Surgical tools facilitating increased accuracy, speed and simplicity in performing joint arthroplasty

• US 8,366,771 B2
• Filed: 05/10/2010
• Issued: 02/05/2013
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Burdulis, Albert G. Jr., Fitz, Wolfgang, Vargas-Voracek, Rene, Lang, Philipp, Steines, Daniel, Tsougarakis, Konstantinos
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US12/776,701
• Publication Number:
  US 20100281678A1
• Time in Patent Office: 1,002 Days
• Field of Search: 623/14.12, 606/88, 606/80, 606/96, 606/102, 606/86.R, 600/587, 335/12, 295/92, 295/271, 295/57
• US Class Current: 623/14.12
• 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 17/1677 for the patella
• CPC Class Codes: A61B 17/1767 for the patella
• CPC Class Codes: A61B 2017/0023 disposable
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4514 Cartilage
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture
• CPC Class Codes: Y10T 29/4998 Combined manufacture including applying or shaping of fluent material
• CPC Class Codes: Y10T 29/49995 Shaping one-piece blank by removing material

Abstract

Disclosed herein are tools for repairing articular surfaces repair materials and for repairing an articular surface. The surgical tools are designed to be customizable or highly selectable by patient to increase the speed, accuracy and simplicity of performing total or partial arthroplasty.

Claims

1. A method of making a patient-specific surgical tool having at least one surface portion derived from image data of a joint of a patient, the method comprising:

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

obtaining additional information related to the joint of the patient, wherein the additional information includes information about surface shape and/or geometry, and/or cartilage thickness of at least a portion of the joint of the patient;

determining at least one of a mechanical and an anatomical axis associated with the joint;

generating a surgical tool based in part on the image data of the patient and the additional information, wherein the surgical tool includes at least one surface portion having a shape that substantially conforms to a corresponding surface portion of the joint of the patient, and includes a guide having a predetermined position relative to the surface portion such that the guide defines a predetermined cutting or drilling path relative to the mechanical axis when the surface portion is aligned with and placed against the corresponding surface portion of the joint, and wherein the predetermined cutting or drilling path defines at least in part a planned flexion, extension, abduction, adduction, internal rotation and external rotation angle of an orthopedic implant relative to the joint of the patient when the orthopedic implant is implanted in the joint.

2. The method of claim 1, wherein the additional information includes information derived from a separate imaging test.

3. The method of claim 2, wherein the separate imaging test is X-ray imaging.

4. The method of claim 1 and claim preceding, wherein the additional information includes cartilage thickness added to the shape that substantially conforms to the corresponding bone surface portion of the joint.

5. A method of making a patient-matched surgical tool for use in a surgical procedure on a knee joint of a patient, the method comprising:

obtaining image data associated with the knee joint of the patient, wherein the image data includes image data for the knee, hip and ankle of the patient;

determining from the 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 image data and the determined axis, 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; and

wherein said corresponding surface is, at least in part, a cartilage surface derived or estimated based on cartilage thickness, cartilage loss and/or residual cartilage.

6. The method of claim 5, wherein the image data is image data from the group of CT and MRI image data.

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

8. The method of claim 5, wherein the image data is image data of a full leg.

9. The method of claim 8, wherein the image data includes standing or weight-bearing image data.

10. The method of claim 9, wherein the guide is aligned based at least in part on the determined position of an implant.

11. The method of claim 5, 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.

12. The method of claim 5, 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.

13. The method of claim 5, 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.

14. The method of claim 5, 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.

15. The method of claim 5, further comprising determining a size of an implant.

16. The method of claim 15, wherein the guide is aligned based at least in part on the determined size of the implant.

17. The method of claim 5, further comprising determining a dimension of an implant to be implanted using at least in part the surgical tool.

18. The method of claim 17, wherein the guide is aligned based at least in part on the determined dimension of the implant.

19. The method of claim 5, wherein the guide is a cutting guide.

20. The method of claim 5, wherein the guide is a drilling guide.

21. The method of claim 5, wherein the guide is a linkage for attaching a separate component.

22. The method of claim 5, wherein the guide is a slot.

23. The method of claim 5, wherein the guide is a circular hole.

24. The method of claim 5, 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.

25. The method of claim 5, further comprising incorporating information regarding a surgical plan and wherein the surgical tool is created based at least in part on the information.

