Cement delivery guide and corresponding hollow screw

Abstract

Various bone cement guides are disclosed that can be connected directly to a hollow bone screw or to a spinal construction coupled to a hollow bone screw. In various embodiments, the cement guide may include a three-part assembly including a hollow outer sleeve (30) and a hollow inner sleeve (20) and a removable inner rod (10). In various embodiments, the hollow inner sleeve may be movable between a retracted position and an extended position, and in the extended position, a distal end of the inner sleeve may expand outwardly and capture a head portion of the hollow bone screw. In other embodiments, a distal end of the outer sleeve may surround and capture a tab of an extended tulip head connector, while the inner sleeve is coupled to an inner surface of the extended tulip head connector.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application incorporates by reference the entire disclosure of U.S. Patent No. 11,083,501, entitled “Surgical System and Method,” filed on April 24, 2019, and U.S. Application No. 17 / 354,450, entitled “Surgical System and Method,” filed on June 22, 2021. This application also incorporates by reference the entire disclosure of U.S. Patent No. 11,026,736, entitled “Surgical Instrument and Method,” filed on February 19, 2018, and U.S. Application No. 17 / 338,909, entitled “Surgical Instrument and Method,” filed on June 4, 2021. This application also incorporates by reference the entire disclosure of U.S. Patent Publication No. 20090264895, entitled “Systems and methods for implanting a bone fastener and delivering a bone filling material,” filed on April 22, 2008. The entire disclosure of each of the above citations is hereby incorporated by reference in its entirety. Technical Field

[0003] The present technology generally relates to surgical tools and cannulated bone screws for delivering cement or other flowable materials to a patient's bony anatomy (e.g., the posterior thoracic lumbar and / or sacral spaces of the spine). Background Art

[0004] In selected surgeries, bone screws may be installed in the patient, and flowable materials such as bone growth promoting materials (BGM) and / or cements may be used to further strengthen or solidify the bone screws to the bony anatomical structure or promote fusion. In some applications, cannulated bone screws with through holes may be used to guide BGM and / or cement delivery through the bone screws and around them via channels. A variety of tools may be used to deliver BGM and / or cement materials to a target location. Summary of the invention

[0005] The technology of the present disclosure generally relates to tools and cannulated bone screws for delivering BGM and / or cement to a target location.

[0006] In one aspect, the present disclosure provides a surgical tool, such as a bone cement guide or a guide for delivering other flowable materials, for delivering bone cement or other flowable materials. Throughout the present disclosure, reference has been made to "bone cement guide", but it should be understood that the guide can be provided for other flowable materials, such as BGM. In τ embodiments, the bone cement guide may include a hollow outer sleeve with an elongated cylindrical shape and a hollow inner sleeve with an elongated cylindrical shape. In τ embodiments, the hollow inner sleeve may be arranged inside the hollow outer sleeve, and, for example, has a first thread pattern at its proximal end and has a coupling portion at its distal end. In τ embodiments, for example, the hollow inner sleeve may be able to move between a retracted position and an extended position. In τ embodiments, for example, a hollow inner rod may be removably arranged in the hollow inner sleeve, and has a distal end configured to guide bone cement to a bone screw. In the first embodiment, the hollow inner rod may include a second thread pattern having a size and shape corresponding to the size and shape of the first thread pattern. In some embodiments, for example, in the extended position, the coupling portion extends beyond the distal end of the hollow outer sleeve and is configured to flare outward to surround and capture the head portion of the bone screw. In some embodiments, for example, in the retracted position, the coupling portion moves inside the distal end of the hollow outer sleeve and is restricted from flaring outward, thereby firmly connecting the surgical tool to the head portion of the bone screw. In another aspect, the present disclosure provides a surgical system for delivering bone cement to a target site, such as a bone cement guide. In the first embodiment, for example, the system may include a surgical implant, the surgical implant including a U-shaped connector having a first connecting tab and a second connecting tab opposite to the first connecting tab, the U-shaped connector can be configured to be connected to the head portion of the bone screw in the lower cavity. In the first embodiment, for example, the guide may include a hollow outer sleeve having an elongated cylindrical shape and a distal end, the distal end including a first engagement tab and a second engagement tab opposite the first engagement tab. In at least some embodiments, for example, the first engagement tab may be configured to be coupled to the first connection tab, and the second engagement tab may be configured to be coupled to the second connection tab. In the first embodiment, the hollow inner sleeve may have an elongated cylindrical shape, and a distal end may be provided, the distal end including a third engagement tab and a fourth engagement tab opposite the third engagement tab. In the first embodiment, for example, the hollow inner sleeve may be disposed inside the hollow outer sleeve and have a first thread pattern at its proximal end, and the hollow inner sleeve may be capable of moving between a retracted position and an extended position.In one embodiment, for example, the bone cement guide may include a hollow inner rod that can be removably disposed within the hollow inner sleeve and has a distal end that is configured to guide bone cement to the head portion of the bone screw when it is disposed in the lower cavity of the U-shaped connector. In at least some embodiments, for example, the hollow inner rod may include a second thread pattern having a size and shape corresponding to the size and shape of the first thread pattern. In at least some embodiments, for example, in the extended position, the third engagement tab and the fourth engagement tab extend beyond the distal end of the hollow outer sleeve, and in the retracted position, the first engagement tab and the second engagement tab extend beyond the distal end of the hollow inner sleeve.

[0007] The details of one or more aspects of the present disclosure are set forth in the following drawings and description. Other features, objectives, and advantages of the techniques described in the present disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a first perspective view of a first embodiment of an adhesive delivery guide.

