Spinal Stability System

Abstract

A device for a spinal stabilization procedure includes a cannulated tubular body configured for insertion into a spinal surgical site and an expansion component coupled to the cannulated tubular body. The expansion component can include a plurality of elongated mechanical supports, can be axially aligned with the cannulated tubular body when in a compressed state, and can bend radially outward when in an expanded state. The mechanical expansion can be controlled using one or more adjustment elements of the device. Related devices, systems, kits, techniques, and articles are also described.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 18 / 514,825, filed November 20, 2023, which is a continuation-in-part of U.S. Patent Application No. 18 / 497,922, filed October 30, 2023, which is a continuation-in-part of U.S. Patent Application No. 18 / 087,738, filed December 22, 2022, the contents of all of which are incorporated herein by reference in their entireties.

[0002] The subject matter described herein relates generally to systems and methods for spinal surgery. More particularly, the subject matter described herein relates to the treatment of spinal injuries or deformities by reconstruction, augmentation, and / or stabilization of vertebral bodies. [Background technology]

[0003] Internal spinal fixation devices can be used during spinal surgery to provide stability to injured or damaged vertebrae. For example, the use of pedicle screw instruments is becoming increasingly widespread in these procedures. Pedicle screws are often inserted through the cancellous bone of the vertebral body to provide stability and correct vertebral deformities. Pedicle screw performance is directly related to the strength of attachment to the spine, and pedicle screw failure can have significant clinical consequences for patients. In fact, pedicle screw loosening is a common complication after spinal surgery.

[0004] Relatedly, spinal augmentation procedures, such as vertebroplasty, are also often used to provide stability to injured or damaged vertebrae. Percutaneous spinal procedures, such as these, involve the injection of bone cement through small holes in the skin into a collapsed or fractured vertebra. Specifically, vertebroplasty first restores the kyphosis height and angle of the fractured vertebra, followed by stabilization using injected bone cement. This procedure typically involves the use of a small balloon, which is inflated within the vertebral body to create a void within the cancellous bone prior to cement delivery. Once the void is created, bone cement is delivered into the newly created void. It is important that the creation of the void and delivery of the bone cement result in proper restoration of the vertebral height and vertebral angulation. However, the balloon exerts an expanding force within the vertebra, typically deflated and removed before the bone cement is introduced, potentially altering the volume and / or shape of the void. As a result, this multi-step process can lead to unreliable correction of vertebral height and angulation, resulting in inconsistent patient outcomes. Summary of the Invention

[0005] The subject matter described herein offers many technical advantages over the prior art. For example, in some aspects, the methods, devices, and kits described herein provide an efficient, minimally invasive solution for physicians seeking minimally invasive options for vertebral body reconstruction, augmentation, and stabilization in severe osteoporotic and tumor-induced fractures, as well as other procedures. Specifically, in some aspects, fractured or otherwise damaged vertebrae can be restored to a desired configuration using bone cement delivered to an expanded metal mesh within the surgical site, which acts to guide the delivery of the bone cement and helps temporarily maintain the shape of the created cavity before the bone cement hardens. In some aspects, when bone cement is delivered to the vertebral body via a cement-injected pedicle screw, it provides 360° of vertebral internal fixation, minimizing the risk of displacement compared to traditional augmentation techniques. Initial stabilization of the vertebral body using an expandable metal mesh delivered via a balloon-tipped cannula can significantly improve surgical outcomes.

[0006] In one aspect, a method of spinal stabilization can include inserting pedicle screws using a cannulated screwdriver into a surgical site stabilized by an expandable metal mesh delivered by a balloon-tipped cannula, and delivering bone cement to the surgical site by passing the bone cement through the cannulated screwdriver, wherein the bone cement exits at least one cement injection window or cannulation in the pedicle screw such that the bone cement combines with the pedicle screw to maintain a desired anatomical distance within the surgical site.

[0007] In this method, the pedicle screw may include multiple cement injection windows positioned along the axial direction of the pedicle screw. The pedicle screw may include an inflatable balloon covering at least one cement injection window, the inflatable balloon inflating when bone cement exits the at least one cement injection window. The inflatable balloon may be dissolvable. The inflatable balloon may be coupled to the pedicle screw via one or more O-ring seals.

[0008] The method may further include controlling a location where bone cement is dispensed within the surgical site. The pedicle screw may include one or more cement injection windows arranged in a substantially similar axial direction, and controlling the location where bone cement is dispensed may include rotating the pedicle screw until at least one of the cement injection window or the cannulation portion is positioned within the target direction before dispensing the bone cement. The pedicle screw may include a threaded portion and an unthreaded portion having one or more cement injection windows, and the unthreaded portion of the pedicle screw is configured to rotate relative to the threaded portion. Controlling the location where bone cement is dispensed may include changing the position of a cement cannula within a cannulation screwdriver relative to the pedicle screw. The pedicle screw may include an internal flow divider valve, the internal flow divider valve fluidly separating a first chamber including the first cement injection window from a second chamber including the second cement injection window, and the cement cannula including a directional element configured to selectively dispense bone cement into the first chamber, the second chamber, or both chambers.

[0009] The surgical site can be located within a vertebral body. The desired anatomical distance can be a predetermined distance representing the height of the vertebral body. The cannulation screwdriver can include a locking mechanism configured to lock the screwdriver in position along the length of the delivery wire. The bone cement can include polymethyl methacrylate (PMMA).

[0010] In another aspect, a method of spinal stabilization includes inserting a wire into the surgical site using a trephine needle with a stylet, overlaying a working sleeve over the wire, creating a cavity inside the surgical site using a cannulation drill that passes through the working sleeve, delivering an inflatable balloon surrounded by an inflatable metal mesh through the working sleeve and into the cavity using a balloon-tipped cannula, inflating the balloon until a desired anatomic distance is achieved, deflating the balloon while maintaining the desired anatomic distance using the inflatable metal mesh, and removing the balloon, inserting a delivery wire through the working sleeve and into the lumen of the inflatable metal mesh, and removing the working sleeve. The method may include inserting a pedicle screw into the surgical site using a cannulated screwdriver guided by a delivery wire, the pedicle screw having at least one cement injection window or cannulation; inserting a cement cannula through the cannulation of the screwdriver; and delivering bone cement to the cavity by passing the bone cement through the cement cannula exiting the at least one cement injection window or cannulation of the pedicle screw, such that the bone cement combines with the pedicle screw to maintain the desired anatomical distance.

[0011] In this method, the pedicle screw may include multiple cement injection windows positioned along the axial direction of the pedicle screw. The pedicle screw may include an inflatable balloon covering at least a portion of at least one cement injection window or cannulation, the inflatable balloon inflating when the bone cement exits the at least one cement injection window or cannulation. The inflatable balloon may be dissolvable. The inflatable balloon may be coupled to the pedicle screw via one or more O-ring seals.

[0012] The method can further include controlling a location within the cavity where the bone cement is dispensed. The pedicle screw can include one or more cement injection windows arranged in a substantially similar axial direction, and controlling the location where the bone cement is dispensed includes rotating the pedicle screw until at least one of the cement injection windows or cannulae is positioned within the target direction before dispensing the bone cement. Controlling the location where the bone cement is dispensed can include changing a position of a cement cannula relative to the pedicle screw. The pedicle screw can include an internal flow divider valve that fluidly separates a first chamber including the first cement injection window from a second chamber including the second cement injection window, and the cement cannula includes a directional element configured to selectively dispense bone cement into the first chamber, the second chamber, or both chambers.

[0013] The surgical site can be located within a vertebral body. The desired anatomical distance can be a predetermined distance representing the height of the vertebral body. The cannulation screwdriver can include a locking mechanism configured to lock the screwdriver in position along the length of the delivery wire. The bone cement can include polymethyl methacrylate (PMMA). The expandable metal mesh can be configured to expand into a substantially spherical shape. The method can further include injecting an imaging agent into the balloon and monitoring the inflation volume of the balloon to determine when the desired anatomical distance has been achieved.

