Mixing device and method for making bone cement

Abstract

To provide a mixing device and method for making bone cement.SOLUTION: The piston of the mixing device 102 is positioned in a first region of the chamber such that the mixing paddle rotates to mix the bone cement components at a first pressure to create a bone cement mixture. The piston passes through the inlet opening to be positioned within the second region of the chamber to compress the bone cement mixture to a second pressure greater than the first pressure to form the bone cement. The bone cement can be transferred to the delivery device 104. The mixing device includes features that automatically initiate the compression and transfer phases after completion of the mixing phase, and may further include features that automatically terminate the operating cycle. To improve efficiency in the operating room, a three step intuitive workflow utilizing the mixing device is also disclosed.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] [Priority claim] This application is a continuation of U.S. Provisional Patent Application No. 62 / 861,698, filed June 14, 2019. No. 60 / 699,999, filed on Oct. 1, 2003, which claims priority to and all benefit of the same, the entire contents of which are incorporated herein by reference. do. [Background technology]

[0002] A common cause of low back pain is loss of height or collapse of weakened or damaged vertebral bodies. Vertebral compression fractures. Vertebral weakening can result from acute injury or, more commonly, osteoporosis. One treatment involves vertebral augmentation, which In vertebral augmentation, the height of the vertebral body is increased or restored, and at this increased or restored height, stiffening is performed. The bone cement is typically stabilized by a biodegradable bone cement. powder polymer and liquid monomer), which are packaged separately and are used for vertebral body reinforcement treatment. The bone cement components are mixed immediately before or during placement. A consistent and reproducible mix ensures that the bone cement has the expected mechanical properties and characteristics. This is an area of ​​particular interest in development to ensure that the product is devices (e.g., "open bowl" or vacuum techniques) are used by operating room staff The need for vigorous stirring of the bone cement components makes it inefficient. but with varying or different intensities and / or varying or different durations During implantation, the bone cement components may be mixed, resulting in a non-uniform bone cement. Furthermore, some manual mixing devices can result in poor quality and non-reproducible results. This is undesirable as it may expose staff to bone cement components. Mixed-use devices overcome some of the problems mentioned above, but require staff to become familiar with the devices. This requires staff to engage in highly complex workflows, especially if the workflow is not well-organized. Therefore, an improved method for making bone cement that overcomes one or more of the aforementioned drawbacks is provided. There is a need in the art for improved mixing devices and methods. Summary of the Invention

[0003] A first aspect of the present disclosure relates to a mixing device for making bone cement from bone cement components. The chamber defines an inlet opening and has first and second ends and a first The chamber has a longitudinal axis extending between a first end and a second end. a first end of the chamber and an end of the inlet opening closest to the second end of the chamber; The second region of the chamber is defined by a length between the first region and the second end of the chamber. The mixing device includes a piston disposed within the chamber. The piston includes a surface. The mixing device includes a mixing paddle rotatable within the chamber. The surface is where the mixing paddle rotates to mix the bone cement components to create the bone cement mixture. configured to be located within a first region of the chamber such that the chamber is at subatmospheric pressure when Further movement of the piston in the second region causes the bone in the chamber to move. Forming a fluid-tight closure between the piston and the chamber to compress the cement mixture and a second region of the chamber, the second region being movable along the longitudinal axis to position the second region of the chamber. is.

[0004] In some embodiments, a motor is operably coupled to the piston and the mixing paddle; The mixing paddle is configured to move the piston and / or rotate the mixing paddle. The housing further defines an exit port adjacent the second end of the chamber. A switch may be coupled to the housing and connected to the motor. The first switch can be brought into a conducting state to operate the motor while the first switch is in the first region. The first switch may be a momentary switch biased toward a non-energized state. A second switch may be coupled to the housing and connected to the motor. The second switch activates the motor while the piston is in the second region. The second switch may be capable of being initially energized and then transitioned to a non-energized state that prevents the The first switch and the second switch may be non-momentary switches in the energized state. A switch may be wired in series with the motor.

[0005] In some embodiments, an actuator is coupled to the housing and engages the switch. and the piston is movable against a bias while the piston moves from the first region to the second region. The switch is maintained in an energized state. A transfer gear is coupled to the motor and is rotatable during the operating cycle. The stop nut may be moved along the transfer gear while the piston is in the second region. It may be configured to translate and engage the actuator.

[0006] A second aspect of the present disclosure is a method for mixing bone cement using a mixing device according to the first aspect of the present disclosure. It includes a method of making and, optionally, any of its corresponding implementations.

[0007] A third aspect of the present disclosure relates to a mixing device for making bone cement from bone cement components. The mixing device includes a housing and a chamber within the housing. The mixing device has a first region and a second region separate from the first region. a mixing chamber that is rotatable within the chamber to mix the cement components to form the bone cement mixture; A piston is movable within the chamber to compress the bone cement components. A motor is coupled to the piston and the mixing paddle. A first switch is connected to the motor. The first switch is momentary and has a non-conductive state that prevents the motor from starting. The first switch is energized to a non-energized state to activate the motor and The operation cycle is performed by moving the ton and / or rotating the mixing paddle. The second switch is configured to transition to a conducting state in which the first switch and the The second switch is non-momentary and is wired in series with the motor. The second switch is initially placed in a conducting state to allow the motor to The power supply is configured to transition to a de-energized state that disables the power supply and terminates the operating cycle. The piston moves from a first region to a second region within the chamber to compress the bone within the chamber. The piston is configured to mix and compress the cement mixture. It is in the first region during actuation and in the second region during actuation of the second switch.

[0008] In some embodiments, the chamber is at subatmospheric pressure when the piston is in the first region. and the chamber is above atmospheric pressure when the piston is in the second region. An actuator is coupled to the housing and is spaced apart from the first switch. and a second position that engages and activates the first switch. It can be dynamic.

[0009] A fourth aspect of the present disclosure is a method for mixing bone cement using a mixing device according to the third aspect of the present disclosure. It includes a method of making and, optionally, any of its corresponding implementations.

[0010] A fifth aspect of the present disclosure relates to a mixing device for making bone cement from bone cement components. The mixing device includes a housing and a chamber within the housing. The mixing paddle defines an inlet opening configured to receive the bone cement components. , which is rotatable within the chamber to mix the bone cement components to form the bone cement mixture. A piston is movable within the chamber to compress the bone cement component. a housing connected to the motor and the mixing paddle; The first switch is initially in a de-energized state. The second switch is mounted in the housing and spaced apart from the first switch. The switch is in a conducting state. The first switch and the second switch are arranged in series with the motor. An actuator is coupled to the housing and is spaced apart from the first switch. a first position in which the inlet opening is open to the ambient environment; a second position engaging the first switch to transition the first switch from a de-energized state to a conductive state; The stop nut moves the second switch from an energized state to a de-energized state. The switch is movable to engage the second switch to activate the second switch.

[0011] In some embodiments, the actuator comprises a slider body and a slider body extending from a lower surface thereof. and an arm extending from the slider. The arm is laterally deflected to engage the first switch. The first switch and the second switch are configured to engage with a printed circuit They may be attached directly to the housing at separate locations without being bonded to the substrate.

[0012] A sixth aspect of the present disclosure is a method for mixing bone cement using a mixing device according to the fifth aspect of the present disclosure. It includes a method of making and, optionally, any of its corresponding implementations.

[0013] A seventh aspect of the present disclosure is directed to a mixing device for making bone cement. The chair includes a housing and a chamber within the housing. The chamber contains a bone cement component. The mixing device defines an inlet opening configured to receive the bone cement components. a mixing paddle rotatable within the chamber to mix the components to form the bone cement mixture. A piston is movable within the chamber to compress the bone cement component. The actuator is connected to the motor and the mixing paddle. is coupled to the housing and is movable between a first position and a second position. In this case, the actuator is spaced from the switch and the inlet opening is open to the ambient environment. In the second position, the actuator engages the switch and simultaneously (i) The motor is operated from the de-energized state to move the piston and rotate the mixing paddle. By doing at least one of the following, the switch will enter a powered state, starting one operating cycle. and (ii) closing the inlet opening.

[0014] In some embodiments, the housing defines an aperture. The actuator is positioned between the inlet opening and the bore when the actuator is in the second position. The entrance opening may include a door disposed therein. The entrance opening may further allow bone cement components guided through the hole. The gas is positioned below the hole so that it passes through the inlet opening and into the chamber under the influence of gravity. A funneling device is inserted into the widened portion and into the hole in the housing. and a stem sized to receive the flexible tether. A funnel device can be coupled to the housing. The funnel device has a detent on the stem. The detent may include a locking feature adapted to releasably engage a complementary locking feature on the housing. It is configured as follows.

[0015] In some embodiments, the actuator of the ninth aspect comprises the first, third, fifth, and Included in the mixing device of any one of the seventh aspects, and optionally, their corresponding It may be included in any of the embodiments.

[0016] An eighth aspect of the present disclosure is a method for mixing bone cement using a mixing device according to the seventh aspect of the present disclosure. It includes a method of making and, optionally, any of its corresponding implementations.

[0017] A ninth aspect is directed to a mixing device for making bone cement, the mixing device comprising: The housing includes an upper shell and a lower shell coupled to the upper shell. A chamber is within the housing. The chamber is configured to receive a bone cement component. The mixing paddle mixes the bone cement components to form a bone cement mixture. The piston compresses the bone cement components and is rotatable within the chamber to create a composite. The motor is coupled to the piston and the mixing paddle. The shell includes a funnel with a sloped surface defining a hole in communication with the inlet opening.

[0018] In some embodiments, the upper shell has an upper surface with a sloped surface extending downward from the upper surface. The funnel is frusto-conical in shape.

[0019] In some embodiments, the integrated funnel of the ninth aspect comprises a first, third, fifth, and and the seventh aspect, and optionally the mixing device of any one of these corresponding The mixing device may be included in any one of the embodiments.

[0020] A tenth aspect of the present disclosure is a method for mixing bone cement using a mixing device according to the ninth aspect of the present disclosure. and optionally any of the corresponding implementations thereof.

[0021] An eleventh aspect is directed to a mixing device for making bone cement. a housing; and a bone cement component disposed within the housing and configured to receive the bone cement component. and a chamber defining an inlet opening. A mixing paddle mixes the bone cement components to form a bone cement. The piston is rotatable within the chamber to create the cement mixture. A motor is coupled to the piston and the mixing paddle. A display device is coupled to the housing and displays information indicative of operation of the mixing device. It is configured to:

[0022] In some embodiments, the display device may include a liquid crystal display (LCD), a series of light sources, a digital The timer may be a digital or analog timer. The information includes the remaining time of operation of the mixing device, the time of bone cell The elapsed time of the procedure using bone cement and the estimated remaining time of the procedure using bone cement It can be one.

[0023] In some embodiments, the display device of the eleventh aspect includes the first, third, fifth, seventh, and and the ninth aspect of any one of the mixing devices of the ninth and ninth aspects, and optionally the mixing device of any one of the corresponding embodiments of the ninth and ninth aspects of any one of the mixing devices of the ninth and ninth aspects ... It can be included in either one.

[0024] A twelfth aspect of the present disclosure is a method for mixing bone cement using a mixing device according to the ninth aspect of the present disclosure. and optionally any of the corresponding implementations thereof.

[0025] A thirteenth aspect of the present disclosure is directed to a mixing device for making bone cement. The vice includes a housing and a chamber within the housing. The chamber includes a first region and and a second region separate from the first region. The mixing device mixes the bone cement components. The mixing paddle is rotatable within the chamber to form the bone cement mixture. A piston is movable within the chamber to compress the bone cement component. and coupled to the mixing paddle. A switch is connected to the motor. The switch The motor operates to move the piston and / or rotate the mixing paddle. The switch is turned on to start the operating cycle and the switch is turned off to stop the motor. and a de-energized state that terminates the operating cycle by The switch is biased toward a de-energized state. An actuator is coupled to the housing. a first position spaced from the switch and a second position engaging the switch to disable the switch; A second position for transitioning from a live state to a live state and maintaining the switch in the live state against bias. The piston is movable between the actuator and the piston when the piston is in the second region. The motor is mechanically disconnected from the switch and the switch is energized and returned to the de-energized state. The device is configured to move from the first region to the second region within the chamber so that the

[0026] In some embodiments, the switch is a momentary switch. The stop nut is connected to the transfer gear and is rotatable during the operating cycle. The stop nut moves in translation along the transfer gear and the actuator configured to engage the actuator to mechanically disengage the actuator from the switch. The stop nut has an inner diameter that threads onto the outer diameter of the transfer gear, and a nut portion. A flange portion extending from the switch portion provides a mechanical disconnection of the actuator from the switch. and a flange portion configured to engage the actuator to effect the release. .

