JP5331138B2 - Interspinous implant - Google Patents

Description

The present invention relates to an interspinous process implant.
(Priority claim)
Registered on March 21, 2005, by James F. Zuckerman et al., US Provisional Patent Application No. 60 / 663,885 entitled "Interspinous Process Implants and Implantation with Expandable Wings",
Registered March 21, 2005, by James F. Zuckerman et al., US Provisional Patent Application No. 60 / 663,918, entitled “Interspinous Process Implants and Implantation with Expandable Wings”,
Registered March 22, 2005, by James F. Zuckerman et al., US Provisional Patent Application No. 60 / 664,076, entitled `` Interspinous Process Implant and Implantation with Wings Expandable as an Auxiliary Device for Vertebral Fusion '',
Registered March 17, 2006, by James F. Zuckerman et al., US patent application Ser. No. 11 / 377,971 (US Publication No. 2006/0264938) entitled “Interspinous Process Implants and Implantation with Expandable Wings”.
US Patent Application No. 11 / 378,108 (US Publication No. 2007/0010813), entitled “Interspinous Process Implants and Implants with Expandable Wings”, registered by Mar. 17, 2006, by James F. Zuckerman et al., And ,
US patent application Ser. No. 11 / 378,894, registered on Mar. 17, 2006, entitled “Interspinous process implant and implantable wing with deployable wing as a vertebral fusion aid” by James F. Zuckerman et al. 2006/0271194).

  The spinal column is a biomechanical structure composed primarily of ligaments, muscles, vertebrae, and intervertebral discs. The biomechanical functions of the spinal column are: (1) support of the body including weight movement and bending movement of the head, trunk, and arms toward the pelvis and both legs; (2) complex physiology between each of the body parts Exercise, and (3) protection of the spinal cord and nerve roots.

  As the current society ages, the unpleasant spinal pathology characteristic of the elderly is expected to increase. By way of example only, an increase in spinal stenosis (including but not limited to central canal stenosis and lateral stenosis) and vertebral arthropathy appears with age. Spine stenosis results in a reduction in intervertebral foramen area (ie, space available for nerve and vascular passage), which compresses the cervical nerve root and leads to nerve root pain. Humpreys, SC et al., “Flexion and traction effect on C5-C6 foraminal space,” Arch. Phys. Med. Rehabil., Vol. 79, 1105 (1998) September). Another symptom of spinal stenosis is spinal cord injury, which leads to cervical / lumbar pain and muscle weakness. The above literature. Neck extension and ipsilateral rotation further narrow the pore area, leading to pain, nerve root compression, and nerve damage. Yoo, JU et al., “Effect of cervical spine motion on the neuroforaminal dimensions of human cervical spine,” Spine, vol. 17, 1131 (1992 November 10). On the other hand, bending of the neck increases the hole area. Humpeys, S.C. et al., 1105, supra.

  Over time, disc height is lost not only in the thoracic and lumbar regions, but also in the cervical region, which leads to a series of degenerative events that involve degeneration of all components of the motion segment, resulting in segmental instability and eventual Causes spinal stenosis. During this process of degeneration, the disc may escape (hernia) and / or tear internally and become chronically painful. If the symptom is felt to originate from both anterior (disc) and posterior (vertebral joint and foramen) structures, the patient cannot tolerate either the extended or bent position.

The pain associated with stenosis can be relieved by medication and / or surgery. It is preferable to avoid major surgery for all individuals, especially for the elderly.
Accordingly, there is a need to develop spinal implants that relieve the pain caused by spinal stenosis caused by spinal column damage or degeneration, and other similar conditions. Such implants distract adjacent vertebrae, increase intervertebral space, thereby increasing the intervertebral foramen area and relieving pressure on the spinal nerves and blood vessels.

Furthermore, there is a need for the development of a surgical implant method for spinal implants that maintains the physiology of the spine with minimal surgical invasion.
There is also a need for implants that adapt to different anatomical structures of the spine, minimize new trauma to the spine, and avoid the need for invasive, surgical implantation methods. Furthermore, there is a need for a response to the pathological condition of the spinal cord that is aggravated by spinal extension.

  An interspinous implant according to the invention for solving the above-described problem is an interspinous implant adapted to be inserted between spinous processes, and includes a first wing, a spacer extending from the first wing, and the spacer. A distracting guide extending between the spacer and the distracting tip of the distracting guide, and moving between a contracted form and a deployed form. A first winglet and a second winglet which are particularly suitable, wherein the first winglet and the second winglet are expanded to be between the distraction guide and the spacer, When the interstitial implant is placed between the spinous processes, it restricts the movement of the interspinous implant.

  Preferably, an actuator operatively associated with the first winglet and the second winglet is further provided, and the first winglet and the second winglet are expanded by operating the actuator. The

  Also preferably, a collar having a threaded surface, further comprising a collar associated with the actuator, the actuator comprising a threaded surface, wherein the first winglet and the second winglet are , And is rotatably associated with the collar.

  Further preferably, the first winglet and the second winglet each have a first inner surface and a second inner surface, and are first pins disposed in the distraction guide, which are in contact with the first inner surface. A first pin suitable for guiding the movement of the first winglet, and a second pin disposed in the distraction guide, the second winglet moving in contact with the second inner surface And a second pin suitable for guiding.

  Preferably, the actuator is rotatable about the long axis of the interspinous implant, and the first winglet and the second winglet are expanded by rotating the actuator.