[0009] Figure 2 is a second perspective view of the adhesive delivery guide.

[0010] Figure 3 Front view of the adhesive delivery guide.

[0011] Figure 4 is a first exploded partial view of the adhesive delivery guide.

[0012] Figure 5 is a second exploded partial view of the adhesive delivery guide.

[0013] Figure 6 is an enlarged view of the distal end of the inner sleeve of the adhesive delivery guide.

[0014] Figure 7 is an enlarged view of the distal end of the inner rod of the adhesive delivery guide.

[0015] Figure 8 is a perspective view of a cannulated bone screw.

[0016] Fig. 9 is a cross-sectional view of a cannulated bone screw.

[0017] Fig.10 is a perspective view of the adhesive delivery guide.

[0018] Fig.11is a cross-sectional view of a cement delivery guide coupled to a cannulated bone screw and a cement delivery device inserted into a counterbore of the cannulated bone screw.

[0019] Fig.12 is a first perspective view of a second embodiment of an adhesive delivery guide.

[0020] Fig.13 is a second perspective view of the adhesive delivery guide.

[0021] Fig.14 is a front view of the adhesive delivery guide.

[0022] Fig.15 is a first exploded partial view of the adhesive delivery guide.

[0023] Fig.16 is a second exploded partial view of the adhesive delivery guide.

[0024] Fig.17 is an enlarged view of the distal end of the adhesive delivery guide.

[0025] Fig.18 is a perspective view of a connector for use with the type of adhesive delivery guide disclosed herein.

[0026] Fig.19 is a partially exploded view of a connector for use with the type of adhesive delivery guide disclosed herein.

[0027] Fig. 20 is a cross-sectional view of a cement delivery guide coupled to a cannulated bone screw and a cement delivery device inserted into a counterbore of the cannulated bone screw. DETAILED DESCRIPTION

[0028] Embodiments of the present disclosure relate generally to, for example, spinal stabilization systems, and more particularly to surgical instruments for use with spinal stabilization systems. Embodiments of apparatus and methods are described below with reference to the drawings.

[0029] The following discussion omits or only briefly describes certain components, features and functions related to medical implants, installation tools and related surgical techniques, which are obvious to those of ordinary skill in the art. It should be noted that τ embodiments are described in detail with reference to the accompanying drawings, where similar reference numerals represent similar parts and components in several views, where possible. Reference to τ embodiments does not limit the scope of the appended claims, as these embodiments are examples of the inventive concepts described herein. In addition, any examples set forth in this specification are intended to be non-limiting and only set forth some embodiments applicable to many possible embodiments of the appended claims. Moreover, unless the context or other statements clearly indicate otherwise, the specific features described herein may be used in combination with other described features in each of τ possible combinations and arrangements.

[0030] As used herein, the terms "same", "equal", "planar", "coplanar", "parallel", "perpendicular", etc. are intended to encompass identical meanings, while also including possible variations, such as those due to manufacturing processes. The term "substantially" may be used herein to emphasize this meaning, especially when the described embodiments have the same or nearly the same functions or characteristics, unless the context or other statements clearly indicate otherwise.

[0031] Generally speaking, reference Figures 1 to 20 , discloses a delivery system 100, 200 for delivering cement or other flowable materials. The components of the disclosed system can be made of biologically acceptable materials suitable for medical applications, including metals, synthetic polymers, ceramics and bone materials and / or their composites. For example, the components can be made individually or collectively of materials such as stainless steel alloys, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, superelastic metal alloys (e.g., Nitinol), superelastic plastic metals such as GUM ), ceramics and their composites, such as calcium phosphate (e.g., SKELITE TM), thermoplastics such as polyaryletherketone (PAEK) (including polyetheretherketone (PEEK), polyetherketoneketone (PEKK) and polyetherketone (PEK)), carbon-PEEK composites, PEEK-BaSO4 polymerized rubber, polyethylene terephthalate (PET), fabrics, silicones, polyurethanes, silicone-polyurethane copolymers, polymerized rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomeric composites, rigid polymers (including polyphenylene, polyamide, polyimide, polyetherimide, polyethylene, epoxy resins), bone materials (including autografts, allografts, xenografts Plant or transgenic cortical bone and / or corticomedullary bone) and tissue growth or differentiation factors, partially resorbable materials (such as, for example, composites of metals and calcium-based ceramics, composites of PEEK and calcium-based ceramics, composites of PEEK and resorbable polymers), fully resorbable materials (such as, for example, calcium-based ceramics, such as calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate), or other resorbable polymers, such as polyaetide, polyglycolide, polytyrosine carbonate, polycaprolactone, polylactic acid or polylactide, and combinations thereof. As used herein, the term "bone cement" can be used to refer to any known filling composition that can be used as an adhesive and / or bone growth promoting material. In some embodiments, the bone cement can be a flowable material having any suitable viscosity, which can be used alone or in combination with a non-flowable material (such as a bone graft). In various embodiments, "bone cement" can refer to a material having an osteoinductive demineralized bone matrix (DBM), such as a material sold under the trade name "Grafton" by Medtronic, Minneapolis Minnesota, USA. Another exemplary material can be hydroxyapatite, polymethylmethacrylate (PMMA) bone cement containing hydroxyapatite; and Kyphon HV-R bone cement sold under the trade name "Kyphon" by Medtronic, Minneapolis, Minnesota, USA, and variant formulations thereof. Exemplary bone graft materials can include recombinant human bone morphogenetic protein-2 (rhBMP-2), such as a material sold under the trade name "Infuse" and / or "Magnifuse" by Medtronic, Minneapolis, Minnesota, USA. In some embodiments, the bone cement can be formed by a two-part system shortly before injection into the target site, wherein an epoxy-based substance is mixed with a bone growth promoting material in a mixing device, and shortly after mixing the material begins to cure from a low viscosity, relatively free-flowing liquid to a hardened, non-flowing state.

