Bone cement dispenser systems and associated methods of application

Abstract

A bone cement dispensing system includes a dispensing device comprises a body extending from a first end to a second end and defining a chamber. The second end defines an outlet opening. The dispensing device further includes an extractor structured to move within the chamber. Bone cement is contained in the chamber of the dispensing device. The bone cement is UV-curable bone cement and is loaded into the chamber in a premixed form. The system further includes a UV radiation source and a power source in communication with the UV radiation source, the movement of the extractor within the chamber urges the bone cement from the chamber to the outlet opening and dispenses the bone cement from the outlet opening. The UV radiation source is configured to expose the dispensed bone cement to UV radiation for a period of time to cure the bone cement.

Description

BONE CEMENT DISPENSER SYSTEMS AND ASSOCIATED METHODS OF APPLICATIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 652,334, filed May 28, 2024, which is incorporated by reference as if disclosed herein in its entirety.BACKGROUND

[0002] Over 1.5 million individuals are treated for Vertebral Compression Fractures (VCFs) every year in the United States. In order to repair VCFs, surgeons use bone cement to fill in voids in the vertebral body formed by the VCF. Once the bone cement is applied or dispensed into the void, it must set in order to be effective. The curing time for this bone cement may be at least 30 minutes. Unfortunately, during this time period, the bone cement may leak or otherwise drain from the void during this long curing time. In addition to leakage, the traditional treatments for VACFs may result in secondary adjacent level fractures (SALFs), which are fractures that occur next to a previously treated fracture. Both the leakage of the bonce cement from the void and SALFs significantly detract from patient outcomes.

[0003] The idea of a system and method that integrates a specialized, photo-activated bone cement with a precision dispenser would greatly help to improve the outcomes for patients being treated for bone fractures, such as VACFs, as well as decrease overall associated healthcare costs.SUMMARY

[0004] Aspects of the following disclosure are directed to embodiments of a bone cement dispensing system that includes a dispensing device comprising. In some embodiments, the dispensing device includes a body defining a chamber that extends from a first end to a second end. In some embodiments, the second end defines an outlet opening. In some embodiments, the dispensing device further includes an extractor that is structured to move within the chamber. In some embodiments, the system includes a bone cement contained in the chamber of the dispensing device. In some embodiments, the bone cement is UV-curable bone cement and is loaded into the chamber is a premixed form. In some embodiments, the system further includes a UV radiation source and a power source in communication with the UV radiation source. In some embodiments of the system, themovement of the extractor within the chamber urges the bone cement from the chamber to the outlet opening and dispenses the bone cement from the outlet opening. In some embodiments of the system, the UV radiation source is configured to expose the dispensed bone cement to UV radiation for a period of time to cure the bone cement.

[0005] In some embodiments of the system, the UV radiation source is integrated into the dispensing device. In some embodiments of the system, the UV radiation source includes a UV delivery lumen, the outlet opening is coupled to a dispensing lumen, and the UV delivery lumen is positioned side-by- side relative to the dispensing lumen. In some embodiments of the system, the period of time is from about 2 to 3 minutes. In some embodiments, the system further includes a controller in communication with at least one of (i) the dispensing device; and (ii) the UV radiation source. In some embodiments of the system, the dispensing device further includes a nozzle coupled to the outlet opening, wherein the nozzle includes UV reflectance shielding that is structured to inhibit UV radiation from reaching bone cement in the nozzle. In some embodiments, the system further includes one or more thermal sensors positioned on the nozzle and configured to monitor heat generated by the bone cement during curing. In some embodiments, the system further includes a support device configured to support and / or retain the dispensing device. In some embodiments, the system further includes a driver operatively coupled to the extractor and configured to automatically drive the extractor relative to the chamber to dispense the cement from the outlet opening. In some embodiments of the system, the bone cement comprises at least one of Polyfmethyl methacrylate) (PMMA), Zirconium dioxide (ZrCh), Diurethane dimethacrylate (DUDMA), Triethylene glycol di methacryl ate (TEGDMA), N,N-dimethyl-p-toluidine (DmPT), and Hydroquinone (HQ). In some embodiments of the system, the bone cement comprises one or more photoinitiators components that exhibit distinct absorption peaks in both long wave (UV-A) and visible light spectrum. In some embodiments of the system, the one or more photoinitiators include photocurable urethanes and / or photocurable polyester based monomers. In some embodiments of the system, the photoinitiator component comprises at least one of 2,2-Dimethoxy-2-phenylacetophenone (DMPA), lithium phenyl- 2, 4, 6-trimethylbenzolphoshinate (LAP), camphorquinone (CQ), and poly(ethylene glycol) diacrylate (PEGDA).