FIG. 1A is a perspective view of an implant including a spacer having a water droplet-shaped cross section, a distraction guide, a first wing, and a second wing connectable to the distraction guide. FIG. 1B is a perspective view of an implant including a rotatable spacer having an elliptical cross section, a distraction guide, a first wing, and a second wing connectable with the distraction guide. FIG. 2A is a perspective view of an implant according to an embodiment of the present invention including a distraction guide, a spacer having a central body with a first wing, and an insert. FIG.2B is the implant of FIG.2A, wherein when the implant is placed between adjacent spinous processes, the insert is placed in the body so that the distraction guide coupled to the body restricts the movement of the implant or FIG. 3 is a perspective view of an implant in a blocking state. FIG. 3A is a side view of the body of the implant of FIGS. 2A and 2B positioned between adjacent spinous processes. FIG. 3B is a side view of the implant of FIG. 3A with the insert positioned within the body. FIG. 4 is a perspective view of an implant according to another embodiment that includes a hook to limit relative movement of adjacent spinous processes during flexion movement. FIG. 5 is a side view of the implant of FIG. 4 positioned between adjacent spinous processes and adapted for hooks to contain the adjacent spinous processes. FIG. 6A is a perspective view of another embodiment of an implant according to the present invention, wherein the first section and the second section of the distraction guide are deployable to form a second wing. . FIG. 6B is a perspective view of the implant of FIG. 6A with the insert disposed within the body and thus the first and second sections of the distraction guide deployed. FIG. 7A is a perspective view of yet another embodiment of an implant according to the present invention including a rotatable spacer. FIG. 7B is a perspective view of the implant of FIG. 7A with the insert positioned within the central body and thus the distraction guide deployed as the second wing. FIG. 7C is a side cross-sectional view of the distraction guide of FIG. 7A. FIG. 7D is a side cross-sectional view of the distraction guide of FIG. 7B. FIG. 8 is a side view of the implant of FIGS. 7A-7D positioned between adjacent spinous processes. FIG. 9A is a side view of another embodiment of an implant disposed between adjacent spinous processes. 9B is a partial cross-sectional view from the side showing the deployable winglet of the implant of FIG. 9A disposed within the distraction guide of the implant. FIG. 9C is a partial cross-sectional view of the implant of FIG. 9B from the side of the implant with the winglets deployed. FIG. 10A is a side view of another embodiment of an implant disposed between adjacent spinous processes. FIG. 10B is a side view of the implant of FIG. 10A positioned between adjacent spinous processes with winglets deployed. FIG. 10C is a partial cross-sectional view from the end face of the implant of FIG. 10A showing a deployable winglet disposed within the distraction guide of the implant. FIG. 10D is a partial cross-sectional view from the end face of the implant of FIGS. 10A-10C showing the winglets deployed and extending from the distraction guide of the implant. FIG. 10E is an end view of the implant of FIGS. 10A-10D showing the distraction guide and the winglets deployed relative to the distraction guide. FIG. 11A is a partial cross-sectional view from an end view of another embodiment of an implant according to the present invention including a different actuator device. FIG. 11B is a partial cross-sectional view of the implant of FIG. 11A from the end face showing the winglet deployed and projecting from the extension guide of the implant. FIG. 12A is a partial cross-sectional view, as seen from the end face, of yet another embodiment of an implant according to the present invention having another actuator device wherein the winglet includes two hinge portions. 12B is a partial cross-sectional view of the implant of FIG. 12A, as viewed from the end surface, showing the winglets deployed and protruding from the distraction guide of the implant. FIG. 13 is a partial cross-sectional view, as seen from the end face, of yet another embodiment of the implant according to the invention, in which a plurality of implants are arranged in adjacent motion segments. FIG. 14 illustrates an embodiment of a method for implanting the interspinous implant of FIGS. 2A-8 between adjacent spinous processes according to the present invention. FIG. 15A shows an embodiment of a method for implanting the interspinous implant of FIGS. 2A-8 between adjacent spinous processes according to the present invention. FIG. 15B shows an embodiment of a method for implanting the interspinous implant of FIGS. 9A-13 between adjacent spinous processes according to the present invention.

Interspinous Implant FIG. 1A is a perspective view of an implant described in US Patent Application No. 10 / 850,267 (US Publication No. 2005/0010293), registered on May 20, 2004. FIG. This application is incorporated herein by reference. The implant 100 includes a first wing 130, a spacer 120, and a leading tissue dilator (also referred to herein as a distraction guide) 110. The distraction guide 110 in this particular embodiment has a wedge shape. That is, the implant has a cross section that expands from the proximal end of the implant 100 toward the region where the guide 110 connects to the spacer 120 (the reference point for the figure is based on the insertion point of the implant between adjacent spinous processes). The distraction guide 110 having the above configuration functions to activate the distraction of soft tissue and spinous processes when the implant 100 is surgically inserted between adjacent spinous processes. It should be understood that the distraction guide 110 may be pointed or the like to facilitate insertion of the implant 100 between the spinous processes of adjacent cervical vertebrae. To reduce trauma to the surgical site, promote early healing, and prevent destabilization of normal anatomy, it is advantageous that the insertion technique not disturb the bone and surrounding tissue or ligament as much as possible . In an embodiment similar to that shown in FIGS. 1A and 1B, there is no need to remove the spinous process bone and to remove the ligament and tissue directly associated with the spinous process from the body. For example, it is not necessary to cut the supraspinatric ligament of the lower spine or the nubral ligament (corresponding to the supraspinatric ligament) that partially buffers the impact on the upper cervical spinous process.

  As can be seen from the figure, the spacer 120 may have a water droplet shape in a cross section perpendicular to the long axis 125 of the implant 100. In this way, the shape of the spacer 120 can substantially match the wedge-shaped space between adjacent spinous processes, or a portion of the space, in which the implant 100 is housed. As shown in FIG. 1A, spacers 120 (and first wings 130) are formed on the spinous processes (and / or the lamina), preferably on the spinous processes (and / or the lamina) of the C6 and C7 cervical vertebrae. It has a configuration that adapts to its anatomy or contour so that it can be placed between the protrusions (ie, the C6-C7 motion segment). This same shape, or a variant of this shape, can also be used to adapt to other motion segments, such as the thoracic or lumbar region. In other embodiments, the spacer 120 may take other forms, such as round, wedge-shaped, egg-shaped, egg-like, football-shaped, and rounded squares, and other shapes. For a particular patient, the shape of the spacer 120 may be chosen for the patient so that the physician can position the implant 100 as closely as possible to the anterior portion of the spinous process surface. The shape chosen for the spacer 120 can affect the surface area of contact between the implant 100 and the spinous process to be distracted. Increasing the contact surface area between the implant 100 and the spinous process allows the load force to be distributed between the spinous process frame and the implant 100.

  Similarly, the first wing 130 has a water droplet shape in a cross section with respect to the long axis 125 of the spacer 120 and the distraction guide 110. The size of the first wing 130 is larger with respect to the size of the spacer 120, particularly along the axis of the vertebra, so that the lateral movement of the implant 100 is limited or prevented in the insertion direction along the long axis 125. Is possible. As with the spacer 120, the first wing 130 may have other cross-sectional shapes, such as an ellipse, a wedge, a circle, an oval, an egg-like, a football, and a square with rounded corners, and other shapes. May be.

