Autoinjector System

Abstract

Systems and methods are provided for automatically reconstituting a medication and then administering it to a patient. The systems and methods may include a reconstituting auto-injector having a first chamber with a powder therein, a second chamber with a liquid therein, a first power source, and a second power source. The first power source may be actuated to compress the liquid into the first chamber along with the powder. The second power source may be actuated to inject the reconstituted medication into the patient.

Description

[Technical field]

[0001] (Priority) This application claims priority to U.S. Provisional Patent Application No. 63 / 262,597, filed April 6, 2022, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] (background) Lyophilized drugs and vaccines are commercially limited due to the complexity of reconstituting the drug into a usable form. Traditionally, lyophilized drugs are reconstituted from a vial using equipment and several steps. Once reconstituted, the drug is delivered to the patient by IV, intramuscular, or subcutaneous injection. Summary of the Invention [Means for solving the problem]

[0003] (overview) An exemplary embodiment of the system and method described herein is designed to reconstitute a drug and automatically administer it to a patient. The system stores powdered substances, such as a drug (lyophilized) and its diluent, in two separate chambers. Upon administration, the system and method is 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 is understood to include a substance used for human health. A drug may include a drug to address a disease and / or condition and / or to prevent such disease and / or condition. Although the embodiments are described herein with respect to a liquid used for the powdered drug and the diluent, other combinations of mixed substances may also be used in accordance with the embodiments described herein. For example, two liquids may be combined, two powders may be combined, a combination of a powder and a liquid, etc.

[0004] Exemplary embodiments described herein include a reconstituted auto-injector and / or a system that uses the reconstituted auto-injector to administer a medication to a patient. Exemplary embodiments of the reconstituted auto-injector may include a first chamber configured to store a powder therein; and a second chamber configured to store a liquid. Although described herein with respect to a first chamber configured to store and / or having stored a powder, the first chamber may also store a liquid. Although described herein with respect to a second chamber configured to store and / or having stored a liquid, the second chamber may also store a powder. References to first and / or second are intended to distinguish one chamber from another, and are not intended to specify a particular number of chambers or to define the order of the chambers. Thus, a first chamber may be a second chamber or vice versa when describing different exemplary embodiments of the present invention. The first chamber and the second chamber may be arranged side by side and separated by a separator.

[0005] The reconstituted auto-injector can include a body. The body can include an outer body at a first end and an inner body at a second end. The second end can include an end of the system configured to be positioned adjacent an injection site during use. A portion of the inner body can be located within a portion of the outer body. The outer body can move independently of the inner body. The inner body can slide longitudinally within the outer body. The configuration and / or location of the inner and outer bodies can provide for automatic actuation of the system to combine a medication and administer the medication to a patient by injection.

[0006] In an exemplary embodiment, the first chamber can be configured and / or capable of holding a powder disposed therein, and the second chamber can be configured and / or capable of holding a liquid disposed therein. A separator between the first and second chambers can include a flow path providing fluid communication between the first and second chambers. The reconstituted auto-injector can also include a stopper disposed in the second chamber to block the flow path such that the first and second chambers are not in fluid communication in a first configuration or position of the stopper. The configuration of the chambers and / or stopper can allow for separation of the drug and its diluent for long-term storage. The configuration of the chambers and / or stopper and / or flow path is configured to allow for reconstitution of the drug and diluent upon actuation of the system to more easily administer the combined drug to the patient. Exemplary embodiments can also use liquids and / or gases to aid in reconstitution of the drug by mixing the powder with the liquid.

[0007] The reconstituted auto-injector can include a first power source and a second power source. The first power source is configured to engage with a first plunger and move the plunger away from the first power source, and the second power source is configured to engage with a second plunger and move the plunger away from the second power source. As described herein, power source is understood to include not only electrical power, but also mechanical power, such as movement and / or actuation of components of a system for automatic reconstitution and / or automatic injection of a reconstituted medicament.

[0008] The second power source can be actuated by pressure on the inner body when the system is pressed against an injection site on a patient. The second power source can include a first compression spring configured to release and expand upon actuation to move the second plunger rod and the second plunger away from the second power source and compress the volume of the second chamber containing the liquid.

[0009] The first power source can include a second compression spring configured to be released and expand when actuated to move the first plunger rod and the first plunger away from the first power source and compress the volume of the first chamber.

