Patient selectable joint arthroplasty devices and surgical tools

• US 8,066,708 B2
• Filed: 02/06/2007
• Issued: 11/29/2011
• Est. Priority Date: 05/25/2001
• Status: Active Grant

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Burdulis, Albert G. Jr., Lang, Philipp, Steines, Daniel, Bojarski, Raymond A., Vargas-Voracek, Rene, Fitz, Wolfgang
• Primary Examiner(s): Philogene; Pedro
• Application Number:
  US11/671,745
• Publication Number:
  US 20070198022A1
• Time in Patent Office: 1,757 Days
• Field of Search: 606/80, 606/86.R, 606/87, 606/88, 606/96, 623/901, 623/16.11, 623/14.12, 345/420, 345/620, 600/407, 600/587
• US Class Current: 606/88
• 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 17/1666 for the acetabulum
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 17/1677 for the patella
• CPC Class Codes: A61B 17/1682 for the foot or ankle
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1746 for the acetabulum
• CPC Class Codes: A61B 17/1767 for the patella
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• 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 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 5/4523 : Tendons
• CPC Class Codes: A61B 5/4528 : Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 5/4533 : Ligaments
• CPC Class Codes: A61F 2/30756 : Cartilage endoprostheses A61F2/3603 takes precedence
• 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 2/38 : for elbows or knees
• CPC Class Codes: B33Y 80/00 : Products made by additive manufacturing
• CPC Class Codes: G06F 30/00 : Computer-aided design [CAD]
• CPC Class Codes: G06F 30/10 : Geometric CAD
• CPC Class Codes: Y10T 29/49 : Method of mechanical manufacture

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 system for joint arthroplasty, the system comprising:

(a) a first template, the first template including;

(i) at least one contact surface substantially conforming to and for engaging a first cartilage surface of a joint; and

(ii) at least one guide for directing movement of a surgical instrument; and

(b) a linkage for cross-referencing at least one surgical tool relative to the guide and relative to one of an anatomical and a biomechanical axis of a limb.

2. The system according to claim 1, wherein the surgical tool is a second template, the second template including at least one guide for directing movement of a surgical instrument.

3. The system according to claim 2, wherein the second template includes a contact surface substantially conforming to and for engaging a second joint surface.

4. The system according to claim 3, wherein the second joint surface opposes the first joint surface.

6. The system according to claim 1, wherein a shape and/or position of the at least one guide of the first template is based, at least in part, on one or more axes related to the joint.

7. The system according to claim 1, wherein the linkage is an attachment mechanism.

8. The system according to claim 7, wherein the attachment mechanism causes the first template to directly contact the at least one surgical tool.

9. The system according to claim 7, wherein the attachment mechanism attaches the first template and the at least one surgical tool such that the first template and the at least one surgical tool do not directly contact each other.

10. The system according to claim 1, wherein the linkage allows for rotation relative to one of the anatomical and biomechanical axis of a limb.

11. The system according to claim 1, wherein the first template includes a removably attached block, the block including the at least one guide of the first template.

12. The system according to claim 1, wherein the linkage comprises a hole created by the movement of said surgical instrument.

13. The system according to claim 1, wherein the linkage comprises a tool inserted into a hole created by the movement of said surgical instrument.

14. The system according to claim 1, wherein the linkage comprises a tool applied or attached to a cut plane created by the movement of said surgical instrument.

15. The system according to claim 1, wherein the linkage is configured to indirectly cross-reference the at least one surgical tool relative to the guide.

5. The system according to clam 2, wherein the at least one guide of the second template directs the surgical instrument in at least one of a cut, a milling, and a drilling oriented in a predefined location relative to the first template and is adapted in shape, size or orientation to an implant shape.

16. A system for joint arthroplasty, the system comprising:

(a) a first template, the first template including;

(i) at least one contact surface substantially conforming to and for engaging a first joint surface; and

(ii) at least one guide for directing movement of a surgical instrument; and

(b) a tool for cross-referencing at least one surgical tool on a second joint surface opposing the first joint surface.

17. The system according to claim 16, wherein the tool comprises a tool applied or attached to a cut plane created by the movement of said surgical instrument.

