Surgical templates

• US 9,125,674 B2
• Filed: 07/08/2013
• Issued: 09/08/2015
• Est. Priority Date: 03/23/2007
• Status: Active Grant

• Current Assignee: Xiros Limited
• Original Assignee: Xiros Limited
• Inventors: Seedhom, Bahaa, Chelule, Kenneth Langat, White, Derrick
• Primary Examiner(s): BECCIA, CHRISTOPHER J
• Application Number:
  US13/937,007
• Publication Number:
  US 20130296873A1
• Time in Patent Office: 792 Days
• Field of Search: 606/86.R, 606 87- 89, 606 96- 98, 606/104
• US Class Current: 1/1
• 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; and

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

wherein the tool guide block is non-adjustably attached to the locating means such that the member bone-engaging 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 bone-engaging surfaces, and the bone-engaging 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 bone-engaging 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 surgical template system in accordance with claim 1, wherein at least one of said bone-engaging surfaces is an end surface of the respective locating member.

3. A surgical template system in accordance with claim 1, wherein each said bone-engaging surface is an end surface of the respective locating member.

4. 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.

5. A system in accordance with claim 1, wherein a plurality of said member bone-engaging 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.

6. A system in accordance with claim 1, wherein at least one member bone-engaging 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.

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

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

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

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

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

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

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

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

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

16. 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.

17. A system in accordance with claim 16, wherein at least one said member comprises a bore extending through the member to the member'"'"'s bone-engaging 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.

18. A system in accordance with claim 17, further comprising a sleeve arranged to line said bore, wherein the pin is adapted to extend through the sleeve.

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

20. A system in accordance with claim 17, 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 bone-engaging surface is adapted to seat.

21. A system in accordance with claim 17, wherein the locating means and guide block are arranged such that 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.

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

23. A system in accordance with claim 22, wherein at least one of said locating members comprises a slit arranged to allow unhindered movement of the saw blade guided by said slot.

24. A system in accordance with claim 22, wherein said at least one slot comprises an open ended slot.

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

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

27. 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 bone-engaging surfaces, and said body portion is attached to the tool guide block.

28. A system in accordance with claim 27, wherein said body portion and the members extending from it are integral.

29. A system in accordance with claim 27, wherein the locating means further comprises an additional locating member having a bone-engaging 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 bone-engaging 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.

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

31. A system in accordance with claim 1, wherein the tool guide block is attached to the locating means by at least one screw or bolt.

32. 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.

33. A system in accordance with claim 32, wherein the tool guide block further comprises a connecting portion connecting said first portion to the second portion.

34. A system in accordance with claim 33 wherein the first, second, and connecting portions are integral.

35. A system in accordance with claim 33, wherein the connecting portion comprises a web.

36. A system in accordance with claim 35, 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.

37. A system in accordance with claim 32, 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.

38. A system in accordance with claim 32, 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.

39. A system in accordance with claim 1 and for working on a femur, wherein the locating means is arranged such that the member bone-engaging 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.

40. A system in accordance with claim 39, 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.

41. A system in accordance with claim 40, 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.

42. A system in accordance with claim 39, wherein the locating means comprises an additional locating member having a bone-engaging surface for positioning against an anterior surface of the femur.

43. A system in accordance with claim 42, wherein the additional locating member bone-engaging surface is adapted for positioning against the trochlea of the femur.

44. A system in accordance with claim 42, further comprising means for releasably securing the additional locating member with respect to the guide block and locating member bone-engaging 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.

45. A system in accordance with claim 1 and for working on a tibia, wherein the locating means is arranged such that a plurality of said member bone-engaging 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.

46. 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 bone-engaging surfaces, and a separate second body portion and a second plurality of said locating members extending from the second body portion to their respective bone-engaging surfaces, and said first body portion is attached to the tool guide block and said second body portion is attached to the tool guide block.

47. A system in accordance with claim 46, wherein the first body portion and the first plurality of said locating members are integral.

48. A system in accordance with claim 46, wherein the second body portion and the second plurality of said locating members are integral.

49. A system in accordance with claim 46, 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 said first body portion is attached to the first portion of the tool guide block and said second body portion is attached to the second portion of the tool guide block.

50. A system in accordance with claim 49, wherein said first portion of the guide block is adapted to extend around an arc of less than 100 degrees.

51. A system in accordance with claim 49, wherein said first portion is generally arcuate.

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

53. A system in accordance with claim 49, 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.

54. A system in accordance with claim 46 and adapted for working on a tibia, wherein the bone-engaging 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 bone-engaging surfaces of the second plurality of locating members are adapted to seat on respective portions of an articular surface of the specific tibia.

55. 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.

56. A system in accordance with claim 55, 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.

57. A system in accordance with claim 55, 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.

58. A system in accordance with claim 55, wherein said first tool guide block comprises at least one bore and the system further comprises a pin adapted to pass through the bore and into the bone, wherein the first tool guide block is adapted to slide off said pin, and the second tool guide block further comprises a bore adapted to accommodate said pin such that the second tool guide block may be slid onto said pin after the first tool guide block has been slid off said pin, to guide the second tool guide block into place with respect to the bone, and then the additional guide aperture of the second tool guide block may be used to guide a tool to work on the bone.