[0032] Generally speaking, reference Figures 1 to 11 , discloses a first embodiment of a delivery system for a variety of flowable materials (including, for example, adhesives). Figures 1 to 3 is a perspective view of the adhesive delivery guide 100. Figures 4 to 5 This is a disassembled partial view of the adhesive delivery guide 100.

[0033] Figure 6 is an enlarged view of the distal end of the inner sleeve 20 of the cement delivery guide 100, and Figure 7 is an enlarged view of the distal end of the inner shaft 10 of the adhesive delivery guide 100.

[0034] In an exemplary embodiment, the cement delivery guide 100 extends in a longitudinal direction from a proximal end 100P to a distal end 100D. Figures 4 to 5 As best seen in the exploded partial view of FIG. 1 , the guide 100 may include a three-part assembly including a hollow outer sleeve 30, a hollow inner sleeve 20, and a hollow inner rod 10. In the first embodiment, the outer sleeve 30 extends in a longitudinal direction from a proximal end 30P to a distal end 30D, and includes a central aperture 34 extending from the proximal end 30P to the distal end 30D. Additionally, the outer sleeve 30 may include a first portion 32 and a second portion 31, wherein the first portion 32 defines a portion of the aperture 34 having an inner diameter that is relatively larger than the inner diameter of the second portion 31.

[0035] In an exemplary embodiment, the hollow inner sleeve 20 can extend from the proximal end 20P to the distal end 20D in the longitudinal direction and include a central aperture 24 extending from the proximal end 20P to the distal end 20D. In various embodiments, the inner sleeve 20 can be disposed inside the aperture 34 and movably coupled to the outer sleeve 30 so that the inner sleeve 20 can move forward and backward in the longitudinal direction by a distance substantially corresponding to the length of the first portion 32 in the longitudinal direction. In some embodiments, the inner sleeve 20 can move forward and backward in the longitudinal direction by a distance that is less than the full length of the first portion 32 in the longitudinal direction. In this exemplary embodiment, the inner sleeve 20 can include a necked portion 23 that can be necked to accommodate a positioning pin 41 extending through the pin hole 36. In some embodiments, the pin 41 may not be included. In addition, a biasing element such as a coil spring 40 can be disposed inside the first portion 32 to bias the inner sleeve 20 toward the retracted position. For example, the spring 40 can apply a force that pushes the stop ring 22 of the inner sleeve 20 in the proximal direction (i.e., toward the proximal end 30P of the outer sleeve). In this way, the inner sleeve 20 can be movably coupled to the outer sleeve 30 so that it can move forward and backward in the longitudinal direction between an intermediate position (i.e., a retracted position) and an extended position. In other embodiments, the spring 40 may not be included. As will be explained in more detail below, in the extended position, the distal end 20D of the inner sleeve 20 can extend further than the distal end 30D of the outer sleeve 30, for example, in the distal direction.

[0036] In an exemplary embodiment, the inner rod 10 can extend in a longitudinal direction from a proximal end 10P to a distal end 10D and include a central aperture 14 extending from the proximal end 10P to the distal end 10D. In this embodiment, the inner rod 10 can be removably disposed and / or coupled to the inner sleeve 20. For example, the inner rod 10 can be disposed inside the aperture 24. In addition, the inner rod 10 can include a threaded portion 11 that can be threadedly connected to a corresponding threaded portion at the proximal end of the aperture 24 (see Figure 1 ). In this way, the inner rod 10 can be threadedly engaged with the corresponding threads of the aperture 24, which has a size and shape corresponding to the thread pattern of the threaded portion 11. Therefore, the end user can couple the inner rod 10 to the inner sleeve 20 and decouple the inner rod from the inner sleeve by rotating the handle 12 to engage the threaded portion 11 of the inner rod 10 with the threaded portion of the aperture 24. As will be explained in further detail below, the distal end 10D of the inner rod may include an engagement feature 15 having a size and shape corresponding to the drive feature 52 and / or counterbore 56 opening of the cannulated bone screw 50 (see Figures 8 to 9). In some embodiments, engagement feature 15 may be referred to as a distal-most tip or aperture.

