CA2478311A1 - Instrumentation and procedure for implanting spinal implant devices - Google Patents

Instrumentation and procedure for implanting spinal implant devices Download PDF

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Publication number
CA2478311A1
CA2478311A1 CA002478311A CA2478311A CA2478311A1 CA 2478311 A1 CA2478311 A1 CA 2478311A1 CA 002478311 A CA002478311 A CA 002478311A CA 2478311 A CA2478311 A CA 2478311A CA 2478311 A1 CA2478311 A1 CA 2478311A1
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CA
Canada
Prior art keywords
implant
spreader
separator
members
connector
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002478311A
Other languages
French (fr)
Other versions
CA2478311C (en
Inventor
Michael E. Landry
Ronald C. Todd
Erik J. Wagner
Stephen H. Hochschuler
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Zimmer Spine Inc
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Individual
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Publication date
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Priority to CA2702131A priority Critical patent/CA2702131A1/en
Publication of CA2478311A1 publication Critical patent/CA2478311A1/en
Application granted granted Critical
Publication of CA2478311C publication Critical patent/CA2478311C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/4657—Measuring instruments used for implanting artificial joints
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Abstract

An instrumentation set may include insertion instruments for forming an implant between bone structures. The insertion instruments may include a spreader (400) and a separator (300). The bone structures may be vertebrae.
Implant members (12) may be attached to the spreader and positioned between the bone structures. The separator may be inserted into the spreader to establish a desired separation distance between the implant members.
Connectors (14) may be inserted into the implant members to join the implant members together and form the implant. The insertion instruments may be removed. A seater (1100) may be used to set the position of the connectors relative to the implant members to inhibit disassembly of the implant.

Claims (221)

WHAT IS CLAIMED IS:
1. An instrument set, comprising:
a spreader configured to couple to and insert members of an implant between bone structures; and a separator configured to be inserted into the spreader to establish a separation distance between the members and facilitate insertion of a connector between the members.
2. The instrument set of claim 1, further comprising a depth gauge configured to position the connector at a desired position between the members.
3. The instrument set of claim 2, wherein the depth gauge comprises an end configured to engage a backing plate to facilitate insertion of the backing plate between members positioned between the bone structures.
4. The instrument set of claim 1, further comprising a mallet.
5. The instrument set of claim 1, further comprising locking pins configured to secure the members to the spreader.
6. The instrument set of claim 1, further comprising a slap hammer.
7. The instrument set of claim 1, further comprising an extender configured to provide an impact surface for driving the separator into the spreader.
8. The instrument set of claim 1, further comprising an end cap for the spreader.
9. The instrument set of claim 1, further comprising a width and depth spacer.
10. The instrument set of claim 1, further comprising a height spacer.
11. The instrument set of claim 1, further comprising a backing plate configured to be positioned between members inserted between the bone structures.
12. The instrument set of claim 1, further comprising an insertion guide configured to facilitate insertion of members coupled to the spreader between the bone structures.
13. The instrument set of claim 1, further comprising an insertion guide configured to facilitate insertion of members coupled to the spreader between the bone structures, wherein the insertion guide comprises a first arm, a second arm, and a shaft; and wherein the members are positionable between the first arm and the second arm after removal of the shaft.
14. The instrument set of claim 1, further comprising a seater configured to apply force to the connector and to a first member that fixes the position of the connector relative to the first member.
15. The instrument set of claim 14, further comprising a retainer configured to be positioned between a second member and the seater to inhibit release of the seater from the first implant member.
16. The instrument set of claim 14, further comprising a retainer configured to be positioned between a second member and the seater, and wherein the seater comprises a bracket configured to hold a portion of the retainer.
17. The instrumentation set of claim 1, further comprising forceps, the forceps configured to hold a connector so that the connector can be positioned and released into the separator.
18. The instrument set of claim 1, further comprising members.
19. The instrument set of claim 1, further comprising members, wherein each implant member of a first set of the members have a surface area that contacts or is adjacent to bone structure when inserted into a patient that is larger than a corresponding surface area of each member of a second set of the members.
