TOTAL HIP REPLACEMENT SURGICAL GUIDE TOOL

• US 20090222016A1
• Filed: 02/23/2009
• Published: 09/03/2009
• Est. Priority Date: 02/29/2008
• Status: Active Grant

• Current Assignee: Howmedica Osteonics Corp. (Stryker Corporation)
• Original Assignee: Otismed Corporation (Stryker Corporation)
• Inventors: Koehle, Michael, Park, Ilwhan, Deveza, Lorenzo R.
• Granted Patent: US 9,408,618 B2
• Time in Patent Office: Days
• US Class Current: 606/89
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• CPC Class Codes: A61B 17/175 for preparing the femur for hip prosthesis insertion
• 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 2034/107 Visualisation of planned trajectories or target regions
• 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: A61F 2/3603 implanted without ablation of the whole natural femoral head endoprosthetic cartilage A61F2/30756
• CPC Class Codes: A61F 2/3609 Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts A61F2/3601 takes precedence
• 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 2002/505 using CAD-CAM techniques or NC-techniques
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: G05B 19/41885 characterised by modeling, simulation of the manufacturing system
• CPC Class Codes: Y02P 90/02 Total factory control, e.g. smart factories, flexible manufacturing systems [FMS] or integrated manufacturing systems [IMS]

Abstract

Disclosed herein is a surgical guide tool for use in total hip replacement surgery. The surgical guide tool may include a customized mating region and a resection guide. The customized mating region and the resection guide are referenced to each other such that, when the customized mating region matingly engages a surface area of a proximal femur, the resection guide will be aligned to guide a resectioning of the proximal femur along a preoperatively planned resection plane.

Claims

1. A surgical guide tool for use in the preparation of a proximal portion of a femur for the implantation of a total hip replacement prosthetic implant, the implant including a feature configured to abut against a resection surface of the proximal femur when the implant is fully implanted in the proximal femur in a manner that generally replicates a preoperatively planned implantation for the implant, the tool comprising:

a mating region and a saw guide, wherein, when the mating region matingly contacts the proximal portion, the saw guide is aligned with a resection plane generally corresponding to the resection surface.

2. The tool of claim 1, wherein the saw guide includes at least one planar surface.

3. The tool of claim 2, wherein the at least one planar surface forms a saw slot.

4. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the tool comprising:

a body including a saw guide and a mating region configured to matingly contact the surface region, the saw guide and mating region being positioned relative to each other so the saw guide is positioned to guide a resection that generally corresponds to a preoperatively planned resection plane when the mating region matingly contacts the surface region, the surface region including at least a portion of a superior-posterior region of the neck, the at least a portion of a superior-posterior region of the neck starting between approximately 1 mm and approximately 5 mm after a cartilage covering the head terminates distally and extending between approximately 15 mm and approximately 35 mm towards a trochanteric fossa.

5. The tool of claim 4, wherein the saw guide includes at least one planar surface.

6. The tool of claim 4, wherein the at least a portion of a superior-posterior region of the neck has an inferior border that begins approximately midway along an intertrochanteric crest and follows along the axis of the neck.

7. The tool of claim 6, wherein the at least a portion of a superior-posterior region of the neck has a superior border between approximately 1 mm and approximately 3 mm below a junction between superior and anterior surfaces of the neck.

8. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the tool comprising:

a body including a saw guide and a mating region configured to matingly contact the surface region, the saw guide and mating region being positioned relative to each other so the saw guide is positioned to guide a resection that generally corresponds to a preoperatively planned resection plane when the mating region matingly contacts the surface region, the surface region including at least a portion of a superior-posterior region of the neck, the at least a portion of a superior-posterior region of the neck including a narrow band that follows along an intertrochanteric crest and has a medial-lateral width of between approximately 0.5 mm and approximately 8 mm.

9. The tool of claim 8, wherein the saw guide includes at least one planar surface.

10. The tool of claim 8, wherein the at least a portion of a superior-posterior region of the neck begins approximately midway along the intertrochanteric crest and extends at least approximately 5 mm towards a most superior tip of a posterior surface of a greater trochanter.

11. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the tool comprising:

a body including a saw guide and a mating region configured to matingly contact the surface region, the saw guide and mating region being positioned relative to each other so the saw guide is positioned to guide a resection that generally corresponds to a preoperatively planned resection plane when the mating region matingly contacts the surface region, the surface region including at least a portion of a superior-anterior region of the neck, the at least a portion of a superior-anterior region of the neck starting between approximately 1 mm and approximately 5 mm after a cartilage covering the head terminates distally and extending between approximately 15 mm and approximately 35 mm to terminate before a tubercle.

12. The tool of claim 11, wherein the saw guide includes at least one planar surface.

13. The tool of claim 11, wherein the at least a portion of a superior-anterior region of the neck has a superior border approximately 1 mm to approximately 3 mm below a junction between superior and anterior surfaces of the neck.

14. The tool of claim 13, wherein the at least a portion of a superior-anterior region of the neck has an inferior border that is between approximately 5 mm and approximately 10 mm from the superior boarder.

15. The tool of claim 11, wherein the at least a portion of a superior-anterior region of the neck lies on an anterior greater trochanter, distal to a tubercle, and inferior to an origin of an obturator internus.

16. The tool of claim 15, wherein the at least a portion of a superior-anterior region has a medial-lateral distance that measures between approximately 3 mm to approximately 14 mm.

17. The tool of claim 15, wherein the at least a portion of a superior-anterior region has an inferior-superior distance that measures between approximately 3 mm to approximately 10 mm.

18. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the tool comprising:

a body including a saw guide and a mating region configured to matingly contact the surface region, the saw guide and mating region being positioned relative to each other so the saw guide is positioned to guide a resection that generally corresponds to a preoperatively planned resection plane when the mating region matingly contacts the surface region, the surface region including at least a portion of a superior-posterior region of the neck and at least a portion of a superior-anterior region of the neck, but does not include a junction between the superior-posterior and superior-anterior regions of the neck.

19. The tool of claim 18, wherein the saw guide includes at least one planar surface.

20. The tool of claim 18, wherein the at least a portion of the superior-posterior region of the neck includes an area that extends along the intertrochanteric chest, but does not include an area that spans portions of a trochanteric fossa.

21. The tool of claim 20, wherein the at least a portion of a superior-anterior region of the neck lies on an anterior greater trochanter, distal to a tubercle, and inferior to an origin of an obturator internus, but does not include portions of the tubercle.

22. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the tool comprising:

a body including a saw guide and a mating region configured to matingly contact the surface region, the saw guide and mating region being positioned relative to each other so the saw guide is positioned to guide a resection that generally corresponds to a preoperatively planned resection plane when the mating region matingly contacts the surface region, the surface region including at least a portion of a posterior region of the neck, the at least a portion of the posterior region of the neck including an area that extends towards a trochanteric fossa between approximately 15 mm and approximately 35 mm from a first point being between approximately 1 mm and approximately 5 mm distal of a distal termination of a cartilage covering the head.

23. The tool of claim 22, wherein the saw guide includes at least one planar surface.

24. The tool of claim 22, wherein the at least a portion of a posterior region of the neck has an inferior border that terminates up to approximately 5 mm superior to a border between posterior and inferior surfaces of the neck.

25. The tool of claim 22, wherein the at least a portion of a posterior region of the neck has a superior border that terminates approximately 0 mm to approximately 5 mm posterior of a border between posterior and anterior surfaces of the neck.

26. The tool of claim 22, wherein the at least a portion of a posterior region of the neck extends along an intertrochanteric crest from a lesser trochanter to a point near a tip of a greater trochanter.

27. The tool of claim 26, wherein the at least a portion of a posterior region of the neck does not include at least one of a portion of the trochanteric fossa and a portion of posterior region of the greater trochanter.

28. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the tool comprising:

a body including a saw guide and a mating region configured to matingly contact the surface region, the saw guide and mating region being positioned relative to each other so the saw guide is positioned to guide a resection that generally corresponds to a preoperatively planned resection plane when the mating region matingly contacts the surface region, the surface region including at least a portion of a posterior region of the neck, the at least a portion of the posterior region of the neck including an area that includes a narrow band measuring between approximately 0.5 mm and approximately 12 mm and following along an intertrochanteric crest.