[0010] The reconstituted auto-injector can include an actuator disposed between the first plunger and the first power source, the actuator releasing the first spring upon movement of the first plunger toward the first power source.

[0011] The reconstituted auto-injector may also include a needle, a stopper, and an (optional) end cap. The stopper may be disposed in the first chamber adjacent to the end cap. The needle may extend into the stopper and may move through the stopper and the end cap when the plunger again presses the terminal end of the needle. The needle may have a sharp end at the end of the needle opposite the terminal end pressed by the plunger.

[0012] The reconstituted auto-injector may optionally be equipped with a safety cap.

[0013] Exemplary embodiments described herein include a method of using a reconstituted auto-injector, which may include the steps of providing a reconstituted auto-injector, activating the reconstituted auto-injector, reconstituting a drug in powder form into a reconstituted drug mixture, and injecting the reconstituted drug mixture into a patient.

[0014] The reconstituted auto-injector used in this method may have any combination of the components described herein. For example, the reconstituted auto-injector may have a powder contained in a first chamber and a liquid contained in a second chamber. The powder and liquid may be separated from each other in the first configuration prior to use.

[0015] Exemplary embodiments of the methods described herein may include activating a reconstituted auto-injector by pressing the reconstituted auto-injector against the patient's skin to automatically initiate reconstitution and injection.

[0016] The method may include the step of releasing, upon actuation, a second compression spring to move the second plunger away from the second compression spring and in a direction toward the injection site.

[0017] The method may include opening a flow path between the second chamber and the first chamber such that liquid moves into the first chamber when the second plunger is moved by the second spring.

[0018] The method may include adding a gas through the flow path after the liquid in the second chamber has moved into the first chamber to agitate the liquid and reconstitute the powder into the liquid to prepare a reconstituted mixture, and blocking the flow path with a second plunger.

[0019] The method may include the step of actuating a first compression spring by filling a first chamber with liquid from a second chamber and moving a first plunger within the first chamber, thereby releasing the first compression spring and applying a force to the first plunger to move the first plunger away from the first spring in a direction toward the injection site.

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

[0021] The method may include venting gas contained in the first chamber through the needle when the end of the needle exits the stopper and is within a gap formed by the end cap and before the end of the needle enters the patient's skin.

[0022] The method may include the step of moving a needle into an injection site of the patient to inject the reconstituted mixture into the patient.

[0023] Exemplary embodiments described herein may include a reconstituted auto-injector comprising a body, the body comprising: a first chamber configured to store a powder therein; a first plunger in the first chamber; a first power source configured to push the first plunger to reduce a volume in the first chamber; a first actuator configured to activate the first power source; a second chamber configured to store a liquid; a second plunger in the second chamber; a second power source configured to push the second plunger to reduce a volume in the second chamber; and a flow path between the first chamber and the second chamber such that the liquid can flow into the first chamber when the second plunger is moved by the second power source. The first plunger, first actuator, and first power source may be configured such that the actuator automatically activates the first power source when liquid in the second chamber flows into the first chamber and the plunger moves in a first direction to increase the volume of the first chamber. Once actuated, the first power source can be configured to push the first plunger in an opposite direction to reduce a volume within the first chamber.

[0024] The reconstituted auto-injector can include a stopper configured to cover the fluid path in a first configuration and to uncover the fluid path in a second configuration, the second configuration being configured to occur when liquid in the second container is compressed by the second plunger following activation of the second power source.

[0025] An exemplary embodiment of a method of using a reconstituted auto-injector described herein may include providing a reconstituted auto-injector comprising a first chamber having a powder therein, a second chamber having a liquid therein, a first power source, and a second power source; activating the second power source to initiate the first power source to compress the liquid and cause the liquid to flow from the second chamber to the first chamber; reconstituting a drug in powder form into a reconstituted drug mixture; and automatically activating the first power source to inject the reconstituted drug mixture into a patient.

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

[0027] The method may include activating the second power source by pressing the reconstituted auto-injector against the patient's skin to activate the second power source.

[0028] The method may include maintaining the first and second chambers out of fluid contact via a stopper on the flow path, and then allowing fluid flow from the second chamber to the first chamber by moving the stopper out of the flow path. [Brief description of the drawings]

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

[0030] [Diagram 2] Figure 2A illustrates a side view of an exemplary auto-injector according to an embodiment of the present invention, and Figure 2B illustrates a cross-sectional view to illustrate the internal components of the system according to an embodiment of the present invention.