[0037] like Figure 6 As best seen, the distal end 20D of the inner sleeve 20 can include a coupling portion 29 surrounding the distal end 20D of the aperture 24. In an exemplary embodiment, for example, the coupling portion 29 can be configured to couple to the head portion 51 of the bone screw 50 by capturing the head portion 51 of the bone screw 50 between the tangs 25. In another embodiment, the inner sleeve 20 can include at least one deformable tang 25 configured to flare outwardly from the central axis of the aperture 24, for example, in an opposite direction away from the longitudinal extension direction defined by the aperture 24. In an exemplary embodiment, the coupling portion 29 includes four deformable tangs 25 that are equally spaced around the circumference of the distal end 20D of the aperture 24. Each tang 25 can be delineated by a pair of adjacent slits 26 that form a gap in the distal end 20D and extend a relatively short distance in the longitudinal direction from the distal end 20D toward the proximal end 20P. In an exemplary embodiment, each slit 26 extends from the distal-most end 20D toward the release aperture 27. This configuration can allow for elastic deformation, wherein the shank 25 temporarily expands outward to surround and capture the head portion 51 of the bone screw 50. In addition, the inner periphery of the distal-most end 20D of the aperture 24 can include a circumferential edge or lip portion 28 that facilitates retaining the head portion 51 of the bone screw 50. For example, the inner surface of the shank 25 can include a lip portion 28 and / or an arcuate edge. In use, the surgeon can extend the inner sleeve 20 from the retracted position to the extended position that exposes the coupling portion 29. Thereafter, the surgeon can push the sleeve 20 downward so that the coupling portion 29 is in direct contact with the head portion 51 of the bone screw 50, and by doing so, the shank 25 of the coupling portion 29 can expand outward to accommodate the relatively wide middle portion of the head 51 of the bone screw 50, and then retract to a non-deformed state to retain the head portion 51 of the bone screw 50 via the underside of the head portion 51. For example, once the head portion 51 is captured by the shank 25, the circumferential lip 28 can directly contact the underside of the head portion. In addition, the spring 40 can push the inner sleeve 20 back toward the retracted position, thereby causing the coupling portion 29 to retract into the aperture 34 of the outer sleeve 30, and the inner surface of the aperture 34 can prevent the shank 25 from opening outward, thereby firmly holding the bone screw 50 through the cooperation of the outer sleeve 30 and the inner sleeve 20.

[0038] like Figure 7As best seen, the distal end 10D of the inner rod 10 may include an engagement feature 15. In one embodiment, the engagement feature 15 may have a size and shape corresponding to the drive feature 52 of the bone screw 50. Thus, the engagement feature 15 may take any suitable shape corresponding to the specific drive feature 52 of the bone screw. In one embodiment, the engagement feature 15 may have a substantially circular shape as shown, or alternatively, the engagement feature 15 may correspond roughly to a quincunx, polygonal, square, or hexalobular shape. In this exemplary embodiment, the engagement feature 15 includes an annular ring shape having an inclined portion 16 that generally surrounds the distal-most end of the orifice 14. In other embodiments, portion 16 may have a relatively flat surface, a planar surface, or be inclined to a greater degree than shown. In at least one embodiment, the end user may insert the engagement feature 15 into the drive feature 52 of the bone screw 50 while the stop surface 17 directly contacts the uppermost surface of the head portion 51 of the bone screw 50 (see Fig.11 ). In some embodiments, the stop surface 17 can be substantially flat or planar.

[0039] Figures 8 to 9 An example cannulated bone screw 50 is shown. Figure 8 is a perspective view of a cannulated bone screw 50, and Fig. 9 5 is a cross-sectional view of a cannulated bone screw 50. In an exemplary embodiment, the bone screw 50 can include any suitable type of thread 53 and a uniaxial or polyaxial head 51. As shown, the bone screw 50 can include a head portion 51 having a generally spherical shape having a drive feature 52 at its upper end and having an underside 57 (the lower end of the head 51). In various embodiments, the head 51 can include a planar side surface 59 that allows a spinal implant (such as a tulip bulb connector) to be coupled to the bone screw 50. In an exemplary embodiment, the bone screw 50 is a cannulated bone screw that includes an aperture 55 or channel (see FIG. 5 ) extending through the bone screw 50 from a proximal end 50P to a distal end 50D. Fig. 9 ). The channel 55 can allow bone cement to be injected therein so that the bone cement flows through the channel 55 at the proximal end 50P toward the distal end 50D and out of the distal end. In addition, in some embodiments, for example, the channel 55 can provide a flow path for the bone cement to pass through the fenestration 54, which can be a second form of aperture extending through the side wall of the bone screw 50 that communicates with the channel 55. In an exemplary embodiment, the bone screw 50 can include a counterbore 56 having an angled portion 58 that facilitates the movement of the bone cement through the channel 55. For example, the counterbore 56 can facilitate the funneling of the bone cement through the channel 55.

[0040] Fig.1060 is a perspective view of a cement delivery device (CDD 60); in some embodiments, the cement delivery device 60 may be referred to as a cement delivery tube. In an exemplary embodiment, the CDD 60 may include a hollow shaft 61 extending from a proximal end 60P to a distal end 60D in a longitudinal direction. In an exemplary embodiment, for example, the outer diameter of the shaft 61 may correspond in size and shape to the inner diameter of the inner rod 10. In addition, the hollow shaft 61 may include a necked portion 63 and a small diameter tip portion 64 adjacent to the distal end 60D. The CDD 60 may include any suitable handle assembly 62 that may be pressed and / or squeezed by an end user to push the bone cement through the interior of the shaft 61 and away from the distal end 60D.

[0041] Fig.11 60 is a cross-sectional view of the bone cement guide 100 and CDD 60 in operation. As shown, the connecting portion 29 of the inner sleeve 20 is securely coupled to the head portion 51 of the bone screw 50. For example, the tang 25 surrounds and captures the head portion 51 of the bone screw 50 and is prevented from flaring outward by the outer sleeve 30 due to the inner sleeve 20 being positioned in the retracted position. In addition, the inner rod 10 is threadedly engaged with the inner sleeve 20 so that the engagement feature 15 is partially inserted into the drive feature 52 of the bone screw 50, while the stop surface 17 directly contacts the uppermost surface of the head portion 51. In addition, the CDD 60 can be inserted into the interior of the inner rod 10 so that the shaft 61 extends therethrough and the tip portion 64 is completely seated inside the counterbore 56. In this way, the CDD 60 can deliver bone cement directly into the counterbore portion 56 of the cannulated bone screw 50 through the cement delivery guide 100. In an exemplary embodiment, the engagement feature 15 may not extend completely into the counterbore portion 56, although in some embodiments it may extend into the counterbore portion. For example, in some embodiments, the engagement feature 15 (or a portion thereof) may have a size and shape that generally corresponds to the size and shape of the counterbore 15, such that a CDD is not required to deliver bone cement to the cannulated bone screw 50.