[0014] In another aspect, a method of spinal stabilization includes inserting a wire into a surgical site using a trephine needle with an interlocking hub and stylet, overlaying a working sleeve over the wire, creating a cavity inside the surgical site using a drill passed through the working sleeve, delivering an inflatable balloon surrounded by an expandable metal mesh through the working sleeve using a balloon-tipped cannula and into the cavity, inflating the balloon until a desired anatomic distance is achieved, deflating the balloon while maintaining the desired anatomic distance using the expandable metal mesh, removing the balloon, and delivering bone cement into the lumen of the expandable metal mesh.

[0015] In another aspect, a kit for performing a spinal stabilization procedure can include a balloon-tipped cannula having an inflatable balloon surrounded by an expandable metal mesh, the balloon-tipped cannula configured to pass through a working sleeve and inflate the inflatable balloon and the expandable metal mesh within a surgical site, and a pedicle screw having at least one cement injection window or cannulation configured to be inserted into the surgical site.

[0016] The kit may further include an injection system configured to deliver bone cement through at least one cement injection window or cannulation of the pedicle screw to the surgical site when the pedicle screw is positioned within the injection site. The injection system may include a bone cement cannula configured to be inserted through a cannulation screwdriver. The kit may further include one or more additional pedicle screws, each having a different axial length. The kit may further include a source of bone cement. The kit may further include an inflation device configured to apply inflation pressure to the balloon-tipped cannula.

[0017] In one aspect, the screwdriver system can include a cannulated tubular body, a pedicle screw coupling positioned at a first end of the cannulated tubular body, the pedicle screw coupling configured to couple to the pedicle screw in a manner that allows the pedicle screw to be driven while the pedicle screw coupling is rotated, and a cement cannula positioned within the cannulated tubular body, the cement cannula configured to deliver bone cement through the cannulated portion of the tubular body and to the coupled pedicle screw.

[0018] The cement cannula can be configured to remain within the cannulated tubular body while the pedicle screw coupling is rotated. The screwdriver system can further include a cement cannula port coupled to the cement cannula. The cement cannula can include a directional element configured to selectively deliver bone cement to the pedicle screw attached to the pedicle screw coupling. The cement cannula can include a directional element configured to selectively deliver bone cement to the pedicle screw within an adjustable direction. The pedicle screw coupling can include a cutting element, the cutting element configured to provide access to the surgical site. The screwdriver system can further include a handle coupled to the second end of the cannulated tubular body.

[0019] In another aspect, a screwdriver system can include a cannulated tubular body, a pedicle screw coupling positioned at a first end of the cannulated tubular body, the pedicle screw coupling configured to couple to a pedicle screw in a manner that allows the pedicle screw to be driven while the pedicle screw coupling is rotated, a handle attached to a second end of the cannulated tubular body, an inner shaft positioned within the cannulated tubular body, the inner shaft having a threaded portion protruding from the first end of the cannulated tubular body, and a handle knob positioned within at least a portion of the handle, the handle knob coupled to the inner shaft in a manner that rotating the handle knob causes rotation of the threaded portion of the inner shaft.

[0020] The threaded portion can be configured to thread into the pedicle screw to form an attachment between the inner shaft and the pedicle screw. The pedicle screw coupling can include a cutting element, the cutting element configured to provide access to the surgical site. The handle can include at least one aperture configured to provide access to the handle knob. The handle knob can be substantially enclosed by the handle. At least a portion of the handle knob can partially protrude through the aperture and extend beyond the face of the handle. The handle knob can include an annular body having a flat top surface, a flat bottom surface, and an annular sidewall. The annular sidewall can include a plurality of ridges arranged axially relative to the cannulation tubular body. The annular body can include a central aperture configured to provide access from the top surface to the bottom surface. The handle can include a first handle arm and a second handle arm, the first handle arm and the second handle arm can extend outward in opposite radial directions relative to the cannulation tubular body. The first and second handle arms may each have an outer end and an inner end, with the width of each handle arm at the outer end being smaller than the width at the inner end.

[0021] In one aspect, a pedicle screw for use in a spinal stabilization procedure can include a cylindrical body, a threaded portion positioned along at least a portion of the cylindrical body, a drill coupling member positioned at a first end of the cylindrical body, a first cement injection window positioned along the cylindrical body, a second cement injection window positioned along the cylindrical body, and an internal flow divider valve fluidly separating a first chamber including the first cement injection window and a second chamber including the second cement injection window, wherein the internal flow divider valve is configured such that bone cement introduced into the first chamber exits only through the first cement injection window and bone cement introduced into the second chamber exits only through the second cement injection window.

[0022] The internal flow divider valve may include an internal cannulation configured to receive a wire passing through the pedicle screw. The internal cannulation may be fluidly isolated from the first chamber and the second chamber. The first cement injection window and the second cement injection window may be positioned at the same axial position on opposite sides of the cylindrical body. The pedicle screw may include at least two additional cement injection windows positioned along the cylindrical body. The pedicle screw may be threaded along the entire length of the cylindrical body. The drill coupling may include a hexalobular socket.

[0023] In another aspect, a pedicle screw for use in a spinal stabilization procedure can include a cylindrical body, a threaded portion positioned along at least a portion of the cylindrical body, a drill coupling member positioned at a first end of the cylindrical body, a first cement injection window positioned along the cylindrical body, and an inflatable balloon attached to the cylindrical body and covering the first cement injection window, the inflatable balloon configured to expand when bone cement exits the first cement injection window.

[0024] The inflatable balloon may be dissolvable. The inflatable balloon may be coupled to the pedicle screw via one or more O-ring seals. The pedicle screw may include at least one additional cement injection window positioned along the cylindrical body. The drill coupling may include a hexalobular socket.

[0025] In one aspect, a device for a spinal stabilization procedure is provided. The device can include a cannulated tubular body having a first end configured for insertion into a surgical site and a second end. The device can also include an expansion component coupled to the cannulated tubular body. The expansion component can include a plurality of elongated mechanical supports, configured for axial alignment with the cannulated tubular body when in a compressed state, and configured for radial outward bending when in an expanded state.

[0026] In another aspect, a pedicle screw for use in a spinal stabilization procedure is provided. The pedicle screw can include a cannulated tubular body having a first end configured to be inserted into a surgical site and a second end, a threaded cover positioned on the second end configured to be secured to bone within the surgical site, and an expansion component coupled to the cannulated tubular body. The expansion component can include a plurality of elongated mechanical supports configured to be axially aligned with the cannulated tubular body when in a compressed state and further configured to flex radially outward when in an expanded state.

[0027] In one aspect, a device for a spinal stabilization procedure is provided. The device can include a cannulated tubular body having a first end configured to be inserted into a spinal surgical site and an expansion component coupled to the cannulated tubular body. The expansion component can include a plurality of elongated mechanical supports configured to be axially aligned with the cannulated tubular body when in a compressed state and configured to flex radially outward when in an expanded state. The expansion component can further include a plug positioned within the cannulated tubular body, the plug configured to move axially to contact and apply a force to the mechanical supports such that movement of an adjustment element toward the first end of the cannulated tubular body shifts the mechanical supports from the compressed state to the expanded state.

[0028] The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]

[0029] [Figure 1] FIG. 1 is a first process flow diagram illustrating a spinal stabilization procedure.

[0030] [Figure 2] FIG. 1 is a process flow diagram illustrating a spinal stabilization procedure.