[0027] In some embodiments, the actuator comprises a slider body and a slider body extending from a lower surface thereof. an arm extending from the switch; and a stop mechanism coupled to the arm and configured to engage the switch. The slider is coupled to the arm and includes a stop nut. is arranged to be engaged by the stop nut when translated by rotation of the transfer gear, The arm may further include an inclined surface, and engagement of the stop nut with the inclined surface may cause the arm to bend. A stop is applied to disengage the stop feature from the switch.

[0028] A fourteenth aspect of the present disclosure is a method for mixing bone cement using a mixing device according to the third aspect of the present disclosure. and optionally any of the corresponding implementations thereof.

[0029] A fifteenth aspect of the present disclosure is directed to a kit for performing a vertebral augmentation procedure using bone cement. The kit is designed to mix bone cement components to create a bone cement mixture, and then use the bone cement mixture. The mixing device includes a chamber and a mixing device for compressing the mixture. The chamber includes a movable piston and a mixing paddle movable within the chamber. The kit defines an opening, and an outlet port in communication with the inlet opening. a delivery device having a chamber defining an inlet port for receiving bone cement from the delivery device; The kit includes a packaging sized to accommodate the mixing device and the delivery device. The inlet port of the delivery device is adapted to allow the mixing device and the delivery device to be interchangeable within the package. The mixing device is in communication with the outlet port of the mixing device so as to be removably coupled thereto. The device and delivery device are configured to be removed from the packaging as a single unit. .

[0030] In some embodiments, the mixing device and the delivery device are removably coupled to one another. The longitudinal axis of the chamber of the mixing device and the longitudinal axis of the chamber of the delivery device are The manual axis is such that the mixing device and the delivery device are arranged in a side-by-side configuration within the package. The outlet port of the mixing device and the inlet port of the delivery device are in parallel. For ease of placement, they may be oriented perpendicular to their respective longitudinal axes.

[0031] In some embodiments, the kit includes a funnel device and a mixing device. The funnel device may be removed from the packaging as a single unit. Alternatively, the funnel device may be integrated into the housing. The kit may further include a liquid monomer and a powdered polymer disposed in a sterile package. The packaging may be a blister pack.

[0032] The advantages of the present disclosure will be better understood from the following detailed description taken in conjunction with the accompanying drawings. It will be readily appreciated that the drawings are purely illustrative and are not necessarily to scale. Please understand that this is not depicted as such. [Brief explanation of the drawings]

[0033] [Figure 1] FIG. 1 is a rear perspective view of a mixing and delivery system including a mixing device and a delivery device. [Figure 2] FIG. 1 is a front perspective view of a mixing device. [Figure 3] FIG. 1 is a front perspective view of the mixing device with the upper shell of the housing removed. [Figure 4] FIG. 2 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. [Figure 5] FIG. 10 is a cross-sectional elevation view of the mixing device showing the piston positioned within the second region of the chamber of the mixing device. [Figure 6] FIG. 1 is a perspective view of a subassembly of the mixing device, including a switch, a piston, and a mixing paddle. [Figure 7]FIG. 10 is a perspective view of a gear train of the mixing device coupled to the piston and mixing paddle. [Figure 8] FIG. 1 is an elevational view of the gear train, piston, and mixing paddle. [Figure 9] FIG. 8 is an elevational view of the gear train and mixing paddle of FIG. 7 with the transfer gear and translation shaft removed to show the paddle drive gear that couples the mixing paddle to the gear train. [Figure 10] FIG. 1 is an exploded view of a subassembly of a mixing device configured to effect longitudinal movement of a piston (and mixing paddle) within a chamber, the subassembly including a transfer gear, a translation shaft, a rear chamber housing, and a push cap. [Figure 11] 1 is an elevational view of a component of a mixing device configured to provide automatic termination of an operating cycle, the component including a stop nut disposed in a first position on a transfer gear. [Figure 12] FIG. 12 is an elevational view of the components of FIG. 11 with the stop nut positioned in a second position on the transfer gear and engaging the actuator. [Figure 13] FIG. 1 is a perspective view of a slider forming an actuator. [Figure 14] FIG. [Figure 15] FIG. 10 is a top perspective view of a portion of a mixing device with the mounting portion of the actuator deflected laterally to engage the mounting portion of the switch. [Figure 16] FIG. 10 is a top perspective view of a portion of the mixing device in which a mounting portion of the stop nut is configured to engage a second switch to effect automatic termination of the operating cycle. [Figure 17] FIG. 10 is a rear perspective view of the mixing device with the release assembly in the unlocked position. [Figure 18] FIG. 12 is a perspective view of a front chamber housing including a transfer conduit. [Figure 19A] 19A is a detailed view of the transfer conduit and release assembly within dashed line 19A-19A of FIG. 17. [Figure 19B]FIG. 10 is a detailed view of another embodiment of a transfer conduit and release assembly. [Figure 20] FIG. 19B is a perspective view of the release assembly of FIG. 19A. [Figure 21] 2 is a pictorial representation of one step of a method of using a kit including the mixed delivery system of FIG. 1. [Figure 22] 1 is a visual representation of another step of the method. [Figure 23] 1 is a visual representation of another step of the method. [Figure 24] 1 is a visual representation of another step of the method. [Figure 25] 1 is a visual representation of another step of the method. [Figure 26] FIG. 1 is a front perspective view of a mixing and delivery system including a mixing device and a delivery device. DETAILED DESCRIPTION OF THE INVENTION

[0034] Referring now to the drawings, in which like numerals indicate corresponding parts throughout the several views, A mixed delivery system 100 is shown in Figure 1. The system 100 mixes multiple components. a mixing device 102 for creating a mixture by mixing the mixture with the liquid and a delivery device 103 for delivering the mixture to a target site. The system 100 may be used in any application requiring delivery of a mixture to a target site. In one example, the mixing device 102 mixes bone cement components to A bone cement mixture is made and transferred to the delivery device 104 . In particular, when activated, the mixing device 102 undergoes an operating cycle that includes a mixing stage and a compression stage. and automatically performs the steps to deliver the bone cement to the delivery device 104 using the intuitive workflow described. The intuitive workflow minimizes user exposure to bone cement components. This increases the efficiency of the operating room as well as the density of the bone cement mixture while reducing the delivery time. Once transferred to the device 104, the delivery device 104 is manipulated by the user to deliver the bone cement. The agent is delivered into the vertebral body during, for example, vertebroplasty or kyphoplasty. An example of a delivery device 104 suitable for the present application is described in The entire contents of which are disclosed in International Publication No. 2019 / 200091, which is owned by the The present invention relates to a delivery device 104 suitable for this system. Another example is commonly owned U.S. Patent No. 6,629,499, issued April 15, 2003. No. 547,432, the entire contents of which are incorporated herein by reference. .

[0035] FIG. 1 shows a delivery device 104 removably coupled to a mixing device 102 . The delivery device 104 is in sealed fluid communication with the outlet port 108 of the mixing device 102. The inlet port 106 is configured to be removably disposed. A release assembly 110 facilitates communication between the mixing device 102 and the delivery device 104. This establishes communication between the inlet port 106 and the outlet port 108. The communication between the inlet 106 and the outlet port 108 is further provided by the chamber 112 of the mixing device 102. (see FIGS. 4 and 5) and the interior of a delivery device 104 for transporting the bone cement mixture. A fluid communication is established between the chamber (not explicitly shown) and the

[0036] The mixing device 102 includes a housing 116. 1 shows an embodiment of a housing 116, with like numerals representing like components but different functional parts and designs. The housing 116 in FIG. 1 is, for example, a housing for supporting the delivery device 104. , including a cradle 114 and / or a hook 117 coupled to the housing 116. The cradle 114 secures the housing 118 of the delivery device 104 from the mixing device 102. The hook 117 is sized and shaped to facilitate separation from the delivery device. The extension tube 105 of the tube 104 is sized and shaped to facilitate transport and separation. FIG. 1 illustrates the cradle 114 as part of the housing 118 of the delivery device 104. In this coupling configuration, The cradle 114 cooperates with the release assembly 110 to allow the system 100 to be mounted as a unit. In one configuration, the outlet port 108 is a mixing device. When placed to the side of the delivery device 104, the delivery device 104 and the mixing device 102 can be With the advantages to be described in detail, the device is packaged in a combined configuration before being deployed in the operating room. However, other arrangements of the outlet port 108 are also contemplated.

[0037] The embodiment of FIG. 2 removes the housing 118 of the delivery device 104 from the cradle 114. a control surface 115 configured to receive input from a user to enable the device to be removed; In particular, the cradle 114 is configured to receive input from a user. Thus, the cradle 114 can be made from a material that allows it to flex. Without the input, the cradle 114 is held in the housing 118 of the delivery device 104. In another embodiment, the transfer conduits 306, 307 of the mixing device 102 may be 06' and delivery device 104 by release assembly 110 (see FIGS. 17-20). The force is sufficient to maintain the relative positions of the mixing device 102 and the delivery device 104. The cradle 114 supports the delivery device 104 but does not otherwise provide a holding force. I can't.

[0038] Referring now to FIG. 2, the mixing device 102 includes a housing 116. The housing 116 can be formed from any suitable material and manufacturing process. , an upper shell 120, and a lower shell 122 connected to the upper shell 120. The upper shell 120 and the lower shell 122 may include a The cavity is sized to accommodate most of the components of the mixing device 102 . The upper shell 120 and the lower shell 122 may be permanently attached to each other or may be removably attached to each other. The mixing device 102 may optionally be disposable after a single use. Because of the components, access to the interior 124 of the housing 116 is required. However, even in such cases, the housing 116 receives input from the user. The upper shell 120 is separated from the lower shell 122 by the force of the a separation feature configured to expose components housed within the interior 124 of the housing 116; 1 illustrates the separation feature 126 between the upper shell 120 and the lower shell 122. 122 and adjacent to the gripping feature 130. An input applied to the tab 128 while maintaining the 0 position will cause the upper shell 120 and the lower shell overcome the retention force provided by the detents at the interface between the shells 122 (FIG. 3 shows the detents (The female portion 132 of the nut is clearly shown.) A separate extending gripping feature 134 may be optionally attached to the housing 116 and the system 100. However, for example, it can be made to be able to be operated as a unit with one hand, as mentioned above.

[0039] With continued reference to Figure 2, the housing 116 includes or defines an aperture 135. 135 extends through the top wall of the upper shell 120 of the housing 116. 35 broadly means before the start of an operating cycle that includes a mixing stage, a compression stage, and a transfer stage. The orifice through which the bone cement components are introduced into the chamber 112. 5 indicates the chamber 112, and more specifically, the hole 135 and the chamber 112. The front chamber housing 164 is shown containing or defining the inlet opening 136. 36 is a part of the bone cement component guided through the hole 135, which is subjected to the influence of gravity and flows through the inlet opening 1 36 and into chamber 112. The chamber 112 is disposed within a housing 116.

[0040] To facilitate effective introduction of bone cement components through the holes 135, a funnel device may be provided. 138. Bone cement components typically include a liquid monomer and a powdered polymer. The funnel device 138 is adapted to be received in the bore 135 of the housing 116. Opposite the narrow opening defined by the sized stem 140 is a widened opening. Additionally, the funnel device 138 includes a coupling member for coupling the funnel device 138 to the housing 116. The flexible connection 142 may include a flexible connector 142 that connects the upper end of the housing 116 to the upper end of the housing 116. The retainer 124 may be held by passing through a slot in the shell 120, although other suitable attachment means are contemplated. Among other advantages, the flexible connection 142 allows the funnel device 138 to The funnel device 116 can be packaged while still attached to the housing 116. The system 100 including the funnel 38 can be operated as a unit, for example, with one hand. In known systems, including those involving the use of a funnel, the funnel must be handled separately and the funnel must be kept sterile in the operating room. Additional transport is required across the barrier. Flexible connection 142 is shown in FIGS. As such, in its initial configuration, the funnel device 138 is placed upside down in the housing 116. During the steps of the intuitive workflow, the user inserts the stem 140 into the hole. Operate the funnel device 138 to place it into the section 135. This operation is numbered "1". The first step in the workflow is as indicated by the indicia 144 on the funnel device 138. In some embodiments, the funnel device 138 may be thought of as a stem. The detent may include a detent (not shown) located at 140 near the hole 135. 116. The housing 116 is adapted to releasably engage a complementary opening 143 defined therein. When the detents are engaged, the funnel device is adapted to receive the bone cement component. Visual and / or tactile feedback that the 138 is properly placed. The user is then given a funnel device leading to the chamber 112. The bone cement component is introduced into the vice 138 .

