Patient Selectable Joint Arthroplasty Devices and Surgical Tools

• US 20090222014A1
• Filed: 03/05/2009
• Published: 09/03/2009
• Est. Priority Date: 05/25/2001
• Status: Active Grant

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Lang, Philipp, Fitz, Wolfgang, Bojarski, Raymond
• Granted Patent: US 8,439,926 B2
• Time in Patent Office: Days
• US Class Current: 606/88
• 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 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/17 Guides or aligning means for drills , mills, pins or wires
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1746 for the acetabulum
• CPC Class Codes: A61B 17/175 for preparing the femur for hip prosthesis insertion
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 17/1767 for the patella
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61B 2034/2065 Tracking using image or pattern recognition
• 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 5/4514 Cartilage
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

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 system for articular repair, the system comprising:

a first template having a first surface and a second surface, the first surface conforming with, and substantially a negative of, at least a portion of a first side of a joint;

a second template having a third surface that conforms with, and is substantially a negative of, a portion of the first side of the joint, the second template including at least one guide for guiding a surgical instrument in making a cut on the first side of the joint; and

an attachment mechanism for attaching the second template to the first template.

2. The system according to claim 1, wherein the first or second template includes a guide for making a vertical cut.

3. The system according to claim 1, wherein the second surface is at least one of substantially flat, substantially concave, substantially convex, and matched to one of the first or second sides of the joint.

4. The system according to claim 1, further comprising at least one other template having a first surface and a second surface, the first surface of the at least one other template conforming with, and substantially a negative of, the at least a portion of the first side of the joint, each of the other templates capable of attaching to the second template, wherein the first template and each of the other templates vary in thickness.

5. The system according to claim 1, wherein at least a portion of the first surface substantially conforms to at least one of uncut subchondral bone, uncut cartilage, and uncut bone of a first or second side of the joint.

6. The system according to claim 1, wherein at least a portion of the second surface substantially conforms to at least one of uncut subchondral bone, uncut cartilage, and uncut bone of a first or second side of a joint.

7. The system according to claim 1, wherein at least a portion of the third surface substantially conforms to at least one of uncut subchondral bone, uncut cartilage, and uncut bone of a first or second side of a joint.

8. The system according to claim 1, wherein the attachment mechanism includes at least one of a snapfit, dovetail and a cross-pin.

9. The system according to claim 1, wherein the attachment mechanism allows for rotation relative to one of an anatomical and a biomechanical axis.

10. The system according to claim 1, wherein the joint is at least one of a hip, knee, ankle, toe joint, shoulder, elbow, wrist, finger joint, spine or spinal joint.

11. A system for articular joint repair, the system comprising:

a first template having a first surface and a second surface, the first surface substantially a negative of at least a portion of the tibial plateau;

a second template having a third surface that is substantially a negative of a portion of the tibia, the second template including at least one guide for guiding a surgical instrument in making a cut on the tibia; and

an attachment mechanism for attaching the second template to the first template.

12. The system according to claim 11, wherein the first or second template includes a guide for making a vertical tibial cut.

13. The system according to claim 11, wherein the second surface is at least one of substantially flat, substantially concave, substantially convex, and matched to one of the tibia and the femur.

14. The system according to claim 11, further comprising at least one other template having a first surface and a second surface, the first surface of the at least one other template conforming with, and substantially a negative of, the at least a portion of the tibial plateau, each of the other templates capable of attaching to the second template, wherein the first template and each of the other templates vary in thickness.

15. The system according to claim 11, wherein at least a portion of the first surface substantially is a negative of at least one of uncut subchondral bone, uncut cartilage, and uncut bone of a tibia.

16. The system according to claim 11, wherein at least a portion of the second surface substantially is a negative of at least one of uncut subchondral bone, uncut cartilage, and uncut bone of a tibia.

17. The system according to claim 11, wherein at least a portion of the third surface substantially is a negative of at least one of uncut subchondral bone, uncut cartilage, and uncut bone of a tibia.

18. The system according to claim 11, wherein the attachment mechanism includes at least one of a snapfit, dovetail and a cross-pin.

19. The system according to claim 11, wherein the attachment mechanism allows for rotation relative to one of an anatomical and a biomechanical axis.