  In addition to distraction guide 110, spacer 120, and first wing 130, implant 100 in FIG. 1A further includes an adjustable wing 160 (also referred to herein as a second wing). This second wing 160 can be connected to the distraction guide 110 (and / or the spacer 120) once the implant 100 is positioned between adjacent spinous processes. Similar to the first wing 130, the second wing 160 can limit or prevent lateral movement of the implant 100. On the other hand, the displacement is also limited or prevented in the opposite direction to insertion. When both the first wing 130 and the second wing 160 are connected to the implant 100 and the implant 100 is disposed between adjacent spinous processes, a portion of the spinous process becomes part of the first wing 130 and the second wing 160. Between them, the displacement is limited to the long axis 125. As can be seen from the figure, the second wing 160 may have a water drop type cross section. A lip 180 that defines a space 170 that passes through the second wing 160 allows the second wing 160 to pass over the distraction guide 110 and to meet and connect with the distraction guide 110 and / or the spacer 120. Next, the second wing 160 is fixed to the distraction guide 110 and / or the spacer 120. The second wing 160 may be designed to achieve coherent fit to the spacer 120 or to a portion of the distraction guide 110 adjacent to the spacer 120. If the second wing 160 is coherently matched, there is no further attachment device for fastening the second wing 160 to the remainder of the implant 100.

  Alternatively, various fasteners can be used to secure the second wing 160 for the remaining portion of the implant 100. For example, FIG. 1A shows an embodiment of an implant 100 that includes a water drop-type second wing 160 having a tongue 158 at the rear end of the second wing 160. An opening 155 is disposed through the tongue 158 and this opening is above the spacer 120 when the second wing 160 is in place relative to the remainder of the implant 100 by surgical insertion. The axis is aligned with the corresponding opening 156 provided. A threaded screw 154 is inserted in the front-rear direction through the axially aligned openings 155 and 156 to fix the second wing 160 to the spacer 120. A screw 154 having a posterior to anterior insertion direction fits in the openings 155, 156 and the remainder of the implant 100 along a direction generally perpendicular to the long axis 125. This orientation is most advantageous when the physician needs to use the screw 154 to secure the second wing 160 to the remainder of the implant 100. The second wing 160 is further attached to the spacer 120 by some other mechanism, for example, a flexible hinge (not shown) having a protrusion that fits into a recess provided in one of the distraction guide 110 and the spacer 120. It may be fixed to. Alternatively, the second wing 160 may be secured to one of the distraction guide 110 and the spacer 120 by yet another mechanism.

  FIG. 1B is a perspective view of the implant described in US Pat. No. 6,695,842 to Zuckerman et al. This patent is incorporated herein by reference. The implant 200 has a body that includes a spacer 220, a first wing 230, a leading tissue dilator 210 (also referred to herein as a distraction guide), and an alignment track 203. The body of the implant 200 is inserted between adjacent spinous processes and remains in place (desired) without being attached to the bone or ligament.

  The distraction guide 210 includes a tip by which the distraction guide 210 expands. The apex has a diameter that is small enough to allow an opening to be opened into the interspinous ligament and / or inserted into a small initial opening. The diameter and / or cross-sectional area of the distraction guide 210 increases gradually and eventually becomes approximately equal to the diameter of the spacer 220. This tapered front end makes it easier for the physician to push the implant 200 between adjacent spinous processes. When the body of the implant 200 is pushed between adjacent spinous processes, the front end of the distraction guide 210 extends the adjacent spinous processes and widens the interspinous ligament so that the space between adjacent spinous processes is approximately equal to the diameter of the spacer 220. To.

  As shown in FIG. 1B, the spacer 220 is elliptical in cross section and can be freely rotated so that the spacer 220 is naturally aligned with the non-uniform surface of the spinous process. Self-alignment allows compression addition to be distributed across the bone surface. As discussed in Zucherman '842, spacer 220 may have a diameter of, for example, 6 millimeters, 8 millimeters, 10 millimeters, 12 millimeters, and 14 millimeters. These diameters refer to the height at which the spacer 220 distracts and keeps the spinous processes away. For the elliptical spacer 220, the chosen height (ie, diameter) is an ellipsoidal minor axis measurement. The long axis runs transversely over the latter with respect to the spinous process axis.

  The first wing 230 has a lower portion 231 and an upper portion 232. The upper portion 232 has a shape that conforms to the anatomy or contour of the spinous process (and / or lamina) of the L4 (for L4-L5 placement) or L5 (for L5-S1 placement) vertebrae. This same shape, or a variant of this shape, can also be used to adapt to other motion segments, such as motion segments in the thoracic or lumbar region. The lower portion 231 is also chamfered to accommodate the spinous processes. The lower portion 231 and the upper portion 232 of the first wing 230 act as a stop mechanism when the implant 200 is inserted between adjacent spinous processes. The implant 200 cannot be inserted beyond the surface of the first wing 230. Further, when the implant 200 is inserted, the first wing 230 can prevent lateral or forward / backward movement of the implant 200.

  As with the implant 100 of FIG. 1A, the implant 200 of FIG. 1B further includes a second wing 260. Similar to the first wing 230, the second wing 260 includes a lower portion 261 and an upper portion 262 that are sized and / or shaped to accommodate the anatomy or contour of the spinous process and / or lamina. The second wing 260 is fixed to the main body of the implant 200 by a fastener 254. The second wing 260 also has an alignment tab 268. First, when the second wing 260 is installed in the main body of the implant 200, the alignment tab 268 is fitted into the alignment track 203. The alignment tab 268 slides through the alignment track 203 to help keep the adjustable wing 260 substantially parallel to the first wing 230. When the body of the implant 200 is inserted into the patient's body and the second wing 260 is attached, displacement in the insertion direction or in the direction opposite to the insertion along the long axis 225 is limited or prevented. Furthermore, the second wing 260 can prevent a slight lateral or longitudinal displacement.

  In both the implant 100 of FIG. 1A and the implant 200 of FIG. 1B, the second wings 160, 260 are connected to the implants 100, 200 after the implants 100, 200 are placed between the spinous processes. The process of placing this plant 100, 200 and then connecting the second wings 160, 260 to the implant 100, 200 may require bilateral approach. That is, the physician must reach both sides of the interspinous ligament. That is, on the first side, the first wing is placed so that it penetrates and / or distracts the interspinous ligament and places the implants 100, 200 and the movement in the insertion direction is sufficiently restricted by the first wings 130, 230. On the second side, the second wing 160, 260 must be mounted so that the movement in the opposite direction of insertion is sufficiently limited by the second wing 160, 260.

