Automatic syringe system

Abstract

A system and method are provided for automatically reconstituting a drug and then administering it to a patient. This system and method may include a reconstitutive auto-injector comprising a first chamber containing powder, a second chamber containing liquid, a first power source, and a second power source. The first power source can be activated to compress the liquid and cause it to flow into the first chamber containing the powder. The second power source can be activated to inject the reconstituted drug into the patient.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit and priority of U.S. Provisional Application No. 63 / 504,439, filed on May 25, 2023, which is hereby incorporated by reference in its entirety for all purposes as if fully restated and described herein, including all references contained therein.

Background Art

[0002] (Background of the Invention) Lyophilized drugs and vaccines are commercially limited because the reconstitution of the drugs into a usable form is complex. Conventionally, lyophilized drugs are reconstituted from vials using equipment and several steps. Once reconstituted, the drugs are delivered to patients, for example, by intravenous injection, intra - vascular injection, intramuscular injection, or subcutaneous injection.

Summary of the Invention

Means for Solving the Problems

[0003] (Summary of the Invention) Exemplary embodiments of the systems (e.g., reconstituted autoinjectors) and methods (e.g., using a reconstituted autoinjector) described herein are designed to reconstitute a drug and administer it automatically (e.g., to a patient). The system stores powdered substances, such as a drug (e.g., a lyophilized drug) and its diluent, in two separate chambers. Upon administration, the system and method are configured to reconstitute the drug by automatically mixing the diluent with the powder, and then inject the reconstituted substance into the recipient. As used herein, a drug will be understood to include substances used for the health of an individual. Drugs may include drugs for treating diseases and / or symptoms, and / or for preventing such diseases and / or symptoms. Embodiments are described herein with respect to the liquids used for powdered drugs and diluents, but other combinations of mixed substances may also be used according to the embodiments described herein. For example, two liquids may be combined, two powders may be combined, or a combination of powder and liquid, and so on.

[0004] The exemplary embodiments described herein include reconstituted auto-injectors and / or systems and / or methods for using a reconstituted auto-injector for purposes such as administering a drug to a patient. In certain embodiments, the drug is in powder form and can later be reconstituted into an injection mixture. In certain embodiments, the drug in powder form may include lyophilized drugs. It should be understood that the term drug as used herein does not necessarily have to be in powder form, and the terms powder or drug in powder form as used herein do not necessarily have to be lyophilized drugs. Also, the embodiments described herein are illustrative and not limiting, so it will be obvious to those skilled in the art that variations of certain embodiments described herein are still encompassed in the present invention. An exemplary embodiment of a reconstituted auto-injector may comprise a first chamber configured therein to store powder; and a second chamber configured therein to store liquid. This specification describes the first chamber configured to store and / or storing powder, but the first chamber may also store liquid. This specification describes the second chamber configured to store and / or storing liquid, but the second chamber may also store powder. A reconfigurable automatic syringe may include a third chamber configured to store a second liquid. The references to the first, second, and / or third are intended to distinguish one chamber or liquid, etc., from another, and are not intended to number or order any particular element. Thus, for example, the first chamber may be the second chamber when describing different exemplary embodiments of the invention, and vice versa. The first and second chambers may be arranged side by side and separated by a separator.

[0005] A reconfigurable auto-injector may comprise a body. The body may comprise an outer body at a first end and an inner body at a second end. The second end may include an end of the reconfigurable auto-injector configured to be positioned adjacent to the injection site during use. Part of the inner body may be located within a part of the outer body. The outer body may move independently of the inner body. The inner body may slide longitudinally within the outer body. The configuration and / or position of the inner and outer bodies may provide automatic operation of the reconfigurable auto-injector for recombining drugs and administering them to a patient by injection.

[0006] In one exemplary embodiment, a first chamber may be configured to hold and / or be able to hold a powder placed therein, and a second chamber may be configured to hold and / or be able to hold a liquid placed therein. A separator between the first and second chambers may include a flow path that provides fluid communication between the first and second chambers. The reconfigurable autoinjector may also include a stopper, which is positioned in the second chamber to block the flow path so that the first and second chambers do not have fluid communication in its first configuration or position. The configuration of the chambers and / or stopper may allow for the separation of the drug and its diluent for long-term storage. The configuration of the chambers and / or stopper and / or flow path may be configured to allow for the reconfiguration of the drug and diluent when the reconfigurable autoinjector is in operation, for example, to facilitate the administration of combination drugs to a patient. In the exemplary embodiment, a liquid and / or gas that may contain a diluent may be used to assist in the reconfiguration of the drug by mixing the powder and the liquid.

[0007] A reconfigurable autoinjector may be equipped with a first power source and a second power source. The first power source may be configured to work with a first plunger and move the first plunger away from the first power source, and the second power source may be configured to work with a second plunger and move the second plunger away from the second power source. As described herein, the power source is understood to include not only electricity but also mechanical power such as the movement and / or operation of components of the system for the automatic reconfiguration and / or autoinjection of the reconfigured drug.

[0008] A second power source can be actuated by the pressure on the inner body when the reconfigurable autosyner is pressed against the injection site (e.g., a patient's). The second power source may include a second compression spring, which is configured to be released and extended when actuated, moving the second plunger rod and the second plunger away from the second power source and compressing the volume of the second chamber containing the liquid.

[0009] The first power source may include a first compression spring, which is released and extended when operated, causing the first plunger rod and the first plunger to move away from the first power source, thereby compressing the volume of the first chamber.

[0010] A reconfigurable automatic syringe may include an actuator positioned between the first plunger and the first power source, which releases a first spring when the first plunger moves toward the first power source.

[0011] A reconfigurable autosyner may also comprise a needle, a needle stopper, and an (optional) end cap. The needle stopper may be located in a first chamber adjacent to the end cap. The needle may extend within the needle stopper and move through the needle stopper and end cap when a first plunger is pressed against the end of the needle. The needle may have a pointed end on the end of the needle opposite to the end that is pressed by the first plunger.

[0012] Reconfigurable auto-injectors can optionally be equipped with a safety cap.

[0013] Exemplary embodiments described herein may include a method using a reconstituted auto-injector. This method may include the steps of: providing a reconstituted auto-injector; operating the reconstituted auto-injector; reconstituted a drug in powder form into a reconstituted mixture; and injecting the reconstituted mixture into an injection site (e.g., a patient). This method may further include the step of injecting a second liquid from a third chamber into the injection site.

[0014] The reconfigurable auto-injector used in this method may have any combination of the components described herein. For example, the reconfigurable auto-injector may have a powder (e.g., a drug in powder form) contained in a first chamber and a liquid contained in a second chamber. The powder and liquid can be separated from each other in the first configuration before use.

[0015] Exemplary embodiments of the methods described herein may include the step of activating a reconfigurable auto-injector by pressing it against an injection site (e.g., the patient's skin) to automatically initiate reconfiguration and injection.

[0016] This method may include the step of releasing a second compression spring during operation, thereby moving the second plunger away from the second spring and toward the injection site.

[0017] This method may include the step of opening a flow path between the second chamber and the first chamber so that when the second plunger separates from the second spring, the liquid moves into the first chamber.

[0018] The method may include the steps of adding gas through a channel after the liquid in the second chamber has moved into the first chamber, stirring the liquid and the drug in powder form to prepare a reconstituted mixture, and blocking the channel with a second plunger.

[0019] This method may include the steps of filling a first chamber with the liquid from a second chamber to activate a first compression spring by moving a first plunger within the first chamber, thereby releasing the first spring and applying force to the first plunger to move it away from the first spring and toward the injection site.

[0020] This method may include the step of moving the needle in the first chamber through a needle stopper with a first plunger and out of the end cap.

