Surgical tools for arthroplasty

• US 8,062,302 B2
• Filed: 06/09/2008
• Issued: 11/22/2011
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Lang, Philipp, Steines, Daniel, Bojarski, Ray, Vargas-Voracek, Rene, Fitz, Wolfgang, Burdulis, Albert G.
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US12/135,719
• Publication Number:
  US 20080281328A1
• Time in Patent Office: 1,261 Days
• Field of Search: 606/86.R, 606/87, 606/88, 606/90, 606/96, 606/102, 606/84, 623/20.14
• 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

Disclosed herein are methods, compositions and tools for repairing articular surfaces repair materials and for repairing an articular surface. The articular surface repairs are customizable or highly selectable by patient and geared toward providing optimal fit and function. 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 patient-specific surgical tool for use in surgically repairing a joint of a patient, comprising:

a block having a patient-specific surface and first and second drilling holes;

the patient-specific surface having at least a portion that is substantially a negative of a corresponding portion of a diseased or damaged articular surface of the joint and having a predetermined position and orientation relative to the corresponding portion;

the first and second drilling holes having predetermined positions and orientations relative to the patient-specific surface and each having an axis that extends through a portion of the joint when the patient-specific surface is fit to the corresponding portion of the diseased of damaged articular surface of the joint.

2. The patient-specific surgical tool of claim 1, wherein the tool is comprised of multiple components.

3. The patient-specific surgical tool of claim 1, wherein the block containing the patient-specific surface and the drilling holes are comprised of a single component.

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

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

6. The patient-specific surgical tool of claim 5, wherein the patient-specific surface is made of a polymer.

7. The patient-specific surgical tool of claim 1, wherein the surface of the joint is a femoral surface of a knee of the patient and the drilling holes are configured to define a path through a femoral surface when the patient-specific surface is engaged and aligned with the corresponding portion of the diseased or damaged articular surface of the joint.

8. The patient-specific surgical tool of claim 7, wherein the 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 portion of the diseased or damaged articular surface of the joint.

9. The patient-specific surgical tool of claim 7, wherein the 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 portion of the diseased or damaged articular surface of the joint.

10. The patient-specific surgical tool of claim 7, wherein the 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 portion of the diseased or damaged articular surface of the joint.

11. The patient-specific surgical tool of claim 7, wherein the path is configured to extend through a portion of two femoral condyles when the patient-specific surface is engaged and aligned with the corresponding portion of the diseased or damaged articular surface of the joint.

12. The patient-specific surgical tool of claim 1, wherein the surface of the joint is a femoral surface of a knee of the patient and the drilling holes define a path through a proximal portion of the femoral surface.

13. The patient-specific surgical tool of claim 1, wherein the surface of the joint is a tibial surface of a tibia of the patient the drilling holes define a path through a tibial plateau of the tibia.

14. The patient-specific surgical tool of claim 13, wherein the path has a predetermined cutting slope relative to the tibial plateau.

15. The patient-specific surgical tool of claim 14, wherein the slope is between 0 and 7 degrees.

16. The patient-specific surgical tool of claim 14, wherein the slope substantially matches the normal slope of the tibial plateau.

17. The patient-specific surgical tool of claim 13, wherein the path is substantially parallel to the tibial plateau.

18. The patient-specific surgical tool of claim 13, wherein the path is at a predetermined orientation relative to a mechanical axis of the joint.

19. The patient-specific surgical tool of claim 13, wherein the path is at a predetermined distance relative to a cartilage surface of the tibial plateau.

20. The patient-specific surgical tool of claim 1, wherein the joint is a knee joint and further comprising a spacer selected to fit in a space between a femoral surface and a tibial surface of the knee and to balance ligaments associated with the knee.

21. The patient-specific surgical tool of claim 13, wherein the spacer is not connected to the block.

22. The patient-specific surgical tool of claim 13, wherein the spacer is connected to the block.

23. The patient-specific surgical tool of claim 22, further comprising an attachment mechanism allowing the spacer to be connected to the block.

24. The patient-specific surgical tool of claim 1, wherein the joint is a knee joint and further comprising an adjustment mechanism to balance ligaments associated with the knee.

25. The patient-specific surgical tool of claim 24, wherein the adjustment mechanism is not connected to the block.

26. The patient-specific surgical tool of claim 24, wherein the adjustment mechanism is connected to the block.

27. The patient-specific surgical tool of claim 26, further comprising an attachment mechanism allowing the adjustment mechanism to be connected to the block.

28. The patient-specific surgical tool of claim 1, further comprising a plurality of guide apertures.

29. The patient-specific surgical tool of claim 28, wherein a first guide aperture is configured at an angle to a second guide aperture of the plurality of guide apertures.

