Joint arthroplasty devices and surgical tools

• US 8,377,129 B2
• Filed: 10/27/2009
• Issued: 02/19/2013
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Fitz, Wolfgang, Lang, Philipp, Steines, Daniel, Tsougarakis, Konstantinos, Vargas-Voracek, Rene
• Primary Examiner(s): Philogene, Pedro
• Application Number:
  US12/606,830
• Publication Number:
  US 20100160917A1
• Time in Patent Office: 1,211 Days
• Field of Search: 606/88, 606/84, 606/82, 606/87, 606/89, 606/85, 606/80, 606/86.A, 606/86.R, 623/14.12, 623/15.11, 623/23.61
• US Class Current: 623/14.12
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• 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 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• 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 17/1671 for the spine
• 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 17/1764 for the knee
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• 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 2034/256 having a database of accessory information, e.g. including context sensitive help or scientific articles
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• 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 5/4504 : 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: A61B 6/508 : for non-human patients
• CPC Class Codes: A61F 2/30756 : Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 : Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30771 : applied in original prostheses, e.g. holes or grooves
• 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 2/36 : Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3859 : Femoral components
• CPC Class Codes: A61F 2/4657 : Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/30062 : (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/30677 : Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30787 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30894 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/3092 : having an open-celled or open-pored structure
• CPC Class Codes: A61F 2002/30948 : using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/30962 : using stereolithography
• CPC Class Codes: A61F 2002/3097 : using laser
• CPC Class Codes: A61F 2002/4631 : the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00047 : Aluminium or Al-based alloys
• CPC Class Codes: A61F 2310/00065 : Manganese or Mn-based alloys
• CPC Class Codes: A61F 2310/00071 : Nickel or Ni-based alloys
• CPC Class Codes: A61F 2310/00077 : Copper or Cu-based alloys
• CPC Class Codes: A61F 2310/00083 : Zinc or Zn-based alloys
• CPC Class Codes: A61F 2310/00107 : Palladium or Pd-based alloys
• CPC Class Codes: A61F 2310/00113 : Silver or Ag-based alloys
• CPC Class Codes: A61F 2310/00119 : Tin or Sn-based alloys
• CPC Class Codes: A61F 2310/00131 : Tantalum or Ta-based alloys
• CPC Class Codes: A61F 2310/00143 : Iridium or Ir-based alloys
• CPC Class Codes: A61F 2310/00149 : Platinum or Pt-based alloys
• CPC Class Codes: A61F 2310/00155 : Gold or Au-based alloys
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00383 : Gelatin
• CPC Class Codes: A61F 2310/00395 : Coating or prosthesis-covering structure made of metals or of alloys
• CPC Class Codes: A61F 2310/00592 : Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: B23Q 17/00 : Arrangements for observing, indicating or measuring on machine tools for automatic control or regulation of feed movement, cutting velocity or position of tool or work B23Q15/00
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture
• CPC Class Codes: Y10T 29/49764 : with testing or indicating
• CPC Class Codes: Y10T 29/49778 : with aligning, guiding, or instruction

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 instrument system for surgery of a diseased or damaged knee joint of a patient, the instrument system comprising:

a patient-specific surface for engaging at least a portion of a substantially uncut joint surface of the diseased or damaged knee joint of the patient, the patient-specific surface including cartilage information derived from image data of the diseased or damaged knee joint of the patient; and

a guide for directing a surgical instrument, wherein the guide has a predetermined position relative to the patient-specific surface and relative to from at least one of an anatomical axis and a biomechanical axis associated with said knee joint;

wherein the guide defines a drilling path through at least a portion of the knee joint, the drilling path having a position based on a predetermined internal rotation angle or external rotation angle of an orthopedic implant.

2. The instrument system of claim 1, wherein the patient-specific surface and the guide are included in an integrally formed body.

3. The instrument system of claim 1, wherein the patient-specific surface is included in a first body having a linkage mechanism and the guide is included in a second body having a complimentary linkage mechanism for connecting the first and second bodies.

4. The instrument system of claim 1, wherein the patient-specific surface has a convex portion.

5. The instrument system of claim 1, wherein the instrument system has a plurality of guides therein.

6. The instrument system of claim 5, wherein a first guide of the plurality of guides is configured at an angle to a second guide of the plurality of guides.

7. The instrument system of claim 1 having a first guide and a second guide, wherein the first guide is configured at an angle to the second guide.

8. The instrument system of claim 1 having a second guide, wherein the second guide is configured for drilling.

9. The instrument system of claim 1, wherein the patient-specific surface is configured to prevent at least one movement selected from the group consisting of axial, lateral and rotational.

10. The instrument system of claim 1, wherein the instrument system is configured to position the orthopedic implant, wherein the orthopedic implant is a femoral component of a knee implant.

11. The instrument system of claim 1, wherein the instrument system is configured to position the orthopedic implant, wherein the orthopedic implant is a tibial component of a knee implant.

12. The instrument system of claim 8, wherein the first guide is configured for drilling on a medial tibial plateau of the knee joint.