Implants with Deployable Second Wings Referring to FIGS. 2A-3B, referring to FIGS. 2A-3B, an implant 300, and a method of placing the implant according to the present invention, in one embodiment, includes a deployable second wing 360 that connects with a central body 301. Including. This allows the physician to deploy the second wing 360 simply to reach the first side of the spinous process to limit or prevent movement on the long axis 325.

  As shown in FIG. 2A, the implant 300 includes a body 301 having a fixation spacer 320 and a distraction guide 310. The distraction guide 310 includes a first winglet (also referred to herein as an upper winglet) 312 and a second winglet (also referred to herein as a lower winglet) 314 and is disposed in a first configuration. The distraction guide 310 includes a tip extending therefrom. This tip has a diameter that is small enough to allow opening in the interspinous ligament between the spinous processes and / or to be inserted into a small initial opening. Next, the diameter and / or cross-sectional area of the distraction guide 310 gradually increases and eventually becomes approximately equal to the diameter of the spacer 320. In this regard, the distraction guide 310 of FIG. 2A approximates the aforementioned distraction guide when placed in the first configuration. The winglets 312 and 314 are rotatably connected to the body 301 by a hinge or otherwise, so that when the implant 300 is placed between the spinous processes, the winglets 312 and 314 are in the second configuration (FIG. 2B). It becomes possible to arrange in. In the second configuration, one or both of the winglets 312 and 314 will abut against at least one of the spinous processes and / or related tissue when pushed in the opposite direction of insertion, thereby restricting movement to the long axis 325. To do. Therefore, when arranged in the second arrangement, the distraction guide 310 becomes the second wing 360 as shown in FIG. 2B.

  The implant 300 includes an insertion base 370 having an insert 372 and a first wing 330. As shown in FIG. 2B, the insert 370 can mate with the main body 301 to place the distraction guide 310 of the implant 300 in the second configuration, thereby deploying the second wing 360. To facilitate mating of the body 301 and the insert 370, the spacer 320 includes a cavity sized and shaped to receive the insert substrate 372, which is accessible from the distal end of the body 301. It is. A portion of the upper winglet 312 and the lower winglet 314 extends at least partially into the cavity so that when the insertion substrate 372 is received in the cavity, the insertion substrate 372 displaces the portion, Therefore, the distraction guide 310 can be arranged in the second form. In the illustrated embodiment, the upper winglet 312 and the lower winglet 314 include levers 316 and 318, respectively. The lever includes a curvilinear protrusion that protrudes into the cavity when the distraction guide 310 is in the first configuration. When the insertion base 372 of the insert 370 fills the cavity, the insertion base 372 contacts the first lever 316 and the second lever 318 and applies a force to the first lever 316 and the second lever 318, which rotates. This translates into rotational movement of the upper winglet 312 that is operably connected and the lower winglet 314 that is rotatively connected. The insertion substrate 372 may optionally have a tapered proximal end 374 having a first groove 376 and a second groove 378 corresponding to the first lever 316 and the second lever 318, respectively, if desired. The tapered shape of the proximal end 374 allows the upper winglet 312 and the lower winglet 314 to be deployed slowly and fully deployed when the insertion substrate 372 is fully seated in the cavity. In the figure, the body 301 includes a flange 303. For example, the flange is formed with a notch 305 for receiving an insertion tool (not shown). When the insertion base 372 is accommodated in the cavity, the upper tab 332 and the lower tab 331 of the first wing 330 are accommodated in the notch 322 of the flange 303.

  Referring to FIG. 3A, the body 301 of the implant 300 is depicted as being positioned between adjacent spinous processes of the target motion segment. Although the illustrated motion segment is in the lumbar region, in other embodiments, particularly when a fixation spacer 320 is used, the implant 300 according to the present invention may be placed in the motion segment of the thoracic and cervical regions. Is possible. The body 301 first passes through the opening on the right side of the interspinous ligament located approximately posterior to the right upper articular surface 6 of the vertebra, from which the upper spinous process 2 extends, and between the upper and lower adjacent spinous processes 2,4. By approaching the ligament, it is placed as shown. The main body 301 is connected to one or more insertion tools (not shown), and the distraction guide 310 is arranged in the first form. The distal end of the distraction guide 310 is positioned approximately adjacent to the interspinous ligament so that the distraction guide 310 is pushed through the interspinous ligament, penetrates the interspinous ligament, and / or spines. Distract the fibers of the interligament. Next, the body 301 is pushed through the interspinous ligament and finally the spacer 320 is placed between the adjacent spinous processes 2, 4 so that the spacer 320 is applied by the spinous processes 2, 4 It will be in a state to support the load.

  Referring to FIG. 3B, once the implant 300 is placed as desired, the insertion tool is removed from the opening and the insert 370 is placed at the distal end of the body 301. The insertion base 372 is pushed into the cavity of the central body 301, and finally the proximal end 374 of the insertion base 372 contacts the first lever 316 and the second lever 318. Next, when the insert 370 is further pushed along the long axis 325, the upper winglet 312 and the lower winglet 314 are rotated around the first hinge 313 and the second hinge 315 by the insertion base 372, respectively. It is done. As the first lever 316 and the second lever 318 are moved out of the cavity, the first lever 316 and the second lever 318 are guided along the corresponding grooves 376, 378 in the tapered proximal end 374. When the insertion base 372 is placed in the cavity of the main body 301, the upper winglet 312 and the lower winglet 314 are deployed as the second wing 360. Once the insertion substrate 372 is stored in the body 301, the insertion tool can be removed from the cut. As can be seen, a portion of the upper spinous process and a portion of the lower spinous process are sandwiched between the first wing 330 and the second wing 360, which restricts movement to the long axis 325. .

  It is meant that the implant disposed between the spinous processes according to the present invention and the method of placing the implant between the spinous processes is limited to the embodiments described above and elsewhere herein. Rather, it is meant to include any implant that has a second wing that is deployed by pushing the insert into the body disposed between adjacent spinous processes. A huge variety of variants will be readily apparent to those skilled in the art. For example, in one alternative embodiment, the body 301 of the implant 300 from FIGS. 2A to 3B is coupled to the lower winglet 314 that is rotatably coupled to the body 301 on the one hand and to the body 301 on the other hand. An upper winglet 312 may be included. The insert 370 may be adapted to deploy only the lower winglet 314 when retracted within the cavity of the body 301.