[0031] [Diagram 3] 3A-3B illustrate exemplary features of an auto-injector according to embodiments of the present invention, including a safety feature and an auto-injector during a safety release portion of a method of administering a medication using an auto-injector according to embodiments described herein.

[0032] [Figure 4] FIG. 4 illustrates a cross-sectional view of an auto-injector during an actuation portion of a method of administering a medication using an auto-injector according to embodiments described herein.

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

[0034] [Figure 8] FIG. 8 illustrates a cross-sectional view of an auto-injector during the injection portion of a method of administering a medication using an auto-injector according to embodiments described herein. [Figure 9] FIG. 9 illustrates a cross-sectional view of an auto-injector during the injection portion of a method of administering a medication using an auto-injector according to embodiments described herein.

[0035] [Figure 10] FIG. 10 illustrates a cross-sectional view of a portion of the auto-injector after completing a method of administering a medication using the auto-injector. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0036] (explanation) The following detailed description illustrates the principles of the present invention by way of example and not by way of limitation. The description will clearly enable one skilled in the art to make and use the invention and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including what is currently contemplated to be the best mode for carrying out the invention. It should be understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the invention and are not limiting of the invention and are not necessarily drawn to scale.

[0037] Exemplary embodiments of the systems described herein may include one or more advantages. For example, exemplary embodiments of the systems and methods described herein may meet Federal Drug Administration (FDA) reliability requirements for modern emergency use devices. The systems and methods described herein may reconstitute the drug into a mixture prior to the injection process. The system may be configured to automate the reconstitution and / or injection processor such that user interfaces or steps are minimized, such as through the use of one or more automated power sources. A device interface compatible with current devices may be used and / or may be configured to allow for the addition of needle shields and / or covers. Exemplary embodiments may have a liquid containing a second liquid state drug (or additional drug combination) to administer a combination of two or more drugs. Exemplary embodiments may include a safety feature, such as a safety pin on the front of the device.

[0038] FIG. 1 illustrates a perspective view of an exemplary reconstituted auto-injector according to an embodiment of the present invention.

[0039] Exemplary embodiments of the reconstituted auto-injector described herein include a first chamber configured to store a powder therein and a second chamber configured to store a liquid. The chambers can be contained within the body. The first and second chambers can be disposed side-by-side within the inner body 20 and separated by a separator.

[0040] 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 can include an outer body 19 at a first end of the reconstituted auto-injector and an inner body 20 at a second end. The second end of the reconstituted auto-injector includes an end cap 21 at an end of the inner body 20 that is configured to be positioned adjacent an injection site during use. A portion of the inner body 20 can be positioned within a portion of the outer body.

[0041] Figure 2A illustrates a side view of an exemplary reconstituted auto-injector according to an embodiment of the present invention, and Figure 2B illustrates a cross-sectional view of Figure 2A to illustrate internal components of the system according to an embodiment of the present invention.

[0042] As illustrated, the exemplary reconstituted auto-injector can include an outer body 19 and an inner body 20. A portion of the inner body 20 can be located within a portion of the outer body 19 and extend from an end of the outer body 19. The inner body 20 can define an end that is disposed at an injection site at the end of the reconstituted auto-injector.

[0043] The inner body 20 and the outer body 19 can define a first interior space 7 and a second interior space 6. A first plunger 17 can be disposed within the first interior space 7, and a second plunger 11 can be disposed within the second interior space. The area within the first interior space can be from the first plunger to an end of the interior space toward the injection site (and away from the first power source) and can define a first chamber. The area within the second interior space can be from the second plunger to an end of the interior space toward the injection site (and away from the second power source) and can define a second chamber. The first chamber can be configured to hold, and can hold, a powder 24 therein. The second chamber can be configured to hold, and can hold, a liquid 23 therein. The second chamber can be divided into one or more sections, such as a first section configured to hold, a liquid 23 therein, and a second section configured to hold, a gas 22 therein. The first and second sections can be in fluid communication and can be simply divided by a gas and liquid separation and system arrangement such that the liquid is located towards the end closest to the injection site and the gas is located away from that end. The first and second sections can also include a barrier or other separation between the first and second sections. The barrier can be configured to move within the inner body such that the second plunger can be configured to compress the gas 22 in the second section, pushing against the divider, which in turn compresses the liquid (such as a diluent) 23 in the second section.

