Interspinous implant

Abstract

This invention relates to a system and method for delivering a spinal implant, the spinal implant having a body, a proximal anchor, a distal anchor, and an inner plunger. The proximal anchor includes a nut having an internal cavity. The distal anchor includes a plurality of wings having a first closed configuration and a second open configuration. The inner plunger is received within a central cavity of the body. The distal end of the inner plunger is operatively connected to the first and second wings to selectively move the wings between the first closed configuration and the second open configuration, and vice versa.

Description

Technical Field

[0001] Embodiments of the present invention relate to spinal implants. More specifically, embodiments of the present invention relate to spinous process implants and fusion devices that are introduced percutaneously or posteriorly. Background Technology

[0002] The spine consists of a row of twenty-four vertebrae extending from the skull to the hip. Soft tissue discs are positioned between adjacent vertebrae. Additionally, the spine surrounds and protects the spinal cord, defining a bony passage around the spinal cord called the vertebral canal. There is usually space between the boundary between the spinal cord and the vertebral canal, preventing compression of the spinal cord and its associated nerves.

[0003] Over time, the ligaments and bones surrounding the spinal canal thicken and harden, causing the spinal canal to narrow and compressing the spinal cord or nerve roots. This condition is called spinal stenosis, which causes back and leg pain and numbness, weakness, and / or loss of balance. These symptoms often worsen after walking or standing for a period of time.

[0004] There are many non-surgical treatments for spinal stenosis. These include nonsteroidal anti-inflammatory drugs (NSAIDs) to reduce swelling and pain, and corticosteroid injections to reduce swelling and treat acute pain. While some patients can relieve their symptoms of spinal stenosis with these treatments, many do not and therefore turn to surgery. The most common surgical procedure for treating spinal stenosis is laminectomy, which involves removing part of the vertebra. The purpose of this procedure is to relieve pressure on the spinal cord and nerves by increasing the area of ​​the spinal canal.

[0005] Interspinous decompression (IPD) is a minimally invasive surgical procedure used to treat spinal stenosis. For IPD surgery, there is no need to remove bone or soft tissue. Instead, an implant or spacer is placed behind the spinal cord or nerve and between the spinous processes that protrude from the vertebrae in the lower back.

[0006] Examples of particularly useful interspinous implants and fusion devices are disclosed in commonly assigned U.S. Patent Nos. 9,861,399, 8,945,184, 9,314,276, 9,907,581 and 9,757,164, the entire disclosure of which is incorporated herein by reference.

[0007] This invention provides an improvement over previous interspinous implant devices by constructing an implant that is significantly shorter than previous devices. This advantageously reduces the overall size and profile of the device, thereby making implantation safer and easier.

[0008] If desired, the construction of the implant according to embodiments of the invention also allows for easier removal of the device after implantation. The surgeon's ability to selectively open and close the wings of the device is another advantage over previous devices. Because the wings can be closed after implantation, the implant of the present invention can be removed through the same small lateral incision used during its initial insertion. Removal of previous devices typically requires an additional posterior incision to manually close the wings before removal of the device.

[0009] Furthermore, the device of the present invention does not require removable end pieces. This improves the safety and simplicity of the procedure by reducing the number of steps in the implantation process. Fewer removable parts of the implant also reduce costs and simplify manufacturing. Summary of the Invention

[0010] The embodiments of the present invention solve the above problems by providing a system and method for minimally invasive spinal fusion.

[0011] A first embodiment of the present invention relates to a spinal implant comprising: a body, a proximal anchor, a distal anchor, and an inner plunger. The body has an outer surface, a central aperture therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The proximal anchor includes a nut having a proximal end, a distal end, and an inner aperture. The distal anchor includes a plurality of wings having a first closed configuration and a second open configuration, wherein the plurality of wings includes a first wing and a second wing. The inner plunger has a proximal end and a distal end and is received within the central aperture of the body. The distal end of the inner plunger is operatively connected to the first wing and the second wing to selectively move the plurality of wings between the first closed configuration and the second open configuration.

[0012] Another embodiment of the invention relates to a spinal implant comprising a body, a proximal anchor, a distal anchor, and a linkage assembly. The body has an outer surface, a central aperture therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The body includes external threads located on at least a portion of the outer surface. The proximal anchor includes a nut having a proximal side, a distal side, and an inner aperture having internal threads. The distal anchor includes a first wing and a second wing configured to selectively open and close. The linkage assembly connects the first wing and the second wing to the body.

[0013] Another embodiment of the invention relates to a method of placing a spinal implant at a treatment site, the method comprising: providing a spinal implant in a first closed configuration; placing the spinal implant in a patient at a desired treatment site; and sliding an inner plunger distally along the longitudinal axis to move the plurality of wings into a second open configuration. The method may further comprise sliding the inner plunger proximally along the longitudinal axis to move the plurality of wings into the first closed configuration, thereby removing the spinal implant from the patient.