  In another embodiment, the first wing may not extend from the insert 370, or may further extend from the body 301 in addition to the first wing extending from the insert. When the body 301 is first placed between adjacent spinous processes, movement along the major axis 325 of the body 301 is limited in the insertion direction. When the first wing extending from the body 301 contacts one or both of the adjacent spinous processes, further movement of the body 301 in the insertion direction is limited or prevented. In this way, the first wing acts as a rigid stopper so that it is not necessary to estimate the position of the spinous process of the body 301 and allows the body 301 to be positioned, which simplifies implantation.

  Referring to FIG. 4, in yet another embodiment, an implant 400 according to the present invention includes a first mating element (also referred to herein as an upper hook) 480 and a second to limit bending motion in the motion segment. One or both of the mating elements (also referred to herein as lower hooks) 482 are included. For example, a similar hook is granted to Zuckerman et al., U.S. Patent No. 6,451,019, published September 17, 2002, and Zuckerman et al., U.S. Pat. No. 6,652,527, issued Nov. 25, 2003. Are described in more detail. Both of these patent documents are incorporated herein by reference. The implant according to the invention may comprise such an array element. The implant 400 shown in FIGS. 4 and 5 has an upper hook 480 extending from an upper connecting rod 484 that is rotatably connected to the body 401 and a lower hook extending from a lower connecting rod 486 that is rotatably connected to the body 401. Includes 482. Alternatively, the connecting rods 484, 486 may be fixedly coupled to the body 401. The hooks 480,482 include tapered proximal ends 481,483 that act as leading tissue dilators to distract the interspinous ligaments of the motion segment above and below the target motion segment. When the body 401 is positioned between adjacent spinous processes, the tapered proximal ends 481, 483 of the upper and lower hooks 480, 482 similarly penetrate and / or extend through the interspinous ligament. Thus, when the body 401 is in place, the upper and lower hooks 480, 482 are properly positioned to limit or constrain the bending motion of the target motion segment. As shown, the hooks 480, 482 are rotatably coupled to the connecting rods 484, 486 so that the hooks 480, 482 are rotatable relative to the connecting rods 484, 486 so that the physician improves contact and the hooks 480, 482 It is possible to spread the load between the corresponding spinous processes 2,4. The rotatable upper connecting rod 484 and lower connecting rod 486 provide flexibility in placement so that the anatomy varies from patient to patient and from motion segment to minor axis of the implant 400 around the major axis 425. Even if the major axis varies, the implant 400 can be adapted.

  FIG. 5 is a rear view of an implant 400 having an upper hook 480 and a lower hook 482 disposed between adjacent spinous processes 2, 4 and arranged to restrict both flexion and extension as desired. In addition, the second wing 360 is deployed to limit the movement of the implant 400 to the long axis 325. The upper hook 480 and the lower hook 482 prevent the movement of the long axis 325 opposite to the insertion direction, so that the first wing is unnecessary.

  Referring to FIGS. 6A and 6B, in yet another embodiment, an implant 500 according to the present invention, and a method of placing the implant 500 between spinous processes, is a distraction guide 510, wherein a portion of the distraction guide 510 includes: It is possible to extend from the distraction guide 510, so disposing the insert 370 in the cavity of the body 501 forms the upper winglet 512 and the lower winglet 514, respectively, of the second wing. Includes guide 510. This is in contrast to the previous embodiment where the entire distraction guide is formed by winglets. In this embodiment, the winglets 512, 514 extend from the sides of the distraction guide 510. As seen in FIG. 6A, the winglets 512, 514 form the sides of the distraction guide 510 when not extended. This embodiment is useful when the second wing 560 preferably has a smaller height compared to the previously described implants 300,400 (see FIGS. 2A-3B) where the entire distraction guide 310 is deployed. It is considered. For example, if two implants 500 need to be placed in adjacent motion segments, the second wings 560 of the two implants 500 may be in mutual implants, for example during an extension movement where a compression load is applied to the two implants 500. It is desirable not to interfere. As with the previously described implants, one of ordinary skill in the art can be aware of a vast variety of variations on the implant 500 of FIGS. 6A and 6B. For example, in another aspect, upper winglet 512 and lower winglet 514 may take some other form. For example, the positions of the upper winglet 512 and the lower winglet 514 can be changed with respect to each other, so that it is easier to place two implants 500 placed in adjacent motion segments so as not to interfere with each other. It may be. Such positional variations can also accommodate the anatomical differences when one of the upper and lower spinous processes is wider than the other. If the position variation is accepted, for example, the upper winglet 512 is placed at a position not farther from the distraction tip 511 than the position at which the lower winglet 514 is rotatably attached to the distraction guide 510. It is possible to mount to be rotatable. In yet another embodiment, upper winglet 512 and lower winglet 514 may take some other form.

  Referring to FIGS. 7A-8, in yet another embodiment of an implant 600 according to the present invention, the body 601 may include a hollow central body 605 (shown in FIGS. 7C and 7D) extending from the first wing 630. . A rotatable spacer 620 is disposed around the hollow central body 605. The implant 600 may include, for example, a spacer 620 similar to the spacer described above in FIG. 1B. A distraction guide 610 extends from the hollow central body 605 and may include an upper winglet 612 and a lower winglet 614, and one or both of these winglets rotate into the body portion 611 of the distraction guide 610. For this purpose, the upper winglet 612 and / or the lower winglet 614 may be deployable as the second wing. A pin 606 is inserted into the hollow center body 605 to deploy the second wing 660. Referring to FIG. 7B, when the pin 606 is seated in the body 601, the upper winglet 612 and the lower winglet 614 rotate away from each other, so that the upper winglet 612 and the lower winglet 614 have a long axis 625. Therefore, it is possible to limit or prevent movement in the direction opposite to the insertion. Accordingly, the upper winglet 612 and the lower winglet 614 act as the second wing 660.

  Referring to the partial cross-sectional views of FIGS. 7C and 7D, in one embodiment, the distraction guide 610 may include a cup structure 616 that is sized and arranged to receive the pin 606. A bar structure 618,619 may be rotatably connected to this cup structure 616 and one or both of the upper winglet 612 and the lower winglet 614, so that the force is further increased by the upper winglet 612 and the lower winglet 612. 614, and the upper winglet 612 and the lower winglet 614 may be rotated at hinges 613, 615 that connect with the body portion 611 of the distraction guide 610 so that the second wing 660 can be deployed. . As can be seen from the figure, the pivot points 613, 615 of the upper winglet 612 and the lower winglet 614 are arranged in the vicinity of the mounting point 617 of the bar structure 618, 619, so that the mounting points 617, 619 are inserted into the pin 606. Are pushed together (as seen in FIG. 7D), the upper winglet 612 and the lower winglet 614 are rotated away from each other. In another embodiment, upper winglet 612 and lower winglet 614 may be rotated away from each other by some other mechanism. The implant according to the present invention is not intended to be limited only to such a second wing deployment mechanism as detailed herein.