18. The system according to claim 16, wherein the tool comprises a hole created by the movement of said surgical instrument.

19. The system according to claim 16, wherein the tool comprises a tool inserted into a hole created by the movement of said surgical instrument.

20. The system according to claim 16, wherein the tool is configured to indirectly cross-reference the at least one surgical tool.

21. The system according to claim 16, wherein the tool comprises a device used for ligament balancing.

22. The system according to claim 16, wherein the tool comprises a member of the following group:

a spacer, a hinge or a rachet-like device.

23. A system for joint arthroplasty, the system comprising:

(a) a first template, the first template including;

(i) a first contact surface substantially conforming to and for engaging a first joint surface; and

(ii) a first guide for directing movement of a surgical instrument;

(b) a second template, the second template including;

(i) a second contact surface substantially conforming to and for engaging a second joint surface; and

(ii) a second guide for directing movement of a surgical instrument; and

(c) a linkage for cross-referencing a first cut created by the first template and a second cut created by the second template.

24. The system according to claim 23, wherein the first cut comprises a bone cut.

25. The system according to claim 23, wherein the first cut comprises a hole.

26. The system according to claim 23, wherein the first contact surface and the second contact surface are on the same articular side of the joint.

27. The system according to claim 23, wherein the first contact surface and the second contact surface are on opposing articular sides of the joint.

28. The system according to claim 23, wherein the linkage comprises a member of the following group:

a spacer, a hinge or a rachet-like device.

29. The system according to claim 23, wherein the linkage is configured to indirectly cross-reference the first cut and the second cut.

30. A system for joint arthroplasty, the system comprising:

(a) a first template, the first template including;

(i) at least one contact surface substantially conforming to and for engaging a first joint surface; and

(ii) at least one guide for directing movement of a surgical instrument; and

(b) a linkage for cross-referencing at least one surgical tool, wherein the linkage allows for rotation relative to one of an anatomical and a biomechanical axis of a limb.

31. The system according to claim 30, wherein the linkage comprises a hole created by the movement of said surgical instrument.

32. The system according to claim 30, wherein the linkage comprises a tool inserted into a hole created by the movement of said surgical instrument.

33. The system according to claim 30, wherein the linkage comprises a tool applied or attached to a cut plane created by the movement of said surgical instrument.

34. The system according to claim 30, wherein the linkage is configured to indirectly cross-reference the at least one surgical tool.

35. A method of joint arthroplasty for a joint of the patient, the method comprising:

(a) positioning at least one contact surface of a first template onto a first joint surface, the contact surface of the first template being individualized based on said first joint surface;

(b) cross-referencing a second template to the first template to align a position of the second template on a second joint surface, the second template including at least one guide; and

(c) directing movement of a surgical instrument using the at least one guide relative to the at least one guide and relative to one of an anatomical and a biomechanical axis of a limb.

36. The method according to claim 35, wherein the at least one contact surface of the first template substantially conforms to the first joint surface.

37. The method according to claim 36, further comprising:

obtaining electronic image data of the joint;

determining a shape of the at least one contact surface of the first template based, at least in part, on electronic image data.

38. The method according to claim 35, further comprising:

prior to directing movement of the surgical instrument, positioning at least one contact surface of the second template to the second joint surface.

39. The method according to claim 38, wherein the at least one contact surface of the second template substantially conforms to the second joint surface.

40. The method according to claim 38, further comprising:

obtaining electronic image data of the joint;

determining a shape of the at least one contact surface of the second template based, at least in part, on electronic image data.

41. The method according to claim 35, wherein cross-referencing the second template to the first template includes:

attaching the second template to the first template.

42. The method according to claim 41, wherein attaching the second template to the first template includes performing intraoperative adjustments.

43. The method according to claim 42, wherein the second template is attached to the first template via a pin, and wherein performing intraoperative adjustments includes rotating the second template around the pin.

44. The method according to claim 35 further comprising performing an intraoperative adjustment on the position of the second template on the second joint surface, wherein performing the intraoperative adjustment includes using one of spacers, ratchets, and telescoping devices.