[0041] The user may move the actuator 148, for example, by moving the actuator 148 in a direction movably coupled to the housing 116. The slider 150, which will be described further, is actuated to initiate the operating cycle. The computer 148 displays a symbol 152, in this case, corresponding to the second step in the intuitive workflow. In some cases, the number "2" may be included.

[0042] The operating cycle begins when the mixing paddle 154 located within the chamber 112 mixes the bone cement components. A mixing stage is performed in which the piston 156 disposed in the chamber 112 mixes the bone cement. and transporting the compressed fluid to the delivery device 104 via the exit port 108. 4 and 5, the cross-section of the mixing device 102 Front elevation views are shown, with FIG. 4 illustrating the mixing device 102 during the mixing stage and FIG. 1 illustrates the mixing device 102 during the compression and transfer stages.

[0043] The mixing stage generally refers to the act of piston 156 pumping bone cement enclosed within chamber 112. while the components are in the first region 158 of the chamber 112 to a first pressure; The transfer stage generally refers to the time when the piston 156 is forced to move the bone cement component to a second pressure greater than a first pressure. 1. This occurs when the gas is in the second region 160 of the chamber 112 so that it is compressed to a pressure of 2. In one example, the first pressure is subatmospheric (e.g., at or near 1 atmosphere, the second pressure is greater than atmospheric pressure (e.g., 4 to 100 psi); 7 atmospheres). The chamber 112 is coupled to a rear chamber housing 166 (see FIG. 10). The front chamber housing 164 (see FIG. 18) defines or is defined within the front chamber housing 164. Referring also to FIG. 3, the front chamber housing 164 is cylindrical in shape. The front chamber housing 116 may extend beyond the housing 116. 64 may include an inner surface 168 that at least partially defines the chamber 112. The front chamber housing 166 has a cap-like feature that is complementary to the front chamber housing 164. and at least partially defining the chamber 112 opposite the inner surface 168. 10. The front surface 170 is defined (see FIG. 10). Conventionally, as also shown in FIGS. The front face 170 of the rear chamber housing 166 is positioned adjacent the first end 162 of the chamber 112. The inner surface 168 of the front chamber housing 164 may define a A second end 163 may be defined.

[0044] The first region 158 and the second region 160 are represented schematically in FIGS. 4 and 5. The first region 158 of the chamber 112 is defined by a first end 162 of the chamber 112 and an inner surface 164. A height can be defined between the end 172 of the inlet opening 136 closest to the end 68. More specifically, the first region 158 includes a first end 162 of the chamber 112 and an inlet opening. Between a plane that intersects end 172 of 136 and is perpendicular to the longitudinal axis LA of chamber 112 In other words, to further explain, the movement along the longitudinal axis LA can be defined as A surface 174 of the piston 156 defines a boundary between the first region 158 and the second region 160. The surface 174 is in the first region before the end 172 of the entrance opening 136 is reached. 158, at least a portion of the inlet opening 136 being generally open to the surroundings; The chamber 112 is at least substantially at atmospheric pressure. The second region 160 is 36 and the inner surface 168. In other words, the longitudinal axis The surface 174 of the piston 156 moving along LA is in the second region 160, and the surface 174 Once past the inlet opening 136, a fluid tight seal is formed between the piston 156 and the housing 116. A closure is formed, sealing the chamber 112 from the surroundings. Thus, in operation, face 174 of piston 156 contacts first housing end 162 and open end 172. The bone cement component is located in a first region 158 of the chamber 112 extending longitudinally between the The mixture is mixed by a mixing paddle 154 at a first pressure or atmospheric pressure to form a bone cement mixture. The piston 156 then extends between the open end 172 and the second housing end 163. along the longitudinal axis LA to locate in the second longitudinally extending region 160. The bone cement mixture in the chamber 112 is pressurized to a first pressure or a second pressure greater than atmospheric pressure. The bone cement mixture is also compressed through an outlet port 108 that communicates with the chamber 112. and then transferred to the delivery device 104. Several advantages should be readily apparent: Among other things, the inlet opening during compression of the bone cement and transfer to the delivery device 104 The piston 156 that passes through the portion 136 and seals the chamber 112 is not required for existing systems. Reduces or eliminates the need for many high voltage components required for existing systems. The system may require an attachable lid, and the lid and the method for connecting the lid to the device The method must be designed to withstand the high pressures involved in the compression stage. The lid and its interface are often prone to serious failure. The interface may not be intuitive to the user, leading to installation errors and The lid must be transported to the sterilization room separately from the mixer. Lids also increase the risk of contamination of sterile surfaces if dropped on the floor. This can cause the mixing unit to roll off the table and onto the floor, rendering it unusable. A piston 156 that passes through the mouth opening 136 and seals the chamber 112 can be attached. This eliminates the need for a separate lid, resulting in a self-sealing chamber 112 of the mixing device 102. The anti-slip properties reduce or eliminate the possibility of inadvertent exposure of the user to the bone cement mixture under high pressure. do.

[0045] The mixing device 102 has a fluid-tight closure between the piston 156 and the housing 116. It may include a sealing element (not explicitly shown) coupled to the piston 156 to form Near the face 174 of the piston 156, the piston 156 may include a recess 175. 75 may extend annularly around the piston 156 and may include a sealing element, e.g., O-ring. A gasket is at least partially located within the recess 175. The sealing element is 116 to form a fluid-tight seal between the piston 156 and the housing 116. Forms a chain portion.

[0046] Here, the arrangement of the mixing device 102 for providing rotation of the mixing paddle 154 during the mixing stage is The electromechanical operation will be described with reference to Figures 4 to 9. The mixing device 102 is shown in Figures 4 and 9. 5. The power supply can be provided by a battery pack 176 including multiple batteries, as shown in FIG. In one example, the battery pack 176 includes eight conventional AA batteries, but also includes lithium ion and and / or other disposable or rechargeable batteries are contemplated. Although less convenient for users, the mixing device 102 may also be powered in a corded configuration. The mixing device 102 may also be adapted to connect to a battery pack 176. The mixing device 102 further includes a motor 178. The mixing device 102 further includes a motor 178 connected to the motor 178. and further including a switch 180 configured to be actuated between a conducting state and a non-conducting state. In one example, switch 180 is a momentary microphone that is internally biased to a de-energized state. This advantageously allows the switch 180 to be switched back to its original state if desired. position to discontinue operation of the mixing device 102. Switch 180 is a non-momentary switch, such as a toggle switch. When the switch 180 is actuated in the manner described above, the motor 178 is energized and the output of the motor 178 Rotational output is provided on shaft 182. Motor 178 is optional, and mixing device 102 It is contemplated that the device may be a manual mixing device. In such an example, the piston may be The mixing paddle is similar to an axial plunger and mixing paddle configured to receive input from The plunger may cause the bone cement components to mix with the mixing paddle 154 at atmospheric pressure. The plunger may be in the first region 158 when the plunger is inserted into the chamber 112. to compress the bone cement mixture in the cavity to a pressure greater than atmospheric pressure. Alternatively, the device may be moved to the second region 160 in response to the aforementioned U.S. Patents 6 and 5. As disclosed in 47,432, manual mixing involves providing axial and rotational force to the user. This may be accomplished using a mixing blade on a shaft configured to receive the input of another non-electric The moving arrangement both rotates the mixing paddle 154 and advances the piston 156. A manually operated crank may be included to operate the gear train.

[0047] Output shaft 182 is operatively coupled to a gear train 184, best seen in FIGS. 7-9. The illustrated gear train 184 is a stacked spur configuration, although other suitable gears may be used. Various configurations are also contemplated (e.g., planetary gears, helical spur gears, helical planetary gears, etc.). The gear train 184 includes a pinion gear 186 coupled to the output shaft 182 of the motor 178 . A first spur gear 188 is operatively coupled to the pinion gear 186. 88 has a first spur gear 190 with a larger outer diameter, and the first spur gear 190 is connected to a pinion. A second spur gear 192 coupled to gear 186 and having a smaller outer diameter A second spur gear 194 is operably coupled to the first spur gear 188. The spur gear 194 rotates around a first spur gear 196 having a larger outer diameter. The first spur gear 188 is coupled to the second spur gear 192 and has a smaller outer diameter. A third spur gear 200 operates on the second spur gear 194. The third spur gear 200 is connected to the first spur gear 200, which has a larger outer diameter. 02, with the second spur gear 202 coupled to the second spur gear 198 of the first spur gear 194. The third spur gear 204 includes a second spur gear 205 having a smaller outer diameter. 0, more specifically, the first spur gear 202 of the third spur gear 200 is connected to the paddle drive gear 208 The third spur gear 200 is operatively coupled to the input spur gear 206. The third spur gear 200 also has a fourth spur gear The fourth spur gear 210 is also operatively coupled to a wheel 210. The fourth spur gear 210 has a larger outer diameter. The first spur gear 212 is connected to the second spur gear 20 of the third spur gear 200. 4, and a smaller one coupled to the transfer gear 216 as described. 6 and 7 together show a second spur gear 214 operatively connected to one another. The gear train is located in a combined front gear train housing 218 and rear gear train housing 220. Additionally, the rear chamber housing 166 is shown as a front gear train housing 184. It is operatively coupled to the housing 218 .

[0048] In some embodiments, the vibration and noise may be due to the motor 178 and / or gear train 18 4 and the gear train housing 218. Damping can be reduced by using a lower modulus (i.e., more compliant) materials, such as Hytrel (registered trademark) manufactured by DuPont de Nemours, Inc. (Wilmington, Delaware). By manufacturing one or more gears from an elastomeric polyester such as Vibration isolation can be achieved by providing a means for isolating the vibration between a vibrating component and an adjacent component, e.g. Between the motor 178 and the adjacent portion of the gear train housing 218 (see FIG. 6) or Between the housing and the mixer housing, use a compliant material such as elastomer or foam. This can be done by placing suitable materials in other areas that are suitable for damping or insulating. It rotates the fastest in the gear train 184 and therefore causes the most noise. , a first spur gear 188 and a second spur gear 200. Furthermore, the pinion gear 18 6 and the first spur gear 188 to reduce noise and structural It is also contemplated to further reduce the sensitivity of the adjustment of the component stack.

[0049] With particular reference to FIG. 9, the mixing paddle 154 is a paddle coupled to the input spur gear 206. The output shaft 222 may be coupled to the end of the drive gear 208. The spool of the mixing paddle 154 is attached to the paddle drive gear 208 to rotatably secure the paddle 154 to the paddle drive gear 208. longitudinally extending rails configured to mate with complementary features in stem 224. The mixing paddle 154 further includes a face portion 226 extending generally radially from the stem 224. The surface portion 226 is a surface of the piston 156, as can be seen from FIGS. The mixing function 228 is disposed adjacent to the surface 174 and is rotatable relative to the surface 174. The blending feature 228 extends longitudinally forward of the face portion 226. and at least one leg 230 for agitating the mixed ingredients during rotation of the mixing paddle 154. 7 and 9 show head 2 being configured to form a generally U-shaped mixing function 228. Two of the legs 230 are shown connected to each other by a screw 32. The legs 230 and the head 2 32 during the compression and transfer stages in a manner to be described in more detail. The head 232 is connected to the legs 23 so as to flex or buckle the mixing function 228 relative to the legs 23. The mixing paddle 154 may be a plate-shaped structure angled inward toward the center of the mixing paddle. Other configurations of the configuration are also contemplated.

[0050] In operation, the switch 180 moves from a de-energized state to a powered state. The motor 178 The gear train 184 is configured to draw power from the gearbox 176 or other power source and provide torque to the gear train 184. This operation is the start of the operating cycle, more specifically the mixing phase of the operating cycle. According to the known speed vs. torque characteristics associated with gearing, The gears are connected from pinion gear 186 to first, second, and third spur gears 188, 194, and 200. and through paddle drive gear 208 to mixing paddle 154.