  Referring to FIG. 8, the implant 600 is shown positioned between adjacent spinous processes 2,4. As shown, when the second wing 660 is arranged as the first configuration (ie, the distraction guide 610), the upper winglet 612 and the lower winglet 614 may have the disadvantage of protruding into adjacent tissue. Has no size and shape. However, upper winglet 612 and lower winglet 614 may have different sizes and shapes than those shown in FIG. The upper winglet 612 and the lower winglet 614, when arranged as a second configuration, are sizes that allow the upper and lower winglets 612, 614 to restrict or prevent movement in the opposite direction of insertion, as is the long axis 625. And you only have to have a shape.

  FIGS. 9A to 9C show yet another embodiment of an implant 700 according to the present invention disposed between adjacent spinous processes 2,4. In this embodiment, the upper and lower winglets 712, 714 can be deployed by actuating an actuator device that is disposed within the distraction guide 710 and includes a shaft that connects to the cam 707. In the array element, the shaft has a matable head 706 or includes some other mechanism, such as a gear. As can be seen in FIG. 9A, the implant 700 is disposed between adjacent spinous processes 2, 4 as described above with reference to FIG. A distraction guide 710 of the implant 700 is used to penetrate and / or distract the interspinous ligament 6 connected between adjacent spinous processes 2,4. Next, the implant 700 is pushed between the spinous processes 2, 4, allowing the distraction guide 710 to further distract the interspinous ligament 6, creating a space in which the spacer 720 can be placed. The In the illustrated embodiment, the spacer 720 can rotate around a central body extending from the first wing 730 of the implant 700. The first wing 730 limits and / or prevents movement of the implant 700 in the insertion direction along the long axis 725.

  Once the implant 700 is positioned as desired, the actuator device is actuated to deploy the upper and lower winglets 712, 714 to form a second wing 760 as shown in FIG. 9C. The second wing 760 limits and / or prevents movement in a direction opposite to insertion along the long axis 725. When the second wing 760 is deployed, the adjacent spinous processes 2, 4 are at least partially disposed between the wings 730, 760, so that the implant 700 is out of the space between the adjacent spinous processes 2, 4. Let me escape. As shown in FIG.9C, the first wing 730 and the second wing 760 are sufficiently separated from each other so that the adjacent spinous processes 2, 4 can move slightly relative to each other. The patient is allowed greater flexibility of movement (eg, to the side, during torsional exercises, etc.).

  9B and 9C are partial cross-sectional views from the back of the implant 700 shown in FIG. 9A. In one embodiment, the deployable winglets 712, 714 can be extended from the distraction guide 710 using an actuator device that includes a shaft 707 and a cam 716. When the cam 716 is rotated, the winglets 712 and 714 are rotated outward from the distraction guide 710. As shown, winglets 712, 714 are at least partially disposed within the cavity of distraction guide 710.

  10A to 10E show yet another embodiment of an implant 800 according to the present invention disposed between adjacent spinous processes 2,4. In this embodiment, the upper and lower winglets 812, 814 can be deployed by actuating an actuator device that includes a screw 807 that is disposed in the distraction guide 810 and has a mating head 806. As can be seen in FIG. 10A, the implant 800 is disposed between adjacent spinous processes 2,4 as described above with reference to FIG.

  The distraction guide 810 of the implant 800 is used to penetrate and / or distract the interspinous ligament 6 connected between adjacent spinous processes 2,4. Next, the implant 800 is pushed between the spinous processes 2, 4, allowing the distraction guide 810 to further distract the interspinous ligament 6, creating a space in which the spacer 820 can be placed. The In the illustrated embodiment, the spacer 820 can rotate about a central body extending from the first wing 830 of the implant 800. The first wing 230 limits and / or prevents movement of the implant 800 in the insertion direction along the long axis 825.

  Once the implant 800 is positioned as desired, the actuator device is actuated to deploy the upper and lower winglets 812, 814 to form a second wing 860 as shown in FIG. 10B. The second wing 860 limits and / or prevents movement in the direction opposite to insertion along the long axis 825. When the second wing 860 is deployed, the adjacent spinous processes 2, 4 are at least partially disposed between the wings 830, 860, so that the implant 800 is out of the space between the adjacent spinous processes 2, 4. Let me escape. As shown in FIG. 9B, the first wing 830 and the second wing 860 are sufficiently separated from each other, so that the adjacent spinous processes 2, 4 can move slightly relative to each other. The patient is allowed greater flexibility of movement (eg, to the side, during torsional exercises, etc.).

  10C and 10D are partial end cross-sectional views of the implant 800 shown in FIGS. 10A and 10B. In one embodiment, the deployable winglets 812, 814 can be extended from the distraction guide 810 using an actuator device that includes a screw 807 and a threaded collar 816. The threaded collar 816 is screwed along the screw 807 to rotate the winglets 812, 814 outward from the distraction guide 810. As shown, the winglets 812, 814 are at least partially disposed within the cavity of the distraction guide 810. Winglets 812, 814 are rotatably connected to threaded collar 816 at upper pivot point 817 and lower pivot point 819. Pins 813, 815 or other occlusion devices are placed in the cavity and installed so as not to interfere with the placement of the winglets 812, 814 in the retracted or undeployed position. However, when the threaded collar 816 moves along the screw 807 in the front-rear direction, the inner surfaces of the winglets 812, 814 contact the pins 813, 815, and the winglets 812, 814 rotate to move away from the distraction guide 810. If necessary, the winglets 812 and 813 are spring-displaced with respect to the posts 813 and 815, and the winglets 812 and 814 may be pressed against the posts 813 and 815 in the storage position and in an arbitrary deployed position. .

  As shown in FIGS. 10D and 10E, as the threaded collar 816 moves a distance along the screw 807, the winglets 812, 814 are deployed to form the second wing 860. Winglets 812,814 extend along a substantial portion of the outer surface of spinous processes 2,4. When pushed along the major axis 825 in the opposite direction of insertion, the winglets 812, 814 contact the adjacent spinous processes 2, 4 and resist further movement in that direction. FIG. 10E is an end view of the implant 800 with the second wing 860 deployed. As shown, a screw head 806 projects from the distraction guide 810. However, when embedded, the screw screw head 806 is preferably aligned with the surface of the distraction guide 810 or slightly retracted from the surface of the distraction guide 810. This is to prevent the movement of the implant 800 from being hindered when the interspinous ligament 6 and / or the spinous processes 2 and 4 are distracted. The screw threading head 806 is drawn so as to protrude from the distraction guide 810. This is to show a possible arrangement for the proximal end of the distraction guide 810.