[0006] Aspects of the present disclosure are directed to embodiments of a method of using a bone cement dispensing system to treat a compression bone fracture. In some embodiments, the method includes identifying a site of a compression fracture in a bone, creating a void at the site of thecompression bone fracture, and injecting an amount of bone cement from a dispensing device to fill the void, wherein the bone cement comprises a photoinitiator component. In some embodiments, the method includes irradiating the bone cement with a source of UV radiation for a period of time to cure the bone cement, wherein the period of time is about 2-3 minutes.

[0007] In some embodiments of the method, the bone comprises a vertebral bone. In some embodiments of the method, the photoinitiator component exhibits a distinct absorption peak in a long wave (UV-A) and a visible light spectrum. In some embodiments of the method, the photoinitiator component includes photocurable urethanes and / or photocurable polyester based monomers. In some embodiments of the method, the photoinitiator component comprises at least one of 2,2-Dimethoxy- 2-phenylacetophenone (DMPA), lithium phenyl-2, 4, 6-trimethylbenzolphoshinate (LAP), camphorquinone (CQ), and poly(ethylene glycol) diacrylate (PEGDA). In some embodiments, the method further includes creating the void by inserting a balloon tamp into the compression fracture and inflating the balloon, wherein the inflation of the balloon creates the void at the site of the compression fracture. In some embodiments, the method further includes structuring a controller to automatically inject the amount of bone cement from a dispensing device to fill the void and to irradiate the bone cement with UV radiation for the period of time to cure the bone cement. In some embodiments, the method further includes covering at least a portion of the dispensing device with a UV reflectance shielding to inhibit the bone cement from curing within the dispensing device. In some embodiments, the method further includes structuring a support device to support and retain the dispensing device. In some embodiments, the method further includes structuring one or more thermal sensors to be positioned on the dispensing device and to monitor heat generated during the curing of the bone cement.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The drawings show embodiments of the disclosed subject matter for the purpose of illustrating the invention. However, it should be understood that the present application is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein:

[0009] FIG. 1 schematically illustrates an embodiment of a bone mortar dispensing system according to some embodiments of the present disclosure;

[0010] FIG. 2 schematically illustrates the embodiment of FIG. 1 according to some embodiments of the present disclosure;

[0011] FIG. 3 schematically illustrates another embodiment of the bone mortar dispensing system according to some embodiments of the present disclosure;

[0012] FIG. 4 schematically illustrates a top perspective view of an embodiment of a support device of the embodiment of the bone mortar dispensing system of FIG. 3 according to some embodiments of the present disclosure;

[0013] FIG. 5 schematically illustrates another embodiment of the bone mortar dispensing system according to some embodiments of the present disclosure;

[0014] FIG. 6 schematically illustrates a top perspective view of an embodiment of a support device of the embodiment of the bone mortar dispensing system of FIG. 5 according to some embodiments of the present disclosure;

[0015] FIG. 7 schematically illustrates another embodiment of the bone mortar dispensing system according to some embodiments of the present disclosure;

[0016] FIG. 8 schematically illustrates a sectional view of the embodiment of the bone mortar dispensing system of FIG. 7 along A- A according to some embodiments of the present disclosure;

[0017] FIG. 9 schematically illustrates another sectional view of an embodiment of the bone mortar dispensing system according to some embodiments of the present disclosure;

[0018] FIG. 10A schematically illustrates a close-up view of an embodiment of a nozzle of the bone mortar dispensing system from box B of FIG. 9 according to some embodiments of the present disclosure;

[0019] FIG. 10B schematically illustrates a sectional view of the embodiment of FIG. 10A along C- C according to some embodiments of the present disclosure;

[0020] FIG. 11 A schematically illustrates an embodiment of the bone mortar dispensing system with an embodiment of a cement cartridge in an installed position and a portion of the support device removed according to some embodiments of the present disclosure;

