Surgical tools for arthroplasty

• US 8,083,745 B2
• Filed: 03/14/2008
• Issued: 12/27/2011
• Est. Priority Date: 05/25/2001
• Status: Active Grant

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Lang, Philipp, Fitz, Wolfgang, Bojarski, Ray, Steines, Daniel, Burdulis, Albert G., Vargas-Voracek, Rene
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US12/048,764
• Publication Number:
  US 20080243127A1
• Time in Patent Office: 1,383 Days
• Field of Search: 606/88, 606/86.R, 606/87, 606/79, 606/82, 606/80, 606/90, 600/407, 600/425
• US Class Current: 606/87
• 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 surgical instrument for use in surgically repairing a diseased or damaged joint of a patient, comprising:

a cutting block having a patient-specific surface and a guide configured to accommodate a surgical tool for cutting or drilling tissue;

at least a portion of the patient-specific surface having a shape that is substantially a negative of a corresponding cartilage surface of the diseased or damaged joint; and

the guide having a position and orientation relative to the patient-specific surface to define a predetermined cutting path for the surgical tool that is aligned through a portion of tissue associated with the diseased or damaged joint when the patient specific surface is placed against and aligned with the corresponding cartilage surface; and

wherein the cutting block containing the patient-specific surface and the guide is a single component.

2. The surgical instrument of claim 1, wherein the surgical tool is a saw or a drill.

3. The surgical instrument of claim 1, further comprising an additional component attached to the cutting block.

4. The surgical instrument of claim 3, wherein the cutting block is made of a polymer and the additional component is a metal fitting.

5. The surgical instrument of claim 4, further comprising a surgical device for use with the cutting block and connectable to the cutting block by an attachment mechanism.

6. The surgical instrument of claim 1, wherein the instrument further includes an attachment mechanism to attach additional instrumentation components.

7. The surgical instrument of claim 6, wherein the additional instrumentation components include at least one additional guide for cutting or drilling.

8. The surgical instrument of claim 1, wherein the cutting block includes a plurality of pins that define the patient-specific surface.

9. The surgical instrument of claim 1, wherein the patient-specific surface is a continuous surface.

10. The surgical instrument of claim 9, wherein the patient-specific surface is made of a polymer.

11. The surgical instrument of claim 1, wherein the surface of the diseased or damaged joint is a femoral surface of a knee of the patient and the guide is configured to define a cutting path through a femoral surface when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

12. The surgical instrument of claim 11, wherein the cutting path is configured to extend through a distal portion of a femoral condyle when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

13. The surgical instrument of claim 11, wherein the cutting path is configured to extend through an anterior portion of a femoral condyle when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

14. The surgical instrument of claim 11, wherein the cutting path is configured to extend through a posterior portion of a femoral condyle when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

15. The surgical instrument of claim 11, wherein the cutting path is configured to extend through a portion of two femoral condyles when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

16. The surgical instrument of claim 1, wherein the surface of the diseased or damaged joint is a femoral surface of a knee of the patient and the guide defines a cutting path through a proximal portion of the femoral surface.

17. The surgical instrument of claim 1, wherein the surface of the diseased or damaged joint is a tibial surface of a tibia of the patient and the guide defines a cutting path through a tibial plateau of the tibia.

18. The surgical instrument of claim 17, wherein the cutting path has a predetermined sloped relative to the tibial plateau.

19. The surgical instrument of claim 18, wherein the slope is between 0 and 7 degrees.

20. The surgical instrument of claim 18, wherein the slope substantially matches the normal slope of the tibial plateau.

21. The surgical instrument of claim 17, wherein the cutting path is substantially parallel to the tibial plateau.

22. The surgical instrument of claim 17, wherein the cutting path is at a predetermined orientation relative to at least one of a mechanical axis and an anatomic axis of the tibia.

23. The surgical instrument of claim 17, wherein the cutting path is at a predetermined distance relative to a cartilage surface of the tibial plateau.

24. The surgical instrument of claim 1, wherein the diseased or damaged joint is a knee joint and further comprising a spacer sized to fit in a space between a femoral surface and a tibial surface of the knee and to balance ligaments associated with the knee.

