Limb lengthener

• US 20030144669A1
• Filed: 11/27/2002
• Published: 07/31/2003
• Est. Priority Date: 12/05/2001
• Status: Active Grant

• Current Assignee: Randolph C. Robinson
• Original Assignee: Randolph C. Robinson
• Inventors: Robinson, Randolph C.
• Granted Patent: US 7,601,156 B2
• Time in Patent Office: Days
• US Class Current: 606/90
• CPC Class Codes: A61B 17/66 Alignment, compression or distraction mechanisms
• CPC Class Codes: A61B 17/8004 with means for distracting or compressing the bone or bones
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2090/037 with a frangible part, e.g. by reduced diameter

Abstract

A bone distraction device and a method for installing and using the bone distraction device are disclosed. Separated portions of a bone may be coupled to two or more mounts of the bone distraction device. Each portion of the bone may be coupled to at least one mount. The mounts may be contoured in arcs of at least π/3 radians to accommodate the circumference of the bone. The bone distraction device may include three or more guide rods coupled to the mounts. A distractor may be used to move one mount relative to one or more other mounts to distract the bone portions. In one embodiment, one mount may be coupled to a transport segment of bone for transport distraction between two bone segments. In some embodiments, a hydraulic bone distractor may be used to distract the bone portions.

Claims

1. A bone distraction device, comprising:

a first mount configured to be coupled to a first portion of a bone, wherein the first mount is contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone;

a second mount configured to be coupled to a second portion of the bone, wherein the second mount is contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone;

three or more guide rods, wherein a first end of each guide rod is configured to be coupled to the first mount, and wherein each of the guide rods is configured to couple to the second mount; and

a distractor configured to move the second mount relative to the first mount during use such that the second portion of the bone is distracted from the first portion of the bone.

2. The device of claim 1, wherein the second mount is configured to move relative to the first mount along an axis parallel to the longitudinal axis of the three or more guide rods during use.

3. The device of claim 1, wherein at least two guide rods are configured to be positioned substantially 180°

apart along the circumference of the bone.

4. The device of claim 1, wherein the first mount and the second mount comprise fastening means for coupling to the bone.

5. The device of claim 1, wherein the first mount and the second mount are configured to be fastened to the bone using screws.

6. The device of claim 1, wherein the first mount and the second mount are configured to be coupled to the bone using locking fasteners.

7. The device of claim 1, further comprising locking fasteners, wherein locking fasteners engage the first mount and the second mount, and wherein the locking fasteners secure the first mount and the second mount to the bone.

8. The device of claim 1, wherein the first mount further comprises one or more first openings, wherein the second mount further comprises one or more second openings, and wherein the first openings and the second openings are configured to receive locking fasteners.

9. The device of claim 1, wherein at least one guide rod is hollow.

10. The device of claim 1, wherein the first end of each guide rod is configured to be fixably coupled to the first mount.

11. The device of claim 1, wherein each of the guide rods is configured to slidably pass through an opening in the second mount during use.

12. The device of claim 1, wherein the distractor comprises an output shaft.

13. The device of claim 12, wherein at least one guide rod is positioned in a guide, and wherein a length of the guide is greater than about two times a coefficient of friction between the guide and the guide rod, times the distance between a center axis of the guide rod and a center axis of the output shaft.

14. The device of claim 12, wherein the output shaft comprises a first end configured to be coupled to the first mount, and a second threaded end configured to be threadably received by the second mount.

15. The device of claim 12, wherein the output shaft comprises an output gear.

16. The device of claim 15, wherein the output gear is configured to turn the output shaft during use to move the second mount along the second threaded end of the output shaft.

17. The device of claim 12, further comprising a universal joint coupled to the output shaft.

18. The device of claim 17, wherein the universal joint is configured to extend outside a body of a patient at a desired location.

19. The device of claim 12, further comprising a flexible cable coupled to the output shaft.

20. The device of claim 19, wherein the flexible cable is configured to turn the output shaft during use to move the second mount along the second threaded end of the output shaft.

21. The device of claim 19, wherein the flexible cable is configured to extend outside a body of a patient at a desired location.

22. The device of claim 19, wherein the flexible cable is placed in a sheath.

23. The device of claim 12, further comprising an input shaft, wherein the input shaft is configured to engage the output shaft such that turning the input shaft rotates the output shaft during use.

24. The device of claim 23, further comprising a brake, wherein the brake is configured to maintain a position of the output shaft when the input shaft is removed.