[0014] This summary is provided to introduce, in a simplified form, a series of concepts further described in the detailed embodiments below. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. Other aspects and advantages of the invention will become apparent from the following detailed description of the embodiments and the accompanying drawings. Attached Figure Description

[0015] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings, in which:

[0016] Figure 1 This is a perspective view of a first embodiment of the implant of the present invention in an open configuration;

[0017] Figure 2 This is a cross-sectional view of a first embodiment of the implant of the present invention in an open configuration;

[0018] Figure 3 This is a perspective view of an embodiment of the main body of the present invention;

[0019] Figure 4 This is a perspective view of a first embodiment of the implant of the present invention in a closed configuration;

[0020] Figure 5 This is a perspective view of an embodiment of the plunger of the present invention;

[0021] Figure 6A This is a perspective view of an embodiment of the first link of the present invention;

[0022] Figure 6B This is a perspective view of an embodiment of the second link of the present invention;

[0023] Figure 7 This is another perspective view of the first embodiment of the implant of the present invention in an open configuration;

[0024] Figure 8 This is a cross-sectional view of a first embodiment of the implant of the present invention in an open configuration;

[0025] Figure 9AThis is a side perspective view of a first embodiment of the first wing of the present invention;

[0026] Figure 9B This is a bottom perspective view of a first embodiment of the first wing of the present invention;

[0027] Figure 9C This is a top view of a first embodiment of the first wing of the present invention;

[0028] Figure 10A This is a side perspective view of a first embodiment of the second wing of the present invention;

[0029] Figure 10B This is a bottom perspective view of a first embodiment of the second wing of the present invention;

[0030] Figure 10C This is a top view of the first embodiment of the second wing of the present invention;

[0031] Figure 11 This is a perspective view of the bolt of the present invention;

[0032] Figure 12 This is a perspective view of the removable top cover of the bolt of the present invention;

[0033] Figure 13 This is a perspective view of an embodiment of the nut of the present invention;

[0034] Figure 14 This is a cross-sectional view of a first embodiment of the implant of the present invention in a closed configuration;

[0035] Figure 15 This is another cross-sectional view of the first embodiment of the implant of the present invention in a closed configuration; and

[0036] Figure 16 This is a view of a first embodiment of the implant of the present invention implanted in a patient's spine.

[0037] The accompanying drawings are not intended to limit the invention to the specific embodiments disclosed and described herein. The drawings are not necessarily drawn to scale, but rather to clearly illustrate the principles of the invention. Detailed Implementation

[0038] The following detailed description is taken with reference to the accompanying drawings, which illustrate specific embodiments in which the invention can be practiced. These embodiments are intended to describe aspects of the invention in sufficient detail to enable those skilled in the art to practice it. Other embodiments may be utilized and changes may be made without departing from the scope of the invention. The following detailed description should therefore not be considered limiting. The scope of the invention is defined only by the appended claims and all equivalents granted by such claims.

[0039] In this specification, references to "an embodiment," "an embodiment," or "an embodiment" mean that one or more features mentioned are included in at least one embodiment of the technology. Individual references to "an embodiment," "an embodiment," or "an embodiment" in this specification do not necessarily refer to the same embodiment and are not mutually exclusive, unless so stated and / or readily understood by those skilled in the art from the specification. For example, features, structures, actions, etc., described in one embodiment may also be included in other embodiments, but are not necessarily included therein. Therefore, the technology can encompass various combinations and / or integrations of the embodiments described herein.

[0040] Embodiments of the present invention relate to a minimally invasive interspinous-laminar fusion device for temporary fixation of the thoracic, lumbar, and sacral vertebrae while awaiting bone fusion. The implant can be attached at the spinous process to posterior non-cervical vertebrae to provide segmental fixation and stability of the spinal column. The threaded body of the implant provides controlled dissociation.

[0041] Figure 1 An embodiment of the invention is illustrated, showing an interspinous implant 100 in an open configuration. The implant 100 may include a body 112 having a distal end 114 and a proximal end 116. The implant 100 further includes a nut 200 on the proximal end 116 of the body 112 and extendable first wings 300a and second wings 300b on the distal end 114 of the body 112. Figure 2 As can be seen in the cross-sectional view, the implant 100 further includes a plunger 400 and a first link 500a and a second link 500b for operatively connecting the first wing 300a and the second wing 300b to the body 112, as will be described herein.