[0021] This method may include the step of expelling gas contained in a first chamber through the needle before the end of the needle exits the needle stopper, the end of the needle is in the gap formed by the end cap, and the end of the needle enters the injection site (e.g., the patient's skin).

[0022] This method may include the step of moving a needle into the injection site to administer the reconstituted mixture (for example, into the patient's body).

[0023] Exemplary embodiments described herein may include a reconfigurable autosyringer comprising a body, the body comprising: a first chamber configured therein for storing powder; a first plunger within the first chamber; a first power source configured to push the first plunger to reduce the volume within the first chamber; an actuator configured to actuate the first power source; a second chamber configured therein for storing liquid; a second plunger within the second chamber; a second power source configured to push the second plunger to reduce the volume within the second chamber; and a flow path between the first and second chambers such that when the second plunger is moved by the second power source, the liquid can flow into the first chamber. The reconfigurable autosyringer may also comprise a third chamber configured therein for storing a second liquid, and a bladder between the first and third chambers for separating the second liquid in storage position from the powder. The first plunger, the actuator, and the first power source may be configured such that when liquid from the second chamber flows into the first chamber, causing the first plunger to move in a first direction and increasing the volume of the first chamber, the actuator automatically activates the first power source. When activated, the first power source may be configured to push the first plunger in the opposite direction, thereby decreasing the volume in the first chamber.

[0024] The reconfigurable automatic syringe may include a stopper configured to cover the flow path in the first configuration and not cover the flow path in the second configuration. The second configuration may be configured such that the liquid in the second chamber is exposed after the second power source has been activated and the liquid is compressed by the second plunger.

[0025] Exemplary embodiments of a method of using the reconstitutable auto-injector described in this specification may include the steps of providing a reconstitutable auto-injector comprising a first chamber containing a drug in powder form, a second chamber containing a liquid therein, a first power source, and a second power source; actuating the second power source to compress the liquid and cause it to flow from the second chamber to the first chamber; reconstituting the drug in powder form into a reconstituted mixture; and automatically actuating the first power source to inject the reconstituted mixture into an injection site (e.g., a patient). In certain embodiments of such a method, the reconstitutable auto-injector may further comprise a third chamber containing a second liquid therein, and the first power source is automatically actuated to inject the reconstituted mixture into the injection site and also inject the second liquid.

[0026] This method may include the automatic actuation of the first power source by the movement of a first plunger in a first direction, wherein when actuated, the first power source is configured to move the first plunger in a second direction opposite to the first direction.

[0027] This method may include the actuation of the second power source by pressing the reconstitutable auto-injector against an injection site (e.g., the skin of a patient).

[0028] This method may include the steps of maintaining the first chamber and the second chamber such that they are not in fluid contact via a stopper in the flow path, and then moving the stopper out of the flow path to enable the flow of fluid from the second chamber to the first chamber.

Brief Description of the Drawings

[0029] (Brief Description of the Drawings) [Figure 1] FIG. 1 illustrates a perspective view of an exemplary auto-injector according to an embodiment of the present invention.

[0030] [Figure 2]Figure 2A illustrates a side view of an exemplary automatic syringe according to an embodiment of the present invention. Figure 2B illustrates a cross-sectional view illustrating the internal components of a system according to an embodiment of the present invention.

[0031] [Figure 3] Figures 3A to 3B illustrate the safety features of the auto-injector according to the embodiment of the present invention, including the safety release portion of the auto-injector used to administer a drug using the auto-injector according to the embodiment described herein, and the auto-injector itself.

[0032] [Figure 4] Figure 4 illustrates a cross-sectional view of the operating part of an auto-injector used in a method of administering a drug using an auto-injector according to an embodiment described herein.

[0033] [Figure 5] Figure 5 illustrates a cross-sectional view of an auto-injector during a reconstruction of the method of administering a drug using an auto-injector according to the embodiments described herein. [Figure 6] Figure 6 illustrates a cross-sectional view of an auto-injector during a reconstruction of the method of administering a drug using an auto-injector according to the embodiments described herein. [Figure 7] Figure 7 illustrates a cross-sectional view of an auto-injector during a reconstruction of the method of administering a drug using an auto-injector according to the embodiments described herein.

[0034] [Figure 8] Figure 8 illustrates a cross-sectional view of the injection portion of an auto-injector in a method of administering a drug using an auto-injector according to an embodiment described herein. [Figure 9] Figure 9 illustrates a cross-sectional view of the injection portion of an auto-injector in a method of administering a drug using an auto-injector according to an embodiment described herein.

[0035] [Figure 10] Figure 10 illustrates a cross-sectional view of a portion of an auto-injector after completing the process of administering a drug using the auto-injector.

[0036] [Figure 11] Figure 11 illustrates an exemplary embodiment having additional / multiple chambers as described herein. [Modes for carrying out the invention]

[0037] (Detailed description of the invention) The following detailed description illustrates the principles of the present invention as examples, not as an limitation. This description will make it clear to those skilled in the art how to construct and use the present invention and will describe several embodiments, adaptations, modifications, substitutions, and uses of the present invention. Please understand that the drawings are schematic and general representations of exemplary embodiments of the present invention and are not intended to limit the invention, nor are they necessarily drawn to scale.

[0038] The exemplary embodiments of the systems described herein may include one or more advantages. For example, the exemplary embodiments of the systems and methods described herein may meet the reliability requirements of the Federal Drug Administration (FDA) for modern emergency use devices. The systems and methods described herein may allow the drugs to be reconstituted into a mixture before the injection process. The system may be configured to automate the reconstitution and / or injection process to minimize the user interface or steps, such as through the use of one or more automated power sources. An instrument interface compatible with existing devices may be used, and / or the instrument interface may be configured to allow for the addition of needle shields and / or covers. The exemplary embodiments may have a liquid containing a second liquid-state drug (or additional drug combination) for administering a combination of two or more drugs. The exemplary embodiments may include safety features such as a safety pin on the front of the device.

[0039] Figure 1 illustrates a perspective view of an exemplary reconfigurable automatic syringe according to an embodiment of the present invention.

[0040] An exemplary embodiment of a reconfigurable autosyringer described herein comprises a first chamber configured therein for storing powder and a second chamber configured for storing liquid. The reconfigurable autosyringer may also comprise a third chamber configured for storing a second liquid. These chambers may be contained within a body. The first and second chambers are arranged side by side within an inner body 20 and can be separated by a separator.

[0041] Figure 1 illustrates an exemplary outer body that can be configured to surround and / or define a first chamber and a second chamber. As illustrated, the body may comprise an outer body 19 at the first end of the reconfigurable autosyringer and an inner body 20 at the second end. The second end of the reconfigurable autosyringer comprises an end cap 21 at the end of the inner body 20, configured to be positioned adjacent to the injection site during use. A portion of the inner body 20 may be located within a portion of the outer body 19.

[0042] Figure 2A illustrates a side view of an exemplary reconfigurable automatic syringe according to an embodiment of the present invention. Figure 2B illustrates a cross-sectional view of Figure 2A to illustrate the internal components of the system according to an embodiment of the present invention.

[0043] As illustrated, an exemplary reconfigurable autosyringer may comprise an outer body 19 and an inner body 20. A portion of the inner body 20 may be located within a portion of the outer body 19 and may extend from the end of the outer body 19. The inner body 20 may define the end of the reconfigurable autosyringer that is positioned at the injection site.

