Referring to the figures, wherein like numerals represent like parts throughout the several views. Various embodiments of the present invention will now be discussed with reference to the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope.
The present invention relates to a system and a method for a spinous process fixation implant.
Referring to
The first plate 44 is a substantially flat, rectangular surface extending perpendicularly from the crosspieces 40, 42. It has a first side 52 and a second side 54, and ends in a rounded terminus 56. A first bolt hole 58 passes through the first plate 44 near the terminus 56. Surrounding the bolt hole 58 on the first side 52 is a plurality of teeth 60 which protrude out of the surface of the first side. Indented into the second side 54, between the bolt hole 58 and the terminus 56, is a kidney-shaped first slot 62 (not visible in
At the opposite end of the crosspieces 40, 42 from the first plate 44 are the rings 48, 50. The first ring 48 is a rounded extension of the first crosspiece 40, and the second ring 50 is a rounded extension of the second crosspiece 42. The rings 48, 50 are parallel to each other and a gap 68 between them is sized to hold portions of a straight arm 16 and a bent arm 14, as seen in
The second plate 46 extends at a right angle from the rings 48, 50 and ends in a rounded terminus 76. A second bolt hole 78 penetrates the plate 46 near the terminus 76. On the first side 52, in between the terminus 76 and the bolt hole 78 is a kidney-shaped second slot 82. On the second side 54, surrounding the second bolt hole 78 is a plurality of teeth 80.
As seen in
The plate 96 extends away from the ring 90 such that the plane of the plate is perpendicular to the plane of the ring. The plate has a first side 104, a second side 106, and ends in a terminus 108. Adjacent to the terminus 108 is a bolt hole 110, which is has a diameter to fit a long bolt 22, but is elongated to allow the vertical placement of the arm 16 on the bolt 22 to be adjustable. A plurality of teeth 112 surround the bolt hole 110, projecting outward from the first side 104.
Returning briefly to
At the opposite end of the shaft 122 from the ring 120 is the plate 124. The plate 124 is generally rectangular, and has a first side 126 which is a continuation of the first side of the shaft 122. A second side 128 is a continuation of the second side of the shaft 122. The plate 124 ends in a terminus 144. Passing through the first and second sides 126, 128 adjacent to the terminus 144 is a bolt hole 140. The bolt hole 140 has a diameter to fit a long bolt 22 but is elongated along the long axis of the shaft 122 so the placement of the bent arm 14 can be adjustable relative to the bolt 22. Surrounding the bolt hole 140 and projecting from the first side 126 is a plurality of teeth 142.
As shown in
With all pieces 12, 14, 16 assembled thus, a short bolt 20 is slid into place from the posterior side 38 of the body 12.
The assembled components are implanted into the patient with the use of instrumentation (not shown) between two adjacent spinous processes 4a, 4b, as seen in
Long bolts 22a, 22b may be added to this embodiment to further anchor the device on the spinous processes 4a, 4b, respectively. If they are added, appropriately sized holes must be drilled laterally through the spinous processes prior to placement of the device. Once the device is in place as described above, one long bolt 22a is threaded through the bolt hole 58 on the first plate 44 of the body 12, through the drilled hole in the spinous process 4a, then out through the bolt hole 110 on the straight arm 16. The second long bolt 22b is threaded through the bolt hole 78 on the second plate 46, through the drilled hole in the spinous process 4b, then out through the bolt hole 140 on the bent arm 14. The fit of the device may be adjusted by loosening the short bolt 20 and pivoting the arms 14, 16 until the proper orientation is found. The elongated bolt holes 110, 140 on the arms allow for adjustment of the arms 14, 16 while still being able to receive the ends of the long bolts 22a, 22b. The short bolt 20 is tightened, and nuts 24a, 24b are screwed on the ends of the long bolts 22a, 22b, respectively, and tightened.
In this embodiment of the invention, a plurality of bolts and nuts holds the elements of the device 10 together and secures them to the vertebrae. The use of bolts adds adjunctive tension to the plates, and adds additional strength during flexion and extension. However, pins, screws, cables, or other connecting elements may be implemented instead to connect and secure the elements of the device.
The primary indication of the device 10 is as an adjunctive fixation device, in association with an interbody fusion device. However, if desired, the device as described may also be use as a dynamic stabilization device, if the plates are not clamped down tightly on the spinous processes. The device 10 may also be used as described as an X stop, reducing pressure on the intervertebral disks during extension.
When the device 10 is used as an adjunctive fixation device, it may be desirable to add bone ingrowth surfaces to the edges 66 of the crosspieces 40, 42. The bone ingrowth surfaces may be additive, such as but not restricted to plasma spray, laser deposition of metal, or a sintered bead coating. Alternatively, the bone ingrowth surfaces may be created by electrochemical etching or other removal processes. If the device is to be used as a dynamic stabilization device or an X stop, no bone ingrowth surfaces would be created.