[0051] The step of rotating the mixing paddle 154 causes the mixing of the bone cement components in the chamber 112. Referring again to FIG. 4, the mixing paddle 154 is inserted into the chamber 156 by the piston 156. 112. The surface 174 of the piston 156 is adapted to allow the mixing paddle 154 to pump the bone cement components through the chamber 112. The first end 162 of the chamber 112 is connected to the first end 162 of the chamber 112 so that the mixture is at least substantially at atmospheric pressure. , located between the boundary separating the first region 158 and the second region 160. A door 234 of 150 is positioned to cover the inlet opening 136 during an operating cycle that includes a mixing stage. It is understood that the door 23 is positioned to prevent debris from escaping from the mixing device 102. 4 can cause more than a minimum pressurization of the chamber 112 during movement of the piston 156. Door 234 is connected to a hole 135 defined by housing 116 and an actuator. Inlet opening 1 defined by chamber 112 when etrator 148 is in the second position 36. The bone cement components are mixed in the chamber 112 at atmospheric pressure. At least in part because of the presence of the outlet port 108 of the mixing device 102 A sealing element 236 disposed within the mixing device 102 prevents the bone seal from passing from the mixing device 102 to the delivery device 104. This prevents the cement mixture from spilling or prematurely transferring, thereby forming a sealing element 236. A less complex and more cost effective valve can be utilized to achieve this.

[0052] As can be further seen from FIG. 4, the legs 230 of the mixing paddle 154 are The four heads 232 are positioned adjacent to or adjacent to the inner surface 168 of the front chamber housing 164. The mixing paddle 15 extends forward from the piston 156 so that the 4 is substantially mixed so that no part of the bone cement components is insufficiently mixed or agitated. The entire chamber 112 can be accessed. The bone cement component, if any, adhering to the sidewall at least partially defining the member 112 The head 232 can be effectively removed by at least partially removing the chamber 112. Effectively removing any bone cement components adhering to the defining inner surface 168. However, as previously mentioned and as will be further explained, the piston 156 It moves from the first region 158 to the second region 160 for the compression and transfer steps. As a result, the mixing paddle 154 is forced to move in this longitudinal direction of the piston 156 within the chamber 112. To this end, the mixing paddle 154 must deal with the movement of the piston 1 56 to bend or buckle while compressing the bone cement mixture within the chamber 112. The piston 156 and the mixing paddle 154 are arranged in the head 23 of the mixing paddle 154. along the longitudinal axis LA until the front chamber housing 164 abuts the inner surface 168 of the front chamber housing 164. Because the head 232 is angled inward relative to the legs 230, The continuous force applied by the piston 156 causes the gap between the leg 230 and the face portion 226 to expand. The leg 230 will deform at the interface 238 (see Figures 7 and 8). , can be thought of as buckling at the pivot point induced by the interface 238. The axial profile of the face portion 226 relative to the face 174 of the shaft 156 is substantially or completely curved. At this time, the mixing feature 228 becomes substantially flat and abuts or contacts the face 174 of the piston 156. The legs 230 and head 232 are shaped to be adjacent to each other. Among other things, this arrangement allows the piston 156 to extend substantially throughout the chamber 112. 16. The bone cement mixture is compressed by manually moving the 5. The fluid is then transferred through an outlet port 108 located at the center of the fluid (see FIG. 5).

[0053] Next, a mixing chamber is inserted to provide longitudinal movement of the piston 156 (and mixing paddle 154). The electromechanical operation of the coupling device 102 is described with reference to FIGS. As mentioned above, the fourth spur gear 210 is connected to the second spur gear 216. 7, 8 and 10 show a transfer spur gear 240 and a transfer spur gear 240. The transfer gear 216 is best shown including a threaded shaft 242 extending from the transfer spur gear. 240 indicates that rotation of the gear train 184 including the fourth spur gear 210 imparts rotation to the transfer gear 216. As best seen in FIG. 10, the fourth spur gear 210 is coupled to the second spur gear 214. As shown, the transfer gear 216, and more specifically the threaded shaft 242, 6. At least one rail feature 248 defines a lumen 246 extending therethrough. 246 and oriented along the length of the lumen 246. The lumen 246 includes two rail features 248 arranged diametrically opposite each other. At the rear end of bore 246, it is further defined by the front face (not shown) of transfer spur gear 240. A bore (not shown) having a diameter smaller than the bore 246 is provided in the transfer spur gear 24. 4 and 5, the hole extends through the paddle drive gear 2 08 output shaft 222 is dimensioned to be disposed through the transfer gear 216, A more complete understanding can be obtained by viewing Figures 7 and 9 together.

[0054] With particular reference to FIGS. 8 and 10, a translation shaft 244 is inserted into a bore 246 of the transfer gear 216. The translation shaft 244 is slidably disposed within the bore 246. The translation axis 244 includes an outer diameter that is smaller than the inner diameter of the bore 246. Furthermore, the translation axis 244 is The threads 250 are disposed around the outer surface of the translation shaft 244. The lateral ends 245, 247 define at least one slot 252 extending longitudinally therebetween. 10 clearly shows one slot 252, but the transfer gear 21 6 rail features 248 diametrically opposed to the slots 252 It should be understood that there is another slot that is inserted between the rail feature 248 and the slot 252. When engaged, relative rotation occurs between the translation shaft 244 and the transfer gear 216 while still allowing translation between the translation shaft 244 and the transfer gear 216. The translation shaft 244 also has a bore 254 extending between its opposing ends 245, 247. , and the bore 254 may define a paddle drive gear 2, as shown in FIGS. 08 is dimensioned so that the output shaft 222 can be disposed through the translation shaft 244, 7 and 9 together can be seen to understand the overall picture. The driving gear 208, the translation shaft 244, and the transfer gear 216 may be coaxially arranged.

[0055] A biasing element (not shown), e.g., a coil spring, is positioned within bore 246 of transfer gear 216. The biasing element has an end that is disposed in contact with the transfer spur gear 240 and an end that is disposed in contact with the translation shaft 244. and another end disposed abutting the rear end 247 of the translation shaft 244. The front end 245 opposite the end 247 is biased toward and contacts the rear chamber housing 166. Continuing to refer to FIG. 10, the rear chamber housing 166 has internal threads 258 The paddle drive gear 208, the translation shaft 244, and the bore 256 are connected to each other. and / or can be coaxially aligned with the transfer gear 216. The output shaft 222 of the moving gear 208 is arranged to pass through the rear chamber housing 166. and the internal threads 258 are dimensioned to threadably engage the threads 250 of the translation shaft 244. The rear chamber housing 166 is sized to fit the internal threads 25 8 and threads 250 of translation shaft 244 into rear chamber housing 166. 216) so as to provide translational movement of the translation shaft 244 relative to the mixing It should be understood that this is a fixed component of the device 102 .

[0056] The rear chamber housing 166 communicates with the bore 256 and is located on the opposite side of the translation axis 244. A perforation 260 may be defined, disposed on the side of the rear chamber housing 166. The bore 260 is adapted to initially receive at least a portion of the push cap 262. FIG. 10 shows the push cap 262 being sized to be received in the bore 260. and a bore 260 adjacent to the internal thread 258. The push button is shown as a ring-shaped structure disposed adjacent to the front surface 266. The cap 262 is provided so that the output shaft 222 of the paddle drive gear 208 passes through the push cap 262. The front surface 266 includes a hole 268 sized to allow the The outer portion 264 of the push cap 262 opposite the engaged side is connected to the piston 156 The rear annular slot (not shown) of the casing is adapted to engage with the rear annular slot of the casing.

[0057] In operation, the switch 180 moves from a de-energized state to a powered state. The motor 178 is battery The gear train 184 operates to draw power from the pack 176 and provide torque to the gear train 184. Activate paddle 154. As previously mentioned, this action initiates the mixing phase of the operating cycle. In the illustrated gear train 184, torque is transmitted from pinion gear 186 to Through the first, second and third spur gears 188, 194, 200, respectively, and through the paddles The mixture is transmitted to the mixing paddle 154 via the drive gear 208. The mixing paddle 154 rotates immediately. At the same time, torque is applied to the first, second, and third spur gears 188, 194, and 2 00 from the fourth spur gear 210 to the transfer gear 216. The car 216 immediately begins to rotate, although at a speed different from that of the mixing paddle 154 . by a rail feature 248 of the transfer gear 216 engaging a slot 252 in the translation shaft 244 Due to the restricted rotation, the translation shaft 244 rotates together with the transfer gear 216. The biasing element is configured such that the threads 250 on the translation shaft 244 are threaded with the internal threads 25 on the rear chamber housing 166. 8, biasing the front end 245 into contact with the rear chamber housing 166. The threaded engagement of the threads 250, 258 allows translation of the translation shaft 244 relative to the transfer gear 216. In other words, the translation axis 244 is rotating and translating at the same time. It is possible.

[0058] As previously mentioned, at least a portion of the push cap 262 is initially adjacent the front surface 266. 10 shows the front surface 266 and the rear surface (as shown) opposite the front surface 266. a hole in the rear chamber housing 166 having a depth or length defined between the hole The depth of the hole 256 is determined by the distance between the front end 245 of the translation shaft 244 and the push cap 2. 62, thereby moving the push cap 262 to the piston. This is the distance that the translation axis 244 must move before moving the ton 156. This distance is determined by: Combined with the 250 and 258 thread pitches, the mixing phase of the operating cycle and the It is specifically designed to provide a time lag between the compression and transport stages of the fuel. In other words, during the time lag while the translational axis 244 moves through the depth of the bore 256 The mixing paddle 154 then rotates, mixing the bone cement components in the manner previously described. In one example, the time lag is 30 seconds, but other time frames are contemplated. The force applied to the push cap 262 against the piston 156 is provided via the gear train 184. Continued torque causes the piston 156 to move along its longitudinal axis. This is thought to be a transitional stage in the operating cycle. The reason is that the piston 156 is moving, but the piston The face 174 of the ton 156 must then enter the second region 160 of the chamber 112. (e.g., face 174 of piston 156 partially obscures inlet opening 136. (It may only have passed through it). Thus, the chamber 112 is generally at atmospheric pressure during the transition phase. For at least a short period of time, the mixing paddle 154 may remain fully extended and rotating. It is further noted that the piston 156 may move along the longitudinal axis LA while the piston 156 is in the (As previously explained, the head 232 of the mixing paddle 154 further includes an inner surface 168 and must begin to bend or buckle).

[0059] 5, in relation to FIG. 4, is moved along the longitudinal axis LA to expose the rear chamber housing. The translation shaft 244 is spaced from the pin 166 by the push cap 262 and the pin. The stone 156 is shown moving in response (for clarity, the mixing paddle 154 As previously mentioned, the face 174 of the piston 156 is A fluid-tight closure is formed between the housing 116, sealing the chamber 112 from the environment. 136, more specifically, through the end 172 of the inlet opening 136. FIG. 5 shows the face 174 of the piston 156 in the second region 160. The bone cement mixture in the chamber 112 is compressed to a pressure greater than atmospheric pressure, The fluid also enters the delivery device 104 via an exit port 108 that communicates with the chamber 112. From the above explanation, it can be seen that a single actuation of the switch 180 The vise 102 advantageously includes a mixing stage and a time-lag compression and transfer stage. The bone cement components are mixed at atmospheric pressure, and the bone cement mixture is placed in a self-sealing closure system. It is easily understood that this can be done by compressing and transporting the material in a microwave oven.

[0060] The mixing device 102 also further determines the amount of the mixture based on the completion of the mixing, compression, and transfer stages. The operating cycle is automatically terminated after a predetermined period of time. 5 and further referring to FIGS. 11-14, the user may operate the actuator 148, For example, a slider 150 movably coupled to the housing 116 may be actuated to perform an operating cycle. The slider 150 and the switch 180 are connected to each other to set the slider 150 to the first position (see FIG. 1). When the switch 180 is moved from the ON position (see FIG. 4, 5, 11, 12, and 17) to the second position (see FIG. 4, 5, 11, 12, and 17), are arranged in a complementary manner so that they move from a de-energized state to a powered state to initiate an operating cycle. In one embodiment, the switch 180 can be biased to a non-energized state, and the slide When the switch 150 is in the second position, the switch 180 remains energized against bias. When the piston 156 is in the second region 160, the actuator 148 activates switch 1. 80 to mechanically disengage the energized switch 18 from the energized state to the de-energized state. In one example, the method described in more detail below involves the stop nut 2 72 is configured to disengage the slider 150 from the switch 180, thereby activating switch 180 returns the switch to a non-energized state, completing the operating cycle. In another example, a flange or A structure such as an arm disengages the slider 150 from the switch 180, thereby Activating switch 180 allows the switch to return to a non-energized state. In another embodiment described in more detail, the stop nut 272' is 181' to return the mixing device 102 to a non-energized state, thereby In yet another example, the piston 156 is configured to terminate the cycle. If an act such as cutting the cable occurs while the device is properly within 160, Switch 180 will be biased back to its non-energized state. As such, switch 180 is a non-momentary switch and piston 156 is a second When the switch 180 is within the region 160, the switch 180 automatically and mechanically moves to a non-energized state. It is contemplated that the operating cycle will be terminated and the motor 178 will not operate.