45. The method according to claim 35, further comprising performing an intraoperative adjustment on the position of the second template on the second joint surface, wherein performing the intraoperative adjustment includes adjusting for at least one of joint flexion, joint extension, joint abduction, and joint rotation.

46. The method according to claim 35, wherein directing movement of the surgical instrument using the at least one guide of the second template includes making one or more cuts or drill holes, the method further comprising implanting a joint prosthesis as a function of the one or more cuts or drill holes.

47. The method according to claim 35, wherein the first template includes at least one guide, the method further comprising:

directing movement of a surgical instrument using the at least one guide of the first template.

48. The method according to claim 47, wherein directing movement of the surgical instrument using the at least one guide of the first template includes making one or more cuts or drill holes, the method further comprising implanting a joint prosthesis as a function of the one or more cuts or drill holes.

49. The method according to claim 35, wherein directing movement of the surgical instrument using the at least one guide of the second template includes making at least one of a cut, a drill hole, and a reaming, the method further comprising implanting a joint prosthesis.

50. The method according to claim 35, wherein the first joint surface is a femoral surface and the second joint surface is a tibial surface.

51. The method according to claim 35, further comprising:

obtaining electronic image data of a joint;

determining the at least one of a biomechanical axis and an anatomical axis of the joint based, at least in part, on the electronic image data; and

wherein a shape and/or position of the guide of the second template is based, at least in part, on the at least one of the biomechanical axis and the anatomical axis.

52. The method according to claim 51 wherein the electronic image data is obtained by at least one of pre-operatively, intraoperatively, optically, an MRI, a CT, and a spiral CT.

53. The method according to claim 35, wherein the first template includes a thickness based, at least in part, on at least one of a thickness of an implant to be attached to the first joint surface and a desired space between two opposing joint surfaces.

54. The system according to claim 35, wherein the first joint surface and the second joint surface are on the same articular side of the joint.

55. The system according to claim 35, wherein the first joint surface and the second joint surface are on opposing articular sides of the joint.

56. The system according to claim 35, wherein the cross-referencing is performed using a member of the following group:

a spacer, a hinge or a rachet-like device.

57. The system according to claim 35, wherein the cross-referencing step includes indirectly cross-referencing the second template to the first template.

58. A method of joint arthroplasty, the method comprising:

(a) positioning at least one contact surface of a first template onto a first joint surface, the first template substantially conforming to said first joint surface;

(b) cross-referencing a second template to the first template to align position of the second template on a second joint surface, the second joint surface opposing the first joint surface, the second template including at least one guide; and

(c) directing movement of a surgical instrument using the at least one guide.

59. The system according to claim 58, wherein the cross-referencing is performed using a member of the following group:

a spacer, a hinge or a rachet-like device.

60. The system according to claim 59, wherein the spacer, hinge or rachet-like device is used for ligament balancing.

61. The system according to claim 58, wherein the cross-referencing step includes indirectly cross-referencing the second template to the first template.

62. A method of joint arthroplasty, the method comprising:

(a) positioning at least one contact surface of a first template onto a first cartilage surface, wherein the at least one contact surface of the first template substantially conforms to the first joint surface;

(b) cross-referencing a second template to the first template to align position of the second template onto a second joint surface, the at least one contact surface of the second template substantially conforming to the second joint surface, the second template including at least one guide; and

(c) directing movement of a surgical instrument using the at least one guide.

63. The system according to claim 62, wherein the cross-referencing step comprises cross referencing the second template relative to the first template using a member of the following group:

a spacer, a hinge or a rachet-like device.

64. The system according to claim 62, wherein the cross-referencing step includes indirectly cross-referencing the second template to the first template.

65. A method of joint arthroplasty, the method comprising:

(a) positioning at least one contact surface of a first template onto a first cartilage surface, the first template substantially conforming to said cartilage surface;

(b) cross-referencing a second template to the first template to align a position of the second template on a second joint surface, the second template including at least one guide, wherein cross-referencing allows rotation of the second template relative to one of a biomechanical and an anatomical axis of a limb; and

(c) directing movement of a surgical instrument using the at least one guide of the second template.

66. The system according to claim 65, wherein the cross-referencing step includes indirectly cross-referencing the second template to the first template.