[0044] In one exemplary embodiment of the reconstituted auto-injector, the first plunger 17 and the second plunger 11 are disposed within the inner body 20 to define a first chamber and a second chamber. The first chamber and the second chamber can be disposed side-by-side toward the end of the system configured to be disposed adjacent to the injection site (and opposite the end of the system that includes the first and / or second power source(s)). The inner body can include a separator between the first and second chambers. The separator can include a flow channel 8 that allows fluid flow between the first and second chambers through the flow channel. The second chamber can have a stopper 12 disposed therein that is coupled to a plug 13. The stopper can be disposed such that in a first position it blocks the flow channel 8 and in a second position it allows fluid flow through the flow channel 8. In an exemplary embodiment, the second position is when the stopper is moved toward the end of the system configured to be disposed adjacent to the injection site to compress or move along the plug 13. Thus, the first chamber and the second chamber are separated and not in fluid communication when the stopper is in the first position, but can be in fluid communication via the flow path when the stopper is in the second position.

[0045] In one exemplary embodiment of a reconstituted auto-injector, the inner body 20 can include an end cap 21. The end cap 21 can be on the same side of the body as the first chamber and can be located at the end of the chamber toward the end of the system so that it is located adjacent to an injection site during use. The inner body 20 can include an opening such that the end of the first chamber opens through the inner body. The inner body can include a stopper 15 and an end cap 21 to close the inner body opening and seal the first chamber.

[0046] In an exemplary embodiment of the reconstituted auto-injector, the needle 16 can have a sharpened end for penetrating an injection site. The sharpened end can be positioned toward an end of the reconstituted auto-injector system that is configured to be positioned adjacent to an injection site during use. As illustrated, the sharpened end of the needle 16 can be positioned within a portion of the stopper 15. The opposite end of the needle is configured to abut but not penetrate the first plunger 17. The first plunger 17 can thus be configured to move within the first chamber to apply a force (from a power source as described herein) to the needle and move the needle through the stopper 15 and end cap 21. The first plunger 17 can be positioned within the inner body 20 and the first interior space 7 and moved within the first chamber toward and away from the needle according to the methods described herein. For example, the first plunger 17 can have an outer shape that is approximately 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.

[0047] In one exemplary embodiment of a reconstituted auto-injector, the end cap 21 can be configured to separate the end of the needle after it exits the stopper 15 and before the needle is inserted into an injection site on a patient. The end cap 21 can include a gap to create this separation. This separation can allow the plunger 17 to travel a sufficient distance within the first chamber to allow gas trapped within the first chamber to be expelled from the needle before the needle is inserted into an injection site on a patient and the reconstituted drug mixture is administered to the patient.

[0048] As illustrated, the first chamber contains a gas 25 and a powder 24. The second chamber contains a gas 22 and a liquid 23. The gas can be any gas, such as air. The exemplary gas can be inert to the drug or other components to be administered, such as a powder or liquid. In one exemplary embodiment of a reconstituted auto-injector, the powder contains the drug. The drug can be in lyophilized or other powder form. For example, the drug can include a lyophilized solid drug. The liquid can be a diluent used to reconstitute the drug. In one exemplary embodiment, the liquid can include a second drug or other combination of drugs, vitamins, minerals, actuators, or other compositions to aid in the administration of the drug to the patient. Although described herein in terms of drugs, the powder can be any powdered substance intended to be reconstituted and injected at a site. Although described herein, the injection of the drug is described in terms of a patient. However, any injection site for injecting the reconstituted substance can be considered within the scope of the present disclosure. For example, animals or other mammals can also benefit from the exemplary embodiments described herein.

[0049] As illustrated, the exemplary auto-injector can include a first power source 1 and a second power source 2. The first power source 1 can include a first inner tube 4 having a first spring 26 disposed therein that interfaces with a first plunger rod 10 connected to a first plunger 17 to move the first plunger 17 through a first chamber volume toward an end of the reconstituted auto-injector system configured to be placed at an injection site. The second power source 2 can include a second inner tube 5 having a second spring 27 disposed therein that interfaces with a second plunger rod 9 connected to a second plunger 11 to move the second plunger 11 through a second chamber volume toward an end of the system configured to be placed at an injection site.