25. The surgical instrument of claim 24, wherein the spacer is not connected to the cutting block.

26. The surgical instrument of claim 24, wherein the spacer is connected to the cutting block.

27. The surgical instrument of claim 24, further comprising an attachment mechanism allowing the spacer to be connected to the cutting block.

28. The surgical instrument of claim 1, wherein the diseased or damaged joint is a knee joint and further comprising an adjustment mechanism to balance ligaments associated with the knee.

29. The surgical instrument of claim 28, wherein the adjustment mechanism is not connected to the cutting block.

30. The surgical instrument of claim 28, wherein the adjustment mechanism is connected to the cutting block.

31. The surgical instrument of claim 28, further comprising an attachment mechanism allowing the adjustment mechanism to be connected to the cutting block.

32. The surgical instrument of claim 1, further comprising a plurality of guides.

33. The surgical instrument of claim 1, wherein the first guide aperture is configured at an angle to a second guide aperture of the plurality of guides.

34. The surgical instrument of claim 1, further comprising at least one stabilizer on the surface of the tool oriented to engage the joint surface when the patient-specific surface engages the corresponding cartilage surface.

35. The surgical instrument of claim 34, wherein the stabilizer is selected from the group consisting of pin, peg, post, and nub.

36. The surgical instrument of claim 1, wherein the surgical tool is configured to resist movement when the patient-specific surface is placed against the corresponding cartilage surface.

37. The surgical instrument of claim 1, wherein surgical tool is configured to resist rotation in at least one axis when the patient-specific surface is placed against the corresponding cartilage surface.

38. The surgical instrument of claim 1, wherein the joint is one of a hip, knee, ankle, shoulder, elbow and wrist joint.

39. The surgical instrument of claim 1, wherein the tool is configured to be oriented along a mechanical axis of the joint when the patient-specific surface is placed against and aligned with the corresponding cartilage surface.

40. The surgical instrument of claim 1, wherein the tool is configured to be oriented along an anatomical axis of the joint when the patient-specific surface is placed against and aligned with the corresponding cartilage surface.

41. The surgical instrument of claim 1, wherein the surface of the joint includes portions of at least one of a medial condyle and a lateral condyle.

42. The surgical instrument of claim 1, wherein the surface of the joint includes portions of at least one of a medial tibial plateau and a lateral tibial plateau.

43. The surgical instrument of claim 1, wherein the guide includes a stop to control the movement of the surgical tool.

44. The surgical instrument of claim 1, further comprising an attachment mechanism to secure the instrument to the joint surface.

45. The surgical instrument of claim 44, wherein the attachment mechanism includes a pin or screw extendable through the guide.

46. The surgical instrument of claim 1, further comprising a second guide, wherein the first guide is aligned through a first portion of the joint and the second guide is aligned through a second portion of the joint when the patient-specific surface is placed against and aligned with the corresponding cartilage surface.

47. The surgical tool of claim 46, wherein the first and second guides are sized to accommodate a surgical drill and define parallel drilling paths.

48. The surgical instrument of claim 1, further comprising an adjustment mechanism for adjusting the position of the guide relative to the joint.

49. The surgical instrument of claim 48, wherein the adjustment mechanism includes at least one of a tensiometer, a spacer, a shim, a hinge device, a jack device, and a ratchet device.

50. The surgical instrument of claim 49, wherein said adjustment mechanism includes adjustment means for optimizing balance of the joint.

51. The surgical instrument of claim 1, wherein the corresponding cartilage surface includes at least a portion of diseased or damaged cartilage surface of the diseased or damaged joint.

52. A patient-specific surgical instrument for use in surgically repairing a diseased or damaged joint of a patient, comprising:

a cutting block having a patient-specific alignment surface and a guide;

the patient-specific alignment surface having a first portion that is substantially a negative of a corresponding cartilage surface of the diseased or damaged joint and a second portion that is substantially a negative of a bone surface of the joint;

the guide being sized to accommodate a surgical cutting tool and having a position and orientation relative to the patient-specific alignment surface to provide a predetermined cutting path for the surgical tool that is aligned through a portion of bone associated with the joint when the patient-specific alignment surface is placed against and aligned with the corresponding cartilage surface.

