MX2007011618A - Interspinous process implant having deployable wing and method of implantation. - Google Patents

Abstract

Systems and method in accordance with an embodiment of the present invention can includes an implant comprising a first wing, a spacer extending from the first wing, and a distraction guide. The distraction guide is arranged in a first configuration to pierce and/or distract tissue associated with adjacent spinous processes extending from vertebrae of a targeted motion segment. The implant can be positioned between the adjacent spinous processes and once positioned, the distraction guide can be arranged in a second configuration. When arranged in a second configuration, the distraction guide can act as a second wing. The first wing and the second wing can limit or block movement of the implant along a longitudinal axis of the implant.

Description

IMPLANTATION OF INTERVERTEBRAL PROCESS THAT HAS DEPENDABLE ALA AND METHOD OF IMPLANT PRIORITY CLAIM The provisional patent application of the US. Serial No. 60 / 663,885 with title INTERSPINOUS PROCESS IMPLANT HAVING DEPLOYABLE WING AND METHOD OF IMPLANTATION, by James F. Zucherman et al, filed on March 21, 2005 (File of Agent No. KLYC-Ol 114US0); The provisional patent application of the E.U.A. Serial No. 60 / 663,918 titled INTERSPINOUS PROCESS IMPLANT HAVING DEPLOYABLE WING AND METHOD OF IMPLANTATION, by James F. Zucherman et al, filed on March 21, 2005 (File of Agent No. KLYC-Ol 114US 1); The provisional patent application of the US. Serial No. 60 / 664,076 with title INTERPSINOUS PROCESS IMPLAN! HAVING DEPLOYABLE WING AS AN ADJUNCT TO SPINAL FUSION AND METHOD OF IMPLANTATION, by James F. Zucherman et al, filed on March 22, 2005 (File of Agent No. KLYC-01114US2); The patent application of the U.S.A. Do not give Series 11 /, with title INTERSPINOUS PROCESS IMPLANT HAVING DEPLOYABLE WING AND METHOD OF IMPLANTATION, by James F. Zucherman et al, filed on March 17, 2006 (File of Agent No. KLYC-01114US3); The patent application of the U.S.A. Do not give Series 11 /, titled INTERSPINOUS PROCESS IMPLANT [0009] HAVING DEPLOYABLE WING AND METHOD OF IMPLANTATION, by James F. Zucherman et al, filed on March 17, 2006 (File of Agent No. KLYC-01114US4); And the patent application of the US. Do not give Series 11 /, with title INTERSPINOUS PROCESS IMPLANT [0011] HAVING DEPLOYABLE WING AS AN ADJUNCT TO SPINAL FUSION AND METHOD OF IMPLANTATION, by James F. Zucherman et al, filed on March 17, 2006 (File of Agent No. KYLC-01114US5) . TECHNICAL FIELD This invention refers to intervertebral process implants. BACKGROUND OF THE INVENTION The spine is a biomechanical structure composed primarily of ligaments, muscles, vertebrae and inter-vertebral discs. The bio-mechanical functions of the spine include: (1) supporting the body, which involves the transfer of weight and bending movements of the head, trunk and arms to the pelvis and legs, (2) movement physiological complex between these parts, and (3) protection of the spine and the roots of the nerves. As the present society ages, it is anticipated that there will be an increase in adverse column conditions, which are characteristic of the elderly. By way of example only, with age comes an increase in spinal stenosis (including, but not limited to, central and lateral canal stenosis), and facet arthropathy. The vertebral stenosis results in a reduction of the foraminal area (ie, the space available for the passage of nerves and blood vessels) that compresses the roots of the nerves and causes root pain. Humpreys, S.C. et al., Flexion and traction effect on C5-C6 foraminal space, Arch. Phys. Med. Rehabil., vol. 79 at 1105 (Sept. [0022] 1998). Another symptom of vertebral stenosis is myelopathy, which results in neck and back pain and muscle weakness. Id. Extension and ipsilateral rotation of the neck and back, also reduce the foraminal area and contribute to pain, compression of the roots of the nerves and neural injury. Id .; Yoo, J.U. et al., Effect of cervical spine motion on the neurof oraminal dimensions of human cervical spine, Spine, vol. 17 at 1131 (Nov. 10, 1992). In contrast, the flexion of the neck and back increases the Foraminal area. Humpreys, S.C. et al., anterior, at 1105. Over time, the loss of disc height in the thoracic and lumbar regions, as well as the cervical region can result in a degenerative cascade with deterioration of all the components of a segment of movement that result in segment instability and finally in vertebral stenosis. During the process of deterioration, the discs may herniate and become internally torn and (/ or) with chronic pain. When the symptoms seem to emanate from both anterior (discs) and posterior (facets and foramen) structures, patients can not tolerate extension or flexion positions. The pain associated with stenosis can be relieved by medication and / or surgery. It is convenient to eliminate the need for major surgery for all individuals, particularly for the elderly. Accordingly, there is a need to develop spinal implants that alleviate the pain caused by spinal stenosis and other of these conditions caused by damage to, or degeneration of the spine. These implants will distract, or increase the space between the vertebrae to increase the foraminal area and reduce the pressure of the nerves and blood vessels of the spine.

There is an additional need for the development of a minimally invasive surgical implant method for spinal implants that preserve the physiology of the spine. There is also a need for an implant that accommodates the different anatomical structures of the spine, minimizes more trauma to the spine and avoids the need for invasive surgical implant methods. In addition, there is a need to resolve adverse column conditions that are exacerbated by the extension of the column. BRIEF DESCRIPTION OF THE DRAWINGS FIGURE IA is a perspective view of an implant including a retractor having a teardrop-shaped cross section, a distraction guide, a first wing and a second wing that connects to the distraction guide . FIGURE IB is a perspective view of an implant including a rotating spacer having an elliptical cross section, a distraction guide, a first wing and a second wing that connects to the distraction guide. FIGURE 2A is a perspective view of an implant according to an embodiment of the present invention including a main body and an insert, the Main body has a distraction guide, a spacer and a first wing. FIGURE 2B is a perspective view of the implant of FIGURE 2A where the insert is located within the main body, causing the distraction guide associated with the main body to limit or block the movement of the implant when it is located between adjacent vertebral processes . FIGURE 3A is a side view of the main body of the implant of FIGS. 2A and 2B located between adjacent vertebral processes. FIGURE 3B is a side view of the implant of FIGURE 3A where the insert is located within the main body. FIGURE 4 is a perspective view of an implant according to an alternate embodiment wherein the main body includes hooks to limit the relative movement of adjacent vertebral processes during flexion movement. FIGURE 5 is a side view of the implant of FIGURE 4 located between adjacent vertebral processes and arranged in such a manner that the hooks confine the adjacent vertebral processes. FIGURE 6A is a perspective view of yet another embodiment of an implant according to the present invention, wherein a first section and a The second section of a distraction guide unfolds to form a second wing. FIGURE 6B is a perspective view of the implant of FIGURE 6A where the insert is located within the main body, causing the first section and the second section of the distraction guide to unfold. FIGURE 7A is a perspective view of a still further embodiment of an implant according to the present invention, including a rotating spacer. FIGURE 7B is a perspective view of the implant of FIGURE 7A where the insert is located within a central body such that the distraction guide deploys a second wing. FIGURE 7C is a cross-sectional side view of the distraction guide of FIGURE 7A. FIGURE 7D is a cross-sectional side view of the distraction guide of FIGURE 7B. FIGURE 8 is a side view of the implant of FIGS. 7A-7D located between adjacent vertebral processes. FIGURE 9A is a side view of an alternative embodiment of the implant located between adjacent vertebral processes.