25. The device of claim 23, further comprising a seal, wherein the seal is configured to maintain a position of the output shaft when the input shaft is removed.

26. The device of claim 23, wherein the input shaft comprises an activation stem and an input gear.

27. The device of claim 26, wherein rotation of the activation stem rotates the input gear during use.

28. The device of claim 26, wherein the output shaft comprises an output gear, and wherein the input gear is configured to engage the output gear during use.

29. The device of claim 26, further comprising an indicator configured to monitor activation of the output shaft.

30. The device of claim 26, wherein one full rotation of the activation stem is configured to distract bone segments a predetermined distance during use.

31. The device of claim 26, wherein one full rotation of the activation stem is configured to distract bone segments about 1.0 mm during use.

32. The device of claim 26, wherein the activation stem is configured to engage an activation device, and wherein turning the activation device activates distraction during use.

33. The device of claim 1, wherein the device comprises bioabsorbable materials.

34. The device of claim 1, wherein the device comprises titanium.

35. The device of claim 1, wherein the device comprises aluminum.

36. The device of claim 1, wherein the device comprises steel.

37. The device of claim 1, wherein the bone is an arm bone.

38. The device of claim 1, wherein the bone is a leg bone.

39. The device of claim 1, wherein the bone is an appendage bone.

40. A method of lengthening a bone, comprising:

making an osteotomy in a bone to form a first portion of the bone and a second portion of the bone; and

separating the second portion of the bone from the first portion of the bone using a distraction device coupled to the bone, the distraction device comprising a distractor configured to move a second mount relative to a first mount along three or more guide rods, wherein the first mount is coupled to the first portion of the bone and the second mount is coupled to the second portion of the bone, and wherein the first mount and the second mount are contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone.

41. The method of claim 40, further comprising allowing bone growth between the separated first portion and second portion of the bone.

42. The method of claim 40, further comprising separating the second portion of the bone from the first portion of the bone along an axis parallel to the longitudinal axis of at least one guide rod.

43. The method of claim 40, further comprising turning an output shaft coupled to the distraction device to separate the second portion of the bone from the first portion of the bone.

44. The method of claim 40, further comprising turning an input shaft coupled to an output shaft, wherein the output shaft is coupled to the distraction device.

45. The method of claim 44, further comprising:

removing the input shaft after separation; and

maintaining a position of the output shaft, wherein a seal maintains the position of the output shaft.

46. The method of claim 44, further comprising:

removing the input shaft after separation; and

maintaining a desired position of the output shaft, wherein a brake maintains the position of the output shaft.

47. The method of claim 40, further comprising separating the second portion of the bone from the first portion of the bone at a predetermined rate.

48. The method of claim 40, further comprising separating the second portion of the bone from the first portion of the bone at a rate of about 1 millimeter per day.

49. The method of claim 40, further comprising separating the second portion of the bone from the first portion of the bone between approximately 0 days and approximately 14 days after installation of the distraction device.

50. The method of claim 40, further comprising monitoring a separation distance between the first portion and the second portion with an indicator coupled to the distractor.

51. The method of claim 40, wherein the bone is an arm bone.

52. The method of claim 40, wherein the bone is a leg bone.

53. The method of claim 40, wherein the bone is an appendage bone.

54. A method of installing and using a bone distraction device to lengthen a bone, comprising:

making an osteotomy in a bone to form a first portion of the bone and a second portion of the bone;

coupling a distraction device to the bone, the distraction device comprising a distractor configured to move a second mount relative to a first mount along three or more guide rods, wherein the first mount is coupled to the first portion of the bone and the second mount is coupled to the second portion of the bone, and wherein the first mount and the second mount are contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone; and

separating the second portion of the bone from the first portion of the bone using the distraction device.

55. A bone distraction device, comprising:

a first mount configured to be coupled to a first portion of a bone, wherein the first mount is contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone;

a second mount configured to be coupled to a second portion of the bone, wherein the second mount is contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone;

a third mount configured to be coupled to a bone portion, wherein the third mount is contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone portion, and wherein the third mount is configured to be placed between the first mount and the second mount;

three or more guide rods, wherein a first end of each guide rod is configured to be coupled to the first mount and a second end of each guide rod is configured to be coupled to the second mount, and wherein each of the guide rods is configured to pass through an opening in the third mount; and

a distractor configured to move the third mount relative to the first mount and the second mount during use such that the bone portion is distracted from the first portion of the bone towards the second portion of the bone.