13. The instrument system of claim 8, wherein the second guide is configured for drilling on a lateral tibial plateau of the knee joint.

14. The instrument system of claim 8, wherein the first guide is configured for drilling on a medial femoral condyle of the knee joint.

15. The instrument system of claim 8, wherein the second guide is configured for drilling on a lateral femoral condyle of the knee joint.

16. The instrument system of claim 1, wherein the substantially uncut joint surface includes normal or diseased cartilage.

17. The instrument system of claim 1, wherein the substantially uncut joint surface includes subchondral bone.

18. The instrument system of claim 1, wherein the predetermined internal rotation angle or external rotation angle of the orthopedic implant is selected by an operator.

19. The instrument system of claim 18, wherein the operator is a surgeon.

20. The instrument system of claim 1, wherein the substantially uncut surface portion of the knee joint includes at least a portion of a femoral condyle.

21. The instrument system of claim 1, wherein the substantially uncut surface portion of the knee joint includes at least a portion of a tibial plateau.

22. The instrument system of claim 1, wherein the patient-specific surface is, at least in part, derived by estimating cartilage loss for at least a portion of the knee joint of the patient.

23. A patient-specific instrument system for surgery of a knee joint of a patient, the instrument system comprising:

a patient-specific surface for engaging at least a portion of a substantially uncut joint surface of a tibia of the knee joint of the patient, the patient-specific surface including cartilage information derived from image data of the knee joint of the patient; and

a guide for directing a surgical instrument, wherein the guide has a predetermined position relative to the patient-specific surface and has a predetermined orientation relative to at least one of an anatomical axis and a biomechanical axis associated with said knee joint; and

wherein the guide defines a cutting or drilling path through at least a portion of the tibia of the knee joint, the cutting or drilling pat having a position based on

a predetermined internal rotation angle or external rotation angle of a tibial component of an orthopedic implant.

24. The instrument system of claim 23, wherein the patient-specific surface and the guide are included in an integrally formed body.

25. The instrument system of claim 23, wherein the patient-specific surface is included in a first body having a linkage mechanism and the guide is included in a second body having a complimentary linkage mechanism for connecting the first and second bodies.

26. The instrument system of claim 23, wherein the patient-specific surface has a convex portion.

27. The instrument system of claim 23 further including a plurality of guides therein.

28. The instrument system of claim 27, wherein a first guide of the plurality of guides is configured at an angle to a second guide of the plurality of guides.

29. The instrument system of claim 23 having a first guide and a second guide, wherein the first guide is configured at an angle to the second guide.

30. The instrument system of claim 23, having a second guide, wherein the first is configured for drilling and the first guide is configured for drilling and the second guide is configured for drilling.

31. The instrument system of claim 23, wherein the patient-specific surface is configured to prevent at least one movement selected from the group consisting of axial, lateral and rotational.

32. The instrument system of claim 23, wherein the cartilage information includes information about a cartilage surface of the knee joint of the patient.

33. The instrument system of claim 23, wherein the instrument system is configured to position the tibial component of a the orthopedic implant.

34. The instrument system of claim 23, wherein the cartilage information includes information about a cartilage shape of the substantially uncut joint surface.

35. The instrument system of claim 23, wherein the cartilage information includes information about normal and diseased cartilage of the knee joint.

36. The instrument system of claim 30, wherein the first guide is configured for drilling a hole on a medial plateau of the tibia of the knee joint of the patient.

37. The instrument system of claim 30, wherein the second guide is configured for drilling a hole on a lateral plateau of the tibia of the knee joint of the patient.

38. The instrument system of claim 23, wherein the substantially uncut joint surface includes normal or diseased cartilage.

39. The instrument system of claim 23, wherein the patient-specific surface includes information about subchondral bone.

40. The instrument system of claim 23, wherein the predetermined internal rotation angle or external rotation angle of an orthopedic implant is selected by an operator.

41. The instrument system of claim 40, wherein the operator is a surgeon.

42. The instrument system of claim 23, wherein the substantially uncut joint surface portion of the knee joint includes at least a portion of a tibial plateau.

43. The instrument system of claim 23, wherein the patient-specific surface is, at least in part, derived by estimating cartilage loss for at least a portion of the knee joint of the patient.

44. A patient-specific instrument system for surgery of a knee joint of a patient, the instrument system comprising:

a patient-specific surface for engaging at least a portion of a substantially uncut joint surface of a femoral condyle of the knee joint of the patient, the patient-specific surface including cartilage information derived from image data of the knee joint of the patient; and

a guide for directing a surgical instrument, wherein the guide has a predetermined position relative to the patient-specific surface and is fixed at a predetermined orientation from at least one of an anatomical axis and a biomechanical axis associated with said knee joint; and

wherein the guide defines a cutting or drilling path through at least a portion of the femoral condyle of the knee joint, the cutting or drilling path having a position based on a predetermined internal rotation angle or external rotation angle of a femoral component of an orthopedic implant.

45. The instrument system of claim 44, wherein the patient-specific surface and the guide are included in an integrally formed body.

