Patient selectable joint arthroplasty devices and surgical tools facilitating increased accuracy, speed and simplicity in performing total and partial joint arthroplasty

• US 7,618,451 B2
• Filed: 11/25/2003
• Issued: 11/17/2009
• Est. Priority Date: 05/25/2001
• Status: Expired due to Term

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Fitz, Wolfgang, Berez, Aaron, Lang, Philipp, Steines, Daniel, Vargas-Voracek, Rene, Tsougarakis, Konstantinos, Snyder, Cecily Anne
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US10/724,010
• Publication Number:
  US 20040236424A1
• Time in Patent Office: 2,184 Days
• Field of Search: 606/86, 606/82, 606/87, 606/88, 606/89, 606/85, 606/80, 606/86.A, 606/86.R, 606/84, 623/23.61, 623/14.12, 623/15.2
• 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 17/155 Cutting femur
• CPC Class Codes: A61B 17/157 Cutting tibia
• CPC Class Codes: A61B 17/158 Cutting patella
• CPC Class Codes: A61B 17/1662 for particular parts of the body
• 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 17/7098 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 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 2034/256 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 5/1075 for measuring dimensions by non-invasive methods, e.g. for determining thickness of tissue layer A61B8/0858 takes precedence
• CPC Class Codes: A61B 5/1076 for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/1077 Measuring of profiles
• 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: 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 2/36 : Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3859 : Femoral components
• CPC Class Codes: A61F 2/4202 : for ankles
• CPC Class Codes: A61F 2/4261 : for wrists
• CPC Class Codes: A61F 2/4405 : for apophyseal or facet joints, i.e. between adjacent spinous or transverse processes devices implanted between spinous or transverse processes A61B17/7062
• CPC Class Codes: A61F 2/441 : made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 : Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• CPC Class Codes: A61F 2/46 : Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
• 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 2002/30581 : having a pocket filled with fluid, e.g. liquid
• CPC Class Codes: A61F 2002/30583 : filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30733 : Inserts placed into an endoprosthetic cavity, e.g. for modifying a material property
• 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 2002/30894 : inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30909 : Nets
• 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 2210/0085 : hardenable in situ, e.g. epoxy resins
• 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: 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 tool for surgery of a joint, the tool comprising:

a first component having a surface for engaging a substantially uncut joint surface, the surface conforming to and being substantially a negative of the uncut joint surface; and

a block that communicates with the first component; and

at least one guide in the block and/or the first component, the guide for directing a surgical instrument, wherein the guide has a predetermined position relative to the conforming surface and is fixed at a predetermined orientation from at least one of an anatomical axis and a biomechanical axis associated with said joint.

2. The tool of claim 1 wherein the first component and the block are integrally formed.

3. The tool of claim 1 wherein the surface of the first component has a convex portion.

4. The tool of claim 1 wherein the first component has at least one guide positioned below the at least one guide in the block.

5. The tool of claim 1 wherein at least one of the first component and the block have a plurality of guides therein.

6. The tool of claim 5 wherein a first guide of a plurality of guides is configured at an angle to a second guide of a plurality of guides.

7. The tool of claim 1 wherein the first component has at least one stabilizer on the surface that engages the joint surface.

8. The tool of claim 7 wherein the stabilizer is selected from the group consisting of pin, peg, post, and nub.

9. The tool of claim 1 wherein a surface of the first component that communicates with a surface of the block is configured to prevent at least one movement selected from the group consisting of axial, lateral and rotational.

10. The tool of claim 9 wherein the surface of the block that engages the first component is at least one of convex or concave.

11. The tool of claim 9 wherein the surface of the first component that engages the block is at least one of convex or concave.

12. The tool of claim 1 wherein the surface of at least one of the first component and block has an aperture for receiving at least one of a pin, post and peg located on a surface of the first component.

13. The tool of claim 12 wherein the aperture forms a groove preventing rotational movement.

14. The tool of claim 1 wherein the first component is selected from a library of components.

15. The tool of claim 1 wherein at least one of the first component and block has a reaming aperture.

16. The tool of claim 1 or 2 further comprising spacers.

17. The tool of claim 11 wherein the block engages the first component in a snap fit.

18. The tool of claim 1 or 2 configured to be used in at least one of hip, knee, ankle, shoulder, elbow and wrist.

19. The tool according to claim 1 or 2, wherein the at least one of an anatomical axis and a biomechanical axis includes an anatomic axis.

20. The tool according to claim 1 or 2, wherein the at least one of an anatomical axis and a biomechanical axis includes a biomechanical axis.

21. The tool according to claim 1 or 2, wherein the surface has a concave portion.

22. The tool according to claim 1 or 2, wherein the surface has a flat portion.

23. The tool according to claim 1 or 2, wherein the surface has concave and convex portions.

24. The tool according to claim 1 or 2, wherein the joint surface includes portions of at least one of a medial condyle and a lateral condyle.

