Surgical templates

• US 8,496,663 B2
• Filed: 03/20/2008
• Issued: 07/30/2013
• Est. Priority Date: 03/23/2007
• Status: Active Grant

• Current Assignee: Xiros Limited
• Original Assignee: Xiros Limited
• Inventors: White, Derrick, Seedhom, Bahaa, Chelule, Kenneth Langat
• Primary Examiner(s): Truong, Kevin T
• Assistant Examiner(s): BECCIA, CHRISTOPHER J
• Application Number:
  US12/532,817
• Publication Number:
  US 20100191244A1
• Time in Patent Office: 1,958 Days
• Field of Search: 606/86.R, 606 87- 89, 606 96- 98, 606/104
• US Class Current: 606/88
• 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 17/17 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 17/1764 for the knee
• CPC Class Codes: A61B 17/56 Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
• CPC Class Codes: A61B 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• CPC Class Codes: A61B 90/94 coded with symbols, e.g. text
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/389 Tibial components A61F2/3868 takes precedence
• CPC Class Codes: A61F 2/461 of knees
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A surgical template system for use in working on a bone comprises: a tool guide block comprising at least one guide aperture for receiving and guiding a tool to work on a bone; locating means comprising a plurality of locating members, each member having a respective end surface for positioning against a surface of the bone; and attachment means for non-adjustably attaching the tool guide block to the locating means such that, when attached, the member end surfaces are secured in fixed position with, respect to each other, for engaging different respective portions of the surface of the bone, and the at least one guide aperture is secured in a fixed position with respect to the end surfaces. Corresponding methods of manufacturing a surgical template system, methods of manufacturing locating means for a surgical template system, methods of fitting a prosthesis to a bone, surgical methods, and surgical apparatus are described.

Claims

1. A surgical template system for use in working on a bone, comprising:

a tool guide block comprising at least one guide aperture for receiving and guiding a tool to work on a bone;

patient specific locating means comprising a plurality of locating members, each member having a respective end surface adapted to conform to a respective portion of a predetermined surface of a specific bone of a patient; and

non-adjustable attachment means adapted to non-adjustably attach the tool guide block to the locating means such that, when attached, the member end surfaces are secured in fixed position with respect to each other, for engaging the different respective portions of said surface of the bone, the at least one guide aperture is secured in a fixed position with respect to the end surfaces, and the end surfaces of the locating members conform to said predetermined surface so as to enable the attached locating means and tool guide block to be seated in a defined position with respect to the specific bone, with each member end surface in contact with its respective portion of the bone surface, and wherein the tool guide block is formed from a first material and the locating means is formed from a second, different material.

2. A system in accordance with claim 1, wherein the locating means has been manufactured using a method comprising:

determining a surface shape of said specific bone to be worked on;

manufacturing the locating means according to the determined shape.

3. A system in accordance with claim 1, wherein a plurality of said member end surfaces are adapted to be in contact with respective portions of a non-articular surface of the bone when the attached locating means and tool guide block are seated in said defined position.

4. A system in accordance with claim 1, wherein at least one member end surface is adapted to be in contact with a portion of an articular surface of the bone when the attached locating means and tool guide block are seated in said defined position.

5. A system in accordance with claim 1, wherein the first material is harder than the second material.

6. A system in accordance with claim 1, wherein the tool guide block is formed from a metal.

7. A system in accordance with claim 1, wherein the locating means is formed from a non-metallic material.

8. A system in accordance with claim 1, wherein the locating means is formed from a plastic.

9. A system in accordance with claim 1, wherein the locating means has been formed by a rapid prototyping technique.

10. A system in accordance with claim 1, wherein at least one of said locating members is cylindrical.

11. A system in accordance with claim 1, wherein at least one of said locating members is elongate.

12. A system in accordance with claim 1, wherein at least one of said locating members is a locating finger.

13. A system in accordance with claim 1, wherein the locating means and guide block are arranged such that, when attached together, each guide aperture is arranged to guide a tool so as to avoid the locating means.

14. A system in accordance with claim 1, further comprising securing means for securing the attached locating means and tool guide block to a bone to be worked on.

15. A system in accordance with claim 14, wherein at least one said member comprises a bore extending through the member to the member'"'"'s end surface, and the securing means comprises a pin adapted to extend through the bore so as to be drivable into a bone surface to pin the member to the bone.

16. A system in accordance with claim 15, further comprising a sleeve arranged to line said bore, wherein the pin is adapted to extend through the sleeve.