  FIGS. 11A and 11B show yet another embodiment of an implant 900 having another actuator device. In this embodiment, the arrangement of the winglets 912, 914 is reversed, so that the winglets 912, 914 are deployed by pushing the threaded collar 916 toward the screw threading head 806. FIGS. 12A and 12B show yet another embodiment of an implant 1000 having another actuator device. In this embodiment, winglets 1012 and 1014 include two hinge portions, and each winglet 1012 and 1014 is folded outward to form part of second wing 1060. The second wing 1060 does not project as much along the axis of the spine as before, ie, the overall length of the spine of the second wing 1060 is smaller than in the previous embodiment. The reduced height of the second wing is advantageous when multiple implants are placed in adjacent motion segments. This is because inconvenient contact between adjacent implants is prevented.

  As described above, in another embodiment according to the present invention, a mechanism separate from the screw and threaded collar can be used to deploy the winglet from the stretch guide. For example, one or more gears may be used. In yet another embodiment, the upper and lower winglets may have a shape other than that shown in FIGS. 10A-12B. The present invention is not intended to be limited to winglets having the shape shown. In yet another embodiment, for example, as shown in FIG. 13, the implant 1100 includes only one of the upper and lower winglets. For example, if multiple implants are placed in adjacent motion segments, it may be advantageous that the winglets 814 are short so that adverse contact between adjacent implants 1100 is prevented. As will be apparent to those skilled in the art, a vast variety of variants can be used to form the second wing. The implants according to the present invention are not intended to be limited only to those detailed herein.

Materials Used for Implants of the Invention In certain embodiments, the implant and the components of the implant (ie, spacers, distraction guides, etc.) are medical grade metals such as titanium, stainless steel, cobalt chrome, and alloys thereof, Alternatively, it may be made from a suitable implant material that has a similar high strength and biocompatibility. Further, the implant may be made at least in part from a shape memory metal, such as Nitinol, an alloy of titanium and nickel. Such materials are usually radiopaque and are visible in x-ray imaging and other types of imaging. The implants according to the invention and / or parts thereof can also be manufactured from materials that are slightly more flexible and / or displaceable. In these embodiments, the implant and / or portion thereof can be made in whole or in part from medical grade biocompatible polymers, copolymers, polymer blends, and polymer compositions. A copolymer is a polymer obtained from more than one monomer. A polymer composition is a heterogeneous mixture of two or more substances in which the components do not mix together and thus form an interface between them. A polymer mixture is a macroscopically uniform mixture of two or more different polymers. Many polymers, copolymers, polymer blends, and polymer compositions are x-ray transmissive and are not visible on x-rays or other types of imaging. Implants containing such materials allow the physician to have a relatively unobstructed view of the spinal column being visualized compared to implants made entirely of radiopaque material. However, the implant does not need to contain a radiolucent material.

One group of biocompatible polymers is the polyaryletherketone group, which includes several members, such as polyetheretherketone (PEEK) and polyetherketoneketone (PEKK). PEEK has been found to be a durable material suitable for implants and meets biocompatibility criteria. Medical grade PEEK is commercially available under the product name PEEK-OPTIMA from Victrex, Lancashire, UK. Medical grade PEKK is commercially available from Oxford Performance Materials under the name OXPEKK and from CoorsTek under the name BioPEKK. These medical grade materials are also marketed as reinforced polymer resins, for example, as reinforced resins that exhibit relatively high material strength. In one embodiment, the implant is manufactured from PEEK 450G. This is a non-filled PEEK, approved for medical implantation, available from Victrex. Another source of this material is Gharda, located in Panoli, India. PEEK 450G has the following properties. That is,

Property Value density 1.3 g / cc
Rockwell M 99
Rockwell R 126
Tensile strength 97 MPa
Elastic modulus 3.5 GPa
Flexural strength coefficient 4.1 GPa

PEEK 450G has suitable physical and mechanical properties and is suitable for carrying and distributing physical loads between adjacent spinous processes. The implant, and / or portions thereof, can be formed by extrusion, injection molding, compression molding, and / or machining techniques.

  It should be noted that fillers can be added to the selected material. In order to reinforce the polymer material, fillers can be added to the polymer, copolymer, polymer mixture or polymer composition. Fillers are added to modify properties such as mechanical, optical, and thermal properties. For example, carbon fibers are added as a polymer reinforcement to mechanically enhance strength for certain applications, such as for load carrying devices. In certain embodiments, other grades of PEEK may be utilized and are contemplated for use in implants according to the present invention. For example, 30% glass filled or 30% carbon fiber filled grade PEEK is also considered as long as the use of the material for an implantable device is approved by the FDA or other regulatory body. Glass-filled PEEK reduces the coefficient of expansion and increases the bending strength coefficient of PEEK compared to unfilled PEEK. The resulting product is known to be ideal for enhanced strength, stiffness, or stability. Carbon-filled PEEK is known to have enhanced compressive strength and rigidity and lower expansion rate than unfilled PEEK. Carbon filled PEEK also provides wear resistance and load carrying capacity.

  As will be appreciated, other similarly suitable biocompatible, thermoplastic, or thermoplastic polycondensation materials that withstand fatigue, have excellent memory, bendable, and / or displaceable. In addition, materials with extremely low moisture absorption and excellent wear and / or abrasion resistance can be used without departing from the scope of the present invention. As described above, the implant may be composed of polyether ketone ketone (PEKK). Other materials that can be used include polyetherketone (PEK), polyetherketone etherketoneketone (PEKEKK), polyetheretherketoneketone (PEEKK), and polyaryletherketone in general. Furthermore, other polyketones can be used as well as other thermoplastics. See the following documents for suitable polymers that can be used in the implant. All of these are hereby incorporated by reference. That is, PCT publication WO 02/02158 A1 issued on January 10, 2002, named “Biocompatible polymer material”; PCT publication WO 02/00275, published on January 3, 2002, named “Biocompatible polymer material” A1 and PCT publication WO 02/00270 A1 issued on January 3, 2002 and having the name “biocompatible polymer material”. Other materials, such as Bionate®, polycarbonate urethane marketed by Polymer Technology Group of Berkeley, California, may also be suitable due to their superior oxidation stability, biocompatibility, mechanical strength, and abrasion resistance There is sex. Other thermoplastic materials and high molecular weight polymers can also be used.