FIGURE 9B is a side view in partial cross section of the implant of FIGURE 9A, showing deployable flaps placed within a distraction guide of the implant. FIGURE 9C is a partial cross-sectional side view of the implant of FIGURE 9B where the flaps unfold. FIGURE 10A is a side view of an alternative embodiment of the implant located between adjacent vertebral processes. FIGURE 10B is a side view of the implant of FIGURE 10A that is located between adjacent vertebral processes where the fins deploy. FIGURE 10C is an end view in partial cross section of the implant of FIGURE 10A showing deployable flaps placed within a distraction guide of the implant. FIGURE 10D is an end view in partial cross section of the implant of FIGURES 10A-10C, which shows the flaps deployed in such a way that the flaps extend from the distraction guide of the implant. FIGURE 10E is an end view of the implant of FIGURES 10A-10D showing the guide of distraction and the fins deployed with respect to the distraction guide. FIGURE HA is an end view in partial cross-section of an alternative embodiment of an implant according to the present invention, including an array of actuator or alternating actuator. FIGURE 11B is an end view in partial cross section of the implant of FIGURE 11A, showing the fins deployed such that the fins extend from the distraction guide of the implant. FIGURE 12A is an end view in partial cross-section of yet another embodiment of an implant according to the present invention, having an alternating actuator arrangement wherein the fins comprise two hinged portions. FIGURE 12B is an end view in partial cross section of the implant of FIGURE 12A showing the flaps deployed, such that the flaps extend from the distraction guide of the implant. FIGURE 13 is an end view in partial cross-section of a still further embodiment of an implant according to the present invention, wherein the implants are arranged in segments of adjacent movement. FIGURE 14 illustrates one embodiment of a method for positioning the implant of FIGURES 2A-B between adjacent vertebral processes in accordance with the present invention. FIGURE 15A illustrates one embodiment of a method for placing the tervertebral implant of FIGURES 2A-B between adjacent vertebral processes in accordance with the present invention. FIGURE 15B illustrates one embodiment of a method for positioning the metavertebral implant of FIGURES 9A-13 between adjacent vertebral processes, in accordance with the present invention. DETAILED DESCRIPTION INTERVERTEBRAL IMPLANTS FIGURE A is a perspective view of an implant as described in the U.S. patent application. serial number 10 / 850,267, filed on May 20, 2004, incorporated herein by reference. The implant 100 comprises a first flange 130, a spacer 120 and an inlet tissue reamer (also referred to as a distraction guide) 110. The distraction guide 110 in this particular embodiment is wedge-shaped, ie the prevailing one has a cross section in expansion of a proximal end of the implant 100 to a region 150, wherein the guide 110 is joined to the spacer 120 (referring to the figures, is based on the point of insertion of the implant between vertebral processes). As such, the distraction guide 110 functions to initiate the distraction of soft tissue and vertebral processes, when the implant 100 is surgically inserted between the vertebral processes. It should be understood that the distraction guide 110 may be tapered and the like, in order to facilitate the insertion of the implant 100 between the vertebral processes of the adjacent cervical vertebrae. It is advantageous that the insertion technique disturbs as little as possible the bone and surrounding tissue or ligaments, in order to reduce their trauma to the site and promote an early healed, and avoid destabilization of the normal anatomy. For modalities such as those of FIGURES IA and IB, there is no requirement to remove anything from the bone of the vertebral processes and there is no requirement to cut or remove from the body, ligaments or tissues immediately associated with the vertebral processes. For example, it is unnecessary to cut the supravertebral ligament of the vertebrae and inferior or the entum nuchae ligament (corresponding to the supervertebral ligament) that cushions partially the vertebral processes of the upper cervical vertebrae. As can be seen, the spacer 120 can have a teardrop shape in cross section perpendicular to a longitudinal axis 125 of the implant 100. In this way, the shape of the spacer 120 can be adapted approximately to a wedge-shaped space or a portion of the space, between adjacent vertebral processes within which the implant 100 is to be located. As shown in FIGURE IA, the spacer 120 (and the first wing 108) are shaped to accommodate or accommodate the anatomical shape or contour of the vertebral processes (and / or laminae) preferably of vertebrae C6 and C7 to place between these vertebral processes (i.e. the movement segment C6-C7). The same shape or variations of this form can be used to allow other segments of the movement, for example in the thoracic or lumbar regions. In other embodiments, the spacer 120 may have alternate shapes such as circular, wedge-shaped, oval, ovoid, soccer ball, and rectangular with rounded corners, and other shapes. The shape of the separator 120 can be selected for a particular patient, such that the physician can locate the implant 100 as closely as possible to the anterior portion of the process surface. vertebral The shape selected for spacer 120 can affect the contact surface area of implant 100 and the vertebral processes that are to be distracted. Increasing the contact surface area between the implant 100 and the vertebral processes can distribute a loading force between the vertebral frame and the implant 100. The first flange 130 likewise has a teardrop shape in cross section perpendicular to a longitudinal axis 125 of the spacer 120 and distraction guide 110. The dimensions of the first flange 130 may be larger than that of the spacer 120 particularly on the axis of the spine and may limit or block lateral displacement of the implant 100 in the direction of insertion on the spindle longitudinal 125. As with the spacer 120 the first wing 130 may have other shapes in cross section such as elliptical, wedge-shaped, circular, oval, ovoid, soccer ball and rectangular with rounded corners and other shapes. The implant 100 of FIGURE IA further includes an adjustable wing 160 (also referred to herein as a second wing) separate from the distraction guide 110, the separate 120 and the first wing 130, the second to the 160 is connected to the guide of distraction 110 (and / or the separator 120) once the implant 100 is located between adjacent vertebral spinous processes. The second wing 160 similar to the first wing 130 can limit or block the lateral displacement of the implant 100, however the displacement is limited or blocked in the direction opposite to the insertion. When both the first wing 130 and the second wing 160 are connected to the implant 100 and the implant 100 is located between adjacent vertebral processes, a portion of the vertebral processes can be walled between the first wing 130 and the second wing 160 limiting the displacement about the longitudinal axis 125. As can be seen, the second wing 160 may have a teardrop shape in cross section. A lip 180 defining a space 170 through the second wing 160 allows the second wing 160 to pass over the distraction guide 110, to meet and connect with the distraction guide 110 and / or the spacer 120. The second wing 160 then it is attached to the distraction guide 110 and / or the spacer 120. The second wing 160 may be designed to be interference fit over the spacer 120 or a portion of the distraction guide 110 adjacent to the space 120. When the second wing 160 is adjusted by interference, there is no additional connection device for holding second wing 160 relative to the rest of implant 100.

