Mixing device and method for preparing bone cement

Abstract

The invention discloses a mixing device and method for preparing bone cement. A piston (156) of the mixing device is located in a first region (158) of the chamber (112) such that the mixing paddle (154) rotates to mix the bone cement components at a first pressure to prepare the bone cement mixture. A piston (156) is moved through the inlet opening (136) to be placed within a second region (160) of the chamber (112) to compress the bone cement mixture to a second pressure greater than the first pressure to compress the bone cement mixture and prepare the bone cement. The bone cement can be transferred to a conveying device. The mixing device may include features to automatically initiate compression and transfer phases after completion of the mixing phase, and also include features to automatically terminate an operational cycle. A three-step intuitive workflow utilizing the mixing device to improve inter-surgical efficiency is also disclosed.

Description

[0001] This application is a divisional application of the invention patent application with application date of June 12, 2020, application number 202080040222.X, and invention name “Mixing device and method for preparing bone cement”.

[0002] Priority application

[0003] This application claims priority to and all benefits of U.S. Provisional Patent Application No. 62 / 861,698, filed on June 14, 2019, the entire contents of which are incorporated herein by reference. Background Art

[0004] A common source of back pain is vertebral compression fractures, in which weakened or injured vertebral bodies lose height or collapse. Weakening of the vertebral body may be due to acute trauma, or more commonly, degenerative changes such as osteoporosis. A treatment modality includes vertebral augmentation, in which the height of the vertebral body is raised or restored, and the height of the increase or restoration is stabilized with curable bone cement. Bone cement generally includes bone cement components (e.g., powdered polymers and liquid monomers), which are packaged separately and mixed before or during adjacent vertebral augmentation surgery. Efficient, uniform, safe and reproducible mixing of bone cement components is an area of ​​particular interest during development to ensure that bone cement has the expected mechanical properties and characteristics. Known devices that require manual mixing (e.g., "open bowl" or vacuum technology) are inefficient due to the need for operating room staff to vigorously stir each bone cement component. Different staff may mix bone cement components with varying or different intensities and / or with varying or different durations, which may result in bone cement that is not particularly uniform or reproducible. In addition, some manual mixing devices may not wish to expose staff to bone cement components. Known motorized mixing devices can overcome some of the above problems, but require the technician to participate in an overly complex workflow, particularly when the technician is not familiar with the device. Therefore, there is a need in the art for an improved mixing device and a method for preparing bone cement that overcomes one or more of the above shortcomings. Summary of the invention

[0005] A first aspect of the present disclosure relates to a mixing device for preparing bone cement from bone cement components. A chamber defines an inlet opening and has a first and second end and a longitudinal axis extending between the first and second ends. A first region of the chamber is longitudinally defined between the first end of the chamber and an end of the inlet opening closest to the second end of the chamber. A second region of the chamber is longitudinally defined between the first region and the second end of the chamber. The mixing device includes a piston disposed in the chamber. The piston includes a face. The mixing device includes a mixing paddle rotatable within the chamber. The face of the piston is configured to be located within the first region of the chamber so that when the mixing paddle rotates to mix the bone cement components to prepare a bone cement mixture, the chamber is at or below atmospheric pressure. The piston is movable along the longitudinal axis to position the face within the second region of the chamber, thereby providing a fluid-tight closure between the piston and the chamber, so that further movement of the piston within the second region compresses the bone cement mixture within the chamber.

[0006] In some embodiments, the motor is operably coupled to the piston and the mixing paddle and is configured to achieve at least one of movement of the piston and rotation of the mixing paddle. The housing may also define an outlet port adjacent to the second end of the chamber. A first switch may be coupled to the housing and connected to the motor. The first switch may be moved to an activated state in which the first switch activates the motor when the piston is within the first region. The first switch may be a momentary switch biased toward a deactivated state. The second switch may be coupled to the housing and connected to the motor. The second switch may be moved to a deactivated state in which the second switch deactivates the motor when the piston is within the second region. The second switch may be a non-momentary switch that is initially in an activated state. The first and second switches may be connected to a ground wire in series with the motor.

[0007] In some embodiments, the actuator is coupled to the housing and is movable to engage the switch and maintain the switch in an activated state against a bias as the piston moves from the first region to the second region. The drive gear structure can be coupled to the motor and rotatable during an operating cycle. The stop nut can be configured to translate along the drive gear structure and engage the actuator when the piston is within the second region.

[0008] A second aspect of the present disclosure relates to a method for preparing bone cement using the mixing device according to the first aspect of the present disclosure, and optionally any one of the corresponding embodiments thereof.

[0009] A third aspect of the present disclosure relates to a mixing device for preparing bone cement from bone cement components. The mixing device includes a housing and a chamber within the housing. The chamber has a first region and a second region separated from the first region. The mixing device includes a mixing paddle that can be rotated in the chamber to mix the bone cement components to prepare a bone cement mixture. The piston can move in the chamber to compress the bone cement components. The motor is connected to the piston and the mixing paddle. A first switch is connected to the motor. The first switch is instantaneous and biased to a deactivated state in which the first switch prevents the motor from being activated. The first switch is configured to move from the deactivated state to an activated state in which the switch starts an operating cycle by activating the motor to achieve at least one of movement of the piston and rotation of the mixing paddle. The second switch is connected to the ground wire in series with the first switch and the motor. The second switch is non-instantaneous and is initially set to an activated state to allow the motor to be activated. The second switch is configured to move from the activated state to a deactivated state in which the motor is deactivated to terminate the operating cycle. The piston is configured to move from the first region to the second region in the chamber to mix and compress the bone cement mixture in the chamber. The piston is in the first region during actuation of the first switch and in the second region during actuation of the second switch.

[0010] In some embodiments, the chamber is at or below atmospheric pressure when the piston is in the first region and above atmospheric pressure when the piston is in the second region. The actuator can be coupled to the housing and movable between a first position in which the actuator is spaced apart from the first switch and a second position in which the actuator engages the first switch to actuate the first switch.

[0011] A fourth aspect of the present disclosure relates to a method for preparing bone cement using the mixing device according to the third aspect of the present disclosure, and optionally any one of its corresponding embodiments.

[0012] A fifth aspect of the present disclosure relates to a mixing device for preparing bone cement from bone cement components. The mixing device includes a housing and a chamber within the housing. The chamber defines an inlet opening configured to receive the bone cement component. A mixing paddle can rotate within the chamber to mix the bone cement component to form a bone cement mixture. A piston can move within the chamber to compress the bone cement component. A motor is coupled to the piston and the mixing paddle. A first switch is mounted to the housing and connected to the motor, the first switch being initially in an inactive state. A second switch is mounted to the housing and spaced apart from the first switch. The second switch is in an active state. The first and second switches are connected in series with the motor. An actuator is coupled to the housing and can move between a first position in which the actuator is spaced apart from the first switch and the inlet opening is open to the surrounding environment and a second position in which the actuator engages the first switch to move the first switch from the inactive state to the active state. A stop nut is movable to engage with the second switch to move the second switch from the active state to the inactive state.

[0013] In some embodiments, the actuator is a slider including a slider body, an arm extending from the underside of the slider body. The arm is configured to deflect laterally and engage with the first switch. The first and second switches can be mounted directly to the housing at separate locations without being coupled to a printed circuit board.

[0014] A sixth aspect of the present disclosure relates to a method for preparing bone cement using the mixing device according to the fifth aspect of the present disclosure, and optionally any one of its corresponding embodiments.

[0015] A seventh aspect of the present disclosure relates to a mixing device for preparing bone cement. The mixing device includes a housing and a chamber within the housing. The chamber defines an inlet opening configured to receive a bone cement component. The mixing device includes a mixing paddle that can rotate within the chamber to mix the bone cement components to prepare a bone cement mixture. A piston can move within the chamber to compress the bone cement components. A motor is coupled to the piston and the mixing paddle. A switch is connected to the motor. An actuator is coupled to the housing and can move between a first position and a second position. In the first position, the actuator is spaced apart from the switch and the inlet opening is open to the surrounding environment. In the second position, the actuator engages the switch to simultaneously (i) move the switch from an inactive state to an activated state, in which the switch starts an operating cycle by activating the motor to achieve at least one of movement of the piston and rotation of the mixing paddle, and (ii) closes the inlet opening.

[0016] In some embodiments, the housing defines an aperture. The actuator may include a door arranged to be positioned between the inlet opening and the aperture when the actuator is in the second position. The inlet opening is positioned below the aperture so that the bone cement component guided through the aperture further passes through the inlet opening and enters the chamber under the influence of gravity. The funnel device may include a widened portion and a stem sized to be received in the aperture of the housing. A flexible tether may couple the funnel device to the housing. The funnel device may include a catch on the stem. The catch is configured to releasably engage a complementary locking feature of the housing.

[0017] In some embodiments, the actuator of the ninth aspect may be included on the mixing device of any one of the first, third, fifth and seventh aspects, and optionally included in any corresponding embodiments thereof.

[0018] An eighth aspect of the present disclosure relates to a method for preparing bone cement using the mixing device according to the seventh aspect of the present disclosure, and optionally any one of its corresponding embodiments.

[0019] A ninth aspect relates to a mixing device for preparing bone cement. The mixing device includes a housing having an upper housing and a lower housing coupled to the upper housing. A chamber is located within the housing. The chamber defines an inlet opening configured to receive a bone cement component. A mixing paddle can rotate within the chamber to mix the bone cement components to form a bone cement mixture. A piston is located within the chamber to compress the bone cement components. A motor is coupled to the piston and the mixing paddle. The upper housing includes a funnel having an inclined surface defining an orifice communicating with the inlet opening.

[0020] In some embodiments, the upper housing has an upper surface, and the inclined surface extends downwardly away from the upper surface.The funnel may be frustoconical in shape.

[0021] In some embodiments, the integrated funnel of the ninth aspect may be included on the mixing device of any one of the first, third, fifth and seventh aspects, and optionally on any one of their respective embodiments.

[0022] The tenth aspect of the present disclosure relates to a method for preparing bone cement using the mixing device according to the ninth aspect of the present disclosure, and optionally any one of its corresponding embodiments.

[0023] An eleventh aspect relates to a mixing device for preparing bone cement. The mixing device includes a housing and a chamber within the housing and defining an inlet opening configured to receive a bone cement component. A mixing paddle can rotate within the chamber to mix the bone cement components to prepare a bone cement mixture. A piston can move within the chamber to compress the bone cement components. A motor is coupled to the piston and the mixing paddle. A display is coupled to the housing and is configured to display information indicating the operation of the mixing device.

[0024] In some embodiments, the display is a liquid crystal display (LCD), a series of lights, a digital timer, or an analog timer. The information can be one of the following: the remaining time of operation of the mixing device, the time elapsed working with bone cement, and the estimated remaining time working with bone cement.

[0025] In some embodiments, the display of the eleventh aspect may be included on the hybrid device of any one of the first, third, fifth, seventh and ninth aspects, and optionally on any of their corresponding embodiments.

[0026] The twelfth aspect of the present disclosure relates to a method for preparing bone cement using the mixing device according to the ninth aspect of the present disclosure, and optionally any one of its corresponding embodiments.

[0027] A thirteenth aspect of the present disclosure relates to a mixing device for preparing bone cement. The mixing device includes a housing and a chamber within the housing. The chamber has a first area and a second area separated from the first area. The mixing device includes a mixing paddle that can be rotated in the chamber to mix bone cement components to prepare a bone cement mixture. The piston can move in the chamber to compress the bone cement components. The motor is connected to the piston and the mixing paddle. The switch is connected to the motor. The switch is configured to move between an activated state and a deactivated state, in which the switch starts an operating cycle by activating the motor to achieve at least one of the movement of the piston and the rotation of the mixing paddle, and in the deactivated state, the switch terminates the operating cycle by deactivating the motor. The switch is biased toward the deactivated state. The actuator is connected to the housing and can move between a first position where the actuator is spaced apart from the switch and a second position where the actuator engages the switch to move the switch from the deactivated state to the activated state and resists the bias to keep the switch in the activated state. The piston is configured to move from a first region to a second region within the chamber such that the actuator is mechanically disengaged from the switch when the piston is in the second region to allow the switch to be biased back from an activated state to a deactivated state.