[0042] Figure 3 An embodiment of the body 112 is illustrated. The distal end 114 includes a conical distal tip 118 having a rounded distal end. In some embodiments, the conical distal tip has a sharp, pointed distal end. In some embodiments, the body 112 includes a helical thread 120 on its outer surface. In some embodiments, the body 112 may alternatively or additionally include a cut thread or a female thread. The helical thread 120 may be provided along the entire outer surface of the body 112, or only along a portion of the outer surface of the body 112. In some embodiments, the thread depth may be from about 0.5 to about 3.0 mm, the angle from about 45° to about 100°, and the spacing from about 1.0 mm to about 4.0 mm. In some embodiments, the thread depth may be about 1.0 mm, the angle from about 60°, and the spacing from about 1.75 mm. In some embodiments, the distal tip 118 has a smooth outer surface without any threads. In some embodiments, the distal tip 118 is a solid tip for providing strength during insertion of the implant 100.

[0043] The body 112 further includes a proximal portion 122 extending from the proximal end 116, having a hollow aperture 124. The majority of the hollow aperture 124 may be substantially cylindrical. The proximal end of the hollow aperture 124 may have a specific shape, such as a hexagonal periphery, configured to receive an insertion tool (not shown) therein. The proximal end of the hollow aperture 124 may also include a pawl 125 adapted to receive and lock the distal end (not shown) of the insertion tool therein.

[0044] The main body 112 also includes a distal portion 126 extending from the distal end 114, having a generally rectangular window 128. The window 128 extends from a first side 130 to a second side 132, a top flat inner wall 134, and a bottom flat inner wall 136. At the distal end of the window 128, the top wall 134 includes an opening 138a through it, and the bottom wall 136 includes an opening 138b through it. The openings 138a and 138b are configured to receive bolts 700 for mounting wings 300a and 300b, such as... Figure 4 As shown.

[0045] Figure 4 and 15 An implant 100 with wings 300a and 300b in a closed configuration is shown. The window 128 of the body 112 is configured to receive the distal portion of the plunger 400, the first link 500a and the second link 500b, and the first wing 300a and the second wing 300b when in the closed configuration.

[0046] Figure 5 An embodiment of plunger 400 is shown. Plunger 400 has a distal end 402 and a proximal end 404. As... Figure 2 As shown, the proximal end 404 is configured to be located within the aperture 124 of the body 112 and the distal end 402 is configured to be located within the window 128 of the body 112. The plunger 400 can move longitudinally within the aperture 124 and the window 128 to open and close the wings 300a, 300b, as will be further described below.

[0047] about Figure 5 The plunger 400 has a central bore 406 at its proximal end for receiving an inserter device (not shown). In some embodiments, the central bore 406 of the plunger 400 may be threaded to engage with threads on the inserter device. The plunger 400 has a generally Y-shaped configuration, having a first arm 408a and a second arm 408b extending from a solid central portion 410. A space 409 exists between the first arm 408a and the second arm 408b. The central portion 410 has two opposing curved recesses 412a, 412b on its outer side, as shown... Figure 5As can be seen in the image. The first arm 408a and the second arm 408b each have holes 414a, 414b extending through them for receiving the mounting pin 600. In order to connect the wings 300a, 300b to the plunger 400, the connecting rods 500a, 500b are installed in the space 409 between the arms 408a, 408b.

[0048] In an alternative embodiment, the plunger may have two caps having T-shaped or dovetail features across mating grooves on the undersides of wings 300a and 300b. In another alternative embodiment, the plunger may be connected by an umbrella-shaped feature having a connecting rod across a groove on the undersides of wings 300a and 300b.

[0049] Figure 6A and 6B Embodiments of a first link 500a and a second link 500b are shown respectively. The first link 500a has a first end 502a and a second end 504a. In some embodiments, the first link 500a is substantially elliptical, the first end 502a has a rounded edge 506a, and the second end 504a has a rounded edge 508a. The first link 500a further includes a straight top edge 510a and a serrated curved bottom edge 512a. The first end 502a includes a hole 514a extending therethrough, and the second end 504a includes a hole 516a extending therethrough. Holes 514a and 516a are each configured to receive a mounting pin 600 therein. The first link 500a includes a substantially flat top surface 518a and a substantially flat bottom surface 520a.

[0050] like Figure 6B As can be seen, the second link 500b is substantially the same as the first link 500a. The second link 500b has a first end 502b and a second end 504b. In some embodiments, the second link 500b is substantially elliptical, with the first end 502b having a rounded edge 506b and the second end 504b having a rounded edge 508b. The second link 500b further includes a straight top edge 510b and a serrated curved bottom edge 512b. The first end 502b includes a hole 514b extending therethrough and the second end 504b includes a hole 516b extending therethrough. Holes 514b and 516b are each configured to receive a mounting pin 600 therein. The second link 500b includes a substantially flat top surface 518b and a substantially flat bottom surface 520b.

