Removable actuating cap for use with an auto-injector assembly

0001(Cross-reference of related applications) This application claims the priority of US Provisional Patent Application No. 62 / 147,958 filed on April 15, 2015, which is incorporated herein by reference in its entirety.

0002(Technical field) The present invention relates to auto-injectors and prefilled syringes in general, and in particular to auto-injectors that are stored in a contracted state and allow the production or reconstruction of therapeutic agents for injection.

0003It is known that storing the drug as a dry drug dramatically extends the shelf life. In addition, such agents are often used in emergency applications where self-administration is preferred. In the emergency situation, various operation and mixing steps need to be intuitively feasible. That is, these steps should be reliably feasible, even in emergencies, with minimal complexity. Therefore, a simple auto-injector or injection-type device that realizes automatic drug dispensing processing and realizes a platform that can minimize operation errors and dosage errors by users with minimal user training is useful. There will be.

<p num="0004"> In the present invention, an interface is described that produces a series of mechanical functions that realize a start of mixing, an indication of completion of mixing, and a transition of the device to an injectable state by a single user input with removal of the cap. ..</p>

<p num="0005"> The apparatus and system of the present invention included in the present disclosure includes an auto-injector type mixing device, and the auto-injector has a housing and a frame rotatably arranged in the housing. The frame may be configured to carry the mixed assembly disposed within the frame, or the mixed assembly may be actuated by rotation of the frame within the housing. The auto-injector may further include an injection assembly and a trigger assembly that is configured to extend the injection assembly from within the auto-injector when actuated. A cap arranged around the distal end of the housing to cover the trigger assembly and the injection assembly, the cap being further provided with a cap operably connected to the housing at an internal portion of the cap to the housing. The rotation gives a relative rotation between the frame and the housing, so the housing may actuate the mixed assembly.</p><p num="0006"> In yet another embodiment, the cap further comprises one or more axially aligned internal grooves, and the frame further comprises external protrusions that correspond in shape to the internal grooves of the cap, with internal grooves and external protrusions. The unit is configured to allow relative translation in the axial direction, but may be limited by the degree of rotation of the operation.</p><p num="0007"> In various other embodiments, the cap further comprises one or more protrusions, the housing has a corresponding lip around the distal end, and the cap has one or more protrusions in the stowed and intermediate states. Engages with the lip, the protrusion disengages from the lip in the mixed state, and the rotation of the cap with respect to the housing causes the device to transition from the stowed state through the intermediate state to the mixed state, which causes the cap to release the housing. It may be configured to be removed from the housing. In some embodiments, the one or more engaging lips may be axially inclined to allow movement between the cap and the housing in response to rotation.</p><p num="0008"> In yet another embodiment, the cap may further comprise a spring configured to assist in separating the cap from the housing after actuation.</p><p num="0009"> In yet another embodiment, the cap is configured to have one or more engaging lips on the inner surface, and the housing has one or more corresponding protrusions around the distal end for stowed and intermediate conditions. In, one or more protrusions of the housing engage one or more engaging lips, and in the mixed state one or more protrusions disengage from one or more engaging lips and the rotation of the cap with respect to the housing The device may be configured to transition from a stowed state through an intermediate state to a mixed state and the cap may be configured to release the housing and be removed from the housing as soon as the mixed state is reached.</p><p num="0010"> In yet another embodiment, the cap is configured to have a plurality of threads on the inner surface, the housing is provided with a plurality of corresponding threads on the outer surface, and the rotation of the cap with respect to the housing The device may be configured to transition from a stowed state through an intermediate state to a mixed state and the cap may be configured to release the housing and be removed from the housing as soon as the mixed state is reached.</p><p num="0011"> In yet another embodiment, the cap and housing may be configured to have corresponding cross-sectional shapes. In some embodiments, this cross-sectional shape may be an elliptical cross-sectional shape.</p><p num="0012"> In yet another embodiment, the mixing device is configured to further comprise a locking mechanism, which reverses the cap to a matched state indicating a stowed state after the first relative rotation between the cap and the housing. It may be configured to prevent rotation.</p><p num="0013"> In the present paper, a method of mixing a drug in a mixing device further includes a step of rotating the cap with respect to the housing, in which the internally protruding member of the cap activates the actuating member when rotated and the actuating member. Also provided is a method of mixing the separated drug components in a chamber housed in a housing.</p><p num="0014"> The method may further include initiating the actuating member to release energy from an arranged pre-stored energy member.</p><p num="0015"> The method may further include an internal frame that interacts with and rotates an internal projecting member, which is located within the housing.</p>

