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

• US 7,534,263 B2
• Filed: 12/02/2004
• Issued: 05/19/2009
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Lang, Philipp, Steines, Daniel, Vargas-Voracek, Rene, Fitz, Wolfgang, Burdulis, Albert G. Jr., Tsougarakis, Konstantinos
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US11/002,573
• Publication Number:
  US 20050234461A1
• Time in Patent Office: 1,629 Days
• Field of Search: 606/86, 606/87, 606/88, 606/89, 606/82, 606/80, 606/96, 606/98, 623/14.12
• 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 surgical tool, the method comprising:

obtaining images data associated with at least a portion of a joint; and

deriving a substantially uncut cartilage surface associated with the joint from the image data; and

providing a surgical tool that includes a contact surface for engaging the substantially uncut cartilage surface associated with the joint, the surgical tool further including at least one guide for directing movement of a surgical instrument in preparing an implant site, wherein providing the surgical tool includes;

shaping the contact surface based on the derived cartilage surface such that the contact surface conforms to and is substantially a negative of the derived cartilage surface; and

determining position, shape and/or orientation of the at least one guide from the image data, so that changes induced on the implant site by the surgical instrument ensures a desired orientation of an implant.

2. The method according to claim 1, wherein providing the surgical tool includes providing a second component for engaging a first component, the first component including said contact surface.

3. The method according to claim 2, wherein said second component includes one or more of the at least one guide.

4. The method according to claim 2 , wherein the surgical tool further includes an adjustment mechanism for adjusting the position and/or the orientation of at least one guide on the first and/or second component relative to the contact surface to allow for ligament balancing.

5. The method according to claim 4, wherein the adjustment mechanism includes at least one of a spacer, a shim, a ratchet, a hinge, a tensiometer and a jack.

6. The method according to claim 2, wherein a surface of the first component that engages with a surface of the second component is configured to prevent at least one movement selected from the group consisting of axial, lateral and rotational.

7. The method according to claim 2 wherein a surface of the second component that engages the first component is at least one of convex or concave.

8. The method according to claim 2 wherein a surface of the first component that engages the second component is at least one of convex or concave.

9. The method according to claim 2, wherein a surface of one of the first component and the second component has an aperture for receiving at least one of a pin, post and peg located on a surface of the other of the first component and the second component.

10. The method according to claim 9 wherein the aperture forms a groove providing rotational movement.

11. The method of claim 1, further comprising:

engaging the contact surface of the surgical tool with the cartilage surface associated with the joint; and

directing movement of the surgical instrument in preparing an implant site using the at least one guide.

12. The method according to claim 1, wherein the at least one guide is one of a guide aperture, a reaming aperture, a drill aperture and a cut plane.

13. The method according to claim 1, wherein the shape of the at least one guide includes at least one guide element for ensuring the desired orientation of the implant.

14. The method according to claim 13, wherein the at least one guide element is a groove.

15. The method according to claim 1, wherein the shape of the at least one guide directs the surgical instrument in making a bone cut that mates with a shaped surface on the implant to ensure the desired implant orientation.

16. The method according to claim 1, wherein the guide has a keyed shape that corresponds to a keyed shape of the implant, such that changes induced on the implant site by the surgical instrument ensures that the implant interlocks with the implant site in the predetermined implant orientation.

17. The method according to claim 1, wherein obtaining the images data includes performing cross-sectional imaging.

18. The method according to claim 1, wherein obtaining the image data includes performing at least one of an MRI, a CT, an optical imaging modality, an x-ray imaging modality and an ultrasound.

19. The method according to claim 1, wherein obtaining the image data includes performing a spiral CT scan.

20. The method according to claim 1, wherein obtaining the image data includes scanning more than one joint.

21. The method according to claim 1, wherein determining shape and/or orientation of the at least one guide includes configuring a first guide to be at an angle to a second guide.

22. The method according to claim 1, wherein providing the surgical tool includes providing a stabilizer that engages the joint.

23. The method according to claim 22, wherein the stabilizer is selected from the group consisting of pin, peg, post, and nub.

24. The method according to claim 1 wherein providing the surgical tool includes further providing at least one of a spacer, a shim, a ratchet, a hinge, a tensiometer and a jack.

