Patient selectable joint arthroplasty devices and surgical tools

• US 7,981,158 B2
• Filed: 06/09/2008
• Issued: 07/19/2011
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Steines, Daniel, Lang, Philipp, Bojarski, Raymond A., Fitz, Wolfgang
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US12/135,603
• Publication Number:
  US 20080281426A1
• Time in Patent Office: 1,135 Days
• Field of Search: 606/86.R, 606/88, 606/87, 606/96, 623/17.16, 623/14.12, 623/11.11, 623/21.11, 600/407, 600/410, 703/11, 128/898
• US Class Current: 623/17.16
• 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 17/158 Cutting patella
• CPC Class Codes: A61B 17/1666 for the acetabulum
• 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 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1746 for the acetabulum
• CPC Class Codes: A61B 17/1767 for the patella
• 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 2034/105 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 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2090/063 for measuring volume
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4514 : Cartilage
• CPC Class Codes: A61B 5/4523 : Tendons
• CPC Class Codes: A61B 5/4528 : Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4533 : Ligaments
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/30756 : Cartilage endoprostheses A61F2/3603 takes precedence
• 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 2/38 : for elbows or knees
• CPC Class Codes: A61F 2/3877 : Patellae or trochleae
• CPC Class Codes: A61F 2002/3895 : unicompartimental
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing

Abstract

A patellar 3-D guidance tool includes a template. The template includes at least one contact surface for engaging a surface of the patella. The at least one contact surface substantially conforms with the surface associated with the patellar. At least one guide aperture directs movement of a surgical instrument, wherein the shape and/or position of the guide aperture is based, at least in part, on three or more anatomic reference points associated with the patellar.

Claims

1. A method of generating a patient-matched surgical tool, the method comprising:

obtaining first image data associated with at least a portion of a joint of a patient;

obtaining second image data associated with at least a portion of the joint;

deriving an electronic model of at least a portion of the joint using at least the first image data;

creating a surgical tool using, at least in part, the electronic model;

wherein the tool includes a contact surface substantially matched to a corresponding surface of the joint and a guide for directing movement of a surgical instrument; and

wherein the position or orientation of the guide relative to contact surface is adapted at least in part based on information derived from the second image data.

2. The method of claim 1, wherein the first image data is image data from the group of CT image data and MRI image data.

3. The method of claim 1, wherein the second image data is x-ray image data.

4. The method of claim 1, wherein the first image data is information from a MRI scan and the second image data is information from an x-ray.

5. The method of claim 1, wherein the first image data is digital data.

6. The method of claim 1, wherein the first image data is digital data and the second image data is digital data.

7. The method of claim 1, wherein the first image data is information from a CT scan and the second image data is information from an x-ray.

8. The method of claim 1, wherein the second image data is x-ray image data obtained from a standing or weight-bearing x-ray.

9. The method of claim 8, wherein said standing or weight-bearing x-ray includes the hip and ankle joint.

10. The method of claim 1, wherein the second image data is image data obtained with the joint in a weight-bearing position.

11. The method of claim 1, wherein the electronic model is derived using at least the first and second image data.

12. The method of claim 1, wherein the guide is aligned based at least in part on the electronic model.

13. The method of claim 1, further comprising determining a position of an implant.

14. The method of claim 1, wherein the guide is aligned based at least in part on the determined position of the implant.

15. The method of claim 1, further comprising determining a position of an implant based at least in part on an epicondylar axis of the joint and wherein the guide is aligned based at least in part on the determined position of the implant.

16. The method of claim 1, further comprising determining a position of an implant based at least in part on an anteroposterior axis of the joint and wherein the guide is aligned based at least in part on the determined position of the implant.

17. The method of claim 1, further comprising determining a position of an implant based at least in part on a posterior condylar axis and wherein the guide is aligned based at least in part on the determined rotational position of the implant.

18. The method of claim 1, further comprising determining a rotational position of an implant and wherein the guide is aligned based at least in part on the determined rotational position of the implant.

19. The method of claim 1, further comprising determining a size of an implant.

20. The method of claim 19, wherein the guide is aligned based at least in part on the determined size of the implant.

21. The method of claim 1, further comprising determining a dimension of an implant.

22. The method of claim 21, wherein the guide is aligned based at least in part on the determined dimension of the implant.

