PATIENT SPECIFIC ALIGNMENT GUIDE FOR A PROXIMAL FEMUR

• US 20100286700A1
• Filed: 05/07/2010
• Published: 11/11/2010
• Est. Priority Date: 05/07/2009
• Status: Active Grant

• Current Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Original Assignee: Smith & Nephew Incorporated (Smith & Nephew PLC)
• Inventors: Bourne, Timothy J., Salehi, Abraham B., Demmer, Matthew J., Gatewood, James, Snider, Ashley M., Nishimoto, Bryan I., Mehl, David, Frederick, Phillip
• Granted Patent: US 9,561,041 B2
• Time in Patent Office: Days
• US Class Current: 606/89
• CPC Class Codes: A61B 17/175 for preparing the femur for hip prosthesis insertion
• 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: Y10T 29/49 Method of mechanical manufacture

Abstract

An alignment guide for aligning instrumentation along a proximal femur includes a neck portion configured to wrap around a portion of the neck of the femur, a head underside portion configured to abut a disto-lateral portion of the femoral head and a medial head portion configured to overlie a medial portion of the head. Portions of the guide can have an inner surface generally a negative of the femoral bone of a specific patient that the guide overlies; such surfaces can be formed using data obtained from the specific patient. The neck portion can be configured to rotationally stabilize the guide by abutting and generating a first gripping force on the neck. The femoral head portions can be configured to grip the head portion of the femur and can support a bore guide that is configured to guide an instrument to the femur in a specified location and along a given axis.

Claims

1. An alignment guide configured to conform to portions of a femoral neck and a femoral head of a femur of a specific patient, the guide comprising:

a central member that includes at least one bore guide, the at least one bore guide oriented and configured to guide formation of a bore in the femoral head of the specific patient;

a plurality of arms extending from the central member, each arm having an inner surface, at least a portion of the inner surface of each arm configured in shape to contact at least one portion of the femoral head of the specific patient;

at least one head underside member connected to at least one of the arms, the at least one head underside member including an inner surface;

at least one neck member connected to the at least one head underside member, the at least one neck member including an inner surface;

at least a portion of at least one of the at least one head underside member inner surface and the at least one neck member inner surface configured in shape to contact at least one portion of the femur of the specific patient;

wherein the portions of the inner surfaces of the arms, the at least one head underside member and the at least one neck member that are configured in shape to contact at least one portion of the femoral head and femoral neck of the patient are configured in shape using data obtained from the specific patient regarding the shape of the specific patient'"'"'s femur; and

wherein the plurality of arms, the at least one head underside member and the at least one neck member are configured to cause the alignment guide to grip the specific patient'"'"'s femoral head during formation of the bore in the specific patient'"'"'s femoral head, and to be removably retained in place on the specific patient'"'"'s femoral head in order to orient the at least one bore guide to guide formation of the bore in the specific patient'"'"'s femoral head.

2. An alignment guide according to claim 1 further comprising a curved sleeve cutter guide connected to at least one of the arms, the sleeve cutter guide configured to indicate a potential location of a surface formed by a sleeve cutter.

3. An alignment guide according to claim 1 configured to snap on to the femur of the specific patient.

4. An alignment guide according to claim 1 further comprising indicia located on an outer surface of the guide, the indicia oriented and configured to indicate alignment of the guide relative to varus/valgus angulation or version angulation.

5. An alignment guide according to claim 1 further comprising a slit formed in the central member and the bore guide, the slit configured to permit the guide to be withdrawn from a structure extending from the femoral head of the specific patient.

6. An alignment guide according to claim 1 further comprising a boss formed on the outer surface of the guide, the boss including structure adapted to receive a stylus for aid in alignment of the guide relative to the femoral head.

7. An alignment guide according to claim 1 further comprising two head underside members, the head underside members connected to at least one of the arms and to at least one of the neck members to define a window.

8. An alignment guide according to claim 5 further comprising a finger extending from the central member, the finger including an inner surface, portions of the inner surface of the finger configured in shape to conform to portions of the femoral head of the specific patient.

9. An alignment guide according to claim 8 wherein the finger is bifurcated and configured to permit the guide to be withdrawn from a structure extending from the femoral head of the specific patient.