[0042] Overall reference Figures 12 to 20 , a second embodiment of a bone cement delivery system is disclosed. The second embodiment of the cement delivery guide 200 may include the same, similar and / or substantially the same features, components and functions as explained above with respect to the first embodiment of the cement delivery guide 100. At least one difference may be that the cement delivery guide 200 is configured to facilitate delivery of cement to a bone cement delivery guide coupled to a connector (e.g., Figure 18 to Figure 19 A cannulated bone screw with an extended tulip head connector 70) is shown in FIG.

[0043] Figures 12 to 15 is a perspective view of the adhesive delivery guide 200. Figure 15 to Figure 16 This is a disassembled partial view of the adhesive delivery guide 200. Fig.17 200 is an enlarged view of the distal end of the cement delivery guide 200. In an exemplary embodiment, the cement delivery guide 200 extends in a longitudinal direction from a proximal end 200P to a distal end 200D. Figure 15 to Figure 16 As best seen in the exploded partial view of , the guide 200 may include a three-part assembly including a hollow outer sleeve 230, a hollow inner sleeve 220, and a hollow inner rod 210. In one embodiment, the outer sleeve 230 extends in a longitudinal direction from a proximal end 230P to a distal end 230D, and includes a central orifice 234 extending from the proximal end 230P to the distal end 230D. In addition, the outer sleeve 230 may include a first portion 232 and a second portion 231, wherein the first portion 232 defines a portion of the orifice 234 having an inner diameter that is relatively larger than the inner diameter of the second portion 231. Furthermore, the outer sleeve 230 may include a U-shaped distal end 230D including a first engagement tab 238 and a second engagement tab 238. As will be explained in further detail below, the engagement tab 238 may be configured to couple to a spinal connector, for example, Fig.18 The extended tulip bulb connector 70. Although Fig.18 2 shows an extended tulip bulb connector 70, but it should be understood that the engagement tab 238 can be similarly configured to couple to a non-extended tulip bulb connector, such as a tulip bulb connector having only a height corresponding to the lower tab 73 and without the extended tab 72 (see Fig.18 ). Additionally, in a non-extended tulip bulb connector, some skilled in the art may refer to the tab 73 as an "arm" rather than a tab.

[0044] In an exemplary embodiment, the hollow inner sleeve 220 can extend from the proximal end 220P to the distal end 220D in the longitudinal direction and include a central aperture 224 extending from the proximal end 220P to the distal end 220D. In the first embodiment, the inner sleeve 220 can be disposed inside the aperture 234 and movably coupled to the outer sleeve 230 so that the inner sleeve 220 can move forward and backward in the longitudinal direction by a distance substantially corresponding to the length of the first portion 232 in the longitudinal direction. In some embodiments, the inner sleeve 220 can move forward and backward in the longitudinal direction by a distance that is less than the full length of the first portion 232 in the longitudinal direction. In an exemplary embodiment, the inner sleeve 220 can include a first positioning slot 223 that can accommodate a first positioning pin 241 extending through the first pin hole 236 of the outer sleeve 230. For example, the first positioning pin 241 can extend through the first pin hole 236 and enter the first positioning slot 223 so that the inner sleeve 220 can move forward and backward in the longitudinal direction while preventing the inner sleeve 220 from rotating relative to the outer sleeve 230. In some embodiments, the first positioning slot 223 can extend a specific distance in the longitudinal direction, which corresponds to the desired travel length of the inner sleeve 220. In addition, a biasing element such as a coil spring 240 can be provided inside the first portion 232 to bias the inner sleeve 220 toward the retracted position. In an exemplary embodiment, the first end of the spring 240 can contact the positioning pin 241, and the second end of the spring 240 (opposite to the first end) can contact the stop ring 222. For example, the spring 240 can apply a force that pushes the stop ring 222 of the inner sleeve 220 in the proximal direction (i.e., toward the proximal end 230P of the outer sleeve). In other alternative embodiments, the spring 240 may not be included and / or the pins 241, 242 may not be included (not shown). For example, the inner sleeve 220 and the outer sleeve 230 may be threadedly coupled together. Fig.16As best seen, the engagement tab 238 may also include a second pin aperture 237 through which a second pin 242 may extend into the second locating slot 226. Similar to the functions of the first locating slot 223, the first locating pin 241, and the first pin hole 236 as explained above, the second locating slot 226, the second locating pin 242, and the second pin hole 237 may facilitate and / or allow the inner sleeve 220 to move forward and backward in the longitudinal direction while preventing the inner sleeve 220 from rotating relative to the outer sleeve 230. In this way, the inner sleeve 220 may be movably coupled to the outer sleeve 230 so that it may move forward and backward in the longitudinal direction between an intermediate position (i.e., a retracted position) and an extended position. As will be explained in more detail below, in the extended position, the distal end 220D of the inner sleeve 220 may extend further than the distal end 230D of the outer sleeve 230, e.g., extend further in the distal direction. Although the exemplary embodiment shows first and second means for preventing the inner sleeve 220 from rotating, other embodiments may utilize only one of the two locating slots 223, 226, one of the two sets of pin holes 236, 237, and one of the two sets of pins 241, 242.

