set to facilitate user reconstitution

专利摘要:
SET TO FACILITATE USER RECONSTITUTION. The present invention relates to a reconstitution set includes a housing including a lower sleeve and an upper sleeve, including a first container and a second container placed vertically in front of the first container. A transfer device assembly is disposed within the housing between the first container and the second container. The transfer device assembly is configured to access the contents of the first container and then, after activating a trigger mechanism, create a flow path between the first container and the second container. The firing mechanism includes trigger fingers that ensure the transfer device assembly sequentially accesses the contents of the first container before accessing the contents of the second container. The arrangement of the first container activates the firing mechanism.
公开号:BR112013004191B1
申请号:R112013004191-9
申请日:2011-08-25
公开日:2021-02-02
发明作者:Scott Ariagno；Frederick Charles Houghton Ii；Daniel E. Roush
申请人:Baxalta GmbH；Baxalta Incorporated；
IPC主号:

专利说明:

BACKGROUND
[0001] The present invention relates generally to a set for reconstitution. More specifically, the present invention relates to a drug reconstitution kit for reconstituting a lyophilized drug.
[0002] Certain drugs are supplied in lyophilized form. The lyophilized drug must be mixed with water to reconstitute the drug in a form suitable for injection into a patient. In particular, all components that contact the drugs must be sterilized in order to avoid the possibility of infection.
[0003] The reconstitution process presents difficulties for many people who are in need of injecting themselves or another member of the family, in a domestic environment. The general process requires the exact sequential handling of the drug bottle, the diluent container and the transfer syringes that must use needles to penetrate the rubber stoppers. This process must be done with good asepsis practices.
[0004] In addition, many freeze-dried medicines are supplied in bottles with the interior, at a negative pressure in relation to the atmosphere. This negative pressure, since it facilitates reconstitution, compensates for the volume of diluents that are injected into the bottle for reconstitution. If air is allowed to enter the vial prior to the injection of the diluents, this can make the reconstitution process much more difficult for the patient or healthcare provider.
[0005] Thus, reconstitution presents challenges to ensure the sterility of the product and provide ease of use for the patient or care provider. Lyophilized drugs are often very expensive, making minimizing mechanical and user errors of utmost importance to avoid wasting product. In particular, it is desirable to keep the user's interaction with the assembly for reconstitution to a minimum and to minimize the number of steps in the reconstitution process. In addition, it is desirable to avoid intentional or unintended tampering with the medicine and diluent container or reuse of the set for reconstitution. In addition, it is desirable to minimize or eliminate the user's ability to negatively impact the reconstitution process during user interaction. SUMMARY
[0006] The present invention provides a reconstitution kit that is especially useful for reconstituting a lyophilized drug for use by a patient.
[0007] In one embodiment, the reconstitution set includes a housing that includes an upper sleeve and a lower sleeve. the housing defines a generally tubular passage and has an external surface that defines an easy-to-use configuration. A transfer device assembly is arranged inside the housing between the lower sleeve and the upper sleeve. The transfer device assembly includes a pair of opposing tips that form part of a fluid flow path with the upper and lower ends.
[0008] A first container, usually including a diluent, is disposed inside the upper sleeve, inside the passage and adjacent to the upper end of the flow path. The first container includes a first sealing cap providing a sterile barrier for the contents of the first container. The first container is mounted with the first sealing cap facing downwards. A second container is disposed within the lower sleeve inside the passage and adjacent to the lower end of the flow passage. The second container includes a second sealing cap providing a sterile barrier for the contents of the second container. In one embodiment, the contents of the second container are sealed by the second vacuum sealing cap. The second container is discarded with the second sealing cap facing upwards towards the first sealing cap. The upper sleeve is configured to engage the first container to prevent removal of the container from the first assembly.
[0009] A firing mechanism is adjacent and involved with the second container and arranged inside the lower sleeve of the housing and inside the passage. The firing mechanism is located within the housing to place the second container in a rest position and prevent movement of the second container in relation to the transfer device assembly, until fluid communication is established between the interior of the first container and the end of the flow path. The firing mechanism is also configured to prevent removal of the second container from the assembly.
[0010] In one embodiment, the tip at the upper end of the flow path penetrates the first sealing cap with the application of a first predetermined force to the first container. The first predetermined force can be applied to the end of the first container opposite the first sealing cap. The force can be applied by the user by grabbing the container in a vertical orientation, contacting the lower end of the second container against a surface and pushing the first container down. Subsequent to the tip at the upper end of the flow path that pierces the first sealing cap of the first container, the periphery of a flange of the first container, which accepts the first sealing cap, is configured to engage the firing mechanism.
[0011] The trigger mechanism involved is configured to allow the second container to then move axially in relation to the transfer device assembly. The tip at the lower end of the flow passage pierces the second sealing cap after applying a second predetermined force and engaging the firing mechanism of the first container. When the second sealing cap is perforated, the vacuum of the second container is accessed. The second predetermined force can be applied by maintaining contact between the bottom of the second bottle and the surface and continues to apply a downward force to the first container.
[0012] In one embodiment, the first container includes a liquid and the second container includes a lyophilized product. Since the first cap of the first container is pierced with the needle at the upper end of the flow path and the second sealing cap the second container is then pierced with the tip at the lower end of the flow path, the first and second containers are in fluid communication through the flow path of the transfer device assembly. Due to the vacuum of the second container, the liquid from the first container is sucked through the flow path to the second container, after the first and second containers are placed in fluid communication with each other.
[0013] Thus, the liquid from the first container is pulled into the second container to allow mixing with the medicine in this container and does not require any complicated interaction by the user other than placing the set in a vertical orientation, on a surface and then pushes the top of the assembly. The reconstitution set can then be gently shaken to mix the lyophilized product from the second container with the liquid from the first container to form a reconstituted product.
[0014] The housing of the transfer device assembly includes an orifice and forms an access path to provide fluid communication between the orifice and a part of the second tip that is exposed to the interior of the second container when the second tip pierces the second sealing cap. The orifice is arranged in the housing of the transfer device and extends substantially perpendicular to the flow path through the housing to the outside of the housing. In one embodiment, the orifice is separated from the access route with a valve or an orifice seal. After the reconstituted product is formed, a patient or caregiver accesses the liquid through the orifice through the valve opening or by removing the seal from the orifice and withdrawing the reconstituted product through the access route to a syringe without the use of a needle.
[0015] The additional features and advantages are described here, and will be evident from the following detailed description and the Figures. BRIEF DESCRIPTION OF THE FIGURES
[0016] Figure 1 is a perspective view of a modality of a set for reconstitution.
[0017] Figure 2 is an exploded view of the assembly for reconstitution of Figure 1, showing one embodiment of a trigger mechanism of the present invention.
[0018] Figure 3 is a sectional elevation view of the assembly for reconstitution of Figure 1, in a first configuration.
[0019] Figure 4 is a sectional elevation view of the set for reconstitution of Figure 1, in a second configuration.
[0020] Figure 5 is a sectional elevation view of the set for reconstitution of Figure 1, in a third configuration.
[0021] Figure 6 is a sectional sectional view of an embodiment of the transfer device assembly of the present invention.
[0022] Figure 7 is a cross-sectional elevation of the transfer device assembly of Figure 6 taken along line VII - VII of Figure 6.
[0023] Figure 8 is a sectional elevation view of the firing mechanism of Figure 1, which shows a first phase in the use of the set for reconstitution.
[0024] Figure 9 is a schematic view of the triggering mechanism of Figure 1, which shows a second phase in the use of the set for reconstitution.
[0025] Figure 10 is a schematic view of the triggering mechanism of Figure 1, showing a third phase in the use of the set for reconstitution.
[0026] Figure 11 is a schematic view of the triggering mechanism of Figure 1, which shows a final phase in the use of the set for reconstitution.
[0027] Figure 12 is a perspective view of a modality of the trigger mechanism of the present set.
[0028] Figure 13 is an exploded perspective view of an embodiment of the firing mechanism and a housing sleeve for the reconstitution of the present invention, in an uninvolved configuration.
[0029] Figure 14 is an exploded perspective view of the mode of the firing mechanism and a sleeve of the assembly housing for reconstitution of Figure 13 in a partially involved configuration.
[0030] Figure 15 is an exploded perspective view of a modality of the firing mechanism and a sleeve of the assembly housing for reconstitution of Figure 13 in a fully involved configuration.
[0031] Figure 16 is a top plan view of Figure 13 taken along the line of section XVI - XVI of Figure 13.
