a patient'"'"'s damaged bone region. A CT image or other suitable image is formed of the damaged bone surfaces, and location coordinate values (x_n,y_n,z_n) are determined for a selected sequence of bone surface locations using the CT image data. A mathematical model z=f(x,y) of a surface that accurately matches the bone surface coordinates at the selected bone spice locations, or matches surface normal vector components at selected bone surface locations, is determined. The model provides a production file from which a cutting jig and an implant device (optional), each patient-specific and having controllable alignment, are fabricated for the damaged bone by automated processing. At this point, the patient is cut open (once), the cutting jig and a cutting instrument are used to remove a selected portion of the bone and to provide an exposed planar surface, the implant device is optionally secured to and aligned with the remainder of the bone, and the patient'"'"'s incision is promptly repaired.

Claims

1. A device for assisting in performing arthroplasty on a femur leg bone having a non-resected bone surface and a femoral mechanical axis, the device comprising:

a first component comprising a mating region configured to matingly receive at least the non-resected bone surface in a single relative position, the mating region comprising a contacting surface that is an identical negative shape of the non-resected bone surface, wherein, when the mating region matingly receives the non-resected bone surface in the single relative position, the contacting surface makes surface contact with the non-resected bone surface; and

a second component configured to mate with the first component to form a cutting instrument guide between the first component and the second component, the cutting instrument guide including at least one guide cutting planar surface that is generally perpendicular to the femoral mechanical axis when the non-resected bone surface is matingly received by the mating region.

8. The device as in any of claim 1, 5 or 6, wherein the non-resected bone surface includes at least a portion of the femur distal end.

9. The device as in any of claim 1, 5 or 6, in which at least a portion of the device is manufactured via at least one of CNC or SLA.

10. The device as in claim 1, 5 or 6, wherein the first component further comprises a jig body comprising the mating region.

11. The device of claim 10, wherein the at least one guide cutting planar surface is defined on the jig body.

12. The device of claim 10, the at least one guide cutting planar surface defined on the second component.

13. The device as in any of claim 1, 5 or 6, in which the cutting instrument guide includes a saw slot.

2. A device for assisting in performing an arthroplasty on a femur leg bone having a non-resected bone surface and a femoral mechanical axis defined by a straight line connecting the center of a femoral head of the femur and the center of a distal end of the femur opposite the femoral head, the non-resected bone surface located at the distal end of the femur, the device comprising:

a mating surface configured to engage the non-resected bone surface in a matching manner on account of a patient-specific nature of the mating surface, the matching manner registering a single relative position of the mating surface relative to the non-resected bone surface, the patient specific nature of the mating surface having been generated in the device prior to the device being brought into contact with the bone surface or employed in the arthroplasty; and

a cutting instrument guide including at least one planar guide surface that is generally perpendicular to the femoral mechanical axis when the non-resected bone surface is engaged by the mating surface in the matching manner.

15. The device as in any of claim 2, 3, 4 or 7, wherein the device is a femoral arthroplasty jig.

16. The device as in any of claim 2, 3, or 4, further comprising a jig body, and the mating surface is defined in the jig body.

17. The device of claim 16, wherein the at least one planar guide surface is located on the jig body.

18. The device of claim 16, further comprising a member separate from and supported off of the jig body, the at least one planar guide surface located on the member.

19. The device as in any of claim 2, 3, 4 or 7, wherein the cutting instrument guide includes a saw slot.

3. A device for assisting in performing an arthroplasty on a femur leg bone having a non-resected bone surface and a femoral mechanical axis defined by a straight line connecting the center of a femoral head of the femur and the center of a distal end of the femur opposite the femoral head, the non-resected bone surface located at the distal end of the femur, the device comprising:

a mating surface including a custom fit relationship with the non-resected bone surface, the custom fit relationship registering a single relative position of the mating surface relative to the non-resected bone surface, the custom fit relationship of the mating surface having been generated in the device prior to the device being brought into contact with the non-resected bone surface or employed in the arthroplasty; and

a cutting instrument guide including at least one planar guide surface that is generally perpendicular to the femoral mechanical axis when the mating surface custom fits with the non-resected bone surface.

4. A device for assisting in performing an arthroplasty on a femur leg bone having a non-resected bone surface and a femoral mechanical axis defined by a straight line connecting the center of a femoral head of the femur and the center of a distal end of the femur opposite the femoral head, the non-resected bone surface located at the distal end of the femur, the device comprising:

a mating surface preoperatively planned from image data taken of the non-resected bone surface to match fit with the non-resected bone surface in a single relative position and preoperatively generated to match fit with the non-resected bone surface in the single relative position; and

a cutting instrument guide including at least one planar guide surface that is generally perpendicular to the femoral mechanical axis when the mating surface match fits with the non-resected bone surface.

14. The device of claim 4, wherein the image data includes CT data.

5. A device for assisting in performing arthroplasty on a femur leg bone having a non-resected bone surface and a femoral mechanical axis, the device comprising:

a first component comprising a mating region configured to matingly receive at least the non-resected bone surface in a single relative position, the mating region comprising a contacting surface including surface profiles matching surface profiles of the non-resected bone surface, wherein, when the mating region matingly receives the non-resected bone surface in the single relative position, the contacting surface makes surface contact with the non-resected bone surface; and

a second component configured to mate with the first component to form a cutting instrument guide between the first component and the second component, the cutting instrument guide including at least one guide cutting planar surface that is generally perpendicular to the femoral mechanical axis when the non-resected bone surface is matingly received by the mating region.

6. A device for assisting in performing arthroplasty on a femur leg bone having a non-resected bone surface and a femoral mechanical axis, the device comprising:

a first component comprising a mating region configured to matingly receive at least the non-resected bone surface in a single relative position, the mating region comprising a contacting surface configured to interdigitate with the non-resected bone surface in the single relative position when the mating region matingly receives the non-resected bone surface; and

a second component configured to mate with the first component to form a cutting instrument guide between the first component and the second component, the cutting instrument guide including at least one guide cutting planar surface that is generally perpendicular to the femoral mechanical axis when the non-resected bone surface is matingly received by the mating region.

7. A device for assisting in performing an arthroplasty on a femur leg bone having a non-resected bone surface and a femoral mechanical axis defined by a straight line connecting the center of a femoral head of the femur and the center of a distal end of the femur opposite the femoral head, the non-resected bone surface including surface profiles, the device comprising:

a mating region configured to matingly receive at least the non-resected bone surface in a single relative position, the mating region comprising a contacting surface including surface profiles matching the surface profiles of the non-resected bone surface, wherein, when the mating region matingly receives the non-resected bone surface in the single relative position, the contacting surface makes surface contact with the non-resected bone surface; and

a cutting instrument guide including at least one planar guide surface that is generally perpendicular to the femoral mechanical axis when the contacting surface makes surface contact with the non-resected bone surface when the mating region matingly receives the non-resected bone surface.

20. The device of claim 7, further comprising a jig body, and the mating region is defined in the jig body.