[0021] FIG. 1 IB schematically illustrates an embodiment of the bone mortar dispensing system with an embodiment of a cement cartridge in an uninstalled position and a portion of the support device removed according to some embodiments of the present disclosure;

[0022] FIG. 12 schematically illustrates a sectional view of an embodiment of a UV delivery device according to some embodiments of the present disclosure;

[0023] FIG. 13 schematically illustrates a sectional view of an embodiment of a bone cement dispensing device according to some embodiments of the present disclosure;

[0024] FIG. 14 illustrates steps of an embodiment of a method of using a bone mortar dispensing system according to some embodiments of the present disclosure; and

[0025] FIGS. 15A-E schematically illustrate method steps of FIG. 14.DETAILED DESCRIPTION

[0026] The following discussion relates to various embodiments of systems and methods for treating bone fractures, specifically VCFs. In some embodiments, a bone cement dispensing system of a bone mortar dispensing system 100 includes a dispensing device 110, such as shown in FIGS. 1 and 2, and that is configured to hold and dispense an amount or volume of pre-mixed UV-curable bone cement (bone cement) 130, and a UV radiation source 140. In some embodiments, the amount or volume of bone cement is less than about lOmL. In some embodiments, the amount or volume of bone cement is between about 4mL and 5mL. It will be understood that the herein described versions are examples that embody certain inventive concepts as detailed herein. To that end, other variations and modifications will be readily apparent to those of sufficient skill. The terms “about” or “approximately” as may be used herein may refer to a range of 80%-125% of the claimed or disclosed value.

[0027] Still referring to FIGS. 1 and 2, in some embodiments, the dispensing device 110 includes a body 112 that extends along an axis D from a first end 111 to a second end 113. In some embodiments, the second end 113 defines an outlet opening 114. In some embodiments, the body defines chamber 116 that is structured to hold the bone cement 130. In some embodiment’s a nozzle 118 fluidly couples the chamber 116 to the outlet opening 114. In some embodiments, at least a portion of the body 112 or the dispensing device 110 includes UV reflectance shielding 150 that is configured to inhibit UV- radiation from causing the bone cement in the dispensing device to cure. In some embodiments, the dispensing device 110 further includes an extractor 119 that is structured to cooperate with the body 112 to control the dispensing of the bone cement 130 from the outlet opening 114. In some embodiments, the extractor is structured to move within the chamber 116 to urge the bone cement 130from the chamber through the outlet opening 114. In some embodiments, the dispensing device 110 comprises a syringe and the extractor 119 comprises a plunger that is structured to force the bone cement from the chamber 116 and through the outlet opening 1 14 when the plunger is advanced towards the body 112. One of the advantages of the disclosed systems / methods is that the bone cement 130 is provided preloaded in the dispensing device and in a premixed form so that it may be used immediately.

[0028] In some embodiments, the bone mortar dispensing system 100 includes a source of UV radiation 140. In some embodiments, the UV radiation source is coupled to, or otherwise integrated into the body 112 of the dispensing device 110 and includes a light shaft 142 that extends to a light port 144. In some embodiments, the light port 144 is positioned proximate to the outlet opening 114 so that the bone cement 130 is irradiated as soon as it is expelled from the outlet opening 114 of the body 112. In some embodiments, the UV radiation source comprises a light emitting diode (LED). In some embodiments, the UV radiation source 140 is configured to emit long wave light or UV-A light (315-400nm) and / or visible light (380-780nm).

[0029] The bone cement 130 must be biocompatible with minimal toxicity, while achieving a level of mechanical strength to withstand physiological loads associated with daily activity without degradation over time. In some embodiments, the bone cement 130 comprises Poly(m ethyl methacrylate) (PMMA), and / or Zirconium dioxide (ZrO2), and / or Diurethane dimethacrylate (DUDMA), and / or Triethylene glycol dimethacrylate (TEGDMA), and / or N,N-dimethyl-p-toluidine (DmPT), and / or Hydroquinone (HQ). In some embodiments, the bone cement further includes one or more photoinitiator components that absorb light emitted from the UV radiation source. In some embodiments, the one or more photoinitiator components are selected for their distinct absorption peaks in both the long wave (UV-A) and visible light spectrums. This ensures that an efficient activation of the photoinitiator(s) across a broad range of light sources that are used in clinical settings. By selecting photoinitiators with preferred absorption characteristics, bone cement can achieve rapid and uniform polymerization, leading to reliable clinical outcomes and improved patient satisfaction. In some embodiments, the one or more photoinitiator components include photocurable urethanes and / or photocurable polyester based monomers. In some embodiments, the one or more photoinitiator components comprise at least one of2,2-Dimethoxy-2-phenylacetophenone (DMPA), lithium phenyl- 2, 4, 6-trimethylbenzolphoshinate (LAP), camphorquinone (CQ), and polyethylene glycol) diacrylate (PEGDA). In some embodiments, the bone cement may be manufactured in a cost-effectmanner and scalable manner to meet market demand while maintaining consistent quality and performance.