[0028] In some embodiments, the switch is a momentary switch. The drive gear structure can be coupled to the motor and can rotate during an operating cycle. The stop nut can be coupled to the drive gear structure and constrained from relative rotation relative to the drive gear structure, such that the stop nut is configured to translate along the drive gear structure and engage the actuator to achieve mechanical disengagement of the actuator from the switch. The stop nut can include a nut portion having an inner diameter that is threadedly engaged with an outer diameter of the drive gear structure, and a flange portion extending from the nut portion, wherein the flange portion is configured to engage the actuator to achieve mechanical disengagement of the actuator from the switch.

[0029] In some embodiments, the actuator is a slider having a slider body, an arm extending from an underside of the slider body, and a stop feature coupled to the arm and configured to engage the switch. The slider may also include an inclined surface coupled to the arm and arranged to be engaged by the stop nut when the stop nut translates with rotation of the transmission gear structure, wherein engagement of the stop nut with the inclined surface causes the arm to bend and disengage the stop feature from the switch.

[0030] A fourteenth aspect of the present disclosure relates to a method for preparing bone cement using the mixing device according to the third aspect of the present disclosure, and optionally any one of its corresponding embodiments.

[0031] A fifteenth aspect of the present disclosure relates to a kit for performing vertebral augmentation surgery using bone cement. The kit includes a mixing device for mixing bone cement components to prepare a bone cement mixture and compressing the bone cement mixture. The mixing device includes a chamber, a piston movable in the chamber, and a mixing paddle movable in the chamber. The chamber defines an inlet opening, and an outlet port communicated with the inlet opening. The kit includes a conveying device, which includes a chamber defining an inlet port for receiving bone cement from the mixing device. The kit also includes a package sized to accommodate the mixing device and the conveying device. The inlet port of the conveying device is communicated with the outlet port of the mixing device so that the mixing device and the conveying device are detachably connected to each other in the package. The mixing device and the conveying device are configured to be removed from the package as a single unit.

[0032] In some embodiments, when the mixing device and the delivery device are detachably coupled to each other, the longitudinal axis of the chamber of the mixing device and the longitudinal axis of the chamber of the delivery device are parallel, so that the mixing device and the delivery device are placed in a side-by-side arrangement within the package. The outlet port of the mixing device and the inlet port of the delivery device can be arranged perpendicular to each of the respective longitudinal axes to facilitate this side-by-side arrangement.

[0033] In some embodiments, the kit includes a funnel device, and a flexible tether connecting the funnel device and the mixing device. The funnel device is configured to be removed from the package as a single unit. Alternatively, the funnel device can be integrated into the housing. The kit can also include a liquid monomer and a powdered polymer disposed in a sterile package. The package can be a blister package. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Advantages of the present disclosure may be more readily appreciated and thus more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings.It should be understood that the drawings are purely illustrative and are not necessarily drawn to scale.

[0035] Figure 1 is a rear perspective view of a mixing and conveying system including a mixing device and a conveying device.

[0036] Figure 2 is a front perspective view of the mixing device.

[0037] Figure 3 is a front perspective view of the mixing device with the upper housing of the casing removed.

[0038] Figure 4 is a cross-sectional elevation view of a mixing device showing a piston positioned within a first region of a chamber of the mixing device.

[0039] Figure 5is a cross-sectional elevation view of the mixing device showing the piston positioned within the second region of the chamber of the mixing device.

[0040] Figure 6 is a perspective view of a subassembly of a mixing device including a switch, a piston, and a mixing paddle.

[0041] Figure 7 is a perspective view of the gear train of the mixing device coupled to the piston and the mixing paddle.

[0042] Figure 8 It is a front view of the gear train, piston and mixing paddle.

[0043] Fig. 9 yes Figure 7 A front view of the gear train and mixing paddle of FIG. 1 with the drive gear structure and translation shaft removed to show the paddle drive gear structure coupling the mixing paddle to the gear train.

[0044] Fig.10 is an exploded view of a subassembly of a mixing device configured to effectuate longitudinal movement of a piston (and a mixing paddle) within a chamber, the subassembly comprising a drive gear structure, a translation shaft, a rear chamber housing, and a push cap.

[0045] Fig.11 is an elevation view of components of a mixing device configured to achieve automatic termination of an operating cycle, including a stop nut disposed on a drive gear structure in a first position.

[0046] Fig.12 yes Fig.11 A front view of the components of the drive gear structure, wherein the stop nut disposed on the drive gear structure is in the second position and engages the actuator.

[0047] Fig.13 is a perspective view of a slide forming an actuator.

[0048] Fig.14 is a perspective view of the stop nut.

[0049] Fig.15 is a top perspective view of a portion of a mixing device with an embodiment of an actuator deflected laterally into engagement with an embodiment of a switch.

[0050] Fig.16 is a top perspective view of a portion of a mixing device wherein an implementation of a stop nut is configured to engage a second switch to effectuate automatic termination of an operating cycle.

[0051] Fig.17 is a rear perspective view of the mixing device with the release assembly in the unlocked position.

[0052] Fig.18is a perspective view of the front chamber housing including the transfer catheter.

[0053] Fig.19A yes Fig.17 Detailed view of the transfer catheter and release assembly within the dashed line 19A-19A.

[0054] Fig.19B is a detailed view of another embodiment of a transfer catheter and delivery assembly.

[0055] Fig. 20 yes Fig.19A A perspective view of the release assembly.

[0056] Fig.21 Is to use include Figure 1 Illustration of the steps of a kit of methods of a hybrid delivery system.

[0057] Fig. 22 is a diagrammatic representation of another step of the method.

[0058] Fig.23 is a diagrammatic representation of another step of the method.

[0059] Fig.24 is a diagrammatic representation of another step of the method.

[0060] Fig.25 is a diagrammatic representation of another step of the method.

[0061] Fig.26 is a front perspective view of a mixing and conveying system including a mixing device and a conveying device. DETAILED DESCRIPTION

[0062] Referring now to the drawings, wherein like numerals indicate corresponding parts throughout the several views, a hybrid delivery system 100 is shown. Figure 1. The system 100 includes a mixing device 102 for mixing multiple components to prepare a mixture, and a delivery device 104 for delivering the mixture to a target site. The system 100 can be used for any procedure that requires the mixture to be delivered to a target site. In one example, the mixing device 102 mixes bone cement components to prepare a bone cement mixture, and the bone cement mixture is transferred to the delivery device 104. In particular, the mixing device 102 automatically performs an operating cycle including a mixing phase and a compression phase when actuated, and automatically transfers bone cement to the delivery device 104 in an intuitive workflow to be described. This intuitive workflow improves efficiency between surgeries and consistency of bone cement mixtures while reducing exposure of the user to bone cement components. Once transferred to the delivery device 104, the delivery device 104 is operated by the user to deliver bone cement, such as into a vertebral body during vertebroplasty or kyphoplasty. An example of a delivery device 104 suitable for use with the present system is disclosed in commonly owned International Publication No. WO 2019 / 200091, published on October 17, 2019, the entire contents of which are incorporated herein by reference. Another example of a delivery device 104 suitable for use with the present system is disclosed in commonly owned U.S. Patent No. 6,547,432, issued on April 15, 2003, the entire contents of which are incorporated herein by reference.

[0063] Figure 1 The delivery device 104 is shown removably coupled to the mixing device 102. The delivery device 104 includes an inlet port 106 that is configured to be removably positioned in sealed fluid communication with an outlet port 108 of the mixing device 102. A release assembly 110, which will be described in more detail, facilitates the connection between the mixing device 102 and the delivery device 104, thereby establishing communication between the inlet and outlet ports 106, 108. The communication between the inlet and outlet ports 106, 108 further establishes a chamber 112 of the mixing device 102 (see Figure 4 and Figure 5 ) is fluidically connected to a chamber (not labeled) within the delivery device 104 for transferring the bone cement mixture.

[0064] The mixing device 102 includes a housing 116 . Figure 1 and Figure 2 and Figure 3 1 shows an embodiment of the housing 116, where like numbers refer to like parts but differ in features and design. For example, Figure 1The housing 116 of the mixing device 102 includes a bracket 114 and / or a hook 117 coupled to the housing 116 for supporting the delivery device 104. The size and shape of the bracket 114 are designed to facilitate easy separation of the housing 118 of the delivery device 104 from the mixing device 102, and the size and shape of the hook 117 can be designed to facilitate transportation and separation of the extension tube 105 of the delivery device 104. Figure 1 The bracket 114 is shown as an arcuate protrusion that is roughly sized to conform to a portion of the housing 118 of the delivery device 104. In such a coupled configuration, the bracket 114 cooperates with the release assembly 110 to allow the system 100 to be moved as a unit, such as with one hand. In one configuration, the outlet port 108 is disposed on one side of the mixing device 102 to allow the delivery device 104 and the mixing device 102 to be packaged in such a coupled configuration prior to deployment in an operating room, the advantages of which will be explained in more detail later. However, other locations for the outlet port 108 are also contemplated.

[0065] Figure 2 104 , the housing 118 of the delivery device 104 is removed from the housing 118 of the delivery device 104. In another embodiment, the retaining force from the transfer conduits 306, 306' of the mixing device 102 and the release assembly 110 of the delivery device 104 is provided. Figure 17-20 ) is sufficient to maintain the relative position of the mixing device 102 and the conveying device 104. The bracket 114 supports the conveying device 104 but does not provide a retaining force.

[0066] Reference now Figure 2 , the mixing device 102 includes a housing 116, which can be formed of suitable materials and manufacturing processes. The housing 116 can include an upper shell 120 and a lower shell 122 coupled to the upper shell 120. The cavity defined by each of the upper shell 120 and the lower shell 122 is designed and sized to accommodate most of the components of the mixing device 102. The upper shell 120 and the lower shell 122 can be removably or permanently coupled to each other. In the case where the mixing device 102 may be a disposable component after a single one-time use, it may be rarely necessary to access the interior 124 of the housing 116. However, in this case, the housing 116 may include a separation feature 126, which is configured to receive input from a user to separate the upper shell 120 from the lower shell 122, thereby exposing the components housed within the interior 124 of the housing 116. Figure 1The separation feature 126 is shown as a tab 128 adjacent to the gripping feature 130 at the interface between the upper housing 120 and the lower housing 122. The input applied to the tab 128 while maintaining the position of the gripping feature 130 overcomes the retention force (detent) provided by the interface between the upper housing 120 and the lower housing 122. Figure 3 A detent recessed portion 132 is identified. Another gripping feature 134 extending around at least a portion of the upper housing 120 may be provided to allow the housing 116 and system 100 (if desired) to be moved as a unit, for example, with one hand, as described above.

[0067] Continue to refer Figure 2 , the housing 116 includes or defines an orifice 135. The orifice 135 extends through the upper wall of the upper shell 120 of the housing 116. In the broadest sense, the orifice 135 is a small hole through which the bone cement components are introduced into the chamber 112 before the operation cycle including the mixing, compression and transfer phases begins. Figure 4 and 5 The chamber 112 (more specifically the front chamber housing 164) is shown to include or define an inlet opening 136 that communicates with the aperture 135 and the chamber 112. The inlet opening 136 can be positioned directly below the aperture 135 so that the bone cement components directed through the aperture 135 further pass through the inlet opening 136 and into the chamber 112 under the influence of gravity. The chamber 112 is disposed within the housing 116.