20. The instrument set of claim 1, further comprising members, wherein at least one member of the members has a surface that allows an implant formed from the at least one member to have an anterior height that is different than a posterior height.
21. The instrument set of claim 1, further comprising connectors configured to couple members together.
22. An instrument set for forming an implant between bone structures, comprising:
a plurality of implant members;
a plurality of connectors;
at least one spreader configured to couple to and insert implant members between the bone structures; and at least one separator configured to establish a separation distance between implant members coupled to the at least one spreader, wherein the at least one separator facilitates placement of connectors between implant members inserted between the bone structures.
23. The instrument set of claim 22, further comprising a seater configured to fix the position of connectors relative to implant members that are inserted between the bone structures.
24. The instrument set of claim 23, further comprising at least one retainer configured to be positioned between an implant member and the seater.
25. The instrument set of claim 23, wherein the seater comprises a bracket to allow a retainer to be coupled to the seater during use.
26. The instrument set of claim 22, further comprising at least one depth gauge configured to establish an initial position of a connector relative to implant members that are positioned between the bone structures.
27. The instrument set of claim 22, further comprising at least one slap hammer.
28. The instrument set of claim 22, further comprising at least one locking pin configured to secure implant members to the spreader.
29. The instrument set of claim 22, further comprising at least one width and depth spacer.
30. The instrument set of claim 22, further comprising a plurality of height spacers.
31. The instrument set of claim 22, further comprising at least one insertion guide.
32. The instrument set of claim 22, further comprising an end cap for a spreader, the end cap configured to provide an impact surface for driving the spreader between the bone structures.
33. The instrument set of claim 22, further comprising at least one backing plate.
34. The instrument set of claim 22, further comprising at least one extender configured to facilitate insertion of instruments between bone structures.
35. The instrument set of claim 22, further comprising forceps configured to hold and release connectors.
36. The instrument set of claim 22, wherein at least one separator comprises connector passages configured to guide connectors to implant members coupled to the at least one spreader.
37. The instrument set of claim 22, wherein the plurality of implant members include at least one implant member that is configured to allow for the formation of an implant that has an anterior height that differs from a posterior height.
38. The instrument set of claim 22, wherein the plurality of implant members include a first set of implant members that have a larger surface configured to contact or be adjacent to a vertebral surface than a surface area configured to contact or be adjacent to a vertebral surface of a second set of implant members of the plurality of implant members.
39. The instrument set of claim 22, wherein the plurality of connectors comprise a first set of two connectors, each of the first set of connectors having a height, and a second set of two connectors, each of the second set of connectors having a height, and wherein the height of the first set of connectors is larger than the height of the second set of connectors.
40. A separator, comprising:
a body;
at least one passage through the body; and wherein the body is configured to separate members of an implant in a prepared space between adjacent bone structures.
41. The separator of claim 40, wherein the body comprises a central portion that is open to reduce an overall weight of the separator.
42. The separator of claim 40, further comprising an attachment mount.
43. The separator of claim 42, wherein the attachment mount is configured to couple to an insertion/removal tool.
44. The separator of claim 43, wherein the insertion/removal tool comprises a slap hammer.
45. The separator of claim 40, wherein at least one passage through the body is configured to allow a connector of a specific size to pass through.
46. The separator of claim 40, wherein at least one passage through the body is configured to allow a locking pin to pass through.
47. The separator of claim 40, further comprising a ridge to limit an insertion depth of the separator into a spreader.
48. The separator of claim 47, wherein the ridge mates with a ledge in an opening of the spreader.
49. The separator of claim 47, wherein the body comprises an end configured to separate members of the implant coupled to the spreader.
50. The separator of claim 49, wherein the end comprises a central portion between two outer arms.
51. The separator of claim 50, wherein the central portion comprises chamfered edges to facilitate insertion of the separator into the spreader.
52. The separator of claim 50, wherein the two outer arms inhibit rotational motion of the separator when fully inserted into the spreader.