[0031] [Figure 3] Figures A-D show advanced stages of a spinal stabilization procedure in which a balloon-tipped cannula is inserted into the surgical site. Figure A shows a trephine needle inserted into the surgical site. Figure B shows a wire inserted through the trephine needle into the surgical site after the stylet has been removed. Figure C shows a wire inserted into the surgical site after the hub has been removed. Figure D shows a cannulation drill inserted into the surgical site through the working sleeve.

[0032] [Figure 4] A-D illustrate advanced stages of a spinal stabilization procedure in which a balloon-tipped cannula is inflated within a surgical site. A shows the balloon-tipped cannula inserted into the surgical site through a working sleeve, with the inflatable balloon surrounded by an expandable metal mesh. B shows the balloon and expandable metal mesh in an inflated configuration within the surgical site. C shows the expandable metal mesh in an inflated configuration within the surgical site after the balloon-tipped cannula has been removed and replaced with a delivery wire. D shows the delivery wire inserted into the surgical site after the working sleeve has been removed.

[0033] [Figure 5]1A-1B illustrate advanced stages of a spinal stabilization procedure in which bone cement is delivered to the surgical site. A shows a pedicle screw inserted into the lumen of an expandable metal mesh within the surgical site by a cannulated screwdriver guided by a delivery wire. B shows the cement cannula replacing the delivery wire, and bone cement being delivered through the cement cannula and pedicle screw to the surgical site.

[0034] [Figure 6] FIG. 1 shows an isometric view of a trephine needle and associated surgical wire.

[0035] [Figure 7] FIG. 1 is an isometric view of a cannulation drill with a working sleeve.

[0036] [Figure 8] FIG. 1 shows a front view of a balloon-tipped cannula with an expandable metal mesh.

[0037] [Figure 9A] FIG. 1 shows an isometric view of an expandable metal mesh in a compressed form. [Figure 9B] 9B shows a front view of the expandable metal mesh of FIG. 9A in an expanded configuration.

[0038] [Figure 10A] FIG. 1 shows an isometric view of an expandable metal mesh in a compressed form. [Figure 10B] FIG. 10B shows a front view of the expandable metal mesh of FIG. 10A in an expanded configuration.

[0039] [Figure 11] FIG. 1 shows an isometric view of a bone cement cannula.

[0040] [Figure 12A] FIG. 1 shows an isometric view of a cannulation screwdriver and associated wires.

[0041] [Figure 12B] 12B shows a front view of the handle knob and inner shaft of the cannulation screwdriver of FIG. 12A.

[0042] [Figure 13] 1 shows an isometric view of a pedicle screw.

[0043] [Figure 14] 1 shows an isometric view of a pedicle screw.

[0044] [Figure 15] FIG. 1 shows a front view of a pedicle screw and its internal structure.

[0045] [Figure 16] FIG. 1 is a process flow diagram illustrating a spinal stabilization procedure.

[0046] [Figure 17] 1 illustrates an exemplary kit for performing a spinal stabilization procedure.

[0047] [Figure 18] 1 illustrates an exemplary screwdriver system.

[0048] [Figure 19A] FIG. 1 shows an isometric view of a pedicle screw with a mechanical expansion component in a compressed state.

[0049] [Figure 19B] 19B shows an isometric view of the pedicle screw of FIG. 19A in an expanded state.

[0050] [Figure 19C] 19A-19B show exploded views of the pedicle screw.

[0051] [Figure 19D] 19A-19C show front cross-sectional views of the pedicle screw.

[0052] [Figure 19E] 19A-19D show top views of the pedicle screw.

[0053] [Figure 20A] FIG. 1 shows a front view of a device with a mechanical expansion component in a compressed state.

[0054] [Figure 20B] FIG. 20B shows an isometric view of the device of FIG. 20A in an inflated state.

[0055] [Figure 20C] 20A-20B show exploded views of the device.

[0056] [Figure 20D] 20A-20C are cross-sectional front views of the device. DETAILED DESCRIPTION OF THE INVENTION

[0057] The present subject matter will be better understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, which form a part hereof.

[0058] As used herein, "bone cement" generally refers to any suitable, clinically approved bone stabilization or bone replacement material that can be injected into a subject. For example, bone cement can include a polymer such as polymethyl methacrylate (PMMA) or a polymer mixture substantially formed therefrom. Bone cement can include calcium phosphate, magnesium phosphate, or an equivalent compound. Bone cement can be limited to compounds approved by the FDA (US Food and Drug Administration) for use in spinal procedures.

[0059] As used herein, a "trephine needle" generally refers to a needle with a cylindrical blade. A trephine needle can specifically be a hollow, cylindrical needle with a tapered cutting tip. For example, a trephine needle can be a Jamshidi® needle or an equivalent insertion device.

[0060] The methods, devices, and kits of the present disclosure are described primarily as intended for human spinal procedures, such as fracture reduction in severe osteoporotic and oncologic fractures of the thoracic, lumbar, and spinal cord, and vertebral body reconstruction, augmentation, and stabilization, however, it will be readily understood that the teachings described herein can be applied to additional procedures involving alternative surgical sites, including, but not limited to, procedures involving bones outside the spinal column.

[0061] FIG. 1 illustrates a process flowchart for a spinal stabilization procedure 100, in which, at 102, pedicle screws can be inserted into a surgical site stabilized by an expandable metal mesh delivered through a balloon-tipped cannula. The pedicle screws can be delivered using a cannulated screwdriver. At 104, bone cement can then be delivered to the surgical site by passing it through a cannulated screwdriver that exits at least one cement injection window or cannulation in the pedicle screw, such that the bone cement combines with the pedicle screw to maintain a desired anatomical distance at the surgical site. In this manner, the spinal stabilization procedure 100 can provide stability to the surgical site through the combined delivery of both the pedicle screw and the bone cement, thereby maintaining a desired anatomical distance. In some variations, the spinal stabilization procedure 100 can be performed without the need to insert any guidewires into the surgical site.

[0062] FIG. 2 shows a process flowchart of another spinal stabilization procedure 200, in which a wire can be inserted into the surgical site using a trephine needle with a stylet at 200. A working sleeve can then be placed over the wire at 204. A cannulation drill can then be used to create a cavity inside the surgical site at 206, passing through the working sleeve. An inflatable balloon surrounded by an expandable metal mesh can then be delivered into the cavity at 208 using a balloon-tipped cannula through the working sleeve. In this manner, the spinal stabilization procedure 200 can function to precisely introduce the balloon-tipped cannula into the surgical site. The balloon can then be inflated at 210 until the desired anatomical distance is achieved. The balloon can then be deflated and removed at 212, while maintaining the desired anatomical distance using the expandable metal mesh. A delivery wire can then be inserted through the working sleeve and into the lumen of the expandable metal mesh at 214. The working sleeve can then be removed at 216. At this point in the spinal stabilization procedure 200, the desired anatomical distance has been achieved by inflation of a balloon within the surgical site, and a delivery wire has been introduced to guide the introduction of additional items into the surgical site. Next, at 218, a pedicle screw having at least one cement injection window or cannulation can be inserted into the surgical site using a cannulated screwdriver guided by the delivery wire. Then, at 220, a cement cannula can be inserted through the cannulation of the screwdriver. Next, at 222, bone cement can be delivered to the cavity by passing it through the cement cannula that exits the at least one cement injection window or cannulation of the pedicle screw, such that the bone cement combines with the pedicle screw to maintain the desired anatomical distance.

[0063] The surgical site of the devices, methods, and kits described herein can be located within a subsection of a vertebral body. Specifically, the surgical site can be within the cancellous bone of the vertebral body. The surgical site can be a target location predetermined by a physician prior to the procedure using known imaging systems and techniques. The surgical site can be selected as a location within the vertebral body where, when the surgical site expands, the vertebral body's shape changes to a desired corrective shape.