An alternative embodiment of the device is depicted in
The first plate 164 is generally flat and rectangular, and one rectangular end terminates in a rounded terminus 176. The plate 164 has a flat first side 184 and a flat second side 186. Adjacent to the terminus 176 and passing through both sides 184, 186 is a bolt hole 178. A spur 182 projects from the first side 184, on the opposite side of the bolt hole 178 from the terminus 176.
The second plate 166 extends in the opposite direction but on the same plane as the first plate 164. The second plate 166 is also generally flat and rectangular, and ends in a rounded terminus 188. Adjacent to the terminus 188, a bolt hole 190 is open from the first side 184 to the second side 186. Surrounding the bolt hole 190 are a plurality of teeth 192 which project outward from the first side 184.
The rings 168, 170 are parallel to one another and are perpendicular to the plates 164, 166, extending in the direction of the first side 164. The posterior ring 168 has a central first bore 194 which is sized to fit the diameter of a short bolt 20b. The anterior ring 170 has a central second bore 196 which is wider in diameter, sized to fit the annulus 100 on a straight arm 16 (as seen in
An extension body 18 linked to a straight arm 16 is depicted in
In this embodiment of the invention, the rings 168, 170 are located at one end of the crosspieces 172, 174. The rings 168, 170 and their associated short bolt 20 form a pivot point for adjusting the fit of the plates 96, 166 around the spinous process. In alternative embodiments of the invention, the rings and therefore the pivot point could be located at the center of the crosspieces, at the other end of the crosspieces, or any other location on the extension body which puts the pivot point in the vicinity of or between the spinous process.
Referring to
Several adjustments may be made to fit the device to the spinous processes. The longitudinal angle of the extension body 18 relative to the body 12 is adjusted by pivoting the extension body 18 around the long bolt 22b. The spur 182 slides within the slot 82, allowing for some adjustment but preventing slippage beyond a certain point. Once the correct angle is found, a nut 24b is added to the end of the bolt 22b and tightened.
After the angle adjustment is made to the extension body 18, the final long bolt 22c connects the second plate 166 to the straight arm 16. It is threaded from the second side 186 of the extension body 18 through the bolt hole 190, through the hole in the spinous process 4c, then through the bolt hole 110 on the straight arm 16.
The angle of the straight arm 16 attached to the extension body 18 is adjusted by pivoting it around the short bolt 20b. The elongated shape of the bolt hole 110 allows for some movement of the straight arm 16 while still allowing the long bolt 22c to reach through the hole 110. Once the correct fit is found, the short bolt 20b is tightened. As it is tightened, the radial spline 102 on the straight arm 16 is pressed into the washer 200, creating additional friction. A nut 24c is added to the end of the long bolt 22c and tightened. As the nut 24c is tightened, the plates 96, 166 and their teeth 112, 192 are pressed in and grip the spinous process 4c.
The fit of the spinous fixation device on the spinous processes is determined by two factors: the size of the component pieces and their ability to be pivoted. The body, extension body, straight arm and bent arm components are all available in small, medium and large sizes. All three sizes are of a standard depth (posterior to anterior direction) but increase in length from small to large. The lateral width of the device is determined by the pivotability of the components around the short bolts. The elongated bolt holes on the ends of the straight and bent arms allow those pieces freedom to be pivoted laterally yet still be connectable to the long bolts.
The device is conformed to the lordotic or kyphotic angle of the spine by the pivotability of the components around the long bolts. The plates of the body and the extension body (or bodies, if three or more spinous processes are fixed) are swiveled posteriorly or anteriorly at infinite increments to fit the spine prior to the tightening of the long bolt. The spur and slot mechanism which engages when an extension body is linked to a body allows for several degrees of rotation but prevents slipping.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. As such, the described embodiments are to be considered in all respects only as illustrative and not restrictive. Other embodiments are within the scope of the following claims. For example, vertebras 2a and 2b may be any two vertebras, including lumbar L1-L5, thoracic T1-T12, cervical C1-C7 or the sacrum. The fixation assembly 10 may extend along multiple vertebras. The body structure 12 may be also configured as a mirror image of the structure in
Several embodiments of the present invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.
This application claims the benefit of U.S. provisional application Ser. No. 60/784,557 filed Mar. 21, 2006 and entitled “SPINOUS PROCESS FIXATION DEVICE”, the contents of which are expressly incorporated herein by reference. This application is also a continuation in part of U.S. application Ser. No. 11/609,418 filed on Dec. 12, 2006 and entitled SPINOUS PROCESS FIXATION IMPLANT, the contents of which are expressly incorporated herein by reference.
Number | Date | Country | |
---|---|---|---|
60784557 | Mar 2006 | US |