[0061] 13 is a perspective view of a slider 150 forming the actuator 148. 150 includes a slider body 274 that includes a control surface 276 opposite a lower surface 278. The control surface 276 may, for example, be configured to move the slider 150 from a first position to a second position. The slider 150 can also be thought of as a surface configured to receive user input. It also includes a first arm 280 and a second arm 282 that is separate from the first arm 280. A first arm 280 and a second arm 282 extend from the lower surface 278 or is coupled to the lower surface 278. In particular, FIGS. 11-13 show a The slider body 274 of the slider 150 is shown, including the protrusion 284, and the first arm 280 and The first and second arms 282 each extend generally laterally from the protrusion 284. 4, the first arm 280 and the second arm 282 are inserted into the interior 124 of the housing 116. Further, the slider body 274 including the control surface 276 is positioned for user operation. The first arm 280 and the second arm 282 are external to the housing 116. from the underside 278 of the slider body 274.

[0062] The door 234 is coupled to the first arm 280. The door 234, as previously described, More specifically, the slider 150 is in the second position so as to cover the inlet opening 136 of the nozzle 112. The door 23 covering the entrance opening 136 is sized and contoured to cover the entrance opening 136 when the door 23 is in the 4 forms a closure that is not pressurized and cannot be considered fluid tight. and to prevent the bone cement components from flowing out of the chamber 112 during the mixing phase of the operating cycle. An engagement member 286 is coupled to the second arm 282 and includes a stop feature 288 and a ramp. 13 shows the stop feature 288 as a surface extending laterally from the engagement member 286. When the slider 150 moves from the first position to the second position, the engaging member A stop feature 288 of 286 engages the switch 180 to de-energize the switch 180. The stop function 288 moves the stopper from the energized state to the energized state in a manner to be further described. The internal bias of switch 180 is maintained until disengaged from switch 180 by slot 272. 11, 12 and 15, the switch 180 continues to be energized against the 1 shows slider 150 in a second position such that switch 180 is engaged and energized. (Several support structures in Figures 11, 12, 15 and 16 provide interfacing between the components shown.) (These have been removed to clearly show their relative positions.)

[0063] FIG. 14 illustrates a stop nut 272 including a nut portion 292 and a flange portion 294. The nut portion 292 is ring-shaped in configuration and is secured to the threaded shaft 242 of the transfer gear 216. (including an internal bore 296 and internal threads 298 sized and shaped for threaded engagement with (See Figures 4, 5, 7, and 10 to 12.) The flange portion 294 is The face includes at least one flange 300 extending generally radially outward from the face. Although two flanges 300 separated by a slot are shown, only one flange may also be used. It is contemplated that each of the flanges 300 may be attached to the upper shell 120 of the housing 116. 6. The slot 304 includes a side surface 302 configured to engage with the surface defining the slot 304. 1, one of the flanges 300 is shown positioned within a slot 304. As a result, the stop nut 272 is prevented from rotating relative to the housing 116. Therefore, as the transfer gear 216 rotates, the stop nut 272 engages the threads of the transfer gear 216. The rotation axis 242 is then translated.

[0064] In operation, the user can, for example, select the actuator in the second step of an intuitive workflow. The slider 150 moves from a first position to a second position. The door 234, coupled to the arm 280, moves to cover the entrance opening 136 and opens the second arm. A stop feature 288 coupled to the arm 282 moves to engage the switch 180, Switch 180 is moved from a de-energized state to a conductive state, thereby causing actuator 148 The single act of entering simultaneously provides a barrier over the entrance opening 136 and At this point, the mixing device 102 is as shown in FIG. The stop nut 272 may be attached to a threaded shaft adjacent or adjacent to the transfer spur gear 240. 242. The internal threads 298 of the nut portion 292 are aligned with the threads of the threaded shaft 242. When switch 180 is energized, motor 178 applies torque to the gear train 184, i.e., first, second, and third spur gears 188, 194, and 200, respectively. The fourth spur gear 210 feeds the transfer gear 216 via the transfer gear 216. 1. The stop nut 272 (located in the slot 304 of the housing) is also With the stop nut 27 prevented from rotating (due to the side surface 302 of the flange portion 294), 2 translates along the threaded shaft 242. Referring to FIG. 12, stop nut 272 The flange portion 294 of the engaging member 286 ultimately contacts the engaging member 286, and more specifically, the tilting of the engaging member 286. The second arm 282 of the slider 150 is configured to bend. As stop nut 272 is further translated along threaded shaft 242, The angled portion 294 engages the angled surface 290 to rotate the second arm 282 and the second arm 28 2. The degree of bending is determined by the stop feature 28 8 disengages switch 180 (i.e., moves upward out of the way) and The switch 180 is configured to automatically return to a non-energized state upon receiving an internal bias. When switch 180 is de-energized, motor 178 ceases operation and piston 156 The movement of the mixing paddle 154 and the rotation of the mixing paddle 154 ceases, which can be considered the end of the operating cycle. A single component that can be molded and potentially inexpensive can form the inlet opening 1. 36, a barrier covering the start and stop of the operation cycle I want you to understand that it helps.

[0065] Another implementation for the mixing device 102 to automatically terminate an operating cycle after a predetermined period of time is The embodiment will be described with reference to Figures 15 and 16. Figure 15 shows the second position, i.e. After receiving the input, the switch (hereinafter referred to as the first switch 180') is touched to start the operation cycle. The actuator 148 is shown for initiating the rotation. The first switch 180' is The actuator 148 is a momentary switch biased to a de-energized state. When moving from the first position to the second position, the second arm 282 engages the front gear train housing 218 and and / or translate downward through channel 221 in rear gear train housing 220, The second arm 282 abuts against the inclined surface 223 that defines the hole 221. 5 (leftward) to contact the first switch 180'. The latch 180' is disengaged by mechanical force from the engagement member 286' of the second arm 282. The second arm 282 moves from an energized state to an energized state. The surface 223 can prevent the mixing device 1 from elastically bending back toward its original position. 02 begins the operating cycle as previously described.

[0066] When switch 180' is energized, motor 178 transmits torque to gear train 184, i.e. That is, through the first, second, and third spur gears 188, 194, and 200, respectively, The spur gear 210 feeds the transfer gear 216. FIG. 2 shows stop nut 272' with flange portion 294' extending from it. As the stop nut 272' translates along the threaded shaft 242, , the stop nut 272' is prevented from rotating. The second switch 181' is separate from the switch 180'. , the housing 11 so as to align with the flange portion 294' of the stop nut 272'. 6. The second switch 181' is a non-momentary switch that is initially conductive. The stop nut 272' can be a switch. The flange portion 294' of the stop nut 272' then finally engages the second switch 18. 1', the second switch 181' moves from a conducting state to a non-conducting state. If the first switch 181' is in a non-conductive state (even if the first switch 180' remains in a conductive state), the motor The motor 178 stops moving, stopping the piston 156 from moving and the mixing paddle 154 from rotating. This can be considered the end of the operating cycle. The duration of the operating cycle is , can be specifically adjusted as needed. The stop nut 272 adjusts the distance based on and must move along the threaded shaft 242 to impinge on the second switch 181'. It must be.

[0067] The first switch 180' and the second switch 181' are connected between the battery 176 and the motor 178. Therefore, the first switch 180′ or the second switch If either switch 181' is de-energized, the motor 178 is disabled. In the example, the first switch 180' is initially in a non-conductive state and the second switch 181' is initially in a powered state. The actuator 148 is moved by user input. Then, both the first switch 180' and the second switch 181' are energized, and the motor 178 becomes operable. The stop nut 272' finally engages the second switch 181'. When the contact is made, the second switch 181' is de-energized and the first switch is energized. The motor 178 stops operating and the piston 1 This marks the end of the operating cycle as movement of the mixing paddle 156 and rotation of the mixing paddle 154 ceases. I can think.

[0068] As previously mentioned, the delivery device 104 includes an inlet port for transferring the bone cement mixture. 106 and the outlet port 108. The release assembly 110 is coupled to the mixing device 102 and the delivery device 104. 1 and 2 show the camshaft in the initial or locked position. The release assembly 110 is shown in the figure. The release assembly 110 can be moved from the initial or locked position. to an unlocked position to disconnect the delivery device 104 from the mixing device 102. 17 and 19A show the release assembly in the unlocked position. 17-20, the housing 116 includes an outlet port 110. 18, the transfer conduit 306 is in communication with the transfer conduit 308. 306 may include a boss extending outward from the front chamber housing 164. The first end 308 of the 306 may include an inner wall 310 that defines the exit port 108. Alternatively, the inner wall 310 may be coupled to the side wall of the front chamber housing 164. The length of the tube 306 is defined between a first end 308 and a second end 309, which The length of the closure 236 is dimensioned to receive a sealing element 236, as shown in FIG. 19A. In particular, the sealing element 236 has a slit or self-closing orifice in its base 312. The base 312 may be bucket-shaped with a transfer conduit (not shown). 306. The slit or self-closing ori The phis is adapted to compress the bone cells within chamber 112, particularly during the compression and transport phases of the operating cycle. In contrast, the valve is designed to open when it receives a sufficiently high pressure from the ment mixture. During the mixing phase of the operating cycle, which is carried out at or near atmospheric pressure, the slit or self-closing The orifice can prevent premature flow of the bone cement component or mixture. The stop element 236 extends from the base 312 and terminates near the second end 309 of the transfer conduit 306. The sidewall 314 may include at least one sidewall 314. The defined inner diameter removably receives a complementary male component of the delivery device 104. The outlet port 108 of the mixing device 102 and the inlet port 106 of the delivery device 104 are The electrodes are dimensioned to provide sealed fluid communication therebetween.

[0069] With continued reference to Figures 18 and 19A, the transfer conduit 306 is To facilitate the desired movement and operation of the release assembly 110, a complementary a first mating feature 316 configured to selectively engage the mating feature; and / or The first coupling feature 316 may include a second coupling feature 318. The first coupling feature 316 may include a second coupling feature 318. 309 , and in particular, the first end 308 and the second end 309 18 and 19A, when viewed together, show the two axially opposed axially opposed plates. Two ribs 320 are shown. The first coupling feature 316 is configured to perform in a way that explains the interference for restricting the range within which the release assembly 110 moves relative to the transfer conduit 306. In one example, the maximum range of movement is, for example, a 90-degree counterclockwise rotation as shown in FIG. 17 relative to FIG. 1. The second coupling feature 318 can include ribs 322 that extend along the outer surface of the transfer conduit 306, particularly defining an arc range at or near the second end 309. FIGS. 18 and 19A show two ribs 322 arranged radially opposite to each other. The ribs 322 are configured to axially hold the release assembly 110 on the transfer conduit 306. Further, the transfer conduit 306 can include at least one defeatable feature 324 (hidden in FIG. 19A but identified as not shown), for example, a protrusion or raised structure that extends outward from the outer surface of the transfer conduit 306. The defeatable feature 324 can be arranged adjacent to (behind) one or both of the ribs 322 that form the second coupling feature 318. The defeatable feature 324 is configured to maintain the release assembly 110 in the locked position so as not to accidentally unlock the delivery device 104 from the mixing device 102. When an input from the user is applied to the release assembly 110 with an appropriate force that overcomes the interference engagement of the defeatable feature 324, the release assembly 110 can be moved to the unlocked position. [[ID=]]( The release assembly 110 is described with reference to FIGS. 19A and 20. The release assembly 110 includes a head portion 326 and a body portion 328 coupled to the head portion 326. ( In one example, the maximum range of movement is, for example, a 90-degree counterclockwise rotation as shown in FIG. 17 relative to FIG. 1. ( The second coupling feature 318 can include ribs 322 that extend along the outer surface of the transfer conduit 306, particularly defining an arc range at or near the second end 309. ( FIGS. 18 and 19A show two ribs 322 arranged radially opposite to each other. ( The ribs 322 are configured to axially hold the release assembly 110 on the transfer conduit 306. ( Further, the transfer conduit 306 can include at least one defeatable feature 324 (hidden in FIG. 19A but identified as not shown), for example, a protrusion or raised structure that extends outward from the outer surface of the transfer conduit 306. ( The defeatable feature 324 can be arranged adjacent to (behind) one or both of the ribs 322 that form the second coupling feature 318. ( The defeatable feature 324 is configured to maintain the release assembly 110 in the locked position so as not to accidentally unlock the delivery device 104 from the mixing device 102. ( When an input from the user is applied to the release assembly 110 with an appropriate force that overcomes the interference engagement of the defeatable feature 324, the release assembly 110 can be moved to the unlocked position. ( The second coupling feature 318 can include ribs 322 that extend along the outer surface of the transfer conduit 306, particularly defining an arc range at or near the second end 309. ( The defeatable feature 324 can be arranged adjacent to (behind) one or both of the ribs 322 that form the second coupling feature 318. ( The defeatable feature 324 is configured to maintain the release assembly 110 in the locked position so as not to accidentally unlock the delivery device 104 from the mixing device 102. ( When an input from the user is applied to the release assembly 110 with an appropriate force that overcomes the interference engagement of the defeatable feature 324, the release assembly 110 can be moved to the unlocked position. ( The release assembly 110 is described with reference to FIGS. 19A and 20. ( The release assembly 110 includes a head portion 326 and a body portion 328 coupled to the head portion 326. ( When an input from the user is applied to the release assembly 110 with an appropriate force that overcomes the interference engagement of the defeatable feature 324, the release assembly 110 can be moved to the unlocked position. ( (