[0030] Through extensive testing, the inventors determined concentration ranges for the photoinitiators: 0.25 - 0.5% for Camphorquinone (CQ), 0.25 - 1% for Lithium Phenyl-2,4,6- trimethylbenzoylphosphinate (LAP), and 0.5 - 1.2% for 2,2-Dimethoxy-2-phenylacetophenone (DMPA) seemed to deliver optimal results. Based on these findings, concentrations of 0.5% CQ, 0.5% LAP, and 1% DMPA were chosen to progress to subsequent depth of cure studies. It was found that augmenting the photoinitiator beyond 0.25-1% adversely impacted the handling properties, leading to premature curing.

[0031] Further experiments conducted by the inventors that the temperature thresholds of the bone cement with one of the photoinitiators remained within a safe range, confirming the bone cements suitability for clinical use while prioritizing tissue safety. Moreover, bone cements comprising one of the photoinitiators demonstrated considerably shorter setting times over currently used bonce cements, affirming their potential for rapid curing in surgical contexts. Moreover, additional tests performed by the inventors indicated that bone cement comprising one of the photoinitiators higher rates of temperature increase during curing, which indicates a more efficient curing, which potentially results in beneficial effects on the mechanical properties and durability of the cured bone cement. Furthermore, the bone cements comprising one of the photoinitiators exhibit a bending modulus that more closely aligns with the bending modulus of a vertebral bone as well as exhibiting a bending strength that is less than currently used bone cements, which may reduce stress shielding effects.

[0032] In some embodiments, the bone mortar dispensing system 100 is structured for handheld operation by the user as shown in FIGS. 1 and 2 so that the user manually controls the dispensing of bone cement from the outlet opening 114 of the body 112. In other embodiments, such as shown in FIGS. 3 and 4, the bone mortar dispensing system 200 is structured for automatic dispensing of bone cement. In some embodiments, the dispensing device 210 includes a body 212 that extends along a body axis D' from a first end 211 to a second end 213. In some embodiments, the second end defined an outlet opening 214 that is fluidly coupled to a chamber 216 defined in the body and structured to hold an amount or volume of pre-mixed bone cement similar to previously discussed embodiments. In some embodiments, the amount or volume of bone cement is less than about lOmL. In some embodiments, the amount or volume of bone cement is between about 4mL and 5mL. In some embodiments, the first end 211 of the body 212 includes an extractor 219 that is coupled to a drivemember 220 to operatively couple the extractor 219 to a driver 222 or motor. In some embodiments, the driver 222 comprises a servo-driven mechanism, such as a FS51O3 continuous servo.

[0033] In some embodiments, the bone mortar dispensing system 200 further includes a support device 202 that is structured to support and retain an embodiment of the dispensing device 210. In some embodiments, the support device 202 includes a support surface 204 and one or more anchor members 206 coupled to the support surface 204 and structured to engage a portion of the body 212 of the dispensing device 210 to secure the dispensing device 210 to the support device 202. In some embodiments, the support device includes one or more support members 208 coupled to the surface 204 and structured to support the support surface 204. In some embodiments, the support surface defines one or more openings 209 structured to receive a portion of the body 212 of the dispensing device 210 when the dispensing device 210 is secured to the support surface 204. In some embodiments, the support surface 204 further includes one or more mounts 205 that are structured to facilitate coupling of the driver 222 to the support surface 204.