0016The aforementioned and other objects, features, and advantages of the present invention will become apparent from the following description of certain embodiments of the invention, as shown in the accompanying drawings. In these drawings, similar reference characters refer to the same part throughout the various drawings. It will be appreciated that the drawings are not necessarily on scale and are emphasized to show the principles of the invention.

0017<figref num="1A">Illustrated perspective views of drug mixing and delivery devices by various actuation steps.</figref><figref num="1B">Illustrated perspective views of drug mixing and delivery devices by various actuation steps.</figref><figref num="1C">Illustrated perspective views of drug mixing and delivery devices by various actuation steps.</figref><figref num="2A">FIG. 1 Illustrates a perspective exploded view of a drug mixing and delivery device and a mixing subassembly through the embodiments of FIGS. 1A-C.</figref><figref num="2B">FIG. 1 Illustrates a perspective exploded view of a drug mixing and delivery device and a mixing subassembly through the embodiments of FIGS. 1A-C.</figref><figref num="3">An external perspective side view showing drug mixing with the cap removed is illustrated.</figref><figref num="4">An external perspective side view of the drug mixing device of FIG. 3 in a state where the cap is rotated so that the inside can be seen is illustrated.</figref><figref num="5A">Various internal perspective views of a mixed subassembly with a portion of the housing removed along the internal frame 150 are illustrated by various actuating steps that cause the transition from the stowed state to the mixed state.</figref><figref num="5B">Various internal perspective views of a mixed subassembly with a portion of the housing removed along the internal frame 150 are illustrated by various actuating steps that cause the transition from the stowed state to the mixed state.</figref><figref num="5C">Various internal perspective views of a mixed subassembly with a portion of the housing removed along the internal frame 150 are illustrated by various actuating steps that cause the transition from the stowed state to the mixed state.</figref><figref num="5D">Various internal perspective views of a mixed subassembly with a portion of the housing removed along the internal frame 150 are illustrated by various actuating steps that cause the transition from the stowed state to the mixed state.</figref><figref num="6A">Various internal perspective views of the mixed subassembly are illustrated showing how the internal frame 150 interacts with the cap through various actuating steps that cause the transition from stowed to mixed.</figref><figref num="6B">Various internal perspective views of the mixed subassembly are illustrated showing how the internal frame 150 interacts with the cap through various actuating steps that cause the transition from stowed to mixed.</figref><figref num="6C">Various internal perspective views of the mixed subassembly are illustrated showing how the internal frame 150 interacts with the cap through various actuating steps that cause the transition from stowed to mixed.</figref><figref num="6D">Various internal perspective views of the mixed subassembly are illustrated showing how the internal frame 150 interacts with the cap through various actuating steps that cause the transition from stowed to mixed.</figref><figref num="7">The interior of half of the housing 100 is illustrated and the rail 103 on which the internal frame 150 can be placed is shown.</figref><figref num="8A">An embodiment in which the cap is rotated to show an inconsistent state between the cap and the frame of the drug mixing device is illustrated, and only the outer wall of the cap is shown.</figref><figref num="8B">An embodiment in which the cap is rotated to show an inconsistent state between the cap and the frame of the drug mixing device is illustrated, and only the outer wall of the cap is shown.</figref><figref num="9A">Another embodiment of a cross-sectional view showing a rotation lock mechanism and a cap in a state where the cap and the housing rotate relative to each other and are inconsistent will be illustrated.</figref><figref num="9B">Another embodiment of a cross-sectional view showing a rotation lock mechanism and a cap in a state where the cap and the housing rotate relative to each other and are inconsistent will be illustrated.</figref><figref num="10A">Another embodiment of a mixing device in which a protruding engaging member extends from the frame and / or housing into the cap is illustrated.</figref><figref num="10B">Another embodiment of a mixing device in which a protruding engaging member extends from the frame and / or housing into the cap is illustrated.</figref><figref num="10C">Another embodiment of a mixing device in which a protruding engaging member extends from the frame and / or housing into the cap is illustrated.</figref><figref num="11A">Illustrate various perspective partial cross-sections of the caplock mechanism of a mixer operated by a rotary cap.</figref><figref num="11B">Illustrate various perspective partial cross-sections of the caplock mechanism of a mixer operated by a rotary cap.</figref><figref num="11C">Illustrate various perspective partial cross-sections of the caplock mechanism of a mixer operated by a rotary cap.</figref><figref num="12">Various embodiments of a mixing device having different protrusions (202B, C) and corresponding lips (102B, C) in the cap are illustrated.</figref><figref num="13">Various embodiments of a mixing device having different protrusions (202B, C) and corresponding lips (102B, C) in the cap are illustrated.</figref><figref num="14">Illustrates the gap 600 created by rotating the cap relative to the housing in some embodiments of the mixing apparatus described in this paper.</figref><figref num="15A">Illustrate various external perspective views and interiors of various cap shapes.</figref><figref num="15B">Illustrate various external perspective views and interiors of various cap shapes.</figref><figref num="16A">Illustrate various external perspective views and interiors of various cap shapes.</figref><figref num="16B">Illustrate various external perspective views and interiors of various cap shapes.</figref><figref num="17A">Illustrate various external perspective views and interiors of various cap shapes.</figref><figref num="17B">Illustrate various external perspective views and interiors of various cap shapes.</figref><figref num="18A">Caps provided with a plurality of corresponding threads on a plurality of corresponding threads are illustrated from various viewpoints.</figref><figref num="18B">Caps provided with a plurality of corresponding threads on a plurality of corresponding threads are illustrated from various viewpoints.</figref><figref num="18C">Caps provided with a plurality of corresponding threads on a plurality of corresponding threads are illustrated from various viewpoints.</figref>