[0064] The desired anatomical distance of the devices, methods, and kits described herein can be a measurable length, width, height, or angular position of a vertebral body. In particular, the anatomical distance can be the original height of the vertebral body prior to a compression fracture or other injury. Alternatively, the desired anatomical distance can be a vertebral body height that is predetermined to produce a desired kyphosis or lordosis angle in a subject. The desired anatomical distance can be predetermined using known imaging systems and techniques prior to performing a spinal stabilization procedure.

[0065] The methods described herein may further include controlling the location where the bone cement is dispensed within the surgical site. By controlling the location where the bone cement is released within the surgical site, the physician can better control the final distribution of the bone cement. This control can be achieved using a variety of different techniques. For example, the inserted pedicle screw may include one or more cement injection windows arranged in a substantially similar axial direction, and controlling the location where the bone cement is dispensed may include rotating the pedicle screw until at least one cement injection window or cannulation is positioned within the target direction before dispensing the bone cement. Using such techniques, the bone cement can be dispensed from the pedicle screw in a directional, controlled manner. To assist the physician during surgery, the pedicle screw may include an orientation marker or identifier that can identify a substantially similar axial direction even when the pedicle screw is inserted substantially into the surgical site.

[0066] Alternatively, controlling the location where the bone cement is dispensed can include changing the position of a cement cannula within a cannulated screwdriver relative to the pedicle screw. For example, the pedicle screw can include an internal flow divider valve that fluidly separates a first chamber including a first cement injection window from a second chamber including a second cement injection window, and the cement cannula includes a directional element configured to selectively dispense bone cement into the first chamber, the second chamber, or both chambers. The directional element can be changed from dispensing cement from one chamber to the other by an active step, such as rotating the cement cannula within the cannulated screwdriver.

[0067] The methods described herein can include monitoring the position of at least one of an inflatable balloon, a pedicle screw, or a cavity created within a surgical site. For example, the method can include injecting an imaging agent into the balloon and monitoring the inflation volume of the balloon to determine when the desired anatomical distance is achieved. Imaging devices and techniques commonly known in the art can be employed, including, but not limited to, fluoroscopy.

[0068] Consistent with certain aspects of methods 100 and 200, Figures 3A-3D, 4A-4D, and 5A-5B illustrate progressive stages of a spinal stabilization procedure. In particular, these figures illustrate the stages associated with inserting a balloon-tipped cannula into a surgical site, inflating the balloon-tipped cannula within the surgical site, and delivering bone cement through pedicle screws to the surgical site stabilized by an expandable metal mesh. While Figures 3A-3D, 4A-4D, and 5A-5B are directed to stages of related surgical procedures, they do not necessarily depict a single sequential method, but rather surgical milestones that may be achieved using certain aspects of the methods described herein.

[0069] FIG. 3A shows a trephine needle 302 inserted into a surgical site 300. The trephine needle can serve to create an initial entry point into the surgical site 300. In this illustration, the surgical site 300 is within a vertebral body, and the trephine needle 302 has been inserted through a pedicle bone. FIG. 3B shows a wire 304 inserted through the trephine needle 302 into the surgical site 300 after the stylet of the trephine needle 302 has been removed. FIG. 3C shows the wire 304 inserted into the surgical site 300 after the trephine needle 302 has been removed. FIG. 3D shows a cannulation drill 307 inserted into the surgical site 300 through a working sleeve 306. The wire 304 can serve to guide the cannulation drill 307 into the surgical site 300, after which the cannulation drill 307 is used to create a cavity within the surgical site 300.

[0070] Figure 4A shows a balloon-tipped cannula 409 with an inflatable balloon 408 inserted through a working sleeve 406 into a cavity within a surgical site 400, with the inflatable balloon 408 surrounded by an expandable metal mesh. Figure 4B shows the balloon and expandable metal mesh in an expanded configuration 410 within the expanded cavity of the surgical site 400. Figure 4C shows the expandable metal mesh in an expanded configuration 410 within the surgical site 400 after the balloon-tipped cannula 409 has been removed and replaced with a delivery wire 412. Figure 4D shows the delivery wire 412 still inserted into the surgical site 400 after the working sleeve 406 has been removed.

[0071] Figure 5A shows a pedicle screw 514 inserted into the lumen of an expanded metal mesh 509 within a surgical site 500. The pedicle screw 514 is inserted using a cannulated screwdriver 516 guided by a delivery wire 518. Figure 5B shows a cement cannula 520 replacing the delivery wire 518 within the cannulated screwdriver 516, and bone cement 522 being delivered through the cement cannula 520 and the pedicle screw 514 to the surgical site 500.

[0072] FIG. 6 illustrates an exemplary trephine needle 600 and associated wire 650 that can be utilized in the systems and methods described herein. The trephine needle 600 can include a removable stylet 602 coupled to a first removable hub segment 604. Once attached, the removable stylet 602 can be positioned within a sleeve 606 coupled to a second hub segment 608. In this manner, the trephine needle 600 can be configured to access a surgical site, at which point the stylet 602 and first removable hub segment 604 can be removed and the associated wire 650 can be inserted into the sleeve 606. Trephine needles suitable for use in accordance with the systems and methods described herein include, but are not limited to, Jamshidi® needles and other equivalent biopsy needles. The trephine needle 600 can be formed from a high-strength biocompatible material, such as stainless steel. The wire 650 can be formed from stainless steel or an equivalent material and can be configured to guide a cannulation drill when inserted into a surgical site. Wire 650 may specifically be a stainless steel Kirschner wire.

[0073] 7 illustrates an exemplary cannulated drill 700 that can be utilized in the systems and methods described herein. The cannulated drill 700 can have a reamer bit 702 coupled to a first, removable drill segment 704. Once attached, the reamer bit 702 and removable drill segment 704 can be positioned within a working sleeve 706 that is coupled to a second drill segment 708. In this manner, the cannulated drill 700 can be configured to create a cavity within a surgical site when guided by an inserted wire, at which point the reamer bit 702 and removable drill segment 704 can be removed. As a result, access to the created cavity can be gained through the working sleeve 706.

[0074] FIG. 8 illustrates an exemplary balloon-tipped cannula 800 with a balloon 801 and associated expandable metal mesh 802 that can be utilized in the systems and methods described herein. The balloon-tipped cannula 800 can include a cannula body 804 that connects the balloon 801 to a cannula port 806. In this manner, an inflation device, such as a pump or syringe, can be fluidly coupled to the cannula port 806 and used to inflate the balloon 801. The cannula port 806 can utilize any suitable connector, including, but not limited to, a Luer fitting. With the exception of the cannula port 806, the balloon-tipped cannula 800, when in its compressed configuration, can be sized to fit within a working sleeve and cavity positioned within a vertebral body. The balloon 801 can be formed from an expandable material, such as a biocompatible polymer.

[0075] 9A-9B and 10A-10B illustrate various configurations of expandable metal mesh that can be utilized in the systems and methods described herein. As illustrated, the expandable metal mesh can be formed from a variety of patterns depending on the mechanical requirements of a given surgical site. While the expandable metal mesh is depicted as a cylindrical structure, alternative expanded configurations, such as a substantially spherical or box-shaped configuration, are possible. The expandable metal mesh can be formed from an inelastic material capable of expanding and maintaining its expanded configuration. The expandable metal mesh can be formed from a metal, specifically cobalt chrome. The expandable metal mesh can be available in a variety of sizes depending on the particular surgical site and desired anatomical distance. In that regard, the methods described herein can further include selecting an expandable metal mesh of an appropriate size for a particular surgical site. In particular, to fit within the working sleeve and the cavity of the target site, the expandable metal mesh can have a diameter of between 10 and 20 millimeters and / or a length of between 10 and 30 millimeters when in an unexpanded configuration.