29. The tool of claim 28, wherein the saw guide includes at least one planar surface.

30. The tool of claim 28, wherein the narrow band begins approximately 0 mm to approximately 12 mm superior to a lesser trochanter.

31. The tool of claim 30, wherein the narrow band extends approximately 0 mm to approximately 18 mm inferior to a most superior tip of a posterior surface of a greater trochanter.

32. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the tool comprising:

a body including a saw guide and a mating region configured to matingly contact the surface region, the saw guide and mating region being positioned relative to each other so the saw guide is positioned to guide a resection that generally corresponds to a preoperatively planned resection plane when the mating region matingly contacts the surface region, the surface region including at least a portion of a posterior region of the neck, the at least a portion of the posterior region of the neck including an area that extends towards a trochanteric fossa from a first point being between approximately 1 mm and approximately 5 mm distal of a distal termination of a cartilage covering the head, but does not include an area spanning portions of the trochanteric fossa.

33. The tool of claim 32, wherein the saw guide includes at least one planar surface.

34. The tool of claim 32, wherein the area spanning portions of the trochanteric fossa has a width generally transverse to a femoral longitudinal axis of between approximately 0 mm and approximately 20 mm.

35. The tool of claim 32, wherein the at least a portion of the posterior region of the neck further includes an area that includes a band following along an intertrochanteric crest, but does not include portions of a posterior greater trochanter.

36. The tool of claim 32, wherein the portions of the posterior greater trochanter has a distally extending dimension of between approximately 0 mm and approximately 12 mm.

37. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the tool comprising:

a body including a saw guide and a mating region configured to matingly contact the surface region, the saw guide and mating region being positioned relative to each other so the saw guide is positioned to guide a resection that generally corresponds to a preoperatively planned resection plane when the mating region matingly contacts the surface region, the surface region including at least a portion of an anterior region of the neck, the at least a portion of an anterior region of the neck extending up to approximately 8 mm laterally past an intertrochanteric line.

38. The tool of claim 37, wherein the saw guide includes at least one planar surface.

39. The tool of claim 37, wherein the surface region includes a medial surface of a greater trochanter.

40. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the tool comprising:

a body including a saw guide and a mating region configured to matingly contact the surface region, the saw guide and mating region being positioned relative to each other so the saw guide is positioned to guide a resection that generally corresponds to a preoperatively planned resection plane when the mating region matingly contacts the surface region, the surface region including at least a portion of a lateral posterior greater trochanter.

41. The tool of claim 40, wherein the saw guide includes at least one planar surface.

42. The tool of claim 40, wherein the surface region further includes at least a portion of a medial posterior greater trochanter.

43. The tool of claim 42, wherein the surface region does not include at least a portion of an intertrochanteric crest.

44. The tool of claim 40, wherein the surface region further includes at least a portion of a posterior region of the neck.

45. The tool of claim 44, wherein the surface region does not include at least a portion of a trochanteric fossa.

46. The tool of claim 40, wherein the surface region further includes at least a portion of a medial posterior greater trochanter and at least a portion of a posterior region of the neck, and wherein the surface region does not include at least a portion of an intertrochanteric crest and does not include at least a portion of an trochanteric fossa.

47. A surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur, the tool comprising:

a mating region and a saw guide, wherein, when the mating region matingly contacts the proximal portion, the saw guide is generally aligned with a preoperatively planned resection plane.

48. The tool of claim 47, wherein the saw guide includes at least one planar surface.

49. The tool of claim 48, wherein the at least one planar surface forms a saw slot.

50. The tool of claim 47, wherein the mating region includes contact surfaces and non-contact surfaces, wherein, when the mating region matingly contacts the proximal portion, the contact surfaces matingly contact surfaces of the proximal portion opposing the contact surfaces, and the non-contact surfaces are spaced apart from surfaces of the proximal portion opposing the non-contact surfaces.