[0032] Figure 17 is a top view of Figure 14 taken along the line of section XVII - XVII of Figure 14.
[0033] Figure 18 is a top view of Figure 15 taken along the line of section XVIII - XVIII of Figure 15. DETAILED DESCRIPTION
[0034] The present invention provides reconstitution kits, which are especially useful for reconstituting a lyophilized drug. Although the kits are described here with respect mainly to the reconstitution of a lyophilized drug, it will be evident that the kits can be used to reconstitute other materials as well.
[0035] With reference now to the drawings and in particular to Figures 1 and 2, a set for reconstitution 10 is shown. The set includes a housing 12. The housing 12 maintains alignment and restricts the movement of the internal components. The housing 12 includes a first or lower sleeve 20 and a second or upper sleeve 30 and defines a cylindrical inner passage 11. At least part of the first container 70 is arranged in the second or upper sleeve 30 and in the passage 11 and at least a portion a second container 80 is placed in the first or lower sleeve 20 and in the passage 11. the housing 12 can be surrounded by a package during storage and transportation.
[0036] A transfer device set 40 (figure 2) is arranged inside the housing 12, fixed between containers 70 and 80. The transfer device set 40 is latched and fixed in relation to the first sleeve 20 and the second sleeve 30. After activation of the set 10, the transfer device set 40 provides a mechanism for transferring the contents of the first container 70 located in the second sleeve 30 to the second container 80 located in the lower sleeve 20 of the set 10 in a manner efficient and sterile and also to provide a drug reconstituted by a user.
[0037] Sleeves 20 and 30 are made of a suitable moldable and sterilizable plastic, such as ABS, PC or acrylic. Containers 70, 80 can be made of any medical grade material suitable for making a substance, such as glass or plastic, and an elastomeric stopper. In one embodiment, container 70 contains sterile water and container 80 contains lyophilized drug. Set 10 provides a two-stage reconstitution method for adding water 73 to the lyophilized drug 81 to reconstitute the drug and withdraw the reconstituted drug into a syringe. Set 10 provides a sterile mechanism to achieve the objective of reconstitution, minimizes the possibility of user errors and reduces the possibility of wasting lyophilized drug 81.
[0038] It should be noted that each of the sleeves 20 and 30, includes a plurality of windows spaced radially around the sleeves 20, 30. It should be noted that, when including a plurality of windows, the sterilization of parts and components internal is easier. As discussed in more detail below, in the different modalities, the various components are sterilized with hydrogen peroxide vapor, although other gaseous sterilizers, such as ethylene oxide are also contemplated.
[0039] Referring, in addition, to Figure 3, the transfer device assembly 40 includes a housing with an upper tip and a housing with a lower tip. An upper tip 52 forms a part of and is preferably integrated into the upper tip housing. A lower tip 62 forms a part of and is preferably integrated into the lower tip housing. Each of the lower end 62 and upper end 52 defines a flow path 42 for passing through the ends. the housing with tip, top tip 52 and bottom tip 62 can be made of a polymeric material. The transfer device assembly 40 also includes an upper loader 54 that fits at least part of the upper tip 52 and the upper end 42a of the flow path 42 and a lower loader 64 that fits over at least one lower part of the tip 62 and the lower end 42b of flow path 42 (as seen in Figure 8). In one embodiment, the upper loader 54 and the lower loader 64 are made of an elastomeric material to ensure sterility of the flow path 42. The lower loader 64 also provides a barrier for fluid leakage from the flow path 42 to the container 80. It should be appreciated that the loaders 54 and 64 extend from the tip of the upper and lower tips 52 and 62, respectively, towards the base of the tips of the transfer device assembly 40. In various embodiments, the loaders 54, 64 do not extend completely from the tip of each of the tips 52 and 62 to the base of the tips, but extend only partially along the tip exposing a part of the tip to the environment. It should be appreciated that, as discussed further below, the lower loaders 54, 64 result in less elastomeric material which is to be set aside on activation of the reconstitution device. Using less material, interference is minimized, but the flow paths are still protected from the external environment and maintain sterility, after removing set 10 from packaging. In one embodiment, the lengths of tips 52 and 62 are slightly reduced, in order to avoid any contact between loaders 54 and 64 with bottles 70 and 80 before activation. Maintaining a distance between the charger and the bottle facilitates sterilization.
[0040] As can be seen in Figures 1 to 3, the first container 70 is disposed adjacent to the upper loader 54 and the upper end of the tip 52, and is disposed, at least partially within the part of the passage 11 formed by the second sleeve 30. An upper surface 71 of the container 70 is arranged over an upper edge 31 of the second sleeve, at a distance selected to provide the relative movement of the container 70 to the sleeve 30, sufficient to provide a wrapping of the container with the upper tip 52 as described below, keeping the upper surface 71 at or slightly above the edge 31.
[0041] The first container 70 is held in place partly by the wall of the second sleeve 30. An elastomeric blanket 72 or in another embodiment, a semi-rigid thermoplastic washer (not shown) can be inserted between the first container 70 and the top of the sleeve 30. The first container 70 includes a sealing cap 76, which can be a stopper of the standard rubber bottle. The sealing cap 76 can be pierced by the end or tip of the upper tip 52. In an additional embodiment, the joint 72 is formed as an elastomeric O-ring, which provides a contact with friction between the first container 70 and the upper part of the sleeve 30. In one embodiment, the O-ring or joint 72 is coated with a lubricant coating to allow the first container 70 to move relative to the upper sleeve part 30, with reduced frictional resistance. Gasket 72 provides the ideal and consistent frictional resistance over a wide range of bottle diameters, which typically varies within a range of 1 mm.
[0042] A second container 80 is placed close to the lower loader 64 and the lower end of the tip 62, and at least partially within the part of the passage 11 formed by the lower sleeve 20. The lower surface 81 is placed below a lower lip. 21 of the lower sleeve at a selected distance to provide movement of the container 80 with respect to the sleeve 20 sufficient to provide engagement of the container with the lower tip 62, as described below, while still keeping the lower surface 81 at or slightly below the rim 21.
[0043] The second container 80 is partially held in place by an elastomeric joint 82. The second container 80 includes a sealing cap 86, which can be a rubber plug, and is capable of being pierced by the tip of the lower tip 62. Sealing cap 86 provides a seal with the container to maintain a vacuum within the container and to assist drug reconstitution, as described below. In an additional embodiment, the joint 82 is an O-ring, which provides a frictional contact between the second container 80 and the lower sleeve 20. In one embodiment, the O-ring or joint 82 is coated with a lubricant coating to allow that the second container 80 moves with respect to the lower sleeve 20 with reduced frictional resistance. The O-ring 82 provides the ideal and consistent frictional resistance over a wide range of bottle diameters, which typically varies within a range of 1 mm.
[0044] The reconstitution set 10 includes fluid channels or channels for providing fluid communication from the first container 70 to the second container 80 and from the second container 80 to a withdrawal orifice 66 (figure 6) of the assembly device transfer 40 which generally extends perpendicular to the orientation of the tips for access by a user. The withdrawal hole 66 is connected to the lower tip housing of the transfer device assembly 40, as shown in Figure 2. The withdrawal hole 66 extends radially outwardly from the lower tip housing, and extends through a part of the wall of the lower sleeve 20 and the upper sleeve 30 of the housing 12. It should be noted that in various modalities, the cover of the withdrawal hole 69 seals the withdrawn door and is constructed from silicone, which is impervious to any degradation caused by hydrogen peroxide to sterilize the system.
[0045] With reference now to Figures 3 to 5, the reconstitution set 10 is operable between an initial resting or not activated configuration (as shown in Figure 3), a partially activated configuration (as shown in Figure 4), and a fully enabled configuration (as shown in Figure 5). The first container 70 is movable downwardly, or axially with respect to and towards the second container 80.
[0046] With reference specifically to Figure 3, in an initial unactivated or resting configuration, the seal cap 76 of the first container 70 is intact, the seal of cap 86 of the second container 80 is intact to provide a barrier to the interior of each of the first and second containers 70, 80. Each of the upper loader 54 and lower 64 is also intact starting to maintain the sterility of the flow path 42. It should be appreciated that, in the rest position or not activated, by at least, a portion of the upper tip 52 did not penetrate the sealing cap 76 of the first container 70 or broke the sterile barrier maintained by the upper loading 54. In addition, in the rest position or not activated, at least a portion of the lower tip 62 did not penetrate the sealing cap 86 of the second container 80 or the broken sterile barrier maintained by the lower loader 64. As seen in Figure 3, the first container 70 and the second container 80 are positioned ionized either in the resting state or not activated.
[0047] Before activation, the user grasps the set 10 and places it in the vertically oriented assembly position with the bottom surface 81 of the second container 80 resting on a flat surface. Referring specifically to Figure 4, in a partially activated configuration, a manual pressure force is applied to the upper surface 71 of the first container 70 in a downward direction towards the second container 80. The first container 70 moves downwards in relation to the second sleeve 30 and the first sleeve 20. As the upper surface is separated from the edge 31 of the upper part of the sleeve 30, the user can maintain a manual insulated force on the upper surface without engaging the edge 31, during the movement of the first container 70. It should be appreciated that when fluid communication is established between the flow path 42 through the tip 52 of the transfer device assembly 40 and the interior of the first container 70, the first container 70 is in the activated position.