17. A system in accordance with claim 15, wherein a plurality of said members comprise said bores, and the securing means comprises a plurality of said pins.

18. A system in accordance with claim 15, wherein each said bore is arranged so as to be perpendicular to a respective portion of the surface of a predetermined bone against which the respective end surface is adapted to seat.

19. A system in accordance with claim 15, wherein the locating means and guide block are arranged such that, when attached together, the or each guide aperture is arranged to guide a tool so as to avoid the locating means and the or each pin when driven into a bone surface.

20. A system in accordance with claim 1, wherein said at least one guide aperture comprises at least one slot for guiding a saw blade.

21. A system in accordance with claim 20, wherein said at least one slot comprises an open ended slot.

22. A system in accordance with claim 1, wherein said at least one guide aperture comprises at least one hole for guiding a drill bit.

23. A system in accordance with claim 1, wherein said tool guide block comprises a plurality of said guide apertures.

24. A system in accordance with claim 1, wherein the locating means comprises a body portion and a plurality of said locating members extending from the body portion to their respective end surfaces, and the attachment means is adapted to attach said body portion to the tool guide block.

25. A system in accordance with claim 24, wherein said body portion and the members extending from it are integral.

26. A system in accordance with claim 24, wherein the locating means further comprises an additional locating member having an end surface for positioning against a bone surface, and means for releasably attaching the additional locating member to the body portion such that the additional locating member extends from the body portion to its end surface, whereby the additional locating member may be attached to the body portion to assist in seating the attached locating means and guide block against a bone to be worked on, and then removed to facilitate working on the bone.

27. A system in accordance with claim 24, wherein the body portion and guide block are adapted to key together in a defined position.

28. A system in accordance with claim 1, wherein said attachment means comprises at least one screw or bolt.

29. A system in accordance with claim 1, wherein the tool guide block comprises a first portion including at least one guide aperture and a second portion including at least one guide aperture.

30. A system in accordance with claim 29, wherein the tool guide block further comprises a connecting portion connecting said first portion to the second portion.

31. A system in accordance with claim 30 wherein the first, second, and connecting portions are integral.

32. A system in accordance with claim 30, wherein the connecting portion comprises a web.

33. A system in accordance with claim 32, wherein at least one of said guide apertures comprises a slot having a length, and the web has a thickness substantially smaller than said length.

34. A system in accordance with claim 29, wherein said first portion comprises at least one slot for guiding a saw blade to make a cut in a plane, and said second portion comprises at least one slot or guide hole for guiding a saw blade or drill bit respectively to make a cut or hole in a direction perpendicular to said plane.

35. A system in accordance with claim 29, wherein said first portion includes a guide slot for guiding a saw blade to cut off an end portion of a bone against which the assembled locating means and guide block are positioned and said second portion includes a plurality of guide holes to guide a drill bit to drill into the sawn end surface.

36. A system in accordance with claim 1 and for working on a femur, wherein the locating means is arranged such that, when attached to the tool guide block, the member end surfaces are positioned to seat the locating means and guide block in a predetermined position on a specific femur by engaging non-articular surface portions of the femur.

37. A system in accordance with claim 36, wherein the tool guide block comprises a first portion including a guide slot for guiding a saw blade to cut off an end portion of the femur to leave a sawn end surface when the block and locating means are seated in the predetermined position, and a second portion including a plurality of guide holes to guide a drill bit to drill into the sawn end surface.

38. A system in accordance with claim 37, wherein the second portion further comprises at least one guide slot for guiding a saw blade to make at least one further cut in the femur.

39. A system in accordance with claim 36, wherein the locating means comprises an additional locating member having an end surface for positioning against an anterior surface of the femur.

40. A system in accordance with claim 39, wherein the additional locating member end surface is adapted for positioning against the trochlea of the femur.

41. A system in accordance with claim 39, further comprising means for releasably securing the additional locating member with respect to the guide block and locating member end surfaces, whereby the additional locating member may be secured in place to assist in seating the attached locating means and guide block against the femur, and then removed to facilitate working on the femur.

42. A system in accordance with claim 1 and for working on a tibia, wherein the locating means is arranged such that, when attached to the tool guide block, a plurality of said member end surfaces are positioned to seat the locating means and guide block in a predetermined position on a specific tibia by engaging non-articular surface portions of the tibia.