[0068] In order to facilitate the effective introduction of the bone cement component through the orifice 135, a funnel 138 may be provided. The bone cement component typically includes a liquid monomer and a powdered polymer. The funnel 138 includes a widened opening that is opposite to a narrowed opening defined by a stem 140, and the size of the stem 140 is designed to be received in the orifice 135 of the housing 116. In addition, the funnel 138 may include a flexible tether 142 that couples the funnel 138 to the housing 116. The flexible tether 142 may be retained by a slot in the upper shell 120 of the housing 116, but other suitable connection methods may be envisioned. Among other advantages, the flexible tether 142 allows the funnel 138 to be packaged to be coupled to the housing 116 and also allows the system 100 including the funnel 138 to be moved as a unit, such as with one hand. Known systems including funnels require the funnels to be handled separately and require additional transfer of the funnels across the sterile barrier of the surgical room. In the initial configuration, the flexible tether 142 is coupled to the housing 116 and the funnel 138 is inverted, such as Figure 1 and 2As shown. In one step of the intuitive workflow, the user manipulates the funnel 138 to position the stem 140 within the orifice 135. This can be considered the first step of the workflow, as indicated by the number "1" on the mark 144 on the funnel 138. In some embodiments, the funnel 138 may include a detent (not shown) disposed on the stem 140. The detent is configured to releasably engage a complementary opening 143 defined near the orifice 135 in the housing 116. The engagement of the detent provides audible and / or tactile feedback to the user that the funnel 138 is properly installed to receive the bone cement component. Thereafter, the user introduces the bone cement component into the funnel 138 to guide it to the chamber 112.

[0069] The user actuates an actuator 148, such as a slider 150 movably coupled to the housing 116 and described further, to begin the operating cycle. The actuator 148 may include indicia 152, in this example the number "2", corresponding to the second step of the intuitive workflow.

[0070] The operating cycle includes a mixing phase, in which a mixing paddle 154 disposed within the chamber 112 mixes the bone cement components, and a compression and transfer phase, in which a piston 156 disposed within the chamber 112 compresses the bone cement and transfers the bone cement through the outlet port 108 to the delivery device 104. Referring now to Figure 4 and 5 , shows a cross-sectional elevation view of the mixing device 102, wherein Figure 4 The mixing device 102 is depicted during the mixing phase, and Figure 5 The mixing device 102 is depicted during the compression and transfer phases.

[0071] In the broadest sense, when the piston 156 is in the first region 158 of the chamber 112, a mixing phase occurs such that the bone cement components enclosed within the chamber 112 are at a first pressure, and in the broadest sense, when the piston 156 is in the second region 160 of the chamber 112, a transfer phase occurs such that the bone cement components are compressed to a second pressure greater than the first pressure. In one example, the first pressure is equal to or less than atmospheric pressure (e.g., equal to or close to one atmosphere, substantially equal to ambient pressure), and the second pressure is greater than atmospheric pressure (e.g., four to seven atmospheres). The chamber 112 can be coupled to a rear chamber housing 166 (see Fig.10 ) of the front chamber housing 164 (see Fig.18 ) is limited or confined within it. See also Figure 3, the front chamber housing 164 can be cylindrical and extend beyond the housing 116. The front chamber housing 164 can include an interior face 168 that at least partially defines the chamber 112. The rear chamber housing 166 can be a cap-like feature complementary to the front chamber housing 164 and defines a front face 170 that at least partially defines the chamber 112 opposite the interior face 168 (see Fig.10 ). As a matter of practice and as Figure 4 and 5 As shown, the front face 170 of the rear chamber housing 166 may define the first end 162 of the chamber 112 , and the interior face 168 of the front chamber housing 164 may define the second end 163 of the chamber 112 .

[0072] exist Figure 4 and 5158 and 160 are schematically shown in FIG. 159. The first region 158 of the chamber 112 may be defined between the first end 162 of the chamber 112 and the end 172 of the inlet opening 136 closest to the interior face 168 in a front view. More specifically, the first region 158 may be defined between the first end 162 of the chamber 112 and a plane that intersects the end 172 of the inlet opening 136 and is perpendicular to the longitudinal axis LA of the chamber 112. In other words, and as will be further explained, when the face 174 of the piston 156 moving along the longitudinal axis LA has not yet reached the end 172 of the inlet opening 136 that defines the boundary between the first and second regions 158, 160, the face 174 is located in the first region 158 and at least a portion of the inlet opening 136 is substantially open to the surrounding environment and the chamber 112 is at least substantially at atmospheric pressure. The second region 160 may be defined between the end 172 of the inlet opening 136 and the interior face 168. In other words, when the face 174 of the piston 156 moving along the longitudinal axis LA is located in the second region 160, the face 174 has passed the inlet opening 136, and a fluid-tight seal can be formed between the piston 156 and the housing 116 to seal the chamber 112 from the surrounding environment (isolate the two). Therefore, in operation, with the face 174 of the piston 156 in the first region 158 of the chamber 112 extending longitudinally between the first housing end 162 and the open end 172, the bone cement components are mixed with the mixing paddle 154 at a first pressure or atmospheric pressure to prepare a bone cement mixture. Subsequently, the piston 156 is moved along the longitudinal axis LA to be placed in the second region 160, extending longitudinally between the open end 172 and the second housing end 163 to compress the bone cement mixture in the chamber 112 to a second pressure greater than the first pressure or atmospheric pressure. The bone cement mixture can also be transferred to the delivery device 104 through the outlet port 108 communicated with the chamber 112. Among other advantages that are easily understood, the passage of piston 156 through inlet opening 136 to seal chamber 112 during bone cement compression and transfer to delivery device 104 reduces or eliminates the need for many high-pressure components required by existing systems. For example, existing systems may require an attachable lid, and the lid and the way the lid is connected to the device must be designed to withstand the elevated pressures associated with the compression phase. The lid and its interface are often prone to rapid failure. The lid and its interface may not be intuitive to the user, and therefore prone to installation errors and resulting failures. The lid must be transferred to the sterile area separately from the mixer, which increases the risk of contamination of the sterile surface. The lid may also fall to the floor, or may roll from the table to the floor, rendering the mixing unit unusable. The passage of piston 156 through inlet opening 136 to seal chamber 112 eliminates the need for an attachable lid. Therefore, the self-sealing properties of chamber 112 of mixing device 102 reduce or eliminate the possibility of accidental exposure of the user to a high-pressure bone cement mixture.

[0073] The mixing device 102 may include a sealing element (not labeled) coupled to the piston 156 to provide a fluid-tight closure between the piston 156 and the housing 116. The piston 156 may include a groove 175 adjacent a face 174 of the piston 156. The groove 175 may extend annularly around the piston 156, and a sealing element (e.g., an O-ring gasket) is at least partially located within the groove 175. The sealing element interacts with the inner surface of the housing 116 to provide a fluid-tight closure between the piston 156 and the housing 116.

[0074] Now refer to Figure 4-9 The mixing device 102 may be configured to impart rotation to the mixing paddle 154 during the mixing phase. Figure 4 and 5 176 including a plurality of batteries as shown in the figure. In one example, the battery pack 176 includes eight conventional double A batteries; however, alternatives such as lithium ion and / or other disposable or rechargeable batteries can be considered. Although it is not very convenient for the operating room, the hybrid device 102 can also be configured to be powered in a wired arrangement. The hybrid device 102 also includes a motor 178 in communication with the battery pack 176. Further, the hybrid device 102 also includes a switch 180 in communication with the motor 178 and configured to actuate between an activated state and a deactivated state. In one example, the switch 180 is a momentary micro switch that is internally biased to a deactivated state. This advantageously returns the switch 180 to its original position to stop the operation of the hybrid device 102 when necessary. In another example, the switch 180 is a non-momentary switch, such as a toggle switch. The switch 180 is actuated in a manner to be explained in more detail, and the motor 178 is operated to provide a rotational output to the output shaft 182 of the motor 178. It is contemplated that the motor 178 is optional, and the mixing device 102 can be a manual mixing device. In such an example, the piston can be similar to a plunger and a mixing paddle on a shaft that is configured to receive input from a user. When mixing the bone cement components at atmospheric pressure with a mixing paddle 154, the plunger can be in a first region 158, and the plunger can move to a second region 160 in response to input from a user to compress the bone cement mixture in the chamber 112 to a pressure greater than atmospheric pressure. Alternatively, as disclosed in the aforementioned U.S. Patent No. 6,547,432, manual mixing can be performed using a mixing blade on a shaft that is configured to receive axial and rotational inputs from a user. Another non-motorized configuration can include a manually operated crank that operates a gear train that both rotates the mixing paddle 154 and advances the piston 156.

[0075] The output shaft 182 is operably coupled to Figure 7-91 and 1 . The gear train 184 is best shown in FIG. The gear train 184 is shown as a stacked spur configuration, but other suitable configurations are contemplated (e.g., planetary, helical spur, helical planetary, etc.). The gear train 184 includes a pinion 186 coupled to the output shaft 182 of the motor 178. A first spurgear 188 is operably coupled to the pinion 186. The first spurgear 188 includes a first spurgear 190 having a larger outer diameter and a second spurgear 182 having a smaller outer diameter, wherein the first spurgear 190 is coupled to the pinion 186. A second spurgear 194 is operably coupled to the first spurgear 188. The second cylindrical gear structure 194 includes a first cylindrical gear 196 having a larger outer diameter and a second cylindrical gear 198 having a smaller outer diameter, wherein the first cylindrical gear 196 is coupled to the second cylindrical gear 182 of the first cylindrical gear structure 188. The third cylindrical gear structure 200 is operably coupled to the second cylindrical gear structure 194. The second cylindrical gear structure 200 includes a first cylindrical gear 202 having a larger outer diameter and a second cylindrical gear 204 having a smaller outer diameter, wherein the first cylindrical gear 202 is coupled to the second cylindrical gear 198 of the first cylindrical gear structure 194. The third cylindrical gear structure 200, more specifically the first cylindrical gear 202 of the third cylindrical gear structure 200, is operably coupled to the input cylindrical gear 206 of the paddle drive gear structure 208. The third cylindrical gear structure 200 is also operably coupled to the fourth cylindrical gear structure 210. The fourth cylindrical gear structure 210 includes a first cylindrical gear 212 having a larger outer diameter and a second cylindrical gear 214 having a smaller outer diameter, wherein the first cylindrical gear 212 is coupled to the second cylindrical gear 204 of the third cylindrical gear structure 200 and the second cylindrical gear 214 is coupled to a transmission gear structure 216 to be described. Figure 6 and Figure 7 The gear train 184 is shown together arranged within a front gear train housing 218 and a rear gear train housing 220 that are operably coupled to each other. In addition, the rear chamber housing 166 is operably coupled to the front gear train housing 218.

[0076] In certain embodiments, vibration and noise can be reduced by employing damping and / or vibration isolation between the motor 178 and / or the gear train 184 and the complementary components of the gear train housing 218. Damping can be achieved by manufacturing one or more gears from a material having a reduced elastic modulus (i.e., more compliant), such as an elastomeric polyester, such as that manufactured by DuPont deNemours, Inc. (Wilmington, Dela.). Vibration isolation can be achieved by placing a compliant material (such as an elastomer or foam) between the vibrating component and adjacent components, such as between the motor 178 and adjacent portions of the gear train housing 218 (see FIG. Figure 6 ) or between the gear train housing and the mixer housing. Other suitable locations for damping or isolation include the first and second cylindrical gear structures 188, 200, which rotate fastest in the gear train 184 and therefore generate the most noise. It is also contemplated that some compliance may be provided between the pinion 186 and the first cylindrical gear structure 188 to further reduce noise and alignment sensitivity in the component stack.