23. The method of claim 1, further comprising determining a mechanical axis of the joint from the second image data.

24. The method of claim 23, wherein the second image data is image data from an x-ray.

25. The method of claim 1, further comprising determining an anatomical axis of the joint from the second image data.

26. The method of claim 25, wherein the second image data is image data from an x-ray.

27. The method of claim 1, wherein the guide is a cutting guide.

28. The method of claim 1, wherein the guide is a drilling guide.

29. The method of claim 1, wherein the guide has a linkage for attaching a separate component.

30. The method of claim 1, wherein the guide is a slot.

31. The method of claim 1, wherein the guide is a circular hole.

32. The method of claim 1, wherein the guide is a connector having an orientation to provide a predetermined alignment of a separate cutting or drilling guide when connected to the connector.

33. The method of claim 1, further comprising incorporating information regarding a surgical plan and wherein the surgical tool is created based at least in part on the information.

34. The method of claim 1, wherein the contact surface and the guide are located on a single body.

35. The method of claim 1, wherein the contact surface is located on a first component of the tool and the guide is located on a second component of the tool.

36. The method of claim 1, wherein the surgical tool includes a linkage to connect the surgical tool to an additional component.

37. The method of claim 1, wherein the surgical tool includes multiple components.

38. A method of making a patient-matched surgical tool, the method comprising:

obtaining first image data associated with at least a portion of a joint of a patient;

obtaining x-ray image data associated with at least a portion of the joint;

determining from the x-ray image data at least one of an anatomical and mechanical axis associated with the joint;

creating a surgical tool based at least in part on the first image data and the x-ray image data;

wherein the surgical tool includes a contact surface substantially matched to a corresponding surface of the joint and a guide for directing movement of a surgical instrument, the guide having a predetermined orientation based at least in part on the determined axis.

39. The method of claim 38, wherein the first image data is image data from the group of CT and MRI image data.

40. The method of claim 39, wherein the first image data is digital data.

41. The method of claim 38, wherein the first image data is digital data and the second image data is digital data.

42. The method of claim 38, wherein the x-ray image data obtained from a standing or weight-bearing x-ray.

43. The method of claim 42, wherein said standing or weight-bearing x-ray includes the hip and ankle joint.

44. The method of claim 38, wherein the x-ray image data is image data obtained with the joint in a weight-bearing position.

45. The method of claim 38, further comprising determining a position of an implant.

46. The method of claim 45, wherein the guide is aligned based at least in part on the determined position of the implant.

47. The method of claim 38, further comprising determining a position of an implant based at least in part on an epicondylar axis of the joint and wherein the guide is aligned based at least in part on the determined position of the implant.

48. The method of claim 38, further comprising determining a position of an implant based at least in part on an anteroposterior axis of the joint and wherein the guide is aligned based at least in part on the determined position of the implant.

49. The method of claim 38, further comprising determining a position of an implant based at least in part on a posterior condylar axis and wherein the guide is aligned based at least in part on the determined rotational position of the implant.

50. The method of claim 38, further comprising determining a rotational position of an implant and wherein the guide is aligned based at least in part on the determined rotational position of the implant.

51. The method of claim 38, further comprising determining a size of an implant.

52. The method of claim 51, wherein the guide is aligned based at least in part on the determined size of the implant.

53. The method of claim 38, further comprising determining a dimension of an implant.

54. The method of claim 53, wherein the guide is aligned based at least in part on the determined dimension of the implant.

55. The method of claim 38, wherein the guide is a cutting guide.

56. The method of claim 38, wherein the guide is a drilling guide.

57. The method of claim 38, wherein the guide is a linkage for attaching a separate component.

58. The method of claim 38, wherein the guide is a slot.

59. The method of claim 38, wherein the guide is a circular hole.

60. The method of claim 38, wherein the guide is a connector having an orientation to provide a predetermined alignment of a separate cutting or drilling guide when connected to the connector.

61. The method of claim 38, further comprising incorporating information regarding a surgical plan and wherein the surgical tool is created based at least in part on the information.

62. The method of claim 38, wherein the contact surface and the guide are located on a single body.

63. The method of claim 38, wherein the contact surface is located on a first component of the tool and the guide is located on a second component of the tool.