43. A system in accordance with claim 1, wherein the locating means comprises a first body portion and a first plurality of said locating members extending from the first body portion to their respective end surfaces, and a separate second body portion and a second plurality of said locating members extending from the second body portion to their respective end surfaces, and the attachment means is adapted to attach said first body portion to the tool guide block and said second body portion to the tool guide block.

44. A system in accordance with claim 43, wherein the first body portion and the first plurality of said locating members are integral.

45. A system in accordance with claim 43, wherein the second body portion and the second plurality of said locating members are integral.

46. A system in accordance with claim 43, wherein the tool guide block comprises a first portion including at least one guide aperture and a second portion including at least one guide aperture, the tool guide block further comprises a connecting portion connecting said first portion to the second portion, and the attachment means is adapted to attach said first body portion to the first portion of the tool guide block and said second body portion to the second portion of the tool guide block.

47. A system in accordance with claim 46, wherein said first portion of the guide block is adapted to extend around an arc of less than 100 degrees.

48. A system in accordance with claim 46, wherein said first portion is generally arcuate.

49. A system in accordance with claim 46, wherein the connecting portion comprises a web portion connected at or proximal one end of the first portion.

50. A system in accordance with claim 46, wherein said second portion of the guide block comprises a composite guide aperture comprising a hole portion for guiding a drill bit to drill a hole in a bone, and at least one slot portion for guiding a saw blade to make a cut extending from said hole.

51. A system in accordance with claim 43 and adapted for working on a tibia, wherein the end surfaces of the first plurality of locating members are adapted to seat on respective portions of a non-articular surface of a specific tibia and the end surfaces of the second plurality of locating members are adapted to seat on respective portions of an articular surface of the specific tibia.

52. A system in accordance with claim 1, wherein said tool guide block is a first tool guide block, the system further comprising a second tool guide block including at least one additional guide aperture.

53. A system in accordance with claim 52, wherein said first tool guide block comprises at least one guide slot for guiding a saw blade to cut a bone to provide a flat surface and at least one guide hole to guide a drill bit to drill at least one hole in the flat surface, and the second tool guide block has a flat surface adapted to sit on the bone flat surface prepared using the first tool guide block and comprises at least one protruding member extending from the block flat surface to locate in the at least one hole, to locate the second guide block on the bone flat surface.

54. A system in accordance with claim 52, wherein said first tool guide block further comprises mounting means for mounting the second guide block on the first guide block after the first guide block has been used to guide at least one tool to work on the bone.

55. A system in accordance with claim 1, wherein the locating means comprises an additional body portion and at least one additional locating protrusion extending from the additional body portion and having an additional end surface for locating against an additional bone surface portion to help seat the locating means and attached guide block on the bone, and wherein the attachment means is adapted to releasably and non-adjustably attach the additional body portion to the guide block.

87. A system in accordance with claim 1, wherein the attachment means is adapted to releasably and non-adjustably attach the tool guide block to the locating means.

88. A system in accordance with claim 1, wherein said tool guide block further comprises a bore extending through the tool guide block, and the system comprises a pin adapted to extend through the guide block bore so as to be insertable into a bone surface to pin the guide block to the bone.

89. A system in accordance with claim 88, wherein the tool guide block comprises a plurality of said bores, and the system comprises a respective pin for each tool guide block bore.

90. A system in accordance with claim 89, wherein the plurality of tool guide block bores comprises a pair of parallel bores arranged such that when their respective pins are inserted into the bone the pins constrain the tool guide block in directions transverse to the parallel bores, but not in a direction along said parallel bores.

91. A system in accordance with claim 1, wherein the locating means further comprises at least one feature having a dimension measurable to check a manufacturing accuracy of the locating means.

92. A system in accordance with claim 1, wherein the locating means further comprises at least one pair of indicia having a separation measurable to check a manufacturing accuracy of the locating means.

93. A system in accordance with claim 1, wherein the system further comprises a gauge adapted to engage the locating means to provide a check on a manufacturing accuracy of the locating means.

94. A system in accordance with claim 93, wherein the locating means comprises at least one feature adapted to mate with the gauge to provide said check.

98. Surgical apparatus comprising:

locating means for a surgical template system in accordance with claim 1; and

patient identification means providing an indication of the patient to whom said bone to be worked on belongs.

99. Surgical apparatus in accordance with claim 98, further comprising linking means linking the locating means to the patient identification means.

100. Surgical apparatus in accordance with claim 98, wherein the locating means comprises locating means for a template system for a femur and for a template system for a tibia for a specific knee joint of a particular patient.