[0044] The inner body 20 and the outer body 19 can define a first internal space 7 and a second internal space 6. The first internal space 7 can accommodate a first plunger 17, and the second internal space 6 can accommodate a second plunger 11. The region within the first internal space 7 extends from the first plunger 17 to the end of the first internal space 7 toward the injection site (and away from the first power source 1) and can define the first chamber. The region within the second internal space 6 extends from the second plunger 11 to the end of the second internal space 6 toward the injection site (and away from the second power source 2) and can define the second chamber. The first chamber can be configured and can hold powder 24 within it. The second chamber can be configured and can hold liquid 23 within it. The second chamber can be divided into one or more sections, such as a first section configured to hold liquid 23 within it and a second section configured to hold gas 22 within it. The first and second sections can be fluidly connected and simply divided by the separation of the gas 22 and the liquid 23 and the arrangement of the system such that the liquid 23 is positioned toward the end closest to the injection site and the gas 22 is positioned away from the end. The first and second sections may also include a barrier or other separation between the first and second sections. The barrier may be configured to move within the inner body 20 so that the second plunger 11 is configured to compress the gas 22 in the second section, pushing the barrier, and then compress the liquid (such as a diluent) 23 in the second section.

[0045] In one exemplary embodiment of a reconfigurable autosynergy, a first plunger 17 and a second plunger 11 are arranged within an inner body 20, defining a first chamber and a second chamber. The first and second chambers may be arranged side by side toward the end of the system configured to be adjacent to the injection site (and opposite to the end of the system comprising the first and / or second power sources 1, 2). The inner body 20 may include a separator between the first and second chambers. The separator may include a flow path 8, which allows fluid to flow between the first and second chambers through it. The second chamber may contain a stopper 12 coupled to a plug 13. The stopper may be positioned to block the flow path 8 in a first configuration or position, and to allow fluid to flow through the flow path 8 in a second configuration or position. In an exemplary embodiment, the second position is the position when the stopper 12 moves toward the end of the system configured to be positioned adjacent to the injection site, compressing the plug 13, or moving along the plug 13. Thus, the first and second chambers are separated and not in fluid communication when the stopper 12 is in the first position, but can be in fluid communication via the flow path 8 when the stopper 12 is in the second position.

[0046] In one exemplary embodiment of a reconfigurable autosynergy, the inner body 20 may include an end cap 21. The end cap 21 may be on the same body side as the first chamber and may be positioned at the end of the first chamber toward the end of the system so as to be positioned adjacent to the injection site during use. The inner body 20 may have an opening so that the end of the first chamber opens through the inner body 20. The inner body 20 may include a needle stopper 15 and an end cap 21 to close the opening of the inner body 20 and seal the first chamber.

[0047] In one exemplary embodiment of a reconfigurable auto-injector, the needle 16 may have a sharp end for insertion into the injection site. The sharp end may be positioned toward an end of the reconfigurable auto-injector system configured to be positioned adjacent to the injection site during use. As illustrated, the sharp end of the needle 16 may be positioned within a portion of the needle stopper 15. The opposite end of the needle 16 is configured to abut against a first plunger 17 but not to penetrate the first plunger 17. Thus, the first plunger 17 may be configured to move within a first chamber to apply force to the needle 16 (from a first power source 1 as described herein) so that the needle 16 moves through the needle stopper 15 and the end cap 21. The first plunger 17 may be positioned within an inner body 20 and a first internal space 7 and moved within the first chamber toward and toward the needle 16 according to the method described herein. For example, the first plunger 17 may have an outer shape that is substantially equal to or slightly smaller than the inner shape of the first internal space 7 and / or the first chamber, so that the first plunger 17 can slide within the first internal space 7 and the first chamber.

[0048] In an exemplary embodiment of a reconstituted auto-injector, the end cap 21 may be configured such that the end of the needle 16 is separated from the needle stopper 15 from the time the needle 16 exits the needle stopper 15 until the needle 16 is inserted into the injection site (e.g., the patient). The end cap 21 may have a gap to create this separation. This separation may allow the first plunger 17 to travel a sufficient distance within the first chamber for any trapped gases (e.g., gases 22, 25) to be discharged from the needle 16 before the needle 16 is inserted into the injection site (e.g., the patient) and the reconstituted mixture is administered (e.g., to the patient).

[0049] As illustrated, the first chamber contains gas 25 and powder 24. The second chamber contains gas 22 and liquid 23. Gases 22 and 25 may be any gas, such as air, and may be different from each other but the same. The exemplary gases may be inert to the drug or other components to be administered, such as powder 24 or liquid 23. In one exemplary embodiment of the reconstituted autoinjector, powder 24 contains a drug (e.g., in powder form). The drug may be in lyophilized form, or other powder form, or other form. For example, the drug may include a lyophilized solid drug. Liquid 23 may be a diluent used to reconstitute the drug. In one exemplary embodiment, liquid 23 may contain a second drug, or other combinations of drugs, vitamins, minerals, activators, or other compositions to assist in the administration of the drug (e.g., to a patient). While this specification describes drugs, powder 24 may be any powdered substance intended to be reconstituted and injected into a site. The injection of drugs is sometimes described herein in relation to a patient. However, any injection site into which the reconstituted substance is injected can be considered within the scope of this disclosure. For example, humans, mammals, animals, and / or other organisms, including those of different ages, may also benefit from the exemplary embodiments described herein.

[0050] As illustrated, the exemplary auto-injector may comprise a first power source 1 and a second power source 2. The first power source 1 may comprise a first inner tube 4 in which a first spring 26 is disposed, which is coupled to a first plunger rod 10 connected to the first plunger 17, for moving the first plunger 17 through a first chamber volume toward the end of the reconfigurable auto-injector system configured to be positioned at the injection site. The second power source 2 may comprise a second inner tube 5 in which a second spring 27 is disposed, which is coupled to a second plunger rod 9 connected to the second plunger 11, for moving the second plunger 11 through a second chamber volume toward the end of the system configured to be positioned at the injection site.

[0051] The first power source 1 and the second power source 2 can each be configured in a first position where the first spring 26 and the second spring 27 are compressed and the first plunger rod 10 and the second plunger rod 9 are in a retracted position (away from the injection site). Once activated, the springs 26 and 27 are released and extend, applying force through the plunger rods 10 and 9, causing the plungers 17 and 11 to move toward the end of the system located at the injection site, thereby compressing the spaces 7 and 6 and the chamber. The first power source 1 and the second power source 2 are configured to operate continuously and automatically, such that when the second power source 2 is activated, the second spring 27 is released and extends, causing the second plunger 11 to move, and then the first power source 1 is activated, the first spring 26 is released and extends, causing the first plunger 17 to move toward the needle 16.

[0052] In one exemplary embodiment of a reconfigurable autosyringer, the autosyringer may also include an actuator 18. This actuator 18 may be positioned between the first plunger 17 and the first power source 1. During the process described herein, when the first chamber is filled with liquid 23, the actuator 18 can move within the first internal space 7 to push the first power source 1. The actuator 18 can release a first spring 26 to actuate the first power source 1. When the first power source 1 is actuated, the first spring 26 is released and can extend, thereby applying force via the first plunger rod 10, which moves toward the first plunger 17 and needle 16, causing the needle 16 to pass through the needle stopper 15, exit the end cap 21, and penetrate into the injection site (e.g., the patient).

[0053] In an exemplary embodiment of a reconfigurable automatic syringe, each of the power sources 1 and 2 includes springs 26 and 27 that can be held in a compressed state by the interfaces of the collets 30 and 31 and the inner tubes 4 and 5. When the inner tubes 4 and 5 are pressed, the opposite ends of the inner tubes 4 and 5 extend and / or the collets 30 and 31 are crushed / compressed, so that the collets 30 and 31 move beyond their holding position and release the springs 26 and 27.

