Minimally invasive joint implant with 3-dimensional geometry matching the articular surfaces

• US 7,799,077 B2
• Filed: 10/07/2003
• Issued: 09/21/2010
• Est. Priority Date: 10/07/2002
• Status: Active Grant

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Snyder, Cecily Anne, Lang, Philipp, Linder, Barry J., Steines, Daniel, Miller, David, Bouadi, Hacene
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US10/681,749
• Publication Number:
  US 20040138754A1
• Time in Patent Office: 2,541 Days
• Field of Search: 623/18.11, 623/16.11, 623/21.15, 623/20.15, 623/21.11, 623/23.6, 623/14.12, 606/86.R, 264/DIG.30
• US Class Current: 623/14.12
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 2/30942 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 2/32 for the hip
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/3603 implanted without ablation of the whole natural femoral head endoprosthetic cartilage A61F2/30756
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3804 for elbows
• CPC Class Codes: A61F 2/40 for shoulders
• CPC Class Codes: A61F 2/4081 Glenoid components, e.g. cups
• CPC Class Codes: A61F 2/42 for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2/4261 for wrists
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/30016 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3007 Coating or prosthesis-covering structure made of elastic material, e.g. of elastomer
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2002/30113 : circular
• CPC Class Codes: A61F 2002/30125 : elliptical or oval
• CPC Class Codes: A61F 2002/30133 : kidney-shaped or bean-shaped
• CPC Class Codes: A61F 2002/30179 : X-shaped
• CPC Class Codes: A61F 2002/30242 : spherical
• CPC Class Codes: A61F 2002/30245 : Partial spheres
• CPC Class Codes: A61F 2002/30253 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2002/30324 : differing in thickness
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30616 : Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/30822 : Circumferential grooves
• CPC Class Codes: A61F 2002/30841 : Sharp anchoring protrusions for impaction into the bone, e.g. sharp pins, spikes
• CPC Class Codes: A61F 2002/30843 : Pyramidally-shaped
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30884 : Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30894 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30948 : using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 : using CAD-CAM techniques or NC-techniques
• 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 2002/3208 : Bipolar or multipolar joints, e.g. having a femoral head articulating within an intermediate acetabular shell whilst said shell articulates within the natural acetabular socket or within an artificial outer shell
• CPC Class Codes: A61F 2002/3216 : tripolar
• CPC Class Codes: A61F 2002/3412 : with pins or protrusions, e.g. non-sharp pins or protrusions projecting from a shell surface
• CPC Class Codes: A61F 2002/3414 : Polar protrusion, e.g. for centering two concentric shells
• CPC Class Codes: A61F 2002/4007 : implanted without ablation of the whole natural humeral head
• CPC Class Codes: A61F 2002/4233 : for metatarso-phalangeal joints, i.e. MTP joints
• CPC Class Codes: A61F 2002/4251 : for metacarpo-phalangeal joints, i.e. MCP or MP joints, e.g. knuckle joints
• CPC Class Codes: A61F 2002/4631 : the prosthesis being specially adapted for being cemented
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2210/0004 : bioabsorbable
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0008 : elliptical or oval
• CPC Class Codes: A61F 2230/0015 : Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0058 : X-shaped
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/0019 : differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2310/00011 : Metals or alloys
• CPC Class Codes: A61F 2310/00179 : Ceramics or ceramic-like structures
• CPC Class Codes: A61F 2310/00293 : containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 : Proteins; Polypeptides; Degradation products thereof
• 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: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: Y10S 264/30 : Use of anatomy in making a mold or using said mold
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture

Abstract

This invention is directed to orthopedic implants and systems. The invention also relates to methods of implant design, manufacture, modeling and implantation as well as to surgical tools and kits used therewith. The implants are designed by analyzing the articular surface to be corrected and creating a device with an anatomic or near anatomic fit; or selecting a pre-designed implant having characteristics that give the implant the best fit to the existing defect.

Claims

1. An articular implant having a first surface and a second surface wherein the first surface opposes a first articular surface of a joint and the second surface opposes a second articular surface of the joint and further wherein at least a portion of each of the first and second surfaces of the implant has a three-dimensional shape that substantially conforms with or duplicates the shape of the first articular surface so as to have at least one of a convexity and a concavity on the first and second surfaces of the implant, wherein movement of the implant in the joint is limited without an attachment mechanism.