[0048] The transfer set 40 is kept stationary with respect to the second sleeve 30 and the first sleeve 20. As the first container 70 is moving downwardly to the second container 80, the sealing cap 76 comes into contact with the device assembly transfer tip 40 in the upper loader 54. The upper tip end of the upper tip 52 of the upper tip housing pierces the upper loader 54 and the sealing cap 76 of the first container 70. Since the upper end 42a of the flow path 42 formed by the upper tip 52 penetrates through the sealing cap 76 of the first container 70, the contents of the first container 70, for example, sterile water, enter into fluid communication with the flow path 42 and the transfer device assembly 40. When the upper tip 52 fully penetrates the sealing cap 76, the upper surface 71 of the container 70 must be approximately level or extended slightly above the edge 31.
[0049] It should be noted that in various embodiments, a small amount of a lubricant is applied to the tip of the upper end of tip 52 and the lower end of tip 62 before loaders 54 and 64 are installed along the peaks. With the inclusion of a small amount of lubricant in the tip tip, the tips more easily pass through the caps of the first and second containers 70, 80 with a relatively low amount of effort required and with relatively low and constant deflection of the caps of the elastomeric bottles 76 and 86. It should be noted that, at the point of this second configuration in Figure 4, the lower magazine 64 is intact, and a seal within the withdrawal hole 66 (FIG. 6) is still intact.
[0050] As discussed in more detail below, when the first container 70 is moved all the way down over the transfer device assembly 40, and the sealing cap 76 has been fully penetrated, the first container engages and activates the firing mechanism 100 shown in greater detail in Figures 8 to 11. Once the firing mechanism 100 becomes activated, the second container 80 is activated to move in relation to the housing 12 and the container 70 to the first transfer device assembly. 40, and, more particularly, to the lower tip end of the lower tip 62 of the lower tip housing.
[0051] With reference now to Figure 5, in the fully activated configuration, the firing mechanism 100 has been activated and, in the second container 80 it has become free to move in relation to the housing 12 in the direction of the transfer device assembly 40 The second container 80 moves upwards with respect to the lower sleeve 20 and the upper sleeve 30, while the sealing cap 86 first contacts the transfer device assembly 40 in the lower magazine 64. As the force manual is continuously applied axially downward by the user over the first container, the lower tip end of the lower tip 62 pierces the lower magazine 64 and the sealing cap 86 of the second container 80. As the lower surface 81 is separated from the rim 21 of the lower sleeve 20, the second container 80 can move relative to the lower sleeve 20 without the lower sleeve engaging the surface on which the assembly 10 has been placed.
[0052] The moment the lower carrier 64 and the sealing cap 86 are perforated to expose the lower end 42b of the flow path 42 into the second container 80, the flow path 42 provides fluid communication between the the first container 70 and the second container 80 and the fluid 73 from the first container 70 flows through the flow path 42 and comes in contact with the drug 83 of the second container 80.
[0053] Typically, the second container 80 is configured to include its vacuum content, and therefore, when the second sealing cap 86 and the lower magazine 64 are fully penetrated, the vacuum in the second container 80 is opened for the content of the first container 70. After the sealing cap has been penetrated by the lower tip 62, the negative vacuum pressure inside the second container 80 causes the contents of the first container 70 to be sucked through the flow path 42 defined by the assembly transfer device 40 and to the second container 80. During the transfer of fluid from the first container 70 to the second container 80, the seal 69 in the orifice 66 prevents air from entering, which would relieve the vacuum and delay or avoid transferring. Likewise, the lower tip 62 creates a seal where the lower seal cap 86 penetrates. Atmospheric air is allowed to enter the first container 70 through the wind path 404 and the hydrophobic filter 408, as shown in Figures 6 and 7. Venting in this way prevents the accumulation of negative pressure in the first container 70 and increases the speed of fluid transfer. After the liquid content of the first container 70 has been successfully transferred via the fluid path of the transfer device assembly 40 and to the second container 80, the reconstitution set 10 is manually agitated to form a reconstituted drug using the liquid content originally sealed in the first container 70 with the contents originally sealed in the second container 80.
[0054] It should be understood that the vacuum in the second container can be created or recreated at any time, using a syringe connected to the withdrawal orifice. This allows users to recover from errors that result in loss of vacuum, without transferring fluids. Such errors include removing the seal from the withdrawal hole before activating the device or activating the device from top to bottom.
[0055] Referring now to Figures 8 to 15, a more detailed view of the firing mechanism 100 is shown. Similar to Figures 3 to 5, Figures 8 to 11 and 14 and 15 illustrate pre-activated or resting, partially activated and fully activated configurations of the firing mechanism 100 and thus the reconstitution set 10, respectfully. Unlike Figures 3 to 5, however, Figures 8 to 11 show only partial views of the second sleeve 30 and the firing mechanism 100, in each configuration, for ease of illustration and to better illustrate the functionality of the firing mechanism 100 , in cooperation with the second leg 30.
[0056] The firing mechanism 100 includes a circular base 110, with a radial flange 112, and a wall section 114, which in the illustrated embodiment is substantially frustoconical in shape. The section of wall 114 depends on the upper flange 112 of the circular base 110 and forms a lower edge 116 of the circular base 110. Three trigger fingers 102, 104 and 106 (see Figure 2) are arranged radially around the circular base 110, a about one hundred and twenty degrees apart, and extend upwards from flange 112. Other numbers and arrangement of the trigger fingers around the base are also imagined. In the state of the pre-activated firing mechanism of Figure 8, the three trigger fingers 102, 104, 106 are formed to tilt slightly radially inward.
[0057] In one embodiment, the three trigger fingers 102, 104 and 106 include identical characteristics. The features described for trigger finger 106 apply equally to fingers 104 and 102 accordingly. The upper part of the trigger finger 106 includes a shoulder portion 118. The shoulder portion 118 includes shoulders 118a and 118b and a tapered flange 120 extending upwardly between shoulder 118a and shoulder 118b. The surface of the shoulder 118 extends radially into the wall of the external shoulder 119 (figures 6 to 12) to the wall of the internal shoulder 122 (corresponding shown in finger 104). It should be noted that the inner shoulder wall 122 of the trigger finger 106 and the corresponding inner shoulder walls of each of the trigger fingers 102 and 104 are arched. The shoulder walls of each of the trigger fingers 102, 104 and 106, each encounter a common arc and have a common central point, with a central axis through the firing mechanism 100.
[0058] In a non-activated state, the surface of the shoulder 118 resides at least substantially parallel to the flange 112 of the circular base 110 of the firing mechanism 100. The flange 120 includes a base 121, which begins below the shoulder surface 118 and between the shoulder 118a and the shoulder 118b of, as shown, for example, in Figure 13. The base of the flange 121 extends from the wall of the inner shoulder 122 radially outwardly, after the wall of the external shoulder 119 of the shoulder 118. An outer edge 126 of the tapered flange 120 extends from the outer surface 119 of the trigger finger 106 upward to the tip 124. An inner surface 128 of the flange 120 (as shown in Figure 12, finger 104) extends if from the wall of the internal shoulder 122, and is tapered in a radial direction out of the tip 124, where the outer end 126 and the inner edge 128 of the tapered flange 120 meet.
[0059] With reference to Figures 13 to 15, the second sleeve 30 is shown in more detail. The second sleeve 30 includes a floor 210 and a cylindrical section 212 that is concentric with the second sleeve 30 and extends downwardly from the floor 210. The floor 210 of the second sleeve 30 includes three radially spaced flanges 220, 222 and 224 fixing the cylindrical part 212 with an inner wall 32 of the second sleeve 30. Only the flange 220 is visible in the sectional view of Figures 13 to 15, but each of the three flanges 220, 222 and 224 has the same characteristics and geometry of a modality. The top view shown in Figures 16 to 18, which corresponds to the different activation steps shown in Figures 13 to 15, respectively, shows each of the flanges 220, 222 and 224 evenly spaced around the upper sleeve 30, with one hundred and twenty degrees.
[0060] The second sleeve 30 includes three flange elements 230, 232 and 234 connected to the inner wall 32 above the floor 210 and the cylindrical section 212. The three projecting elements 230, 232 and 234 are equally spaced evenly over the inner wall 32 of the upper sleeve 30 and are separated by one hundred and twenty degrees. Other numbers and positioning of the tabs around the inner wall 31 are also imagined. The three flange elements 230, 232 and 234 (only 230 and 232 are illustrated) are each radially displaced from the three flanges 220, 222 and 224 by forty-five degrees and are connected to the inner wall 32 of the second sleeve 30 near its end upper, and extend downwards towards the floor 210 and radially inwards towards the central axis of the second sleeve 30.
[0061] With reference now in general to Figures 3 to 5 and again to Figures 6 to 11, the process of activating the assembly for reconstitution 10 through the triggering mechanism 100 is described in more detail. As mentioned above, the reconstitution set 10 in one embodiment is packaged so that a sterile environment is maintained over the set for reconstitution 10. Removal of the package submits the set to the outside environment, except for fluid passages inside the transfer set and inside the bottles, which remain sterile and closed to the external environment.
[0062] Before activation, and during transport, the first container 70 is held in a static manner in place of the first sleeve 30 by means of the flap elements 230, 232 and 234 and by the washer 72. As discussed above, the elements of the flaps 230, 232 and 234 are connected to the inner wall 32 of the second sleeve 30, and to walk down to the floor 210 of the first sleeve 30.