[0045] In an exemplary embodiment, the inner rod 210 can extend in a longitudinal direction from a proximal end 210P to a distal end 210D and include a central aperture 214 extending from the proximal end 210P to the distal end 210D. In this embodiment, the inner rod 210 can be removably disposed and / or coupled to the inner shaft 220. For example, the inner rod 210 can be disposed inside the aperture 224. In addition, the inner rod 210 can include a threaded portion 211 that can be threadedly connected to a corresponding threaded portion at the proximal end of the aperture 224 (see Fig.12 ). In this way, the inner rod 210 can be threadedly engaged with the corresponding threads of the aperture 224, which has a size and shape corresponding to the thread pattern of the threaded portion 211. Therefore, the end user can couple the inner rod 210 to the inner sleeve 220 and decouple the inner rod from the inner sleeve by rotating the handle 212 to engage the threaded portion 211 of the inner rod 210 with the threaded portion of the aperture 224. As will be explained in further detail below, the distal end 210D of the inner rod may include an engagement feature 215 having a size and shape corresponding to the saddle 79, as well as a drive feature 52 and / or counterbore 56 opening of the cannulated bone screw 50 that can be accessed through the central hole of the saddle 79 (see Figures 8 to 9 ).

[0046] like Fig.17As best seen, the engagement tab 238 may include a curved inner side surface 239 that is configured to directly contact and couple to the curved outer surface of the engagement tab 72 of the connector 70 (see also FIG. Fig.18 ). In the first embodiment, the size and shape of the engaging tab 238 and the curved inner surface 239 can correspond to the size and shape of the extension tab 72. For example, the spacing between the inner surfaces 239 can correspond to the spacing between the first extension tab 72 and the second extension tab 72, and the radius of curvature of the inner surface 239 can correspond to the radius of curvature corresponding to the radius of curvature of the outer surface of the extension tab 72. In addition, the distal-most tip of the curved inner surface 239 can be inclined to facilitate outward expansion movement when the engaging tab 238 contacts the extension tab 72, so that the inner surface of the engaging tab 238 slides along the outer surface of the extension tab 72. In addition, the distal end 220D of the inner sleeve 220 may include a coupling portion 229 surrounding the distal end 220D of the orifice 224. In an exemplary embodiment, the coupling portion 229 can be configured to couple to a spinal connector (e.g., Fig.18 20D). In some embodiments, the tang 225 may be referred to as a tab and / or an engagement tab. In one embodiment, the inner sleeve 220 may include at least one deformable tang 225 configured to flare inwardly and / or outwardly from a central axis of the orifice 224, for example, flare inwardly toward a central axis of the orifice 224 and flare outwardly in a lateral direction opposite to a longitudinal extension direction defined by the orifice 224. In an exemplary embodiment, the coupling portion 229 includes two deformable tangs 225 spaced apart around a portion of a circumference of a distal end 220D of the orifice 24. For example, a first tang 225 is opposed to a second tang 225, and a gap is formed between the first tang 225 and the second tang 225, the gap allowing the tang 225 to be attached to a spinal connector (e.g., Fig.18The tang 225 can be flared inwardly and / or outwardly when connected to the spinal connector (an extended tulip bulb connector). Each tang 225 can be delineated by a slit 227 that forms a gap in the distal end 220D and extends a relatively short distance in the longitudinal direction from the distal end 220D toward the proximal end 220P. In an exemplary embodiment, each slit 227 extends from the distal-most end 20D toward the slot 226, and each slit 227 is partially defined by a relatively narrow slot 226. For example, the slit 227 is relatively wider than the slot 226 and is adjacent to the slot. In addition, the outer side surface of each tang 225 may include an arcuate edge 228 and / or a protrusion. As will be explained in further detail below, this construction can allow for elastic deformation, wherein the tang 225 momentarily flares inwardly when initially connected to the spinal connector, and then flares outwardly once positioned deep enough in the U-shaped cavity of the spinal connector to be seated in a corresponding cavity or track (see Fig.19 ).

[0047] like Fig.17 As best seen, the distal end 210D of the inner rod 210 may include an engagement feature 215. In one embodiment, the engagement feature 215 may have a size and shape corresponding to the drive feature 52 of the bone screw 50. Thus, the engagement feature 215 may take any suitable shape corresponding to the specific drive feature 252 of the bone screw 50. In one embodiment, for example, the engagement feature 215 may have a substantially circular shape as shown, or alternatively, the engagement feature 215 may correspond generally to a quincunx, polygonal, square, or hexalobular shape. In an exemplary embodiment, the engagement feature 215 includes an annular ring shape having an inclined portion 216 that generally surrounds the distal-most end of the aperture 214. In at least one embodiment, the end user may position the engagement feature 215 against the positioning saddle 79 such that the distal end of the engagement feature 215 extends through the central aperture of the positioning saddle 79 and into the drive feature 52 of the bone screw 50. Additionally, the stop surface 217 may include any suitable geometry for directly contacting the uppermost surface of the locating saddle 79 of the tulip head connector 70 (see Fig.18 and Fig.19 ). For example, the stop surface 217 may include a flat surface and / or a curved surface having a size and shape that generally corresponds to the size and shape of the positioning saddle 79.

