Patient selectable knee joint arthroplasty devices

• US 20050267584A1
• Filed: 11/24/2004
• Published: 12/01/2005
• Est. Priority Date: 05/25/2001
• Status: Active Grant

• Current Assignee: Conformis Incorporated
• Original Assignee: Conformis Incorporated
• Inventors: Lang, Philipp, Burdulis, Albert G. Jr., O'Regan, Cecily Anne, Steines, Daniel, Vargas-Voracek, Rene, Miller, David, Fitz, Wolfgang, Bouadi, Hacene, Tsougarakis, Konstantinos
• Granted Patent: US 8,882,847 B2
• Time in Patent Office: Days
• US Class Current: 623/20.190
• CPC Class Codes: A61B 5/4504 Bones A61B5/4547 takes precedence
• CPC Class Codes: A61B 5/4514 Cartilage
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61F 2/30942 for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/30535 Special structural features of bone or joint prostheses not otherwise provided for
• CPC Class Codes: A61F 2250/0058 Additional features; Implant or prostheses properties not otherwise provided for

Abstract

Disclosed herein are methods and devices for repairing articular surfaces in a knee joint. The articular surface repairs are customizable or highly selectable for each patient and geared toward providing optimal fit and function. Kits are also provided to enable customized repairs to be performed.

Claims

1. An implant suitable for a condyle of a femur having a superior surface and an inferior surface wherein the superior surface opposes at least a portion of the condyle of the femur and the trochlea and the inferior surface opposes at least a portion of a weight bearing portion of a tibial surface and a patella and further wherein at least at least a portion of one of the superior or inferior surfaces has a three-dimensional shape that substantially matches the shape of one of the femur and tibia surfaces.

2. The implant of claim 1 wherein the superior surface and the inferior surface have a three dimensional shape that substantially matches the shape of at least one of the articular surface that the superior surface of the implant abuts and the inferior surface of the implant abuts.

3. The implant of claim 1 wherein the implant has a thickness of a cartilage defect in a patient.

4. The implant of claim 1 wherein the implant has a thickness of 85% of a cartilage defect in a patient.

5. The implant of claim 1 wherein the implant has a thickness of between 65%-100% of a cartilage defect of a patient.

6. The implant of claim 1 wherein the implant has a thickness of a cartilage defect plus a predefined offset value.

7. The implant of claim 6, wherein said offset value can be selected to adjust for axis malalignment.

8. The implant of claim 1 wherein the implant is constructed of a material comprising metal or metal alloy.

9. The implant of claim 1 wherein the material comprises one or more biologically active materials.

10. The implant of claim 6 wherein the implant is coated with a biologically active material.

11. The implant of claim 1 wherein the implant is comprised of a metal or metal alloy and a polymer.

12. The implant of claim 1 further having a structure for attachment on at least one of the superior surface and the inferior surface selected from the group consisting of:

ridges, pegs, pins, cruciate stems, cross-members, teeth and protrusions.

13. The implant of claim 12 further having a plurality of structures for attachment.

14. The implant of claim 13 wherein the relative orientation of the structures for attachment are selected from the group consisting of:

symmetrical, asymmetrical, rows, circles, triangles, and random.

15. The implant of claim 1 wherein the implant covers a portion of a patellar surface of the femur.

16. The implant of claim 1 wherein each of the superior surface and inferior surface have a slope relative to a longitudinal axis through at least a portion of the implant and further wherein the slope of the superior surface relative to the slope of the inferior surface is selected from the group consisting of:

positive, negative, and null.

17. The implant of claim 1 wherein the implant approximates the shape of one of the first and second articular surface.

18. The implant of claim 1 wherein a condyle mating surface of the implant has at least one planar surface for mating with a condyle surface.

19. The implant of claim 18 wherein a femoral condyle surface is prepared for receiving the implant.

20. The implant of claim 19 wherein the condyle surface is prepared by forming at least one planar surface to mate with the at least one planar surface of the implant.