25. The method according to claim 1, further comprising using the surgical tool with at least one of hip, knee, ankle, shoulder, elbow, spine and wrist joint.

26. The method according to claim 1, further comprising determining, from said image data, the desired orientation of the implant in relation to at least one of an anatomic landmark, an anatomic axis, and a biomechanical axis associated with the joint.

27. The method according to claim 1, wherein the guide includes a metal covering.

28. The method according to claim 1, wherein the guide directs the surgical instrument in making a bone cut at a predetermined distance from a cartilage surface.

29. The method according to claim 1, wherein the surgical tool farther includes an adjustment mechanism for adjusting the position and/or orientation of the at least one guide relative to the contact surface to allow for ligament balancing.

30. The tool according to claim 29, wherein the adjustment mechanism includes at least one of a spacer, a shim, a ratchet, a hinge, a tensiometer and a jack.

31. The method according to claim 1, wherein providing the surgical tool includes providing at least one surface adapted to rest on bone.

32. The method according to claim 31, wherein the at least one surface adapted to rest on bone is a mirror image of the bone.

33. The method according to claim 1, wherein providing the surgical tool includes providing at least one surface adapted to rest on subchondral bone.

34. The method according to claim 33, wherein the at least one surface adapted to rest on subchondral bone is a mirror image of the subchondral bone.

35. The method according to claim 1, wherein providing the surgical tool includes providing a first component and a second component, the first component including said contact surface, the second component adjustable in position for ligament balancing.

36. The method according to claim 1, wherein the cartilage surface includes diseased cartilage.

37. The method according to claim 1, further comprising using the image data to obtain one of a position, a shape and an orientation of the implant.

38. The method according to claim 1, further comprising evaluating fit between the implant and the implant site using the image data.

39. The method according to claim 38, wherein the image data is three dimensional image data.

40. The method according to claim 11, further comprising determining one of a mechanical axis and an anatomical axis associated with a tibia from the image data, wherein directing movement of the surgical instrument includes cutting the tibia at a predetermined slope in the sagittal plane relative to the one of the mechanical axis and the anatomical axis.

41. The method according to claim 40, wherein said slope is between 0 and 7 degrees from the perpendicular of the one of the mechanical axis and the anatomical axis.

42. The method according to claim 40, wherein the slope matches the normal slope of the tibia.

43. The method according to claim 40, further comprising resting at least a portion of the tool on the tibia prior to directing movement of the surgical instrument.

44. The method according to claim 1, further comprising at least one of generating and selecting an implant based, at least in part, on said image data.

45. The method according to claim 1, further comprising deriving a shape of a joint surface implant based, at least in part, on shape of subchondral bone derived from said image data.

46. The method according to claim 45, wherein said image data is three -dimensional image data.

47. The method according to claim 1, further comprising deriving a shape of a joint surface implant based, at least in part, on shape of cartilage derived from said image data.

48. The method according to claim 47, wherein said image data is three -dimensional image data.

49. The method of claim 15, wherein the bone cut is flat.

50. A method of making a surgical tool, the method comprising:

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

deriving a substantially uncut cartilage surface associated with the joint from the image data; and

providing a surgical tool that includes a contact surface for engaging the substantially uncut cartilage surface associated with the joint, the surgical tool further including at least one guide for directing movement of a surgical instrument in preparing an implant site, wherein providing the surgical tool includes;

shaping the contact surface based on the derived cartilage surface such that the contact surface conforms to and is substantially a negative of the derived cartilage surface; and

determining position, shape and/or orientation of the at least one guide from the image data, so that changes induced on the implant site by the surgical instrument ensures a desired orientation of an implant wherein the shape of that at least one guide surface includes at least one of a groove, receptacle, and a notch, and wherein the shaped surface of the implant includes an extension that mates with the at least one of a groove, receptacle, and a notch so as to ensure a desired orientation of the implant.