[0070] ( The release assembly 110 is described with reference to FIGS. 19A and 20. The release assembly 110 includes a head portion 326 and a body portion 328 coupled to the head portion 326. ( The release assembly 110 includes a head portion 326 and a body portion 328 coupled to the head portion 326. The head portion 326 may be generally tubular in shape and define a lumen 332. The inner diameter of the lumen 332 may be as shown in FIG. 19A. , the head portion 326 of the transfer conduit 306 so as to receive the transfer conduit 306 into the lumen 332 . The head portion 326 extends inwardly from the sidewall 330. The at least one projection 334 extends from the inner wall of the septum 332 and is disposed within the inner wall of the septum 332. The protrusion 334 is made up of two protrusions (one shown) arranged radially opposite each other. The protrusion 334 cooperates with the first coupling feature 316, i.e., the rib 320, to form the release arm. 19A shows the release assembly 110. 10 has a maximum range of motion of 90 degrees counterclockwise rotation relative to the locked configuration , the release assembly 110 engages one of the ribs 320 in the unlocked configuration. Further, the protrusion 334 is shown as one of the protrusions 334 that allows the release assembly 110 to To prevent axial removal from the casing 306, a second coupling feature 318, i.e. ribs 322. More specifically, during assembly of the mixing device 102, An upper shell 120 of the housing 116 and a lower shell 122 of the housing 116 Prior to bonding, protrusions 334 are defined between ribs 322 that form second bonding feature 318. At this time, the release assembly 110 is guided through the gap. The release assembly 110 is in a tensioned clockwise orientation with the projection 334 positioned behind the rib 322. The upper shell 122 of the housing 116 is attached to the lower shell 122 of the housing 116. The release assembly 110 is rotated counterclockwise to assume the position of the shell 120. Interference between the body portion 328 and the upper shell 120 of the housing 116 Clockwise rotation of the release assembly 110 is prevented and the protrusion 334 is again aligned with the gap. (which allows the release assembly 110 to be axially removed). A body portion 328 of the release assembly 110 is defined within the upper shell of the housing 116. When supported in recess 336 (see FIG. 17), release assembly 110 locks It can be thought of as being in position.

[0071] Another embodiment of the transfer conduit 306' is shown in Figure 19B. Wall 310' includes boss 311 extending from wall 310'. Boss 311 is coaxially disposed within head portion 326'. The boss 311 can be arranged to communicate with the chamber 112 of the mixing device 102. The boss 311 includes a sidewall 314' that defines a bore. The annular space between the boss 311 and the head portion 326' contains a sealing element (not shown) which in this embodiment is coupled to the delivery device 104. The head portion 326' can be dimensioned to fit the second coupling feature 318. ', in particular may include ribs 321 extending along the inner surface of the transfer conduit 306'. The ribs 321 may The groove 323 may be configured as a spiral to define a groove 323 that is spiral in shape. is configured to threadably engage with external threads (not shown) disposed on the delivery device 104. More specifically, for example, the assembly and packaging of the system 100 When the release assembly 110 is rotated from the unlocked position to the locked position during loading, the groove 323 The device rotates to pull the delivery device 104 towards the mixing device 102, thereby This ensures a sealing engagement between the two. This sealing engagement further secures the delivery device 1 04 from the mixing device 102. 10 may be rotated from a locked position to an unlocked position, for example, prior to deploying the delivery device 104. When rotated, the groove 323 moves the delivery device 104 away from the mixing device 102. Rotate.

[0072] The body portion 328 may be an elongated structure extending from the head portion 326. 20 shows a body portion 328 that includes two legs 338 that form roughly a right angle. One of the sections 338 includes a control surface 340 configured to receive input from a user. One of the sections 338 also represents the third step of the intuitive workflow, in this case the number "3." The third step in the workflow may also include indicia 342 corresponding to the step. After the second step of the work flow is completed, i.e., the bone cement mixture is delivered to the delivery device 10. 4. This occurs after the completion of an operating cycle of the mixing device 102, including a transfer step in which the mixture is transferred to the mixing device 102. When it is desired to disconnect the delivery device 104 from the mixing device 102, the user An input to move the release assembly 110 from the locked position to the unlocked position is provided on the control surface 340. In particular, the release assembly 110 is rotated counterclockwise relative to the transfer conduit 306. During this time, protrusion 334 abuts against defeatable feature 324. 324. Applied with an appropriate force to overcome the interference engagement of the defeatable feature 324, the release assembly 1 10 moves to the unlocked position shown in Figures 17, 19A and 19B.

[0073] FIG. 20, taken in conjunction with FIG. 1, generally illustrates the release assembly 110 in a locked position. The head portion 326 of the release assembly 110 includes a lip 344 that faces axially outward. The lip 344 extends over an arc so as to define a gap between the two edges 346 of the lip 344. The gap defines a complementary mating feature of the delivery device 104 (e.g., housing 1). 18 and at least partially defining the inlet port 106) and The lip 344 and head portion 326 may be sized to be equal. The lip 344 defines a groove 348 extending at least substantially circumferentially between each edge 346 thereof. The groove 348 is made up of a first groove portion 350 and second groove portions 352 disposed on both sides of the first groove portion 350. The first groove portion 350 is spaced from the second groove portion 352. The second groove portion 352 is wider than the first groove portion 352. ... Dimensioned and configured to retain a portion of the boss (e.g., diametrically opposed tabs extending from the boss). The tabs on the delivery device 104 prevent the delivery device 104 from being axially separated or emptied. The delivery device 104 is secured to the release assembly 106 so that it cannot move radially through the gap. When coupled with the lens 110, it can be positioned at the 6 o'clock and 12 o'clock positions.

[0074] When the release assembly 110 is in the unlocked position, the first groove portion 350 the gap is aligned with one of the tabs of the delivery device 104 and the other of the tabs of the delivery device 104. The relatively large width of the first groove 350 allows the first groove With the portion 350 positioned at the six o'clock position, the delivery device 104 is 0, some axial movement is possible (see Figure 19A). The gap is located at the 12 o'clock position, allowing the delivery device 104 to be connected to the release assembly 110 and the mixing device. 1. Lift the delivery device 104 against the release assembly 110 to disconnect it from the vice 102. Another input is given to the control surface 115 of the cradle 114. 114. The housing 118 of the delivery device 104 can be removed from the cradle 114. You will be able to do it.

[0075] The mixing delivery system 100 provides several advantages in the operating room. First, the mixing The device 102 and delivery device 104 can be efficiently packaged. 19 and 20, a kit including a mixing device 102 and a delivery device 104 is shown. The kit further includes, for example, a base 356 and a cover 358. The base 356 may comprise a package, such as a blister pack 354 containing a mixed delivery system. It may be a thermoformed plastic that is roughly contoured to fit the stem 100; The cover 358 may be a release film bonded to the base 356 with an adhesive. The mixing device 102 and delivery device 104 are attached to the base 356 of the blister pack 354. The space-conscious method involves placing the bone cement components (i.e., liquid monomer 360 (see FIG. 25) and powdered polymer 362) are conveniently contained within blister pack 354. The entire contents of blister pack 354 can be accommodated in a blister pack. The cartridge may be sterile before it is opened, so that the surgical technician can , the mixing device 102, the delivery device 104, the liquid monomer 360 and the powdered polymer 3 blister pack 354 alone can be removed from the operating room without the need to remove each of the 62 individually. Alternatively, the blister pack 354 can be used as a mixed delivery system. To protect the cover 358 from damage due to contact with the packaging insert, e.g. The packaging insert may include, for example, a thermoformed tray. - Includes a feature that allows the 362 to be held and transported to the sterile field in one step. Furthermore, the mixing delivery device 100, the liquid monomer 360, and the powdered polymer can be 362 can also be placed in an inner blister tray covered with a tray insert, these All can be transferred to the sterile field in one step. Fewer items are passed across the sterile barrier. This increases efficiency and reduces the chance of contaminating the sterile field. 60 and powdered polymer 362 are attached to the remainder of the mixed delivery device 100 as a single unit. It can be directly connected to a mixing device so that it can be removed from the package together with the remaining part. In another example, powdered polymer 362 can be placed in chamber 112. The powdered polymer 362 is transferred to the sterile field by placing it in the funnel device. In addition, the liquid monomer 360 is introduced into the chamber 138. The syringe 112 may be placed in a container (e.g., a syringe, foil pouch, or or dispensing device), thereby eliminating the need for a funnel device.

[0076] Second, as previously mentioned, the mixing device 102 and the delivery device 104 are arranged in parallel. This allows the mixing device 102 and delivery device 104 to be in a combined configuration prior to deployment in the operating room. This allows for compact packaging. Referring again to FIG. 1, the mixing device 102 includes the longitudinal axis LAM of the chamber 112 described above with reference to FIGS. Additionally, the delivery device 104 includes a longitudinal axis LAD. The adaxial LAD is generally defined between the ends of the housing 118 of the delivery device 104. and / or can be coaxial with the chamber of the delivery device 104. As can be broadly understood from the above, a delivery device 104 is coupled to the mixing device 102. In this state, the longitudinal axes LAD and LAM are parallel. When the LAD and LAM are arranged in parallel, the efficient packaging described above becomes possible. To facilitate this, the transfer conduit 306 (and the inlet port 106 of the delivery device 104) The outlet port 108 is defined by the In other words, the chamber 112 is first positioned along the longitudinal axis LAM. The moving bone cement mixture generally exits the delivery device 104 through the exit port 108. The bone cement mixture is then directed laterally toward the inlet port 106. The generally transversely oriented Furthermore, the delivery device 104 may be coupled to the mixing device 102. In this case, the respective longitudinal axes LAD and LAM are substantially aligned in parallel to each other. The parallel and side-by-side arrangement is such that the respective housings 116 , 118 are approximately equal in length (when viewed in plan) in the coupled configuration. In other words, the structures of the mixing device 102 and the delivery device 104 extend beyond each other. Stretching occurs rarely, if at all, thereby eliminating unnecessary storage space in the corresponding packaging. The need for

[0077] FIG. 22 shows the mixed delivery system 100 within the base 356 of a blister pack 354. 23 shows the mixed delivery system 100 being installed as a unit from the base 356 to the left hand of the user. (LH) indicates that the device is being removed with one hand. , funnel device 138 together with mixing device 102 and delivery device 104 with one hand. Furthermore, the combined delivery system 100 can be assembled and configured prior to deployment in the operating room. By packaging the device in this form, the user can easily insert the delivery device 1 into the surgical area before or after the start of the surgical procedure. 04 to the mixing device 102. The risk of user error is minimized and the user can 104 and the mixing device 102. This can be done.