Interspinous Implant Implantation Techniques A minimally invasive surgical method for implanting an implant 300 similar to that shown in FIGS. 2A-8 in the cervical spine is disclosed and taught herein. In this method, as shown in FIG. 14, a guide wire 780 is preferably inserted through the placement network 790 and into the neck of the implant recipient. Guide wire 780 is used to locate where implant 300 should be placed relative to the cervical spine including spinous processes. If guide wire 780 is positioned with the aid of imaging techniques, an incision is made on the side of the neck. This positions the implant 300 according to an embodiment of the invention through the incision along the line substantially perpendicular to the guide wire 780 and toward the tip of the guide wire 780 at the neck. The body 301 of the implant 300 is inserted into the patient's neck. Upon insertion, the distraction guide 310 preferably penetrates or separates the tissue without severing the tissue.

  If the body 301 is placed as desired, the insert 370 is placed inside the cavity of the body 301. Accordingly, the distraction guide 310 of the main body 301 is arranged in the second form, and at least a part of the distraction guide 310 forms a second wing. Insert body 370 is inserted along a straight line that generally matches the straight line into which main body 301 is inserted. The cervical anatomy is most convenient and minimally invasive for the body 301 and insert 370 to enter the neck from the side.

  In addition, a minimally invasive surgical method for implanting an implant similar to that shown in FIGS. 2A-8 into the lumbar spine is disclosed and taught herein. In this method, as shown in the flowchart of FIG. 15A, it is preferable to cut one side using the front-rear approach method (step 102). The one-sided incision is provided, for example, at a slight distance to the left side of the axis of the spinous process. The incision or opening is enlarged and a distraction tool is placed in the incision so that the proximal end of the distraction tool (step 104) can reach the exposed side of the interspinous ligament. A distraction tool is pushed through the interspinous ligament, thereby distracting the interspinous ligament and making the implant acceptable (step 106). Once the interspinous ligament has been fully distracted, the distraction tool is removed and removed from the incision (step 108).

  Once the distraction tool is removed from the incision, the implant can be placed in the expanded incision and the distraction guide of the implant is pushed through the expanded opening (step 110). The implant is pushed further through the opening, and finally the spacer is placed between adjacent spinous processes of the target motion segment as expected (step 112). The spacer is freely rotated so that the load is evenly distributed by the spinous process surface. Optionally, the implant is pushed further through the enlarged opening, and eventually the first wing contacts the adjacent spinous process, thereby preventing further movement in the insertion direction. Once the implant is properly installed, it is possible to place the insert at the distal end of the implant and push the insert through the cavity into the hollow cavity of the hollow center body (step 114). ). As the insert fits inside the cavity, the distraction guide is cleaved, and the upper and lower winglets are deployed to form the second wing. The remaining tools are removed from the cut and the cut is closed (step 116). Upon insertion, the distraction tip preferably penetrates or separates the tissue but does not cut off the tissue.

  In addition, a minimally invasive surgical method for implanting an implant similar to that shown in FIGS. 9A-13 into the lumbar spine is disclosed and taught herein. In this method, as shown in the flowchart of FIG. 15B, a cut or an opening is provided using the front-rear approach (step 202). The incision or opening is enlarged and a distraction tool is placed in the incision so that the proximal end of the distraction tool (step 204) can reach the exposed side of the interspinous ligament. A distraction tool is pushed through the interspinous ligament, thereby distracting the interspinous ligament and making the implant acceptable (step 206). Once the interspinous ligament has been fully distracted, the distraction tool is removed and removed from the incision (step 208).

  Once the distraction guide has been removed from the incision, the implant can be placed in the expanded incision, and the distraction guide of the implant is pushed through the expanded opening (step 210). The implant is pushed further through the opening, and finally the spacer is placed between adjacent spinous processes of the target motion segment as expected (step 212). The spacer is freely rotated so that the load is evenly distributed by the spinous process surface. Optionally, the implant is pushed further through the enlarged opening, and eventually the first wing contacts the adjacent spinous process, thereby preventing further movement in the insertion direction. If the implant is properly placed, the activation tool is inserted into the incision at the adjacent spinous process, opposite the insertion point (step 214). The actuator tool engages and activates the actuator device so that the upper and lower winglets are deployed into the second wing as described above (step 216). The remaining tools are removed from the cut and the cut is closed (step 218). Upon insertion, the distraction tip preferably penetrates or separates the tissue but does not cut off the tissue.

  The foregoing description of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Many revisions and variants will be apparent to those skilled in the art. The embodiments best explain the principles of the invention and its practical application, so that those skilled in the art can understand the invention through various embodiments and various modifications suitable for the particular application envisaged. Is selected and described so as to be possible. It is intended that the scope of the invention be defined by the appended claims and their equivalents.

800 Implant 807 Screw 810 Distraction guide 812 Upper winglet 814 Lower winglet 816 Threaded collar 860 Second wing 900 Implant 910 Distraction guide 912 Upper winglet 914 Lower winglet 916 Threaded collar

Claims (2)

An interspinous implant suitable for being inserted between spinous processes,
The first wing,
A spacer extending from the first wing;
An extension guide extending from the spacer, the extension guide having an extension tip away from the spacer;
A first winglet and a second winglet that are disposed between the spacer and the distraction tip of the distraction guide and are suitable for moving between a contracted configuration and a deployed configuration;
Movement of the interspinous implant when the first and second winglets are expanded to be between the distraction guide and the spacer and the interspinous implant is positioned between the spinous processes. Limit
The interspinous implant further includes an actuator operatively associated with the first winglet and the second winglet, and activating the actuator causes the first winglet and the second winglet to move. Expanded
The interspinous implant further comprises a collar having a threaded surface and associated with the actuator;
The actuator includes a threaded surface;
The first winglet and the second winglet are rotatably associated with the collar;
The first winglet and the second winglet each include a first inner surface and a second inner surface;
An interspinous implant is a first pin disposed in the distraction guide, the first pin being in contact with the first inner surface and adapted to guide movement of the first winglet, and the distraction guide An interspinous implant further comprising a second pin disposed therein, the second pin being adapted to contact the second inner surface and guide movement of the second winglet .   The interspinous spine according to claim 1, wherein the actuator is rotatable about a long axis of the interspinous implant, and the first and second winglets are expanded by rotating the actuator. Implant.

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