30. The patient-specific surgical tool of claim 1, further comprising at least one stabilizer oriented to engage the joint surface.

31. The patient-specific surgical tool of claim 30, wherein the stabilizer is selected from the group consisting of pin, peg, post, and nub.

32. The patient-specific surgical tool of claim 1, wherein the tool is configured to resist movement when the patient-specific surface is placed against the corresponding portion of the diseased or damaged articular surface.

33. The patient-specific surgical tool of claim 1, wherein the when tool is configured to resist rotation in at least one axis when the patient-specific surface is placed against the corresponding portion of the diseased or damaged articular surface.

34. The patient-specific surgical tool of claim 1, wherein the joint is one of a hip, knee, ankle, shoulder, elbow and wrist joint.

35. The patient-specific surgical tool 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 the corresponding portion of the diseased or damaged articular surface.

36. The patient-specific surgical tool 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 the corresponding portion of the diseased or damaged articular surface.

37. The patient-specific surgical tool of claim 1, wherein the corresponding portion of the diseased or damaged articular surface of the joint includes portions of at least one of a medial condyle and a lateral condyle.

38. The patient-specific surgical tool of claim 1, wherein the corresponding portion of the diseased or damaged surface of the joint includes portions of at least one of a medial tibial plateau and a lateral tibial plateau.

39. The patient-specific surgical tool of claim 1, wherein each of the drilling holes includes a stop to control the depth of the cutting tool.

40. The patient-specific surgical tool of claim 39, wherein the stop is a drill stop.

41. The patient-specific surgical tool of claim 39, wherein the stop is a blade stop.

42. The patient-specific surgical tool of claim 1, wherein each of the drilling holes includes a metal insert.

43. The patient-specific surgical tool of claim 1, wherein the metal insert is a bushing.

44. The patient-specific surgical tool of claim 1, further comprising an adjustment mechanism for adjusting the position of each of the drilling holes relative to the joint.

45. The patient-specific surgical tool of claim 44, 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.

46. The tool of claim 45, wherein said adjustment mechanism includes adjustment means for optimizing balance of the joint.

47. The patient-specific surgical tool of claim 1, wherein the corresponding portion of the diseased or damaged surface of the joint is a portion of a cartilage surface of the joint.

48. A patient-specific surgical tool for use in surgically repairing a joint of a patient, comprising:

a block having a patient-specific surface and two or more cutting slots;

the patient-specific surface having at least a portion that is substantially a negative of a corresponding portion of a diseased or damaged cartilage surface of the joint and having a predetermined position and orientation relative to the corresponding portion;

the two or more cutting slots having predetermined positions and orientations relative to the patient-specific surface and each having a cutting path that extends through a portion of the joint when the patient-specific surface is referenced to the corresponding portion of the diseased or damaged cartilage surface of the joint.

49. The patient-specific surgical tool of claim 48, wherein the tool is comprised of multiple components.

50. The patient-specific surgical tool of claim 48, wherein the tool is comprised of a single component.

51. The patient-specific surgical tool of claim 48, wherein the block containing the patient-specific surface and the cutting slots is comprised of a single component.

52. The patient-specific surgical tool of claim 48, wherein the block includes a plurality of pins that define the patient-specific surface.

53. The patient-specific surgical tool of claim 48, wherein the patient-specific surface is a continuous surface.

54. The patient-specific surgical tool of claim 53, wherein the patient-specific surface is made of a polymer.

55. The patient-specific surgical tool of claim 48, wherein the surface of the joint is a femoral surface of a knee of the patient and each of the cutting slots is configured to define a cutting path through a femoral surface when the patient-specific surface is engaged and aligned with the corresponding portion of the diseased or damaged cartilage surface of the joint.

56. The patient-specific surgical tool of claim 55, 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 portion of the diseased or damaged cartilage surface of the joint.

57. The patient-specific surgical tool of claim 55, 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 portion of the diseased or damaged cartilage surface of the joint.

58. The patient-specific surgical tool of claim 55, 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 portion of the diseased or damaged cartilage surface of the joint.

59. The patient-specific surgical tool of claim 55, 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 portion of the diseased or damaged surface.

60. The patient-specific surgical tool of claim 48, wherein the diseased or damaged surface of the joint is a femoral surface of a knee of the patient and each of the cutting slots defines a cutting path through a proximal portion of the femoral surface.

61. The patient-specific surgical tool of claim 48, wherein the diseased or damaged surface of the joint is a tibial surface of a tibia of the patient and the each of the cutting slots defines a cutting path through a tibial plateau of the tibia.

62. The patient-specific surgical tool of claim 61, wherein at least one of the cutting paths has a predetermined slope relative to the tibial plateau.