21. The implant of claim 1 wherein a femoral condyle surface is prepared by removing bone.

22. The implant of claim 21 wherein the condyle surface is prepared by removing cartilage.

23. The implant of claim 21 wherein the condyle surface is prepared by forming at least one planar surface to mate with the at least one planar surface of the implant.

24. The implant of claim 1 wherein the implant is selected from a library of implants.

25. The implant of claim 1 wherein the implant is surgically implanted via an incision of 10 cm or less.

26. The implant of claim 1 wherein the implant is surgically implanted via an incision of 6 cm or less.

27. The implant of claim 1 wherein the range of motion of the joint is restored to between 80-99.9% of normal joint motion.

28. The implant of claim 1 wherein the range of motion of the joint is restored to between 90-99.9% of normal joint motion.

29. The implant of claim 1 wherein the range of motion of the joint is restored to between 95-99.9% of normal joint motion.

30. The implant of claim 1 wherein the range of motion of the joint is restored to between 98-99.9% of normal joint motion.

31. The implant of claim 1 wherein the implant is formed to oppose at least a portion of a second condyle on the femur.

32. The implant of claim 1 wherein the implant further comprises a rail extending from the superior surface on one of a medial or lateral side.

33. The implant of claim 1 wherein the implant further comprises a keel extending from the superior surface, wherein the keel is in a recessed position from the medial and lateral side.

34. The implant of claim 1 wherein a portion of the superior surface sits within a plane.

35. The implant of claim 34 wherein the portion of the superior surface that sits within a plane mates with a planar cut on a surface of the femur.

36. The implant of claim 1 wherein the implant mimics an anatomy of a healthy joint.

37. The implant of claim 1 wherein the implant mimics an anatomy of a joint prior to surgery.

38. The implant of claim 1 wherein the implant mimics a targeted anatomy of a joint.

39. The implant of claim 1 wherein the implant is placed within a joint space during a surgery without performing ligament balancing.

40. The implant of claim 1 wherein the implant is a system comprised of a condylar implant and a patellar mating implant.

41. The implant of claim 1 wherein a thickness of the implant at a location is adjusted to account for at least one of valgus deformity, varus deformity and flattening.

42. The implant of claim 1 further having a beveled edge.

43. The implant of claim 1 further having a chamfer cut.

44. The implant of claim 1 further having a fillet.

45. The implant of claim 44 wherein the fillet is exterior to a posterior portion of a tibial spine.

46. A kit for repairing a knee comprising one or more implants selected from the following:

a condylar implant having a superior surface and an inferior surface wherein the superior surface opposes at least a portion of a condyle of the femur and a trochlea and the inferior surface opposes at least a portion of a weight bearing portion of a tibial surface and a patella and further wherein at least one of the superior or inferior surfaces has a three-dimensional shape that substantially matches the shape of one of the femur and tibia surfaces;

a condylar implant having a superior surface and an inferior surface wherein the superior surface opposes at least a portion of a condyle of the femur and the inferior surface opposes at least a portion of a weight bearing portion of a tibial surface and further wherein at least one of the superior or inferior surfaces has a three-dimensional shape that substantially matches the shape of one of the femur and tibia surfaces;

a patellar implant having a first surface that engages the femur mating surface of the patella and a second surface that engages the trochlea; and

an implant suitable for the tibial plateau having a superior surface and in inferior surface wherein the superior surface opposes at least a portion of a femur and the inferior portion opposes at least a portion of the tibial surface and further wherein at least one of the superior or inferior surfaces has a three-dimensional shape that substantially matches the shape of one of the femur and tibial surfaces.

47. A prosthetic device for a knee joint comprising:

a femoral condyle component having a superior surface and an inferior surface and a top portion and a bottom portion with a curved lateral edge extending therebetween; and

a trochlear groove component along the top portion of the device,

wherein the bottom portion of the femoral condyle component terminates prior to a sulcus terminalis on the joint surface.

48. The prosthetic device of claim 47 wherein the device has a thickness determined by a cartilage defect in a patient.

49. The prosthetic device of claim 47 wherein the device has a thickness of about 85% of a cartilage defect in a patient.