[0050] The first power source 1 and the second power source 2 can be configured to be 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, 27 are released and extended, exerting a force through the rods 10, 9, causing the plungers 17, 11 to move towards the end of the system located at the injection site, thereby compressing the space of the chambers 7, 6. The first power source and the second power source are configured to operate continuously and automatically such that when the second power source is activated, the second spring is released and extended, causing the second plunger to move, and when the first power source is activated, the first spring is released and extended, causing the first plunger to move towards the needle.

[0051] In an exemplary embodiment of the reconstituted auto-injector, the auto-injector may also include an actuator 18. The actuator may be disposed between and toward the first plunger 17 and the first power source 1. The actuator may move within the first interior space 7 and be pushed toward the first power source 1 when the first chamber is filled with liquid 23 during the methods described herein. The actuator may release the first spring to activate the first power source 1. When the first power source 1 is activated, the first spring 26 may be released and allowed to extend, exerting a force through the rod 10, moving it toward the plunger 17 and needle 16, which passes through the stopper 15, exits the end cap 21, and enters the patient's injection site.

[0052] In one exemplary embodiment of a reconstituted auto-injector, each power source comprises a spring 26, 27 that may be held in their compressed state by the collet 30, 31 and inner tube interface 4, 5. When the inner tube 4, 5 is pressed, the opposite end of the inner tube 4, 5 expands and / or the collet 30, 31 is allowed to collapse / compress, thereby displacing the collet 30, 31 from its retained position and releasing the spring 26, 27.

[0053] In one exemplary embodiment of a reconstituted auto-injector, the auto-injector can automatically activate the second power source 2 during use. For example, the inner body 20 can be configured to have its end contacting the patient, such as via an end cap 21, and positioned adjacent to an injection site. The outer body 19 can be held by a practitioner who injects the drug mixture into the patient. When the inner body 20 and / or the end cap 21 contact the patient and a force is applied between the inner body and the outer body, the second power source 2 is activated, thereby releasing the second spring 27.

[0054] In one exemplary embodiment of a reconstituted auto-injector, the plunger 17 moves towards the first power source 1 as fluid moves from the second chamber to the first chamber. The fluid exerts pressure on the plunger 17, causing it to move and depress the actuator 18. The actuator 18 can then depress the inner tube 4 of the first power source, releasing the spring 26 of the first power source.

[0055] As illustrated, the system may include 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 an injection site. The safety cap 3 may cover the first and / or second power sources to minimize accidental activation of the system until the auto-injector is ready for use. In one exemplary embodiment of a reconstituted auto-injector, the safety cap 3 may be located around the second end of the system to cover an exposed portion of the first power source and an exposed portion of the second power source. The safety cap may be optional.

[0056] In one exemplary embodiment, the system may also include a disk 14. The disk 14 may be disposed adjacent to the stopper 15. The disk 14 may be located between the stopper 15 and the flow channel 8 and may define a terminal end of a first chamber configured to be contacted by the medicament (whether in powder or combined in a liquid). The disk 14 may thus provide a barrier between the medicament and the stopper.

[0057] As illustrated, each power source includes a spring disposed within the tunnel. The spring is illustrated as a coil spring disposed around a shaft that is coupled to a plunger rod. The shaft includes a flange disposed along the length of the shaft and extending radially outward from the shaft and circumferentially about the shaft. The flange is configured to contact an end of the spring. Thus, the spring can expand and exert a force on the flange, thereby moving the plunger rod. The plunger rod can then contact and move the plunger, compressing the volume of the chamber. Exemplary embodiments may include other configurations of plungers, plunger rods, actuators, and power mechanisms (such as springs) that may be configured to operate in a similar manner. For example, different spring configurations may be used and / or the spring mechanism may be incorporated into the shaft, such as by selection of a compressible / expandable material.

[0058] In an exemplary method of using the reconstituted auto-injector system described herein, a medication is automatically reconstituted and administered. In an exemplary embodiment, the method may include any combination of steps described herein. In an exemplary embodiment, an auto-injector is provided that includes a first chamber having a powder and a second chamber having a liquid. The method may include activating a first power source to apply pressure to the liquid and opening a fluid flow path between the first chamber and the second chamber such that the liquid is transferred under pressure from the second chamber to the first chamber. The method may include introducing gas into the first chamber through the flow path to agitate the powder and the liquid to prepare a reconstituted mixture. The method may include activating a second power source to apply pressure to a plunger of the first chamber. The second power source is configured to move a needle. The second power source continues to apply a force to the needle to move the needle. The method may include continuing to move the needle through a stopper by the second power source to expel gas from the first chamber. The method can continue by moving the needle towards and into the injection site, where the needle can access the reconstituted mixture, allowing the reconstituted mixture to be administered through the needle to the injection site.