20. The system according to claim 11, wherein the at least one guide guides a surgical instrument in making a cut on the tibia having a desired slope relative to at least one of a biomechanical and an anatomical axis.

21. The system according to claim 11, wherein the articular joint repair is a joint resurfacing.

22. The system according to claim 11, wherein the joint resurfacing is a knee joint resurfacing.

23. The system according to claim 11, wherein the articular joint repair is a joint replacement.

24. A system for articular repair, the system comprising:

a first template having a first surface and a second surface, the first surface substantially matching at least a portion of the tibial plateau, the first template including a medial edge that corresponds to a predetermined location for a vertical tibial cut.

25. The system according to claim 24, further comprising a second template having a third surface substantially matching at least a portion of the tibia, the second template including at least one guide for guiding a surgical instrument;

and

an attachment mechanism for attaching the second template to the first template.

26. The system according to claim 25, wherein the first template includes a guide for guiding a surgical instrument.

27. The system according to claim 25, wherein the medial edge is adapted as a guide for making a vertical tibial cut.

28. The system according to claim 25, further comprising at least one other template having a first surface and a second surface, the first surface of the at least one other template substantially matching at least a portion of the tibial plateau, wherein the first template and each of the other templates vary in thickness.

29. The system according to claim 24, wherein at least a portion of the first surface substantially matches at least one of uncut subchondral bone, uncut cartilage, and uncut bone.

30. A kit for testing at least one of ligament balancing and ligament tension, the kit comprising:

a first template having at least one surface substantially conforming with at least a portion of a first articular joint surface;

wherein the template is configured for placement on the first articular joint surface and between the first articular joint surface and a second articular joint surface, the template having a predefined thickness configured to provide a physical spacer for assessing at least one of ligament balance and ligament tension during a surgical procedure.

31. The kit of claim 30, further comprising:

a second template having at least one surface substantially conforming with at least the portion of the first articular joint surface;

wherein the template is configured for placement on the first articular joint surface and between the first articular joint surface and the second articular joint surface, the template having a second predefined thickness configured to provide a physical spacer for assessing at least one of ligament balance and ligament tension during a surgical procedure.

32. The kit of claim 30, further comprising:

at least two additional templates each having at least one surface substantially conforming with at least a portion of the first articular joint surface;

wherein each template is configured for placement on the first articular joint surface and between the first articular joint surface and the second articular joint surface, the templates having unique thicknesses configured to provide a set of spacers of different thicknesses for assessing at least one of ligament balance and ligament tension during a surgical procedure.

33. The kit according to claim 30, further comprising:

a second template having a third surface that substantially conforms with at least a portion of a first or second joint surface, the second template including at least one guide for guiding a surgical instrument; and

an attachment mechanism for attaching the second template to at least one of the first template and the at least one other template.

34. The kit according to claim 30, wherein the joint is one of a knee joint, a hip joint, a shoulder joint, an elbow joint, a wrist joint, a finger joint, a toe joint, and an ankle joint.

35. The kit according to claim 30, wherein at least a portion of the first surface substantially conforms to at least one of uncut subchondral bone, uncut cartilage, and uncut bone.

36. A method of partial or total knee replacement or resurfacing, the method comprising:

positioning a first surface of a first instrument onto at least a portion of the tibial plateau, the first surface being substantially a negative of at least a portion of the tibial plateau;

cross-referencing a second instrument to the first instrument to align position of the second instrument on the tibia, the second instrument including at least one surgical cut guide; and

directing a cut using the at least one surgical guide of the second of the second instrument.

37. The method of claim 36, wherein the cut is a tibial cut.

38. The method of claim 36, wherein the first instrument is a template.

39. The method of claim 36, wherein the second instrument is a template.

40. The method of claim 36, wherein the second instrument is a surgical tool.

41. The method according to claim 36, wherein the first instrument includes a guide for making a cut, the method further comprising directing a surgical cut using the guide.

42. The method of claim 41, wherein guide is a vertical guide and the cut is a tibial cut.

43. The method of claim 41, wherein guide is a horizontal guide and the cut is a tibial cut.

44. The method according to claim 36, wherein the first instrument includes a medial edge that corresponds to a predetermined location for a vertical tibial cut, the method further comprising confirming the proper location of the vertical tibial cut based on the medial edge.