50. The prosthetic device of claim 47 wherein the device has a thickness of between 65% and 100% of a cartilage defect in a patient.

51. The prosthetic device of claim 47 wherein the device has a thickness of the cartilage defect in a patient plus a predetermined offset value.

52. The prosthetic device of claim 47 wherein the device is constructed of a material comprising metal or metal alloy.

53. The prosthetic device of claim 47 further having a structure for attachment on at least one surface.

54. The prosthetic device of claim 53 wherein the structure for attachment is selected from ridges, pegs, pins, cross-members, cruciate stems, teeth and protrusions.

55. The prosthetic device of claim 47 wherein the implant further comprises a rail extending from the superior surface on one of a medial or lateral side.

56. The prosthetic device of claim 47 wherein the implant further comprises a keel extending from the superior surface, wherein the keel is in a recessed position from the medial and lateral side.

57. The prosthetic device of claim 47 wherein a portion of the superior surface sits within a plane.

58. The prosthetic device of claim 57 wherein the portion of the superior surface that sits within a plane mates with a planar cut on a surface of the femur.

59. The prosthetic device of claim 57 wherein the portion of the superior surface that sits within a plane substantially mates with a planar cut on a surface of the femur.

60. A prosthetic device for a knee joint comprising:

a femoral condyle component having a top portion and a bottom portion with a curved lateral edge therebetween; and

a trochlear groove component along the top portion of the device,

wherein the bottom portion of the femoral condyle component terminates at a sulcus terminalis on the knee joint surface.

61. The prosthetic device of claim 60 wherein the device has a thickness determined by a cartilage defect in a patient.

62. The prosthetic device of claim 60 wherein the device has a thickness of about 85% of a cartilage defect in a patient.

63. The prosthetic device of claim 60 wherein the device has a thickness of between 65% and 100% of a cartilage defect in a patient.

64. The prosthetic device of claim 60 wherein the device has a thickness of the cartilage defect in a patient plus a predetermined offset value.

65. The prosthetic device of claim 60 wherein the device is constructed of a material comprising metal or metal alloy.

66. The prosthetic device of claim 60 further having a structure for attachment on at least one surface.

67. The prosthetic device of claim 60 wherein the structure for attachment is selected from ridges, pegs, pins, cross-members, cruciate stems, teeth and protrusions.

68. The prosthetic device of claim 60 wherein the implant further comprises a rail extending from the superior surface on one of a medial or lateral side.

69. The prosthetic device of claim 60 wherein the implant further comprises a keel extending from the superior surface, wherein the keel is in a recessed position from the medial and lateral side.

70. The prosthetic device of claim 60 wherein a portion of the superior surface sits within a plane.

71. The prosthetic device of claim 70 wherein the portion of the superior surface that sits within a plane mates with a planar cut on a surface of the femur.

72. The prosthetic device of claim 70 wherein the portion of the superior surface that sits within a plane substantially mates with a planar cut on a surface of the femur.

73. The implant of claim 60 wherein a femoral condyle surface is prepared for receiving the implant.

74. The implant of claim 73 wherein the femoral condyle surface is prepared by forming at least one planar surface to mate with the at least one planar surface of the implant.

75. The implant of claim 60 wherein a femoral condyle surface is prepared by removing bone.

76. The implant of claim 75 wherein the condyle surface is prepared by removing cartilage.

77. The implant of claim 75 wherein the condyle surface is prepared by forming at least one planar surface to mate with the at least one planar surface of the implant.

78. The implant of claim 60 wherein the implant mimics an anatomy of a healthy joint.

79. The implant of claim 60 wherein the implant mimics an anatomy of a joint prior to surgery.

80. The implant of claim 60 wherein the implant mimics a targeted anatomy of a joint.

81. The implant of claim 60 wherein the implant is placed within a joint space during a surgery without performing ligament balancing.

82. The implant of claim 60 wherein the implant is a system comprised of a condylar implant and a patellar mating implant.

83. The implant of claim 60 wherein a thickness of the implant at a location is adjusted to account for at least one of valgus deformity, varus deformity and flattening.