[0048] Figure 18 to Figure 19A view of an extended tulip head connector 70 is shown. In an exemplary embodiment, the extended tulip ball connector 70 can include a lower cavity 76 for receiving a head portion of a bone screw. In at least one embodiment, the lower cavity 76 is configured to fit over the head portion of a polyaxial bone screw and can include a variety of nested rings that allow a variety of washers, clamps, C-rings, etc. (not shown) to secure the head portion 51 of the bone screw 50 to the connector 70. In addition, the connector 70 can include a relatively large U-shaped channel 71 for receiving a spinal rod (not shown). In addition, the U-shaped channel 71 can be defined by a first arm and a second arm that define a breakaway thread pattern 77 for receiving a set screw (not shown) to constrain the spinal rod (not shown) when the spinal rod is placed therein. In various embodiments, the first arm can include a first extension tab 72 and a first lower tab 73, and the second arm can include a second extension tab 72 and a second lower tab 73. In at least some embodiments, the extension plug 72 can be configured as a disconnect plug 74, although this is not required for all embodiments. At least one advantage of the disconnect plug 74 is that they can provide a relatively large U-shaped channel 71 for the surgeon to facilitate the reset of the spinal rod during the complex reduction process. Once the complex reduction process is completed and the bone cement has been delivered to the cannulated bone screw 50, the extended plug can be broken off. In various embodiments, the extension plug 72 can include a first connection aperture 74, and the lower plug 73 can include a second connection aperture 75, for connecting surgical tools such as anti-torque tools and / or disconnection tools to the connector 70. In various embodiments, the connection apertures 74, 75 can be recesses or they can be through holes. The connector 70 can also include a saddle 79 having a lower spherical cavity corresponding to the shape of the head portion 51 of the bone screw 50. In addition, the saddle 79 can have a concave curved portion on its upper surface to accommodate a spinal rod having a cylindrical shape. Furthermore, as explained above, the engagement feature 215 may have a size and shape that generally corresponds to the geometry of the upper surface of the saddle 79 .

[0049] Fig. 20 6 is a cross-sectional view of the bone cement guide 200 and CDD 60 in operation. As shown, the extended tulip head connector 70 is securely coupled to the bone screw 50. For example, the head portion 51 of the bone screw 50 is securely coupled within the lower cavity 76 of the extended tulip head connector 70. As shown, the engagement tab 238 surrounds and captures the extended tab 72 of the connector 70. For example, the inner surface of the engagement tab 238 directly contacts the outer surface of the extended tab 72. In addition, the tang 225 extends through the U-shaped channel 71 of the connector 70 (see Fig.19) such that the arcuate edge 228 portion of the shank 225 is disposed and / or nested within the lower recess 78. For example, the outer surface of the shank 225 and / or the arcuate edge 228 portion directly contacts the inner surface of the lower insert 73 via the recess 78. In addition, the inner shaft 210 is threadedly engaged with the inner sleeve 220 such that the engagement feature 215 is partially inserted into the drive feature 52 of the bone screw 50, while the stop surface 217 directly contacts the uppermost surface of the saddle 79. In addition, the CDD 60 can be inserted into the interior of the inner shaft 210 such that the shaft 61 extends therethrough and the tip portion 64 is completely disposed within the counterbore 56. In this manner, the CDD 60 can deliver bone cement directly into the counterbore portion 56 of the cannulated bone screw 50 through the bone cement delivery guide 200. In an exemplary embodiment, the engagement feature 215 may not extend completely into the counterbore portion 56, although in some embodiments it may extend therein. For example, in some embodiments, the engagement feature 215 (or a portion thereof) can have a length, size, and shape that generally corresponds to the size and shape of the counterbore 215, such that a CDD is not required to deliver bone cement to the cannulated bone screw 50. Additionally, consistent with the scope of the present disclosure, in alternative embodiments, the engagement feature 215 can have a length, size, and shape that is generally applicable to the particular type of connector being used, i.e., the scope of the present disclosure is equally applicable to both extended and non-extended connectors as disclosed above. Similarly, the engagement feature 215 can take an alternative shape depending on the particular geometry of the saddle 79, and in connectors that do not use a saddle 79, the engagement feature 215 can be coupled directly to the head of the bone screw similar to that explained above with respect to the engagement feature 15 and stop surface 17 of the tool 100. Thus, it should be understood that the structural aspects, functions, and designs of the tool 100 can be interchangeable with the tool 200 (and vice versa), unless the context clearly indicates otherwise.

[0050] It should be understood that the aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. For example, unless the context clearly indicates otherwise, features, functions, and components from one embodiment may be combined with another embodiment, and vice versa. Similarly, features, functions, and components may be omitted unless the context clearly indicates otherwise. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, may be added, merged, or omitted entirely (e.g., not all described actions or events may be required to perform these techniques).

[0051] Unless otherwise specifically defined herein, all terms should be given their broadest possible interpretation, including the meaning implicit from the specification and the meaning understood by those skilled in the art and / or as defined in dictionaries, papers, etc. It must also be noted that, unless otherwise indicated, the singular forms "a", "an" and "the" used in the specification and the appended claims include plural referents, and the terms "comprising" and / or "including" when used in this specification specify the presence of stated features, elements and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components and / or groups thereof.