[0054] In one exemplary embodiment of a reconfigurable autosyringer, the autosyringer can automatically activate a second power source 2 during use. For example, the inner body 20 may be configured such that its end contacts and is positioned adjacent to the injection site (e.g., the patient's skin) via an end cap 21 or the like. The outer body 19 can be held by a healthcare professional injecting a drug mixture into the patient. When the inner body 20 and / or end cap 21 come into contact with the patient and force is applied between the inner body 20 and the outer body 19, the second power source 2 is activated, thereby releasing the second spring 27.

[0055] In one exemplary embodiment of a reconfigurable autosynergy, as the liquid 23 moves from the second chamber to the first chamber, the first plunger 17 moves toward the first power source 1. This liquid 23 pressurizes the first plunger 17, causing it to move and press against the actuator 18. The actuator 18 then presses against the inner tube 4 of the first power source 1, releasing the spring 26 of the first power source 1.

[0056] As illustrated, the system may be equipped with a safety cap 3 (also referred to herein as a safety pin). The safety cap 3 may be located at a second end of the system, away from the end configured to be located at the injection site. The safety cap 3 can cover the first and / or second power sources 1, 2 to minimize malfunction of the system until the autosyneril is ready for use. In one exemplary embodiment of the reconfigurable autosyneril, the safety cap 3 may be located around the second end of the system to cover the exposed portions of the first power source 1 and the second power source 2. The safety cap 3 may be optional.

[0057] In one exemplary embodiment, the system may also include a disk 14. The disk 14 may be positioned adjacent to the needle stopper 15. The disk 14 may be positioned between the needle stopper 15 and the flow path 8 to define the end of the first chamber into which the drug (whether in powder form or combined in a liquid) comes into contact. Thus, the disk 14 can provide a barrier between the drug and the needle stopper 15.

[0058] As illustrated, each of the power sources 1 and 2 comprises coil springs 26 and 27 positioned within a tunnel. The springs 26 and 27 are exemplified as coil springs positioned around a shaft, which is coupled to plunger rods 10 and 9. Each shaft is provided with a flange, which is positioned along the length of the shaft and extends radially outward from the shaft and circumferentially around the shaft. Each flange is configured to contact the ends of the springs 26 and 27. Thus, the springs 26 and 27 can stretch and exert force on the flanges, thereby moving the plunger rods 10 and 9. The plunger rods 10 and 9 can then contact the plungers 17 and 11, moving them and compressing the volume of the chamber. The exemplary embodiment may include other configurations of the plungers 17 and 11, the plunger rods 10 and 9, the actuator 18, and the power mechanism (springs 26 and 27, etc.), which can be configured to operate in a similar manner. For example, different spring configurations can be used, and / or the spring mechanism can be incorporated into the shaft by means of selecting a compressible / expandable material, etc.

[0059] In an exemplary method using the reconstituted auto-injector system described herein, a drug is automatically reconstituted and administered. In an exemplary embodiment, this method may include any combination of the steps described herein. In an exemplary embodiment, an auto-injector is provided comprising a first chamber containing a powder and a second chamber containing a liquid. This method may include the steps of: activating a second power source to pressurize the liquid; and opening a fluid passage between the first and second chambers so that the liquid is pressurized and transferred from the second chamber to the first chamber. This method may include the steps of: introducing a gas into the first chamber through the passage and agitating the powder and liquid to prepare a reconstituted mixture. This method may include the step of activating a second power source to pressurize a first plunger in the first chamber. The second power source may be configured to move a needle, such that the second power source continuously applies force to the needle and moves the needle. The method may include the step of continuously moving the needle through a needle stopper using a second power source to expel gas from the first chamber. The method may include moving the needle toward and into the injection site. The needle can access the reconstituted mixture and allow the reconstituted mixture to be administered to the injection site through the needle. In an exemplary embodiment, the method further includes the step of injecting a second liquid from a third chamber.

[0060] First, a reconstituted auto-injector can be provided according to the embodiments described herein. This auto-injector may comprise a two-chamber system, where the first chamber is configured to store a powder, such as a lyophilized solid drug, and the second chamber is configured to store a liquid (e.g., a diluent). This auto-injector may comprise a three-chamber system, where the third chamber is configured to store a second liquid. This auto-injector may also comprise a second power source configured to mix the powder with the liquid (e.g., a diluent), and a first power source configured to administer the reconstituted drug (and, in some embodiments, the second liquid as well).

[0061] Next, in one exemplary embodiment, a second power source is activated when the nose of the device is pressed against the injection site, thereby causing the syringe body of the automatic syringe to press against the inner tube of the second power source, releasing the second spring of the second power source. When the second spring of the second power source is released, the spring presses against the contents of the second chamber, such as a gas or diluent, and a stopper, opening a flow path to the first chamber. Once the flow path is open, the diluent, under pressure, flows from the second chamber to the first chamber, reconstituting the powder and diluent to prepare the reconstituted mixture.

[0062] After the diluent is transferred to the first chamber, the gas from the second chamber is moved through the flow path, thereby introducing the foaming gas into the reconstituted agent, which is then stirred to promote reconstitution and prepare the reconstituted mixture.

[0063] In one exemplary embodiment, the second power source moves to its final position, compressing the gas in the second chamber by continuously applying pressure, thereby closing the flow path. The compressed gas loads the first plunger, causing it to move toward the first power source. After a certain period, the first plunger can push an actuator, which in turn presses against the inner tube of the first power source, releasing the first spring of the first power source.

[0064] In one exemplary embodiment, the first spring can be released to press the first plunger toward the injection site, compressing the contents of the first chamber (e.g., a gas, a reconstituted mixture). The first spring can continue to apply force to the first plunger, thereby causing the first plunger to push the needle.

[0065] In one exemplary embodiment, the first spring continuously applies force to the first plunger, causing the needle to penetrate the needle stopper and allowing compressed air to be discharged through the needle.

[0066] In one exemplary embodiment, a first spring continuously applies force to a first plunger, thereby continuously moving the needle toward the injection site, after which the needle is inserted into the injection site.

[0067] In one exemplary embodiment, a first spring continuously applies force to a first plunger, causing the needle to access the reconstituted drug mixture, which then flows through the needle hole into the injection site.

[0068] In one exemplary embodiment, the first spring continuously applies force to the first plunger, keeping the needle positioned at the injection site, while simultaneously injecting the reconstituted mixture (e.g., a drug or compound drug).

[0069] In one exemplary embodiment, the first spring continues to apply force to the first plunger, completing the needle placement and continuing drug delivery until the required amount of drug has been administered.

[0070] The injection process is complete when the required amount / dose of the reconfigured drug mixture is administered.

[0071] Figures 3A to 10 illustrate exemplary features of a reconfigurable auto-injector in a method of administering a drug using an auto-injector according to embodiments described herein. As shown herein, this method may include, and may be completed thereafter, a safety release section, an operating section, a reconfiguration section, and an injection section. The safety release section may be optional.

[0072] Figures 3A to 3B illustrate exemplary features of an auto-injector according to an embodiment of the present invention, including the safety features at the safety release portion of an exemplary method of administering a drug using an auto-injector according to an embodiment described herein. The examples in Figures 3A to 3B show a safety cap 3, which is removed from the end of the system and therefore may be a safety pin removed from the outer body 19.

[0073] In one exemplary embodiment, the reconfigurable auto-injector system can be received in a package. Therefore, the system can be removed from the package. The reconfigurable auto-injector can be held (e.g., with one hand) by its outer body 19. Using a holder (e.g., the other hand), the safety cap 3 can be removed from the reconfigurable auto-injector and separated from the outer body 19.

[0074] Figure 4 illustrates a cross-sectional view of the working part of an auto-injector in an exemplary method of administering a drug using an auto-injector according to an embodiment described herein.