0018It will be appreciated by those skilled in the art of drug manufacturing, storage and delivery that keeping the drug dry can significantly increase the life and effectiveness of the drug. Storage in a dry state also slows the rate of deterioration and suppresses temperature-related deterioration effects such as heat exposure. By keeping the drug dry, the device can be stored in a wider variety of environments and the frequency of need for replacement can be reduced.

0019In addition, embodiments having a pre-stored energy source, spring, chamber, flow path, needle, drug, and other components are U.S. Patent Application No. 62 / 120,792 (filed on February 25, 2015), U.S. Patent Application No. It is also described in No. 62 / 126,011 (filed on February 27, 2015). All of these are incorporated herein by reference. FIG. 2A shows an exemplary embodiment of an auto-injector having a pre-stored energy source, mixed components, injection assembly, and actuating assembly with the rotary caps described herein integrated.

0020The present invention exemplifies various principles and devices. These allow storage of devices that contain two or more components inside. In addition, component reconstitution, dissolution, fluidization, and / or suspension, i.e., component mixing, can be achieved quickly and reliably immediately prior to delivery.

0021Drug mixing and delivery devices can be associated with a variety of problems, many of which can be solved by the present invention, as described in various embodiments. One such problem is that the drug is mixed before use and deteriorates before use. In this embodiment, there are several types of sealing systems between agents and / or chambers within the device. These barriers and sealing members are removed, destroyed, or somehow broken through by an actuating process immediately prior to injection. Therefore, it is desirable to provide an index or other mechanism that indicates to the user that these barriers and sealing members are kept in an effective state.