[0034] Another embodiment of the bone mortar dispensing system 300 is shown in FIGS. 5 and 6, and also includes a support device 302 structured to support and retain an embodiment of the dispensing device 310. Similar to previously discussed embodiments, the dispensing device 310 includes a body 312 that extends along a body axis D” from a first end 311 to a second end 313. In some embodiments, the second end defined an outlet opening 314 that is fluidly coupled to a chamber 316 defined in the body and structured to hold an amount of pre-mixed bone cement similar to previously discussed embodiments. In some embodiments, the amount or volume of bone cement is less than about lOmL. In some embodiments, the amount or volume of bone cement is between about 4mL and 5mL. In some embodiments, the first end 311 of the body 312 includes an extractor 319 that is coupled to a drive member 320 to operatively couple the extractor 319 to a driver or motor 322. In some embodiments, the driver 322 comprises a servo-driven mechanism. In some embodiments, the driver 322 is configured to rotate a drive gear 324 that is configured to engage the drive member 320 to transfer the energy output by the driver 322 to the drive member 320.

[0035] In some embodiments, the support device 302 is structured to support and retain an embodiment of the dispensing device 310 in a similar manner as embodiments previously discussed. In some embodiments, the support device 302 includes a support surface 304 and one or more anchor members 306 coupled to the support surface 304 and structured to engage a portion of the body 312 of the dispensing device 310 to secure the dispensing device 310 to the support device 302. In someembodiments, the support device 302 includes one or more support members 308 coupled to the support surface 304 and structured to support the support surface 304. In some embodiments, the support device 302 further includes one or more mounts 312 that are structured to facilitate coupling of the driver 322 to the support device 302.

[0036] Another embodiment of the bone mortar dispensing system 400 is shown in FIGS. 7-10B, and also includes a support device 402 in the form of a housing that structured to surround and support an embodiment of the dispensing device 410. Referring to FIG. 7, in some embodiments, the support device comprises a plurality of sections 402a-d. In some embodiments, the support device 402 is in the shape of a gun and includes a body 403, a grip 404 coupled to a lower end of the body 403, and a barrel 405 coupled to a forward end of the body 403. Referring to FIGS. 8-10B and similar to previously discussed embodiments, the dispensing device 410 includes a body 412 that extends along a body axis D’” from a first end 411 to a second end 413. In some embodiments, the second end defined an outlet opening 414 that is fluidly coupled to a chamber 416 defined in the body 412 and structured to hold an amount of pre-mixed bone cement similar to previously discussed embodiments. In some embodiments, the amount or volume of bone cement is less than about lOmL. In some embodiments, the amount or volume of bone cement is between about 4mL and 5mL. In some embodiments, the first end 411 of the body 412 includes an extractor 419 that is coupled to a drive member 420 to operatively couple the extractor 419 to a driver or motor 422. In some embodiments, the driver 422 comprises a servo-driven mechanism. In some embodiments, the driver 422 is configured to rotate a drive gear 424 that is configured to engage the drive member 420 to transfer the energy output by the driver 422 to the drive member 420.

[0037] Referring to FIGS. 9-10B, in some embodiments, an injector or extension 426 is configured to couple at the outlet opening 414 at a first end 427 and extend away from the housing 402 to a second end 429. In some embodiments, the extension 426 includes a nozzle 430 coupled to the second end 429. In some embodiments, the extension 426 comprises a length L between about 24-36 inches long. In some embodiments, the nozzle 430 is structured with a diameter that is less than about 1mm. In some embodiments, the nozzle 430 is structured with a diameter that is less than about 0.3mm. In some embodiments, the extension 426 comprises a conduit or lumen 428 that is structured to direct the bone cement from the outlet opening 414 of the body 412 to the nozzle 430. In some embodiments, the lumen 428 is at least partially surrounded by a lumen casing 428a. In this manner, the bone cement may be delivered to tight spaces without interference from other components of the bone mortardispensing system 400. In some embodiments, the lumen 428 is a multichannel lumen. Some embodiments of the multichannel lumen include a UV delivery lumen 428a that is connected to the nozzle 430. In some embodiments, the nozzle 430 defines a dispensing portion 432 that is structured to dispense the bone cement from the extension 426. In some embodiments, the nozzle 430 includes one or more sources of UV radiation or UV delivery nodes 440 positioned proximate to the dispensing portion 432. In some embodiments, the UV delivery lumen 428a is connected to the one or more UV delivery nodes 440. In some embodiments, the one or more UV radiation sources 440 may be comprised of one or more LEDs. In some embodiments, the nozzle 430 further includes one or more sensors 434 positioned proximate to the dispensing portion 432. In some embodiments, the one or more sensors 434 comprise thermal sensors configured to monitor the heat generated during the curing process. Excessive heat generation may cause damage to surrounding body tissue as well as impacting the overall curing process. In some embodiments, the nozzle 430 is at least partially covered by a UV reflectance shield 450 that is structured to inhibit UV radiation exposure of bone cement in the nozzle 430. Exposing the bone cement in the nozzle to UV radiation may result in bone cement curing inside the nozzle 430 and clogging the dispensing portion 432. A similar extension and / or nozzle may be used in any of the other embodiments previously discussed in order to facilitate bone cement deposition in tight spaces or spaces that are positioned distally from the body of the dispensing device. In some embodiments, the length of the extension 426 may vary according to the particular surgical procedure and / or setup.