101. Surgical apparatus in accordance with claim 99, wherein the locating means, patient identification means, and linking means have been manufactured together using a rapid prototyping technique.

102. Surgical apparatus in accordance with claim 98, further comprising an indicator, manufactured together with and integrally with a locating means, the indicator comprising at least one feature having a dimension measurable to provide a check on a manufacturing accuracy of the locating means.

103. A system in accordance with claim 1, wherein the non-adjustable attachment means comprises a snap-fit mechanism.

104. A system in accordance with claim 1, wherein the non-adjustable attachment means is adapted to non-releasably and non-adjustably attach the tool guide block to the locating means.

56. A method of manufacturing a surgical template system for use in working on a bone, the template system comprising a tool guide block comprising at least one guide aperture for receiving and guiding a tool to work on a bone, locating means comprising a plurality of locating members, each member having a respective end surface for positioning against a surface of the bone, and attachment means for non-adjustably attaching the tool guide block to the locating means such that, when attached, the member end surfaces are secured in fixed position with respect to each other, for engaging different respective portions of the surface of the bone, and the at least one guide aperture is secured in a fixed position with respect to the end surfaces, the manufacturing method comprising:

determining a surface shape of a bone to be worked on;

manufacturing the locating means according to the determined shape such that when the locating means is attached to the tool guide block the locating member end surfaces conform to different respective portions of the bone surface and enable the attached locating means and tool guide block to be seated in a defined position with respect to the bone, with each member end surface in contact with its respective portion of the bone surface; and

manufacturing the tool guide block from a first material and manufacturing the locating means from a second, different material.

57. A method in accordance with claim 56, wherein said manufacturing of the locating means further comprises manufacturing the locating means according to the determined shape such that a plurality of said member end surfaces are adapted to be in contact with respective portions of a non-articular surface of the bone when the attached locating means and tool guide block are seated in said defined position.

58. A system in accordance with claim 56, wherein at least one member end surface is adapted to be in contact with a portion of an articular surface of the bone when the attached locating means and tool guide block are seated in said defined position.

59. A method in accordance with claim 56, comprising manufacturing the tool guide block from a metal.

60. A method in accordance with claim 56, comprising manufacturing the locating means using a rapid prototyping technique.

61. A method in accordance with claim 56, further comprising manufacturing the locating means and guide block such that, when attached together, the or each guide aperture is arranged to guide a tool so as to avoid the locating means.

62. A method in accordance with claim 56, comprising manufacturing the locating means such that at least one said member comprises a bore extending through the member to the member'"'"'s end surface, such that a pin can be driven through the bore into the bone surface to secure the locating means to the bone.

63. A method in accordance with claim 62, further comprising manufacturing the locating means and guide block such that, when attached together, the or each guide aperture is arranged to guide a tool so as to avoid the or each pin driven into the bone through a respective said bore.

64. A method in accordance with claim 62, wherein each said bore is arranged so as to be generally perpendicular to a respective portion of the surface of said bone against which the respective end surface is adapted to seat.

65. A method in accordance with claim 56, wherein manufacturing the locating means comprises manufacturing a body portion and a plurality of said locating members attached to and extending from the body portion to their respective end surfaces.

66. A method in accordance with claim 65, comprising manufacturing said body portion and the members extending from it as an integral unit.

67. A method in accordance with claim 66, wherein manufacturing the locating means further comprises manufacturing an additional locating member according to the determined shape, the additional locating member having an end surface for positioning against the bone surface, and the method further comprises providing means for releasably attaching the additional locating member to the body portion such that the additional locating member extends from the body portion to its end surface, whereby the additional locating member may be attached to the body portion to assist in seating the attached locating means and guide block against the bone to be worked on, and then removed to facilitate working on the bone.

68. A method in accordance with claim 56, wherein the tool guide block comprises a first portion, comprising at least one guide aperture, a second portion, comprising at least one guide aperture, and a connecting portion connecting said first portion to the second portion, the method comprising manufacturing the first, second, and connecting portions as an integral unit.

69. A method in accordance with claim 56, where the bone is a femur.

70. A method in accordance with claim 67, wherein the bone is a femur, and the additional locating member end surface is arranged for positioning against an anterior surface of the femur.