[0075] In one exemplary embodiment of a method for using a reconfigurable auto-injector, when the reconfigurable auto-injector is ready for use, the end cap 21 (sometimes called the nose of the device) can be positioned to make contact with the injection site (e.g., the patient). The end cap 21 of the system can be positioned adjacent to the injection site, and the system becomes ready for use.

[0076] This method may include the step of pressing the reconfigurable auto-injector system against the injection site. When the reconfigurable auto-injector is pressed against the site (e.g., a patient) while a user (human or non-human) is holding the outer body 19, the syringe body 33 (the inner portion of the outer body 19) can be pressed against the second inner tube 5 to activate the second power source 2. Both the syringe body 33 and the inner body 20 can move independently of the outer body 19. Since the power sources 1 and 2 are attached to the outer body 19, the syringe body 33 can move toward the end of the reconfigurable auto-injector system (e.g., toward the end together with the power sources 1 and 2). The syringe body 33 can be pressed against the inner tube 5 of the second power source 2. The second power source 2 can be activated first and used via the second and first plungers, respectively, to automatically activate the second power source 1. The first power source to be activated is described herein as the second power source 2, and the second power source to be activated is described herein as the first power source 1. Thus, the second power source 2 is activated first to reconstitute the powder (e.g., a drug), and the first power source 1 is activated after the mixture has been reconstituted so that the mixture can be injected (e.g., into a patient). When the second power source 2 is activated, the second spring 27 is released, and the second spring 27 exerts force on the second plunger rod 9.

[0077] Figures 5 to 7 illustrate cross-sectional views of an auto-injector during a reconstruction of an exemplary method for administering a drug using an auto-injector according to an embodiment described herein.

[0078] As can be seen in Figure 5, this method may include the steps of moving the second plunger rod 9 (plunger rod of the dilution chamber) toward the injection site, compressing the gas 22 in the second chamber, and moving the liquid 23 (diluent). The stopper 12 is moved by the compressed gas 22 and liquid 23, and the plug 13 is detached from the syringe body. The stopper 12 then moves to its final position toward the end of the reconfigurable autosyringer adjacent to the injection site. When force is applied by the second plunger 11 (plunger of the dilution chamber), the second plunger 11 causes the liquid 23 (diluent) to flow into the first chamber (powder chamber) via the flow path 8.

[0079] As can be seen in Figure 6, the second plunger (plunger of the dilution chamber) moves the liquid 23 (diluent) into the first chamber (powder chamber). The space in the first chamber is filled, and the addition of liquid 23 into the first chamber (and / or compression of the gas in the first chamber) applies a load to the first plunger 17 (plunger of the powder chamber). When the liquid 23 is injected into the first chamber, the liquid 23 (and / or gas) in the first chamber moves the first plunger 17 away from the end cap 21 (or needle 16). As the liquid 23 enters the first chamber, the diluent begins to reconstitute the powder 24.

[0080] As can be seen in Figures 6 and 7, the second plunger 11 (dilution chamber plunger) moves the gas in the second chamber (dilution chamber gas / air) into the first chamber (powder chamber), thereby mixing the powder 24 and liquid 23. In one exemplary embodiment of the method described herein, the addition of gas from the second chamber to the first chamber via the channel 8 generates bubbles that agitate the drug and liquid, thereby promoting the reconstitution of the drug. When the second plunger 11 reaches the end of the second chamber, it pushes the gas into the liquid / powder 23 / 24 in the first chamber, eventually positioning itself adjacent to the channel 8, thereby closing the channel 8 and retaining the fluid / powder 23 / 24 in the first chamber. In one exemplary embodiment of the method described herein, additional pressure may be generated in the first chamber (powder chamber) during the compression of additional gas from the second chamber to the first chamber (powder chamber) before the second plunger 11 reaches the end of the second chamber. The compressed gas exerts force on the first plunger 17 (powder chamber plunger), thereby moving the first plunger toward the first power source 1 and away from the end of the system adjacent to the injection site (end cap 21). As the first plunger 17 (powder chamber plunger) moves toward the first power source 1, the first plunger 17 exerts force, moving the actuator 18, which then presses against the first inner tube 4 to actuate the first power source 1. When the first power source 1 is actuated, the first spring 26 is released and extended. The first spring 26 applies force to the first plunger rod 10 (plunger rod of the powder chamber), thereby moving the first plunger 17 (plunger of the powder chamber) away from the first power source 1 and toward the system needle 16 or end cap 21 adjacent to the injection site. The first plunger 17 (plunger of the powder chamber) moves toward the reconstituted drug mixture 23 / 24, compressing the contents of the first chamber.

[0081] Figures 8 to 9B illustrate cross-sectional views of a reconfigurable auto-injector at the injection portion of an exemplary method for administering a drug using an auto-injector according to an embodiment described herein.

[0082] As illustrated in Figures 8 and 8A, when the first power source is activated, the first plunger 17 (plunger of the powder chamber) moves toward the reconstituted mixture 23 / 24, compressing the contents of the first chamber (which may include gas) and inserting the needle 16 into the needle stopper 15 (stopper of the powder chamber). The compressed gas is discharged into the space between the injection site formed by the end cap 21 and the needle stopper 15 after the needle stopper 15 has been inserted.

[0083] As illustrated in Figures 9A and 9B, a first power source and a first plunger 17 (plunger of the powder chamber) continuously push the needle 16 into the injection site. As the needle 16 is inserted into the injection site, it moves through the reconstituted drug mixture 23 / 24. The needle 16 has a sharp end for puncturing the injection site (e.g., the patient's skin). The opposite end of the needle 16 has a hole (e.g., on the side of the needle 16) which provides access to the reconstituted mixture (e.g., a drug or compound drug) for delivery through the hollow channel of the needle 16 from there to the opening of the sharp end of the needle 16. Once the needle 16 is inserted, the reconstituted mixture comes into contact and can pass through the hole in the needle 16. Then, once the needle 16 is positioned (e.g., in the tissue), the mixture is injected into the injection site. In certain embodiments, needle positioning and drug delivery are completed when the first plunger 17 moves to the end of the first chamber.

[0084] Figure 10 illustrates a partial cross-sectional view of a reconfigured auto-injector after an exemplary method of administering a drug using an auto-injector according to the embodiments described herein has been completed.

[0085] As illustrated in Figure 10, the reserve drug volume / dose 29 may be available if the device is operated upside down or there is a problem with the drug administration site, and / or if some drug is ejected from the system before the needle is inserted into the injection site. The system can be designed so that the reserve volume 29 does not flow out of the device when the device is operated in the normal position. The reserve volume can be stored in residual volume spaces such as the space provided by the residual volume of the disk 28 and / or the space provided by the needle stopper 15 in the first chamber.

[0086] Figure 11 illustrates an exemplary embodiment with additional chambers (for example, for administering additional drugs to the recipient). As illustrated, the third chamber 1132 is provided for the second liquid, but any number of additional chambers can be used to administer additional substances.

[0087] As illustrated, the three-chamber reconfigurable autoinjector system 1100 shown in Figure 11 may comprise a needle 1116 and two power sources 1101, 1102. The system may comprise two chambers having a liquid / non-liquid combination capable of reconfiguring a drug, for example, first and second chambers 1106, 1107. These chambers and system components and configurations may be similar to those described herein. The system 1100 may comprise, for example, power sources 1101, 1102, which operate continuously to inject liquid from the second chamber 1106 into the first chamber 1107 containing the powdered material to be reconfigured. In addition to the two chambers configured to reconfigure a substance (e.g., a drug), the system 1100 may comprise one or more additional liquid chambers (e.g., a third chamber 1132) for administering additional substances (e.g., to a patient).