[0051] Figure 7 A perspective view of the implant 100 in its open configuration is shown, with wing 300a shown at the front. Figure 7As can be seen, the first link 500a and the second link 500b are installed in the space 409 between the arms 408a and 408b of the plunger 400.

[0052] Figure 8 A cross-sectional view of the implant 100 in its open configuration is shown. (See diagram.) Figure 8 As can be seen, the second end 504a of the first link 500a is connected to the first end 502b of the second link 500b. The flat bottom surface 520a of the first link 500a is positioned to contact the flat top surface 518b of the second link 500b. Figure 2 and 8 As can be seen, mounting pins 600 are inserted through holes 516a in the second end 504a of the first link 500a, holes 514b in the first end 502b of the second link 500b, holes 414a in the first arm 408a of the plunger 400, and holes 414b in the second arm 408b of the plunger 400 to allow the links 500a and 500b to rotate about them. The opposite ends of the links 500a and 500b are connected to the wings 300a and 300b to allow their rotation, as will be further described below.

[0053] Figure 9A , 9B Figure 9C shows a perspective view of an embodiment of the first wing 300a. The wing 300a has a distal end 302a, a proximal end 304a, a first side 306a, and a second side 308a. In some embodiments, the distal end 302a includes at least one tooth extending therefrom, adapted to engage bone and / or tissue. In other embodiments, the bottom surface of the wing 300a may include a flat, roughened surface to facilitate gripping of bone and / or tissue.

[0054] In some embodiments, the distal end 302a includes a first tooth 310a and a second tooth 311a having a gap 312a therebetween. In some embodiments, the gap 312a may be about 1.5 mm to about 6 mm. In some embodiments, the gap 312a may be about 3 mm. In some embodiments, the first tooth 310a has a sharp pointed tip 314a and the second tooth 311a has a sharp pointed tip 313a. The first tooth 310a is disposed on a first side surface 306a and connected to a first extension 316a. The second tooth 311a is disposed on a second side surface 308a and connected to a second extension 318a. The width of the first extension 316a is d1 and the width of the second extension 318a is d2. In some embodiments, the width d2 is greater than the width d1. In some embodiments, the width d1 ranges from about 1.0 mm to about 4.0 mm. In some embodiments, the width d2 ranges from about 1.5 mm to about 6.0 mm. A substantially rectangular slot 320a is provided between the first extension 316a and the second extension 318a to receive the first end 502a of the first connecting rod 500a. Figure 1 , 2 As can be seen in Figure 7, the first extension 316a includes a hole 322a in its inner wall for receiving the pin 600 therein. In some embodiments, the hole 322a does not extend completely through the wall of the first extension 316a. The second extension 318a includes a hole 324a extending therethrough, located opposite the hole 322a of the first extension 316a. The mounting pin 600 is inserted into the hole 322a of the first extension 316a, the hole 514a of the first link 500a, and the hole 324a of the second extension 318a to allow the wing 300a to rotate about it.

[0055] Wing 300a includes a substantially flat top surface 330a, such as Figure 9C As can be seen, wing 300a includes a generally rectangular opening 332a adjacent to the top surface 330a. The rectangular opening 332a is adapted to receive a first end 502a of the first link 500a in a closed configuration of wing 300a. The proximal end 304a of wing 300a further includes a proximal connector portion 326a having an additional hole 328a for operatively connecting wing 300a to body 112. Hole 328a is configured to receive a bolt 700 therein.

[0056] Figure 10A , 10BFigure 10C shows a perspective view of an embodiment of the second wing 300b. The second wing 300b is substantially identical to the first wing 300a. The wing 300b has a distal end 302b, a proximal end 304b, a first side 306b, and a second side 308b. In some embodiments, the distal end 302b includes at least one tooth adapted to engage bone and / or tissue. In other embodiments, the bottom surface of the wing 300b may include a flat, roughened surface to facilitate gripping of bone and / or tissue.

[0057] In some embodiments, the distal end 302b includes a first tooth 310b and a second tooth 311b having a gap 312b therebetween. In some embodiments, the gap 312b may be about 1.5 mm to about 6 mm. In some embodiments, the gap 312b may be about 3 mm. In some embodiments, the first tooth 310b has a sharp pointed tip 314b and the second tooth 311b has a sharp pointed tip 313b. The first tooth 310b is disposed on the first side surface 306b and connected to the first extension 316b. The second tooth 311b is disposed on the second side surface 308b and connected to the second extension 318b. The width of the first extension 316b is d1 and the width of the second extension 318b is d2. In some embodiments, the width d2 is greater than the width d1. A substantially rectangular groove 320b is provided between the first extension 316b and the second extension 318b for receiving the second end 504b of the second connecting rod 500b therein. Figure 2 As can be seen, the first extension 316b includes a hole 322b in its inner wall for receiving the pin 600 therein. The second extension 318b includes a hole 324b extending through it, located opposite the hole 322b of the first extension 316b. The mounting pin 600 is inserted through the hole 322b of the first extension 316b, the hole 516b of the second link 500b, and the hole 324b of the second extension 318b to allow the wing 300b to rotate about it, as... Figure 2 It can be seen in the image.