2. The implant of claim 1 wherein the implant is placed within a joint selected from the group consisting of:

knee, hip, shoulder, elbow, wrist, finger, toe, and ankle

3. The implant of claim 1 wherein the superior surface and the inferior surface have a three dimensional shape that substantially matches the shape of at least one of the articular surface that the superior surface abuts and the inferior surface abuts.

4. The implant of claim 1 wherein the implant has a thickness of a cartilage defect in a patient.

5. The implant of claim 1 wherein the implant has a thickness of 85% of a cartilage defect in a patient.

6. The implant of claim 1 wherein the implant has a thickness of between 65%-100% of a cartilage defect of a patient.

7. The implant of claim 1 wherein the implant has a thickness of a cartilage defect in a patient plus an offset value.

8. The implant of claim 1 wherein the implant has a thickness of 85% of a cartilage defect in a patient plus an offset value.

9. The implant of claim 1 wherein the implant has a thickness of between 65%-100% of a cartilage defect of a patient plus an offset value.

10. The implant of claim 1 wherein the implant is constructed of a material comprising metal or metal alloy.

11. The implant of claim 1 wherein the material comprises one or more biologically active materials.

12. The implant of claim 10 wherein the implant is coated with a biologically active material.

13. The implant of claim 1 wherein the implant is comprised of a metal or metal alloy and a polymer.

14. The implant of claim 1 further having a structure for stabilization on at least one of the first surface or the second surface selected from the group consisting of:

ridges, lips and thickenings.

15. The implant of claim 14 further having a plurality of structures for stabilization.

16. The implant of claim 15 wherein the stabilization mechanism engages the tibial spine.

17. The implant of claim 1 further having a peripheral structure selected from the group consisting of ridges and lips.

18. The implant of claim 17 wherein the peripheral structure extends along an entire perimeter of the implant.

19. The implant of claim 18 wherein the peripheral structure extends along a portion of a perimeter of the implant.

20. The implant of claim 1 wherein each of the first surface and second surface have a slope relative to a longitudinal axis through the implant and further wherein the slope of the first surface relative to the slope of the second surface is selected from the group consisting of:

positive, negative, and null.

21. The implant of claim 1 wherein the implant duplicates the shape of one of the first and second articular surface.

22. The implant of claim 21 wherein the implant is selected from a library of implants.

23. The implant of claim 1 wherein the implant changes configuration after insertion into a joint.

24. The implant of claim 1 wherein the implant changes configuration during loading.

25. The implant of claim 1 wherein the implant further comprises a first component and a second component.

26. The implant of claim 25 wherein the first and second component are one of:

integrally formed, indivisibly formed, interconnectedly formed, and interdependently formed.

27. The implant of claim 25 wherein the first component engages the joint in at least one of fixedly, slideably, rotatably.

28. The implant of claim 25 wherein the second component engages the joint in at least one of fixedly, slidably, and rotatably.

29. The implant as in any one of claim 25, 26, 27, or 28 wherein the first component engages the second component.

30. The implant as in any one of claim 25, 26, 27, or 28 wherein the first component fits within the second component.

31. The implant as in any one of claim 25, 26, 27, or 28 wherein the first component slideably engages the second component.

32. The implant as in any one of claim 25, 26, 27, or 28 wherein the first component rotatably engages the second component.

33. The implant as in any one of claim 25, 26, 27, or 28 wherein a portion of the implant has a magnet.

34. The implant of claim 1 wherein the implant has a shape formed along a perimeter selected from the group consisting of:

circular, elliptical, ovoid, kidney shaped, substantially circular, substantially elliptical, substantially ovoid, and substantially kidney shaped.

35. The implant of claim 1 wherein the implant has a cross-sectional shape of at least one of an inferior surface and a superior surface selected from the group consisting of spherical, hemispherical, aspherical, convex, concave, substantially convex, and substantially concave.

36. The implant of claim 1 wherein the implant is a cartilage defect conforming implant.

37. The implant of claim 1 wherein the implant is a cartilage projected implant.

38. The implant of claim 1 wherein the implant is a subchondral bone conforming implant.

39. The implant of claim 1 wherein the implant is surgically implanted via an incision of 10 cm or less.

40. The implant of claim 1 wherein the implant is surgically implanted via an incision of 6 cm or less.

41. The implant of claim 1 wherein the implant is surgically implanted via an incision of 4 cm or less.

42. The implant of claim 1 wherein the range of motion of the joint is restored to between 80-99.9% of normal joint motion.