64. The method of claim 38, wherein the surgical tool includes a linkage to connect the surgical tool to an additional component.

65. The method of claim 38, wherein the surgical tool includes multiple components.

66. A method of creating a patient-specific instrument for implanting an orthopedic implant in or about a joint of a patient, the method comprising:

creating a patient-specific surgical instrument based at least in part on first and second image data sets,

wherein the first image data set is of a type that is different from the second image data set, and the second image data set is x-ray image data;

wherein the surgical instrument has a patient-specific surface that is derived from at least the first image data and that substantially matches a corresponding surface portion associated with the joint; and

wherein the surgical instrument has a guide that is oriented relative to the patient-specific surface based on information derived from the second image data set.

67. The method of claim 66, wherein the orientation of the guide is based at least in part on at least one of a mechanical axis and an anatomical axis.

68. The method of claim 66, wherein the at least one axis is derived at least in part from the second image data set.

69. A method of designing a patient-specific instrument for use in implanting an orthopedic implant in or about a joint of a patient, the method comprising:

designing a patient-specific surgical instrument based at least in part on first and second image data sets, wherein the first image data set is of a type that is different from the second image data set, and the second image data set is x-ray image data;

wherein the surgical instrument has a patient-specific surface that is derived from at least the first image data and that substantially matches a corresponding surface portion associated with the joint; and

wherein the surgical instrument has a guide that is oriented relative to the patient-specific surface based on information derived from the second image data set.

70. The method of claim 69, wherein the orientation of the guide is based at least in part on at least one of a mechanical axis and an anatomical axis.

71. The method of claim 69, wherein the at least one axis is derived at least in part from the second image data set.

72. A patient specific surgical instrument for use in implanting an orthopedic implant in a patient, the process comprising:

determining at least in part from a first set of image data the surface contours of at least a portion of a surface of or near a joint of the patient;

determining at least in part from a second set of image data an axis associated with the joint;

incorporating a patient-specific surface into the surgical instrument such that the patient-specific surface substantially matches the determined surface contours;

incorporating a guide into the surgical instrument, wherein the guide is oriented relative to the patient-specific surface based at least in part on the determined axis.

73. A method of using a patient-matched surgical instrument to implant an orthopedic implant, comprising:

placing a patient-specific surface of the implant against a corresponding surface portion of or near a joint of the patient such that the patient-specific surface is substantially entirely engaged against the corresponding surface portion of the patient;

cutting or drilling a portion of the tissue in or near the joint of the patient using a guide of or attached to the patient matched surgical instrument; and

implanting an implant in or near the joint;

wherein the guide has a predetermined alignment relative to the patient-specific surface derived at least in part from x-ray image data of at least a portion of the joint; and

wherein the patient-specific surface is derived from other image data of at least a portion of the joint.

74. The method of claim 73, further comprising linking a second surgical instrument to the patient-matched surgical instrument.

75. The method of claim 73, further comprising cutting or drill tissue of or near the joint using the second component.

76. The method of claim 73, further comprising pinning the surgical instrument to tissue of or near the joint.

77. The method of claim 73, further comprising attaching a second surgical instrument to tissue of the patient, wherein the attachment is based on at least one of a cut or drilled surface created during the step of cutting or drilling.

78. The method of claim 73, further comprising forming a series of cuts based at least in part on the cut or drilled surface created during the step of cutting or drilling.

79. The method of claim 73, further comprising aligning a second instrument based at least in part on the cut or drilled surface created during the step of cutting or drilling.

80. The method of claim 79, further comprising using the second instrument to cut or drill tissue of or near the joint of the patient.

81. A method of making a patient-matched surgical tool, the method comprising:

obtaining first image data associated with at least a portion of a joint of a patient;

obtaining x-ray image data associated with at least a portion of the joint;

determining from the x-ray image data information about a desired alignment or correction of the joint;

creating a surgical tool based at least in part on the first image data and the x-ray image data;

wherein the surgical tool includes a contact surface substantially matched to a corresponding articular surface of the joint and a guide for directing movement of a surgical instrument, the guide having a predetermined orientation based at least in part on the information about the desired alignment or correction of the joint.