[0076] 11 illustrates an exemplary bone cement cannula 1100 that can be utilized in the systems and methods described herein. The bone cement cannula 1100 can include a cannula body 1102 that fluidly couples an external port 1104 on a first end to a delivery aperture 1106 on a second end. Thus, the bone cement cannula 1100 can be configured to deliver bone cement to a surgical site by passing the bone cement through the external port 1104 and the cannula body 1102, where it exits through the delivery aperture 1106. The delivery aperture 1106 can include a directional element, as shown, and the aperture can be located on one side of the cannula body 1102. Alternatively, the delivery aperture 1106 can be positioned on a base of the cannula tubular body 1102 and configured to provide a substantially uniform distribution of bone cement in the axial direction. Except for external port 1104, bone cement cannula 1100 can be sized to fit within a working sleeve inserted into the surgical site. Additionally, the second end of cannula body 1102 can be sized to fit within the lumen of a cannulated pedicle screw. Bone cement cannula 1100 can have an inner tube configured to prevent bone cement delivered through cannula body 1102 from contacting wires within the inner tube, such as a delivery wire inserted into the surgical site.

[0077] 12A shows an exemplary cannulation screwdriver 1200 and associated delivery wire 1250 that can be utilized in the systems and methods described herein. The cannulation screwdriver 1200 can include a cannulation tubular body 1202. The cannulation tubular body 1202 can have a length and diameter specifically selected to fit into a cavity at a surgical site. The screwdriver system 1200 can also include a pedicle screw coupling member 1204 attached to a first end of the cannulation tubular body 1202 and a handle 1206 coupled to a second end of the cannulation tubular body 1202 and having first and second handle arms 1210 and 1212 extending outward in opposite radial directions relative to the cannulation tubular body. The first and second handle arms 1210, 1212 each have an outer end and an inner end, with the width of each handle arm at the outer end being smaller than the width at the inner end. In this manner, the handle 1206 is thickened in the center to provide structural stability and support for the handle knob 1218. The pedicle screw coupling member 1204 can be configured to couple to a pedicle screw in a manner that allows the pedicle screw to be driven while the pedicle screw coupling member 1204 is rotated.

[0078] The cannulation screwdriver 1200 can also have an inner shaft 1214 positioned within the cannulation tubular body 1202. The inner shaft 1214 can have a threaded portion 1216 protruding from a first end of the cannulation tubular body 1202. A handle knob 1218 can be positioned within an aperture 1220 of the handle. Specifically, the handle knob can be substantially enclosed by the handle, and at least a portion of the handle knob can protrude partially through the aperture and extend beyond the face of the handle. The handle knob 1218 can be coupled to the inner shaft such that rotation of the handle knob 1218 results in rotation of the threaded portion 1216 of the inner shaft 1214.

[0079] 12B shows a handle knob 1218 attached to the inner shaft 1214 on the end opposite the threaded portion 1216. The threaded portion 1216 can be configured to be inserted into and threaded into the pedicle screw to form an attachment between the inner shaft and the pedicle screw. Such attachment can serve to prevent the pedicle screw from being removed from the pedicle screw coupling 1204 and can be controlled via the handle knob 1218. As shown, the handle knob 1218 can be an annular body having a flat top surface, a flat bottom surface, and an annular side wall. The annular side wall can include a plurality of ridges 1222 arranged axially relative to the cannulation tubular body 1202. The handle knob can have a central aperture configured to provide access from the top surface to the bottom surface.

[0080] The delivery wire 1250 can be pre-inserted through the cannulated portion 1208 of the cannulated screwdriver 1200 and into the surgical site, allowing for controlled and precise delivery of the pedicle screw. The pedicle screw coupling can include a cutting element configured to provide access to the surgical site. Once the pedicle screw is inserted into the surgical site, the delivery wire 1250 can be removed, and the cannulated portion 1208 can provide access to the pedicle screw lumen via the handle 1206, an aperture in the handle knob 1218, and the inner shaft 1214. The cannulated screwdriver 1200 can include a locking mechanism configured to lock the cannulated screwdriver 1200 in a position along the length of the delivery wire 1250. Such a locking mechanism can be incorporated into the handle 1206 and configured to secure the delivery wire 1250 by contacting the delivery wire 1250 within the cannulated portion 1208.

[0081] FIG. 13 illustrates an exemplary pedicle screw 1300 that can be utilized in the systems and methods described herein. The illustrated pedicle screw 1300 includes a cylindrical body 1302 having a screw 1304 positioned thereon. While a screw is depicted, alternative fixation means, such as expansion or curved-path fixation, can be used. A cannulation portion 1306 can be fluidly coupled through the interior of the cylindrical body 1302 to a drill coupling member 1310 as well as several cement injection windows 1308. The cannulation portion 1306 can be sized similarly to an associated delivery wire, thereby enabling delivery of bone cement primarily through the cement injection windows 1308. The drill coupling member 1310 can be configured to engage with and be driven by a screw coupling member of a drill. The drill coupling member 1310 can be configured to engage with a rod or equivalent connector attached to a second pedicle screw positioned within the surgical site or within a second surgical site in a different vertebral body. The pedicle screw 1300 can be formed from a rigid biocompatible material, such as titanium. The pedicle screw 1300 can have a diameter of between about 3 millimeters and about 7 millimeters and / or an axial length of between about 30 millimeters and about 60 millimeters. Pedicle screws can be formed in several different lengths or diameters, and the methods described herein can further include selecting a pedicle screw having a length and diameter appropriate for a particular surgical site.

[0082] While the illustrated pedicle screw 1300 has multiple uniformly positioned cement injection windows, it will be readily appreciated that alternative arrangements (such as FIG. 14 ) can include fewer cement injection windows. For example, the pedicle screw may have only one cement injection window on a portion of the cylindrical body 1302. Alternatively, similar to the illustrated configuration, the pedicle screw can include multiple cement injection windows positioned along the axial direction of the pedicle screw in a manner that provides a substantially uniform radial distribution of bone cement.

[0083] In one embodiment, the pedicle screw 1300 can include an inflatable balloon covering at least one of the cement injection windows, where the inflatable balloon inflates when bone cement exits the at least one cement injection window. Because the balloon is included on the pedicle screw itself, the inflatable balloon does not need to be removed from the surgical site. Because the inflatable balloon can remain permanently within the surgical site, the balloon can be formed from a biocompatible or biodegradable material. The inflatable balloon can be coupled to the pedicle screw via one or more O-ring seals.

[0084] In another aspect, the non-threaded portion of the pedicle screw can be configured to rotate relative to the threaded portion. In this manner, by forming the pedicle screw from two rotating bodies, the threaded portion of the pedicle screw can be screwed into the bone and remain fixed, while the non-threaded portion of the pedicle screw rotates to control the delivery of bone cement through one or more cement injection windows that can be arranged in a substantially similar axial direction.

[0085] 14 illustrates an exemplary pedicle screw 1400 that can be utilized in the systems and methods described herein. The illustrated pedicle screw 1400 can include a cylindrical body 1402 having a screw 1404 positioned thereon. The screw 1404 can be positioned along only a portion of the cylindrical body 1402 or along the entire length of the cylindrical body 1402. An internal flow diverter valve 1412 within the drill coupling member 1410 can fluidly separate a first internal chamber including a first cement injection window 1408 from a second internal chamber including a second cement injection window 1409. In this manner, the internal flow diverter valve 1412 can be configured to ensure that bone cement introduced into the first chamber exits only through the first cement injection window 1408 and that bone cement introduced into the second chamber exits only through the second cement injection window 1409. The first and second cement injection windows can be positioned at the same axial location on opposite sides of the cylindrical body. As shown, the internal flow diverter valve 1412 can include an internal cannulation configured to receive a wire passing through a pedicle screw. The internal cannulation can be fluidly isolated from the first and second chambers.