56. The device of claim 55, wherein the bone portion comprises an allograft bone.

57. The device of claim 55, wherein the bone portion comprises a synthetic bone.

58. The device of claim 55, wherein the bone portion is configured to be compressed against the second portion of bone during use.

59. The device of claim 55, wherein the third mount is configured to move relative to the first mount and the second mount along an axis parallel to the longitudinal axis of the three or more guide rods during use.

60. The device of claim 55, wherein at least two guide rods are configured to be positioned substantially 180°

apart along the circumference of the bone.

61. The device of claim 55, wherein the first mount, the second mount, and the third mount comprise fastening means for coupling to the bone.

62. The device of claim 55, wherein the first mount, the second mount, and the third mount are configured to be fastened to the bone using screws.

63. The device of claim 55, wherein at least one guide rod is hollow.

64. The device of claim 55, wherein the first end of each guide rod is configured to be fixably coupled to the first mount.

65. The device of claim 55, wherein the second end of each guide rod is configured to be fixably coupled to the second mount.

66. The device of claim 55, wherein each of the guide rods is configured to slidably pass through an opening in the third mount during use.

67. The device of claim 55, wherein the distractor comprises an output shaft.

68. The device of claim 67, wherein at least one guide rod is positioned in a guide, and wherein a length of the guide is greater than about two times a coefficient of friction between the guide and the guide rod, times the distance between a center axis of the guide rod and a center axis of the output shaft.

69. The device of claim 67, wherein the output shaft comprises a first end configured to be coupled to the first mount, a second end configured to be coupled to the second mount, and a threaded portion configured to be threadably received by the third mount.

70. The device of claim 67, wherein the output shaft comprises an output gear.

71. The device of claim 70, wherein the output gear is configured to turn the output shaft during use to move the third mount along the threaded portion of the output shaft.

72. The device of claim 67, further comprising a flexible cable coupled to the output shaft.

73. The device of claim 67, further comprising a universal joint coupled to the output shaft.

74. The device of claim 72, wherein the flexible cable is configured to turn the output shaft during use to move the third mount along the threaded portion of the output shaft.

75. The device of claim 72, wherein the flexible cable is configured to extend outside a body of a patient at a desired location.

76. The device of claim 72, wherein the flexible cable is placed in a sheath.

77. The device of claim 67, further comprising an input shaft, wherein the input shaft is configured to engage the output shaft such that turning the input shaft rotates the output shaft during use.

78. The device of claim 77, further comprising a seal, wherein the seal is configured to maintain a position of the output shaft when the input shaft is removed.

79. The device of claim 77, further comprising a brake, wherein the brake is configured to maintain a position of the output shaft when the input shaft is removed.

80. The device of claim 77, wherein the input shaft comprises an activation stem and an input gear.

81. The device of claim 80, wherein rotation of the activation stem rotates the input gear. during use

82. The device of claim 80, wherein the output shaft comprises an output gear, and wherein the input gear is configured to engage the output gear during use.

83. The device of claim 80, wherein one full rotation of the activation stem is configured to distract bone segments a predetermined distance during use.

84. The device of claim 80, wherein one full rotation of the activation stem is configured to distract bone segments about 1.0 mm during use.

85. The device of claim 80, further comprising an indicator configured to monitor activation of the activation stem.

86. The device of claim 80, wherein the activation stem is configured to engage an activation device, and wherein turning the activation device activates distraction during use.

87. The device of claim 55, wherein the device comprises bioabsorbable materials.

88. The device of claim 55, wherein the device comprises titanium.

89. The device of claim 55, wherein the device comprises aluminum.

90. The device of claim 55, wherein the device comprises steel.

91. The device of claim 55, wherein the bone is an arm bone.

92. The device of claim 55, wherein the bone is a leg bone.

93. The device of claim 55, wherein the bone is an appendage bone.

94. A method of lengthening a bone, comprising:

inserting a bone portion between a first portion of the bone and a second portion of the bone; and

distracting the bone portion from the first portion of the bone towards the second portion of the bone using a distraction device coupled to the bone, the distraction device comprising a distractor configured to move a third mount relative to a first mount and a second mount along three or more guide rods, wherein the first mount is coupled to the first portion of the bone, the second mount is coupled to the second portion of the bone, and the third mount is coupled to the bone portion, and wherein the first mount, the second mount, and the third mount are contoured in arcs of at least π

/3 radians to accommodate the circumference of the bone.

95. The method of claim 94, further comprising allowing bone growth between the first portion and the bone portion.

96. The method of claim 94, further comprising distracting the bone portion from the first portion of the bone towards the second portion of the bone such that the bone portion compresses against the second portion.