25. The tool according to claim 1 or 2, wherein the joint surface includes portions of at least one of a medial tibial plateau and a lateral tibial plateau.

26. The tool according to claim 1 or 2, wherein said joint surface includes cartilage.

27. The tool according to claim 1 or 2, wherein said joint surface includes at least one of bone and subchondral bone.

28. The tool according to claim 1 or 2, wherein the guide is dimensioned to control drill depth.

29. The tool according to claim 1 or 2, wherein the guide includes a metal insert.

30. The tool according to claim 1, further comprising attachment means for attaching the block to the first component.

31. The tool according to claim 1, further comprising an adjustment mechanism for adjusting the position of the guide relative to the joint surface.

32. The tool according to claim 31, 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.

33. The tool according to claim 1 or 2, wherein one or more of the at least one of an anatomical axis or a biomechanical axis is associated with the hip.

34. The tool according to claim 1 or 2, wherein one or more of the at least one of an anatomical axis or a biomechanical axis is associated with the ankle.

35. The tool of claim 1 or 2, wherein one or more of the at least one of an anatomical axis or a biomechanical axis is associated with a femoral condyle and/or a femur.

36. The tool of claim 1 or 2, wherein one or more of the at least one of an anatomical axis or a biomechanical axis is associated with a tibial plateau and/or a tibia.

37. The tool of claim 1, wherein the first component is one of a mold and a machined part.

38. The tool of claim 21, wherein said adjustment mechanism includes adjustment means for optimizing at least one of flexion gap, extension gap, flexion, extension, abduction, adduction, internal rotation, and external rotation.

39. The tool of claim 21, wherein said adjustment mechanism includes adjustment means for optimizing balance of the joint.

40. The tool of claim 31, wherein said ajustment mechanism allows for optimizing at least one of flexion gap, extension gap, flexion, extension, abduction, adduction, internal rotation, and external rotation.

41. The tool of claim 31, wherein said adjustment mechanism allows for allows for optimizing balance of the joint.

42. The tool of claim 1, wherein the guide is fixed in position relative to the conforming surface.

43. The tool according to claims 1 or 2, wherein the joint is a tibia, and wherein the guide has a shape and/or position such that when the surface of the first component engages the joint surface, the guide directs movement of the surgical instrument into making a cut at a predetermined slope relative tot he sagittal plane.

44. The tool according to claim 43, wherein said cut is made relative to at least one of a mechanical axis and an anatomic axis of the tibia.

45. The tool according to claim 43, wherein said slope is between 0 and 7 degrees.

46. The tool according to claim 43, wherein the slope matches the normal slope of the tibia.

47. The tool according to claims 1 or 2, wherein at least a portion of the tool is adapted to rest on the tibia plateau prior to directing movement of the surgical instrument.

48. The tool according to claim 1, wherein the uncut joint surface includes diseased cartilage.

49. The tool according to claims 1 or 2, wherein at least one guide is oriented at an angle to a second guide.

50. The tool of claim 1, wherein said surface conforms to cartilage.

51. The tool of claim 50, wherein said cartilage is normal.

52. The tool of claim 50, wherein said cartilage is diseased.

53. The tool of claim 50, wherein said cartilage is normal and diseased.

54. The tool of claim 1, wherein said surface conforms to subchondral bone.

55. The tool of claim 1, wherein said surface conforms to both cartilage and subchondral bone.

56. The tool according to claim 43, wherein at least a portion of the tool is adapted to rest on the tibia plateau prior to directing movement of the surgical instrument.

57. The tool of claim 56, wherein said surface conforms to cartilage.

58. The tool of claim 1, wherein said cartilage is normal.

59. The tool of claim 1, wherein said cartilage is diseased.

60. The tool of claim 1, wherein said cartilage is normal and diseased.

61. The tool of claim 56, wherein said surface conforms to subchondral bone.

62. The tool of claim 56, wherein said surface conforms to both cartilage and subchondral bone.

63. The tool according to claims 1 or 2, wherein the joint is a tibia, and wherein the guide has a shape and/or position such that when the surface of the first component engages the joint surface, the guide directs movement of the surgical instrument into making a cut on the tibial plateau so as to substantially balance the knee.

64. The tool according to claim 63, wherein the guide has a shape and/or position such that when the surface of the first component engages the joint surface, the guide directs movement of the surgical instrument into making the cut at a predetermined slope relative to the sagittal plane.

65. The tool according to claim 64, wherein said cut is made relative to a mechanical or anatomic axis of the tibia.

66. The tool according to claim 64, wherein said tibial slope is adjusted based on the amount of damage to the knee.

67. The tool according to claim 64, wherein the guide directs movement of the surgical instruments into making a cut on the tibial plateau so as to substantially balance the knee in at least one of flexion and extension.