[0038] Referring to FIGS. 11A and 11B, some embodiments of the bone mortar dispensing system 400 are configured to accommodate cement cartridges 500. In some embodiments, the cement cartridges 500 comprise the dispensing device 410 and are configured to enable the user to seamlessly swap out cartridges 500 between procedures without needing to disassemble the dispensing device 410. In some embodiments, a portion of the support device or housing 402 may be removed in order to install or remove the cement cartridge 500. In some embodiments, the cement cartridge 500 is structured to mimic a narrow syringe and comprises a capacity of approximately 4-5mL, which aligns with the typical volume used for vertebral augmentation. Figure 11A shows an embodiment of the cartridge being installed into the housing 402 of the bone mortar dispensing system 400 and FIG. 1 IB shows an embodiment of the cartridge uninstalled from the housing 402 of the bone mortar dispensing system 400. The use of the cement cartridge 500 emphasizes the reusability and efficiency of the bone mortar dispensing system 400 and also caters to the practicality of surgical settings, thereby streamlining the surgical workflow.

[0039] In some embodiments, such as shown in FIG. 12, a UV delivery device 460 is shown that may be used as part of a bone mortar dispensing system. In some embodiments, a housing 462 at least partially surrounds components of the UV delivery device 460. In some embodiments, the UV delivery device 460 includes a UV delivery lumen 464 connected to one or more UV delivery nodes 466. In some embodiments, the UV delivery lumen 464 includes a UV radiation source. In some embodiments, the one or more UV delivery nodes 466 may be included as part of a nozzle that is similar to the nozzle 430 of FIGS. 10A and 10B. In some embodiments, the UV delivery device 460 includes a UV delivery node power source 750 that is connected to the one or more UV delivery nodes 466. In some embodiments, the one or more UV delivery nodes 466 are structures to deliver localized UV radiation for localized polymerization of bone cement.

[0040] In some embodiments, such as shown on FIG. 13, a mortar or bone cement dispensing device 470 is shown that may be used as part of a bone mortar dispensing system. In some embodiments, a housing 472 at least partially surrounds components of the bone cement dispensing device 470. In some embodiments, the bone cement dispensing device 470 includes a cement cartridge 500 or a dispensing body 474 that defines a chamber 476 structured to hold a premixed bone cement 130. In some embodiments, the chamber 476 defines an outlet opening or a chamber outlet 477. In some embodiments, the chamber outlet 477 is connected to a dispensing lumen 478, such as a tube, that extends away from the housing 472. In some embodiments, the dispensing lumen 478 comprises a single channel, however in some embodiments, the dispensing lumen 478 comprises multiple channels. In some embodiments, the multi-channel dispensing lumen 478 also includes aUV delivery lumen 464. In some embodiments, the UV delivery lumen 464 and the dispensing lumen 478 are positioned coaxially or in a side-by-side relationship relative to each other. Combining the bone cement dispensing and the UV radiation delivery into a single device enables precise cement placement and curing while minimizing radiation exposure and optimizing restoration of vertebral height. In some embodiments, the bone cement dispensing device 470 further includes an extractor 479 configured to cooperate with the dispending body 474. In some embodiments, the extractor 479 is structured to move within the chamber 476 to urge the bone cement 130 from the chamber 476 and into the dispensing lumen 478 via the chamber outlet 477. In some embodiments, the extractor 479 is operatively coupled to a driver 480, such as a motor or actuator, that drives the extractor 479 relative to the chamber 476. In some embodiments, the driver 780 is connected to a power source 700 and / or a controller 800.