[0058] Wing 300b includes a substantially flat top surface 330b, such as Figure 10C As can be seen, wing 300b includes a generally rectangular opening 332b adjacent to its top surface 330b. The rectangular opening 332b is adapted to receive a second end 504b of the second link 500b in a closed configuration of wing 300b. The proximal end 304b of wing 300b further includes a proximal connector portion 326b having an additional hole 328b for operatively connecting wing 300b to body 112. Hole 328b is configured to receive a bolt 700 therein.

[0059] In some embodiments, in the open position, wings 300a and 300b extend circumferentially from the body 112 by a distance of approximately 2 mm to approximately 15 mm, the distance being referred to as the extension range R1 of wings 300a and 300b. In some embodiments, the spacing of the gap 312a between teeth 310a and 311a may be the same as the spacing of the gap 312b between teeth 310b and 311b. In other embodiments, the spacing of the gap 312a between teeth 310a and 311a may be different from the spacing of the gap 312b between teeth 310b and 311b. Teeth 310a, 311a, 310b, and 311b are optimally positioned to minimize stress on the spinous processes and prevent their breakage. The length of any tooth among teeth 310a, 311a, 310b, and 311b may be approximately 0.5 mm to approximately 5 mm. In some embodiments, each tooth may have a different length as needed.

[0060] The design of wings 300a and 300b makes the outer surface act as a stop relative to the body 112 to control minimum and maximum movement, thereby preventing them from closing themselves inside the body 112 and also preventing over-deployment.

[0061] Figure 11 An embodiment of bolt 700 is shown and Figure 12 An embodiment for connection with a removable top cover 718 is shown. The bolt 700 includes a shaft 702 having a proximal end 704 and a distal end 706. The proximal end 704 includes an integral top cover 708 having a rounded distal end 710, a lateral circumferential edge 712, and a flat bottom surface 714. The distal end 706 includes a cylindrical portion 716 with a reduced diameter. The shaft 702 can be inserted through holes 328a of wing 300a, holes 328b of wing 300b, and openings 138a, 138b of body 112. Thus, the proximal connector portion 326a of wing 300a is adjacent to and connected to the proximal connector portion 326b of wing 300b via the bolt 700. The diameter of the shaft 702 is configured to mate through holes 328a, 328b and allow wings 300a, 300b to rotate freely about them. Once the bolt 700 is inserted through the body 112 and wings 300a, 300b, the removable top cover 718 can be connected to the cylindrical portion 716 to securely hold the bolt 700 in place. The top cover 718 can be connected by any mechanical fastening method. Figure 12 As shown, the shape of the embodiment with removable top cover 718 is similar to that of an integral top cover 708 having a rounded distal end 720, lateral circumferential edges 722, and a flat bottom surface 724. Top covers 718 and 708 are disposed within openings 138a, 138b such that the distal ends 710, 720 are recessed and do not extend circumferentially beyond the helical thread 120, as... Figure 4 As shown.

[0062] Figure 13 An embodiment of nut 200 is illustrated. Nut 200 may be disposed on the proximal end 116 of body 112. Nut 200 has a proximal side 202, a distal side 204, and an inner bore 206 therethrough. In some embodiments, the inner bore 206 has an internal helical thread 208 for cooperating with a helical thread 120 on the outer surface of body 112. In operation, nut 200 can be rotated to move the nut longitudinally along the axis of body 112, such that the distal side 204 engages tissue and / or bone. In some embodiments, the proximal side 202 has a hexagonal extension 210 with a flat side 212. In some embodiments, the distal side 204 forms a gripping plate having a plurality of flexural arms 214. In one embodiment, the gripping plate includes four flexural arms 214. In other embodiments, the gripping plate may include two flexural arms, three flexural arms, or five or more flexural arms.