[0063] After applying a radial force applied outward, the flaps flex slightly radially outward. The first container 70 includes a neck portion 77, which extends from a main body 73 of the first container 70 to a shoulder 74 of the first container. The shoulder 74 includes a shoulder 75, which defines an opening in which the sealing cap 76 is first protected. During the assembly, when the first container is inserted into the second sleeve 30, the flange 75 first contacts the flange elements 230, 232 and 234 and flexes the lower ends of the flaps outward to allow the flange 75 to pass over tabs. Bending causes the protruding elements 230, 232 and 234 to be tilted radially inward. After the edge 75 has cleaned the flange elements 230, 232 and 234, the smaller diameter neck part 77 provides the space to allow the bottom of the flange elements 230, 232 and 234 to bounce radially inward towards the neck 77. When jumping radially inward, the unique flap inner configuration fits into the inclined surface of the container to collectively resist further downward movement of the first container 70. In addition, the free lower edge of the flange elements 230, 232 and 234 is wedged between the neck 77 and the shoulder 75, thus blocking the first upwardly moving container 70 and removing the container 70 from the sleeve 30 and the passage 11.
[0064] The first container 70 is now suspended inside the sleeve 30 in the rest position or not activated and secured by each of the three elements of the flap 230, 232 and 234, in such a way that the container 70 is not allowed to move in the vertical or axial direction absent a deliberate downward applied force.
[0065] As shipped, the firing mechanism 100 of the set 10 is wrapped with lower floor 210 of the second sleeve 30. The circular base 110 of the firing mechanism 100 surrounds the rim 85 of the second container 80. The second container 80 is held against the downward movement relative to the firing mechanism 100 by a series of tabs 115, 117 forming a part of the upper sleeve, as shown in Figure 13, and shown with the second container 80 in Figure 10, which extends into the space between the rim 111 and the neck of the second container. The shape of the flaps 115, 117 engages the underside of the flange 111. The upper surface of the second container 80 is flush against the flange 112. In this way, the flange 112 and flaps 115, 117 support and engage the flange 111 of the second container 80 and prevent significant relative movement between the container and the trigger mechanism 110. As shown specifically in Figure 10, the flaps 115, 117 encased the underside of the rim 111 of the second container 80, thereby inhibiting the lateral movement of the second container 80 downward. Since the firing mechanism 100 is engaged with the second sleeve 30 to prevent movement before activation of the reconstitution set 10, the second container 80, as surrounded by the firing mechanism 100, is prevented from displacement with respect to the housing 12 , before activation. The firing mechanism assembly 100 and the second container 80 are held in a concentric position with respect to the first sleeve 20, and are limited to a vertical or axial displacement that contacts the section of the wall 114 and the inner surface of the first sleeve 20.
[0066] Three pairs of inclined fins 87a and 87b, 88a and 88b, and 89a and 89b are integrated into the second sleeve 30 and spaced radially one hundred and twenty degrees apart. During activation, each of the three trigger fingers 102, 104 and 106 of the firing mechanism 100 fits between one of the three pairs of angled fins, 88a and 88b, 89a and 89b, and 87a and 87b respectively. It should be noted that in Figures 13 to 15, each of the three pairs of inclined fins 87a / 87b, 88a / 88b and 89a / 89b is not visible from the same point of view. However, in Figures 16 to 18, these pairs of inclined fins are visible, and serve to guide each of the fingers 102, 104 and 106 of the firing mechanism 100, as it moves in relation to the second sleeve 30, as it will be discussed below.
[0067] As discussed above, trigger mechanism 100 surrounds and prevents the second container 80 from displacing with respect to housing 12 and subsequently makes accidental or premature contact with the lower tip 62 of the tip housing of the device assembly transfer 40. As mounted inside the housing, the trigger fingers 102, 104 and 106 of the firing mechanism 100 surround the transfer device assembly 40 and extend upwards and into the floor 210 of the upper sleeve 30. Each one of the three flanges 220, 222 and 224 of the floor 210 defines an opening 219, 223 and 225, respectively, as can be seen in Figure 16, each of the openings configured to accept the upper part of each of the three trigger fingers 102 , 104 and 106. Each of the three openings 219, 223 and 225 in floor 210 of Figure 16 are identical. It should be noted, therefore, that the discussion of opening 219 corresponding to flange 220 applies equally to openings 223 and 225. Opening 219 is defined by shoulders 219a and 219b and notch 219C, located between shoulders 219a and 219b.
[0068] The trigger fingers 102, 104 and 106 as can be seen in Figures 13 to 15 are each angled radially inward, in the non-activated position. As well, the shoulders 118a and 118b, and the inner wall 122 extend towards the central axis of the second sleeve 30, and consequently are placed in direct contact with the lower face of the flange 220, and, specifically, the lower surface of the boss 219a and 219b. As shown in Figure 14 219, the opening is shaped to accept the upper part of the finger on trigger 106. Specifically, as the trigger finger 106 travels through the floor 210, the tapered flange 120 slides into the notch 219c and shoulders 118 and 118 come into contact with the underside of the shoulders 219a and 219b. The contact of the lugs 118a, 118b, with the underside of the lugs 219a and 219b of the flange 220 prevents the finger on the trigger 106 from fully traveling through the opening in the flange 220, and thus keeps the firing mechanism 100 static in relation to the housing 12. The trigger fingers 102 and 104 are also supported between the corresponding shoulders and the underside of the openings 223 and 225 of the floor 210. Each of the trigger fingers 102, 104 and 106 are positioned below an opening in a different from the three flanges 220, 224 and 226. The shoulder 118 of each of the trigger fingers 102, 104 and 106 are supported against the lower face of the floor 210.
[0069] With reference now to Figures 3 to 5 and 12 to 15, a feature of the triggering mechanism is discussed as illustrated. In various embodiments, the trigger mechanism assembly 100, the first container 70 and the lower container 80 in the lower sleeve 20 and the upper sleeve 30 are completed prior to shipment to the end user. It should be noted that it is not desirable for the user to be able to remove the firing mechanism 100 and the second container from within the lower sleeve and passage 11. As seen in Figure 3 and discussed above, during the firing mechanism firing 100 and the second container 80 is inserted in the lower sleeve 20 from the opening defined by the flange 21. In various embodiments, the characteristics of the firing mechanism interact with the characteristics of the lower sleeve to prevent disassembly by the user.
[0070] As seen in Figure 12, the flaps 123 are integrated for part 114 of the circular base wall 110 of the firing mechanism 100. In the illustrated embodiment, the flap 123 is arranged radially for every 120 degrees around the circular base 110. It should be noted that in various modalities, a greater or lesser number and flap arrangements 123 can be integrated into the trigger mechanism 100. In various modalities, flaps 123 are security flaps that interface with housing 20 to avoid the removal of the trigger mechanism 100 after it is inserted in the lower sleeve 20. The flaps 123 interact with the characteristics of the shoulder 101 defined by the inner wall of the lower sleeve 20 when the trigger mechanism 100 is first inserted in the lower sleeve 20 before shipping .
[0071] As can be seen more clearly in Figures 4 and 5, the lower sleeve 20 includes the shoulder 101 on its internal wall. It should be appreciated that, in various embodiments, the shoulder 101 is defined, at various predetermined points around the lower sleeve 20, or continuously around the lower sleeve 20. From the bottom of the lower sleeve 20 leading to the shoulder 101, the inner wall of the lower sleeve 20 begins with a first diameter, and gradually decreases in diameter in movement from the bottom of the lower sleeve 20 towards the upper part of the lower sleeve 20. In one embodiment, when the inner wall of the sleeve bottom 20 reaches the shoulder 101, the diameter is at its narrowest part. Above the shoulder 101, the inner wall of the lower sleeve 20 returns sharply to its original diameter, which is larger than the diameter defined by the shoulder 101. It should be noted that, in the mode in which the shoulder 101 is not continuously defined all 360 degrees around the inner wall of the lower sleeve 20, the diameter discussed here refers to the diameter defined by each of the plurality of shoulders 101 around the inner wall of the lower sleeve 20. In one embodiment, the lower sleeve 20 includes three bosses 101 radially spaced 120 degrees apart.
[0072] As seen in Figure 3 and Figure 12, the firing mechanism 100 and the second container 80 have just been inserted in the lower sleeve 20. As the firing mechanism 100, and in particular the flaps 123, pass to the along the narrowing of the inner diameter wall 20a of the lower sleeve 20, the flaps 123 flex internally to adjust the decreasing diameter 20a of the lower sleeve 20. As seen in Figure 12, in one embodiment the flaps 123 are arranged on a flap, which is separated from the bottom 110 to allow the bending of the flaps without the need for additional force from the assembler or risk of breaking the firing mechanism 100. After the flaps 123 are flexed inwards, to compensate for the decrease in diameter 20a, the firing mechanism 100 continues to move upwardly relative to the lower sleeve 20 until it passes the shoulder 101. When the flaps 123 pass the shoulder 101, the previously flexed internally flaps 123 will flex radially outward, d due to the dramatic increase in diameter defined by the shoulder 101. As shown in Figure 3, the flaps 123 of the firing mechanism 100 have just been allowed to flex radially outward, back, after the shoulder 101 has passed. if the user were to try and pull the firing mechanism 100, or the second container 80 attached to it, back in the opposite direction out of the lower sleeve 20 and the passage 11, the shoulder 101 could prevent any further translation. Thus, the firing mechanism 100 takes the place of the second container 80 in the rest position or not activated by the engagement between the fingers 102, 104, 106 and 220 of the flange and the coupling between the guides 123 and the shoulder 101.