[0077] Special References Fig. 9 , the mixing paddle 154 can be coupled to the end of an output shaft 222 of the paddle drive gear structure 208, which is coupled to the input cylindrical gear 206. The output shaft 222 includes a longitudinally extending guide that is configured to couple with a complementary feature within the stem portion 224 of the mixing paddle 154 to non-rotatably secure the mixing paddle 154 to the paddle drive gear structure 208. The mixing paddle 154 also includes a face portion 226 that extends generally radially from the stem portion 224. Figure 6 and Figure 7 As can be seen, face portion 226 is positioned adjacent to and rotatable relative to face 174 of piston 156. A mixing feature 228 is coupled to face portion 226. Mixing feature 228 extends longitudinally forward of face portion 226 and includes at least one leg 230 for agitating the mixture components during rotation of mixing paddle 154. Figure 7 and Fig. 9 Two of the legs 230 are shown coupled to each other by a head 232 to form a generally U-shaped mixing feature 228. Each of the legs 230 and the head 232 may be plate-like in construction, with the head 232 angled inwardly relative to the legs 230 to impart folding or buckling of the mixing feature 228 relative to the face portion 226 during the compression and transfer phases in a manner that will be described in more detail. Other configurations of the mixing paddle 154 configuration are also contemplated.

[0078] In operation, the switch 180 is moved from the deactivated state to the activated state. The motor 178 draws power from the battery pack 176 or other power source and operates to supply torque to the motor 178. This can be considered the beginning of an operating cycle, specifically the mixing phase of the operating cycle. According to the known speed-to-torque characteristics associated with gear transmissions, torque is transmitted from the pinion 186 through each of the first, second and third cylindrical gear structures 188, 194, 200, and through the paddle drive gear structure 208 to the mixing paddle 154.

[0079] The step of rotating the mixing paddle 154 achieves mixing of the bone cement components within the chamber 112. Figure 4 , the mixing paddle 154 can rotate when the piston 156 is located in the first region 158 of the chamber 112. Again, the face 174 of the piston 156 is located between the first end 162 of the chamber 112 and the boundary separating the first and second regions 158, 160, so that the mixing paddle 154 mixes the bone cement components within the chamber 112 at least substantially at atmospheric pressure. It should be understood that the door 234 of the slide 150 is positioned to cover the inlet opening 136 during an operating cycle including a mixing phase to prevent debris from flowing out of the mixing device 102; however, the door 234 may not produce more than a minimum pressurization of the chamber 112 during movement of the piston 156. When the actuator 148 is in the second position, the door 234 can be positioned between the orifice 135 defined by the housing 116 and the inlet opening 136 defined by the chamber 112. At least in part because the bone cement components are mixed at atmospheric pressure in the chamber 112, the sealing element 236 disposed within the outlet port 108 of the mixing device 102 prevents the bone cement mixture from flowing out of the mixing device 102 or prematurely transferring to the delivery device 104. Thus, a less complex and more cost-effective valve may be used to form the sealing element 236.

[0080] As from Figure 4 As further understood, the leg 230 of the mixing paddle 154 extends forward from the piston 156 so that the head 232 of the mixing paddle 154 is positioned near or adjacent to the interior face 168 of the front chamber housing 164. This arrangement results in the mixing paddle 154 being able to reach substantially the entire chamber 112 to prevent any portion of the bone cement components from being mixed or stirred insufficiently. In other words, the leg 230 can effectively remove any bone cement components adhering to the sidewalls that at least partially define the chamber 112, and the head 232 can effectively remove any bone cement components adhering to the interior face 168 that at least partially defines the chamber 112. However, as mentioned and will be further explained, the piston 156 moves from the first region 158 to the second region 160 for the compression and transfer phases. Therefore, the mixing paddle 154 must accommodate this longitudinal movement of the piston 156 within the chamber 112. To this end, the mixing paddle 154 is configured to fold or bend when the piston 156 compresses the bone cement mixture in the chamber 112. The piston 156 and the mixing paddle 154 move along the longitudinal axis LA until the head 232 of the mixing paddle 154 encounters the interior face 168 of the front chamber housing 164. Due to the inwardly angled orientation of the head 232 relative to the leg 230, the continuous force provided by the piston 156 causes the leg 230 to deform at the interface 238 between the leg 230 and the face portion 226 (see Figure 7 and 8). This deformation can be considered as bending at the pivot point created by the interface 238. The axial profile of the face portion 226 relative to the face 174 of the piston 156 is shaped to accommodate the legs 230 and the head 232 so that when nearly or fully collapsed, the mixing feature 228 is substantially flat and abuts or is adjacent to the face 174 of the piston 156. Among other advantages, this arrangement allows the piston 156 to move longitudinally across nearly the entire chamber 112 to compress the bone cement mixture and transfer the bone cement mixture through the outlet port 108 located near the second end 163 of the chamber 112 (see Figure 5 ).

[0081] Now refer to Figure 4 , 5 , 8, 9 and 10 describe the electromechanical operation of the mixing device 102 to impart longitudinal motion to the piston 156 (and the mixing paddle 154). As described above, the fourth cylindrical gear structure 210 includes a second cylindrical gear 214 coupled to a drive gear structure 216. Figure 7 , 8 10 best illustrates a transmission gear structure 216 including a transmission cylindrical gear 240 and a threaded shaft 242 extending from the transmission cylindrical gear 240. The transmission cylindrical gear 240 is coupled to the second cylindrical gear 214 of the fourth cylindrical gear structure 210, such that rotation of the gear train 184 including the fourth cylindrical gear structure 210 imparts rotation to the transmission gear structure 216. The transmission gear structure 216, and in particular the threaded shaft 242, defines an inner cavity 246 extending through the transmission gear structure 216, as shown in FIG. Fig.10 As best shown, at least one rail feature 248 is disposed within the lumen 246 and oriented along a length of the lumen 246 . Fig.10 Two guide features 248 are shown positioned diametrically opposite one another. The inner cavity 246 is also defined by a front face (not labeled) of the drive spur gear 240 at the rear end of the inner cavity 246. A hole (not shown) having a diameter smaller than the inner cavity 246 extends through the drive spur gear 240, the hole being sized to allow the output shaft 222 of the paddle drive gear structure 208 to be positioned through the drive gear structure 216, as shown. Figure 4 and 5 shown in and combined with Figure 7 and 9 When you look at it, you will basically understand it further.

[0082] Special References Figure 8 and 10, the translation shaft 244 is movably disposed within the inner cavity 246 of the transmission gear structure 216. The translation shaft 244 includes an outer diameter that is smaller than the inner diameter of the inner cavity 246 so as to be slidably movable within the inner cavity 246. In addition, the translation shaft 244 includes a thread 250 disposed around the outer surface, the function of which will be described later. The thread 250 may define at least one slot 252 extending longitudinally between the opposite ends 245, 247 of the translation shaft 244. Fig.10 One slot 252 is identified, but it should be understood that there is another slot diametrically opposite the slot 252 that is configured to engage the guide feature 248 of the drive gear structure 216. The engagement of the guide feature 248 and the slot 252 prevents relative rotation while allowing translation between the translation shaft 244 and the drive gear structure 216. The translation shaft 244 may also define an inner cavity 254 extending between opposite ends 245, 247, wherein the inner cavity 254 is sized to allow the output shaft 222 of the paddle drive gear structure 208 to be positioned through the translation shaft 244, as shown in FIG. Figure 4 and 5 As shown and in combination Figure 7 and 9 Thus, the paddle drive gear structure 208, the translation shaft 244, and the transmission gear structure 216 may be in a coaxial arrangement.

[0083] A biasing element (not shown), such as a coil spring, is disposed within the inner cavity 246 of the transmission gear structure 216. The biasing element includes an end positioned to abut against the transmission cylindrical gear 240 and another end positioned to abut against the rear end 247 of the translation shaft 244. The biasing element pushes the front end 245 opposite the rear end 247 of the translation shaft 244 toward the rear chamber housing 166 and into contact with the rear chamber housing 166. Fig.10 , the rear chamber housing 166 defines an aperture 256 with internal threads 258. The aperture 256 can be coaxially aligned with the paddle drive gear structure 208, the translation shaft 244, and / or the drive gear structure 216. The aperture 256 is sized to allow the output shaft 222 of the paddle drive gear structure 208 to be positioned through the rear chamber housing 166, and is further sized so that the internal threads 258 are configured to threadingly engage with the threads 250 of the translation shaft 244. It should be understood that the rear chamber housing 166 is a fixed component of the mixing device 102, such that the threaded engagement between the internal threads 258 and the threads 250 of the translation shaft 244 imparts translational movement to the translation shaft 244 relative to the rear chamber housing 166 (and relative to the drive gear structure 216).

[0084] The rear chamber housing 166 can define an inner bore 260 in communication with the aperture 256 and positioned on a side of the rear chamber housing 166 opposite the translation axis 244. The inner bore 260 is sized to initially receive at least a portion of the push cap 262. Fig.10 The push cap 262 is shown as an annular structure that includes an outer portion 264 that is sized to be received within the inner bore 260 and positioned adjacent a front face 266 of the inner bore 260 adjacent the internal threads 258. The push cap 262 includes an aperture 268 that is sized to allow the output shaft 222 of the paddle drive gear structure 208 to be positioned through the push cap 262. As opposed to engaging the front face 266, the outer portion 264 of the push cap 262 is configured to engage an annular slot (not shown) on the rear side of the piston 156.

[0085] In operation, the switch 180 is moved from the deactivated state to the activated state. The motor 178 draws power from the battery pack 176 and operates to supply torque to the gear train 184 to activate the mixing paddle 154. As previously described, this can be considered the beginning of the mixing phase of the operating cycle, and torque is transmitted from the pinion 186 through each of the first, second and third cylindrical gear structures 188, 194, 200 and through the paddle drive gear structure 208 to the mixing paddle 154 in the gear train 184 shown. The mixing paddle 154 immediately begins to rotate. At the same time, torque is transmitted through each of the first, second and third cylindrical gear structures 188, 194, 200 and from the fourth cylindrical gear structure 210 to the transmission gear structure 216. The transmission gear structure 216 immediately rotates, although its speed is different from the speed of the mixing paddle 154. Due to the rotational constraint provided by the guide feature 248 of the transmission gear structure 216 engaging the slot 252 of the translation shaft 244, the translation shaft 244 rotates with the transmission gear structure 216. At the same time, the biasing element pushes the front end 245 into contact with the rear chamber housing 166, so that the threads 250 of the translation shaft 244 engage with the internal threads 258 of the rear chamber housing 166. The threaded engagement of the threads 250, 258 results in translational movement of the translation shaft 244 relative to the transmission gear structure 216. In other words, the translation shaft 244 can rotate and translate simultaneously.

[0086] As described above, at least a portion of push cap 262 is initially positioned within inner bore 260 adjacent front face 266. Fig.10The aperture 256 of the rear chamber housing 166 is shown to have a depth or length defined between a front face 266 opposite a rear face (not shown). The depth of the aperture 256 is the distance that the translation shaft 244 needs to move before the front end 245 of the translation shaft 244 engages the inner portion 270 of the push cap 262 and thus moves the push cap 262 to move the piston 156. This distance and the pitch combination of the threads 250, 258 are specifically designed to provide a time lag or time interval between the mixing phase of the operating cycle and the compression and transfer phase of the operating cycle. In other words, during the time interval during which the translation shaft 244 moves through the depth of the aperture 256, the mixing paddle 154 rotates and mixes the bone cement components in the aforementioned manner. In one example, the time interval is thirty seconds; however, other time frames are also contemplated. Once the translation shaft 244 pushes the push cap 262 into the piston 156, the continuous torque provided by the gear train 184 causes the piston 156 to move along the longitudinal axis. This can be considered a transition phase of the operating cycle because the piston 156 is moving but the face 174 of the piston 156 has not yet entered the second region 160 of the chamber 112 (e.g., the face 174 of the piston 156 may only partially intersect the inlet opening 136). Therefore, the chamber 112 can remain at substantially atmospheric pressure during the transition phase. It should also be appreciated that, at least for a brief period of time, the piston 156 can move along the longitudinal axis LA while the mixing paddle 154 is fully extended and rotating (because the head 232 of the mixing paddle 154 has not yet contacted the interior face 168 and begun to fold or bend as previously described).