[0078] When the mixed delivery system 100 is in the sterile field of the operating room, the user may You can get started with an intuitive three-step workflow, outlined in The first stage, as indicated by the indicia 144 on the funnel device 138, is numbered "1." The step involves the user inverting the funnel device 138 and placing it into the hole 135 . The number "1" marking also helps inform the user where to insert the funnel device 138. 135. The housing 116 may be provided with a plurality of holes 135, preferably near the holes 135, so that the holes 135 are easily accessible. The laser mixes the liquid monomer 360 and the powdered polymer 362 through a channel in the mixing device 102. The active material is introduced into the funnel device 138 so that it is guided to the member 112. The second step is for the user to activate the computer 148, as indicated by indicia 152 on the computer 148. By providing an input to the input device 148, for example, moving the slider 150 from a first position to a second position, The actuator 148 is moved to the position described in detail above. In the method, the mixing device 102 mixes the bone cement components at atmospheric pressure and deposits the bone cement. The mixture is compressed and transported in a self-sealing manner, and the operation cycle is automatically carried out. The mixing device 102 then determines the desired time based on the completion of the mixing, compression, and transfer stages. After a certain period of time, the mixing device 102 is automatically de-energized to end the operation cycle. This indicates the completion of step 2 of the intuitive workflow. For example, less than one minute or more than one minute), and / or the motor 178, gear train 184, etc. The de-energization of the mixing device 102 can be recognized by the absence of any associated noise. As shown by indicia 342 on the release assembly 110, which is number "3," The third step in the flow is to provide an input to release assembly 110 to release assembly 11. 0 from the locked position to the unlocked position, thereby mixing the delivery device 104. The delivery device 104 includes a detachable device 102. Ready for use as shown.

[0079] Although the bone cement mixture has been described as including a liquid monomer component and a powdered polymer component, Contains more than two components, contains two liquid components, or contains one or more Other exemplary bone cement compositions, including those containing paste components, can be used in accordance with the methods and systems described above. In addition, the above-described systems and methods can be used to mix bone graft materials, biocompatible materials, and other materials. Non-bone cement mixtures, such as biologics, other hardening substances, and combinations thereof It can also be used to deliver goods.

[0080] Many modifications and variations are possible in light of the above teachings and the present invention It is further contemplated that the may be practiced otherwise than as specifically described. For example, referring to FIG. 26, a stylized mixing device 102 and delivery device 104 1 shows a mixed delivery system 100 including the embodiments described above. The delivery device 104 includes: Among other things, the aforementioned WO 2019 / 200091 or the aforementioned The same as that shown in FIG. 1, as disclosed in U.S. Pat. No. 6,547,432, Alternatively, the delivery device 104 may include a hydraulic mechanism, which In this case, the mixing device 102 transfers the bone cement to a cartridge that can be pressurized by a hydraulic pump. do.

[0081] The mixing device 102 is similar to that previously discussed, with only certain variations described for the sake of brevity. It may include internal structure and operation that is at least similar in many respects to the embodiment described. With continued reference to FIG. 26, the funnel device 138 may be integrated into the housing 116. In particular, the upper shell 120 of the housing 116 has a bottom surface extending downward. The inclined surface 139 defines a funnel 138'. The funnel 138' leads to a chamber (not shown). The funnel 138' is integral with the mixing device. 102, and therefore the footprint of the mixed delivery system 100. Reduced weight may simplify packaging and consume less space in the operating room. Additionally, the funnel 138' can be integrated so that the user can insert the funnel device 138 of FIG. It can simplify the user's workflow by removing the need to enter .

[0082] The release assembly 110 of the mixing device 102 is a button, as opposed to a lever as previously described. 27 shows the top surface of the upper shell 122 of the housing 116. 3 shows a button 364 marked "eject" as it is known. The release assembly internal mechanism (not shown) coupled to the button 364 can be actuated. (not shown) moves the system 100 from the initial or locked position to the unlocked position, The delivery device 104 may be detached from the mixing device 102. The lock 110 moves the system 100 from the initial or locked position to the unlocked position. , the internal mechanism is configured to lock the delivery device 104 when it is no longer docked and ready for use. To provide a visual indication that it is appropriate to completely remove the delivery device 104, A portion of the delivery device 104 may be further configured to be slightly spaced from the mixing device 102. It is possible.

[0083] In one embodiment, the release or "drop" of the delivery device 104 from the mixing device 102 The "unlocking" may be based on the movement of one or more components of the mixing device 102. For example, mechanical, electromechanical, or electrical actuator(s) can be used. ) is a position within the second region 160 of the chamber 112 indicating the completion of the compression and transfer stages. Based on this position, the actuator can detect when the piston 156 is in the The controller(s) move the system 100 from a locked position to an unlocked position, and and / or moving a portion of the delivery device 104 slightly away from the mixing device 102 .

[0084] The mixing device 102 may include a display 366, which may be, for example, a digital numeric display. The display device 366 is shown disposed on the front surface of the upper shell 120. However, other suitable locations are contemplated. Display device 366 may be used to provide information about the operation of system 100, more specifically Specifically, it is configured to provide the user with information regarding the operation of the mixing device 102. In one example, the display 366 displays the time remaining in the operating cycle. Display 366 counts down from the initial time to zero. In other words, the display 366 displays the elapsed time of the operating cycle. In yet another example, the display 366 may count up from the remaining work of bone cement. A time estimate is displayed. A temperature sensor (not shown) may be included in the mixing device 102. The total working time of the cement depends on the external temperature, so the temperature detected by the temperature sensor Algorithm to determine total working time of bone cement based on temperature (e.g., room temperature) In combination with a timer function, the processor , the remaining work time can be determined as the difference between the total work time and the elapsed work time. In addition to the display 366 that displays the work time numerically, other types of visual indicia are provided. The display 366 may change color when the remaining task time falls below a predetermined threshold. The display 366 may be illuminated (e.g., green, yellow, red). Similarly, the display 366 may be illuminated. Additionally, the timer may include a series of light sources, moving It may be a bar, an analog clock, etc.

[0085] In some embodiments, the display 366 may display information about the operation of the mixing device 102 or the bone cement. It can be configured to selectively or automatically transition between information about the For example, the display device 366 may display a first output containing the time remaining in the operating cycle, as described above. Then, after reaching zero, the display 366 displays the progress from the first output. Automatic transition to a second output that includes a count up from zero to indicate work time. The user may select between the first input, the second input, and / or any additional inputs. can be selectively switched with

[0086] The mixing device 102 may include at least one indicator light 368 for increased usability. 370, 372. At least in some respects, indicator lights 368, 37 0, 372 are indicia 146, 152, 342 to guide the user through the workflow (See FIGS. 2 and 20). The first indicator light 368 is The bone cement may be placed near, on, near, or around the chair 138, thus This corresponds to directing the feed component into chamber 112 via funnel device 138. The second indicator light 370 is located near, above, near, or around the power button 374. , and thus the mixing device 102 to begin an operating cycle. The third indicator lamp 372 corresponds to the step of operating the button 364. The release assembly 110 can be located on, near, or around the This corresponds to the steps that transition from a locked configuration to an unlocked configuration. Lamps 368, 370, 372 may be light emitting diodes (LEDs) or other suitable indicator lamps. It can be said that:

[0087] The indicator lights 368, 370, 372 may be connected to a controller or processor. Based on some operation, the controller turns on the indicator lights 368, 370, Selectively control one or more of the 72 lights to illuminate and let the user know what to do next. In one workflow, the user can activate the power button 374. , turning on the mixing device 102, i.e., putting the mixing device 102 into a sleep state. The controller controls the bone cement components to flow into the chamber 112. The first step in the workflow is to guide the patient through the funnel device 138 into the Since the first indicator lamp 368 is turned on, a signal is sent to turn on the first indicator lamp 368. sensors connected to the controller (e.g., load sensors in the chamber 112, and and an optical sensor near the hole 135) detects when the bone cement components are introduced into the chamber 112. The controller may remain lit until it detects that the power button 374 is pressed. This can be the second step in the workflow, so that the and correspondingly turning off the first indicator lamp 368 and turning on the second indicator lamp 370. The mixing device 102 transmits a signal to the mixing stage, compression stage, and The display 366 provides information regarding the status of the operating cycle. Once complete, the controller may return the release assembly 110 to the locking configuration. Moving from a configured to an unlocked configuration can be the third step in the workflow. , a corresponding signal for turning off the second indicator lamp 370 and turning on the third indicator lamp 372. The user presses button 364 to connect the delivery device 104 to the mixing device 10. 2. When the button 364 is pressed, the display device 366 displays, for example, Start showing remaining work time as the difference between total work time and elapsed work time, based on room temperature It is possible.

[0088] Some implementations can be described with reference to the following exemplary clauses.

[0089] Clause 1 - Mixing bone cement using a mixing device including a chamber defining an inlet opening A method of making a chamber, the method comprising: forming a chamber having a first end opposite a second end; a mixing device between the first end and the second end and a piston disposed within the chamber; a mixing paddle disposed within the chamber, the face of the piston contacting the first portion of the chamber. When located within a first region of the chamber extending longitudinally between the end and the inlet opening, Mixing the bone cement components with a mixing paddle at a first pressure to form a bone cement mixture. and the piston is moved toward the second end of the chamber until the face of the piston passes the inlet opening. and displacing the bone cement mixture at a first pressure into a second region of the chamber. and compressing the mixture at a second pressure greater than the first pressure.

[0090] Clause 2 - The method of clause 1, wherein the first pressure is atmospheric pressure.

[0091] Clause 3 - Forming a fluid-tight closure between the piston and the chamber in the second region 3. The method of claim 1 or 2, further comprising the step of:

[0092] Clause 4 - The chamber further defines an exit port adjacent the second end of the chamber. The step of moving the piston includes moving the piston along the longitudinal axis within the second region. and forcing the bone cement out of the mixing device through the exit port. 4. The method according to any one of clauses 1 to 3, comprising:

[0093] Clause 5 - Rotating the mixing paddle to mix the bone cement components in the chamber 5. The method according to any one of clauses 1 to 4, including

[0094] Clause 6 - A piston moving along a longitudinal axis and defining a second end of the chamber. The method further includes bending the mixing paddle with a force associated with each of the mixing paddles against the inner surface of the housing. 10. The method according to any one of clauses 1 to 5.

[0095] Article 7 - Using a mixing device to prepare bone cement and dissolving the bone cement in the mixing device. a mixing device defining an inlet opening, a chamber for determining the pressure, a piston disposed in the chamber, and a mixing piston disposed in the chamber. a motor coupled to the piston and mixing paddle; and an actuator coupled to the housing. and a door coupled to the actuator, the method comprising: introducing bone cement components into the chamber through an inlet opening; The motor is moved from the first position to the second position to cover the entrance opening with the door, and at the same time, the motor is driven and activating the motor while the motor is within the first region, wherein activating the motor activates the mixing pad. The spindle rotates, mixing at least two bone cement components in the chamber at atmospheric pressure to form the bone cement. The ment mixture is created and the piston moves through the inlet opening into the second region of the chamber. (i) compressing the bone cement mixture at a second pressure greater than atmospheric pressure; and (ii) compressing the bone cement mixture. and transferring the agent to a delivery device.

[0096] Clause 8 - The mixing device may include a release assembly that couples the mixing device to the delivery device and wherein the method further comprises: attaching the release assembly to a delivery device; From a locked position in which the tool is engaged with a complementary orientation feature of the vise, The directing feature is disengaged to disconnect the delivery device from the mixing device. 8. The method of claim 7, further comprising providing an input to move the locking mechanism to an unlocked position. method.

[0097] Article 9 - At least two bone cement components are a liquid monomer and a powdered polymer. and introducing the bone cement components into the chamber by introducing a liquid monomer through the inlet opening. 9. The method of claim 7 or 8, further comprising conducting both the polymer and the powder.

[0098] Clause 10 - A mixing device for making bone cement, comprising a housing; a chamber within the housing having a first region and a second region distinct from the first region; a chamber for mixing the bone cement components to form the bone cement mixture; a piston movable within the chamber to compress the bone cement components; a motor coupled to the piston and mixing paddle; and a switch connected to the motor. and actuating a motor to move the piston and / or rotate the mixing paddle. This allows the switch to enter an energized state where it starts the operating cycle, and the motor to be de-energized. The switch is configured to transition between a powered and unpowered state, which causes the switch to terminate an operating cycle. a switch configured to be biased toward a non-energized state; An actuator coupled to the housing, the actuator being spaced from the switch. a first position in which the actuator is disposed so as to engage the switch and close the switch; a second position that transitions from the energized state to the energized state and maintains the switch in the energized state against bias; and an actuator movable between the piston and the second region, the piston being in the second region. When the actuator is mechanically disconnected from the switch, the switch is no longer energized. A device for moving from a first region to a second region within the chamber so as to be biased back to a non-powered state. Mixed devices that are configured to

[0099] Clause 11 - A mixed device as described in clause 10, wherein the switch is a momentary switch. vinegar.