[0073] As illustrated in Figure 4 and again in Figures 9, 10 and 14, the patient or caregiver begins the reconstitution process, using one hand to hold the housing 12 and place the reconstitution set 10 in an orientation vertical with the bottom surface of the second container 80 resting on a surface such as a table or desk. The user will use the other hand and apply a first downward force directly to the upper surface 71 of the first container 70. As the first force is applied to the upper part of the first container 70, the main body 73 comes into contact with each of the projecting elements 230, 232, 234, exerting a radially outwardly directed force. This contact and the force causes the flange elements 230, 232, 234 to flex towards the inner wall 32 of the second sleeve 30, thus allowing the main body 73 of the first container 70 to become free of the hanging force within second sleeve 30. As the flange elements 230, 232 and 234 are flexed out of the path of the main body 73, the first container 70 is free to start the journey axially downwards in the vertical direction towards the transfer device assembly 40 The tongue elements 230, 232, 234 arranged in one hundred and twenty radial degrees increase around the first container 70 and the joint 72 keeps the first container centered and concentric to the first sleeve 30.
[0074] Figures 4, 9 and 10 show that, that the first container 70 is forced through the three flange elements 230, 232 and 234, the first sealing cap 76 compresses or crushes the upper loader 54 of the device assembly transfer device 40. As the strength of the first container increases, and the transfer device assembly 40 resists this force, the end of the upper tip of the upper tip 52 penetrates through the upper magazine 54. Since through the upper magazine 54, the upper tip end of the upper tip 52 pierces the sealing cap 76 of the first container 70. As the first container 70 is further moved down axially, the upper tip end of the upper tip 52 fully penetrates the first sealing flange 76, such that the fluid content 73 of the first container 70 is placed in fluid communication with the transfer device assembly 40 through the upper end r 42a of the flow path 42 and the upper tip 52.
[0075] After the upper tip end of the upper tip 52 has completely penetrated the sealing cap 76 of the first container 70, the first container 70 finds the possibility of continuing to move axially downward towards the transfer device assembly 40 The force continued downwards and for the movement of the first container 70 after the penetration of the sealing cap 76 begins the activation of the firing mechanism 100. As described above, in the non-activated position, the lugs 118a and 118b of the trigger fingers 102 , 104 and 106 of the firing mechanism 100 are supported against the underside of the flange 220, and the tapered flange 120 of the trigger fingers 102, 104 and 106 extend through the opening in the floor 210. When the first container 70 is forced axially downward, the rim 75 of the sealing cap 76 contacts the inner surfaces 128 of the tapered flanges 120 on the trigger fingers 102 to 106, which protrude through the floor 210 of the second sleeve 30, as seen in Figures 9, 14 and 17. At the same time, the shoulder 75 also comes into contact with the corresponding tapered flanges on each of the other two trigger fingers 102, 104 around the circumference of the first container 70. In one embodiment, the first sealing cap 76 can be formed such that the radial outer surface can extend outward such that the first sealing cap can initially come into contact with the trigger fingers 102, 104, 106.
[0076] Due to the tapered profile of the flange 120, the other first container moves axially downwards in relation to the second sleeve 30, a greater force will be exerted in a radially outward direction, against the upper part of each of the three fingers of trigger 102, 104 and 106. The resulting force applied radially outwardly on the tapered flange 120 by the downward displacements of the first container 70 causes each of the trigger fingers 102, 104, 106 to flex in a radially outward direction, as can be seen in Figures 9 and 10.
[0077] As a result of the trigger fingers 102, 104, 106 being each simultaneously flexed outwardly and towards the inner wall 32 of the second sleeve 30, the shoulders 118 move away from the lower surface of the floor 210. Once the shoulder 118 is forced radially outward, the shoulders 118a and 118b lose contact with the bottom surface, and move into the opening in the floor 210. As described above, before engaging flange 75 and tapered flanges 120, the firing mechanism 100 is supported from the movement in relation to the first sleeve 30 by the contact between the shoulders 118a, 118b, and the shoulders 219a and 219B of the lower surface of the floor 220. Because the shoulders 118 are now disengaged from this supported position, the mechanism trigger 100 is now free to move axially with respect to housing 12. It should be noted that the shoulder 75 is not configured to activate trigger mechanism 100 or contact any one of the decreasing thickness flaps 120 of the trigger fingers 102, 104, 106 until the upper end of the upper tip tip 52 has penetrated the first seal 76 and has placed the flow path 42 of the transfer device assembly 40 in fluid communication with the fluid content of the first container 70.
[0078] As the downward force is applied continuously on the first container 70, the container continues to move axially downwards towards the transfer device assembly 40 until the rim 75 contacts the floor 210 of the upper sleeve 30 At the point where the rim 75 of the first container 70 is flush against the upper surface of the floor 210, each of the three trigger fingers 102, 104, 106 has been flexed out radially, as discussed above, and the first container 70 it is prevented from any further displacement in relation to the housing 12. It should be noted that, at this point in the reconstitution process, the transfer device assembly 40 and the first container 70 are in fluid communication with each other. The lower loader 64 keeps the fluid inside the first container 70 and the transfer device assembly 40, as seen in Figures 4 and 8.
[0079] With reference to Figures 10 and 11, the second container 80 is no longer impeded by the trigger mechanism 100 of movement in relation to the floor 210 of the second sleeve 30, because the trigger fingers 102, 104 and 106 have been released from of the coupling and now the mechanism is allowed to move in relation to the housing 12, sliding along the rim 75 and the neck head 74. As shown in Figures 10, 15 and 18, the continued shape at the top 71 of the first container 70 results in movement of the entire housing 12, first container 70, and transfer device assembly 40 downwardly relative to and towards the second container 80.
[0080] As the housing 12, the first container 70 and the transfer device assembly move axially down together with respect to the second container and the trigger mechanism 100, and the transfer device assembly 40 enter in contact with the second sealing cap 86 of the second container. More specifically, the lower carrier 64 first contacts the second sealing cap 86 of the second container 80. As the force of the transfer device assembly 40 moves downwards against the second sealing cap increases 86 of the second container 80, the resistance of the lower loader 64 of the second seal cap 86 forms the lower end of the lower tip 62. The lower tip of the lower tip 62 pierces the lower loader 64, and then continues to pierce the second seal cap 86 for putting interior of the second container 80 in fluid communication with the lower end 42b of the flow path 42 and thus in fluid communication with the interior of the first container 70, through the flow path 42 of the transfer set 40, such as seen in Figures 5 and 9.
[0081] It should be noted that, in an embodiment, according to compartment 12, first container 70 and the transfer device assembly move downwards in relation to the second container 80 and firing assembly 100, the trigger fingers 102, 104 and 106 will naturally move radially inward, back to their natural configuration, skewed inward after the rim 75 of the first container 70 has passed the tapered flange 120 of each trigger finger. The tapered flange 120 will then move in volume around the neck 77 of the container. The lower surface 121 then wedges against the upper surface of the shoulder 74 to prevent the separation movement in relation to the container 70 and the container 80. The first container 70 and second container 80 are thus attached together and to the assembly of the transfer device by the firing assembly 100 thus retaining the containers inside the passage 11 and the housing 12.
[0082] As can be seen in Figures 3 to 5, in various modalities, the first container 70 includes a closure or resistance feature that interacts with a joint 72 of the housing 12 to prevent the separation movement in relation to the container 70 and to container 80. It should be appreciated that the locking device can be integrated into the first container 70 at the time of manufacture, or can be added to the first container 70 prior to assembly. In the example example illustrated, the product label 79 is used as the locking device in the container 70. In this embodiment, the gasket 72 meets tolerances so that the gasket 72 extends over the product label 79 in the first container 70. Because it is stretched, the joint 72 is tilted radially inward as it slides along the part of the first container 70 with the product label 79. In several embodiments, the joint 72 is constructed from a plastic material or polymeric.
[0083] It should be noted that in various modalities, product labels 79, 89 are made of a plastic film that is more impermeable to hydrogen peroxide and sterilization chemicals than the paper label. In addition, it should be noted that the plastic labels provide better friction for labels 79, 89 to pass easily through joints 72, 82, respectively. In various embodiments, product labels 79, 89 do not wrap completely around the first and second containers 70, 80, and the label does not overlap itself, in any location. In one embodiment, the label covers about 350 degrees of the respective container. It should be noted that any overlapping of the label may unduly increase the force required to activate the assembly.