[0087] Relative to Figure 4 , Figure 5 The translation shaft 244 is shown moving along the longitudinal axis LA and spaced apart from the rear chamber housing 166, with the push cap 262 and the piston 156 moving in a corresponding manner (the mixing paddle 154 is removed for clarity). As previously described, the face 174 of the piston 156 passes through the inlet opening 136, and more specifically, the end 172 of the inlet opening 136, so that a fluid-tight closure is formed between the piston 156 and the housing 116 to seal the chamber 112 from the surrounding environment. Figure 5 The face 174 of the piston 156 is shown in the second region 160. The piston 156 compresses the bone cement mixture in the chamber 112 to a pressure greater than atmospheric pressure, and the bone cement can also be transferred to the delivery device 104 through the outlet port 108 in communication with the chamber 112. As can be readily seen from the above description, with a single actuation of the switch 180, the mixing device 102 advantageously performs a mixing phase and a delayed compression and transfer phase in the following manner: mixing the bone cement components at atmospheric pressure and compressing and transferring the bone cement mixture in a self-sealing closed system.

[0088] In addition, the mixing device 102 is further configured to automatically terminate the operating cycle after a predetermined period of time based on the completion of the mixing, compression and transfer phases. Figure 4 and 5 And further reference Figure 11-14 , the user actuates the actuator 148, such as a slider 150 movably coupled to the housing 116 to start the operating cycle. The slider 150 and the switch 180 are complementary arranged so that the slider 150 moves from the first position (see Figure 1 ) moves to the second position (see Figure 4 , 5 , 11, 12 and 17) to move the switch 180 from the deactivated state to the activated state to begin the operating cycle. In one embodiment, the switch 180 may be biased to the deactivated state; and when the slider 150 is in the second position, the switch 180 remains in the activated state against the bias. When the piston 156 is in the second region 160, the actuator 148 mechanically disengages from the switch 180 to allow the switch 180 to be biased from the activated state back to the deactivated state. In one example and in a manner to be explained in more detail, the stop nut 272 is configured to disengage the slider 150 from the switch 180, thereby allowing the bias of the switch 180 to return it to the deactivated state to terminate the operating cycle. In another example, a structure such as a flange or arm coupled to the piston 156 may disengage the slider 150 from the switch 180, thereby allowing the bias of the switch 180 to return it to the deactivated state. In another embodiment, which will be described in more detail, the stop nut 272' is configured to engage the second switch 181' to return the mixing device 102 to the deactivated state to terminate the operating cycle. In yet another example, when the piston 156 is properly located within the second region 160, an action such as a cable being cut may occur that results in the biasing of the switch 180 to return it to the deactivated state. Alternatively, it is contemplated that the switch 180 is a non-momentary switch, as mentioned, and when the piston 156 is within the second region 160, the switch 180 automatically and mechanically moves to the deactivated state to terminate the operating cycle and deactivate the motor 178.

[0089] Fig.13 1 is a perspective view of a slider 150 forming an actuator 148. The slider 150 includes a slider body 274 including a control surface 276 opposite an underside 278. The control surface 276 can be considered a surface configured to receive user input, such as to move the slider 150 from a first position to a second position. The slider 150 also includes a first arm 280 and a second arm 282 separate from the first arm 280. The first arm 280 and the second arm 282 extend from or are coupled to the underside 278. In particular, Figure 11-13The slider body 274 of the slider 150 is shown including a protrusion 284 extending downwardly from the underside 278, wherein each of the first arm 280 and the second arm 282 extends generally laterally from the protrusion 284. The protrusion 284 is used to space the first arm 280 and the second arm 282 from the underside 278 of the slider body 274 such that the first arm 280 and the second arm 282 are disposed within the interior 124 of the housing 116 while the slider body 274 including the control surface 276 is outside the housing 116 for user actuation.

[0090] The door 234 is coupled to the first arm 280. As previously described, the door 234 is sized and contoured to cover the inlet opening 136 of the chamber 112, more specifically, when the slide 150 is in the second position. The door 234 covering the inlet opening 136 provides a closure that is not pressurized and may not be considered fluid-tight, but prevents the flow of bone cement components from the chamber 112 during the mixing phase of the operating cycle. The engagement member 286 is coupled to the second arm 282 and includes a stop feature 288 and an inclined surface 290. Fig.13 The stop feature 288 is shown as a flange extending laterally from the engagement member 286. When the slider 150 moves from the first position to the second position, the stop feature 288 of the engagement member 286 engages the switch 180 to move the switch 180 from the deactivated state to the activated state. The stop feature 288 also holds the switch 180 in the activated state against the internal bias of the switch 180 until disengaged from the switch 180 by the stop nut 272 in a manner that will be further explained. Fig.11 , 12 15 and 16 show the slider 150 in the second position, so that the switch 180 is engaged and activated (for clarity, Fig.11 , 12 , 15 and 16 are removed to show the relative positions between the components shown).

[0091] Fig.14 The retaining nut 272 is shown to include a nut portion 292 and a flange portion 294. The nut portion 292 is annular in configuration and includes an inner cavity 296 and internal threads 298 that are sized and shaped to threadably engage the threaded shaft 242 of the drive gear structure 216 (see FIG. Figure 4 , 5 , 7 and 10-12). The flange portion 294 includes at least one flange 300 extending generally radially outward from the outer surface of the nut portion 292. Fig.14 Two flanges 300 are shown separated by a slot, but a single flange is also contemplated. Each of the flanges 300 includes a side surface 302 configured to engage a surface of a slot 304 defined in the upper shell 120 of the housing 116. Figure 6 , one of the flanges 300 is shown disposed within the slot 304. In this manner, the stop nut 272 is prevented from rotating relative to the housing 116, and thus rotation of the drive gear structure 216 causes the stop nut 272 to translate along the threaded shaft 242 of the drive gear structure 216.

[0092] In operation, a user provides input to the actuator 148, such as in the second step of the intuitive workflow. The slide 150 moves from the first position to the second position. The door 234 coupled to the first arm 280 is moved to cover the inlet opening 136, and the stop feature 288 coupled to the second arm 282 is moved to engage the switch 180 and move the switch 180 from the deactivated state to the activated state. Thus, the single action of providing input to the actuator 148 simultaneously provides a barrier over the inlet opening 136 and begins the operating cycle. At this point, the mixing device 102 can be operated as shown in FIG. Figure 4 2 and 3. As shown, the stop nut 272 is positioned on the threaded shaft 242 near or adjacent to the drive cylindrical gear 240. The internal threads 298 of the nut portion 292 are engaging the threads of the threaded shaft 242. With the switch 180 in an activated state, the motor 178 supplies torque to the gear train 184, namely through each of the first, second and third cylindrical gear structures 188, 194, 200 and from the fourth cylindrical gear structure 210 to the drive gear structure 216. As the drive gear structure 216 rotates and the stop nut 272 is prevented from rotating (due to the side surface 302 of the flange portion 294 being disposed in the narrow groove 304 of the housing), the stop nut 272 translates along the threaded shaft 242. Reference Fig.12 , the flange portion 294 of the stop nut 272 eventually encounters the engagement member 286, and more specifically the inclined surface 290 of the engagement member 286. The second arm 282 of the slider 150 is configured to bend, and as the stop nut 272 is further translated along the threaded shaft 242, the flange portion 294 engages the inclined surface 290 to bend the second arm 282 and the engagement member 286 connected to the second arm 282 upward. The degree of bending causes the stop feature 288 to disengage from the switch 180 (i.e., move upward to disengage interference), and the switch 180 is allowed to automatically return to the deactivated state under its internal bias. After the switch 180 is in the deactivated state, the motor 178 stops operating and the movement of the piston 156 and the rotation of the mixing paddle 154 are stopped, which can be considered to be the end of the operating cycle. It should be understood that a single component that can be molded and is not expensive promotes the barrier above the inlet opening 136, starts the operating cycle, and stops the operating cycle.

[0093] Reference Fig.15 and 16Another embodiment is described in which the mixing device 102 automatically terminates an operating cycle after a predetermined period of time. Fig.15 The actuator 148 is shown in a second position, i.e., after receiving an input to contact a switch (hereinafter referred to as the first switch 180') to begin an operating cycle. The first switch 180' is a momentary switch that is internally biased to a deactivated state. When the actuator 148 moves from the first position to the second position, the second arm 282 translates along the channel 221 within the front and / or rear gear train housing 218, 220 and encounters an inclined surface 223 defining the channel 221. The second arm 282 can deflect laterally (towards Fig.15 The first switch 180' is moved from the deactivated state to the activated state by the mechanical force from the engagement member 286' of the second arm 282. The second arm 282 may be restricted by the inclined surface 223 of the rear gear train housing 218, 220 and cannot be elastically bent to its original position. The mixing device 102 begins an operating cycle as previously described.

[0094] When the switch 180 ′ is in an activated state, the motor 178 supplies torque to the gear train 184 , namely through each of the first, second and third spur gear arrangements 188 , 194 , 200 , and from the fourth spur gear arrangement 210 to the transfer gear arrangement 216 . Fig.16 A stop nut 272' is shown threadedly engaged with the drive gear structure 216, wherein the flange portion 294' extends laterally from the drive gear structure 216. When the stop nut 272' is translated along the threaded shaft 242, the stop nut 272' is prevented from rotating. The mixing device 102 includes a second switch 181' separate from the first switch 180'. The second switch 181' is coupled to the housing 116 to align with the flange portion 294' of the stop nut 272'. The second switch 181' can be a non-momentary switch that is initially in an activated state. Once the stop nut 272' is translated along the threaded shaft 242, the flange portion 294' of the stop nut 272' eventually encounters the second switch 181' to move the second switch 181' from the activated state to the deactivated state. When the switch 181' is in the deactivated state (even if the first switch 180' remains in the activated state), the motor 178 stops operating and the movement of the piston 156 and the rotation of the mixing paddle 154 stop, which can be considered the end of the operating cycle. The time that the operating cycle has elapsed can be specifically adjusted as needed, based on the distance that the stop nut 272 must travel along the threaded shaft 242 to encounter the second switch 181'.

[0095] The first and second switches 180', 181' can be wired in series between the battery 176 and the motor 178. Therefore, when the first switch 180' or the second switch 181' is in a deactivated state, the motor 178 is inoperable. In the above example, the first switch 180' is initially in a deactivated state and the second switch 181' is initially in an activated state. Once the input from the user moves the actuator 148, both the first and second switches 180', 181' will be in an activated state and the motor 178 is operative. Once the stop nut 272' eventually encounters the second switch 181', the second switch 181' is in a deactivated state and the first switch is in an activated state; the motor 178 is again unable to operate. The motor 178 stops operating and the movement of the piston 156 and the rotation of the mixing paddle 154 stop, which can be considered the end of the operating cycle.

[0096] As described above, the delivery device 104 is removably coupled to the mixing device 102 to establish communication between the inlet and outlet ports 106 , 108 for transferring the bone cement mixture, and the release assembly 110 facilitates the removable connection between the mixing device 102 and the delivery device 104 . Figure 1 and 2 The release assembly 110 is shown in an initial or locked position. The release assembly 110 is configured to move from the initial or locked position to an unlocked position to allow the delivery device 104 to be separated from the mixing device 102. Fig.17 and 19A The release assembly 110 is shown in an unlocked position. Figure 17-20 , the housing 116 includes a transfer conduit 306 that communicates with the outlet port 108. Fig.18 As best shown, the transfer conduit 306 may include a boss extending outwardly from the front chamber housing 164. The first end 308 of the transfer conduit 306 may include an interior wall 310 that defines the outlet port 108. Alternatively, the interior wall 310 may be associated with a side wall of the front chamber housing 164. Fig.19AAs shown, the length of the transfer catheter 306 is defined between the first end 308 opposite the second end 309, and the length is sized to receive the sealing element 236. In particular, the sealing element 236 can be barrel-shaped, with a slit or self-closing aperture (not identified) located in its base 312, wherein the base 312 is positioned adjacent to or abutting the inner wall 310 of the transfer catheter 306. The slit or self-closing aperture is configured to open when subjected to sufficiently high pressure from the bone cement mixture in the chamber 112, particularly during the compression and transfer phases of the operating cycle. In contrast, during the mixing phase of the operating cycle performed at atmospheric pressure or near atmospheric pressure, the slit or self-closing aperture can prevent the bone cement component or mixture from flowing out prematurely. The sealing element 236 may include at least one sidewall 314 extending from the base 312 and terminating near the second end 309 of the transfer catheter 306. The inner diameter defined at least in part by the sidewall 314 is sized to removably receive a complementary male component of the delivery device 104 to provide sealed fluid communication between the outlet port 108 of the mixing device 102 and the inlet port 106 of the delivery device 104 .