[0088] An exemplary embodiment of system 1100 first automatically reconstitutes and administers a powder / lyophilized drug; and then administers a second liquid drug. System 1100 can initiate the drug administration procedure of an emergency-use auto-injector using a two-stage safety release, as described herein. The second power source 1102 can be activated to mix the powder / lyophilized drug in the first chamber 1107 with the diluent in the second chamber 1106, thereby reconstituting the drug. Reconstitution can follow exemplary system configurations and methods described herein (e.g., those relating to Figures 1 to 10). After the reconstitution of the drug in the first chamber 1107, the first power source 1101 is automatically activated to insert the needle 1116 to various injection depths (e.g., intramuscularly) and administer the reconstituted drug and the second liquid in the third chamber 1132 to various injection depths.

[0089] As illustrated in Figure 11, the exemplary auto-injector includes a reconfigurable auto-injector system 1100 comprising a body comprising a first chamber 1107 configured to store powder; a second chamber 1106 configured to store liquid; and a third chamber 1132 configured to store a second liquid. An exemplary embodiment described herein includes a method of using a reconfigurable auto-injector such as 1100, the method comprising: providing the reconfigurable auto-injector; operating the reconfigurable auto-injector; reconfiguring a powdered drug into a reconfigured mixture; injecting the reconfigured mixture into an injection site (e.g., a patient); and injecting the second liquid from the third chamber 1132.

[0090] As illustrated, the system 1100 may comprise a body having a first side and a second side. The first side and the second side may be separated by a separator between them, the separator comprising a stopper and a flow path mounted thereon to separate the first side and the second side. Each side may comprise one or more different chambers. Each chamber of the one or more chambers on each side may be longitudinally positioned along the body on one side of the system 1100. The first chamber 1107 may be longitudinally positioned and separated from the second chamber 1106 (and any further continuous chambers (if any are positioned along one or both sides of the system)). Each chamber on the same side of the system may be separated by a bladder. In an exemplary embodiment, the system may comprise the first chamber 1107 at its distal end, the first chamber 1107 containing the powder described herein to be reconstituted with a liquid located in the second chamber 1106 on the opposite side of the system. A second liquid may be contained in a third chamber 1132 positioned from the first chamber 1107 toward the proximal end of the system 1100. As illustrated in Figure 11, the system 1100 includes an outer body at its distal end and an inner body at its proximal end, the inner body comprising first and second power sources 1101, 1102, and the outer body comprising first, second, and third chambers 1107, 1106, 1132. The outer body does not necessarily have to be at its distal end, nor does the inner body necessarily have to be at its proximal end (see, for example, embodiments in Figures 1 to 10). Similarly, the inner body does not necessarily have to contain power sources, and the outer body does not necessarily have to contain chambers (see, for example, embodiments in Figures 1 to 10). In all embodiments throughout this disclosure, the power sources and chambers may be any body, end, and / or side, and the variations therein will be obvious to those skilled in the art. Similarly, in System 1100 of Figure 11, as with all embodiments throughout this disclosure, terms such as first, second, third, etc., are used to distinguish components, but do not determine, limit, require, or necessitate any arrangement, configuration, order, or sequence.For example, the first power source 1101 may be on the second side or vice versa, and the second chamber 1106 may be on the first side or vice versa. Similarly, variations therein will be obvious to those skilled in the art.

[0091] Once the mixture is reconstituted, the first power source 1101 is used to inject the reconstituted mixture and the second liquid (for example, into the patient's body) as described herein with respect to the embodiments described above. Once reconstituted, the first power source 1101 can be activated to press the first plunger against the second liquid in the third chamber located at the proximal end of the system 1100. The second liquid is compressed, and the bladder between the first chamber 1107 and the third chamber 1132 moves, pushing the needle 1116 (for example, into the patient's body). The reconstituted mixture is then injected after the needle 1116 has been inserted into the injection site, and the reconstituted mixture is injected into the injection site from the first chamber 1107 through the hole at the proximal end of the needle 1116.

[0092] After the first chamber 1107 is compressed by the first plunger, the second fluid in the third chamber 1132 is moved to the distal end of the system 1100. The second fluid contained in the third chamber 1132 then enters the needle 1116, for example, through a bypass pathway within the body. The second fluid in the third chamber 1132 can bypass the bladder and enter fluid communication with the needle 1116 to inject the second fluid into the injection site. Other bypass options may also be used, such as valves in the bladder, bypass passages, or other methods.

[0093] An exemplary embodiment of the system described herein may comprise a system 1100 having a first side and a second side, the first side and the second side being separated except for a flow path between them that allows fluid flow through them. The system may comprise a stopper that blocks the flow path, which in the first configuration blocks the flow path between the first side and the second side and separates them from each other. In the exemplary embodiment, the stopper may be moved during the operation of the system 1100 described herein so that in the second configuration, the first side and the second side are in fluid communication. The first side and / or the second side may each comprise one or more chambers. As illustrated by example, the second side may comprise a second chamber 1106 configured to contain a liquid. The first side may comprise a first chamber 1107 and a third chamber 1132. The first chamber 1107 and the third chamber 1132 may be separated by a bladder. The first chamber 1107 and the third chamber 1132 can be offset longitudinally along the system 1100. Thus, the first chamber 1107 can be positioned at the distal end of the system 1100, and the first chamber 1107 is configured to contain, or already contains, a powder to be reconstituted with the liquid in the second chamber 1106. The third chamber 1132 can be positioned proximal to the first chamber 1107. The third chamber 1132 can be configured to hold the second liquid. The first chamber 1107 and the third chamber 1132 can be separated by a bladder, which can be coupled to a needle 1116 for injection (e.g., into a patient). In storage, the first chamber 1107 and the third chamber 1132 can be separated and not in fluid communication. During use, the bladder can be moved distally. At the distal position, the reconstituted mixture in the first chamber 1107 can be injected (for example, into the patient's body), and the third chamber 1132 can be fluidly communicated with the needle 1116 for injecting the second liquid.

[0094] When activated, the system 1100 can be configured such that a first plunger pushes the proximal chamber of one or more chambers on the first side (e.g., a third chamber 1132), thereby compressing the contents (e.g., a second liquid), and pushing the needle 1116 / bladder, moving the needle 1116 to a predetermined location (e.g., inside the patient's body). A hole at the proximal end of the needle 1116 may allow the reconstituted mixture (and the second liquid, and possibly additional substances) to be injected (e.g., into the patient's body).

[0095] Using the continuous operation of two power sources 1102 and 1101, it is possible to enable two steps: the step of reconstituting a powder (e.g., a lyophilized drug), and the step of subsequently administering the reconstituted mixture and the second liquid, each containing one or more drugs, with or without additional substances, for example, intramuscularly or by other means.

[0096] The exemplary embodiments described herein include a method for automatically administering a drug to a patient. For example, the device may be configured to operate in a two-step safety release and activation process. In one exemplary embodiment, this method may include the patient (or other user and / or recipient), the release of the safety release of an auto-injector, and pressing the end of the needle against a part of the patient's body, for example, the thigh or another part of the body. This method may include the steps of pressing the end of the needle against the part of the body and holding the auto-injector in place as the auto-injector administers the drug by extension of the needle after the drug has been reconstituted according to the exemplary embodiments described herein.

[0097] The exemplary embodiments described herein include two separate power sources that operate automatically and cooperatively for automatic continuous operation, enabling reconstitution without requiring user intervention (e.g., membrane disruption, vigorous shaking). The configuration of the two-chamber reconstitution structure is set up for complete drug reconstitution before the initiation of the injection process.