43. The implant of claim 1 wherein the range of motion of the joint is restored to between 90-99.9% of normal joint motion.

44. The implant of claim 1 wherein the range of motion of the joint is restored to between 95-99.9% of normal joint motion.

45. The implant of claim 1 wherein the range of motion of the joint is restored to between 98-99.9% of normal joint motion.

46. The implant of claim 1 wherein the joint is a knee joint and wherein a shape formed along a perimeter selected from the group consisting of:

circular, elliptical, ovoid, kidney shaped, substantially circular, substantially elliptical, substantially ovoid, and substantially kidney shaped.

47. The implant of claim 1 wherein the joint is a knee joint and wherein the superior surface of the implant is substantially convex.

48. The implant of claim 1 wherein the joint is a knee joint and wherein the inferior surface of the implant is substantially concave.

49. The implant of claim 1 wherein the joint is a knee joint and wherein the superior surface of the implant is comprised of convex and concave sections.

50. The implant of claim 1 wherein the joint is a knee joint and the inferior surface of the implant is substantially concave.

51. The implant of claim 1 wherein the joint is a hip joint and wherein a cross-section of the implant is selected from the group consisting of:

spherical and aspherical.

52. The implant of claim 1 wherein a periphery of the implant is of greater thickness than a central portion of the implant.

53. The implant of claim 1 wherein a central portion of the implant is of greater thickness than a periphery.

54. The implant of claim 1 having an anterior portion, posterior portion, lateral portion and medial portion wherein the implant has a thickness along the posterior portion of the device that is equal to or greater than a thickness of at least one of the lateral, medial and anterior portion of the implant.

55. The implant of claim 1 having an anterior portion, posterior portion, lateral portion and medial portion wherein the implant has a thickness along a posterior portion of the device that is equal to or less than a thickness of at least one of the lateral, medial and anterior portion of the implant.

56. The implant of claim 1 having an anterior portion, posterior portion, lateral portion and medial portion wherein the implant has a thickness along a medial portion of the device that is equal to or less than a thickness of at least one of a anterior portion, posterior portion, and lateral portion.

57. The implant of claim 1 having an anterior portion, posterior portion, lateral portion and medial portion wherein the implant has a thickness along a medial portion of the device that is equal to or greater than a thickness of at least one of a anterior portion, posterior portion, and lateral portion.

58. The implant of claim 25 having an anterior portion, posterior portion, lateral portion and medial portion wherein at least one component of the implant has a thickness along the posterior portion of the device that is equal to or greater than a thickness of at least one of the lateral, medial and anterior portion of the implant.

59. The implant of claim 25 having an anterior portion, posterior portion, lateral portion and medial portion wherein at least one component of the implant has a thickness along a posterior portion of the device that is equal to or less than a thickness of at least one of the lateral, medial and anterior portion of the implant.

60. The implant of claim 25 having an anterior portion, posterior portion, lateral portion and medial portion wherein at least one component of the implant has a thickness along a medial portion of the device that is equal to or less than a thickness of at least one of a anterior portion, posterior portion, and lateral portion.

61. The implant of claim 25 having an anterior portion, posterior portion, lateral portion and medial portion wherein at least one component of the implant has a thickness along a medial portion of the device that is equal to or greater than a thickness of at least one of a anterior portion, posterior portion, and lateral portion.

62. The implant of claim 1, wherein the implant is placed in a joint associated with a vertebrae.

63. The implant of claim 1, wherein the implant height is adjusted to account for anatomic malalignment.

64. The implant of claim 1, wherein the implant height, profile or other dimension is selected or adjusted to correct ligamentous laxity.

65. An articular implant having a first surface and a second surface wherein the first surface opposes a first articular surface of a joint and the second surface opposes a second articular surface of the joint and further wherein at least a portion of each of the first and second surfaces of the implant has a three-dimensional shape that substantially conforms with or duplicates the shape of the first articular surface so as to have at least one of a convexity and a concavity on the first and second surfaces of the implant, the first articular surface being one of a substantially uncut articular cartilage surface and a substantially uncut subchondral bone surface, wherein the implant has a plurality of components, and wherein a first component of the plurality of components engages a second component of the plurality of components in at least one of slideably and rotatably.