[0097] Continue to refer Fig.18 and 19A , the transfer catheter 306 can include a first coupling feature 316 and / or a second coupling feature 318 that are configured to selectively engage complementary features of the release assembly 110 to be described to facilitate the desired movement and operation of the release assembly 110. The first coupling feature 316 can be a rib 320 extending along the outer surface of the transfer catheter 306, particularly between the first and second ends 308, 309. Fig.18 and 19A Two ribs 320 are shown positioned diametrically opposite each other when viewed in conjunction. The first coupling feature 316 is configured to provide interference to limit the range of motion of the release assembly 110 relative to the transfer catheter 306 in a manner to be described. In one example, the maximum range of motion is ninety degrees counterclockwise rotation, such as Fig.17 Relative to Figure 1 The second coupling feature 318 can include a rib 322 extending along the outer surface of the transfer conduit 306 , particularly extending subtending an arc at or near the second end 309 . Fig.18 and 19A Two ribs 322 are shown that are diametrically positioned relative to each other. The ribs 322 are configured to axially retain the release assembly 110 on the transfer catheter 306. In addition, the transfer catheter 306 may include at least one defeatable feature 324 (one identified as being hidden but not shown). Fig.19A324 ), such as a protrusion or bump-like structure extending outwardly from the outer surface of the transfer catheter 306. The defeatable feature 324 can be positioned adjacent to one or both of the ribs 322 forming the second coupling feature 318. The defeatable feature 324 is configured to maintain the release assembly 110 in the locked position to prevent the delivery device 104 from being accidentally unlocked from the mixing device 102. Once input is provided from the user to the release assembly 110 with a force suitable for overcoming the interference engagement of the defeatable feature 324, the release assembly 110 can be moved to the unlocked position.

[0098] Reference Fig.19A and 20 The release assembly 110 is described. The release assembly 110 includes a head portion 326 and a body portion 328 coupled to the head portion 326. The head portion 326 can be generally tubular in form and include at least one sidewall 330 defining an inner lumen 332. The inner diameter of the inner lumen 332 is slightly larger than the outer diameter of the transfer catheter 306, so that the head portion 326 receives the transfer catheter 306 in the inner lumen 332, as shown in FIG. Fig.19A As shown. The head portion 326 includes at least one protrusion 334 extending inwardly from the side wall 330 and positioned within the inner cavity 332. The at least one protrusion 334 can be two protrusions (one is shown) positioned opposite each other in the diametrical direction. The protrusion 334 is configured to cooperate with the first coupling feature 316, that is, the rib 320, to limit the range of motion of the release assembly 110. Fig.19A One of the protrusions 334 is shown engaging one of the ribs 320 while the release assembly 110 is in the unlocked configuration, such that the release assembly 110 has a maximum range of motion of 90 degrees of counterclockwise rotation relative to the locked configuration. In addition, the protrusion 334 selectively engages the second coupling feature 318, i.e., the rib 322, to prevent the release assembly 110 from being axially removed from the transfer conduit 306. More specifically, during assembly of the mixing device 102, before the upper shell 120 of the housing 116 is coupled to the lower shell 122 of the housing 116, the protrusion 334 is guided through the gap defined between the ribs 322 forming the second coupling feature 318. At this point, the release assembly 110 is in an exaggerated clockwise orientation relative to the locked position. The release assembly 110 is rotated counterclockwise such that the protrusion 334 is located behind the rib 322 and the upper shell 120 of the housing 116 and the lower shell 122 of the housing 116. Interference between the body portion 328 of the release assembly 110 and the upper shell 120 of the housing 116 prevents the release assembly 110 from rotating clockwise, otherwise the protrusion 334 may be aligned with the gap again (thereby allowing axial removal of the release assembly 110). The body portion 328 of the release assembly 110 is supported on a groove 336 defined in the upper shell of the housing 116 (see Fig.17 ), the release assembly 110 can be considered to be in the locked position.

[0099] Another embodiment of the transfer catheter 306' is as follows Fig.19B As shown. The transfer conduit 306' includes a boss 311 extending from the inner wall 310'. The boss 311 can be coaxially disposed within the head portion 326'. The boss 311 includes a side wall 314' that defines an inner cavity that is connected to the chamber 112 of the mixing device 102. In this embodiment, the size of the annular space between the boss 311 and the head portion 326' can be designed to accommodate a sealing element (not shown) connected to the delivery device 104. The head portion 326' can include a second coupling feature 318', specifically a rib 321 extending along the inner surface of the transfer conduit 306'. The rib 321 can be arranged in a spiral shape to define a spiral-shaped groove 323. The groove 323 provides a female thread that is configured to threadably engage with a male thread (not shown) provided on the delivery device 104. More specifically, when the release assembly 110 is rotated from the unlocked position to the locked position, such as during assembly and packaging of the system 100, the groove 323 rotates to pull the delivery device 104 toward the mixing device 102, thereby ensuring a sealed engagement therebetween. The sealed engagement also prevents accidental unlocking of the delivery device 104 from the mixing device 102. When the release assembly 110 is rotated from the locked position to the unlocked position, such as before deploying the delivery device 104, the groove 323 rotates to move the delivery device 104 away from the mixing device 102.

[0100] The body portion 328 may be an elongated structure extending from the head portion 326 . Fig. 20 The body portion 328 is shown to include two legs 338 that form a generally right angle. One of the legs 338 includes a control surface 340 configured to receive input from a user. One of the legs 338 may also include a marking 342, in this example the number "3", which may correspond to a third step of the intuitive workflow. The third step of the workflow occurs after the second step of the intuitive workflow is completed, i.e., after the operating cycle of the mixing device 102 is completed, including a transfer phase in which the bone cement mixture is transferred to the delivery device 104. Once it is desired to separate the delivery device 104 from the mixing device 102, the user provides input to the control surface 340 to move the release assembly 110 from the locked position to the unlocked position. Specifically, the release assembly 110 is rotated counterclockwise relative to the transfer guide tube 306, during which time the protrusion 334 encounters a defeatable feature 324. Further input is provided with an appropriate force for overcoming the interference engagement of the defeatable feature 324, and the release assembly 110 is moved to the unlocked position. Fig.17 , 19A and the unlocked position shown in FIG19B.

[0101] Combination Figure 1 When observing, Fig. 20The release assembly 110 is generally shown in a locked position. The head portion 326 of the release assembly 110 includes a lip 344 that extends axially outward and subtends an arc such that a gap is defined between two edges 346 of the lip 344. The gap can be sized to be at least equal to the width of a complementary coupling feature of the delivery device 104 (e.g., a boss extending from the housing 118 and at least partially defining the inlet port 106). The lip 344 and the head portion 326 define a groove 348 that extends at least substantially circumferentially between the edges 346 of the lip 344. The groove 348 includes a first groove portion 350 and a second groove portion 352 (one shown) disposed on each side of the first groove portion 350. The first groove portion 350 is wider than the second groove portion 352. The second groove portion 352 is sized and configured to retain a complementary coupling feature of the delivery device 104 (e.g., diametrically opposed tabs extending from the boss). The tabs on the delivery device 104 may be positioned at the six o'clock and twelve o'clock positions when the delivery device 104 is coupled to the release assembly 110 such that the delivery device 104 cannot be axially separated or radially moved through the void.

[0102] With the release assembly 110 in the unlocked position, the first groove portion 350 is in registration with one tab on the delivery device 104, and the gap is in registration with another tab of the delivery device 104. The relatively large width of the first groove portion 350 allows for some axial movement of the delivery device 104 relative to the release assembly 110, wherein the first groove portion 350 is positioned at the six o'clock position (see Fig.19A ). In combination, the gap is located at the twelve o'clock position and allows the delivery device 104 to be manipulated upward relative to the release assembly 110 to separate the delivery device 104 from the release assembly 110 and the mixing device 102. Another input can be provided to the control surface 115 of the bracket 114 to allow the housing 118 of the delivery device 104 to be removed from the bracket 114.

[0103] The hybrid delivery system 100 provides several advantages in the operating room. First, the mixing device 102 and the delivery device 104 can be packaged efficiently. Fig.21 and 22 , a kit including a mixing device 102 and a delivery device 104 is shown. The kit may also include packaging, such as a blister pack 354 having a base 356 and a cover 358. The base 356 may be a thermoformed plastic contoured to generally conform to the mixing delivery system 100, and the cover 358 may be a peel-off film coupled to the base 356 with an adhesive. The spatially conscious arrangement of the mixing device 102 and the delivery device 104 within the base 356 of the blister pack 354 may accommodate the placement of the bone cement component (i.e., the liquid monomer 360 (see Fig.25 ) and powder polymer 362) are conveniently included in the blister package 354. Before the blister package is opened, the entire contents of the blister package 354 can be in a sterile state. Therefore, the surgical technician only needs to present the blister package 354 across the sterile barrier of the operating room without having to retrieve each of, for example, the mixing device 102, the delivery device 104, the liquid monomer 360 and the powder polymer 362 separately. Alternatively, the blister package 354 may include a packaging insert, such as a thermoformed tray, to protect the cover 358 from damage caused by contact with the hybrid delivery system 100. The packaging insert may include features for holding the liquid monomer 360 and the powder polymer 362, allowing them to be transferred to the sterile area in one step. In addition, the hybrid delivery device 100, the liquid monomer 360 and the powder polymer 362 can be packaged in an internal blister tray, covered with a tray insert, all of which can be transferred to the sterile area in one step. Fewer items are presented across the sterile barrier to improve efficiency and reduce the possibility of contamination of the sterile area. In another example, the liquid monomer 360 and the powdered polymer 362 can be directly coupled to the mixing device so that they can be removed from the package as a single unit along with the rest of the mixing delivery device 100. In another example, the powdered polymer 362 can be packaged in the chamber 112. This arrangement eliminates the steps of transferring the powdered polymer 362 to the sterile field and introducing the powder through the funnel 138. In addition, the liquid monomer 360 can be packaged in a manner that allows it to be directly engaged with the chamber 112 (e.g., a syringe, foil bag, or dispensing device), thereby eliminating the need for a funnel.