59. A system in accordance with claim 58, wherein said pin is adapted to be drilled into place in the bone through the bore.

60. A system in accordance with claim 58, wherein the first and second tool guide blocks each comprise two said bores and the system comprises two said pins, the bores of the first tool guide block being parallel such that when the pins are inserted through the bores into the bone said pins are parallel, the first tool guide block being slidable off the parallel pins, and the second tool guide block being slidable onto the parallel pins.

61. 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 bone-engaging surface for locating against an additional bone surface portion to help seat the locating means and attached guide block on the bone, and the system comprises attachment means adapted to releasably and non-adjustably attach the additional body portion to the guide block.

94. A system in accordance with claim 1, wherein the tool guide block is releasably and non-adjustably attached to the locating means.

95. 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.

96. A system in accordance with claim 95, wherein the tool guide block comprises a plurality of said bores, and the system comprises a respective pin for each tool guide block bore.

97. A system in accordance with claim 96, 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.

98. 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.

99. 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.

100. 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.

101. A system in accordance with claim 100, wherein the locating means comprises at least one feature adapted to mate with the gauge to provide said check.

105. 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.

106. Surgical apparatus in accordance with claim 105, further comprising linking means linking the locating means to the patient identification means.

107. Surgical apparatus in accordance with claim 105, 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.

108. Surgical apparatus in accordance with claim 106, wherein the locating means, patient identification means, and linking means have been manufactured together using a rapid prototyping technique.

109. Surgical apparatus in accordance with claim 105, 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.

110. A system in accordance with claim 1, wherein the tool guide block is non-adjustably attached to the locating means by a snap-fit mechanism.

111. A system in accordance with claim 1, wherein the tool guide block is non-releasably and non-adjustably attached to the locating means.

62. 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, and locating means comprising a plurality of locating members, each member having a respective bone-engaging surface for positioning against a surface of the bone, the tool guide block being non-adjustably attached to the locating means such that the member bone-engaging 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 bone-engaging 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 bone-engaging 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 bone-engaging 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.

63. A method in accordance with claim 62, further comprising attaching the tool guide block to the locating means.

64. A method in accordance with claim 62, 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 bone-engaging 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.

65. A system in accordance with claim 62, wherein at least one member bone-engaging 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.

66. A method in accordance with claim 62, comprising manufacturing the tool guide block from a metal.

67. A method in accordance with claim 62, comprising manufacturing the locating means using a rapid prototyping technique.

68. 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 locating means.

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

70. A method in accordance with claim 69, 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.

71. A method in accordance with claim 69, 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 bone-engaging surface is adapted to seat.

72. A method in accordance with claim 62, 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 bone-engaging surfaces.

73. A method in accordance with claim 72, comprising manufacturing said body portion and the members extending from it as an integral unit.

74. A method in accordance with claim 73, wherein manufacturing the locating means further comprises manufacturing an additional locating member according to the determined shape, the additional locating member having a bone-engaging 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 bone-engaging 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.

75. A method in accordance with claim 62, 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.

76. A method in accordance with claim 62, where the bone is a femur.

77. A method in accordance with claim 74, wherein the bone is a femur, and the additional locating member bone-engaging surface is arranged for positioning against an anterior surface of the femur.

78. A method in accordance with claim 62, where the bone is a tibia.

79. A method in accordance with claim 78, wherein the locating means is manufactured such that, when attached to the tool guide block, a plurality of said member bone-engaging 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.

80. A method in accordance with claim 79, further comprising manufacturing the locating means such that, when attached to the tool guide block, a plurality of said member bone-engaging 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.

81. A method in accordance with claim 62, 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 bone-engaging 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 bone-engaging surfaces.

82. A method in accordance with claim 81 wherein the bone-engaging 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 bone-engaging surfaces of the integral second plurality of locating members are adapted to seat on respective portions of an articular surface of the bone.

83. A method in accordance with claim 62, wherein said step of determining a surface shape of the bone comprises non-invasive scanning of a patient.

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

manufacturing a surgical template system using a method in accordance with claim 62;

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.

86. A method in accordance with claim 85, further comprising scanning a patient to determine the surface shape of the bone, and selecting the prosthesis from a plurality of prostheses.

87. A method in accordance with claim 85, further comprising selecting a desired position for the prosthesis relative to the bone.

88. A method in accordance with claim 87, 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.

89. A method in accordance with claim 87, 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.

90. A method in accordance with claim 89, 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.

91. A surgical method comprising:

manufacturing a surgical template system using a method in accordance with claim 62;

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.

92. A surgical method in accordance with claim 91, 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.

93. A surgical method in accordance with claim 91, 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.

102. A method in accordance with claim 62, 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.

103. A method in accordance with claim 102, wherein said at least one feature or pair of indicia is provided on the locating means.

104. A method in accordance with claim 102, wherein said feature is provided on a portion of material attached to the locating means and manufacturing integrally with the locating means.

84. 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, and locating means comprising a plurality of locating members, each member having a respective bone-engaging surface for positioning against a surface of the bone, the tool guide block being non-adjustably attached to the locating means such that the member bone-engaging 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 bone-engaging 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 bone-engaging 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 bone-engaging surface in contact with its respective portion of the bone surface.