53. The separator of claim 50, wherein the central portion and two arms define a guide for insertion of the separator into the spreader.
54. The separator of claim 49, wherein insertion of the end between the members of the implant inhibits over-distraction of the adjacent bone structures.
55. The separator of claim 40, further comprising a groove configured to guide the separator between members of the implant coupled to holders of a spreader during insertion of the separator into the spreader.
56. The separator of claim 40, wherein the attachment mount comprises an impact surface for impacting the separator between members of the implant coupled to a spreader.
57. The separator of claim 40, wherein the body comprises openings for engaging a retention mechanism of a spreader to inhibit movement of the separator when fully inserted into the spreader.
58. The separator of claim 40, wherein a connector is inserted into an opening in at least one passage of the body.
59. The separator of claim 40, wherein a connector is inserted into a side opening proximate an insertion end of at least one passage of the body prior to inserting the separator into a spreader.
60. The separator of claim 59, wherein the side opening of at least one passage is configured to allow insertion of the connector in only one direction.
61. The separator of claim 59, wherein the side opening comprises a pair of detents to inhibit unintentional release of the connector from the side opening.
62. The separator of claim 40, further comprising an opening at a top portion of each passage to accept a gauge configured to extend through and release a connector from the passage.
63. The separator of claim 62, wherein the gauge is configured to position the connector to a correct depth within slots between members of an implant.
64. The separator of claim 62, wherein the gauge is impacted into the passage with a mallet.
65. The separator of claim 62, wherein the opening comprises a ledge to limit an insertion depth of the gauge in the passage of the separator.
66. A separator, comprising:

a body configured to establish a separation distance between implant members;
a first passage in a portion of the body, the first passage configured to allow a connector to pass from the body into portions of implant members; and a connector inhibitor in the first passage, the inhibitor configured to inhibit undesired release of a connector positioned in the first passage.
67. The separator of claim 66, further comprising a second passage in communication with the first passage, wherein an instrument positioned through in the second passage is configured to release a connector positioned in the first passage during use.
68. The separator of claim 66, wherein the body comprises a first guide, and wherein the first guide is configured to couple to a portion of a spreader during use to facilitate placement of the body relative to the spreader.
69. A spreader for forming an implant between adjacent bone structures, comprising:
a body; and a first holder and a second holder configured to couple to inner surfaces of implant members;
wherein the body is configured to insert the first and second holders coupled to the implant members in an initial position into a prepared space between adjacent bone structures.
70. The spreader of claim 69, wherein the first and second holders comprise removably attachable mounts to couple to the inner surfaces of the implant members to the first and second holders.
71. The spreader of claim 69, wherein the first holder is an integral part of the body of the spreader.
72. The spreader of claim 69, wherein the first and second holders are an integral part of the body of the spreader.
73. The spreader of claim 69, wherein the first and second holders comprise at least one protrusion on an outer surface configured to press-fit into an opening of the implant members to couple the implant members to the first and second holders.
74. The spreader of claim 69, wherein the first and second holders comprise tongues configured to engage recesses in the inner surfaces of the implant members.
75. The spreader of claim 69, wherein the first and second holders comprise raised portions to engage recesses in the inner surfaces of the implant members.
76. The spreader of claim 69, wherein the first and second holders comprise slots configured to deflect to allow a press-fit engagement of the first and second holders to the implant members.
77. The spreader of claim 76, wherein the slots are further configured to inhibit a change in spring properties of the first and second holders.
78. The spreader of claim 69, wherein the first and second holders comprise a slot, the slot extending to the end of the first and second holders, and wherein the slot is configured to allow for deflection of the first holder and the second holder to allow a press-fit engagement of the first and second holders to the implant members.
79. The spreader of claim 69, wherein the first and second holders comprise dovetailed sidewalls configured to engage a recess in the inner surface of the implant members.
80. The spreader of claim 69, wherein the first and second holders comprise straight sidewalls configured to engage a recess in the inner surface of the implant members.
81. The spreader of claim 69, wherein the first and second holders comprise a stop, the stop configured to limit an insertion depth of the first and second holders into the implant members.