97. The method of claim 94, wherein the bone portion comprises an allograft bone.

98. The method of claim 94, wherein the bone portion comprises a synthetic bone.

99. The method of claim 94, further comprising distracting the bone portion from the first portion of the bone along an axis parallel to the longitudinal axis of at least one guide rod.

100. The method of claim 94, further comprising turning an output shaft coupled to the distraction device to distract the bone portion from the first portion of the bone.

101. The method of claim 94, further comprising distracting the bone portion at a predetermined rate.

102. The method of claim 94, further comprising distracting the bone portion at a rate of about 1 millimeter per day.

103. The method of claim 94, further comprising distracting the bone portion between approximately 0 days and approximately 14 days after installation of the distraction device.

104. The method of claim 94, wherein the bone is an arm bone.

105. The method of claim 94, wherein the bone is a leg bone.

106. The method of claim 94, wherein the bone is an appendage bone.

107. A method of installing and using a bone distraction device to lengthen a bone, comprising:

coupling a distraction device to the bone, the distraction device comprising a distractor configured to move a third mount relative to a first mount and a second mount along three or more guide rods, wherein the first mount is coupled to a first portion of the bone, the second mount is coupled to a second portion of the bone, and the third mount is coupled to a bone portion, and wherein the first mount, the second mount, and the third mount are contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone; and

distracting the bone portion from the first portion of the bone towards the second portion of the bone using the distraction device.

108. A bone distraction device, comprising:

a hydraulic housing configured to be coupled to a first portion of a bone; and

a piston at least partially enclosed in the hydraulic housing, wherein the piston is configured to be coupled to a second portion of the bone, and wherein the piston is further configured to move relative to the hydraulic housing such that the second portion of the bone is distracted from the first portion of the bone during use.

109. The device of claim 108, further comprising one or more seals configured to substantially surround a portion of the piston enclosed in the hydraulic housing.

110. The device of claim 109, wherein the one or more seals are configured to inhibit hydraulic fluid from escaping the hydraulic housing during use.

111. The device of claim 109, wherein the one or more seals are configured to stabilize the piston during use.

112. The device of claim 108, further comprising one or more plates coupled to the hydraulic housing, wherein the one or more plates are configured to couple the hydraulic housing to the first portion of the bone.

113. The device of claim 108, further comprising one or more plates coupled to the piston, wherein the one or more plates are configured to couple the piston to the second portion of the bone.

114. The device of claim 108, further comprising a pump coupled to the hydraulic housing, wherein the pump is configured to provide hydraulic fluid into the hydraulic housing during use.

115. The device of claim 114, wherein providing the hydraulic fluid into the hydraulic housing is configured to move the piston relative to the hydraulic housing during use.

116. The device of claim 114, further comprising a valve coupled to the pump, wherein the valve is configured to inhibit backflow of hydraulic fluid towards the pump during use.

117. The device of claim 116, wherein the valve is placed in the hydraulic housing.

118. The device of claim 114, wherein a volume of hydraulic fluid provided to the hydraulic housing is selected to move the piston a desired distance during use.

119. The device of claim 114, wherein the hydraulic fluid comprises saline fluid.

120. The device of claim 114, wherein the pump is placed subcutaneously.

121. The device of claim 114, wherein the pump is battery powered.

122. The device of claim 114, wherein the pump is operated as a syringe.

123. The device of claim 108, wherein the hydraulic housing is configured to be coupled to a first mount, wherein the first mount is coupled to the first portion of the bone.

124. The device of claim 108, wherein the piston is configured to be coupled to a second mount, wherein the second mount is coupled to the second portion of the bone.

125. The device of claim 108, further comprising a bleed valve coupled to the hydraulic housing.

126. The device of claim 108, wherein the hydraulic housing and the piston are contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone

127. The device of claim 108, wherein the device comprises bioabsorbable materials.

128. The device of claim 108, wherein the bone is an arm bone.

129. The device of claim 108, wherein the bone is a leg bone.

130. The device of claim 108, wherein the bone is an appendage bone.

131. The device of claim 108, wherein the bone is a skull bone.

132. The device of claim 108, wherein the bone is a facial bone.

133. The device of claim 108, further comprising an intermediate hydraulic cylinder in the hydraulic housing, wherein the intermediate hydraulic cylinder encloses at least a portion of the piston, and wherein the intermediate hydraulic cylinder is configured to move relative to the hydraulic housing during use.