[0086] FIG. 15 illustrates yet another exemplary pedicle screw 1500 that can be utilized with the systems and methods described herein. The illustrated pedicle screw 1500 can include a cylindrical body 1502 having a thread 1504 positioned thereon. A cannulated portion 1506 can be fluidly coupled to a drill coupling member 1510 through the interior of the cylindrical body 1502, as well as several cement injection windows 1508. As shown, the drill coupling member 1510 can include a socket 1512, such as a hexalobular socket or another equivalent pedicle screw socket. The drill coupling member 1510 can also include internal threads 1514 to provide additional mounting support. An inflatable balloon 1516 can be attached as part of the pedicle screw 1500 and can cover at least one of the cement injection windows 1508. The inflatable balloon 1516 can be configured to inflate as bone cement advances through the cannulation 1506 and exits the cement injection window 1508. The inflatable balloon 1516 can be coupled to the cylindrical body 1504 via one or more O-ring seals or using equivalent attachment techniques. The inflatable balloon 1516 can be dissolvable and can be biocompatible or biodegradable.

[0087] FIG. 16 shows a process flowchart of a spinal stabilization procedure 1600, in which, at 1602, a wire can be inserted into the surgical site using a trephine needle with an interlocking hub and stylet. A working sleeve can then be placed over the wire at 1604. A cavity can then be created inside the surgical site at 1606. A drill can be used to create the cavity through the working sleeve. At 1608, an inflatable balloon surrounded by an expandable metal mesh can then be delivered through the working sleeve using a balloon-tipped cannula into the cavity. At 1610, the balloon can then be inflated until the desired anatomical distance is achieved. At 1612, the balloon can then be deflated and removed while maintaining the desired anatomical distance using the expandable metal mesh. At 1614, bone cement can then be delivered into the lumen of the expandable metal mesh. In this manner, the spinal stabilization procedure 1600 can provide stabilization and create the desired anatomical distance at the surgical site without utilizing pedicle screws. Spinal stabilization procedure 1600 can incorporate the teachings described herein, including those detailed for spinal stabilization procedure 100 and spinal stabilization procedure 200.

[0088] FIG. 1700 illustrates an exemplary kit for performing a spinal stabilization procedure. The kit 1700 can include a balloon-tipped cannula 1702 having an inflatable balloon surrounded by an expandable metal mesh, and the balloon-tipped cannula can be configured to pass through a working sleeve and inflate the inflatable balloon and expandable metal mesh within a surgical site. The kit 1700 can further include a pedicle screw 1704 configured to be inserted into the surgical site and an injection system 1706 configured to deliver bone cement through at least one cement injection window or cannulation in the pedicle screw to the surgical site when the pedicle screw is positioned within the injection site. The components of the kit 1700 can be sterile and intended for single use.

[0089] The kit 1700 can incorporate any of the devices, materials, or components of the systems and methods described herein. For example, the injection system 1706 can include a bone cement cannula configured to be inserted through a cannulation screwdriver. The kit 1700 can further include one or more additional pedicle screws, each having a different axial length. Including multiple pedicle screws of different sizes allows the physician to easily select the pedicle screw best suited to a particular patient's needs and unique surgical site. The kit 1700 can include a bone cement supply to provide the physician with convenient access to the amount of bone cement typically required for a spinal procedure.

[0090] Alternative kit arrangements are possible using the systems and devices described herein. For example, an access kit can include components associated with accessing a surgical site, such as a trephine needle, a working sleeve and associated drill or reamer, a cement cannula, a cannulation screwdriver, and one or more surgical wires. A balloon kit can include a balloon-tipped cannula with an associated metal mesh. A screw kit can include multiple quantities of pedicle screws, each having a different diameter or length. A cement kit can include a cement mixer and a source of cement components, e.g., bone cement. Any of the kits described herein can be combined with one another. For example, a combination access-screw kit can include elements of an access kit and a screw kit. Similarly, a combination balloon-screw kit can include elements of a balloon kit and a screw kit.

[0091] FIG. 1800 illustrates an exemplary screwdriver system 1800 with an integrated bone cement injection system in accordance with the techniques described herein. The screwdriver system 1800 can include a cannulated tubular body 1802. The cannulated tubular body 1802 can have a length and diameter specifically selected to fit into a cavity at a surgical site. The screwdriver system 1800 can also include a pedicle screw coupling 1804 attached to a first end of the cannulated tubular body 1802. The pedicle screw coupling 1804 can be configured to couple to a pedicle screw in a manner that allows the pedicle screw to be driven while the cannulated tubular body 1802 is rotated. To appropriately apply sufficient torque to drive the screw, the screwdriver system can include a handle coupled to a second end of the cannulated tubular body. While a manual handle is depicted, it will be readily understood that a mechanical drive mechanism can be used instead.

[0092] The illustrated screwdriver system 1800 can include an injection system attached to the cannulated tubular body 1802, which can be configured to deliver bone cement through the cannulation of the cannulated tubular body 1802 and to the coupled pedicle screw. The injection system can include a cement cannula 1808 positioned within the cannulation of the cannulated tubular body 1802 and a cement cannula port 1810 coupled to the cement cannula 1808. The cement cannula can be coupled to the cannulated tubular body in a manner that allows the screwdriver system 1800 to drive the pedicle screw into the surgical site while the cement cannula 1808, including the attached cement cannula port 1810, is coupled. In this manner, the cement cannula 1808 can be configured to remain within the cannulated tubular body while the pedicle screw coupling is rotated. In other words, the cement cannula 1808 can be integrated with the screwdriver system 1800 during its use, eliminating the need for the physician to change tools and thereby enabling a more efficient procedure. Similarly, to avoid the use of additional equipment, the tubular body 1802 can have a cutting element positioned on its first end. The addition of a cutting element, such as a reamer bit or boring bit, allows the screwdriver system 1800 to be versatile in forming cavities within the surgical site, inserting pedicle screws, and / or delivering bone cement to the surgical site.

[0093] The cement cannula port 1810 can be fluidly coupled to the cement cannula such that bone cement is introduced through the cement cannula port 1810, passes through the cement cannula 1808, and exits into a pedicle screw coupled to the pedicle screw coupling member 1804. The pedicle screw port 1810 can be configured to fluidly connect the cement cannula 1808 to a syringe, mechanical pump, or similar device capable of providing a pressure differential to introduce bone cement via the screwdriver system 1800. The cement cannula 1808 can include a directional element configured to selectively deliver bone cement to a pedicle screw attached to the pedicle screw coupling 1804.

[0094] Mechanical Expansion The present disclosure further provides systems and methods relating to various devices for spinal stabilization procedures having a mechanical expansion component. In other words, instead of utilizing a balloon for expansion within the surgical site as previously described herein, mechanical expansion devices can additionally or alternatively use a mechanical element to provide a similar expansion force at the surgical site, for example, by using some mechanical support (e.g., a bendable rod or shaft) that expands outward from the device into the surgical site. It will be readily understood that such mechanical expansion devices can rely on any of the conventional aspects described herein.

[0095] 19A-19E show an example of a pedicle screw 1900 with a mechanical expansion component 1930 that can be controllably switched from a compressed state (FIG. 19A) to an expanded state (FIG. 19B). As seen in FIG. 19A, the pedicle screw 1900 can be formed from three components: a cannulated tubular body 1920, a threaded cover 1910 that can be coupled to and positioned on one end of the cannulated tubular body 1920, and an expansion component 1930 that is coupled to the cannulated tubular body. In this example, the cannulated tubular body 1920 can be configured to freely rotate within the expansion component 1930, such that this rotational movement changes the expansion component 1930 from a compressed state to an expanded state, or vice versa. In this manner, the pedicle screw 1900 can be inserted into the surgical site while in a compressed state, at which point the operator can expand the volume of the surgical site by intentionally rotating the cannulation tubular body 1920. Once the surgical site has expanded, bone cement can be injected into the surgical site through the pedicle screw 1900.