82. The spreader of claim 69, wherein the first holder comprises a compression member configured to apply a force against a recess in the inner surface of an implant member to frictionally couple the implant member to the first holder.
83. The spreader of claim 82, wherein the compression member comprises a stop configured to limit an insertion depth of the first and second holders into the implant members.
84. The spreader of claim 82, wherein the compression member is configured to engage an opening in the recess of the implant member to provide an interference coupling of the implant member to the first holder.
85. The spreader of claim 69, further comprising a locking pin, wherein a portion of the locking pin is insertable through a slot in the first holder and through a slot in the second holder to reside in slots of the implant members during use.
86. The spreader of claim 85, wherein the locking pin comprises a tapered portion to slide through aligned slots of the first and second holders and engage the slots of the implant members.
87. The spreader of claim 86, wherein the tapered portion of the locking pin comprises a compression slot, the compression slot configured to be compressed when engaging the slots of the implant members to frictionally secure the locking pins to the implant members during use.
88. The spreader of claim 85, wherein the locking pin is configured to pass through passages of a separator to guide the separator during insertion of the separator into the spreader.
89. The spreader of claim 69, wherein the first holder and the second holder comprise depth markings configured to indicate a depth that implant members coupled to the first holder and the second holder are inserted between adjacent bone structures.
90. The spreader of claim 69, wherein the body comprises a depth indicator to indicate a depth that implant members coupled to the first holder and the second holder are inserted between adjacent bone structures.
91. The spreader of claim 69, wherein the body comprises a pair of opposing channel members configured to couple the first and second holders to the body of the spreader.
92. The spreader of claim 91, wherein inner surfaces of the pair of channel members are separated by a distance to allow insertion of a separator between the first holder and the second holders and the pair of channel members.
93. The spreader of claim 91, wherein the channel members inhibit lateral and rotational movement of a separator inserted between the first and second holders.
94. The spreader of claim 69, wherein the first holder and the second holder are angled such that there is substantially no separation distance between an end of the first holder and an end of the second holder when in an initial position.
95. The spreader of claim 94, further comprising a spring member configured to hold the first and second holders in the initial position.
96. The spreader of claim 95, wherein a first end of the spring member is attached to the body of the spreader and a second end contacts the second holder.
97. The spreader of claim 69, wherein the body comprises an opening configured to allow insertion of a device into the spreader.
98. The spreader of claim 97, wherein the opening in the body comprises a ledge to limit an insertion depth of the device into the spreader.
99. The spreader of claim 97, wherein the body further comprises at least one retention mechanism configured to inhibit movement of the device inserted into the opening in the body.
100. The spreader of claim 97, wherein the device comprises a separator to separate the implant members coupled to the spreader.
101. The spreader of claim 100, wherein the separator comprises a ridge that mates with a ledge in the opening to limit an insertion depth of the separator into the spreader.
102. The spreader of claim I00, wherein the separator is configured to couple to a slap hammer to remove the separator and spreader from between the adjacent bone structures.
103. The spreader of claim 97, wherein the device comprises an end cap to provide an impact surface for driving the spreader between adjacent bone structures.
104. The spreader of claim 103, wherein the end cap and spreader comprise a limit system that limits an insertion depth of the impact end cap into the body of the spreader.
105. The spreader of claim 69, wherein the first holder and the second holders comprise sloped inner surfaces, the sloped inner surfaces configured to allow controlled separation of the implant members coupled to the spreader by a separator inserted between the first and second holders.
106. The spreader of claim 69, wherein the first holder comprises a limiter to limit an insertion depth of a separator into the spreader.
107. The spreader of claim 69, wherein the implant members comprise a portion of a spinal fusion device.
108. The spreader of claim 69, further comprising a handle for positioning the holders between adjacent bone structures.
109. A spreader, comprising:
a body;
a locking mechanism in the body configured to inhibit removal of a separator inserted into the body;
a first arm extending from the body, the first arm having a first holder, wherein the first holder is configured to couple to an implant member; and a second arm extending from the body, the second arm having a second holder, wherein the second holder is configured to couple to an implant member.