26. The method of claim 5, wherein the contact surface and the guide are located on a single body.

27. The method of claim 5, 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.

28. The method of claim 5, wherein the surgical tool includes a linkage to connect or reference the surgical tool to an additional component.

29. The method of claim 5, wherein the surgical tool includes multiple components.

30. The method of claim 5, further comprising determining a desired position of an implant.

31. The method of claim 5, wherein the surgical tool includes multiple guides.

32. The method of claim 31, wherein the surgical tool includes at least one drilling guide and one cutting guide.

33. The method of claim 5, wherein the surgical tool includes a second contact surface.

34. The method of claim 33, wherein said second contact surface is substantially matched to a corresponding cortical bone surface of the patient.

35. The method of claim 33 wherein said second contact surface is substantially matched to a corresponding subchondral bone surface of the patient.

36. The method of claim 5, wherein the cartilage thickness, cartilage loss and/or residual cartilage is derived from an x-ray image.

37. The method of claim 5, wherein an estimated shape of the residual cartilage is added to a corresponding bone surface of the knee joint of the patient.

38. The method of claim 5, further comprising determining a position of an implant based at least in part on an axis of the joint and wherein the guide is aligned based at least in part on the determined position of the implant.

39. A method of making a patient-matched surgical tool for use in a surgical procedure on a knee joint of a patient, the method comprising:

obtaining image data associated with the knee joint of the patient, wherein the image data includes a full length image of the leg of the patient;

determining from the 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 image data and the determined axis, wherein the surgical tool includes a contact surface substantially matched to a corresponding cartilage 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, wherein the corresponding cartilage surface is derived and/or estimated based on cartilage thickness, cartilage loss and/or residual cartilage.

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

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

42. The method of claim 39, wherein the image data is image data of a full leg.

43. The method of claim 42, wherein the image data includes standing or weight-bearing image data.

44. The method of claim 39, further comprising determining a desired position of an implant.

45. The method of claim 44, wherein the guide is aligned based at least in part on the determined position of the implant.

46. The method of claim 39, 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.

47. The method of claim 39, 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.

48. The method of claim 39, 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.

49. The method of claim 39, further comprising determining a position of an implant based at least in part on a epicondylar 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 39, 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 39, 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 39, further comprising determining a dimension of an implant to be implanted using at least in part the surgical tool.

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 39, wherein the guide is a cutting guide.

56. The method of claim 39, wherein the guide is a drilling guide.

57. The method of claim 39, wherein the guide is a linkage for attaching or referencing the surgical tool to a separate component.

58. The method of claim 39, wherein the guide is a slot.

59. The method of claim 39, wherein the guide is a circular hole.

60. The method of claim 39, 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 39, 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 39, wherein the contact surface and the guide are located on a single body.

63. The method of claim 39, 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 39, wherein the surgical tool includes a linkage to connect the surgical tool to an additional component.

65. The method of claim 39, wherein the surgical tool includes multiple components.

66. The method of claim 39, wherein the surgical tool includes multiple guides.

67. The method of claim 39, wherein the surgical tool includes at least one drilling guide and one cutting guide.

68. The method of claim 39, wherein the surgical tool includes a second contact surface.

69. The method of claim 68, wherein said second contact surface is substantially matched to a corresponding cortical bone surface of the patient.

70. The method of claim 68, wherein said second contact surface is substantially matched to a corresponding subchondral bone surface of the patient.

71. The method of claim 39, wherein the cartilage thickness, cartilage loss and/or residual cartilage is derived from an x-ray image.

72. The method of claim 39, wherein an estimated shape of the residual cartilage is added to a corresponding bone surface of the knee joint of the patient.

73. A method of making a patient-matched surgical tool for use in a surgical procedure on a knee joint in a leg of a patient, the method comprising:

determining at least one of a mechanical and anatomical axis of the leg of the patient from image data of a hip joint of the patient and image data of an ankle joint of the patient;

determining from image data of the knee joint at least one of a desired internal or external rotation of a knee implant for implantation in the joint;

creating a surgical tool based at least in part on the image data, wherein the surgical tool includes at least one surface portion that substantially conforms to a corresponding surface portion of the joint and a guide having a predetermined position relative to at least one surface portion that is based on both the determined axis and the desired rotation of the implant.