[0096] In Figure 19B, the expansion component 1930 is shown in an expanded state, with the four mechanical supports 1932A, 1932B, 1932C, 1932D undergoing a shape change from a substantially straight configuration to a bent configuration, thereby protruding radially inward from the cannulation tubular body 1920. As shown, compared to Figure 19A, the expansion component 1930 has shifted downward toward the first end of the pedicle screw 1900 to accommodate these shape changes of the mechanical supports 1932A, 1932B, 1932C, 1932D. In this example, there are four mechanical supports in the form of bars with a central joint configured to bend, although it will be readily understood that an alternative number of mechanical supports having different configurations can be utilized.

[0097] 19C shows an exploded view of the pedicle screw. As shown, the cannulated tubular body can have a first end 1921 that receives the expansion component 1930 and a second end 1922 that receives the threaded cover 1910. The threaded cover 1910 can include a threaded portion 1912 and a drill coupling member 1914. Although not shown, the drill coupling member 1914 can include a screw tulip. The expansion component 1930 can include an adjustment element 1934 that contacts the mechanical supports 1932A, 1932B, 1932C, and 1932D. The adjustment element 1934 can be configured to move axially along the tubular body 1920, which movement can shift the mechanical supports 1932A, 1932B, 1932C, and 1932D from a compressed state to an expanded state, or vice versa.

[0098] In this example, the cannulation tubular body 1920 can include a plurality of cement injection windows 1924 to aid in the injection of bone cement through the pedicle screws 1900. The cannulation tubular body 1920 can also include an external thread 1926 at the first end 1921. The adjustment element 1934 of the expansion component 1930 can include internal threads or other structural features configured to contact and interact with the external threads 1926 of the tubular body 1920. Based on this interaction, rotation of the cannulation tubular body 1920 can effect axial translation of the adjustment element 1934. As shown in FIGS. 19D-19E , the cannulation tubular body 1920 can include a coupling member 1928 at its second end 1922. The coupling member 1926 can be configured to receive a driver and, when coupled to the driver, allow an operator to rotate the cannulation tubular body 1920 and controllably change the state of the inflation component 1930.

[0099] The pedicle screw 1900 may further include a handle or related device configured to control the placement of the pedicle screw 1900 and the adjustment of the expansion component 1930. A driver may be configured to couple to the coupling member 1926 and drive the pedicle screw 1900 into the surgical site. For example, the driver may include a first handle element (e.g., an outer handle) configured to control the rotation of the threaded cover 1910. To control the expansion component 1930, the driver may further include a second handle element (e.g., an inner handle) configured to rotate to adjust the expansion component 1930. For example, the first handle element may be held in a stationary position, while the second handle element may be intentionally rotated to cause rotation of the cannulation tubular body 1920, thereby controllably changing the state of the expansion component 1930. The driver may be specifically designed for cannulation, so that a cement cannula may be inserted after the surgical site is dilated. K-wires can be particularly used to control such cannulation drivers and subsequent or simultaneous cement cannulation.

[0100] FIG. 20A shows an expander device 2000 with a mechanical expansion component 2020 that can be controllably switched from a compressed state (FIG. 20A) to an expanded state (FIG. 20B). As can be seen, the expander device 2000 can generally include a tubular body 2010 configured to be inserted into a spinal surgical site and an expansion component 2020 coupled to the tubular body 2010. The expansion component 2020 functions in a manner similar to the expansion component 1930 of FIGS. 19A-19E, switching from a compressed state to an expanded state to apply an expansion force to the surgical site.

[0101] In FIG. 20B, the expansion component 2020 is shown in an expanded state, with the three mechanical supports 2022A, 2022B, and 2022C undergoing a shape change to arc outwardly and radially inward from the tubular body 2010. Unlike the mechanical supports of FIGS. 19A-19B, the mechanical supports 2022A, 2022B, and 2022C do not have designated joints that must undergo shape deformation. Rather, the mechanical supports 2022A, 2022B, and 2022C can be formed from an elastic material configured to flex throughout its length to cause radial expansion. In other words, the mechanical supports 2022A, 2022B, and 2022C can be formed from flexible rods configured to undergo a shape change when in the expanded state. While numerous suitable materials are possible, the mechanical supports 2022A, 2022B, and 2022C can specifically comprise or consist essentially of nitinol.

[0102] FIG. 20D shows a cross-sectional view of the inflation device 2000. In this example, a plug 2024 functions as an adjustment element and can be positioned within the cannulation tubular body 2010. The plug 2024 can be configured to move axially inward and contact and apply force to the mechanical supports 2022A, 2022B, 2022C. As shown, the cannulation tubular body 2010 can include an internal thread 2012 that can axially abut the plug when the mechanical supports are in a compressed state. A bolt 2030 with threads 2032, or similar threaded component, can be rotated to apply a downward force to the plug 2024, thereby moving the plug 2024 axially inward and changing the state of the inflation component 2020.

[0103] The inflation device 2000 can further include a handle or associated device configured to control the positioning of the inflation device 2000 and the adjustment of the inflation component 2020. For example, a first handle element (e.g., an outer handle) can be coupled to the tubular body 2010, and a second handle element can be coupled to the inflation component 2020, such as by contacting the plug 2024 either directly or indirectly. The second handle element can be configured to adjust the state of the inflation component 2020 such that rotation of the second handle element causes axial movement of the plug 2024. When the second handle element is used to adjust the state of the inflation component 2020, the first handle element can be held in a stationary position to prevent movement of the remainder of the inflation device 2000.

[0104] Although not shown in these examples, consistent with the discussion above, a mesh or similar structure can be positioned adjacent to the mechanical supports 2022A, 2022B, 2022C and configured to expand radially in conjunction with the mechanical supports 2022A, 2022B, 2022C. The use of such a mesh can help ensure proper and uniform expansion of the surgical site and controlled delivery of the subsequently injected bone cement.

[0105] While many of the devices and systems described herein are described as manually operated tools that can improve control and precision during the procedure, it will be readily understood that mechanically powered tools and techniques can be used instead.

[0106] In the description above and in the claims, phrases such as "at least one of" or "one or more of" may occur following a linked list of elements or features. Also, the term "and / or" may occur with a list of two or more elements or features. Unless implicitly or explicitly contradicted by the context of use, such phrases are intended to mean any of the listed elements or features individually, or any of the listed elements or features in combination with any of the other elements or features listed. For example, the phrases "at least one of A and B," "one or more of A and B," and "A and / or B" are intended to mean "A alone, B alone, or A and B together," respectively. A similar interpretation is also intended for lists containing more than two items. For example, the phrases "at least one of A, B, and C," "one or more of A, B, and C," and "A, B, and / or C" are intended to mean "A only, B only, C only, A and B together, A and C together, B and C together, or A, B, and C together," respectively. Additionally, use of the phrase "based on" above and in the claims is intended to mean "based at least in part on," allowing for unrecited features or elements.

[0107] The subject matter described herein may be embodied in systems, devices, methods, and / or articles, depending on the desired configuration. The implementations set forth in the foregoing description do not represent all implementations consistent with the subject matter described herein. Instead, they are merely some examples consistent with aspects related to the described subject matter. While several variations have been described in detail above, other modifications or additions are possible. In particular, additional features and / or variations may be provided in addition to those described herein. For example, the above-described embodiments may be directed to various combinations and combinations of the disclosed features and / or combinations and combinations of several additional features disclosed above. Other implementations may be within the scope of the following claims.

Claims

1. 1. A device for a spinal stabilization procedure, comprising: a cannulation tubular body having an end configured to be inserted into a surgical site; an inflation component coupled to the cannulation tubular body; and the expansion component comprises: The device includes a plurality of elongated mechanical supports (i) configured to be axially aligned with the cannulation tubular body when in a compressed state, and (ii) configured to bend radially outward when in an expanded state.