Alternatively, various fasteners may be employed to secure the second wing 160 relative to the rest of the implant 100. For example, FIGURE IA illustrates one embodiment of an implant 100 including a second teardrop shaped wing 160 having a tab 158 in the trailing end of the second wing 160. A piercing 155 is placed through the tab 158 and is aligned with a corresponding pierce 156 in the spacer 120 when the second wing 160 is put into position by surgical insertion with respect to the rest of the implant 100. A threaded screw 154 can be inserted through the aligned perforations 155, 156 in a posterior-anterior position to secure the second wing 160 to the spacer 120. The direction of insertion from a posterior direction to an anterior direction, has the screw 154 that engages the perforations 155, 156 and the rest of the implant 100 in a direction that is generally perpendicular to the longitudinal axis 125. This orientates It is more convenient when the physician is required to use a screw 154, to secure the second wing 160 to the rest of the implant 100. The second wing 160 can further be attached to the spacer 120 by some other mechanism, for example such as a flexible hinge ( not shown) with a projection that couples an indentation of the distraction guide 110 and the spacer 120. Alternately, the second wing 160 can be secured to one of the distraction guide 110 and the spacer 120 by still another mechanism. FIGURE IB is a perspective view of an implant as described in U.S. Pat. No. 6,695,842, issued to Zucherman, et al, incorporated herein by reference. The implant 200 has a main body that includes a spacer 220, a first flange 230, a tissue entry tissue stretcher 210 (also referred to as a distraction guide) and an alignment tracks 203. The main body of the implant 200 is inserted between adjacent vertebral processes and remains in place (when desired) without connecting to the bone or ligament. The distraction guide 210 and includes a tip from which the distraction guide 210 expands, the tip has a sufficiently small diameter such that the tip can pierce an opening in an intervertebral ligament and / or can be inserted into a small opening Initial dilated. The diameter and / or cross-sectional area of the distraction guide 210 gradually increases until it is substantially similar to the diameter of the retractor 220. The tapered front end facilitates a physician's ability to move the implant 200. between adjacent vertebral processes. When the main body of the implant 200 is moved between adjacent vertebral processes, the front end of the distraction guide 210 distracts the adjacent vertebral processes and dilates the intervertebral ligament such that a space between the adjacent vertebral processes is approximately the diameter of the separator. 220. As illustrated in Figure IB, the spacer 220 is elliptical in cross section and can oscillate such that the spacer 220 can self-align with the non-uniform surfaces of the vertebral processes. Self-alignment can ensure that compression loads are distributed across the surface of the bone. As contemplated in the Zucherman patent '842, the spacer 220 may for example have a diameter of six millimeters, eight millimeters, ten millimeters, twelve millimeters and fourteen millimeters. These diameters refer to the height by which the spacer 220 distracts and keeps the vertebral process separate. For an elliptical shaped spacer 220, the selected height (ie, diameter) is the measurement in the smallest dimension across the ellipse. The larger dimension is transversal to the alignment of the vertebral process, one over the other.