46. The instrument system of claim 44, wherein the patient-specific surface is included in a first body having a linkage mechanism and the guide is included in a second body having a complimentary linkage mechanism for connecting the first and second bodies.

47. The instrument system of claim 44, wherein the patient-specific surface has a convex portion.

48. The instrument system of claim 44, wherein the instrument system has a plurality of guides therein.

49. The instrument system of claim 48, wherein a first guide of the plurality of guides is configured at an angle to a second guide of the plurality of guides.

50. The instrument system of claim 44, having a first guide and a second guide, wherein the first guide is configured at an angle to the second guide.

51. The instrument system of claim 44 having a second guide, wherein the second guide is configured for drilling.

52. The instrument system of claim 44, wherein the patient-specific surface is configured to prevent at least one movement selected from the group consisting of axial, lateral and rotational.

53. The instrument system of claim 44, wherein the instrument system is configured to position the femoral component of the orthopedic implant.

54. The instrument system of claim 51, wherein the first guide is configured for drilling a hole on a medial femoral condyle of the knee joint of the patient.

55. The instrument system of claim 51, wherein the second guide is configured for drilling a hole on a lateral femoral condyle of the knee joint of the patient.

56. The instrument system of claim 44, wherein the substantially uncut cartilage surface includes normal or diseased joint.

57. The instrument system of claim 44, wherein the patient-specific surface includes information about subchondral bone.

58. The instrument system of claim 44, wherein the predetermined internal rotation angle or external rotation angle of the femoral component of the orthopedic implant is selected by an operator.

59. The instrument system of claim 58, wherein the operator is a surgeon.

60. The instrument system of claim 44, wherein the substantially uncut joint surface portion of the femur of the knee joint includes at least a portion of a femoral condyle.

61. The instrument system of claim 44, wherein the patient-specific surface is, at least in part, derived by estimating cartilage loss for at least a portion of the knee joint of the patient.

62. A patient-specific instrument system for surgery of a knee joint of a patient, the instrument system comprising:

a patient-specific surface for engaging at least a portion of a substantially uncut joint surface of the knee joint of the patient, the patient-specific surface including cartilage information derived from image data of the knee joint of the patient; and

a guide for directing a surgical instrument, wherein the guide has a predetermined position relative to the patient-specific surface and a predetermined orientation relative to at least one of an anatomical axis and a biomechanical axis associated with said knee joint when the patient-specific surface is engaged with the joint surface; and

wherein the guide defines a cutting or drilling path through at least a portion of the knee joint the cutting or drilling path having a position based on at least one of a predetermined orientation of an orthopedic implant configured to correct a varus or valgus condition of the knee joint of the patient.

63. The instrument system of claim 62, wherein the patient-specific surface and the guide are included in an integrally formed body.

64. The instrument system of claim 62, wherein the patient-specific surface is included in a first body having a linkage mechanism and the guide is included in a second body having a complimentary linkage mechanism for connecting the first and second bodies.

65. The instrument system of claim 62, wherein the patient-specific surface has a convex portion.

66. The instrument system of claim 62, wherein the instrument system has a plurality of guides therein.

67. The instrument system of claim 66, wherein a first guide of the plurality of guides is configured at an angle to a second guide of the plurality of guides.

68. The instrument system of claim 62 having a first guide and a second guide, wherein the first guide is configured at an angle to the second guide.

69. The instrument system of claim 62 having a second guide, wherein the second guide is configured for drilling.

70. The instrument system of claim 62, wherein the patient-specific surface is configured to prevent at least one movement selected from the group consisting of axial, lateral and rotational.

71. The instrument system of claim 62, wherein the instrument system is configured to position a femoral component of the orthopedic implant.

72. The instrument system of claim 62, wherein the instrument system is configured to position a tibial component of the orthopedic implant.

73. The instrument system of claim 69, wherein the first guide is configured for drilling a hole on a medial plateau of a tibia of the knee joint of the patient.

74. The instrument system of claim 69, wherein the second guide is configured for drilling a hole on a lateral plateau of a tibia of the knee joint of the patient.

75. The instrument system of claim 69, wherein the first guide is configured for drilling a hole on a medial femoral condyle of the knee joint of the patient.

76. The instrument system of claim 69, wherein the second guide is configured for drilling a hole on a lateral femoral condyle of the knee joint of the patient.

77. The instrument system of claim 62, wherein the substantially uncut cartilage surface includes normal or diseased joint.

78. The instrument system of claim 62, wherein the patient-specific surface includes information about subchondral bone.

79. The instrument system of claim 62, wherein the predetermined orientation of the orthopedic implant is selected by an operator.

80. The instrument system of claim 79, wherein the operator is a surgeon.

81. The instrument system of claim 62, wherein the substantially uncut joint surface portion of the knee joint includes at least a portion of a femoral condyle.

82. The instrument system of claim 62, wherein the substantially uncut joint surface portion of the knee joint includes at least a portion of a tibial plateau.

83. The instrument system of claim 62, wherein the patient-specific surface is, at least in part, derived by estimating cartilage loss for at least a portion of the knee joint of the patient.