[0100] Clause 12 - A transfer gear coupled to the motor and rotatable during the operating cycle; a stop nut connected to the transfer gear, which translates along the transfer gear and moves with the actuator; configured to engage the actuator to mechanically disengage the actuator from the switch Clause 10 further includes a stop nut that is rotationally constrained relative to the transfer gear so as to Or the mixing device according to 11.

[0101] Clause 13 - The stop nut has an inner diameter that threads onto the outer diameter of the transfer gear a flange portion extending from the nut portion, and a flange portion extending from the switch a flange portion configured to engage an actuator to effect mechanical decoupling; 13. The mixing device of clause 12, further comprising:

[0102] Clause 14 - The actuator comprises a slider body and an actuator extending from the underside of the slider body. a stop feature coupled to the arm and configured to engage the switch. 14. The mixing device according to any one of clauses 10 to 13, which is a slider.

[0103] Clause 15 - The slider is connected to the arm and the stop nut prevents the rotation of the transfer gear. The stop nut is further arranged to engage an inclined surface when translated by rotation. The stop nut engages with the inclined surface, causing the arm to bend, and the stop function from the switch.

[0104] Clause 16 - A mixing device for making bone cement, comprising a housing; a chamber within the housing having a first region and a second region distinct from the first region; a chamber; and a rotating member within the chamber for mixing the bone cement components to form a bone cement mixture. a piston movable within the chamber for compressing the bone cement components; a motor coupled to the piston and the mixing paddle; and a switch connected to the motor. and actuating a motor to move the piston and / or rotate the mixing paddle. This allows the switch to enter an energized state where it starts its operating cycle, and the motor to be de-energized. The switch is then turned on to transition between a powered and unpowered state, thereby terminating the operating cycle. The switch is momentary and biased toward a de-energized state. a switch having a housing; and an actuator coupled to the housing, wherein the actuator a first position spaced from the switch and a second position where the actuator engages the switch; to transition the switch from a de-energized state to a conductive state and to maintain the switch in a conductive state against the bias. and an actuator movable between a first position holding the mixing device and a second position holding the mixing device.

[0105] The above disclosure is not intended to be exhaustive or to limit the present invention to any particular form. The terms used are intended to be descriptive rather than limiting in nature. This is what happens.

Claims

1. 1. A mixing device for producing a bone cement from bone cement components, said mixing device but, Housing and a chamber within the housing and defining an inlet opening, the chamber comprising: a first end and a second end, and a longitudinal length extending between the first end and the second end; a first region of the chamber having an adjoining axis and a first end of the chamber and a second end of the chamber; a longitudinal edge of the inlet opening that is closest to the second end of the barrel; A second region of the chamber extends longitudinally between the first region and the second end of the chamber. a chamber defined in a direction a piston disposed within the chamber and having a face; a mixing paddle rotatable within the chamber; The face of the piston is adapted to rotate the mixing paddle forward to create the bone cement mixture. The chamber is maintained at sub-atmospheric pressure when mixing the bone cement components. configured to be located within the first region of the bar; The piston moves the chamber by further movement of the piston within the second region. A fluid is disposed between the piston and the chamber to compress the bone cement mixture within the piston. and a second area of ​​the chamber adapted to position the surface within the second area of ​​the chamber to form a sealed closure. a mixing device configured to be movable along the longitudinal axis.

2. a motor operably coupled to the piston and the mixing paddle; A motor is configured to move the piston and / or rotate the mixing paddle. The mixing device of claim 1 , configured as follows:

3. The chamber further defines an exit port adjacent the second end of the chamber.

3. The mixing device according to claim 1 or 2.

4. a first switch coupled to the housing and connected to the motor; The first switch is configured to turn on while the piston is in the first region.

4. The mixing device of claim 3, wherein a switch is capable of being put into an energized state to operate the motor. 。

5. a second switch coupled to the housing and connected to the motor; The second switch is configured to turn on while the piston is in the second region.

5. The method of claim 4, wherein the switch can be switched to a non-energized state to prevent the motor from operating. Mixed devices.

6. the first switch is a momentary switch biased toward the de-energized state; 6. The mixing device according to claim 4 or 5.

7. the first switch and the second switch are wired in series with the motor. Item 6. The mixing device according to item 5.

8. a front switch coupled to the housing and movable to engage the first switch; 5. The method according to claim 4, further comprising an actuator for maintaining the first switch in the energized state.

8. A mixing device according to any one of claims 1 to 7.

9. a rotatable transfer gear coupled to the motor; While the piston is in the second region, it moves along the transfer gear to a stop nut configured to engage the switch; The mixing device of claim 5 further comprising:

10. 1. A mixing device for making bone cement, said mixing device comprising: Housing and a chamber within the housing; and The bone cement components are rotatable within the chamber to mix and form a bone cement mixture. With a mixed paddle, a piston movable within the chamber for compressing the bone cement component; a motor coupled to the piston and the mixing paddle; a switch connected to the motor, the switch being momentary; and a switch, the switch being biased to a non-energized state that prevents activation of the motor; The switch operates the motor from the non-energized state to move the piston. and / or rotating the mixing paddle. configured to transition to a powered state in which The piston moves from a first region to a second region within the chamber to fill the chamber. the piston is configured to mix and compress the bone cement mixture within the first a mixing device within the first region during actuation of the switch.

11. the switch is a first switch, and the mixing device is a and a second switch wired in series with the motor, the second switch being in a non-motor state. and is initially placed in an energized state to enable starting of the motor; The second switch is configured to stop the motor from operating in the energized state. a de-energized state that ends the cycle, and the piston is configured to The mixing device of claim 10, wherein the mixing device is within the second region during actuation of the switch.

12. When the piston is in the first region, the chamber is at subatmospheric pressure, and 11. The method of claim 10, wherein the chamber is above atmospheric pressure when the stone is in the second region. Or a mixing device according to 11.

13. coupled to the housing and spaced apart from the first switch a first position and a second position that engages and activates the first switch; 13. The method of claim 11 or 12, further comprising an actuator movable between the Mixed devices.

14. 1. A mixing device for making bone cement, said mixing device comprising: Housing and a chamber within the housing configured to receive a bone cement component; the chamber defining an inlet opening; A rotatable member is provided within the chamber to mix the bone cement components to form a bone cement mixture. Mixed paddles, which are noh, a piston movable within the chamber for compressing the bone cement component; a motor coupled to the piston and the mixing paddle; a switch mounted on the housing and connected to the motor, the switch being initially in a de-energized state; an actuator coupled to the housing, the actuator being configured to a second switch spaced apart from the first switch and the inlet opening is open to the surroundings; a first position, and a second position, in which the actuator engages the first switch and turns on the first switch; an actuator movable between a first position and a second position that transitions the actuator from the de-energized state to the energized state; Eta and A mixing device comprising:

15. The switch is a first switch, and the mixing device is a switch mounted on the housing and spaced apart from the first switch; a second switch, which is initially in a conducting state, and which is connected to the first switch and the second switch; a second switch, the switch being wired in series with the motor; To transition the second switch from the conducting state to the non-conducting state, a stop nut movable to engage the switch; The mixing device of claim 14 further comprising:

16. The actuator includes a slider body and an arm extending from a lower surface of the slider body. wherein the arm is configured to move and engage the first switch.

16. The mixing device of claim 15,

17. the first switch and the second switch are not coupled to a printed circuit board; 17. The mixing device of claim 15 or 16, which is attached directly to the housing at separate locations. device.

18. 1. A mixing device for making bone cement, said mixing device comprising: Housing and a chamber within the housing configured to receive a bone cement component; a chamber defining an inlet opening; A rotatable member is provided within the chamber to mix the bone cement components to form a bone cement mixture. Mixed paddles, which are noh, a piston movable within the chamber for compressing the bone cement component; a motor coupled to the piston and the mixing paddle; a switch connected to the motor; an actuator coupled to the housing, the actuator a first inlet opening spaced from the switch and open to the surroundings; and the actuator engages the switch and simultaneously (i) deactivates the switch. In the energized state, the motor is operated to move the piston and rotate the mixing paddle. By performing at least one of the above, the switch is brought into a conducting state to start an operating cycle. and (ii) a second position that closes the inlet opening. with A mixing device comprising:

19. a widened portion and dimensioned to be received within the inlet opening of the chamber; a funnel device having a stem fixed thereto; a flexible connection connecting the funnel device to the housing; 20. The mixing device of claim 18, further comprising:

20. The housing defines a bore, and the entrance opening allows a bone sensor to be guided through the bore. The constituents then pass through the inlet opening into the chamber under the influence of gravity. The actuator is disposed under the hole so that the actuator a door disposed between the entrance opening and the hole when in position 2; 19. The mixing device of claim 18, further comprising:

21. a widened portion and a housing portion sized to be received within the opening in the housing; a funnel device including a stem; a flexible connection connecting the funnel device to the housing; 21. The mixing device of claim 19 or 20, further comprising:

22. The funnel device is disposed on the stem and fitted with a complementary locking member on the housing.

22. The method of claim 21, further comprising: a locking feature configured to releasably engage the feature.

2. The mixing device according to claim 1 .

23. 1. A mixing device for making bone cement, said mixing device comprising: A housing including an upper shell and a lower shell coupled to the upper shell. and a chamber within the housing configured to receive a bone cement component; the chamber defining an inlet opening; A rotatable member is provided within the chamber to mix the bone cement components to form a bone cement mixture. Mixed paddles, which are noh, a piston movable within the chamber for compressing the bone cement component; a motor coupled to the piston and the mixing paddle; the upper shell having a sloped surface defining a hole in communication with the inlet opening; A mixing device comprising:

24. the upper shell has an upper surface, and the inclined surface extends downward from the upper surface, 24. The mixing device of claim 23.

25. 25. The mixing device of claim 23 or 24, wherein the funnel is frusto-conical in shape.

26. 1. A mixing device for making bone cement, said mixing device comprising: A housing including an upper shell and a lower shell coupled to the upper shell. and a chamber within the housing configured to receive a bone cement component; the chamber defining an inlet opening; A rotatable member is provided within the chamber to mix the bone cement components to form a bone cement mixture. Mixed paddles, which are noh, a piston movable within the chamber for compressing the bone cement component; a motor coupled to the piston and the mixing paddle; a device coupled to the housing and adapted to display information indicative of operation of the mixing device; A display device configured as A mixing device comprising:

27. The display device may be a liquid crystal display (LCD), a series of indicator lights, a digital timer, or 27. The mixing device of claim 26, wherein is an analog timer.

28. The information may include the remaining time of operation of the mixing device, the progress of the work using the bone cement, and an estimated remaining time for working with the bone cement.

28. The mixing device according to claim 6 or 27.

29. 1. A kit for performing a vertebral augmentation procedure using bone cement, the kit comprising: Mixing the bone cement components to form a bone cement mixture and compressing the bone cement mixture. a mixing device for mixing the mixture, the mixing device comprising: a chamber defining an inlet opening and an outlet port in communication with said inlet opening; a piston movable within the chamber; a mixing paddle rotatable within the chamber; a chamber defining an inlet port for receiving bone cement from said mixing device; a delivery device comprising: and a package sized to contain the mixing device and the delivery device. picture, The inlet port of the delivery device is adapted to allow the mixing device and the delivery device to releasably joined together within the package and removed from said package as a single unit a mixing device configured to receive a sample from the mixing chamber; 。

30. When the mixing device and the delivery device are removably 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 Counter-axial means that the mixing device and the delivery device are arranged in a side-by-side configuration within the package.

30. The kit of claim 29, wherein the two or more components are parallel to each other.

31. The outlet port of the mixing device and the inlet port of the delivery device are To facilitate parallel arrangement, the longitudinal axes of the electrodes are arranged perpendicular to each other. The kit according to claim 30.

32. a funnel device, said funnel device being removed from said packaging as a single unit; a flexible connection connecting the funnel device and the mixing device so as to be configured to 32. The kit of any one of claims 29 to 31, further comprising:

33. 30. The method of claim 29, further comprising disposing a liquid monomer and a powdered polymer within the package.

33. The kit according to any one of claims 32 to 32.

34. 45. The kit of any one of claims 29 to 44, wherein the packaging is a blister pack. to.

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