134. A bone distraction device, comprising:

a hydraulic housing configured to be coupled to a first portion of a bone;

an intermediate hydraulic cylinder at least partially enclosed in the hydraulic housing, wherein the intermediate hydraulic cylinder is configured to move relative to the hydraulic housing during use; and

a piston at least partially enclosed in the intermediate hydraulic cylinder, wherein the piston is configured to be coupled to a second portion of the bone, and wherein the piston is further configured to move relative to the intermediate hydraulic cylinder and the hydraulic housing such that the second portion of the bone is distracted from the first portion of the bone during use.

135. The device of claim 134, further comprising one or more seals configured to substantially surround a portion of the piston enclosed in the intermediate hydraulic cylinder, and one or more seals configured to substantially surround a portion of the intermediate hydraulic cylinder enclosed in the hydraulic housing.

136. The device of claim 135, wherein the one or more seals are configured to inhibit hydraulic fluid from escaping the hydraulic housing during use.

137. The device of claim 135, wherein the one or more seals are configured to stabilize the piston during use.

138. The device of claim 134, further comprising one or more plates coupled to the hydraulic housing, wherein the one or more plates are configured to couple the hydraulic housing to the first portion of the bone.

139. The device of claim 134, further comprising one or more plates coupled to the piston, wherein the one or more plates are configured to couple the piston to the second portion of the bone.

140. The device of claim 134, further comprising a pump coupled to the hydraulic housing, wherein the pump is configured to provide hydraulic fluid into the hydraulic housing during use.

141. The device of claim 140, wherein providing the hydraulic fluid into the hydraulic housing is configured to move the piston relative to the hydraulic housing during use.

142. The device of claim 140, further comprising a valve coupled to the pump, wherein the valve is configured to inhibit backflow of hydraulic fluid towards the pump during use.

143. The device of claim 140, wherein a volume of hydraulic fluid provided to the hydraulic housing is selected to move the piston a desired distance during use.

144. The device of claim 134, wherein the hydraulic housing and the piston are contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone

145. The device of claim 134, wherein the device comprises bioabsorbable materials.

146. The device of claim 134, wherein the bone is an arm bone.

147. The device of claim 134, wherein the bone is a leg bone.

148. The device of claim 134, wherein the bone is an appendage bone.

149. The device of claim 134, wherein the bone is a skull bone.

150. The device of claim 134, wherein the bone is a facial bone.

151. A method of lengthening a bone, comprising:

making an osteotomy in a bone to form a first portion of the bone and a second portion of the bone; and

separating the second portion of the bone from the first portion of the bone using a distraction device coupled to the bone, the distraction device comprising a piston coupled to the second portion of the bone configured to move relative to a hydraulic housing coupled to the first portion of the bone.

152. The method of claim 151, wherein the hydraulic housing and the piston are contoured in an arc of at least π

/3 radians to accommodate the circumference of the bone.

153. The method of claim 151, further comprising allowing bone growth between the separated first portion and second portion of the bone.

154. The method of claim 151, further comprising providing hydraulic fluid from a pump into the hydraulic housing to move the piston relative to the hydraulic housing.

155. The method of claim 154, further comprising inhibiting backflow of hydraulic fluid towards the pump with a valve.

156. The method of claim 151, further comprising separating the second portion of the bone from the first portion of the bone at a predetermined rate.

157. The method of claim 151, further comprising separating the second portion of the bone from the first portion of the bone at a predetermined rate by controlling a flow of hydraulic fluid into the hydraulic housing.

158. The method of claim 151, further comprising separating the second portion of the bone from the first portion of the bone at a rate of about 1 millimeter per day.

159. The method of claim 151, further comprising separating the second portion of the bone from the first portion of the bone between approximately 0 days and approximately 14 days after installation of the distraction device.

160. The method of claim 151, wherein the bone is an arm bone.

161. The method of claim 151, wherein the bone is a leg bone.

162. The method of claim 151, wherein the bone is an appendage bone.

163. The method of claim 151, wherein the bone is a skull bone.

164. The method of claim 151, wherein the bone is a facial bone.

165. A method of installing and using a bone distraction device to lengthen a bone, comprising:

making an osteotomy in a bone to form a first portion of the bone and a second portion of the bone;

coupling a distraction device to the bone, the distraction device comprising a piston coupled to the second portion of the bone configured to move relative to a hydraulic housing coupled to the first portion of the bone; and

separating the second portion of the bone from the first portion of the bone using the distraction device.