[0098] The power source in the exemplary embodiments described herein may be shown and described as a spring load. However, other power sources are also intended herein. For example, the power source may be any combination of compressed gas, springs, or other operating mechanisms.

[0099] The exemplary embodiments described herein may include an automatic needle stick prevention system.

[0100] Embodiments of the present invention may include specific agents, powders, diluents, and / or second liquids, or combinations thereof, as illustrated herein. These examples are not limiting and should be understood to include agents of the same or similar class and / or mechanism of action, including equivalents with generic or other names, all of which will be apparent to those skilled in the art. Those skilled in the art will understand that the scope of the present invention encompasses agents across various categories, including, for example, antibiotics, anticonvulsants, antidotes, antifungals, antihistamines, anti-inflammatory agents, antimicrobial agents, antivirals, immunization agents, vaccines, and sympathetic and parasympathetic agonists and antagonists, and that the invention relates to such agents.

[0101] In certain embodiments, the drug and / or powder may contain at least one substance selected from the group consisting of: acyclovir, albuterol, amoxicillin, amphotericin B, ampicillin, anidurafungin, artesunate, atropine, azithromycin, benzylpenicillin, brincidofovir, buprenorphine, caspofungin, cefazolin, cefepime, cefoperazone, cefotaxime, ceftazidime, ceftriaxone, cefuroxime, cephalexime, cilastatin, clavulanic acid, clindamycin, clobazam, clonazepam, cloxacillin, cortisone, dantrolene, dexamethasone, Diazepam, epinephrine, ertapenem, erythromycin, flumazenil, ganciclovir, hydrocortisone, imipenem, ketoconazole, lamotrigine, levetiracetam, meropenem, methylprednisolone, micafungin, midazolam, morphine, naloxone, naltrexone, norepinephrine, penicillin, pentamidine, perampanel, piperacillin, pralidoxime, prednisolone, prednisone, rufinamide, sulbactam, sulfamethoxazole, sumatriptan, tazobactam, topiramate, trimethoprim, valacyclovir, valproate, valproic acid, vancomycin, voriconazole, and zonisamide.

[0102] In certain embodiments, the diluent may include at least one substance selected from the group consisting of dextrose, Ringer's lactate solution, Ringer's solution, physiological saline, and water. The concentrations may vary and will be obvious to those skilled in the art. For example, the dextrose solution may include a 5% aqueous dextrose solution (D5), a 10% aqueous dextrose solution (D10), and so on. Furthermore, the physiological saline may be a hypotonic solution, e.g., 0.45% sodium chloride or half physiological saline (1 / 2NS); a nearly isotonic solution, e.g., 0.9% sodium chloride or physiological saline (NS); or a hypertonic solution, e.g., 3% sodium chloride. In addition, the diluent may include combinations such as D5 and NS, D5 and 1 / 2NS, and so on. Other concentrations and / or combinations will be obvious to those skilled in the art. The diluent may further include preservatives and / or additives, which will be obvious to those skilled in the art. The diluent may also include one or more emollients and / or oils.

[0103] In exemplary embodiments, the powder may contain the antiviral drug brincidofovir, which is particularly useful for treating viral infections in remote locations, such as infections with members of the Ebolavirus genus.

[0104] In exemplary embodiments, the powder may include vaccines such as those against influenza (flu), tuberculosis (TB), poxviridae, bariolar virus infections (e.g., smallpox), and varicella-zoster virus infections (e.g., chickenpox and / or herpes zoster). In specific embodiments, the powder may include polysaccharide-conjugated vaccines. One example is a Haemophilus influenzae type B (HIB) vaccine (e.g., which can be reconstituted with 0.4% saline).

[0105] In exemplary embodiments, the powder may contain an antidote for nerve gas or pesticide poisoning. In specific embodiments, the powder may contain atropine, its diluent may contain pralidoxime, and their second liquid may contain scopolamine. In other embodiments, the powder may contain 2-pyridinealdoxime methyl chloride (2PAM), its diluent may contain atropine. In other embodiments, the powder may contain atropine, its diluent may contain sterile water or saline, and their second liquid may contain pralidoxime.

[0106] In exemplary embodiments, the powder may contain epinephrine, such as lyophilized epinephrine. In further embodiments, the diluent may contain physiological saline, such as NS (0.9% sodium chloride). Epinephrine in solution is sensitive to the material of the container, which can limit storage, transport, and shelf life. The possibility of epinephrine in powder form due to the emergence of the inventive features of the present invention enables a more tolerable and durable product with improved shelf life and drug stability, including all wide range of container materials (e.g., plastic).

[0107] Where used herein, the terms “about,” “substantially,” or “approximately” with respect to any numerical value, range, shape, distance, relative relationship, etc., indicate appropriate dimensional tolerances that enable some or all of the components to perform their intended purpose as described herein. Numerical ranges may also be given herein. Unless otherwise specified, each range is intended to include an endpoint and any quantity within the range shown. Thus, the range 2–4 includes 2, 3, 4, and any subdivisions between 2 and 4 such as 2.1, 2.01, 2.001. Ranges also encompass any combination of ranges, such that 2–4 includes 2–3 and 3–4.

[0108] While embodiments of the present invention have been fully described with reference to the accompanying drawings, it should be noted that various changes and modifications will be apparent to those skilled in the art. Such changes and modifications should be understood as falling within the scope of embodiments of the present invention as defined by the accompanying claims. Specifically, exemplary components are described herein. Any combination of these components can be used in any combination. For example, any component, feature, step, or part can be combined, separated, subdivided, removed, repeated, added, or used in any combination and still remain within the scope of this disclosure. The embodiments are merely illustrative and provide exemplary combinations of features, but are not limited thereto.

[0109] As used herein and in the claims, the terms “comprise” and “comprising,” and their variations, mean that the specified feature, step, or integer is included. These terms should not be construed as excluding the presence of other features, steps, or components.

[0110] The features disclosed in the foregoing description, or in the following claims, or in the accompanying drawings, are expressed in their specific forms, or in terms of means for performing the disclosed functions, or methods or processes for achieving the disclosed results, and may be used, as necessary, separately or in any combination of such features, to realize the present invention in their various forms.

Claims

1. A reconfigurable automatic syringe comprising a main body, wherein the main body is: A first chamber configured to store the powder inside; A second chamber configured to store liquid; and The reconfigurable automatic syringe comprising a third chamber configured to store a second liquid.

2. The reconfigurable auto-injector according to claim 1, wherein the body comprises an outer body at a first end and an inner body at a second end, the second end including an end of a reconfigurable auto-injector configured to be positioned adjacent to the injection site during use, a portion of the inner body being positioned within a portion of the outer body, the first chamber and the second chamber being positioned side by side and separated by a separator.

3. The reconfigurable automatic syringe according to claim 2, wherein the first chamber contains a powder disposed therein, the second chamber contains a liquid disposed therein, the separator has a flow path that provides fluid communication between the first chamber and the second chamber, and the second chamber has a stopper that is disposed to block the flow path so that the first chamber and the second chamber do not have fluid communication in the first configuration.

4. The reconfigurable automatic syringe according to claim 3, further comprising a first power source and a second power source, wherein the first power source is configured to work in conjunction with a first plunger to move the first plunger away from the first power source, and the second power source is configured to work in conjunction with a second plunger to move the second plunger away from the second power source.

5. The reconfigurable automatic syringe according to claim 4, wherein the second power source is configured to activate when the reconfigurable automatic syringe is pressed against the injection site and pressure is applied to the inner body.

6. The reconfigurable automatic syringe according to claim 5, wherein the second power source comprises a second compression spring, which is released and extended when in operation, moving a second plunger rod and the second plunger away from the second power source, thereby compressing the volume of the second chamber containing the liquid.