[0041] In some embodiments of the bone mortar dispensing system, UV delivery device 460, and bone cement dispensing device 470 discussed herein, the driver and / or the source of UV radiation may be connected a power source 700, such an electrical power source via one or more connections 702. In some embodiments, the power source 700 comprises a battery, such as a lithium battery. In some embodiments, the power source 700 comprises an electrical outlet. In some embodiments, the power source 700 may be supported or otherwise enclosed by the housing such that the dispensing system 200, 300, 400, the UV delivery device 460, or the bone cement dispensing device 470 is contained as a single unit. In some embodiments, the power source 700 may be positioned remotely from the dispensing system 200, 300, 400, the UV delivery device 460, or the bone cement dispensing device 470. In some embodiments, the power source 700 may be in communication with the driver 222, 322, 422, 780 the one or more UV radiation sources 140, 440, 464, and the one or more sensors 434.

[0042] In some embodiments of the bone mortar dispensing system 200, 300, 400, UV delivery device 460, and bone cement dispensing device 470, one or more of the described components are in communication with a controller 800. In some embodiments, the UV delivery node power source 750 also includes a controller as described herein. In some embodiments, the controller 800 includes a user interface 810 configured to receive input from the user. In some embodiments, the user interface 810 further includes a display configured to display output from the controller 800. In some embodiments, the user interface 810 comprises a plurality of buttons, knobs, and / or toggles or switches, and / or a trigger. In some embodiments, the user interface 810 is configured to activate and / or deactivate any of the components / embodiments described herein. In some embodiments, the controller 800 includes one or more processors and memory units. In some embodiments, the controller 800 is configured to generate signals based on the user input and transmit those signals to the driver 222, 322, 422 to control operation of the driver to the In some embodiments, the controller is a computer. In some embodiments, the UV radiation source 140, 440 and / or the one or more sensors 434 are also in electrical communication with the controller 800 and configured to be operated based on signals sent by the controller 800 that are generated in response to a user input and / or a stored program. In some embodiments, the housing, or the support device 402 may support and at least partially surround the controller 800. In some embodiments, the controller 800 may be located away from the support device 202, 302. In some embodiments, the controller 800 is in communication with the power source 700.

[0043] Embodiments of a method 900 of using the bone mortar dispensing system is shown in FIGS. 14-15E and includes identifying a compression fracture in a bone 902. In some embodiments, the bone is a vertebral bone 10 having a VCF 12 as shown in FIG. 15 A. A void 14 is then created at the site of the compression fracture 12 at 904. In some embodiments, the void 14 is created by inserting a balloon tamp 20 into the fracture 12 and inflating the balloon 20 to create the void 14 as shown in FIGS. 15A and 15B. An amount of bone cement 130 is injected or dispensed into the void 14 to at least partially fill the void at 906. In some embodiments, the bone cement 130 is dispensed from the chamber 116, 216, 316, 416, 476 by applying a force to the extractor 119, 219, 319, 419, 479. In some embodiments, the user manually applies the force. In some embodiments, the driver applies the force. In some embodiments, the user controls the dispensing rate using the user interface 810 of the controller 800. In some embodiments, the dispensing rate is controlled by a preprogrammed dispensing protocol executed by the controller. The cement in the void is the exposed to UV radiation for period of time to cure or polymerize the bone cement at 908. In some embodiments, the UV radiation source 140 is positioned to begin the exposure as the bone cement is dispensed. In some embodiments, such as shown in FIGS. 15C and 15D, the bone cement 130 may be dispensed and irradiated at the same time. In some embodiments, a separate bone cement dispensing device 470 with dispensing lumen 478 may be used along with a separate UV delivery device 460 with UV delivery lumen 464 and UV delivery nodes 466. In some embodiments, a single device including a bone cement dispensing lumen 428 and a UV delivery lumen 428a may be used. If the latter is used, the bone cement dispensing lumen 428 and the UV delivery lumen 428a would be positioned in a side-by-side relationship relative to each other. In some embodiments, the exposure time is manually controlled by the user by turning the radiation source on and off. In some embodiments, the exposure time is controlled by an input to the user interface 810 of the controller 800. In some embodiments, the controller controls the exposure time 800 implementing a stored protocol. In some embodiments, the exposure time is less than 5 minutes. In some embodiments, the exposure time is less than 3 minutes. In some embodiments, the bone cement cures within about 2-3 minutes. The method ends at 910 when the bone cement has cured into a solid plug 25 as shown in FIG. 15E.