66. The implant of claim 65 wherein a first component of the plurality of components engages the joint in at least one of fixedly, slideably, and rotatably.

67. The implant of claim 65 wherein a second component of the plurality of components engages the joint in at least one of fixedly, slidably, and rotatably.

68. The implant as in any one of claim 65, 66 or 67 wherein the first component of the plurality of components fits within the second component of the plurality of components.

69. The implant as in any one of claim 65, 66 or 67 wherein the first component of the plurality of components slideably engages the second component of the plurality of components.

70. The implant as in any one of claim 65, 66 or 67 wherein the first component of the plurality of components rotatably engages the second component of the plurality of components.

71. The implant as in any one of claim 65, 66 or 67 wherein the first component of the plurality of components rotatably and slidably engages the second component of the plurality of components.

72. The implant of claim 65 having an anterior portion, posterior portion, lateral portion and medial portion wherein at least one component of the implant has a thickness along the posterior portion of the device that is equal to or greater than a thickness of at least one of the lateral, medial and anterior portion of the implant.

73. The implant of claim 65 having an anterior portion, posterior portion, lateral portion and medial portion wherein at least one component of the implant has a thickness along the posterior portion of the device that is equal to or greater than a thickness of at least one of the lateral, medial and anterior portion of the implant.

74. The implant of claim 65 having an anterior portion, posterior portion, lateral portion and medial portion wherein at least one component of the implant has a thickness along the posterior portion of the device that is equal to or greater than a thickness of at least one of the lateral, medial and anterior portion of the implant.

75. The implant of claim 65 having an anterior portion, posterior portion, lateral portion and medial portion wherein at least one component of the implant has a thickness along the posterior portion of the device that is equal to or greater than a thickness of at least one of the lateral, medial and anterior portion of the implant.

76. A method of making an implant suitable for a joint, the method comprising the steps of:

determining three-dimensional shapes of one or more articular surfaces of the joint; and

producing an implant having a first surface and a second surface, wherein the first surface and second surface of the implant oppose a first and second articular surface of the joint, respectively, and further wherein at least a portion of each of the first and second surfaces of the implant substantially conforms with or duplicates the three-dimensional shape of the first articular surface so as to have a plurality of convexities and a plurality of concavities on the first and second surfaces of the implant, wherein movement of the implant in the joint is limited without an attachment mechanism.

77. The method of claim 76 wherein the three-dimensional shape is determined by obtaining an image of the joint.

78. The method of claim 77 wherein the image is selected from the group consisting of MRI, CT, x-ray, and combinations thereof

79. A cartilage conforming implant having a first surface and a second surface wherein the first surface opposes a first articular surface of a joint and the second surface opposes a second articular surface of the joint and further wherein at least a portion of each of the first and second surfaces of the implant has a three-dimensional shape that substantially conforms with or duplicates the shape of cartilage on the first articular surface so as to have a plurality of convexities and a plurality of concavities on the first and second surfaces of the implant, wherein movement of the implant in the joint is limited without an attachment mechanism.

80. A subchondral bone conforming implant having a first surface and a second surface wherein the first surface opposes a first articular surface of a joint and the second surface opposes a second articular surface of the joint and further wherein at least a portion of each of the first and second surfaces of the implant has a three-dimensional shape that substantially conforms with or duplicates the shape of subchondral bone on the first articular surface so as to have a plurality of convexities and a plurality of concavities on the first and second surfaces of the implant, wherein movement of the implant in the joint is limited without an attachment mechanism.

81. An articular implant having a first surface and a second surface wherein the first surface opposes a first articular surface of a joint and the second surface opposes a second articular surface of the joint and further wherein at least a portion of each of the first and second surfaces of the implant has a three-dimensional shape that substantially conforms with or duplicates the shape of the first articular surface so as to have at least one of a convexity and a concavity on the first and second surfaces of the implant, the first articular surface being one of substantially uncut cartilage and substantially uncut bone.

82. The implant according to claim 81, wherein the implant replaces less than 80% of the one of the first and second articular surfaces of the joint.

83. The implant according to claim 81, wherein the implant replaces less than 50% of the one of the first and second articular surfaces of the joint.

84. The implant according to claim 81, wherein the implant replaces less than 20% of the one of the first and second articular surfaces of the joint.