7. The reconfigurable automatic syringe according to claim 5, wherein the first power source comprises a first compression spring, the first compression spring being released and extended during operation, causing the first plunger rod and the first plunger to move away from the first power source, thereby compressing the volume of the first chamber.

8. The reconfigurable automatic syringe according to claim 7, further comprising an actuator between the first plunger and the first power source, wherein the actuator is configured to release the first spring when the first plunger moves toward the first power source.

9. The reconfigurable automatic syringe according to claim 1, further comprising a needle, a needle stopper, and an end cap, wherein the needle stopper is located in the first chamber adjacent to the end cap, and the needle extends into the needle stopper and is configured to move through the needle stopper and the end cap.

10. The reconfigurable auto-injector according to claim 9, further comprising a safety cap.

11. A method using a reconfigurable auto-injector: Steps to provide the reconfigurable auto-injector; Steps to activate the reconfigurable automatic syringe; A step of reconstituting a drug in powder form into a recomposed mixture; The steps of injecting the reconstituted mixture into the injection site; and The method comprising the step of injecting the second liquid from the third chamber into the injection site.

12. The method according to claim 11, wherein the reconfigurable automatic syringe comprises a drug in powder form contained in a first chamber and a liquid contained in a second chamber, wherein the drug in powder form and the liquid are maintained separately from each other in the first configuration before use.

13. The method according to claim 12, wherein the step of activating the reconfigurable automatic syringe includes the step of pressing the reconfigurable automatic syringe against the injection site to automatically start reconfiguration and injection.

14. The method according to claim 13, wherein the step of operating the reconfigurable automatic syringe includes the step of releasing a second compression spring to move a second plunger away from the second compression spring and toward the injection site.

15. The method according to claim 14, further comprising the step of opening a flow path between the second chamber and the first chamber so that when the second plunger moves away from the second spring, the liquid moves into the first chamber.

16. The method according to claim 15, further comprising the steps of: adding gas through the flow path after the liquid in the second chamber has moved to the first chamber; stirring the liquid and the drug in powder form to prepare a reconstituted mixture; and blocking the flow path with a second plunger.

17. The method according to claim 15, further comprising the steps of: when the first chamber is filled with the liquid of the second chamber, moving the first plunger within the first chamber thereby acting a first compression spring, thereby releasing the first compression spring, and applying force to the first plunger to move it away from the first spring and toward the injection site.

18. The method according to claim 17, further comprising the step of moving the needle in the first chamber through a needle stopper with the first plunger to exit the end cap.

19. The method according to claim 18, further comprising the step of discharging gas contained in the first chamber through the needle before the end of the needle exits the needle stopper and the end of the needle is in a gap formed by the end cap and the end of the needle enters the injection site.

20. The method according to claim 19, further comprising the step of moving the needle into the injection site and injecting the reconstituted mixture into the injection site.

21. A reconfigurable automatic syringe comprising a main body, wherein the main body is: A first chamber configured to store the powder inside; A third chamber configured to store a second liquid within it; The first plunger in the first chamber; A first power source configured to push the first plunger to reduce the volume in the first chamber; An actuator configured to operate the first power source; A second chamber configured to store liquid; The second plunger in the second chamber; A second power source configured to push the second plunger to reduce the volume in the second chamber; A flow path between the first chamber and the second chamber, such that when the second plunger is moved by the second power source, the liquid can flow into the first chamber; and A bladder is provided between the first chamber and the third chamber for separating the powder from the second liquid in the storage position. The reconfigurable automatic syringe, comprising a first plunger, an actuator, and a first power source, wherein when liquid from the second chamber flows into the first chamber and the first plunger moves in a first direction, increasing the volume of the first chamber, the actuator automatically activates the first power source, and when the first power source is activated, it pushes the first plunger in the opposite direction, thereby decreasing the volume in the first chamber.

22. The reconfigurable automatic syringe according to claim 21, further comprising a stopper configured to cover the flow path in the first configuration and not to cover the flow path in the second configuration, wherein the second configuration is configured to appear when the liquid in the second chamber is compressed by the second plunger after the operation of the second power source.

23. A method using a reconfigurable auto-injector: The step of providing a reconfigurable auto-injector comprising a first chamber containing a drug in powder form, a second chamber containing a liquid, a third chamber containing a second liquid, a first power source, and a second power source; The steps include: activating the second power source to compress the liquid and cause it to flow from the second chamber to the first chamber; The step of reconstituting the drug in powder form into a recomposed mixture; and The method comprising the step of automatically activating the first power source to inject the reconstituted mixture and the second liquid into the injection site.

24. The method according to claim 23, wherein the step of automatically activating the first power source includes the step of moving the first plunger in a first direction, and the first power source is configured, when activated, to move the first plunger in a second direction opposite to the first direction.

25. The method according to claim 24, wherein the step of activating the second power source includes the step of pressing the reconfigurable automatic syringe against the injection site.

26. The method according to claim 25, further comprising the steps of maintaining the first chamber and the second chamber so as not to be in fluid contact with a stopper in the flow path, and then moving the stopper out of the flow path to allow fluid flow from the second chamber to the first chamber.

27. The reconstituted automatic syringe according to claim 1, wherein the powder contains epinephrine and the liquid contains physiological saline.

28. The reconstituted auto-injector according to claim 1, wherein the powder comprises lyophilized epinephrine and the liquid comprises 0.9% sodium chloride.

29. The reconfigurable auto-injector according to claim 1, wherein the powder contains atropine, the liquid contains pralidoxime, and the second liquid contains scopolamine.

30. The reconstituted automatic syringe according to claim 1, wherein the powder comprises 2-pyridinealdoxime methyl chloride and the diluent comprises atropine.

31. The reconfigurable auto-injector according to claim 1, wherein the powder contains atropine, the diluent contains sterile water, and the second liquid contains pralidoxime.

32. The reconstituted auto-injector according to claim 1, wherein the powder contains atropine, the diluent contains physiological saline, and the second liquid contains pralidoxime.

33. The reconstituted automatic syringe according to claim 21, wherein the powder contains epinephrine and the liquid contains physiological saline.

34. The reconstituted auto-injector according to claim 21, wherein the powder comprises lyophilized epinephrine and the liquid comprises 0.9% sodium chloride.

35. The reconfigurable auto-injector according to claim 21, wherein the powder contains atropine, the liquid contains pralidoxime, and the second liquid contains scopolamine.

36. The reconstituted auto-injector according to claim 21, wherein the powder comprises 2-pyridinealdoxime methyl chloride and the diluent comprises atropine.

37. The reconfigurable auto-injector according to claim 21, wherein the powder contains atropine, the diluent contains sterile water, and the second liquid contains pralidoxime.

38. The reconstituted autoinjector according to claim 21, wherein the powder contains atropine, the diluent contains physiological saline, and the second liquid contains pralidoxime.

39. The method according to claim 23, wherein the powder contains epinephrine and the liquid contains physiological saline.

40. The method according to claim 23, wherein the powder comprises freeze-dried epinephrine and the liquid comprises 0.9% sodium chloride.

41. The method according to claim 23, wherein the powder contains atropine, the liquid contains pralidoxime, and the second liquid contains scopolamine.

42. The method according to claim 23, wherein the powder comprises 2-pyridinealdoxime methyl chloride and the diluent comprises atropine.

43. The method according to claim 23, wherein the powder contains atropine, the diluent contains sterile water, and the second liquid contains pralidoxime.

44. The method according to claim 23, wherein the powder contains atropine, the diluent contains physiological saline, and the second liquid contains pralidoxime.

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