0022In various embodiments, the cap is provided at the injection side end of the autoinjector. The rotary cap may be configured to couple to the auto-injector and seal around the injection assembly to prevent contamination of the injection assembly. This allows the injection assembly to remain sterile regardless of the storage environment of rucksacks, pockets, wallets, car glove boxes and the like.

0023Removing the cap according to any of the embodiments described above exposes an injection assembly that can utilize the bump switch, allows the needle to be extended and inserted into the patient, allowing proper delivery of the drug.

0024It is also solved by the present invention that the needle or injection assembly should not be exposed until the device is ready for injection. As briefly mentioned above, auto-injectors are often used in emergencies. In such a situation, anaphylactic shock may be treated by mixing epinephrine and delivering an appropriate amount. Alternatively, glucagon may be used to treat hypoglycemia, sumatriptan may be used for migraine, diazepam may be used for seizures, coagulation factors may be used for hemophilia, and the like. This situation can be quite busy. And the injection assembly is activated before use, the sterility is impaired due to improper cleaning of the drug bottle before the dosage is manually delivered, and the injection needle sticks out unintentionally. To reduce, the injection assembly and its corresponding needle and corresponding injector mechanism may be coated or shielded until the device is ready for injection, i.e., until complete mixing is complete. In this embodiment, the cap is configured to interact with the actuating assembly held in the housing. That is, twisting and removing the cap suggests that the device is ready for injection.

0025A further effect of the various embodiments described in this paper is to reduce the steps that the user needs to perform. As mentioned above, in a super-tensioned state, many steps may not be remembered. Therefore, omission of necessary steps and rationalization of motion processing would be very effective in proper drug delivery. The apparatus of the present invention shown in FIGS. 1A to 1C shows various aspects of the present invention including providing the auto-injector 10. Figure 1A shows the stowed state. The injector 10 may include a housing 100 and a cap 200. Rotation of the cap 200 with respect to the housing 100 may actuate an internal mixing assembly (not shown) to perform mixing of the various agents contained within the housing. FIG. 1B shows a state in which the relative rotation between the cap 200 and the housing 100 is partially or partially performed. FIG. 1C shows that the mixing process was started when the cap 200 was released from the housing 100 as a result of the full rotation, and the device was ready to inject the mixed drug component. Other indicators may be provided to indicate a fully mixed state, to make the mixed drug visible, and then to expose the injection assembly 300 and switch 310. At this point, the device may be pressed against the injection site, the patient's skin, which pushes the switch 310 into the housing 100 and the injection assembly 300 extends the needle (not shown here) inside it. The mixed drug may be injected.

0026As shown in FIGS. 1C and 3-6, the cap 200 may include one or more grooves 220 that may be axially aligned. The groove 220 is provided in the frame 150 and is configured to correspond and interact with one or more axially extending protrusions 170 in shape. The groove 220 and the protrusion 170 act as an internal cam system that rotates the frame 150 with respect to the housing 100 as the cap 200 rotates, which causes operations such as opening the valve to mix various chemicals in the housing. It will be possible. For example, when the valve is opened and the displacement mechanism is released, the wetting solvent may flow into the drying agent contained in the sub-drying chamber, and the agent may be soluble. It will be understood that by aligning the grooves and protrusions in the axial direction, the cap can be removed by sliding in the axial direction with respect to the frame after the rotational operation for operation is completed.

0027As shown in FIGS. 1C, 2B, 3-6, in some embodiments, the cap 200 further comprises one or more protrusions 202, and the housing 100 has a lip 102 around the distal or injection side end. Further may be provided. Here, one or more protrusions 202 of the cap 200 engage the corresponding lips 102 in the stowed and intermediate states, respectively, as shown in FIGS. 1A and 1B, respectively, and correspond in the mixed state shown in FIG. 1C. It may be configured to come off the lip 102.