[0084] With reference to Figure 5, as discussed above, at the time of delivery of the set for reconstitution, the first container 70 and the second reservoir 80 are already assembled in the housing 12. Since the first container 70 and the second container 80 are placed in fluid communication with each other through the transfer device assembly 40, it is desirable to avoid separating the two containers 70, 80. In operation, the first container 70 is pushed down in relation to the second container 80. As the first container 70 is moving downwards inside the housing 12 to the second container 80, the joint 72 disposed in the housing 12 surrounds and contacts the product label 79 in the first container 70. In an exemplary embodiment , the product label 79 has a specifically designated thickness, and is attached to the first container 70 at a specific first location. Since gasket 72 has completely passed the product label 79, and specifically the edge 79a of the product label 79, as the first container 70 moves down, the gasket 72 passes the edge 79a of the product label 79, and the gasket 72 radially skewed inward will cause it to contact the outer surface of the first container 70. Due to the tolerances of the joint 72 and the thickness of the product label 79, this mechanism works to prevent a user from displacing the first container in a opposite direction, thus avoiding the undesirable separation of the first and second containers. If a user could attempt to move the first container in the opposite direction, the lower edge 72a of the joint 72 abuts the edge 79a of the product label 79, thus preventing further translation of the container in relation to the housing. It should be noted that the second container 80 also includes a similarly sized product label 89 and gasket 82. Gasket 82, gasket edge 82a, product label 89 and product label edge 89a operate from same way to prevent the second container from separating from the lower sleeve 20.
[0085] As seen in Figure 5, since the gaskets 72 and 82 each lighten the label of the entire product 79 and 89, respectively, reversing the direction of stretching backwards along the product label, which allows the removal of the first container 70, it would be necessary to overcome the resistance of the joints 72, 82, and specifically of the edges of the joints 72a ', 82a' by confining the edges 79a, 89a of the product labels 79, 89 of the containers 70 and 80, respectively.
[0086] It should be noted that, in various embodiments, containers of different sizes are usable with the same housing 12. For example, in various embodiments, the first container 70 and the second container 80 are exchanged for a first larger container and a second larger container, which corresponds to a drug of different reconstitution, or treatment. It would be appreciated that the use of the same accommodation, for several different types of drugs and treatments, provides valuable flexibility and versatility. It should be noted that, regardless of the diameter dimensions of the containers to be used, the neck of all containers are standardized according to ISO or other standard convention, and are predictable in the industry. Therefore, when a larger container is exchanged with the container 70 or 80 discussed above, the trigger fingers, the locking mechanism and the transfer device assembly will consistently interface. In various embodiments, the only parts that need to be modified are the joints 72, 82 and the ribs 87a, 88a, 89a used for the center of the container. It should be noted that in various embodiments, the upper sleeve 30 and the lower sleeve 20 include a plurality of ribs, similar to ribs 87a, 87b and 87c, in a first position and a plurality of ribs in a second position, depending on the diameter of the containers to be used. In various modalities, it should be noted that the modified joints that replace joints 72, 82, when exchanged for a larger diameter container, are color coordinated to easily notify the user of the type of drug or which container should be used.
[0087] As discussed above, the contents of the second container 80 are vacuum sealed. Therefore, when the lower end 42b of the flow path 42 is placed in fluid communication with the interior of the second container, the sealed vacuum is exposed to the flow path 42. The level of negative pressure inside the second container is then equaled by pulling fluid 73 from the first container 70 through the flow path 42 facilitated by the transfer assembly 40 to the second container 80. When the fluid 73 has been fully transferred from the first container 70 through the transfer device assembly 40 and to the second container 80, the solids content 83 of the second container 80 is mixed with the liquid content 73 from the first container 70 to form a reconstituted drug. In one embodiment, the patient or caregiver gently shakes the entire reconstitution set 10 to mix the liquid content 73 and the solid content 83 appropriately to form a homogeneous mixture for use as, for example, injectable drugs. It should be noted that, due to the penetration of the upper tip and the lower tip into the first container and the lower container of the flow path after activation is completed, it is limited to the first container 70, the transfer device assembly 40, and the second container 80. After agitation, the reconstituted drug will not escape this sealed boundary.
[0088] Referring now to Figures 6 and 7, a more detailed view of the transfer set 40 is shown. Figure 6 shows a cross-sectional view of the transfer assembly 40 with an orifice 66, the lower end of the flow path 42b and the upper end of the flow path 42a. The transfer set 40 defines a ventilation path 404 in the upper tip housing 52, and an access path 400 equipped with a filter 402 or the valve in the lower tip housing. It should be noted that in various embodiments, the filter 402 or the valve is a check valve.
[0089] Figure 7 illustrates the transfer device set 40 of Figure 6, as in section along line VII - VII of Figure 6. It should be appreciated that when the fluid is to be transferred from the first container 70 for the second container 80 to prevent the vacuum from being drawn into the second sealed container, the air has to replace the transferred liquid. The ventilation path 404 is connected to the ventilation hole 406, which accesses the ambient air outside the sealed transfer set 40. The ventilation hole 406 includes a hydrophobic filter 408 to allow filtered air to be introduced from outside the transfer set 40 into the ventilation hole 406, through the ventilation path 404, and into the first container 70. The filter 408 is hydrophobic, in one embodiment, so that any liquid that moves down the ventilation path 404 and to the orifice 406 must not leak out of the transfer device assembly 40 through the filter 408 or be contaminated. Filter 408 is selected to prevent airborne pathogens from entering containers 70 and 80. The porosity of the filter can vary anywhere from about 0.2 microns to 150 microns. In several embodiments, the ventilation hole filter 408 is both hydrophobic, as discussed above, and also oleophobic, which prevents any leakage into the lubricating silicone filter or other lubricant used on the tip tip from clogging or blocking the pores. ventilation.
[0090] After the drug has been completely reconstituted, the patient or caregiver accesses the reconstituted drug through the withdrawal hole 66 of the lower tip housing of the transfer device assembly 40. To facilitate the complete emptying of the second container 80 , the user will typically invert the set 10, so that the second container is now at the top of the set. The withdrawal hole 66 is configured as a female luer connector and extends radially outwardly from the lower tip housing. In one embodiment, orifice 66 includes a series of segments 67 to provide a sealed connection with a male luer tip having an annular locking flange. The orifice seal 69 is configured to engage or conflict the segments 69 and to close the withdrawal orifice 66 in a sealed way. The product filter 402 is arranged inside the port 66 in a modality, which is configured to prevent any particles unmixed solids 83 of the reconstituted drug is removed.
[0091] As seen in Figure 6, transfer set 40 includes opening 66, which allows a user to remove the reconstituted drug from the set for reconstitution 10 via access path 400 formed in the set of transfer device 40 As seen in Figure 4, the withdrawal hole 66 extends through the housing 12 and is exposed to the outside of the housing. As discussed with Figure 11, a lower tip part 62 penetrates the sealing cap 86 to place the flow path 42, and the access path 400 in fluid communication with the interior of the second container 80. In one embodiment a Access route 400 may include a check valve (not shown), which can be opened by inserting a syringe or male luer into orifice 66. It should be noted that the check valve in a way (not shown) allows both removing user content and preventing air from entering the transfer device assembly 40 from orifice 66 if the user mistakenly removes the seal from orifice 69 prior to removal. Alternatively, in the forms of the reconstitution set 10, the orifice of cover 69 is no longer necessary, because the check valve keeps air contamination out of the sterile internal environment during activation, but allows access of the liquid when it is opened with a luer tip or syringe. It should also be noted that a non-return valve acts to prevent significant product deviation. In some situations, if the user mistakenly attaches a syringe to the orifice and, instead of pulling the syringe to extract the drug, pushes the syringe, the net result without a check valve would be forcing the solution from the second container 80 for the first container 70. A non-return valve prevents this misuse. Any resulting introduction of air through the extraction port 66 would result in the loss of valuable drugs.
[0092] The access route 400 provides fluid communication between the opening 66 and the interior of the second container 80 (which contains the reconstituted drug). The user is then activated to extract the reconstituted drug out of the second container 80 via access route 400, and the opening 66, and into a medical syringe or other suitable medical device, without the use of needles. In one embodiment, including a check valve (not shown) along access path 400, fluid will be able to pass through the check valve.
[0093] It should be noted that while the user is holding the housing and applying a force to the first container 70 to cause the initial movement of the first container in relation to the housing 12, followed by the movement of the second container in relation to the housing, the external configuration of the housing remains static or fixed. This is important, because the clamping force applied by the user is directed radially inwards. If the reconstitution process necessary for bending or radial deformation out of the container the clamping force applied by the user can actually interfere with the movement of the containers or other aspects of the reconstitution process.
[0094] It should be understood that various changes and modifications to the presently preferred modalities described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. And, therefore, it is intended that such changes and modifications are covered by the appended claims.