The first wing 230 has a minor portion 231 and an upper portion 232. The upper portion 232 is shaped to accommodate the anatomical shape or contour of the vertebral processes (and / or laminae) preferably the L4 vertebra (for a L4-placement). L5) or L5 (for a L5-S1 installation). The same shape or variations of this form can be used to accommodate other movement segments, such as the movement segments in the cervical and thoracic regions. The minor portion 231 may also be rounded to accommodate the vertebral processes. The minor portion 231 and the upper portion 232 of the first flange 230 act as a stop mechanism when the implant 200 is inserted between adjacent vertebral processes. The implant 200 can not be inserted beyond the surfaces of the first wing 230. Additionally, once the implant 200 is inserted, the first wing 230 can prevent some side-to-side or rear-to-anterior movement of the implant. 200. As with the implant 100 of Figure IA, the implant 200 of Figure IB further includes a second wing 260. Similar to the first wing 230, the second wing 260 includes a lower portion 261 and a dimensioned upper portion 262 and / or shaped to accommodate the anatomical shape or contour of the vertebral processes and / or sheet. The second wing 260 can be secured to the main body of the implant 200 with a fastener 254. The second wing 260 also has an alignment tab 268. When the second wing 260 is initially placed in the main body of the implant 200, the alignment tab 268 the alignment track 203 engages. The alignment tab 268 slides within the alignment track 203 and helps maintain the adjustable wing 260 substantially parallel with the first leg 230. When the main body of the implant 200 is inserted into the patient and the second wing 260 has been connected, the displacement on the longitudinal axis 225, either in the direction of insertion or the direction opposite to that of insertion, can be limited or blocked. In addition, the second wing 260 may also prevent some movement side-by-side, or posterior-to-anterior. Both for the implant 100 of Figure IA and the implant 200 of Figure IB, when a second wing 160, 260 is connected with the implant 100, 200 after the implant 100, 200 is located between the vertebral processes, a procedure to place this implant 100, 200 and subsequently connect the second wing 160, 260 with the implant 100, 200, may require a bilateral approach where a physician must have access to both sides of the inter-vertebral ligament, a first side to perforate and / or distract the invertebral ligament and locate the implant 100, 200, such that the movement in the direction of insertion is satisfactorily limited by the first flange 130, 230 and a second side for connecting the second flange 160, 260 in such a way that the movement in the direction opposite to the insertion is It is satisfactorily limited by the second wing 160, 260. IMPLANTS THAT HAVE SECOND FOLDING WING With reference to Figures 2A to 3B, the implants 300 and methods for placing these implants according to the present invention can in one embodiment, include a second deployable wing 360 associated with the main body 301, such that the second wing 360 can be deployed by a physician who only requires access to a first side of the vertebral processes to limit or block movement on the longitudinal axis 325. As illustrated in FIG. Figure 2A, the implant 300 includes a main body 301 having a fixed spacer 320 and a distraction guide 310. The distraction guide 310 comprises a first fin (also referred to herein as an upper fin) 312 and a second fin (also referred to herein as a lower fin) 314, and when disposed in a first configuration can include a tip from which the distraction guide 310 expands, the tip has a sufficiently small diameter such that the tip can pierce an opening in an intervertebral ligament and between vertebral processes and / or can be inserted in a small initial dilated opening. The diameter and / or cross-sectional area of the distraction guide 310 gradually increases until it is substantially similar to the diameter of the spacer 320. In this aspect, the distraction guide 310 of Figure 2A may resemble a distraction guide as shown in FIG. described earlier when it is available in the first configuration. The wings 312, 314 may be hinged or otherwise rotatably connected with the main body 301, such that the wings 312, 314 may be arranged in a second configuration (Figure 2B) once the implant 300 is located between vertebral processes. In a second configuration, one or both of the wings 312, 314 buttress at least one of the related vertebral and / or tissue processes as they move in an opposite direction of insertion, thus limiting movement on the longitudinal axis 325 In this way, when they are arranged in a second configuration, the guidance of distraction 310 becomes a second wing 360, as illustrated in Figure 2B. The implant 300 includes an insert 370 having an insert body 372 and a first flange 330. As illustrated in FIG. 2B, the insert 370 can be engaged with the main body 301 to arrange the distraction guide 310 of the implant 300 in the second configuration, thus deploying the second wing 360. To facilitate the coupling of the main body 301 and the insert 370, the spacer 320 includes a cavity sized and shaped to receive the insert body 372 and accessible from a remote end of the main body 301. A portion of the upper flange 312 and the lower flange 314 may extend at least partially into the cavity, such that when the insert body 372 is received within the cavity, the insert body 372 displaces the portions, causing the distraction guide 310 to be disposed in a second configuration. In the embodiment shown, the upper flange 312 and the lower flange 314 each include a lever 316, 318 comprising a curved projection projecting into the cavity when the distraction guide 310 is in the first configuration. As the insert body 372 of the insert 370 fills the cavity, the insert body 372 contact the first lever 316 and the second lever 318, applying a force to the first lever 316 and the second lever 318 which results in a rotational movement of the hinged upper wing 312 and the hinged lower wing 314. The insert body 372 can optionally having a tapered proximal end 374 having a first slot 376 and a second slot 378 corresponding to the first lever 316 and the second lever 318, respectively. The tapered shape of the proximal end 374 allows the upper flange 312 and the lower flange 314 to unfold gradually, deploying fully as the insert body 372 rests fully within the cavity. The main body 301 is illustrated to include a flange 303 where notches 305 are formed to receive an insertion tool (not shown), for example. As the insert body 372 abuts within the cavity, an upper tab 332 and a lower tab 331 of the first flange 330 abuts within the cuts 322 of the flange 303. With reference to Figure 3A, the main body 301 of the implant 300, illustrated is located between adjacent vertebral processes of the target or target movement segment. The segment of movement shown is within the lumbar region, but in others modalities, particularly when using a fixed spacer 320, implants 300 according to the present convention, can be located in segments of movement of the thoracic or cervical region. The main body 301 is located as shown when initially approaching the intervertebral ligament between the adjacent upper and lower vertebral processes 2, 4 through an opening to the right of the intervertebral ligand, approximately posterior to the right inferior articular facet 6 of the vertebrae from which the upper vertebral process extends. The main body 301 may be associated with one or more insertion tools (not shown), and the distraction guide 310 may be arranged in the first configuration. The tip of the distraction guide 310 is located approximately adjacent a point on the intervertebral ligament and the distraction guide 310 then moves through the intervertebral ligament, perforating the intervertebral ligand and / or separating and distracting fibers from the intervertebral ligaments. The main body 301 then travels through the intervertebral ligament until the spacer 320 is located between the adjacent vertebral processes 2, 4, such that the spacer 320 supports a load applied by the vertebral processes 2, 4. With reference to Figure 3B, once the implant 300 is positioned as desired, the insertion tools can be removed from the opening and the insert 370 can be located in the Distant end of the main body 301. The insert body 372 can move within the cavity within the main body 301, until the proximal end 374 of the insert body 372 contacts the first lever 316 and the second lever 318. The insert 370 can then move further on the longitudinal axis 325, such that the insert body 372 moves the first lever 316 and the second lever 318 away from the insert body 372, causing the upper flange 312 and the lower flange 314 to rotate with respect to the first hinge 313 and second hinge 315, respectively. As the first lever 316 and the second lever 318 move from the cavity, the first lever 316 and the second lever 318 are guided over corresponding grooves 376, 378 of the tapered proximal end 374. As the insert body 372 rests within the the main body cavity 301, the upper wing 312 and the lower wing 314 deploy a second wing 360. The insertion tool can be removed from the incision, once the insert body 372 is supported within the main body 301. As can be seen a portion of the upper vertebral process and a portion of the lower vertebral process are sandwiched between the first wing 330 and the second wing 360, limiting movement on the longitudinal axis 325. Implants and methods for placing these implants between vertebral processes according to the present invention, are not intended to be limited to modalities as described above and otherwise here, but rather are intended to include any implant that has a second deployable wing when moving an insert inside a main body located between adjacent vertebral processes. A myriad of different variations can easily be apparent to a person with ordinary skill in the specialty. For example, in an alternate embodiment, the main body 301 of the implant 300 of Figures 2A to 3B may include a lower wing 314 rotatably associated with the main body 301 while an upper wing 312 is fixedly associated with the main body 301 An insert 370 can be adapted to deploy only the lower flange 314 when it is supported within the cavity of the main body 301.