63. The patient-specific surgical tool of claim 62, wherein the slope is between 0 and 7 degrees.

64. The patient-specific surgical tool of claim 62, wherein the slope substantially matches the normal slope of the tibial plateau.

65. The patient-specific surgical tool of claim 61, wherein the cutting path is substantially parallel to the tibial plateau.

66. The patient-specific surgical tool of claim 61, wherein the cutting path is at a predetermined orientation relative to a mechanical axis of the tibia.

67. The patient-specific surgical tool of claim 61, wherein the cutting path is at a predetermined distance relative to a cartilage surface of the tibial plateau.

68. The patient-specific surgical tool of claim 48, wherein the joint is a knee joint, 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.

69. The patient-specific surgical tool of claim 68, wherein the spacer is not connected to the block.

70. The patient-specific surgical tool of claim 68, wherein the spacer is connected to the block.

71. The patient-specific surgical tool of claim 70, further comprising an attachment mechanism allowing the spacer to be connected to the block.

72. The patient-specific surgical tool of claim 48, wherein the joint is a knee joint, and further comprising an adjustment mechanism to balance ligaments associated with the knee.

73. The patient-specific surgical tool of claim 72, wherein the adjustment mechanism is not connected to the block.

74. The patient-specific surgical tool of claim 72, wherein the adjustment mechanism is connected to the block.

75. The patient-specific surgical tool of claim 74, further comprising an attachment mechanism allowing the adjustment mechanism to be connected to the block.

76. The patient-specific surgical tool of claim 48, further comprising a plurality of guide apertures.

77. The patient-specific surgical tool of claim 76, wherein a first guide aperture is configured at an angle to a second guide aperture of the plurality of guide apertures.

78. The patient-specific surgical tool of claim 48, further comprising at least one stabilizer oriented to engage the joint surface.

79. The patient-specific surgical tool of claim 78, wherein the stabilizer is selected from the group consisting of pin, peg, post, and nub.

80. The patient-specific surgical tool of claim 48, wherein the tool is configured to resist movement when the patient-specific surface is placed against the corresponding portion of the diseased or damaged cartilage surface.

81. The patient-specific surgical tool of claim 48, wherein the tool is configured to resist rotation in at least one axis when the patient-specific surface is placed against the corresponding diseased or damaged cartilage surface.

82. The patient-specific surgical tool of claim 48, wherein the joint is one of a hip, knee, ankle, shoulder, elbow and wrist joint.

83. The patient-specific surgical tool of claim 48, wherein the tool is configured to be oriented along a mechanical axis of the joint when the patient-specific surface is placed against the corresponding portion of the diseased or damaged cartilage surface.

84. The patient-specific surgical tool of claim 48, wherein the tool is configured to be oriented along an anatomical axis of the joint when the patient-specific surface is placed against the corresponding portion of the diseased or damaged cartilage surface.

85. The patient-specific surgical tool of claim 48, wherein the diseased or damaged cartilage surface of the joint includes portions of at least one of a medial condyle and a lateral condyle.

86. The patient-specific surgical tool of claim 48, wherein the diseased or damaged cartilage surface of the joint includes portions of at least one of a medial tibial plateau and a lateral tibial plateau.

87. The patient-specific surgical tool of claim 48, wherein each of the cutting slots includes a stop to control the depth of the cutting tool.

88. The patient-specific surgical tool of claim 87, wherein the stop is a saw stop.

89. The patient-specific surgical tool of claim 87, wherein the stop is a blade stop.

90. The patient-specific surgical tool of claim 48, wherein each of the cutting slots includes a metal cover.

91. The patient-specific surgical tool of claim 48, wherein the metal insert is a bushing.

92. The patient-specific surgical tool of claim 48, further comprising an adjustment mechanism for adjusting the position of each of the cutting slots relative to the joint.

93. The patient-specific surgical tool of claim 92, 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.

94. The patient-specific surgical tool of claim 93, wherein said adjustment mechanism includes adjustment means for optimizing balance of the joint.

95. A patient-specific surgical tool for use in surgically repairing a joint of a patient, comprising:

a block having a patient-specific surface and first and second guides;

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

the first and second guides having predetermined positions and orientations relative to the patient-specific surface and being oriented to provide two predetermined drilling or cutting paths that are aligned relative to a biomechanical or anatomical axis of the joint and through a portion of the joint when the patient-specific surface is placed against the corresponding diseased or damaged cartilage surface of the joint.

96. The patient-specific surgical tool of claim 95, wherein the first and second guides are holes.

97. The patient-specific surgical tool of claim 95, wherein the first and second guides are slots.

98. The patient-specific surgical tool of claim 95, wherein the first and second guides are aligned along distinct cutting planes when the patient-specific surface is fit to the corresponding portion of the diseased or damaged cartilage surface of the joint.