权利要求:
Claims (16)
[0001]
1. A reconstitution set comprising: (a) a housing (12, 20, 30) that is generally cylindrical in shape; (b) a first container (70), arranged inside the housing (12) and configured to be axially displaced with respect to the housing (12, 20, 30), the first container having a first sealed opening with a first sealing cap (76); (c) a second container (80), arranged inside the housing (12) having a second opening sealed with a second sealing cap (86), wherein the first container (70) is arranged inside the housing (12) coincident with the second container (80); characterized by the fact that the set for reconstitution comprises: (d) a set of the transfer device (40), disposed inside the housing (12) and between the first container (70) and the second container (80), the set the transfer device configured to fluidly access the content first through the first sealing cap (76) of the first container (70) and fluidly accessing the second content through the second sealing cap (86) of the second container (80); and (e) a trigger mechanism (100), configured to ensure that the first contents of the first container (70) are accessed by the transfer device assembly (40), before the second contents of the second container (80) are accessed by the the transfer device assembly, the firing mechanism having a base part in contact with the second container (80) and a plurality of fingers extending from the base part, the firing mechanism operable in a non-activated state and an activated state, in which: (i) in the non-activated state, the plurality of radially spaced fingers (102 - 106) engages with the housing (12, 30) to prevent axial displacement of the second container (80) with respect to the housing (12, 20, 30) and the transfer device assembly (40); and (j)) in the activated state: (l) first, the first container (70) is displaced axially with respect to the housing (12) and the transfer device assembly (40), so that the transfer device assembly (40) pierces the first sealing cap (76) to access the first content, the first container (70), then causes the trigger fingers (102 - 106) to disengage from the housing (12), after the assembly the transfer device (40) has accessed the first content, (m) secondly, the second container (80) is displaced axially in relation to the housing (12) and the transfer device assembly (40), so that the transfer device assembly (40) pierces the second sealing cap (86) to access the second content.
[0002]
2. Reconstitution assembly according to claim 1, characterized in that the transfer device assembly (40) includes a first end of the tip (42a) for piercing the first sealing cap (76) and a second end of the tip (42b) to pierce the second sealing cap (86).
[0003]
Reconstitution set according to claim 2, characterized in that the transfer device set (40) includes a first magazine (54) that covers the first tip end (42a) and a second magazine (64) ) that covers the end second point (42b).
[0004]
Reconstitution set according to any one of claims 1 to 3, characterized in that the transfer device set (40) includes an extraction port (66) in fluid communication with at least one of the first and second containers.
[0005]
5. Reconstitution set according to claim 4, characterized by the fact that the extraction port (66) extends through the housing (12, 20, 30).
[0006]
6. Reconstitution set according to any one of claims 1 to 5, characterized by the fact that the housing includes a first part (30) adjacent to the second part (20), the first part of the housing (30) that holds the first container (70), the second part of the housing (20) that holds the second container (80), the trigger fingers (102 - 106) of the firing mechanism (100) engaged with the first housing part (30) in the not activated state.
[0007]
7. Reconstitution set according to claim 6, characterized by the fact that the first part of the housing (30) defines a plurality of openings, each opening dimensioned to receive one of the trigger fingers (102 - 106).
[0008]
Reconstitution set according to any one of claims 6 to 7, characterized by the fact that the transfer device set (40) is kept fixed between the first part of the housing (30) and the second part of the housing ( 20).
[0009]
9. Reconstitution set according to any one of claims 1 to 8, characterized by the fact that the housing (12, 30) holds the first container (70), through at least one flexible flap (230 - 234), the flexible tab configured to flex to allow the first container (70) to be moved axially in the direction of the transfer assembly.
[0010]
10. Reconstitution set according to any one of claims 1 to 9, characterized in that the first container (70) includes a first product label (79) configured to interface with a connected first joint (72) to the housing (12, 30) to inhibit an opposite axial displacement of the first container (70) after having completed the activated state.
[0011]
11. Reconstitution set according to any one of claims 1 to 10, characterized in that after the activated state, the trigger fingers (102 - 106) of the firing mechanism (100) engage with the first container (70 ) to inhibit axial movement of the first container (70) away from the transfer device assembly (40).
[0012]
12. Reconstitution kit for reconstituting a medicament contained in a second container with a diluent contained in a first container, the first container includes a first opening sealed with a first penetrable sealing cap, the second container including a second opening, including a second penetrable sealing cap, characterized by the fact that the assembly comprises: (a) a housing (12, 20, 30) forming a passage (11), at least part of the first container (70), disposed within the passage ( 11), the housing movably retaining the first container in a first resting position, at least part of the second container arranged in the passage (11), the first and second containers (70, 80) arranged in such a way that the first opening of the first container faces the second opening of the second container; (b) a transfer device assembly (40) connected to the housing (12) and positioned between the first container (70) and the second container (80), the transfer device assembly (40), including a first tip ( 52) extending to the first penetrable seal cover and a second tip (62) extending to the second penetrable seal cover, the assembly forming a flow path (42) that extends through at least part of the first tip and part of the second tip, the first tip not penetrating the first sealing cap when the first container is in the first resting position; (c) a firing mechanism (100) configured to engage the second container and which includes a plurality of fingers (102, 104, 106) extending inside the passage (11) to removably engage the housing and hold the second container in a second resting position with the second seal not penetrated by the second tip, the fingers configured to be engaged by the first container, when the first movements of containers pass through a first activated position, with at least part of the first tip penetrating the first sealing cap to establish fluid communication between the interior of the first container and the flow path, the engagement of the first container with the fingers disengaging the fingers from the housing sufficiently to allow the second container to move into the first container for a second position activated with at least part of the second point that penetrates through the second sealing cap to establish with fluid unification with the flow path.
[0013]
13. Assembly according to claim 12, characterized in that the transfer device assembly (40) forms an access path (400) and an external part of the transfer assembly extends through the housing to form an extraction port (66) for access by a user, the access route providing fluid communication between the withdrawal port and a part of the second point.
[0014]
14. Assembly according to claim 13, characterized by the fact that the access path (400) is formed to provide fluid communication between the interior of the second container and the withdrawal port (66), when the second container is in the activated position.
[0015]
15. Assembly according to any one of claims 12 to 14, characterized in that the first container (70) includes a flange extending around the opening, the fingers of the firing mechanism (100) configured to engage the flange when the second container is in the second activated position to avoid the return movement of the first container to the first resting position.
[0016]
16. Assembly according to any one of claims 12 to 15, characterized in that the housing (12, 20, 30) maintains a static configuration as the first container (70) moves from the first resting position to the second activated position and the second container (80) moves from the second resting position to the second activated position.