53. The surgical instrument of claim 52, wherein the surgical tool is a saw or a drill.

54. The surgical instrument of claim 52, further comprising an additional component attached to the cutting block.

55. The surgical instrument of claim 54, wherein the cutting block is made of a polymer and the additional component is a metal fitting.

56. The surgical instrument of claim 55, further comprising a surgical device for use with the cutting block and connectable to the cutting block by an attachment mechanism.

57. The surgical instrument of claim 52, wherein the surgical instrument further comprises an attachment mechanism to connect additional instrumentation components.

58. The surgical instrument of claim 57, wherein the additional instrumentation components include at least one aperture for cutting or drilling.

59. The surgical instrument of claim 52, wherein the cutting block includes a plurality of pins that define the patient-specific surface.

60. The surgical instrument of claim 52, wherein the patient-specific surface is a continuous surface.

61. The surgical instrument of claim 60, wherein the patient-specific surface is made of a polymer.

62. The surgical instrument of claim 52, wherein the surface of the joint is a femoral surface of a knee of the patient and the guide is configured to define a cutting path through a femoral surface when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

63. The surgical instrument of claim 62, wherein the cutting path is configured to extend through a distal portion of a femoral condyle when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

64. The surgical instrument of claim 62, wherein the cutting path is configured to extend through an anterior portion of a femoral condyle when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

65. The surgical instrument of claim 62, wherein the cutting path is configured to extend through a posterior portion of a femoral condyle when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

66. The surgical instrument of claim 62, wherein the cutting path is configured to extend through a portion of two femoral condyles when the patient-specific surface is engaged and aligned with the corresponding femoral surface.

67. The surgical instrument of claim 52, wherein the surface of the joint is a femoral surface of a knee of the patient and the guide defines a cutting path through a proximal portion of the femoral surface.

68. The surgical instrument of claim 52, wherein the surface of the joint is a tibial surface of a tibia of the patient and the guide defines a cutting path through a tibial plateau of the tibia.

69. The surgical instrument of claim 68, wherein the cutting path has a predetermined sloped relative to the tibial plateau.

70. The surgical instrument of claim 69, wherein the slope is between 0 and 7 degrees.

71. The surgical instrument of claim 69, wherein the slope substantially matches the normal slope of the tibial plateau.

72. The surgical instrument of claim 68, wherein the cutting path is substantially parallel to the tibial plateau.

73. The surgical instrument of claim 68, wherein the cutting path is at a predetermined orientation relative to at least one of a mechanical axis and an anatomic axis of the tibia.

74. The surgical instrument of claim 68, wherein the cutting path is at a predetermined distance relative to a cartilage surface of the tibial plateau.

75. The surgical instrument of claim 52, wherein the joint is a knee joint and further comprising a spacer sized to fit in a space between a femoral surface and a tibial surface of the knee and to balance ligaments associated with the knee.

76. The surgical instrument of claim 75, wherein the spacer is not connected to the cutting block.

77. The surgical instrument of claim 75, wherein the spacer is connected to the cutting block.

78. The surgical instrument of claim 75, further comprising an attachment mechanism allowing the spacer to be connected to the cutting block.

79. The surgical instrument of claim 52, wherein the joint is a knee joint and further comprising an adjustment mechanism to balance ligaments associated with the knee.

80. The surgical instrument of claim 79, wherein the adjustment mechanism is not connected to the cutting block.

81. The surgical instrument of claim 79, wherein the adjustment mechanism is connected to the cutting block.

82. The surgical instrument of claim 79, further comprising an attachment mechanism allowing the adjustment mechanism to be connected to the cutting block.

83. The surgical instrument of claim 52, further comprising a plurality of guides.

84. The surgical instrument of claim 52, wherein the first guide is configured at an angle to a second guide of the plurality of guides.

85. The surgical instrument of claim 52, further comprising at least one stabilizer on the surface of the tool oriented to engage the joint surface when the patient-specific surface engages the corresponding cartilage surface.

86. The surgical instrument of claim 85, wherein the stabilizer is selected from the group consisting of pin, peg, post, and nub.

87. The surgical instrument of claim 52, wherein the surgical tool is configured to resist movement when the patient-specific surface is placed against the corresponding cartilage surface.