10. An alignment guide according to claim 1 wherein the central member, arms, at least one head underside member, and neck member are configured in shape to feature minimal size sufficient to snap on to the femoral head and to grip the femoral head while conforming to the femoral head, whereby the alignment guide is configured to be installed and withdrawn in anterior approach hip surgery on the specific patient.

11. An alignment guide according to claim 1 wherein at least one arm is configured to extend distally from the central member when the guide is installed on the femur of the specific patient, and another arm is configured to extend anteriorly or posteriorly from the central member when the guide is installed on the femur of the specific patient.

12. An alignment guide according to claim 1 wherein substantially all of the inner surfaces of the arms, the at least one head underside member and the at least one neck member are configured in shape to conform to a portion of the femur of the specific patient.

13. An alignment guide according to claim 1, further comprising an alignment structure connected to the alignment guide, the alignment structure including a plane or axis that is substantially coplanar to a longitudinal axis of at least one bore guide.

14. An alignment guide according to claim 1 comprising a plurality of bore guides, the bore guides configured and oriented to allow adjustment of angulation of the bore formed in the specific patient'"'"'s femoral head in at least one of varus/valgus and version angulation.

15. An alignment guide according to claim 14 wherein the bore guides are formed in the central member, and the central member is generally planar in shape.

16. An alignment guide according to claim 14 wherein the bore guides are formed in the central member, and the central member is generally cruciform in shape.

17. An alignment guide configured to conform to portions of a femoral neck and a femoral head of a femur of a specific patient, the guide comprising:

a central member that includes at least one bore guide, the at least one bore guide oriented and configured to guide formation of a bore in the femoral head of the specific patient;

at least two arms extending from the central member, each arm having an inner surface, at least a portion of the inner surface of each arm configured in shape to contact portions of the specific patient'"'"'s femur, wherein a first of the arms is configured to extend distally from the central member when the guide is installed on the specific patient'"'"'s femur, and a second of the arms is configured to extend from the central member in a direction different than the direction in which the first arm extends;

at least one head underside member connected to at least one of the arms, the at least one head underside member including an inner surface;

at least one neck member connected to the at least one head underside member, the at least one neck member including an inner surface;

at least one of the at least one head member inner surface and the at least one neck member inner surface including a portion that is configured in shape to contact portions of the specific patient'"'"'s femur;

a slit formed in the central member and the bore guide, the slit configured to permit the guide to be withdrawn from a structure extending from the patient'"'"'s femoral head;

wherein the portions of the inner surfaces of the arms, the at least one head underside member and the at least one neck member that are configured in shape to contact portions of the femoral head and femoral neck of the specific patient are configured using data obtained from the specific patient regarding the shape of the specific patient'"'"'s femur;

wherein all parts of the alignment guide are configured to be sufficiently small and nonobtrusive relative to the specific patient'"'"'s anatomy so as to permit the guide to be usable in anterior approach hip resurfacing surgery on the specific patient; and

wherein the guide is configured to grip the specific patient'"'"'s femoral head in removable fashion when placed on the specific patient'"'"'s femoral head in order to allow orientation of the at least one bore guide for formation of a bore in the specific patient'"'"'s femoral head.

18. An alignment guide according to claim 17 further comprising a curved sleeve cutter guide connected to the alignment guide, the sleeve cutter guide configured to indicate potential location of a surface formed by a sleeve cutter.

19. An alignment guide according to claim 17 further comprising indicia on the alignment guide, the indicia configured to aid in orienting the alignment guide relative to the specific patient'"'"'s anatomy in at least on of the following alignment directions:

varus/valgus, and version.

20. An alignment guide according to claim 17 further comprising a boss on the guide, the boss including structure configured to receive a stylus.

21. An alignment guide according to claim 17 further comprising two head underside members, the head underside members connected to at least one arm and at least one neck member to define at least one window.

22. An alignment guide according to claim 17 further comprising a finger extending from the central member, the finger including an inner surface, portions of the inner surface of the finger configured in shape to contact portions of the femoral head of the specific patient.

23. An alignment guide according to claim 22 wherein the finger is bifurcated and configured to permit the guide to be withdrawn from a structure extending from the femoral head of the specific patient.

24. An alignment guide according to claim 17 wherein substantially all of the inner surfaces of the arms, the at least one head underside member and the at least one neck member are configured in shape to contact a portion of the femur of the specific patient.