110. The spreader of claim 109, a portion of the first arm is configured to interact with a portion of a separator to maintain alignment of the separator relative to the first arm during use.
111. A Beater for forming an implant between adjacent bone structures, comprising:
an attachment end, comprising:
a first engager configured to couple to an implant member of the implant; and a second engager configured to engage a connector coupled to the implant member; and an activator configured to move the first engager relative to the second engager to lock the connector to the implant member.
112. The seater of claim 111, wherein the seater applies a force to the connectors and implant member to drive a portion of the connector into a slot of the implant member with enough force to inhibit subsequent removal of the portion from the slot.
113. The seater of claim 111, wherein a force that moves the first engager relative to the second engager is about thirty to about one hundred times greater than a force applied to the activator.
114. The seater of claim 111, wherein the Beater applies at least about 1600 N
of force is applied to move the first engager relative to the second engager.
115. The seater of claim 111, wherein use of the activator moves the first engager.
116. The seater of claim 111, wherein use of the activator moves the second engager.
117. The seater of claim 111, further comprising an indicator that allows a user to know when sufficient force is applied to fix the connector to the implant member.
118. The seater of claim 117, wherein the indicator comprises a pin attached to a first member of the activator that contacts a second member of the activator to indicate when sufficient force is applied to fix the connector to the implant member.
119. The seater of claim 117, wherein the indicator comprises a button that extends from a portion of the seater when sufficient force is applied to fix the connector to the implant member.
120. The seater of claim 111, further comprising at least one bracket coupled to the seater, the at least one bracket configured to allow for placement of an end portion of a retainer at a desired position relative to the first engager and the second engager.
121. The seater of claim 111, wherein the first engager is configured to couple to at least one opening in the implant member.
122. The seater of claim 111, wherein the first engager is removably attached to the seater.
123. A seater, comprising:
a first engager configured to couple to a first implant member;
a second engager configured to engage a connector, wherein the connector couples the first implant member to a second implant member;

an activator configured to move the first engager relative to the second engager to fix the connector in the first implant member.
124. The Beater of claim 123, further comprising a shaft that couples the activator to the second engager, and a spacer in working relation to the shaft, wherein a portion of the spacer is positionable between the first implant member and the second implant member when the first engager is moved relative to the second engager.
125. A system for forming an implant between adjacent bone structures, comprising:
a spreader comprising holders, wherein each holder is configured to couple to an inner surface of an implant member of the implant;
at least one separator comprising passages for inserting connectors between the implant members; and a seater;
wherein the separator is configured to be inserted between coupled implant members inserted between the adjacent bone structures by the spreader, and wherein the seater is configured to couple an implant member of the implant and lock connectors inserted between the implant members by the separator to the coupled implant member.
126. The system of claim 125, wherein a holder of the spreader comprises dovetailed sidewalls configured to engage a recess in the inner surface of an implant member.
127. The system of claim 125, wherein a holder of the spreader comprise straight sidewalls configured to engage a recess in the inner surface of an implant member.
128. The system of claim 125, wherein a holder of the spreader comprise a compression member, the compression member configured to apply a force against a recess in the inner surface of an implant member to frictionally couple the implant member to the holder.
129. The system of claim 128, wherein the compression member comprises a ridge configured to limit an insertion depth of the holder into the implant member.
130. The system of claim 128, wherein the compression member is configured to engage an opening in the recess of the implant member to provide an interference coupling of the implant members to the holder.
131. The system of claim 125, wherein the spreader comprises a depth indicator to indicate an insertion depth into a space between adjacent bone structures of implant members coupled to the spreader.
132. The system of claim 131, wherein the depth indicator comprises markings.
133. The system of claim 125, wherein the holders of the spreader are angled such that there is substantially no separation distance between ends of the holders coupled to implant members when the spreader is in an initial position.
134. The system of claim 125, wherein the holders of the spreader comprise a stop surface to limit an insertion depth of a separator into the spreader.