In other embodiments, a first wing 310 may extend from the main body 301 instead of or in addition to a first wing extending from the insert 370. When the main body 301 is initially located between the adjacent vertebral processes, the movement of the main body 301 on the longitudinal axis 325 may be limited in the direction of insertion. As the first wing 310 extends from the main body 301 contacts one or both of the adjacent vertebral processes, greater movement of the main body 301 in the direction of insertion may be limited or blocked. The first wing 310 can thus act as a hard stop, allowing the main body 301 to locate without requiring a position of the main body 301 to be estimated on the vertebral processes, thus facilitating the implant. With reference to Figure 4, in still further embodiments, implants 400 in accordance with the present invention may include one or both of a first coupling element (also referred to herein as an upper hook) 480 and a second coupling element (also referred to here as a lower hook) 482 to limit the flexing movement in a movement segment. By example, similar hooks have been described in greater detail in the U.S. patent. No. 6,451,019 issued on September 17, 2002 to Zucherman et al., And the US patent. No 6, 652,527 granted on November 25, 2003 to Zucherman et al., Both incorporated herein by reference. Implants according to the present invention can include these arrangements. The implant 400 shown in Figures 4 and 5 includes an upper hook 480 extending from an upper connecting rod 484 rotatably associated with the main body 401 and a lower hook 482 extending from a lower connecting rod 486 rotatably associated with the main body 401. Alternatively, the connecting rods 484, 486 may be fixedly associated with the main body 401. The hooks 480, 482 include tapered proximal ends 481, 483 which act as ingress tissue reamers to distract intervertebral ligaments from the movement segments above and below the target movement segment. Since the main body 401 is located between adjacent vertebral processes, the tapered proximal ends 481, 483 of the upper and lower hooks 480, 482 can also pierce and / or distract intervertebral ligaments such that the upper and lower hooks 480, 482 can be appropriately positioned to limit or restrict the bending movement of the target movement segment when the main body 401 is in place. As shown, the hooks 480, 482 can be rotatably associated with the connecting rods 484, 486, such that the hooks 480, 482 can be rotated with respect to the connecting rods 484, 486, thereby allowing a physician improve the contact and disperse loads between the hooks 480, 482 and corresponding vertebral processes 2, 4. The upper rotating connecting rod 484 and the lower connecting rod 486 can provide flexibility in the placement, such that when an anatomy varies between patients and varies between movement segments such that the arrangement of a smaller dimension and larger dimension of the implant 400 relative to the longitudinal axis 425 varies, the implant 400 can be adjusted. Figure 5 is a rear view of the implant 400 located between adjacent vertebral processes 2, 4 and having an upper hook 480 and a lower hook 482, arranged in such a way that both flexion and extension are limited as desired. In addition, the second wing 460 is deployed to limit the movement of the implant 400 about the longitudinal axis 425. The upper hook 480 and the lower hook 482 prevent movements on the longitudinal e 425 in the opposite direction to the insertion, making a first wing unnecessary. With reference to Figures 6A and 6B, still in other embodiments, implants 500 and methods for locating these implants 500 between vertebral processes according to the present invention, can include a distraction guide 510 wherein portions of the distraction guide 510 can extending from the distraction guide 510 to form an upper flange 512 and a lower flange 514, respectively, of a second flange 560 when placing an insert 570 within a cavity of the main body 501. This is in contrast to the previous embodiment where The entire distraction guide is formed by the wings. In this embodiment, the wing 512, 514 extends out of the side of the distraction guide 510. When it does not extend, as seen in Figure 6A, the wings 512, 514 partially form the sides of the distraction guide 510. These embodiments are considered useful when desired so that the second wing 560 has a limited height with respect to the implants 300, 400 as described above, wherein all of the distraction guide 310 is deployed (see Figures 2A to 3B). For example, when the implants 500 are to be located in adjacent movement segments, the second wings 560 of the implants 500 may be convenient, do not interfere with another implant, for example during an extension movement when compressive loads are applied to the implants 500. As with the implants described above, a person with ordinary dexterity in the The technique can appreciate the myriad of different variations of the implant 500 of Figures 6A and 6B. For example, in alternate embodiments, upper flange 512 and lower flange 514 may have some other shape. For example, the positions of the upper flange 512 and the lower flange 514 are staggered so that the implants 500 located in adjacent movement segments can be located more easily without interfering with each other. This staggering can also accommodate anatomies where one vertebral processes superior and inferior is wider than the other. With stepping, for example the upper wing 512 can be mounted rotatable in the distraction guide 510 at a position less distant from the distraction end 511 than the location where the lower wing 514 is mounted rotatable in the distraction guide 510. Still in other embodiments, upper flange 512 and lower flange 514 may have some other shape. With reference to Figures 7A to 8, still in additional implant modalities 600 in accordance with the present invention, the main body 601 can include a hollow central body 605 (shown in Figures 7C and 7D) extending from the first wing 630. A rotary separator 620 is positioned relative to the hollow central body 605. The implant 600 can include a separator 620 that resembles the separators, for example as described above in Figure IB. A distraction guide 610 may extend from the hollow central body 605 and may include an upper flange 612 and a lower flange 614, one or both of which may be rotatable associated with a main portion 611 of the distraction guide 610, so such that the upper wing 612 and / or the lower wing 614 can be deployed as a second wing 660. A pin 606 can be inserted into the hollow central body 605 to deploy the second wing 630. With reference to Figure 7B, once the pin 606 is supported within the main body 601, the upper flange 612 and the lower flange 614 can be turned away from each other, in such a way that the upper flange 612 and the lower flange 614 limit or block the movement on the longitudinal axis 625 in the opposite direction of insertion. The upper flange 612 and the lower flange 614 in this manner act as a second flange 660.