[0059] First, a reconstituted auto-injector can be provided according to the embodiments described herein. The auto-injector can include a two-chamber system, where a first chamber is configured to store a powder, such as a lyophilized solid drug, and a second chamber is configured to store a liquid diluent. The auto-injector can also include a first power source configured to mix the powder with the diluent, and a second power source configured to administer the reconstituted drug.

[0060] In one exemplary embodiment, the nose of the device can then be pressed against the injection site to activate a first power source, causing the syringe body of the auto-injector to press against the inner tube of the first power source, releasing a spring in the first power source. When the spring in the first power source is released, the spring can press against the gas in the dilution chamber, the diluent, and the stopper in the dilution chamber to open a flow path to the powder chamber. When the flow path is open, the diluent can flow under pressure from the second chamber to the first chamber to reconstitute the powder and diluent to obtain a reconstituted drug.

[0061] After the diluent is transferred to the first chamber, gas from the second chamber is transferred to the reconstituted drug via a flow path that bubbles the gas, causing the bubbled gas to flow into the reconstituted drug and agitate it to facilitate reconstitution, resulting in a reconstituted drug mixture.

[0062] In one exemplary embodiment, the first power source continues to apply pressure to compress the gas in the first chamber as it moves to its final position, closing the flow path. The compressed gas can load a plunger in the first chamber, moving it toward the second power source. The plunger in the first chamber can press an actuator after a period of time, which can press against an inner tube of the second power source, releasing a second spring in the second power source.

[0063] In one exemplary embodiment, the spring of the second power source can be released to push the plunger of the first chamber toward the injection site compressing the gas in the first chamber. The spring of the second power source can continue to exert a force on the plunger of the first chamber, which can then push the needle.

[0064] In one exemplary embodiment, the spring of the second power source continues to apply force to the plunger of the first chamber, causing the plunger of the first chamber to move the needle through the stopper of the first chamber and expel compressed air through the needle.

[0065] In one exemplary embodiment, the spring of the second power source continues to apply force to the plunger of the first chamber, thereby continuing to move the needle toward the injection site and subsequently inserting the needle into the injection site.

[0066] In one exemplary embodiment, the spring of the second power source continues to apply force to the plunger of the first chamber, causing the needle to access the reconstituted drug mixture, which flows through the needle bore and into the injection site.

[0067] In one exemplary embodiment, the spring of the second power source continues to apply force to the plunger of the first chamber, injecting the medication while keeping the needle positioned at the injection site.

[0068] In one exemplary embodiment, the spring of the second power source continues to apply force to the plunger of the first chamber, completing needle placement and continuing drug delivery until the required amount of drug has been administered.

[0069] Once the required amount / dose of reconstituted drug mixture has been administered, the injection process is complete.

[0070] 3A-10 illustrate exemplary features of a reconstituted auto-injector during a method of administering a medication using the auto-injector according to embodiments described herein. As shown herein, the method may include a safety release portion, an actuation portion, a reconstitution portion, an injection portion, and may be completed thereafter. The safety release portion may be optional.

[0071] 3A-3B illustrate exemplary features of an auto-injector according to an embodiment of the present invention including a safety feature and an auto-injector during a safety release portion of a method of administering a medication using an auto-injector according to an embodiment described herein. The illustrations in Figures 3A-3B show the safety cap, represented as a safety pin, removed from the end of the system, thus separating the cap from the outer body.

[0072] In one exemplary embodiment, the reconstituted auto-injector system can be received in a package. The system can then be removed from the package. The reconstituted auto-injector can be held by the outer body 19 in one hand. Using the other hand, the safety cap 3 can be removed from the reconstituted auto-injector and separated from the outer body.

[0073] FIG. 4 illustrates a cross-sectional view of an auto-injector during an actuation portion of a method of administering a medication using an auto-injector according to embodiments described herein.