99. The patient-specific surgical tool of claim 98, wherein the first and second guides are co-planar.

100. The patient-specific surgical tool of claim 98, wherein the first and second guides are not co-planar.

101. The patient-specific surgical tool of claim 98, wherein the first and second guides are oriented at an angle of substantially 90 degrees relative to each other.

102. The patient-specific surgical tool of claim 98, wherein the first and second guides are oriented at an angle different than zero and different than 90 degrees relative to each other.

103. The patient-specific surgical tool of claim 102, further comprising a third guide aligned along a third distinct cutting plane.

104. The patient-specific surgical tool of claim 102, further comprising a fourth guide aligned along a fourth distinct cutting plane.

105. The patient-specific surgical tool of claim 102, wherein the first guide is oriented through a portion of a first femoral condyle of the joint, and the second aperture is oriented through a portion of a second femoral condyle of the joint when the patient-specific surface is fit to the corresponding portion of the diseased or damaged cartilage surface of the joint.

106. The patient-specific surgical tool of claim 102, wherein the first guide extends across first and second condyles of the joint when the patient-specific surface is engaged against the corresponding portion of the diseased or damaged cartilage surface of the joint.

107. The patient-specific surgical tool of claim 98, further comprising a third guide.

108. The patient-specific surgical tool of claim 98, wherein the third guide is a slot aligned along a second plane to provide a second cutting path that is aligned through a portion of the joint when the patient-specific surface is placed against the corresponding portion of the diseased or damaged cartilage surface of the joint.

109. A patient-specific surgical tool for use in surgically repairing a joint of a patient, comprising:

a block having a patient-specific surface and two or more slots;

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

the two or more slots having predetermined positions and orientations relative to the patient-specific surface and each being located along a plane to provide a predetermined cutting path for a cutting tool that is aligned through a portion of the joint when the patient-specific surface is placed against the corresponding portion of the diseased or damaged surface of the joint.

110. A patient-specific surgical tool for use in surgically repairing a joint of a patient, comprising:

a block having a patient-specific surface and multiple guides;

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

a first set of guides oriented relative to the patient-specific surface and being located along corresponding axes and defining one or more predetermined paths for a cutting tool that is aligned through a portion of the joint when the patient-specific surface is placed against the corresponding portion of the diseased or damaged surface of the joint; and

a second set of guide guides oriented relative to the patient-specific surface and being located along corresponding axes and defining one or more predetermined paths for a cutting tool that is aligned through a portion of the joint when the patient-specific surface is placed against the corresponding portion of the diseased or damaged surface of the joint.

111. The patient-specific surgical tool of claim 110, wherein the first set of guides are drilling holes.

112. The patient-specific surgical tool of claim 110, wherein the second set of guides are cutting slots sized to accommodate a surgical saw.

113. The patient-specific surgical tool of claim 110, wherein the first set of guides includes only one guide.

114. The patient-specific surgical tool of claim 110, wherein the first set of guides includes more than guide.

115. The patient-specific surgical tool of claim 110, wherein the second set of guides includes only one guide.

116. The patient-specific surgical tool of claim 110, wherein the second set of guides includes more than one guide.

117. A patient-specific surgical tool for use in surgically repairing a joint of a patient, comprising:

a block having a patient-specific surface and first and second sets of guides;

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

a first set of guides oriented relative to the patient-specific surface and being located along a first plane to define a predetermined cutting path for a cutting tool that is aligned through a portion of a bone of the joint when the patient-specific surface is placed against the corresponding portion of the diseased or damaged surface of the joint; and

a second set of guides oriented relative to the patient-specific surface and being located along a second plane to define a predetermined cutting path for a cutting tool that is aligned through a portion of a bone of the joint when the patient-specific surface is placed against the corresponding portion of the diseased or damaged of the joint.

118. The patient-specific surgical tool of claim 117, wherein the first set includes only one guide.

119. The patient-specific surgical tool of claim 117, wherein the first set includes more than one guide.

120. The patient-specific surgical tool of claim 119, wherein the second set includes only one guide.

121. The patient-specific surgical tool of claim 119, wherein the second set includes more than one guide.

122. The patient-specific surgical tool of claim 117, wherein the first and second set of guides are co-planar.

123. The patient-specific surgical tool of claim 117, wherein the first and second set of guides are not co-planar.

124. The patient-specific surgical tool of claim 117, wherein the first and second set of guides are oriented at an angle of substantially 90 degrees relative to each other.

125. The patient-specific surgical tool of claims 117, wherein the first and second set of guide slots are oriented at an angle different than zero and different than 90 degrees relative to each other.