With reference to the partial cross sections of Figures 7C and 7D, in one embodiment the distraction guide 610 may include a cup 616 with a structure sized and arranged to receive the pin 606. The bar structures 618, 619 may be pivotally connected between the cup structure 616 and one or both of the upper flange 612 and the lower flange 614, such that when a force is applied to the cup structure 616 by the pin 606, the force is additionally transferred to the upper flange 612 and the lower flange 614, causing the upper flange 612 and the lower flange 614 to pivot on hinges 613, 615 associated with the main portion 611 of the diversion guide 610 in such a manner that the second flange 660 unfolds. As can be seen, the pivot points 613, 615 of the upper flange 612 and the lower flange 614 are arranged next to the mounting points 617, 619 of the bar structures 618, 619 causing the upper flange 612 and the lower flange 614 rotate away from each other when the mounting points 617, 619 are displaced together by the insertion of the pin 606 (as seen in Figure 7D). In other embodiments, upper flange 612 and lower flange 614 can be made to rotate away from each other using some other mechanism. Implants according to this invention is not intended to be limited to these second wing deployment mechanisms, as described in detail herein. With reference to Figure 8, the implant 600 is shown to be located between adjacent vertebral processes 2, 4. The second wing 660 as illustrated is dimensioned such that when it is arranged in a first configuration (ie, as a distraction guide) 610), the upper wing 612 and the lower wing 614 do not undesirably extend into adjacent tissues. However, the upper flange 612 and the lower flange 614 can be sized and shaped differently as shown in Figure 8. The upper flange 612 and the lower flange 614 only need to be dimensioned and shaped in such a way that when they are arranged in a second configuration, the upper and lower wings 612, 614 limit or block the movement on the longitudinal axis 625 in an opposite direction of insertion. Figures 9A to 9C illustrate a further embodiment of an implant 700 according to the present invention disposed between adjacent vertebral processes 2, 4. In this embodiment, upper and lower wings 712, 714 can be placed within the distraction guide 710 and can deployed when operating an actuator assembly including an arrow connected to a cam 707, the arrow has a mating head 706 or alternately including some other mechanism such as a gear. As can be seen in Figure 9A the implant 700 can be placed between adjacent vertebral processes 2, 4 as described above with reference to Figure 3. The distraction guide 710 of the implant 700 can be used to pierce and / or distract an intervertebral ligament 6 connected between the adjacent vertebral processes 2, 4. The implant 700 can then be displaced. between the vertebral processes 2, 4, so that the distraction guide 710 additionally distracts the intervertebral ligament 6, to form a space within which a spacer 220 can be placed. In the embodiment shown, the spacer 220 can rotate with respect to a central body extending from first flange 230 of implant 700. First flange 230 limits and / or blocks movement on a longitudinal axis 725 of implant 700 in the insertion direction. Once the implant 700 is arranged as desired, the actuator assembly can be operated to deploy the upper and lower wings 712, 714, thereby forming a second wing 760 as illustrated in Figure 9C. The second wing 760 limits and / or blocks movements on the longitudinal axis 725 in a opposite direction to the insertion direction. With the second wing 760 deployed, the adjacent vertebral processes 2, 4 are placed at least partially between the wings 730, 760, preventing the implant 800 from detaching undesirably from the space between the adjacent vertebral processes 2, 4. As illustrated in Figure 9C, the first wing 730 and the second wing 760 can be disposed sufficiently apart such that the adjacent vertebral processes 2, 4 can move with each other slightly (eg, laterally - such as during a twisting movement), allowing the Patient greater flexibility of movement. Figures 9B and 9C are rear views in partial cross section of the implant 700 shown in Figure 9A. In one embodiment, the deployable wings 712, 714 can extend from the distraction guide 710 using an actuator arrangement comprising an arrow 707 and a cam 716. The cam 716 can be rotated to force the wings 712, 714 to rotate outward from the distraction guide 710. As shown, the wings 712, 714 at least are partially positioned within a cavity of the distraction guide 710. Figures 10A to 10E illustrate a still further embodiment of an implant 800 according to the present invention. arranged between the processes adjacent vertebral 2, 4. In this embodiment, the upper and lower wings 812, 814 can be placed within the distraction guide 810 and can be deployed by actuating an actuator assembly including a screw 807 having a coupling head 806, or shaped alternate include some other mechanism such as a gear. As can be seen in Figure 10A the implant 800 can be placed between adjacent vertebral processes 2, 4 as described above with reference to Figure 3. The distraction guide 810 of the implant 800 can be used to pierce and / or distract an intervertebral ligament 6. connected between the adjacent vertebral process 2, 4. The implant 800 can then move between the vertebral processes 2, 4 in such a way that the distraction guide 810 further distracts the intervertebral ligand 6 to form a space within which a spacer 220 can be placed. In the embodiment shown, the spacer 220 can rotate with respect to a central body extending from the first wing 230 of the implant 800. The first wing 230 limits and / or blocks the movement on a longitudinal axis 825 of the implant 800 in the direction of insertion Once the implant 800 is arranged as desired, the actuator assembly can be operated to deploying upper and lower wings 812, 814, thereby forming a second wing 860 as shown in Figure 9B. The second wing 860 limits and / or blocks movement on the longitudinal axis 825 in a direction opposite to the insertion direction. With the second wing 860 deployed, the adjacent vertebral processes 2, 4 are at least partially positioned between the wings 830, 860, preventing the implant 800 from being disengaged from the space between the adjacent vertebral processes 2, 4. As illustrated in FIG. Figure 9B, the first wing 830 and the second wing 860 can be arranged sufficiently spaced such that the adjacent vertebral processes 2, 4 can move with each other slightly (for example, laterally - such as during a twisting movement), allowing the patient greater flexibility of movement. Figures 10C and 10D are partial cross-sectional end views of the implant 800 shown in Figures 10A and 10B. In one embodiment, the deployable wings 812, 814 can extend from the distraction guide 810 using an actuator assembly comprising a screw 806 and a threaded collar 816. The threaded collar 816 can be moved over the screw 806 to force the wings 812, 814 to rotate outward from the distraction guide 810. As illustrated, the wings 812, 814 are at least partially positioned within a cavity of the distraction guide 810. The wings 812, 814 are rotatably connected with the threaded collar 816 at an upper pivot point 817 and a lower pivot point 819. The pins 813, 815 or other obstruction devices may be placed within the cavity and arranged such that the pins 813, 815 do not interfere with the arrangement of the wings 812, 814 in a nested position, or not deployed. However, as the threaded collar 816 travels over the screw 806 in a posterior-to-anterior direction, the inner surface of the wings 812, 814 contacts the pins 813, 815 and the wings 812, 814 rotate away from the distraction guide 810. If desired, the wings 812, 814 may be spring-loaded against the posts 813, 815 in such a manner as in the nested positions and in the deployed position. the wings 812, 814 are held against the posts 813, 815. As illustrated in Figures 10D and 10E, when the threaded collar 816 has traveled a distance over the screw 806, the wings 812, 814 deploy to form a second wing 860. The wings 812, 814 extend over a significant portion of the outer surface of the vertebral processes 2, 4. When they travel on the longitudinal axis 825 in one direction opposite the direction of insertion, the wings 812, 814 contact the adjacent vertebral processes 2, 4 and resist greater movement in said direction. Figure 10E is an end view of the implant 800 with the second wing 860 deployed. As shown, the screw head 806 extends from the distraction guide 810; however, when implemented, it is preferable that the screw head 806 be either flush with the surface of the distraction guide 810 or slightly retracted from the surface of the distraction guide 810, such that the movement of the implant 800 is not obstructed during distraction of the intervertebral ligament 6 and / or vertebral processes 2, 4. The screw head 806 is shown to have from the distraction guide 810 to demonstrate possible arrangement with respect to the proximal end of the distraction guide 810. Figures HA and 11B illustrate yet another embodiment of the implant 900 having an alternating drive arrangement. In such embodiment, the wings 912, 914 can be inverted in such a manner that the wings 912, 914 are deployed when the threaded collar 916 is displaced toward the screw head 806. Figures 12A and 12B illustrate a still further embodiment of the implant 1000 which has an alternate drive assembly. In these modalities, the wings 1012, 1014 they include two hinged portions, each wing 1012, 1014 bends outward to form a portion of a second wing 1060. The second wing 1060 does not extend so far above the axis of the column, i.e. the total height of the second wing 1060 on the column is smaller than the previous modalities. A reduced second wing height can be advantageous when placing implants in adjacent movement segments, thereby avoiding undesirable contact of adjacent implants. As mentioned above, in other embodiments according to the present invention, the wings can be deployed from the distraction guide using a mechanism other than a threaded screw and collar. For example, one or more gears may be employed. In addition, still in other embodiments the upper and lower wings may have a different shape from those forms shown in Figures 10a to 12B. The invention is not intended to be limited to wings that have shapes such as those shown. In still further embodiments, as illustrated in Figure 13, the implant 1100 may include only the upper and lower wings. For example, when the implants are located in adjacent movement segments it may be advantageous to have a lower flange 814, of this way avoiding unwanted contact of adjacent implants 1100. As will be evident to a person with ordinary skill in the art, myriads of different drive arrangements can be used to form a second wing. Implants according to the present invention are not intended to be limited to those described in detail herein. MATERIALS FOR USE IN IMPLANTS OF THE PRESENT INVENTION In some embodiments, the implant and implant components (i.e., the spacer, the distraction guide, etc.) can be fabricated from medical grade metals such as titanium, stainless steel, cobalt chromium and its alloys, or other suitable implant material having similar biocompatible and high strength properties. Additionally, the implant may be at least partially fabricated from a shape memory metal, for example Nitinol, which is a combination of titanium and nickel. These materials are typically radiopaque, and appear during X-ray imaging and other types of imaging. Implants according to the present invention, and / or their portions can also be made of a material somewhat flexible and / or capable of deviating. In these modalities, the implant and / or its portions can manufactured in whole or in part from biocompatible polymers, copolymers, mixtures and compounds of medical grade. A copolymer is a polymer derived from more than one species of monomer. A composite polymer is a heterogeneous combination of two or more materials, wherein the constituents are not miscible and therefore exhibit an interface with each other. A polymer mixture is a macroscopically homogeneous mixture of two or more different polymer species. Many polymers, copolymers, blends and polymer compounds are radiolucent and do not appear during X-ray imaging or other types of imaging. Implants comprising these materials can provide a physician with a less obstructed view of the spine under imaging than with an implant comprising totally radiopaque materials. However, the implant does not require to understand radiolucent materials. A group of biocompatible polymers is the polyaryletherketone group having several members including polyether ether ketone (PEEK), and polyetherketone ketone (PEKK). PEEK proves to be a durable material for implants, and meets biocompatibility criteria. PEEK medical grade is available from Victrex Corporation of Lancashire, Great Britain, under the product name PEEK-OPTIMA. PEKK medical grade is available from Oxford Performance Materials under the name OXPEKK, and also of CoorsTek under the name of BioPEKK.