[0074] In one exemplary embodiment of a method of using a reconstituted auto-injector, when the reconstituted auto-injector is ready for use, the end cap 21 (sometimes called the nose of the device) can be placed in contact with the patient, the end of the system can be placed adjacent to the injection site, and the system is ready for use.

[0075] The method may include pressing the reconstituted auto-injector system against an injection site. When the reconstituted auto-injector is pressed against a patient and the user is holding the outer body 19, the syringe body 33 (the inner portion of the outer body 19) may be pressed against the inner tube 5 to activate the second power source 2. Both the syringe body 33 and the inner body 20 may move independently of the outer body 19. Because the power sources 1, 2 are attached to the outer body 19, the syringe body 33 may move with the power sources 1, 2 towards the end of the reconstituted auto-injector system. The syringe body 33 may be pressed against the inner tube 5 of the second power source 2. The second power source 2 may be activated first and may be used via the respective plungers to automatically activate the second activated first power source 1. The first activated power source is referred to herein as the second power source 2 and the second activated power source is referred to herein as the first power source 1. Thus, the second power source 2 is first activated to reconstitute the medication, and the second power source 1 is activated after the medication is reconstituted so that the medication can be injected into the patient. When the second power source 2 is activated, the second spring 27 is released and the spring exerts a force on the second plunger rod 9.

[0076] 5-7 show cross-sectional views of an auto-injector during the reconstitution portion of a method of administering a medication using an auto-injector according to embodiments described herein.

[0077] As can be seen from Fig. 5, the method may include the steps of moving the second plunger 9 (dilution chamber plunger) towards the injection site, compressing the gas 22 in the second chamber, and displacing the liquid 23 (diluent). The stopper 12 is displaced by the compressed gas 22 and liquid 23, and the plug 13 is dislodged from the syringe body. The stopper 12 then moves towards its final position towards the end of the reconstituted autoinjector adjacent to the injection site. Due to the force exerted by the second plunger 11 (dilution chamber plunger), it forces the liquid 23 (diluent) to flow through the flow passage 8 into the first chamber (represented as the powder chamber).

[0078] As can be seen in Figure 6, the second chamber plunger 17 (diluent chamber plunger) moves the liquid 23 (diluent) into the first chamber (powder chamber). The space in the first chamber is filled and a load is applied to the first plunger 17 (powder chamber plunger) by the addition of the liquid 23 into the first chamber and / or the compression of the gas 22 in the first chamber. As the liquid 23 is injected into the first chamber, the liquid 23 and / or gas 22 in the first chamber move the plunger away from the end cap 21 (or needle). As the liquid 23 enters the first chamber, the diluent begins to reconstitute the powdered drug 24.

[0079] As can be seen in Figures 6 and 7, the second chamber plunger 11 (dilution chamber plunger) transfers the gas (dilution chamber gas / air) in the second chamber to 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 flow path 8 creates bubbles in the drug, agitating the drug and liquid and facilitating reconstitution of the drug. When the second plunger 11 reaches the end of the second chamber, it compresses the gas 22 in the liquid / gas 23 / 24 into the first chamber, eventually reaching a position adjacent to the flow path 8, thereby closing the flow path and retaining the fluid / gas 23 / 24 in the first chamber. In one exemplary embodiment of the method described herein, additional pressure may be created in the first chamber (powder chamber) during compression of additional gas from the second chamber into the first chamber before the second plunger reaches the end of the second chamber. The compressed gas exerts a force on the first plunger 17 (powder chamber plunger), which moves the first plunger toward the first power source 1 and away from the end of the system adjacent the injection site (end cap 21). As the first plunger 17 (powder chamber plunger) moves toward the first power source 1, it exerts a force to move the actuator 18, which then presses against the first inner tube 4 to activate the first power source 1. When the first power source 1 is activated, the first spring 26 is released and extends. A first spring 26 exerts a force on the first plunger rod 10 (powder chamber plunger rod) which causes the plunger 17 (powder chamber plunger) to move away from the first power source 1 towards the needle or end cap 21 of the system adjacent the injection site. The first plunger 17 (powder chamber plunger) moves towards the reconstituted drug mixture 23 / 24, compressing the gas in the first chamber.

[0080] 8-9B illustrate cross-sectional views of a reconstituted auto-injector during the injection portion of a method of administering a medication using an auto-injector according to embodiments described herein.