0028The corresponding lip allows the cap 200 and protrusion 202 to be detached from the housing 100 and the corresponding lip 102 during radial relative rotation to expose the injection assembly 300 and injection trigger 310 for smooth release after mixing is complete. It will be appreciated that the 102 may be provided with a release groove or notch 104.

0029In some situations, the user may want some indicator that the device is responding to user input and performing the required internal functions, and simply uncapping is not sufficient for such functions. It will be understood that it can be. Therefore, in some embodiments, as shown in FIGS. 12-14 and 18A-C, they are inclined with respect to the axial direction so as to engage the internal protrusions 202B-D extending from the cap 200. One or more configured engaging lips 102B-D may be provided. This results in axial translation or movement between the cap 200 and the housing 100 as a result of the relative rotation between the cap 200 and the housing 100. This axial translation causes the cap and housing to be manually separated. Thus, the user creates a gap 600 that is a constant tactile indicator and thus a visual indicator that the rotational input to the housing and cap leads to the performance of the desired internal function, i.e. the mixing is achieved. .. In some embodiments, the gap 600 created between the cap 200 and the housing 100 may be further provided with additional visual or tactile indicators for internal motion confirmation. In some embodiments, the housing 100 may be provided with a hidden color band. The color band is hidden by the cap in the stowed state, but when the cap translates to the housing, the color band becomes visible through the gap 600, which increases with relative rotation between the elements.

0030It will be appreciated that FIGS. 10A-C show that the cap and frame can be provided with axial protrusions and grooves in reverse. That is, the frame 150 is provided with a groove 172, and the internal protrusion 222 corresponding to the cap 200 is provided. In FIGS. 10A-C, the configuration of the retaining mechanism can also be reversed, i.e., a tab 102A that engages the corresponding lip 202A provided on the cap 200 may be provided on the housing 100.

0031In a further embodiment, the cap 200 may be provided with a spring 250, as shown in FIG. The spring 250 is configured to facilitate or assist the cap 200 withdrawing from the housing 100, indicating the completion of the mixing operation by the mixing assembly 400, upon completion of the required relative rotation between the cap 200 and the housing 100. (See Figure 2A). That is, the spring generates a force for separation, and the cap 200 is separated from the housing 100 when the required relative rotation is completed because the user no longer pulls out or inputs the tensile force. Specifically, the spring corresponds to the protrusion as described above until the protrusion 202 is aligned with the separation groove 104 (see FIGS. 5B and 5D) at the desired relative rotation position between the cap 200 and the housing 100. It does not exceed the tensile force of the lip.

0032In some alternative embodiments, as shown in FIGS. 10A-10C, the engaging member of the cap 200 and the housing 100 may be provided in reverse of the embodiment described above. That is, in the embodiment, the cap 200 may be provided with one or more engaging lips 202A on the inner surface, and the housing 100 may be provided with one or more corresponding protrusions 102A around the distal end. In an embodiment, one or more protrusions 102A of the housing 100 engage one or more engaging lips 202A in the stowed and intermediate states. In the mixed state, the one or more protrusions 102A disengage from the one or more engaging lips 202A. Here, the rotation of the cap 100 with respect to the housing causes the device to transition from the retracted state through the intermediate state to the mixed state, and the cap is configured to release the housing and be removed from the housing as soon as the mixed state is reached. Will be done.

0033In a further embodiment, as shown in FIGS. 18A-C, the cap 200 may be provided with a plurality of threads 102D on the inner surface and the housing 100 may be provided with a plurality of corresponding threads 102D on the outer surface. Good. The relative rotation of the cap with respect to the housing causes the device to transition from the retracted state through the intermediate state to the mixed state, and as soon as the mixed state is reached, the corresponding threads are disengaged and the cap 200 is placed in the housing. It is configured to release 100 and be removed from housing 100.

0034Figures 15A-17B show that it is possible to have various cross-sectional shapes of housing 100 and cap 200. Here, the housing 100 and the cap 200 have cross-sectional shapes corresponding to each other. It will be further understood that the correspondence between the relative shapes provides proper alignment and flushness in the stowed state. However, the various cross-sectional shapes here make any relative rotation between the cap 200 and the housing 100 particularly easy to see. That is, it is easy to confirm the inconsistency tactilely and visually with every rotation. Figures 8A-9B clearly show such visual and tactile inconsistencies between the cap and the housing.