These medical grade materials are also available as reinforced polymer resins such as reinforced resins that exhibit even greater material strength.

In one embodiment, the implant can be manufactured from PEEK 450G, which is a PEEK without filler approved for medical implant, available from Victrex. Other sources of this material include Gharda located in Panoli, India. PEEK 450G has the following approximate properties: Property Value Density 1.3 g / cc Rockwell M 99 Rockwell R 126 Traction Resistance 97 MPa Elasticity Module 3.5 GPa Flexural Module 4.1 GPa PEEK 450G has appropriate physical and mechanical properties and is suitable for transporting and dispersing a physical load between vertebral processes adjacent. The implant and / or its portions can be formed by extrusion, injection, compression molding and / or machining techniques.

It should be noted that the selected material can also be filled. Fillers can be added to a polymer, copolymer, polymer blend or polymer composite to reinforce a polymeric material. Fillers are added to modify properties such as mechanical, optical and thermal properties. For example, carbon fibers can be added to mechanically reinforce polymers to improve strength for certain uses, such as for load-bearing devices. In some embodiments, other grades of PEEK are available and are contemplated for use in implants according to the present invention, such as degrees with 30% glass filler or 30% carbon filler, provided that these materials are authorized by the manufacturer. FDA for use in implantable devices, or other regulatory entity. PEEK with glass filler reduces the speed of expansion and increases the flexural modulus of PEEK compared to PEEK without filler. The resulting product is known to be ideal for improved strength, rigidity or stability. PEEK with carbon filler is known to have improved resistance to compression and rigidity, and a lower expansion ratio compared to PEEK without filler. PEEK with carbon filler also offers resistance to wear and load carrying capacity.

As will be appreciated, other similarly convenient biocompatible thermoplastic or thermoplastic polycondensate materials that resist fatigue, have good memory, are flexible and / or can be deflected, have very low moisture absorption, and good resistance to wear and / or abrasion, can be used without departing from the scope of the invention. As mentioned, the implant may comprise polyetherketone ketone (PEKK). Other material that can be used includes polyetherketone (PEK), polyetherketoneethetonaketone (PEKEKK), polyether ether ketoneketone (PEEKK), and in general a polyaryletherketetone. In addition, other polyketones can be used as well as other thermoplastics. Reference to suitable polymers that can be employed in the implant can be made to the following documents, all of which are incorporated herein by reference. These documents include: PCT publication WO 02/02158 Al, dated January 10, 2002, entitled "Bio-Compatible Polymeric Materials; "PCT publication WO 02/00275 Al, dated January 3, 2002, entitled" Bio-Compatible Polymeric Materials; "and PCT publication WO 02/00270 Al, dated January 3, 2002, with title "Bio-Compatible Polymeric Materials." Other materials such as Bionate®, polycarbonate urethane, available from Polymer Technology Group, Berkeley, California, may also be appropriate due to good oxidative stability, biocompatibility, mechanical strength and abrasion resistance. Other thermoplastic materials and other high molecular weight polymers can be employed. METHODS FOR PLACING INTERVERTEBRAL IMPLANTS A minimally invasive surgical method for positioning an implant 300 as illustrated in Figures 2A-8 in the cervical spine is described and illustrated herein. In this method, as shown in Figure 14, preferably a guide wire 780 is inserted through a positioning network 790 in the neck of the implant receiver. The guidewire 780 is used to locate where the implant 300 will be placed relative to the cervical spine, including the vertebral processes. Once the guide wire 780 is located with the aid of imaging techniques, an incision is made in the side of the neck, such that an implant 300 according to one embodiment of the present invention, can be placed in the neck through an incision and over a line that is approximately perpendicular to the guidewire 780 and directed to the end of the guidewire 780. The main body 301 of the implant 300 is inserted into the neck of the patient.