84. The implant of claim 60 further having a beveled edge.

85. The implant of claim 60 further having a chamfer cut.

86. The implant of claim 60 further having a fillet.

87. The implant of claim 86 wherein the fillet is exterior to a posterior portion of a tibial spine.

88. An implant suitable for a distal femur in a knee joint having a superior surface and an inferior surface wherein the superior surface is configured to communicate with the femoral surface of a tibiofemoral articulation surface and the inferior surface is configured to communicate with the tibial surface of the tibiofemoral articulation surface.

89. The implant of claim 88 wherein prior to an implantation step, a bone cut is performed on the surface of the femur.

90. The implant of claim 88 wherein the bone cut is posterior.

91. The implant of claim 90 wherein the implant has a high posterior extension along the femoral condyle.

92. The implant of claim 91 wherein the knee joint has a high degree of knee flexion.

93. The implant of claim 88 wherein at least a portion of one of the superior surface or inferior surface has a three-dimensional shape that substantially matches the shape of the joint surface with which it mates.

94. The implant of claim 88 wherein the portion of one of the superior surface or inferior surface is greater than 2 cm in length.

95. The implant of claim 88 wherein the implant further comprises a rail extending from the superior surface on one of a medial or lateral side.

96. The implant of claim 88 wherein the implant further comprises a keel extending from the superior surface, wherein the keel is in a recessed position from the medial and lateral side.

97. The implant of claim 88 wherein a portion of the superior surface sits within a plane.

98. The implant of claim 97 wherein the portion of the superior surface that sits within a plane mates with a planar cut on a surface of the femur.

99. The implant of claim 88 wherein the portion of the superior surface that sits within a plane substantially mates with a planar cut on a surface of the femur.

100. The implant of claim 88 further having an attachment structure, wherein the structure for attachment is selected from ridges, pegs, pins, cross-members, cruciate stems, teeth and protrusions.

101. An implant system comprising:

a femoral component, wherein the femoral component replaces a femoral surface of the patellofemoral articulation surface and a tibiofemoral articulation surface; and

a tibial component, wherein the tibial component replaces a tibial surface of the tibiofemoral articulation surface.

102. The implant system of claim 101 wherein the femoral component has a thickness determined by a cartilage defect in a patient.

103. The implant system of claim 101 wherein the tibial component has a thickness determined by a cartilage defect in a patient.

104. The implant system of claim 101 wherein the femoral component has a thickness of about 85% of a cartilage defect in a patient.

105. The implant system of claim 101 wherein the femoral component has a thickness of between 65% and 100% of a cartilage defect in a patient.

106. The implant system of claim 101 wherein the femoral component has a thickness of the cartilage defect in a patient plus a predetermined offset value.

107. The implant system of claim 101 wherein the femoral component is constructed of a material comprising metal or metal alloy.

108. The implant system of claim 101 further having a structure for attachment on at least one surface.

109. The implant system of claim 108 wherein the structure for attachment is selected from ridges, pegs, pins, cross-members, cruciate stems, teeth and protrusions.

110. The implant system of claim 101 wherein the superior surface of the femoral component has a substantially flat section designed to mate with a bone cut on a femoral condyle.

111. The implant system of claim 101 wherein one or more components are sized using x-ray sizing.

112. The implant system of claim 101 wherein one or more components are manufactured using standard casting techniques.

113. The implant of claim 101 wherein the implant further comprises a rail extending from the superior surface on one of a medial or lateral side.

114. The implant of claim 101 wherein the implant further comprises a keel extending from the superior surface, wherein the keel is in a recessed position from the medial and lateral side.

115. The implant of claim 101 wherein a portion of the superior surface sits within a plane.

116. The implant of claim 115 wherein the portion of the superior surface that sits within a plane mates with a planar cut on a surface of the femur.

117. The implant of claim 101 wherein the portion of the superior surface that sits within a plane substantially mates with a planar cut on a surface of the femur.

118. The implant of claim 101 wherein the tibial component has a dome positioned on a plate.

119. The implant of claim 118 wherein the dome is positioned on the plate such that an apex of the dome is off-center a center point of the plate.