[0063] In some embodiments, each flexure arm 214 may have a fixed portion 216 with a smooth top surface 218 and a movable portion 220 with a textured top surface 222. The movable portion 220 may have a space 226 beneath it. The textured top surface 222 is configured to engage bone or tissue when the implant is placed in the body to help anchor the implant 100 in place. The movable portion 220 is configured to bend into the open space 226 when the implant 100 engages with tissue and / or bone. In some embodiments, the movable portion 220 may bend proximally by an amount from about 1 degree to about 50 degrees. In some embodiments, the movable portion 220 may bend proximally by an amount from about 1 degree to about 10 degrees. In some embodiments, the textured top surface 222 may include teeth, spikes, or any other type of mechanical gripping surface. In one embodiment, the textured top surface 222 may include three substantially triangular teeth 224. In other embodiments, the distal portion 204 has an overall circumferentially rough or textured surface without any flexure arm. The nut 200 extends circumferentially from the body 112 by a distance of approximately 2 mm to approximately 15 mm. In some embodiments, the nut 200 extends circumferentially by a distance of approximately 2 mm to approximately 8 mm. This extension range allows for adequate bone fixation while ensuring easy insertion of the implant 100 through a standard tissue expansion cannula / tube.

[0064] Implant 100 may be provided in different selected sizes to suit the desired space of a particular patient. The diameter of the implant body can provide spinous process space separation ranging from about 6 to 20 mm. In some embodiments, the diameter of the body 112 may be about 8 mm, about 10 mm, about 12 mm, about 14 mm, or about 16 mm. The size of the implant may be color-coded to allow surgeons to easily identify the size of the implant and match it to an appropriately sized insertion tool (not shown), which may have similar size color coding.

[0065] In some embodiments, all or part of the implant may be made of titanium or titanium alloy. In other embodiments, all or part of the implant may be made of stainless steel. In some embodiments, all or part of the implant may be made of polymer or bioresorbable material. In some embodiments, the implant may be manufactured using an additive manufacturing process. In some embodiments, the implant may be manufactured by machining or molding. In some embodiments, all or part of the implant may include a coating on at least one surface thereon. In some embodiments, at least one outer surface of the implant may be coated with hydroxyapatite (HA).

[0066] In some embodiments, the total length of the implant can be from about 30 mm to 45 mm. In some embodiments, the total length of the implant can be from about 32 mm to about 34 mm. In some embodiments, the total length of the implant can be about 33 mm.

[0067] In some embodiments, the body 112 may be adapted to contain bone graft material therein. Bone graft material can be added to the implant 100 by keeping the wings 300a open and the wings 300b closed and injecting the bone graft material into the body 112 (or vice versa). Bone graft material may also be applied around the external helical threads 120 before the implant 100 is inserted into the body. In some embodiments, the bone graft material may be adhesive to avoid any interference with the normal function of the wings 300a, 300b. Depending on the size of the implant 100, the volume of the bone graft material can range from about 0.5 cc to about 3.0 cc or from about 1.2 cc to about 2.5 cc.

[0068] The implant 100 can be inserted into the patient's body in a closed configuration using an inserter device (not shown), such as... Figure 4 , 14 As shown in Figure 15. Regarding... Figure 14 and 15 The plunger 400 is in the proximal position, such that the first link 500a and the second link 500b form a first angle A between them, and the wings 300a and 300b are in a closed configuration. Once the implant 100 is inserted into the desired location in the patient's body, the wings 300a and 300b can be moved to an open configuration, such as... Figure 1 , 2 As shown in Figures 7 and 8, the plunger 400 can be moved distally, causing ends 502a and 504b of the connecting rods 500a and 500b to separate, forming a second angle B between them, as shown in Figures 7 and 8. Figure 8As shown. Angle B is greater than angle A. In some embodiments, angle A is approximately 35° and angle B is approximately 85°. When the connecting rods 500a and 500b are separated, the wings 300a and 300b rotate about the pin 600 and bolt 700 into an open configuration.

[0069] The implant can then be moved proximally to allow wings 300a and 300b to engage with the bone and / or tissue at the implantation site, such as... Figure 16 As can be seen in the image. The nut 200 can then be moved proximally, such as by rotation, to engage bone and / or tissue and form a proximal anchor. Specifically, the nut 200 engages the first lateral surface 801 of the first spinous process 800 and the second lateral surface 804 of the second spinous process 802. In some embodiments, the flexure arm 214 can be bent proximally when the nut 200 is tightly engaged with bone and / or tissue at the implantation site. Additionally, the wings 300a, 300b engage the third opposing surface 803 of the first spinous process 800 and the fourth opposing surface 806 of the second spinous process 802. Specifically, the teeth 310a, 311a, 310b, 311b of the wings 300a, 300b can engage with bone and / or tissue at the implantation site to form a distal anchor. In some embodiments, when the implant 100 is in place, the wings 300a, 300b and the nut 200 can engage on opposite sides of the spinous processes, such as... Figure 16 As shown.