135. The system of claim 125, wherein a body of a spreader comprises an opening configured to allow insertion of a separator of the at least one separators into the spreader.
136. The system of claim 135, wherein the separator of the at least one separators comprises an impact surface.
137. The system of claim 135, wherein the opening in the body comprises a ledge to limit an insertion depth of the separator into the spreader.
138. The system of claim 135, wherein the body further comprises at least one retention mechanism configured to inhibit movement of the separator relative to the spreader when the separator is inserted into the opening in the body.
139. The system of claim 135, wherein the opening is configured to allow for insertion of an end cap, and wherein the end cap provides an impact surface for driving the spreader between bone structures.
140. The system of claim 139, wherein an insertion depth of the end cap into the spreader is limited.
I41. The system of claim 139, wherein the body comprises at least one retention mechanism configured to inhibit movement of the end cap when the end cap is inserted into the opening in the body.
142. The system of claim 125, wherein the holders of the spreader comprise sloped inner surfaces configured to allow desired separation of implant members that are coupled to the spreader when a separator is inserted between the holders.
143. The system of claim 125, wherein the adjacent bone structures are vertebrae.
144. The system of claim 125, wherein the implant members comprise a portion of a spinal fusion device.
145. The system of claim 125, wherein the passages of a separator of the at least one separator are configured to allow a selected size of connector to pass through.
146. The system of claim 145, wherein the selected size of connector is a size configured to form an implant with a height ranging from greater than about 8 mm to less than about 24 mm.
147. The system of claim 125, wherein the separator comprises an end configured to establish a separation distance between implant members coupled to the spreader.
148. The system of claim 147, wherein the end comprises a central portion between two outer arms.
149. The system of claim 148, wherein the central portion comprises chamfered edges to facilitate insertion of the separator into the spreader.
150. The system of claim 148, wherein the two outer arms inhibit rotational motion of the separator when the separator is inserted into the spreader.
151. The system of claim 148, wherein the central portion and two arms define a guide for insertion of the separator into the spreader.
152. The system of claim 148, wherein insertion of the end between the implant members coupled to the spreader inhibits over-distraction of the adjacent bone structures.
153. The system of claim 125, wherein insertion of the separator between the implant members coupled to the spreader inhibits over-distraction of the adjacent bone structures.
154. The system of claim 125, wherein the separator comprises a groove configured to guide the separator between the implant members coupled to the holders of the spreader.
155. The system of claim 125, wherein the separator comprises openings for engaging a retention mechanism of the spreader to inhibit movement of the separator when the separator is inserted into the spreader.
156. The system of claim 125, wherein connectors are inserted into side openings proximate an insertion end of the passages of the separator prior to inserting the separator into the spreader.
157. The system of claim 156, wherein the side openings of the passages are configured to allow insertion of a connector in only one direction.
158. The system of claim 156, wherein each side opening comprises a detents to inhibit undesired release of connectors from the side openings.
159. The system of claim 125, wherein the separator further comprises openings at a top portion of each passage to accept a gauge configured to extend through and release a connector from the passage.
160. The system of claim 159, wherein the gauge is configured to position the connector to a correct depth within slots between the implant members.
161. The system of claim 125, wherein the seater applies a force to the connectors and implant members to drive the connectors into slots of the implant members.
162. The system of claim 125, wherein the seater comprises an indicator to inform a user when a desired amount of force is applied to fix the connectors to the implant members.
163. The system of claim 162, wherein the indicator comprising a pin on a first arm of an activator that is configured to contact a portion of a second arm of the activator.
164. The system of claim 125, further comprising a retainer positionable between the seater and an implant member during use of the seater.
165. The system of claim 164, wherein the seater comprises at least one bracket configured to hold a portion of the retainer to facilitate positioning of the retainer during use of the seater.
166. A method of forming an implant between adjacent bone structures, comprising;
inserting a pair of implant members a space between bone structures;
separating the implant members to a desired separation distance;
inserting connectors between the pair of implant members; and locking the connectors to the pair of implant members.