Claims

1. A surgical tool for delivering bone cement, the surgical tool comprising: a hollow outer sleeve having an elongated cylindrical shape; a hollow inner sleeve having an elongated cylindrical shape disposed inside the hollow outer sleeve and having a first thread pattern adjacent a proximal end of the hollow inner sleeve and a coupling portion at a distal end of the hollow inner sleeve, the hollow inner sleeve being movable between a retracted position and an extended position; and a hollow inner rod removably disposed within the hollow inner cannula and having a distal end configured to direct a flowable material to the bone screw, the hollow inner rod comprising a second thread pattern having a size and shape corresponding to the size and shape of the first thread pattern, wherein in the extended position, the coupling portion extends beyond the distal end of the hollow outer sleeve and is configured to flare outwardly to surround and capture a head portion of the bone screw, and Wherein in the retracted position, the coupling portion moves within the interior of the distal end of the hollow outer sleeve and is restrained from expanding outwardly, thereby securely coupling the surgical tool to the head portion of the bone screw.

2. The surgical tool of claim 1, wherein the coupling portion comprises at least one slot extending from the distal end of the hollow inner sleeve, and wherein the flowable material comprises an adhesive. 3 . The surgical tool of claim 1 , wherein the coupling portion comprises four slots extending from the distal end of the hollow inner sleeve toward the proximal end of the hollow inner rod. 4 . The surgical tool of claim 3 , wherein each of the four slots is evenly spaced apart from an adjacent one of the four slots. 5 . The surgical tool of claim 1 , wherein the coupling portion includes a lip portion configured to retain the bone screw from an underside of the bone screw.

6. The surgical tool of claim 1, further comprising an adhesive delivery tube configured to be disposed within the inner rod.

7. The surgical tool according to claim 1, wherein: The bone screw is a cannulated bone screw and the head portion includes a counterbore, and the hollow inner shaft is configured to deliver bone cement along an axis coaxial with the counterbore.

8. The surgical tool of claim 1, further comprising a cement delivery tube configured to be disposed within the inner rod, Wherein the adhesive delivery tube includes a distal end having a size and shape corresponding to the size and shape of the counterbore.

9. The surgical tool of claim 1, wherein: The bone screw is a cannulated bone screw and the head portion includes a counterbore; and the distal end of the hollow inner rod includes an engagement feature configured to contact the head portion of the cannulated bone screw, the engagement feature including a distal end including a central opening therein, the central opening having a size and shape corresponding to the size and shape of the counterbore.

10. The surgical tool of claim 1, wherein: The hollow outer sleeve includes a first portion having a first inner diameter and a second portion having a second inner diameter, the first inner diameter being greater than the second inner diameter; the hollow inner sleeve comprising a stop ring at a proximal end of the hollow inner sleeve, the stop ring being configured to prevent the hollow inner sleeve from moving further than the extended position; and A spring disposed in the first portion biases the hollow inner sleeve toward the retracted position.

11. A surgical system for delivering bone cement to a target site, the surgical system comprising: a medical implant comprising a U-shaped connector having a first connecting tab and a second connecting tab opposite the first connecting tab, the U-shaped connector being configured to couple to a head portion of a bone screw in a lower cavity; a hollow outer sleeve having an elongated cylindrical shape and a distal end, the distal end including a first engagement tab and a second engagement tab opposite the first engagement tab, the first engagement tab being configured to couple to the first connection tab and the second engagement tab being configured to couple to the second connection tab; a hollow inner sleeve having an elongated cylindrical shape and a distal end including a third engagement tab and a fourth engagement tab opposite the third engagement tab, the hollow inner sleeve being disposed inside the hollow outer sleeve and having a first thread pattern at a proximal end of the hollow inner sleeve, the hollow inner sleeve being movable between a retracted position and an extended position; and a hollow inner rod removably disposed within the hollow inner sleeve and having a distal end configured to direct bone cement to the head portion of the bone screw when the bone screw is disposed in the lower cavity of the U-shaped connector, the hollow inner rod including a second thread pattern having a size and shape corresponding to the size and shape of the first thread pattern, wherein in the extended position, the third engagement tab and the fourth engagement tab extend beyond the distal end of the hollow outer sleeve, and Wherein in the retracted position, the first engagement tab and the second engagement tab extend beyond the distal end of the hollow inner sleeve.

12. The system of claim 11, wherein an inner surface of the first engagement tab is configured to directly contact an outer surface of the first connection tab, and an inner surface of the second engagement tab is configured to directly contact an outer surface of the second connection tab.

13. The system of claim 12, wherein the inner surface of the first engagement tab includes a beveled end, and the inner surface of the second engagement tab includes a beveled end.

14. The system of claim 11, wherein in the extended position, the third engagement tab and the fourth engagement tab directly contact opposing interior side wall surfaces of the U-shaped connector.

15. The system of claim 12, wherein the third engagement tab includes an arcuate track on an outer surface of the third engagement tab and the fourth engagement tab includes an arcuate track on an outer surface of the fourth engagement tab.

16. The system of claim 15, wherein in the extended position, the arcuate track of the third engagement tab is configured to nest within a first channel of the U-shaped connector, and the arcuate track of the fourth engagement tab is configured to nest within a second channel of the U-shaped connector.

17. The system of claim 11, further comprising an adhesive delivery tube configured to be disposed within the inner rod.

18. The system of claim 17, wherein the bone screw is a cannulated bone screw and the head portion includes a counterbore.

19. A surgical tool according to claim 18, wherein the adhesive delivery tube includes a distal end having a size and shape corresponding to the size and shape of the counterbore.

20. The surgical tool of claim 11, wherein: The bone screw is a cannulated bone screw and the head portion includes a counterbore; and the distal end of the hollow inner rod includes an engagement feature configured to contact the head portion of the cannulated bone screw, the engagement feature including a tip portion defining a central opening having a size and shape corresponding to the size and shape of the counterbore.

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