51. A method of making a patient specific surgical tool for engaging a surface of a patella, the method comprising:

obtaining image data associated with at least a portion of the patella; and

deriving a substantially uncut cartilage surface associated with the patella from the image data; and

providing a surgical tool that includes a contact surface for engaging the substantially uncut cartilage surface associated with the patella, the surgical tool further including at least one guide for directing movement of a surgical instrument in preparing an implant site, wherein providing the surgical tool includes;

shaping the contact surface based on the derived cartilage surface such that the contact surface conforms to and is substantially a negative of the derived cartilage surface; and

determining position, shape and/or orientation of the at least one guide from the image data, so that changes induced on the implant site by the surgical instrument ensures a desired orientation of an implant.

52. The method according to claim 51, wherein providing the surgical tool includes providing a second component for engaging a first component, the first component including said contact surface.

53. The method according to claim 52, wherein said second component includes one or more of the at least one guide.

54. The method according to claim 52, wherein the surgical tool further includes an adjustment mechanism for adjusting the position and/or the orientation of at least one guide on the first and/or second component to a desired position relative to the contact surface to allow for ligament balancing.

55. The method according to claim 52, wherein the adjustment mechanism includes at least one of a spacer, a shim, a ratchet, a hinge, a tensiometer and a jack.

56. The method according to claim 52, wherein a surface of the first component that engages with a surface of the second component is configured to prevent at least one movement selected from the group consisting of axial, lateral and rotational.

57. The method according to claim 52, wherein a surface of the second component that engages the first component is at least one of convex or concave.

58. The method according to claim 52, wherein a surface of the first component that engages the second component is at least one of convex or concave.

59. The method according to claim 52, wherein a surface of one of the first component and the second component has an aperture for receiving at least one of a pin, post and peg located on a surface of the other of the first component and the second component.

60. The method according to claim 59, wherein the aperture forms a groove providing rotational movement.

61. The method of claim 51 further comprising:

engaging the contact surface of the surgical tool with the substantially uncut cartilage associated with the patella; and

directing movement of the surgical instrument in preparing an implant site using the at least one guide.

62. The method according to claim 51, wherein the at least one guide is one of a guide aperture, a reaming aperture, a drill aperture and a cut plane.

63. The method according to claim 51, wherein the shape of the at least one guide includes at least one guide element for ensuring the desired orientation of the implant.

64. The method according to claim 63, wherein the at least one guide element is a groove.

65. The method according to claim 51, wherein the guide has a keyed shape that corresponds to a keyed shape of the implant, such that changes induced on the implant site by the surgical instrument ensures that the implant interlocks with the implant site in the predetermined implant orientation.

66. The method according to claim 51, wherein the shape of the at least one guide directs the surgical instrument in making a bone cut that mates with a shaped surface on the implant to ensure the desired implant orientation.

67. The method according to claim 66, wherein the shaped guide surface is a groove, and the shaped surface of the implant is an extension.

68. The method according to claim 51, wherein obtaining the image data includes performing cross-sectional imaging.

69. The method according to claim 51, wherein obtaining the image data includes performing at least one of an MRI, a CT, an optical imaging modality, an x-ray imaging modality and an ultrasound.

70. The method according to claim 51, wherein obtaining the image data includes performing a spiral CT scan.

71. The method according to claim 51, wherein obtaining the image data includes scanning more than one joint.

72. The method according to claim 51, wherein determining shape and orientation of the at least one guide includes configuring a first guide to be at an angle to a second guide.

73. The method according to claim 51, wherein providing the surgical tool includes providing a stabilizer that engages the patella.

74. The method according to claim 73, wherein the stabilizer is selected from the group consisting of pin, peg, post, and nub.

75. The method according to claim 51, wherein providing the surgical tool includes further providing at least one of a spacer, a shim, a ratchet, a hinge, a tensiometer and a jack.

76. The method according to claim 51, further comprising determining, from said image data, the desired orientation of the implant in relation to at least one of an anatomic landmark, an anatomic axis, and a biomechanical axis associated with the patella.

77. The method according to claim 51, wherein the guide includes a metal covering.

78. The method according to claim 51, wherein the guide directs the surgical instrument in making a bone cut at a predetermined distance from a cartilage surface.

79. The method according to claim 51, wherein the surgical tool further includes an adjustment mechanism for adjusting the position and/or orientation of the at least one guide relative to the contact surface to allow for ligament balancing.

80. The tool according to claim 79, wherein the adjustment mechanism includes at least one of a spacer, a shim, a ratchet, a hinge, a tensiometer and a jack.