120. The implant of claim 118 wherein an apex of the dome is positioned to correspond to a patellar ridge.

121. The implant of claim 101 wherein a femoral condyle surface is prepared for receiving the implant.

122. The implant of claim 121 wherein the femoral condyle surface is prepared by forming at least one planar surface to mate with the at least one planar surface of the implant.

123. The implant of claim 121 wherein the femoral condyle surface is prepared by removing cartilage.

124. The implant of claim 121 wherein the femoral condyle surface is prepared by forming at least one planar surface to mate with the at least one planar surface of the implant.

125. The implant of claim 121 wherein the implant mimics an anatomy of a healthy joint.

126. The implant of claim 101 wherein the implant mimics an anatomy of a joint prior to surgery.

127. The implant of claim 101 wherein the implant mimics a targeted anatomy of a joint.

128. The implant of claim 101 wherein the implant is placed within a joint space during a surgery without performing ligament balancing.

129. The implant of claim 101 wherein the implant is a system comprised of a condylar implant and a patellar mating implant.

130. The implant of claim 101 wherein a thickness of the implant at a location is adjusted to account for at least one of valgus deformity, varus deformity and flattening.

131. The implant of claim 101 further having a beveled edge.

132. The implant of claim 101 further having a chamfer cut.

133. The implant of claim 101 further having a fillet.

134. The implant of claim 133 wherein the fillet is exterior to a posterior portion of a tibial spine.

135. An implant system comprising:

a femoral component, wherein the femoral component replaces a femoral surface of the patellofemoral articulation surface and a tibiofemoral articulation surface;

a tibial component, wherein the tibial component replaces the tibial surface of the tibiofemoral articulation surface; and

a patellar component designed to replace a patellar surface of the patellofemoral articulation surface.

136. The implant system of claim 135 wherein the femoral component has a thickness determined by a cartilage defect in a patient.

137. The implant system of claim 135 wherein the tibial component has a thickness determined by a cartilage defect in a patient.

138. The implant system of claim 135 wherein the femoral component has a thickness of about 85% of a cartilage defect in a patient.

139. The implant system of claim 135 wherein the femoral component has a thickness of between 65% and 100% of a cartilage defect in a patient.

140. The implant system of claim 135 wherein the femoral component has a thickness of the cartilage defect in a patient plus a predetermined offset value.

141. The implant system of claim 135 wherein the femoral component is constructed of a material comprising metal or metal alloy.

142. The implant system of claim 135 further having a structure for attachment on at least one surface.

143. The implant system of claim 142 wherein the structure for attachment is selected from ridges, pegs, pins, cross-members, roll-bars, cruciate stems, teeth and protrusions.

144. The implant system of claim 135 wherein the superior surface of the femoral component has a substantially flat section designed to mate with a bone cut on the femoral condyle.

145. The implant system of claim 135 wherein one or more components are sized using x-ray sizing.

146. The implant system of claim 135 wherein one or more components are manufactured using standard casting techniques.

147. The implant system of claim 135 wherein the implant further comprises a rail extending from the superior surface on one of a medial or lateral side.

148. The implant system of claim 135 wherein the implant further comprises a keel extending from the superior surface, wherein the keel is in a recessed position from the medial and lateral side.

149. The implant system of claim 135 wherein a portion of the superior surface sits within a plane.

150. The implant system of claim 149 wherein the portion of the superior surface that sits within a plane mates with a planar cut on a surface of the femur.

151. The implant system of claim 135 wherein the portion of the superior surface that sits within a plane substantially mates with a planar cut on a surface of the femur.

152. The implant system of claim 135 wherein the tibial component has a dome positioned on a plate.

153. The implant system of claim 152 wherein the dome is positioned on the plate such that an apex of the dome is off-center a center point of the plate.

154. The implant system of claim 152 wherein an apex of the dome is positioned to correspond to a patellar ridge.

155. The implant of claim 135 wherein a femoral condyle surface is prepared for receiving the implant.

156. The implant of claim 155 wherein the femoral condyle surface is prepared by forming at least one planar surface to mate with the at least one planar surface of the implant.