类似技术:

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公开号 | 公开日 | 专利标题

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BR112013004191B1|2021-02-02|set to facilitate user reconstitution

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JP6371369B2|2018-08-08|System for closed transfer of fluid

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同族专利:

---

公开号 | 公开日

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JP2019093302A|2019-06-20|

---

US8545476B2|2013-10-01|

---

EP3235489A1|2017-10-25|

---

JP2017113649A|2017-06-29|

---

JP6506792B2|2019-04-24|

---

HRP20170892T1|2017-09-22|

---

BR112013004191A2|2016-05-10|

---

RS56017B1|2017-09-29|

---

LT2923688T|2017-06-12|

---

EP2923688A1|2015-09-30|

---

CY1118998T1|2018-01-10|

---

CA2808888A1|2012-03-01|

---

JP2016026106A|2016-02-12|

---

KR20200044137A|2020-04-28|

---

CO6680701A2|2013-05-31|

---

HRP20151055T1|2015-11-20|

---

KR20180105246A|2018-09-27|

---

HUE025736T2|2016-04-28|

---

US20130334078A1|2013-12-19|

---

KR20130099005A|2013-09-05|

---

DK2923688T3|2017-06-19|

---

SI2923688T1|2017-07-31|

---

EP2608758B1|2015-07-22|

---

ES2550769T3|2015-11-12|

---

EP2923688B1|2017-03-22|

---

JP2021000553A|2021-01-07|

---

PL2923688T3|2017-09-29|

---

JP6807485B1|2021-01-06|

---

RS54198B1|2015-12-31|

---

CA2808888C|2018-10-16|

---

KR101899449B1|2018-09-17|

---

PT2923688T|2017-06-06|

---

KR102103453B1|2020-04-23|

---

ES2627186T3|2017-07-27|

---

AU2011293341A1|2013-02-28|

---

HUE034815T2|2018-02-28|

---

PL2608758T3|2015-12-31|

---

US20120053555A1|2012-03-01|

---

SI2608758T1|2015-11-30|

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KR102253635B1|2021-05-20|

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US9358181B2|2016-06-07|

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JP2013536049A|2013-09-19|

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WO2012027563A1|2012-03-01|

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CN103153260A|2013-06-12|

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NZ606732A|2015-01-30|

---

SMT201600018B|2016-02-25|

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PT2608758E|2015-09-24|

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JP5844367B2|2016-01-13|

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JP6342872B2|2018-06-13|

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AU2011293341B2|2015-05-21|

---

CN103153260B|2016-06-08|

---

EP2608758A1|2013-07-03|

---

DK2608758T3|2015-10-05|

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法律状态:
2018-03-06| B25C| Requirement related to requested transfer of rights|Owner name: BAXTER INTERNATIONAL INC (US) , BAXTER HEALTHCARE |

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2018-05-29| B25A| Requested transfer of rights approved|Owner name: BAXALTA GMBH (CH) , BAXALTA INCORPORATED (US) |

---

2018-12-26| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

---

2019-08-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

---

2020-02-18| B25G| Requested change of headquarter approved|Owner name: BAXALTA GMBH (CH) ; BAXALTA INCORPORATED (US) |

---

2020-03-31| B25G| Requested change of headquarter approved|Owner name: BAXALTA GMBH (CH) ; BAXALTA INCORPORATED (US) |

---

2020-06-16| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|

---

2020-11-03| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

---

2021-02-02| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/08/2011, OBSERVADAS AS CONDICOES LEGAIS. |

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2021-08-03| B25A| Requested transfer of rights approved|Owner name: TAKEDA PHARMACEUTICAL COMPANY LIMITED (JP) |

---

2022-03-08| B25L| Entry of change of name and/or headquarter and transfer of application, patent and certificate of addition of invention: publication cancelled|Owner name: BAXALTA INCORPORATED (US) ; BAXALTA GMBH (CH) Free format text: ANULADA A PUBLICACAO CODIGO 25.1 NA RPI NO 2639 DE 03/08/2021 POR TER SIDO INDEVIDA. |

优先权:

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申请号 | 申请日 | 专利标题

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US37691210P| true| 2010-08-25|2010-08-25|

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US61/376,912|2010-08-25|

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PCT/US2011/049135|WO2012027563A1|2010-08-25|2011-08-25|Assembly to facilitate user reconstitution|

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