[0104] Second, as previously described, the side-by-side arrangement of the mixing device 102 and the delivery device 104 allows the mixing device 102 and the delivery device 104 to be compactly packaged in a coupled configuration prior to deployment within an operating room. Figure 1 , the mixing device 102 includes the previously referenced Figure 4 and 5 The longitudinal axis LA of the chamber 112 is depicted as M In addition, the delivery device 104 includes a longitudinal axis LA D The longitudinal axis LA of the conveying device 104 D The housing 118 of the delivery device 104 may be generally defined between the two ends thereof and / or coaxially with the chamber of the delivery device 104. Figure 1 Generally, it can be understood that when the conveying device 104 is coupled to the mixing device 102, each longitudinal axis LA D , LA M The longitudinal axes LA are parallel. D , LA MThe parallel arrangement provides the aforementioned efficient packaging. To facilitate this parallel arrangement, the outlet port 108 defined by the transfer conduit 306 (and the inlet port 106 of the delivery device 104) is arranged perpendicular to the respective longitudinal axes LA. D , LA M In other words, initially within chamber 112 along longitudinal axis LA M The moved bone cement mixture is generally directed laterally to be directed through the outlet port 108 and into the inlet port 106 of the delivery device 104. Thereafter, the bone cement mixture may be generally directed laterally to be directed along the longitudinal axis LA D The conveying device 104 moves within the chamber of the conveying device 104. In addition, when the conveying device 104 is coupled to the mixing device 102, the respective longitudinal axes LA D , LA M The housings 116, 118 are coplanar in a substantially horizontal plane to achieve the aforementioned side-by-side arrangement. The parallel and side-by-side arrangement allows the lengths of the respective housings 116, 118 to be substantially equal (when viewed in a plane) in the coupled configuration. In other words, the structures of the mixing device 102 and the delivery device 104 rarely (if ever) extend beyond each other, thereby minimizing the need for unnecessary containment in the respective packaging.

[0105] Fig. 22 The hybrid delivery system 100 is shown within the base 356 of the blister pack 354, and Fig.23 The mixing delivery system 100 is shown being removed as a unit from the base 356 with one hand (the user's left hand (LH)). In addition, the flexible tether 142 allows the funnel 138 to be moved with one hand along with the mixing device 102 and the delivery device 104. Furthermore, packaging the mixing delivery system 100 in a coupled configuration prior to deployment into the operating room allows the user to use the system 100 directly before or after commencing a surgical procedure without coupling the delivery device 104 to the mixing device 102. The risk of user error is minimized, and the user can be confident that a closed, sealed system is provided between the delivery device 104 and the mixing device 102.

[0106] Once the hybrid delivery system 100 is in the sterile field of the operating room, the user can begin an intuitive three-step workflow such as Fig. 22 and 23135 . As indicated by the number "1" on the marking 144 on the funnel 138, the first step includes the user inverting the funnel 138 to be positioned within the orifice 135. The number "1" marking may also be included on the housing 116, preferably near the orifice 135, to help inform the user where the funnel 138 is to be inserted. The user introduces the liquid monomer 360 and the powdered polymer 362 into the funnel 138 to be directed to the chamber 112 within the mixing device 102. As indicated by the number "2" on the marking 152 on the actuator 148, the second step includes the user providing input to the actuator 148, such as moving the slider 150 from a first position to a second position. In the manner previously explained in detail, through the actuation of the actuator 148, the mixing device 102 automatically performs an operating cycle to mix the bone cement components at atmospheric pressure and compress and transfer the bone cement mixture in a self-sealing manner. In addition, the mixing device 102 is automatically deactivated after a predetermined time period based on the end of the mixing, compression, and transfer phases to terminate the operating cycle. Deactivation of the mixing device 102 indicates the completion of step two of the intuitive workflow. The user can discern the deactivation of the mixing device 102 from the elapsed time (e.g., less than, equal to, or greater than one minute) and / or the absence of noise that may be associated with the motor 178, the gear train 184, etc. As indicated by the marking 342 on the release assembly 110 being the number "3", the third step of the intuitive workflow includes providing an input to the release assembly 110 to move the release assembly 110 from a locked position to an unlocked position, thereby allowing the delivery device 104 to separate from the mixing device 102. Fig.25 As shown, the delivery device 104 is ready for use.

[0107] Although the bone cement composition has been described as including a liquid monomer component and a powder polymer component, other exemplary bone cement compositions may also be mixed according to the above-described methods and systems, including those comprising more than two components, those comprising two liquid components, or those comprising one or more paste components. In addition, the above-described systems and methods can be used to deliver compositions other than bone cement, such as bone graft materials, biologics, other hardenable substances, and combinations thereof.

[0108] It is further contemplated that numerous modifications and variations are possible in light of the above teachings, and that the invention may be practiced otherwise than as specifically described. Fig.26 , a hybrid delivery system 100 is shown as a stylized embodiment including a mixing device 102 and a delivery device 104. The delivery device 104 may be coupled to Figure 1The same or similar to that shown in , disclosed in the aforementioned International Publication No. WO2019 / 200091, or disclosed in the aforementioned U.S. Patent No. 6,547,432, etc. Alternatively, the delivery device 104 may include a hydraulic mechanism, and the mixing device 102 transfers the bone cement to a cylinder that can be pressurized by a hydraulic pump.

[0109] The mixing device 102 may include an internal structure and operation similar in at least many respects to the previously discussed embodiments, with only certain changes, which will be described for the sake of brevity. Fig.26 , a funnel-type device 138 can be integrated into the housing 116. In particular, the upper shell 120 of the housing 116 defines a funnel 138' as an inclined surface 139 extending downward from the upper surface. The funnel 138' is connected to an orifice (not shown) leading to a chamber (not shown). The integration of the funnel 138' also reduces the footprint of the mixing device 102, thereby reducing the footprint of the mixing delivery system 100. The reduced footprint can simplify packaging and occupy less space in the operating room. In addition, the integration of the funnel 138' eliminates the need for the user to place the mixing device 102 in the mixing delivery system 100. Figure 1 The need to insert the funnel-type device 138 into the orifice 135 can simplify the user's workflow.

[0110] Unlike the previously described lever, the release assembly 110 of the mixing device 102 may be a button 364 . Fig.26 A button 364 is shown disposed on the upper surface of the upper housing 122 of the housing 116, with what is known to many as "pop-up" indicia. The button 364 can be actuated, and an internal mechanism (not shown) of a release assembly coupled to the button 364 can move the system 100 from an initial or locked position to an unlocked position to allow the delivery device 104 to be separated from the mixing device 102. When the release assembly 110 moves the system 100 from the initial or locked position to the unlocked position, the internal mechanism can be further configured to slightly move a portion of the delivery device 104 away from the mixing device 102 to provide a visual indication that the delivery device 104 is no longer docked and is now suitable for complete removal of the delivery device 104 for use.

[0111] In one embodiment, the release or "disengagement" of the delivery device 104 from the mixing device 102 can be based on the movement of one or more components of the mixing device 102. For example, a mechanical, electromechanical, or electrical actuator can detect when the piston 156 reaches a position within the second region 160 of the chamber 112 that indicates the compression and transfer phase is complete. Based on this position, the actuator moves the system 100 from a locked position to an unlocked position and / or moves a portion of the delivery device 104 slightly away from the mixing device 102.

[0112] The mixing device 102 may include a display 366, such as a digital display. The display 366 is shown as being disposed on the front surface of the upper housing 120, but other suitable locations are also contemplated. The display 366 is configured to provide information to the user about the operation of the system 100, particularly the mixing device 102. In one example, the display 366 displays the remaining time of the operating cycle. In other words, the display 366 counts down from the start time to zero. In another example, the display 366 displays the time elapsed in the operating cycle. In other words, the display 366 starts counting from zero. In yet another example, the display 366 displays an estimate of the remaining working time for bone cement. A temperature sensor (not shown) may be included on the mixing device 102. Since the total working time for bone cement depends on the external temperature, an algorithm may be stored in a memory (not shown) to determine the total working time for bone cement based on the temperature sensed by the temperature sensor (e.g., room temperature). In conjunction with the timer function, the processor may determine the remaining working time as the difference between the total working time and the elapsed working time. In addition to the display 366 that displays the remaining working time as a numerical value, other types of visual markers may be provided. When the remaining operating time is below a predetermined threshold, the display 366 may change color (e.g., green, yellow, red). Likewise, the display 366 may flash, and / or an audible alarm may also be provided. Furthermore, the timer may be a series of lights, a moving bar, an analog clock, etc.

[0113] In some embodiments, the display 366 can be configured to selectively or automatically move between information about the operation of the mixing device 102 or the bone cement. For example, as described above, the display 366 can provide a first output including the remaining time of the operating cycle. Then, after reaching zero, the display 366 can automatically move from the first output to a second output, wherein the second output includes a value counting from zero to indicate the amount of operating time that has elapsed. The user can selectively switch between the first input, the second input, and / or any additional inputs.

[0114] The mixing device 102 may include at least one light 368, 370, 372 to improve usability. The lights 368, 370, 372 may be similar to the markings 146, 152, 342 (see FIG. Figure 2 and 20) to guide the user through the workflow. The first light 368 can be positioned near, on, around, or around the funnel 138, thereby corresponding to the step of directing the bone cement component into the chamber 112 through the funnel 138. The second light 370 can be positioned near, on, around, or around the power button 374, thereby corresponding to the step of operating the mixing device 102 to start the operation cycle. The third light 372 can be positioned near, on, around, or around the button 364, thereby corresponding to the step of moving the release assembly 110 from the locked configuration to the unlocked configuration. The lights 368, 370, 372 can be light emitting diodes (LEDs) or other suitable light sources.

[0115] The lights 368, 370, 372 can communicate with a controller or processor. Based on a specific action, the controller can selectively control one or more of the lights 368, 370, 372 to light up to remind the user what to do next. In one workflow, the power button 374 can be actuated to turn on the mixing device 102; that is, to wake up the mixing device 102 from a sleep-like state. The controller sends a signal to light up the first light 368 because guiding the bone cement component into the chamber 112 through the funnel 138 can be the first step of the workflow. The first light 368 can remain lit until a sensor communicating with the controller (e.g., a load sensor in the chamber 112, and an optical sensor near the orifice 135) detects that the bone cement component has been guided into the chamber 112. The controller sends a corresponding signal based on the signal received from the sensor to stop lighting the first light 368 and light up the second light 370 because pressing the power button 374 can be the second step of the workflow. The mixing device 102 begins the mixing, compression, and transfer phases of the previously described operating cycle. The display 366 can provide information about the status of the operating cycle. Once completed, the controller sends a corresponding signal to stop illuminating the second light 370 and illuminate the third light 372, because moving the release assembly 110 from the locked configuration to the unlocked configuration can be the third step of the workflow. The user can press the button 364 and remove the delivery device 104 from the mixing device 102. Once the button 364 is pressed, the display 366 can start displaying the remaining operating time as the difference between the total operating time and the operating time that has elapsed, for example, based on the room temperature.

[0116] Certain embodiments may be described with reference to the following exemplary clauses:

[0117] Item 1 - A method for preparing bone cement using a mixing device, the mixing device comprising a chamber defining an inlet opening, the chamber comprising a first end opposite to a second end, the inlet opening being between the first end and the second end, the mixing device further comprising a piston disposed in the chamber, and a mixing paddle disposed in the chamber, the method comprising the steps of: stirring bone cement components with a mixing paddle at a first pressure to prepare a bone cement mixture when a face of the piston is located within a first region of the chamber extending longitudinally between the first end of the chamber and the inlet opening; and moving the piston toward the second end of the chamber so that the face of the piston passes through the inlet opening and is placed within a second region of the chamber to compress the bone cement mixture at a second pressure greater than the first pressure.

[0118] Clause 2—The method of Clause 1 , wherein the first pressure is atmospheric pressure.

[0119] Clause 3 - The method of clause 1 or 2, further comprising the step of forming a fluid-tight closure between the piston and the chamber in the second region.

[0120] Clause 4 - A method as described in any of Clauses 1-3, wherein the chamber further defines an outlet port adjacent to a second end of the chamber, wherein the step of moving the piston further includes moving the piston along the longitudinal axis within the second region to push bone cement out of the mixing device through the outlet port.

[0121] Clause 5 - The method of any of clauses 1-4, further comprising rotating a mixing paddle to mix the bone cement components within the chamber.

[0122] Clause 6 - The method of any of clauses 1-5, further comprising the step of folding the mixing paddle with a force associated with each of the piston moving along the longitudinal axis and an interior face of the housing defining the second end of the chamber.