167. The method of claim 166, wherein the adjacent bone structures comprise vertebrae.
168. The method of claim 167, wherein the space is prepared during a discectomy that removes at least a portion of a disc between vertebrae.
169. The method of claim 167, wherein the implant members comprise implant members of a spinal implant.
170. The method of claim 166, wherein the pair of implant members are coupled to holders of a spreader for insertion in the space between the adjacent bone structures.
171. A method for forming an implant between bone structures, comprising:
inserting a pair of implant members into a space between the bone structures;
joining the implant members together with a connector; and locking the connector to the implant members.
172. The method of claim 171, wherein inserting the pair of implant members comprises:
coupling implant members to a portion of a spreader; and inserting the portion of the spreader into the space.
173. The method of claim 171, wherein inserting the pair of implant members comprises:
coupling implant members to a portion of a spreader;
placing insertion guides adjacent to the bone structures;
inserting the portion of the spreader between the insertion guides so that the implant members are positioned between the bone members; and removing the insertion guides.
174. The method of claim 171, wherein preparing the space comprises performing a discectomy to remove at least a portion of a disc between the vertebrae.
175. The method of claim I7I, further comprising leaving the adjacent surfaces of the vertebrae intact.
176. The method of claim 171, wherein the proper size of the space allows an implant to contact approximately 70% of a surface of the adjacent vertebrae.
177. The method of claim 171, further comprising selecting the pair of implant members depending on a desired lordotic alignment of the adjacent vertebrae.
178. The method of claim 171, wherein the pair of implant members is selected from a plurality of implant members of different lordotic angles.
179. The method of claim 171, wherein the pair of implant members comprise protrusions on an outer surface to engage surfaces of the adjacent vertebrae.
180. The method of claim 171, wherein a spacer is used to determine a proper width and depth of the space between the adjacent vertebrae.
181. The method of claim 180, further comprising using radiological images of the spacer positioned between the adjacent bone structures to determine the proper width and depth of the space between the adjacent vertebrae.
182. The method of claim 171, further comprising marking the adjacent bone structures to determine a proper lateral position of the implant.
183. The method of claim 171, wherein a spacer is used to determine a proper height of the space between the adjacent vertebrae.
184. The method of claim 171, further comprising selecting the pair of implant members from a plurality of implant members depending on the size of the prepared space.
185. The method of claim 171, further comprising selecting the connectors from a plurality of connectors depending on a height of the implant to be formed.
186. The method of claim 171, wherein the pair of implant members are coupled to member holders of a spreader for insertion in the space between the adjacent vertebrae.
187. The method of claim 186, wherein the member holders are press-fit into openings of the pair of implant members.
188. The method of claim 186, further comprising using a mallet to impact an impact cap coupled to the spreader to insert the spreader into the space between the adjacent vertebrae.
189. The method of claim 186, further comprising separating the implant members coupled to the spreader between the adjacent vertebrae with a separator inserted into the spreader.
190. The method of claim 189, wherein the separator is configured to distract the implant members to a desired separation distance of the adjacent vertebrae.
191. The method of claim 189, wherein the spreader comprises a ledge that mates with a ridge of the separator to limit an insertion depth of the separator within the spreader.
192. The method of claim 189, wherein an indicator indicates a proper depth of the separator within the spreader.
193. The method of claim 192, wherein the indicator comprises observing when top surfaces of the separator and spreader are flush with each other.
194. The method of claim 189, further comprising using a mallet to impact the separator into the spreader.
195. The method of claim 189, wherein the separator comprises passages configured to guide a selected size of connectors in a proper direction to be positioned between the implant members when separated.
196. The method of claim 195, wherein a depth gauge is configured to fit within the passages of the separator to push the connectors to a proper depth into tapered slots of the pair of implant members.
197. The method of claim 196, wherein the passages of the separator comprise a ledge that mates with a ridge of the depth gauge to limit an insertion depth of the depth gauge within the separator.
198. The method of claim 196, wherein an indicator indicates a proper depth of the depth gauge in the separator.
199. The method of claim 198, wherein the indicator comprises top surfaces of the depth gauge and separator flush with each other.