157. The implant of claim 155 wherein the femoral condyle surface is prepared by removing cartilage.

158. The implant of claim 155 wherein the femoral condyle surface is prepared by forming at least one planar surface to mate with the at least one planar surface of the implant.

159. The implant of claim 155 wherein the implant mimics an anatomy of a healthy joint.

160. The implant of claim 135 wherein the implant mimics an anatomy of a joint prior to surgery.

161. The implant of claim 135 wherein the implant mimics a targeted anatomy of a joint.

162. The implant of claim 135 wherein the implant is placed within a joint space during a surgery without performing ligament balancing.

163. The implant of claim 135 wherein the implant is a system comprised of a condylar implant and a patellar mating implant.

164. The implant of claim 135 wherein a thickness of the implant at a location is adjusted to account for at least one of valgus deformity, varus deformity and flattening.

165. The implant of claim 135 further having a beveled edge.

166. The implant of claim 135 further having a chamfer cut.

167. The implant of claim 135 further having a fillet.

168. The implant of claim 167 wherein the fillet is exterior to a posterior portion of a tibial spine.

169. A prosthetic device for a knee joint comprising:

a femoral condyle component having a top portion and a bottom portion with a curved lateral edge therebetween; and

a trochlear groove component along the top portion of the device,

wherein the bottom portion of the femoral condyle component terminates before a sulcus terminalis on the knee joint surface.

170. A prosthetic device for a knee joint comprising:

a femoral condyle component having a top portion and a bottom portion with a curved lateral edge therebetween; and

a trochlear groove component along the top portion of the device,

wherein the bottom portion of the femoral condyle component terminates near a sulcus terminalis on the knee joint surface.

171. A prosthetic device for a knee joint comprising:

a femoral condyle component having a top portion and a bottom portion with a curved lateral edge therebetween; and

a trochlear groove component along the top portion of the device,

wherein the bottom portion of the femoral condyle component terminates beyond a sulcus terminalis on the knee joint surface.

172. An implant system comprising:

a femoral component, wherein the femoral component replaces a femoral surface of the patellofemoral articulation surface and a tibiofemoral articulation surface; and

a tibial component, wherein the tibial component replaces the tibial surface of the tibiofemoral articulation surface,

wherein at least one of the tibial component and femoral component is asymmetric.

173. An implant system comprising:

a femoral component, wherein the femoral component replaces a femoral surface of the patellofemoral articulation surface and a tibiofemoral articulation surface;

a tibial component, wherein the tibial component replaces the tibial surface of the tibiofemoral articulation surface; and

a patellar component designed to replace a patellar surface of the patellofemoral articulation surface

wherein at least one of the tibial, femoral and patellar component is asymetrical.

174. A prosthetic device for a knee joint comprising:

a femoral condyle component having a superior surface and an inferior surface and a top portion and a bottom portion with a curved surface extending therebetween; and

a trochlear groove component along the top portion of the device,

wherein the bottom portion of the femoral condyle component terminates after a sulcus terminalis.

176. The tibial implant of claim 174 wherein the dome has an apex positioned to correspond to a patellar ridge.

175. A tibial implant having a first surface having a substantially planar surface and a second surface with a partially planar surface wherein the second surface with a partially planar surface further comprises a dome structure.

177. The tibial implant of claim 175 wherein the dome is positioned on the second surface such that the apex of the dome is off-center to a center of the implant.

178. A tibial implant having a first surface having a substantially planar surface and a second surface with a partially planar surface wherein the second surface with a partially planar surface further comprises a dome structure located on the partially planar surface such that the planar surface forms a lip around the dome.

179. The tibial implant of claim 178 wherein the lip around the dome is symmetrical around the circumference of the dome.

180. The tibial implant of claim 178 wherein the lip around the dome is asymmetrical around the circumference of the dome.

181. The tibial implant of claim 178 wherein the implant forms a blank.

182. The tibial implant of claim 178 wherein an edge of the planar surface is modified in a patient-specific manner.