88. The surgical instrument of claim 52, wherein the surgical tool is configured to resist rotation in at least one axis when the patient-specific surface is placed against the corresponding cartilage surface.

89. The surgical instrument of claim 52, wherein the joint is one of a hip, knee, ankle, shoulder, elbow and wrist joint.

90. The surgical instrument of claim 52, wherein the tool is configured to be oriented along a mechanical axis of the joint when the patient-specific surface is placed against and aligned with the corresponding cartilage surface.

91. The surgical instrument of claim 52, wherein the tool is configured to be oriented along an anatomical axis of the joint when the patient-specific surface is placed against and aligned with the corresponding cartilage surface.

92. The surgical instrument of claim 52, wherein the surface of the joint includes portions of at least one of a medial condyle and a lateral condyle.

93. The surgical instrument of claim 52, wherein the surface of the joint includes portions of at least one of a medial tibial plateau and a lateral tibial plateau.

94. The surgical instrument of claim 52, wherein the guide includes a stop to control the depth of the surgical tool.

95. The surgical instrument of claim 94, wherein the stop is a drill stop.

96. The surgical instrument of claim 94, wherein the stop is a blade stop.

97. The surgical instrument of claim 52, wherein the guide includes a metal insert.

98. The surgical instrument of claim 52, wherein the metal insert is a bushing.

99. The surgical instrument of claim 52, further comprising an adjustment mechanism for adjusting the position of the guide relative to the joint.

100. The surgical instrument of claim 99, wherein the adjustment mechanism includes at least one of a tensiometer, a spacer, a shim, a hinge device, a jack device, and a ratchet device.

101. The surgical instrument of claim 100, wherein said adjustment mechanism includes adjustment means for optimizing balance of the joint.

102. The surgical instrument of claim 52, wherein the corresponding cartilage surface includes at least a portion of diseased or damaged cartilage surface of the diseased or damaged joint.

103. A patient-matched surgical instrument for single use in a patient, comprising:

a single body having a reference surface for placement against an articular surface of a diseased or damaged joint of the patient during surgery and a cutting slot for directing a surgical tool during surgery;

wherein the reference surface has at least a portion that is substantially a negative of an uncut articular surface of the diseased or damaged joint of the patient that includes subchondral bone; and

wherein the cutting slot has a predetermined position relative to the reference surface and is fixed at a predetermined orientation relative to at least one of an anatomical axis and a biomechanical axis associated with said diseased or damaged joint, and wherein the cutting slot is aligned along a predetermined plane and in a predetermined direction to provide a predetermined cutting plane through joint tissue of the patient when the reference surface is placed against and aligned with the articular surface.

104. A patient-specific jig for use in surgically repairing a joint of a patient, comprising:

a single body having a reference surface for placement against an articular surface of a diseased or damaged joint of the patient during surgery, a cutting slot configured to direct a surgical instrument during surgery and a guide configured to direct a surgical saw during surgery;

wherein the reference surface has at least a portion that is substantially a negative of an uncut articular surface of the patient that includes subchondral bone; and

wherein the guide has a predetermined position relative to the reference surface, and wherein the cutting slot is positioned at a predetermined location relative to the articular surface to provide a substantially planar cutting plane through a portion of the joint when the reference surface is placed against the articular surface.

105. A patient-matched surgical jig for use in surgically repairing a joint of a patient, comprising:

a cutting block having a patient-specific alignment surface and a guide;

the patient-specific alignment surface having a first portion that is substantially a negative of a corresponding cartilage surface of the diseased or damaged joint and a second portion that is substantially a negative of a bone surface of the diseased or damaged joint;

the guide being sized to accommodate a surgical tool and having a position and orientation relative to the patient-specific surface to provide a predetermined path for the surgical tool that is aligned through a portion of bone of the joint when the patient-specific alignment surface is placed against the corresponding cartilage surface; and

wherein the cutting block containing the patient-specific alignment surface and the guide is a single component.

106. The surgical jig of claim 105, wherein the bone surface of the diseased or damaged joint includes at least a portion of cortical bone surface.

107. The surgical jig of claim 105, wherein the bone surface of the diseased or damaged joint includes at least a portion of subchondral bone surface.