200. The method of claim 189, further comprising removing the separator and spreader together from between the adjacent vertebrae using a slap hammer coupled to the separator.
201. The method of claim 171, further comprising inserting insertion guides within the space to protect scoring of surfaces of the adjacent vertebrae during insertion of the pair of implant members into the space.
202. The method of claim 171, further comprising using radiological images to ensure the implant members and inserted connectors are laterally and transversely positioned properly in the space between the adjacent vertebrae.
203. The method of claim 171, further comprising locking the connectors between the pair of implant members with a cold weld.
204. The method of claim 171, further comprising using a seater configured to couple to one of the implant members inserted between the adjacent vertebrae to lock the connectors to the coupled implant member.
205. The method of claim 204, further comprising inserting a retainer in a space between the seater coupled to the implant member and the other implant member to inhibit removal of the seater from the coupled implant member.
206. The method of claim 204, wherein the seater comprises engagers configured to apply a force to the connectors to lock the connectors to the implant member.
207. The method of claim 171, further comprising positioning a backing plate at a posterior end between the inserted pair of implant members.
208. The method of claim 171, further comprising perforating surfaces of the adjacent vertebrae through opening in the pair of implant members with a bone awl.
209. The method of claim 171, further inserting bone growth material between the pair of implant members.
210. A connector for an implant, comprising:
a body having a first end and a second end, wherein the body is formed of a substantially rigid material, and wherein the body comprises at least one opening configured to allow compression of the body when a compressive load is applied to the body; and a limiter coupled to the body, the limiter configured to limit a distance of travel of the first end towards the second end.
211. The connector of claim 210, wherein a plurality of openings are formed in the body to allow for compression of the body when a compressive load is applied to the body, and wherein the plurality of openings form an "X" pattern in the body.
212. An implant, comprising:
a first implant member;
a second implant member; and a connector insertable between the first implant member and the second implant member, wherein the connector comprising a body having an opening that allows the body to compress when a compressive load is applied to the first implant member and the second implant member, and a limiter configured to limit a distance of travel of a first end of the body towards a second end of the body.
213. The implant of claim 212, wherein the first implant member includes a slot, wherein the second implant member includes a slot, wherein the first end of the body is configured to insert into the slot of the first implant member to join together the first member and the connector, and wherein the second end of the connector is configured to insert into the slot of the second implant member to join together the second member and the connector.
214. implant for separating bone structures, comprising:
a pair of implant members configured to couple to the bone structures; and a connector configured to join the pair of implant members together, the connector comprising:
a flexible member configured to allow a reduction in distance separating the pair of implant members when the implant members are subjected to a compressive load, the flexible member having a first portion separated from a second portion by a gap; and a limiter positioned in the gap, the limiter configured to inhibit reduction of the formed implant beyond a predetermined distance.
215. The implant device of claim 214, wherein the pair of implant members and the pair of connectors comprise a spinal implant.
216. The implant device of claim 214, wherein at least a portion of the implant members comprises a biocompatible material.
217. The implant device of claim 214, wherein at least a portion of outer surfaces of the implant members is configured to promote osseointegration of the implant members and adjacent bone structures.
218. The implant device of claim 214, wherein an outer surface of the implant members comprises curvature to substantially conform to a shape of surfaces of adjacent bone structures.
219. The implant device of claim 214, wherein an implant member comprises a sloped outer surface.
220. The implant device of claim 214, wherein an inner surface of each implant members comprises a recessed surface, wherein at least one angled wall defines each recessed surface, and wherein the angled walls are configured to engage a spreader that allows the implant members to be inserted between vertebrae.
221. A method of forming a connector for an implant, comprising:
removing material from a blank to provide flexibility to the material of the blank;
coupling a limiter to the blank to limit the amount of flexibility the blank;
and forming ends of the connector so the ends are configured to couple to implant members.
CA2478311A 2002-03-11 2003-03-11 Instrumentation and procedure for implanting spinal implant devices Expired - Fee Related CA2478311C (en)

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