[0123] Item 7 - A method for preparing bone cement using a mixing device and transferring the bone cement to a delivery device connected to the mixing device, the mixing device comprising a chamber defining an inlet opening, a piston disposed in the chamber, a mixing paddle disposed in the chamber, a motor connected to the piston and the mixing paddle, an actuator connected to the housing, and a door connected to the actuator, the method comprising the steps of: introducing at least two bone cement components into the chamber through the inlet opening; and, when the piston is located in a first area, moving the actuator from a first position to a second position to cover the inlet opening with the door and simultaneously activating the motor, wherein activation of the motor causes the mixing paddle to rotate to mix the at least two bone cement components in the chamber at atmospheric pressure to prepare a bone cement mixture, and causing the piston to pass through the inlet opening into a second area of ​​the chamber to (i) compress the bone cement mixture at a second pressure greater than atmospheric pressure, and (ii) transfer the bone cement to the delivery device.

[0124] The method described in clauses 8 to 7, wherein the mixing device further includes a release assembly that connects the mixing device to the conveying device, the method further including the step of providing an input to move the release assembly from a locked position to an unlocked position, wherein an directional feature of the release assembly engages a complementary directional feature of the conveying device, and wherein the directional feature and the complementary directional feature disengage to allow the conveying device to be separated from the mixing device.

[0125] Clause 9 - The method of clause 7 or 8, wherein the at least two bone cement components are a liquid monomer and a powdered polymer, wherein the step of introducing the bone cement components into the cavity further comprises directing both the liquid monomer and the powdered polymer through the inlet opening.

[0126] Item 10 - A mixing device for preparing bone cement, the mixing device comprising: a housing; a chamber within the housing, the chamber having a first region and a second region separate from the first region; a mixing paddle rotatable within the chamber to mix bone cement components to form a bone cement mixture; a piston movable within the chamber to compress the bone cement components; a motor coupled to the piston and the mixing paddle; and a switch coupled to the motor, wherein the switch is configured to move between an activated state and a deactivated state, in which the switch is switched on by activating the motor to effect at least one of movement of the piston and rotation of the mixing paddle. The invention relates to a method of controlling a first piston in a housing and a second piston chamber, wherein the piston is configured to move from a first region to a second region within the chamber so that when the piston is within the second region, the actuator is mechanically disengaged from the switch to allow the switch to be biased back from the activated state to the deactivated state.

[0127] Clause 11 - The mixing device of Clause 10, wherein the switch is a momentary switch.

[0128] Item 12 - The mixing device described in Item 10 or 11, further comprising: a transmission gear structure that is connected to the motor and is rotatable during an operating cycle; and a stop nut that is connected to the transmission gear structure and is constrained from relative rotation relative to the transmission gear structure, such that the stop nut is configured to translate along the transmission gear structure and engage the actuator to achieve mechanical disengagement of the actuator from the switch.

[0129] Item 13 - A mixing device as described in Item 12, wherein the stop nut further includes a nut portion having an inner diameter threadedly engaged with the outer diameter of the drive gear structure, and a flange portion extending from the nut portion, wherein the flange portion is configured to engage the actuator to achieve mechanical disengagement of the actuator from the switch.

[0130] Clause 14 - The mixing device of any of clauses 10-13, wherein the actuator is a slider comprising a slider body, an arm extending from an underside of the slider body, and a stop feature coupled to the arm and configured to engage the switch.

[0131] Item 15 - A mixing device as described in Item 14, wherein the slide also includes an inclined surface that is connected to the arm and is arranged to be engaged by the stop nut when the stop nut translates with the rotation of the drive gear structure, wherein engagement of the stop nut with the inclined surface causes the arm to bend and disengage the stop feature from the switch.

[0132] Item 16 - A mixing device for preparing bone cement, the mixing device comprising: a housing; a chamber within the housing, the chamber having a first region and a second region separate from the first region; a mixing paddle rotatable within the chamber to mix bone cement components to form a bone cement mixture; a piston movable within the chamber to compress the bone cement components; a motor coupled to the piston and the mixing paddle; a switch coupled to the motor, the switch being configured to move between an activated state and a deactivated state, in which the switch begins an operating cycle by activating the motor to effect at least one of movement of the piston and rotation of the mixing paddle, and in which the switch terminates the operating cycle by deactivating the motor, wherein the switch is momentary and biased toward the deactivated state; and an actuator coupled to the housing and movable between a first position in which the actuator is spaced apart from the switch and a second position in which the actuator engages the switch to move the switch from the deactivated state to the activated state and maintains the switch in the activated state against the bias.

[0133] The foregoing disclosure is not intended to be exhaustive or to limit the invention to any specific form. The terminology used is intended to be in the nature of words of description rather than limitation.

Claims

1. A mixing device for preparing bone cement from bone cement components, the mixing device comprising: shell; a chamber within the housing and defining an inlet opening and an outlet port configured to be removably coupled to a delivery device, the chamber having a first end and a second end defining a longitudinal axis, wherein a first region of the chamber is longitudinally defined between the first end of the chamber and an end of the inlet opening proximal to the second end of the chamber, and wherein a second region of the chamber is longitudinally defined between the first region and the second end of the chamber; a piston disposed in the chamber and including a face; a mixing paddle rotatably disposed in the chamber; and a motor operably coupled to the piston and the mixing paddle, wherein the motor is configured to rotate the mixing paddle when the face of the piston is located in the first region of the chamber so that the mixing paddle mixes the bone cement components to prepare a bone cement mixture, wherein the chamber is at or below atmospheric pressure, wherein the motor is further configured to move the piston along the longitudinal axis to the second region of the chamber so that the face passes through the inlet opening to provide a fluid-tight closure for compressing the bone cement mixture within the chamber and transferring the bone cement mixture to the delivery device through the outlet port.

2. The mixing device according to claim 1, wherein The outlet port is adjacent the second end of the chamber.

3. The mixing device of claim 1, further comprising a sealing element disposed within the outlet port, wherein the sealing element is a self-closing aperture configured to be opened by the bone cement mixture during compression of the bone cement mixture.

4. The mixing device of any one of claims 1-3, further comprising a release assembly removably coupled to the housing and configured to receive a user input for separating the delivery device from the mixing device.

5. The mixing device of claim 4, further comprising a tubular head portion coupled to the housing adjacent the outlet port, and a body portion extending from the tubular head portion.

6. The mixing device according to claim 5, wherein: The upper shell of the housing includes a recess, and wherein the body portion of the release assembly is disposed within the recess when the release assembly is in the locked position.

7. The mixing device according to claim 4, wherein: The release assembly is movable from a locked position, in which an orientation feature of the release assembly engages a complementary orientation feature of the delivery device, to an unlocked position, in which the orientation feature and the complementary orientation feature are disengaged.

8. The mixing device of claim 1, further comprising a slide movably coupled to the housing and comprising a door slidable to close the outlet opening.

9. The mixing device according to claim 8, wherein: The piston is positioned within a first region of the chamber before the slider receives a user input causing the door to close the outlet opening.

10. The mixing device according to claim 8, wherein: The door is positioned within the aperture defined by the housing and between the inlet opening defined by the chamber.

11. The mixing device according to claim 8, wherein: The door is configured to close the outlet opening in a manner that is not fluid-tight but prevents the bone cement components from flowing out of the chamber during the mixing phase of the operating cycle.

12. The mixing device of claim 8, further comprising a switch connected to the motor and initially in an inactive state, and wherein: The slide includes an arm and an engagement member coupled to the arm and is configured to activate the switch to initiate an operating cycle in which the motor is activated.

13. The mixing device according to claim 12, wherein: The switch is a first switch, and the device also includes a second switch connected to the ground in series with the first switch and the motor, the second switch is non-momentary and is initially set in an activated state to allow activation of the motor, wherein the second switch is configured to move from the activated state to a deactivated state, in which the motor is deactivated to terminate an operating cycle, wherein the piston is in the second area during actuation of the second switch.

14. The mixing device of claim 1, further comprising a hopper coupled to the housing, wherein the hopper includes a first numerical indicia corresponding to a first step of an operational workflow.

15. The mixing device of claim 14, further comprising a slide coupled to the housing and slidable to close the outlet opening, and wherein The slide includes a second numerical indicia corresponding to a second step of the operational workflow.

16. The mixing device of claim 15, further comprising a release assembly for releasably coupling the mixing device to the delivery device, and wherein The release component includes a third indicia corresponding to a third step of the operational workflow.

17. The mixing device according to claim 16, wherein: The funnel device includes a detent that releasably engages a complementary opening of the housing.

18. A mixing device for preparing bone cement from bone cement components, the mixing device comprising: shell; a chamber within the housing and defining an inlet opening and an outlet port, the chamber including a first end and a second end defining a longitudinal axis, wherein a first region of the chamber is longitudinally defined between the first end of the chamber and an end of the inlet opening proximate the second end of the chamber, and wherein a second region of the chamber is longitudinally defined between the first region and the second end of the chamber; a piston disposed in the chamber and including a face; a mixing paddle rotatably disposed in the chamber; a motor operably coupled to the piston and the mixing paddle; and a sealing element disposed within the outlet port, wherein the motor is further configured to move the piston along the longitudinal axis to the second region of the chamber such that the face passes through the inlet opening to provide a fluid-tight closure for compressing the bone cement mixture, and wherein the sealing element is a self-closing orifice configured to be opened by the bone cement mixture during compression of the bone cement mixture such that the bone cement mixture is transferred through the outlet port.

19. A mixing device for preparing bone cement, the mixing device comprising: shell; a chamber within the housing, the chamber having a first portion and a second portion separate from the first portion; a mixing paddle rotatable within the chamber to mix the bone cement components to prepare the bone cement; a piston movable within the chamber to compress the bone cement component; a motor coupled to the piston and the mixing paddle; a switch coupled to the motor, the switch configured to move between an activated state in which the switch begins an operating cycle by activating the motor to effect at least one of movement of the piston and rotation of the mixing paddle, and a deactivated state in which the switch terminates the operating cycle by deactivating the motor, wherein the switch is biased toward the deactivated state; and an actuator coupled to the housing and movable between a first position in which the actuator is spaced apart from the switch and a second position in which the actuator engages the switch to move the switch from a deactivated state to an activated state and holds the switch in the activated state against a bias, wherein the piston is configured to move from a first region to a second region within the chamber such that when the piston is within the second region, the actuator mechanically disengages from the switch to allow the switch to be biased to return from the activated state to the deactivated state.

20. A kit for performing vertebral augmentation surgery using bone cement, the kit comprising: A mixing device for mixing bone cement components to prepare a bone cement mixture and compressing the bone cement mixture, the mixing device comprising: a chamber defining an inlet opening and an outlet port in communication with the inlet opening; a piston movable within the chamber; a mixing paddle movable within the chamber; a delivery device including a chamber defining an inlet port for receiving bone cement from the mixing device; and a package sized to accommodate said mixing device and said delivery device, Wherein, the inlet port of the delivery device is in communication with the outlet port of the mixing device, such that the mixing device and the delivery device are detachably coupled to each other within the package and are configured to be removed from the package as a single unit.

21. A mixing device for preparing bone cement, the mixing device comprising: a housing including an upper housing and a lower housing coupled to the upper housing; a chamber within the housing, the chamber defining an inlet opening configured to receive a bone cement component; a mixing paddle rotatable within the chamber to mix the bone cement components to prepare a bone cement mixture; a piston movable within the chamber to compress the bone cement component; and a motor coupled to the piston and the mixing paddle, Wherein, the upper housing includes a funnel having an inclined surface defining an orifice communicating with the inlet opening.

22. A mixing device for preparing bone cement, the mixing device comprising: a housing including an upper housing and a lower housing coupled to the upper housing; a chamber within the housing, the chamber defining an inlet opening configured to receive a bone cement component; a mixing paddle rotatable within the chamber to mix the bone cement components to prepare a bone cement mixture; a piston movable within the chamber to compress the bone cement component; a motor coupled to the piston and the mixing paddle; and A display is coupled to the housing and is configured to display information indicative of operation of the mixing device.

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