45. The method according to claim 36, wherein at least a portion of the first surface substantially conforms to at least one of uncut subchondral bone, uncut cartilage, and uncut bone.

46. The method according to claim 36, wherein the first surface of the instrument is based, at least in part, on electronic image data of the tibial plateau.

47. The method according to claim 36, wherein cross-referencing includes attaching the first instrument to the second instrument.

48. The method according to claim 36, wherein the at least one guide of the second instrument guides a surgical instrument in making a cut on the tibia having a desired slope relative to at least one of a biomechanical and an anatomical axis.

49. A method for testing at least one of ligament balancing and ligament tension of a joint, the method comprising:

inserting a first template having a first surface onto a first joint surface, the first surface substantially conforming to the first joint surface; and

inserting a second template onto the first joint surface, the second template having a first surface that conforms with, and is substantially a negative of, the first joint surface, the second template having a thickness that varies from the first template.

50. The method according to claim 49, further comprising selecting one of the first and second templates based on at least one of ligament balancing and ligament tension.

51. The method according to claim 50, further comprising:

attaching a third template to the selected template, the third template, including at least one guide for guiding a surgical instrument;

positioning the first surface of the selected template onto the first joint surface; and

guiding the surgical instrument using the at least one guide.

52. The method according to claim 49, wherein the joint is one of a knee joint, a hip joint, a shoulder joint, an elbow joint, a wrist joint, a finger joint, a toe joint, and an ankle joint.

53. A system for articular repair, the system comprising:

a first template having a first surface and a second surface, the first surface substantially conforming with, and substantially a negative of, at least a portion of a distal femur;

a second template having a third surface that conforms with, and is substantially a negative of, a portion of the distal femur, the second template including at least one guide for guiding a surgical instrument in making a cut on the distal femur; and

an attachment mechanism for attaching the second template to the first template.

54. The system according to claim 53, wherein the first or second template includes a guide for making a vertical femoral cut.

55. The system according to claim 53, wherein the second surface is at least one of substantially flat, substantially concave, substantially convex, and matched to one of the tibia and the femur.

56. The system according to claim 53, further comprising at least one other template having a first surface and a second surface, the first surface of the at least one other template conforming with, and substantially a negative of, the at least a portion of the distal femur, each of the other templates capable of attaching to the second template, wherein the first template and each of the other templates vary in thickness.

57. The system according to claim 53, wherein at least a portion of the first surface substantially conforms to at least one of uncut subchondral bone, uncut cartilage, and uncut bone of a distal femur.

58. The system according to claim 53, wherein at least a portion of the second surface substantially conforms to at least one of uncut subchondral bone, uncut cartilage, and uncut bone of a distal femur.

59. The system according to claim 53, wherein at least a portion of the third surface substantially conforms to at least one of uncut subchondral bone, uncut cartilage, and uncut bone of a tibia.

60. The system according to claim 53, wherein the attachment mechanism includes at least one of a snapfit, dovetail and a cross-pin.

61. The system according to claim 53, wherein the attachment mechanism allows for rotation relative to one of an anatomical and a biomechanical axis.

62. A system for articular repair, the system comprising:

a first template having a first surface and a second surface, the first surface substantially conforming to at least a portion of the distal femur, the first template including a medial edge that corresponds to a predetermined location for a vertical femoral or tibial cut.

63. The system according to claim 62, further comprising a second template having a third surface substantially conforming to at least a portion of the distal femur or tibial plateau, the second template including at least one guide for guiding a surgical instrument;

and

an attachment mechanism for attaching the second template to the first template.

64. The system according to claim 62, wherein the first template includes a guide for guiding a surgical instrument.

65. The system according to claim 62, wherein the medial edge is adapted as a guide for making a vertical tibial or femoral cut.

66. The system according to claim 62, further comprising at least one other template having a first surface and a second surface, the first surface of the at least one other template substantially conforming to at least a portion of the tibial plateau, wherein the first template and each of the other templates vary in thickness.

67. The system according to claim 62, wherein at least a portion of the first surface substantially conforms to at least one of uncut subchondral bone, uncut cartilage, and uncut bone.