25. An alignment guide according to claim 17, further comprising an alignment structure coupled to the alignment guide, the alignment structure including an axis or plane that is substantially coplanar to a longitudinal axis of at least one of the at least one bore guides.

26. An alignment guide according to claim 17 comprising a plurality of bore guides, the bore guides configured and oriented to allow adjustment of angulation of the bore formed in the specific patient'"'"'s femoral head in at least one of varus/valgus and version angulation.

27. An alignment guide according to claim 26 wherein the bore guides are formed in the central member, and the central member is generally planar in shape.

28. An alignment guide according to claim 26 wherein the bore guides are formed in the central member, and the central member is generally cruciform in shape.

29. A method for making an alignment guide configured to conform to portions of a femoral neck and a femoral head of a femur of a specific patient, comprising:

receiving data obtained from the specific patient regarding shape of the specific patient'"'"'s femur; and

preparing, using the data, the alignment guide, including;

preparing a central member that includes at least one bore guide, including orienting and configuring the at least one bore guide to guide formation of a bore in the femoral head of the specific patient;

preparing at least two arms extending from the central member, including preparing on each arm an inner surface, including automatically configuring, using the data, at least a portion of the inner surface of each arm to conform in shape to contact portions of the specific patient'"'"'s femur, and including configuring a first of the at least two arms to extend distally from the central member when the guide is installed on the specific patient'"'"'s femur, and a second of the at least two arms to extend from the central member in a direction different from the direction in which the first arm extends;

preparing at least one head underside member connected to at least one of the arms, including preparing on the at least one head underside member an inner surface;

preparing at least one neck member connected to the at least one head underside member, including preparing on the at least one neck member an inner surface;

automatically configuring, using the data, at least a portion of at least one of the at least one head underside member inner surface and the at least one neck member inner surface to conform in shape to contact portions of the specific patient'"'"'s femur; and

wherein such preparation of the alignment guide configures all parts of the guide to be sufficiently small and nonobtrusive relative to the specific patient'"'"'s anatomy so as to permit the guide to be usable in anterior approach hip resurfacing surgery on the specific patient; and

wherein such preparation of the alignment guide configures the alignment guide to grip the specific patient'"'"'s femoral head in removable fashion when placed on the specific patient'"'"'s femoral head in order to allow orientation of the at least one bore guide for formation of a bore in the specific patient'"'"'s femoral head.

30. A method according to claim 29 further comprising preparing a curved sleeve cutter guide on the alignment guide, including configuring the sleeve cutter guide to indicate potential location of a surface on the specific patient'"'"'s femoral head to be formed by a sleeve cutter.

31. A method according to claim 29 further comprising preparing indicia on the guide to aid in orienting the guide relative to the specific patient'"'"'s femoral head in at least one of the following directions:

varus/valgus and version.

32. A method according to claim 29 further comprising preparing a boss on the guide, including preparing boss structure to receive a stylus.

33. A method according to claim 29 further comprising preparing two head underside members, the head underside members connected to at least one arm and at least one neck member to define at least one window.

34. A method according to claim 29 further comprising preparing a finger extending from the central member, the finger including an inner surface, including configuring portions of the inner surface of the finger to conform in shape to portions of the femoral head of the specific patient.

35. A method according to claim 34 further comprising preparing the finger to be bifurcated and configured to permit the guide to be withdrawn from structure extending from the femoral head of the specific patient.

36. A method according to claim 29 including automatically configuring substantially all of the inner surfaces of the arms, the at least one head underside member and the at least one neck member to conform in shape to a portion of the femur of the specific patient.

37. A method according to claim 29 including forming an alignment structure coupled to the alignment guide, the alignment structure including an axis or plane that is substantially coplanar to a longitudinal axis of at least one of the at least one bore guides.

38. A method according to claim 29 including configuring the alignment guide to include a plurality of bore guides, including configuring the bore guides to be oriented to allow adjustment of angulation of the bore formed in the specific patient'"'"'s femoral head in at least one of varus/valgus and version angulation.

39. A method according to claim 38 including forming the bore guides in the central member, and forming the central member to be generally planar in shape.

40. A method according to claim 38 including forming the bore guides in the central member, and forming the central member to be generally cruciform in shape.