0035In addition, the elliptical cross-sectional shape simplifies assembly during the initial fabrication stage of the device. That is, in the space between the main diameter and the width diameter, various assembly tools, lock mechanisms, etc. can be intruded, lowered, and engaged.

0036As briefly mentioned in the above description, it will be appreciated that any rotation from storage and alignment can lead to partial removal or nullification of barriers or encapsulation members arranged to separate various agents. Any mixture of the agent tends to accelerate the degradation process and can lead to inactivation or contamination of the agent. Therefore, the device may be provided with a locking mechanism to prevent any reverse rotation after the initial rotation between the cap and the housing. 6B to 6D and 11A to 11C show an embodiment of the locking mechanism. The locking mechanism 500 may be provided as a series of ratchet protrusions 520 that engage the corresponding protrusions 132 within the frame 150 or housing 100, as shown in FIGS. 11A-C. As the frame 150 rotates with respect to the housing 100, the torsional force between the cap 200 and the housing 100 causes the ratchet to engage the fixed plunger and the protrusion 132. As a result, it is possible to move in one direction of rotation, but it does not rotate in the opposite direction and become aligned again. Thus, when the cap 200 rotates from the stowed state, the user cannot return it to the stowed state again. Therefore, it is indicated that the contained drug may deteriorate and the device may need to be replaced.

00379A to 9B show another embodiment of the locking mechanism. Here, the cap itself is provided with an inclined elastic lock 510. The tilt lock is disengaged during initial assembly and, upon initial rotation from stowed state, engages the corresponding tab 512 or other protrusion on the frame or housing to return to stowed state. It is possible to prevent reverse rotation.

0038Alternatively, in yet another embodiment, as shown in FIG. 11, the locking mechanism 500 is provided as a series of ratchet-type protrusions 520 provided on the frame 150 and extends inwardly to rotate and fix the plunger device 410 of the mixed assembly. It may be one that engages with.

0039It will be appreciated that caps of various shapes, circular or non-circular, are available. Non-circular geometry, especially elliptical caps, has several advantages. Due to the elliptical shape, the internal space between the main diameter and the width diameter is expanded, and tabs and corresponding locking grooves can be formed. Not only does the interior space expand, but the relative rotation between the cap 200 and the frame of the drug mixing system causes a visible change in relative position. That is, when the cap is twisted, the relative position of the edges of these elements changes according to the rotation distance.

0040Further, it will be appreciated that the rotational distance, i.e. the distance the cam must move to fully activate or release the valve, can be adjusted to virtually any constant value. In particular, in the case of an elliptical shape, the relative rotation distance is preferably 35 to 90 degrees. At 90 degrees, the two elliptical layers are the most distant from each other. This indicates that the two shapes are in a fully open state before they move further to fit the layers, giving the psychological impression that they move back to their original state so that the valve closes.

0041It will be appreciated that the cross section of the frame 150 may be circular. The circular cross section of such a frame 150 rests on or engages with a series of internal rails 130 of the housing 100. The rail 130 effectively circularizes the internal contours of the housing 100, allowing the frame 150 and housing 100 to rotate with each other during operation.

0042In addition, other user interface elements or systems that do not necessarily correspond to the caps shown in some of the above-described embodiments may be adopted. That is, similar rotary separation interface elements may be employed that communicate with the main housing of the mixing and / or injection device. One purpose of such an interface element is to function to implement a start step for initiating a mixing process. Another purpose is to transition the device from the unusable state to the usable state. Other purposes will be apparent to those skilled in the art.

0043The embodiments and features described in this paper are given as examples and are not intended to limit the scope of claims described at the end of this specification. A plurality of combinations and equal components are considered to be within the scope of this specification.