51. The tool of claim 50, wherein the non-contact surfaces are a result of an overestimation process.

52. A method of manufacturing a surgical guide tool for use in total hip replacement surgery on a proximal portion of a femur having a head, a neck extending distally from the head, and a surface region distal the head, the method comprising:

a) generating medical imaging data associated with the proximal portion of the femur;

b) employing the imaging data to generate a three-dimensional computer-generated femur model of the proximal portion of the femur;

c) providing a three-dimensional computer-generated implant model;

d) providing a three-dimensional computer-generated tool model of at least a portion of at least a surgical guide tool and a surgical guide tool blank;

e) superimposing the femur model and implant model;

f) superimposing the tool model with the superimposed femur model and implant model;

g) computer generating manufacturing instructions from data determined from step f; and

h) employing the manufacturing instructions at a manufacturing machine to generate the surgical guide tool.

53. The method of claim 52, wherein the surgical guide tool is generated from a surgical guide tool blank.

54. The method of claim 52, wherein the implant model includes a shaft portion and a head portion.

55. The method of claim 54, wherein superimposing the femur model and implant model includes:

causing a center of the head of the implant model to generally coincide with a center of a head of the femur model; and

causing the shaft of the implant model to generally align with a shaft of the femur model.

56. The method of claim 52, wherein superimposing the tool model with the superimposed femur model and implant model includes causing the superimposed location of the tool model to generally correspond to a tool position to be employed by a selected surgical approach.

57. The method of claim 52, further comprising providing at least one of a three-dimensional computer generated sphere model and a computer generated rod model and at least one of:

superimposing the sphere model with the femur model so a center of the sphere model is caused to generally coincide with a center of a head of the femur model; and

superimposing the rod model with the femur model so the rod model is caused to generally align with a shaft of the femur model.

58. The method of claim 57, wherein superimposing the femur model and implant model includes at least one of:

causing a center of the head of the implant model to generally coincide with the center of the sphere model; and

causing the shaft of the implant model to generally align with the rod model.

59. The method of claim 52, wherein the medical imaging data is generated via at least one of MRI and CT.

60. The method of claim 52, wherein the manufacturing machine is at least one of a CNC machine and a SLA.

61. The method of claim 52, further comprising subjecting the medical imaging data to a segmentation process that determines bone contour lines and then adjusting the bone contour lines outward in locations of the bone contour lines corresponding to regions of the proximal portion of the femur that have surface topography that is unlikely to be accurately replicated during at least one of a three-dimensional computer modeling process and generating the tool via the machine.

62. The method of claim 61, wherein the surface topography is at least one of highly varied and too small to be manufactured into the tool.

63. The method of claim 61, further comprising employing the adjusted bone contour lines to generate the three-dimensional computer-generated femur model of the proximal portion of the femur.

64. The method of claim 61, wherein the regions of the proximal portion of the femur that have surface topography that is unlikely to be accurately replicated includes at least one of a portion of a tubercle and a portion of a superior intersection between anterior and posterior regions of the neck.

65. The method of claim 61, wherein the regions of the proximal portion of the femur that have surface topography that is unlikely to be accurately replicated includes at least one of a portion of a trochanteric fossa and a portion of a superior intersection between anterior and posterior regions of the neck.

66. The method of claim 61, wherein the regions of the proximal portion of the femur that have surface topography that is unlikely to be accurately replicated includes at least one of a portion of a trochanteric fossa and a portion of a posterior greater trochanter near an intertrochanteric crest.

67. The method of claim 61, wherein the regions of the proximal portion of the femur that have surface topography that is unlikely to be accurately replicated includes at least one of a portion of a trochanteric fossa and a portion of an intertrochanteric crest.

68. The method of claim 52, wherein the data determined from step f includes a resection plane corresponding to a planar surface of a spacer region of the implant model.

69. The method of claim 68, wherein the data determined from step f further includes a mating surface corresponding to a region of the femur model contacted by the tool model.

70. The method of claim 69, wherein the mating surface and resection plane are positionally referenced to each other.

71. The method of claim 70, wherein the mating surface and resection plane are respectively used to define an indexing surface and a saw guide in the tool, the indexing surface and saw guide being configured such that, when the indexing surface matingly contacts the proximal femur, the saw guide will be positioned to facilitate a resection of the proximal femur corresponding to a preoperatively planned resection.