41. A method of installing an alignment guide configured to conform to portions of a femoral neck and a femoral head of a femur of a specific patient;

including;

receiving an alignment guide that comprises;

a central member that includes at least one bore guide, the at least one bore guide oriented and configured to guide formation of a bore in the femoral head of the specific patient;

a plurality of arms extending from the central member, each arm having an inner surface, at least a portion of the inner surface of each arm configured in shape to contact at least one portion of the femoral head of the specific patient;

at least one head underside member connected to at least one of the arms, the at least one head underside member including an inner surface;

at least one neck member connected to the at least one head underside member, the at least one neck member including an inner surface;

at least a portion of at least one of the at least one head underside member inner surface and the at least one neck member inner surface configured in shape to contact at least one portion of the femur of the specific patient;

wherein the portions of the inner surfaces of the arms, the at least one head underside member and the at least one neck member that are configured in shape to contact at least one portion of the femoral head and femoral neck of the patient are configured in shape using data obtained from the specific patient regarding the shape of the specific patient'"'"'s femur; and

wherein the plurality of arms, the at least one head underside member and the at least one neck member are configured to cause the alignment guide to grip the specific patient'"'"'s femoral head during formation of the bore in the specific patient'"'"'s femoral head, and to be removably retained in place on the specific patient'"'"'s femoral head in order to orient the at least one bore guide to guide formation of the bore in the specific patient'"'"'s femoral head;

creating an incision in the specific patient and accessing the specific patient'"'"'s femoral head;

installing the alignment guide on the specific patient'"'"'s femur;

preparing a bore in the specific patient'"'"'s femoral head using the alignment guide;

resecting the specific patient'"'"'s femur using the bore;

installing an implant on the resected femur; and

completing the surgery.

42. A method according to claim 41 further comprising providing an alignment guide that further comprises a curved sleeve cutter guide configured to indicate potential location of a surface formed by a sleeve cutter, and using the sleeve cutter guide to aid in aligning the alignment guide on the specific patient'"'"'s femur.

43. A method according to claim 41 further comprising providing an alignment guide that comprises indicia configured to aid in orienting the guide relative to the specific patient'"'"'s femur in at least one of varus/valgus and version alignment directions, and using the indicia to aid in aligning the alignment guide on the specific patient'"'"'s femur.

44. A method according to claim 41 further comprising providing an alignment guide that further comprises a boss, the boss including structure configured to receive a stylus, placing a stylus in the boss, and using the stylus to aid in aligning the alignment guide on the specific patient'"'"'s femur

45. A method according to claim 41 further comprising providing an alignment guide that further comprises two head underside members, the head underside members connected to at least one arm and at least one neck member to define at least one window, and using the at least one window to aid in aligning the alignment guide on the specific patient'"'"'s femur.

46. A method according to claim 41 further comprising providing an alignment guide that further comprises a finger extending from the central member, the finger including an inner surface, portions of the inner surface of the finger configured in shape to contact portions of the femoral head of the specific patient.

47. A method according to claim 46 further comprising providing a finger that is bifurcated and configured to permit the alignment guide to be withdrawn from a structure extending from the femoral head of the specific patient.

48. A method according to claim 41 further comprising providing an alignment guide wherein substantially all of the inner surfaces of the arms, the at least one head underside member and the at least one neck member are configured in shape to conform to a portion of the femur of the specific patient.

49. A method according to claim 41 further comprising providing an alignment guide wherein the inner surfaces of the arms, the at least one head underside member and the at least one neck member that are configured in shape to contact portions of the femoral head and femoral neck of the patient are configured using data obtained from the specific patient regarding the shape of the specific patient'"'"'s femur.

50. A method according to claim 41 further comprising providing an alignment guide further comprising an alignment structure coupled to the alignment guide, the alignment structure including a plane or axis that is substantially coplanar to a longitudinal axis of the bore guide, and using the alignment structure to aid in aligning the alignment guide on the specific patient'"'"'s femur.

51. A method according to claim 41 further comprising providing an alignment guide comprising a plurality of bore guides, the bore guides configured and oriented to allow adjustment of angulation of the bore formed in the specific patient'"'"'s femoral head in at least one of varus/valgus and version angulation.

52. A method according to claim 51 further comprising providing an alignment guide wherein the bore guides are formed in the central member, and the central member is generally planar in shape.

53. A method according to claim 51 further comprising providing an alignment guide wherein the bore guides are formed in the central member, and the central member is generally cruciform in shape.