Preferably, during insertion, the distraction guide 310 pierces or separates the tissue without cutting it. Once the main body 301 is positioned satisfactorily, an insert 370 can be located within a cavity of the main body 301, causing the distraction guide 310 of the main body 301 to be disposed in a second configuration, such that at least one portion of the distraction guide 310 forms a second wing. The insert 370 can be placed on a line that is generally co-linear with the line on which the main body 301 is inserted. The anatomy of the neck is such that it is more convenient and minimally invasive to enter the neck from the side with respect to the body principal 301 and insert 370. In addition, a minimally invasive surgical method for placing an implant as described in 2A-8 in the lumbar spine is described and illustrated here. In this method, as described in the flow chart of Figure 15A, a unilateral opening or incision may preferably be made using a posterior approach and an anterior approach (step 102). The unilateral incision can be performed for example at a site some distance to the left of an axis on the vertebral process. The incision or opening can be enlarged, and a tool can be placed distraction within the incision, such that the proximal end of the distraction tool (step 104) may have access to an exposed side of the intervertebral ligament. The distraction tool can move through the intervertebral ligament, thereby distracting the intervertebral ligament to receive the implant (step 106). Once the intervertebral ligament is distracted enough, the distraction tool can be detached and removed from the incision (step 108). Once the distraction tool has been removed from the incision, the implant can be placed in the dilated opening, and the distraction guide of the implant can travel through the dilated opening (step 110). The implant can also be moved through the opening until the spacer is positioned as desired between the adjacent vertebral processes of the target movement segment (step 112). The spacer is free to rotate in such a way that the load is distributed more evenly over the surface of the vertebral processes. Optionally, the implant can be displaced through the dilated opening until the first wing contacts the adjacent vertebral processes, thus blocking further movement in the insertion direction. Once the implant is properly fixed, the insert can be located at the distal end of the implant, such that the insert can move in and through the hollow cavity of the hollow central body (step 114). As the insert is supported within the cavity, the distraction guide divides, and the upper wing and the lower wing deploy a second wing. The remaining tools can be removed from the incision and the incision closed (step 116). Preferably during insertion, the distraction end pierces or separates the tissue without cutting the tissue. In addition, a minimally invasive surgical method for placing an implant as illustrated in Figures 9A-13 in the lumbar spine or lumbar region of the spine is described and illustrated herein. In this method, as described in the flow chart of Figure 15B, an incision or aperture can be made using a posterior approach and an anterior approach (step 202). The incision or opening may be enlarged and a distraction tool may be placed within the incision such that the proximal end of the distraction tool (step 204) may have access to an exposed side of the intervertebral ligament. The distraction guide can scroll through the intervertebral ligament and distract, thus distracting the intervertebral ligament to receive the implant (stage 206). Once the intervertebral ligament is distracted enough, the distraction tool can be detached and removed from the incision (step 208). Once the distraction guide has been removed from the incision, the implant can be located in the dilated opening, and the distraction guide of the implant can travel through the dilated opening (step 210). The implant can also be moved through the opening until the spacer is positioned as desired between the adjacent vertebral processes of the target movement segment (step 212). The spacer is free to rotate, so that the load distributes more evenly on the surface of the vertebral processes. Optionally, the implant can move through the dilated opening until the first wing contacts the adjacent vertebral processes, thereby blocking further movement in the insertion direction. Once the implant is properly disposed, a drive tool can be inserted into the incision on an opposite side of the adjacent vertebral processes from the insertion point (step 214). The tool The actuator assembly can couple the drive assembly and can actuate the drive assembly such that the upper wing and the lower wing deploy a second wing, as described above (step 216). The remaining tools can be removed from the incision and the incision closed (step 218). Preferably during insertion, the distraction end pierces or separates the tissue without cutting the tissue. The above 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 forms described. Many modifications and variations will be apparent to those with skill in the specialty that practice it. The modalities were chosen and described in order to explain the principles of the invention and their practical application, thus enabling others with skill in the art to understand the invention for various modalities and with various modifications as is suitable for the particular use contemplated. . It is intended that the scope of the invention be defined by the following claims and their equivalents.

Claims (10)

1. CLAIMS 1. A tervertebral implant adapted to be inserted between vertebral processes, the implant is characterized because it comprises: a separator; a distraction guide that has a first configuration; wherein the distraction guide can be arranged in a second configuration, and wherein when the distraction guide is disposed in the second configuration, the distraction guide limits movement in the intervertebral implant when the intervertebral implant is placed between vertebral processes. The implant according to claim 1, characterized in that it also includes a first wing; and wherein the spacer is placed between the first wing and the distraction guide 3. The implant according to claim 1, characterized in that the spacer includes a cavity; and the implant further includes: an insert adapted to move in the cavity; and when the insert is displaced in the cavity, the distraction guide is arranged from the first configuration to the second configuration. 4. The implant according to claim 1, characterized in that it also comprises a first rotating associated portion with one of the guide of distraction and the spacer, a first protrusion extending from the first portion, a second rotatable associated portion with one of the distraction guide and the spacer, and a second protrusion extending from the second portion; and wherein the distraction guide is arranged in a second configuration by applying a force to the first protrusion and the second protrusion, such that the first portion and the second portion rotate away from each other. The implant according to claim 1, characterized in that the distraction guide includes a first alite and a second alite; the second wing is associated rotating with the separator; where the distraction guide is arranged in a second configuration, by moving the second wing to rotate away from the first wing. The implant according to claim 1, characterized in that the distraction guide includes a distraction end and a wing rotatably mounted on the distraction guide rearward of the distraction end; the wing is rotatable from a first position adjacent to the distraction end to a second position away from the distraction end. 7. An intervertebral implant adapted to be inserted between vertebral processes, the implant is characterized in that it comprises: a separator; a distraction guide that includes an alite that can be extended from the distraction guide; an actuator operatively associated with the flange, such that when the actuator is operated, the flange extends from the diversion guide. The implant according to claim 7, characterized in that it further includes: a central body; and wherein the spacer is rotatably disposed with respect to the central body and the distraction guide extends from the central body. The implant according to claim 7, characterized in that the alite is a first alite, and the distraction guide further includes a second alite; the second wing extends from the distraction guide; and when the actuator is operated, the second wing extends from the distraction guide. 10. An intervertebral implant adapted to be inserted between vertebral processes, the implant is characterized because it comprises: a first wing; a central body extending from the first wing; a separator rotatably positioned with respect to the central body; a distraction guide that extends from the central body, the distraction guide includes an actuator placed at least partially inside the distraction guide; a first alita and a second alita operatively associated with the actuator and adapted to extend from the distraction guide; where the first wing and the second wing extend when operating the actuator.