71. A method in accordance with claim 56, where the bone is a tibia.

72. A method in accordance with claim 71, wherein the locating means is manufactured such that, when attached to the tool guide block, a plurality of said member end surfaces are positioned to seat the locating means and guide block in a predetermined position on the tibia by engaging non-articular surface portions of the tibia.

73. A method in accordance with claim 72, further comprising manufacturing the locating means such that, when attached to the tool guide block, a plurality of said member end surfaces are positioned to seat the locating means and guide block in a predetermined position on the tibia by engaging articular surface portions of the tibia.

74. A method in accordance with claim 56, wherein manufacturing the locating means comprises manufacturing a first body portion and an integral first plurality of said locating members extending from the first body portion to their respective end surfaces, and a separate second body portion and an integral second plurality of said locating members extending from the second body portion to their respective end surfaces.

75. A method in accordance with claim 74 wherein the end surfaces of the integral first plurality of locating members are adapted to seat on respective portions of a non-articular surface of the bone and the end surfaces of the integral second plurality of locating members are adapted to seat on respective portions of an articular surface of the bone.

76. A method in accordance with claim 56, wherein said step of determining a surface shape of the bone comprises non-invasive scanning of a patient.

78. A method of fitting a prosthesis to a bone, the method comprising:

manufacturing a surgical template system using a method in accordance with claim 56;

using the attachment means to attach the locating means to the tool guide block;

arranging the attached locating means and tool guide block such that they are seated in the defined position with respect to the bone;

using the at least one guide aperture to guide a tool to work on the bone to prepare the bone for receiving the prosthesis; and

fitting the prosthesis to the prepared bone.

79. A method in accordance with claim 78, further comprising scanning a patient to determine the surface shape of the bone, and selecting the prosthesis from a plurality of prostheses.

80. A method in accordance with claim 78, further comprising selecting a desired position for the prosthesis relative to the bone.

81. A method in accordance with claim 80, comprising forming a virtual model of said bone and manipulating a virtual model of the selected prosthesis relative to the bone virtual model to determine said desired position.

82. A method in accordance with claim 80, wherein the selected prosthesis has a defined interior surface shape, and the method further comprises using the selected desired position and the defined interior surface shape to determine the position of each guide aperture when the assembled template is seated in the defined position on the bone.

83. A method in accordance with claim 82, further comprising selecting the tool guide block from a plurality of tool guide blocks, the selected block comprising a plurality of guide apertures corresponding to said defined interior surface shape.

84. A surgical method comprising:

manufacturing a surgical template system using a method in accordance with claim 56;

using the attachment means to attach the locating means to the tool guide block;

arranging the attached locating means and tool guide block such that they are seated in the defined position with respect to the bone;

using the at least one guide aperture to guide a tool to work on the bone.

85. A surgical method in accordance with claim 84, comprising using the tool guide block to guide a saw blade to cut a flat surface on the bone and to guide a drill bit to drill at least one locating hole in the cut flat surface, locating a second guide block on the cut flat surface and at least one locating hole, and using the second guide block to guide a tool to perform further work on the bone.

86. A surgical method in accordance with claim 84, further comprising mounting a second tool guide block comprising at least one guide aperture on the first guide block and using the second guide block to guide a tool to perform further work on the bone.

95. A method in accordance with claim 56, wherein manufacturing the locating means comprises manufacturing at least one feature having a dimension, or at least one pair of indicia having a separation, measurable to determine a manufacturing accuracy of the locating means.

96. A method in accordance with claim 95, wherein said at least one feature or pair of indicia is provided on the locating means.

97. A method in accordance with claim 95, wherein said feature is provided on a portion of material attached to the locating means and manufacturing integrally with the locating means.

77. A method of manufacturing locating means for a surgical template system for use in working on a bone, the template system comprising a tool guide block comprising at least one guide aperture for receiving and guiding a tool to work on a bone, locating means comprising a plurality of locating members, each member having a respective end surface for positioning against a surface of the bone, and attachment means for non-adjustably attaching the tool guide block to the locating means such that, when attached, the member end surfaces are secured in fixed position with respect to each other, for engaging different respective portions of the surface of the bone, and the at least one guide aperture is secured in a fixed position with respect to the end surfaces, the manufacturing method comprising:

determining a surface shape of a bone to be worked on;

manufacturing the locating means according to the determined shape such that when the locating means is attached to the tool guide block the locating member end surfaces conform to different respective portions of the bone surface and enable the attached locating means and tool guide block to be seated in a defined position with respect to the bone, with each member end surface in contact with its respective portion of the bone surface.