[0044] Although the invention has been described and illustrated with respect to exemplary embodiments thereof, it should be understood by those skilled in the art that the foregoing and various other changes, omissions, and additions may be made therein and thereto, without parting from the spirit and scope of the present invention.

Claims

CLAIMSWhat is claimed is:

1. A bone cement dispensing system comprising: a dispensing device comprising, a body defining a chamber and extending from a first end to a second end, wherein the second end defines an outlet opening; and an extractor structured to move within the chamber; a bone cement contained in the chamber of the dispensing device, wherein the bone cement is UV-curable bone cement and is loaded into the chamber in a premixed form; a UV radiation source; and a power source in communication with the UV radiation source, wherein the movement of the extractor within the chamber urges the bone cement from the chamber to the outlet opening and dispenses the bone cement from the outlet opening, wherein the UV radiation source is configured to expose the dispensed bone cement to UV radiation for a period of time to cure the bone cement.

2. The system of claim 1, wherein the UV radiation source is integrated into the dispensing device.

3. The system of claim 1, wherein the period of time is from about 2 to 3 minutes.

4. The system of claim 1, further comprising a controller in communication with at least one of: the dispensing device; and the UV radiation source.

5. The system of claim 1, wherein the dispensing device further comprises a nozzle coupled to the outlet opening, wherein the nozzle includes UV reflectance shielding configured to inhibit UV radiation from reaching bone cement in the nozzle.

6. The system of claim 5, further comprising one or more thermal sensors positioned on the nozzle and configured to monitor heat generated by the bone cement during curing.

7. The system of claim 2, wherein: the UV radiation source comprises a UV delivery lumen; the outlet opening is coupled to a dispensing lumen; and wherein the UV delivery lumen is positioned side-by-side relative to the dispensing lumen.

8. The system of claim 7, further comprising a driver operatively coupled to the extractor and configured to automatically drive the extractor relative to the chamber to dispense the cement from the outlet opening.

9. The system of claim 4, wherein the controller comprises a user interface configured to receive an input from a user to control the at least one of: the dispensing device; and the UV radiation source.

10. The system of claim 1, where the bone cement comprises a photoinitiator component that exhibit distinct absorption peaks in both long wave (UV-A) and visible light spectrum.

11. The system of claim 10, wherein the photoinitiator component comprises at least one of: 2,2- Dimethoxy-2-phenylacetophenone (DMPA); lithium phenyl-2, 4, 6-trimethylbenzolphoshinate (LAP); and camphorquinone (CQ).

12. A method of using a mortar bone cement system to treat a compression bone fracture, comprising: identifying a site of a compression fracture in a bone; creating a void at the site of the compression bone fracture; injecting an amount of bone cement from a dispensing device to fill the void, wherein the bone cement comprises a photoinitiator component; and irradiating the bone cement with a source of UV radiation for a period of time to cure the bone cement, wherein the period of time is about 2-3 minutes.

13. The method of claim 12, wherein the bone comprises a vertebral bone.

14. The method of claim 12, where the photoinitiator component exhibits a distinct absorption peak in a long wave (UV-A) and a visible light spectrum.

15. The method of claim 14, wherein the photoinitiator component comprises photocurable urethanes or photocurable polyester based monomers.

16. The method of claim 12, further comprising creating the void by: inserting a balloon tamp into the compression fracture; and inflating the balloon, wherein the inflation of the balloon creates the void at the site of the compression fracture.

17. The method of claim 12, further comprising structuring a controller to automatically inject the amount of bone cement from a dispensing device to fill the void and irradiate the bone cement with UV radiation for the period of time to cure the bone cement.

18. The method of claim 17, further comprising covering at least a portion of the dispensing device with a UV reflectance shielding to inhibit the bone cement from curing within the dispensing device.

19. The method of claim 17, further comprising structuring a support device to support and retain the dispensing device.

20. The method of claim 17, further comprising structuring one or more thermal sensors to be positioned on the dispensing device and to monitor heat generated during the curing of the bone cement.

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