2. 10. The device of claim 1, wherein at least a portion of the mechanical support comprises a bar with a central joint, and wherein at least a portion of the mechanical support is configured to bend at the central joint when in the expanded state.

3. 3. The device of claim 1 or 2, wherein the mechanical support is formed from a flexible rod configured to undergo a change in shape when in the expanded state.

4. 10. The device of any preceding claim, wherein the expansion component further includes an adjustment element in contact with the mechanical support, the adjustment element configured to move axially such that movement of the adjustment element toward the end of the cannulation tubular body shifts the mechanical support from the compressed state to the expanded state.

5. a portion of the expansion component is threaded and configured to contact the adjustment element; The device of claim 4 , wherein the cannulation tubular body is configured to rotate within the adjustment element to move the adjustment element in the axial direction.

6. Further comprising a handle, said handle comprising: a first handle element coupled to the cannulation tubular body; a second handle element coupled to the inflation component, wherein rotation of the second handle element effects the movement of the adjustment element; and The apparatus of claim 4 , comprising:

7. further comprising a mesh positioned adjacent to the mechanical support; 10. The device of any preceding claim, wherein the mechanical support is configured to contact the mesh during the expanded state and expand the mesh.

8. 10. The device of any preceding claim, further comprising a screw portion configured to be secured to bone within the surgical site.

9. 1. A pedicle screw for use in a spinal stabilization procedure, comprising: a cannulation tubular body having a first end configured for insertion into a surgical site and a second end; a threaded cover positioned on the second end of the cannulation tubular body, the threaded cover configured to be secured to bone within a surgical site; and an inflation component coupled to the cannulation tubular body; and the expansion component comprises: The pedicle screw includes a plurality of elongated mechanical supports (i) configured to be axially aligned with the cannulated tubular body when in a compressed state, and (ii) configured to bend outward in a radial direction when in an expanded state.

10. The pedicle screw of claim 9 , wherein the cannulated tubular body is configured to rotate freely within the threaded cover.

11. The pedicle screw according to claim 9 or 10, wherein the cannulated tubular body comprises an external thread at the first end.

12. 12. The pedicle screw of claim 9, wherein the expansion component further comprises an adjustment element contacting the mechanical support, the adjustment element configured for axial movement such that movement of the adjustment element toward the first end of the cannulated tubular body shifts the mechanical support from the compressed state to the expanded state.

13. a portion of the inflation component is threaded and configured to contact the external threads of the cannulation tubular body; The pedicle screw of claim 12 , wherein the cannulated tubular body is configured to rotate within the adjustment element to move the adjustment element axially.

14. 14. The pedicle screw of claim 9, wherein the mechanical support comprises a bar with a central joint, and at least a portion of the mechanical support is configured to bend at the central joint when in the expanded state.

15. The pedicle screw of any of claims 9 to 14, wherein the cannulated tubular body further comprises a cement injection window positioned along the cannulated tubular body.

16. The pedicle screw according to any one of claims 9 to 15, wherein the threaded cover further comprises a drill coupling member.

17. The pedicle screw of claim 16, wherein the drill coupling member comprises a screw tulip.

18. 1. A device for a spinal stabilization procedure, comprising: a cannulation tubular body having a first end configured for insertion into a spinal surgical site and a second end; an inflation component coupled to the cannulation tubular body; and the expansion component comprises: (i) a plurality of elongated mechanical supports configured to be axially aligned with the cannulation tubular body when in a compressed state, and (ii) configured to bend radially outward when in an expanded state; a plug positioned within the cannulation tubular body; Including, the plug is configured to move axially to contact and apply a force to the mechanical support such that movement of the adjustment element toward the first end of the cannulation tubular body shifts the mechanical support from the compressed state to the expanded state.

19. 19. The device of claim 18, wherein the cannulation tubular body includes internal threads at the second end that are axially adjacent the plug when the mechanical support is in a compressed state.

20. 20. The device of claim 18 or 19, wherein the mechanical support is formed from a flexible rod configured to undergo a change in shape when in the expanded state.

21. 21. The device of claim 20, wherein the mechanical support is formed from a material comprising Nitinol.

22. a first cannula having a cannulation tubular body configured to expand an expandable metal mesh, the cannulation tubular body passing through a working sleeve and configured to expand the expandable metal mesh within a surgical site; a pedicle screw coupling positioned at a first end of the cannulated tubular body, the pedicle screw coupling configured to couple to the pedicle screw in a manner that allows the pedicle screw to be driven while the pedicle screw coupling is rotated; a cement cannula positioned within the interior of the cannulated tubular body, the cement cannula configured to deliver bone cement through the cannulated portion of the tubular body to a coupled pedicle screw, and configured to remain within the interior while the pedicle screw coupling is rotated; Including, the system.

23. 23. The system of claim 22, wherein the cement cannula is configured to remain within the cannulation tubular body while the pedicle screw coupling is rotated.

24. 24. The system of claim 22 or 23, further comprising a cement cannula port coupled to the cement cannula.

25. The system of any of claims 22-24, wherein the cement cannula includes a directional element configured to selectively deliver bone cement to pedicle screws attached to the pedicle screw coupling.

26. 26. The system of claim 25, wherein the directional element is configured to selectively deliver the bone cement to the pedicle screw within an adjustable direction.

27. The system of any of claims 22-26, wherein the pedicle screw coupling includes a cutting element, the cutting element configured to provide access to the surgical site.

28. The system of any of claims 22 to 27, wherein the screwdriver system includes a handle coupled to a second end of the cannulation tubular body.

29. a first cannula having a cannulation tubular body configured to expand an expandable metal mesh, the cannulation tubular body passing through a working sleeve and configured to expand the expandable metal element within a surgical site; a pedicle screw coupling positioned at a first end of the cannulated tubular body, the pedicle screw coupling configured to couple to the pedicle screw in a manner that allows the pedicle screw to be driven while the pedicle screw coupling is rotated; a handle attached to the second end of the cannulation tubular body; an inner shaft positioned within the cannulation tubular body, the inner shaft having a threaded portion protruding from the first end of the cannulation tubular body; a handle knob positioned within at least a portion of the handle, the handle knob coupled to the inner shaft in a manner such that rotating the handle knob causes rotation of the threaded portion of the inner shaft; Including, the system.

30. 30. The system of claim 29, wherein the threaded portion is configured to be threaded into the pedicle screw to form an attachment between the inner shaft and the pedicle screw.

31. 31. The system of claim 29 or 30, wherein the pedicle screw coupling includes a cutting element, the cutting element configured to provide access to a surgical site.

32. The system of any of claims 29 to 31, wherein the handle includes at least one aperture configured to provide access to the handle knob.

33. 33. The system of claim 32, wherein the handle knob is substantially enclosed by the handle.

34. 34. The system of claim 33, wherein at least a portion of the handle knob protrudes partially through the aperture and extends beyond the face of the handle.

35. The system of any of claims 29 to 34, wherein the handle knob comprises an annular body having a flat top surface, a flat bottom surface, and an annular sidewall.

36. 36. The system of claim 35, wherein the annular sidewall includes a plurality of ridges arranged axially relative to the cannulation tubular body.

37. 36. The system of claim 35, wherein the annulus includes a central aperture configured to provide access from the top surface to the bottom surface.

38. 38. The system of any one of claims 22 to 37, wherein the handle includes a first handle arm and a second handle arm, the first handle arm and the second handle arm extending outward in opposite radial directions relative to the cannulation tubular body.

39. 39. The system of claim 38, wherein the first handle arm and the second handle arm each have an outer end and an inner end, and wherein a width of each of the handle arms at the outer end is less than a width at the inner end.

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