[0070] Without departing from the scope of this document, the features described above and the features claimed below can be combined in various ways. The following examples illustrate some possible, non-limiting combinations:

[0071] (A1) A spinal implant comprising: a body, a proximal anchor, a distal anchor, and an inner plunger. The body has an outer surface, a central aperture therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The proximal anchor includes a nut having a proximal end, a distal end, and an inner aperture. The distal anchor includes a plurality of wings having a first closed configuration and a second open configuration, wherein the plurality of wings includes a first wing and a second wing. The inner plunger has a proximal end and a distal end and is received within the central aperture of the body. The distal end of the inner plunger is operatively connected to the first wing and the second wing to selectively move the plurality of wings between the first closed configuration and the second open configuration.

[0072] (A2) For the spinal implant according to (A1), it further includes: a first link connecting the first wing to the inner plunger, wherein the first link has a proximal end and a distal end; and a second link connecting the second wing to the inner plunger, wherein the second link has a proximal end and a distal end.

[0073] (A3) For the spinal implant according to (A2), the distal end of the inner plunger includes a first arm, a second arm, and a space between the first arm and the second arm, and the proximal end of the first link and the proximal end of the second link are mounted in the space between the first arm and the second arm of the inner plunger.

[0074] (A4) For any one of (A2) to (A3) a spinal implant, the first link and the second link are rotatably attached to the inner plunger by a mounting pin.

[0075] (A5) For a spinal implant according to any one of (A2) to (A4), the distal end of the first link is connected to the first wing, and the distal end of the second link is connected to the second wing.

[0076] (A6) For any one of (A2) to (A5) a spinal implant, the first wing includes a first groove for receiving the first link therein, and the second wing includes a second groove for receiving the second link therein.

[0077] (A7) For a spinal implant according to any one of (A1) to (A6), the distal end of the first wing includes at least one pointed projection adapted to engage tissue or bone.

[0078] (A8) For a spinal implant according to any one of (A1) to (A7), the distal end of the second wing includes at least one pointed projection adapted to engage tissue or bone.

[0079] (A9) For a spinal implant according to any one of (A1) to (A8), an external thread is located on at least a portion of the outer surface of the body; and an internal thread is located within the inner bore of the nut, wherein the internal thread of the nut is configured to cooperate with the external thread of the body.

[0080] (A10) For a spinal implant according to any one of (A1) to (A9), the distal side of the nut includes at least one flexure arm adapted to engage tissue or bone.

[0081] (A11) For a spinal implant according to any one of (A1) to (A10), the at least one flexor arm includes a roughened surface or teeth adapted to engage tissue or bone.

[0082] (A12) For a spinal implant according to any one of (A1) to (A11), the proximal side of the nut includes a hexagonal extension.

[0083] (B1) A spinal implant comprising a body, a proximal anchor, a distal anchor, and a linkage assembly. The body has an outer surface, a central aperture therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The body includes external threads located on at least a portion of the outer surface. The proximal anchor includes a nut having a proximal end, a distal end, and an inner aperture having internal threads. The distal anchor includes a first wing and a second wing configured to selectively open and close. The linkage assembly connects the first wing and the second wing to the body.

[0084] (B2) For the spinal implant according to (B1), the linkage assembly includes: an inner plunger, a first link and a second link, the inner plunger being installed in the central hole of the body.

[0085] (B3) For the spinal implant according to (B2), the first link has a proximal end and a distal end, and the second link has a proximal end and a distal end, wherein the first link connects the first wing to the inner plunger and the second link connects the second wing to the inner plunger.

[0086] (B4) For the spinal implant according to (B2) or (B3), the distal end of the inner plunger includes a first arm, a second arm, and a space between the first arm and the second arm, wherein the proximal end of the first link and the proximal end of the second link are mounted in the space between the first arm and the second arm of the inner plunger.

[0087] (B5) For any one of (B2) to (B4) of the spinal implant, the first link and the second link are rotatably attached to the inner plunger by means of a mounting pin.

[0088] (B6) For a spinal implant according to any one of (B1) to (B5), the proximal side of the nut includes a hexagonal extension.

[0089] (C1) A method of placing a spinal implant at a treatment site, the method comprising: providing a spinal implant in a first closed configuration; placing the spinal implant in a patient at a desired treatment site; and sliding an inner plunger distally along the longitudinal axis to move a plurality of wings into a second open configuration. The method may further comprise sliding the inner plunger proximally along the longitudinal axis to move the plurality of wings into the first closed configuration, thereby removing the spinal implant from the patient. The spinal implant includes a body, a proximal anchor, a distal anchor, and an inner plunger. The body has an outer surface, a central aperture therein, a proximal end, a distal end, and a longitudinal axis extending therebetween. The proximal anchor includes a nut having a proximal side, a distal side, and an inner aperture. The distal anchor includes a plurality of wings having the first closed configuration and the second open configuration, wherein the plurality of wings includes a first wing and a second wing. The inner plunger has a proximal end and a distal end, the inner plunger being received within the central aperture of the body, the distal end of the inner plunger being operatively connected to the first wing and the second wing to selectively move the plurality of wing between the first closed configuration and the second open configuration.

[0090] (C2) The method according to (C1) further includes: sliding the inner plunger proximally along the longitudinal axis to move the plurality of wings toward the first closed configuration, thereby engaging the plurality of wings with bone or tissue at the treatment site.

[0091] (C3) For the method according to (C1) or (C2), it further includes: moving the nut distally along the body to engage the distal side of the nut with tissue or bone.

[0092] (C4) For the method according to any one of (C1) to (C3), the inner plunger is slid proximally along the longitudinal axis to move the plurality of wings into the first closed configuration, thereby removing the spinal implant from the patient.

[0093] (C5) For the method according to any one of (C1) to (C4), the proximal side of the nut further includes a hexagonal extension.

[0094] Although the invention has been described with reference to the embodiments shown in the accompanying drawings, it should be noted that equivalents and substitutions may be used without departing from the scope of the invention as set forth in the claims.

[0095] Various embodiments of the invention have now been described, and the new claims that are desired to be protected under patent law are contained in the claims.

Claims

1. A spinal implant comprising: a body having an outer surface, a proximal end, a distal end, and a longitudinal axis extending therebetween, the body including a central bore therein; a proximal anchor comprising: a nut having a proximal side, a distal side, and an inner bore; a distal anchor comprising: a plurality of wings having a first closed configuration and a second open configuration, wherein the plurality of wings includes a first wing and a second wing; and an inner plunger having a proximal end and a distal end, the inner plunger housed within the central bore of the body, the distal end of the inner plunger operatively connected to the first wing and the second wing by a linkage assembly to selectively move the plurality of wings between the first closed configuration and the second open configuration, wherein the linkage assembly includes a first linkage connected to the first wing and a second linkage connected to the second wing.

2. The spinal implant of claim 1, wherein the first linkage connects the first wing to the inner plunger, the first linkage having a proximal end and a distal end; and wherein the second linkage connects the second wing to the inner plunger, the second linkage having a proximal end and a distal end.

3. The spinal implant of claim 2, wherein the distal end of the inner plunger comprises: a first arm; a second arm; and a space between the first arm and the second arm, wherein the proximal end of the first linkage and the proximal end of the second linkage are mounted in the space between the first arm and the second arm of the inner plunger.

4. The spinal implant of claim 3, wherein the distal end of the first linkage is connected to the first wing and the distal end of the second linkage is connected to the second wing.

5. The spinal implant of claim 4, wherein the first wing includes a first slot for receiving the first linkage therein and the second wing includes a second slot for receiving the second linkage therein.

6. The spinal implant of claim 1, wherein a distal end of the first wing includes at least one pointed protrusion adapted to engage tissue or bone.

7. The spinal implant of claim 1, wherein a distal end of the second wing includes at least one pointed protrusion adapted to engage tissue or bone.

8. The spinal implant of claim 1, further comprising: an external thread on at least a portion of the outer surface of the body; and an internal thread within the inner bore of the nut, wherein the internal thread of the nut is configured to cooperate with the external thread of the body.

9. The spinal implant of claim 1, wherein the distal side of the nut includes at least one flexing arm adapted to engage tissue or bone.

10. The spinal implant of claim 9, wherein the at least one flexing arm includes four flexing arms.

11. The spinal implant of claim 9, ​ ​ wherein the flexure arm has a fixed portion and a movable portion, wherein the movable portion is positioned over a space below it.

12. The spinal implant of claim 1, wherein, the first wing is rotatably attached to the first link by a first mounting pin, the second wing is rotatably attached to the second link by a second mounting pin, wherein distal movement of the inner plunger causes the plurality of wings to rotate about the bolt from the first closed configuration to the second open configuration.

13. The spinal implant of claim 12, wherein the distal movement of the inner plunger separates a distal end of the first link from a distal end of the second link.

14. The spinal implant of claim 13, wherein separation of the distal end of the first link from the distal end of the second link causes the first wing to rotate about the first mounting pin and the second wing to rotate about the second mounting pin, thereby moving the first wing and the second wing from the first closed configuration to the second open configuration.

15. The spinal implant of claim 1, wherein a window included in the body is configured to accommodate the first wing and the second wing when they are in the first closed configuration.

16. The spinal implant of claim 11, wherein the fixed portion has a smooth top surface.

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