[0081] As illustrated in Figures 8 and 8A, when the first power source 1 is actuated, the first plunger 17 (powder chamber plunger) moves towards the reconstituted drug mixture 23 / 24, compressing the gas in the first chamber and forcing the needle 16 into the stopper 15 (powder chamber stopper). The compressed gas is vented into the space between the injection site and the stopper formed by the end cap 21 after the stopper is punctured.

[0082] As illustrated in Figures 9A-9B, the first power source 1 and the first plunger 17 (powder chamber plunger) continue to push the needle 16 into the injection site. As the needle 16 is inserted into the injection site, it travels through the reconstituted drug mixture 23 / 24. The needle 16 comprises a sharp end for penetrating the patient's injection site. The opposite end of the needle comprises a hole in the side of the needle, providing access to the drug for delivery through the hollow flow path of the needle from the hole to the opening in the sharp end of the needle. As the needle is inserted, the reconstituted drug mixture can contact and pass through the hole in the needle. The drug is then injected into the injection site as the needle is positioned in the tissue. Needle placement and drug delivery is completed when the first plunger 17 travels to the end of the first chamber.

[0083] FIG. 10 illustrates a cross-sectional view of a portion of a reconstituted auto-injector after a method of administering a medication using the auto-injector has been completed.

[0084] As illustrated in Fig. 10, the reserve drug volume / dose 29 may be available if the device is actuated upside down or there is a problem with the drug delivery position and if some drug is ejected from the system before the needle is inserted into the injection site. The system may be designed such that the reserve volume does not flow out of the device when actuated in a neutral position. The reserve volume may be stored in the reserve volume space of the device, such as in the space of the disk and / or in the volume between the disk and the stopper 15 in the first chamber.

[0085] As used herein, the terms "about," "substantially," or "approximately" for any numerical value, range, shape, distance, relative relationship, etc., indicate the appropriate dimensional tolerance that allows a portion or collection of components to perform its intended purpose as described herein. Numerical ranges may also be provided herein. Unless otherwise indicated, each range is intended to include the endpoints and any quantity within the range provided. Thus, the range 2-4 includes 2, 3, 4, and any subvalue between 2 and 4, such as 2.1, 2.01, 2.001, etc. Ranges also include any combination of ranges, such as 2-4 includes 2-3 and 3-4.

[0086] Although the 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 become apparent to those skilled in the art. Such changes and modifications should be understood as being included within the scope of the embodiments of the present invention as defined by the appended claims. Specifically, exemplary components are described herein. Any combination of these components can be used in any combination. For example, any components, features, steps, or parts can be integrated, separated, subdivided, removed, repeated, added, or used in any combination and still be within the scope of the present disclosure. The embodiments are merely illustrative and provide exemplary combinations of features, but are not limited thereto.

[0087] As used in this specification and claims, the terms "comprise" and "comprising" and variations thereof mean that the specified features, steps, or integers are included. These terms are not to be interpreted as excluding the presence of other features, steps, or components.

[0088] The features disclosed in the foregoing description, or the following claims, or the accompanying drawings, are expressed in their specific form, or in terms of means for performing a disclosed function, or a method or process for achieving a disclosed result, and can, where appropriate, be utilized to realize the invention in various of its forms, either separately or in any combination of such features.

Claims

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

2. The reconfigurable automatic syringe 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 system configured to be positioned adjacent to an 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 communicates with a first plunger and is configured to move the plunger away from the first power source, and the second power source communicates with a second plunger and is configured to move the plunger away from the second power source.

5. The reconfigurable auto-injector according to claim 4, wherein the second power source is configured to activate when the system is pressed against the patient's 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 first compressed spring, the first compressed spring being released and extended during operation, causing a second plunger rod and the second plunger to move 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 second compressed spring, the second compressed 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 stopper, and an end cap, wherein the stopper is located in the first chamber adjacent to the end cap, and the needle is configured to protrude into the stopper and move through the stopper and the end cap.

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

11. Steps to provide a reconfigurable auto-injector; Steps to activate the reconfigurable automatic syringe; The step of reconstituting a drug in powder form into a recomposed drug mixture; and The step of injecting the reconstituted drug mixture into the patient. The reconfigurable auto-injector for use in a method including the following.

12. A reconfigurable auto-injector according to claim 11, comprising a powder contained in a first chamber and a liquid contained in a second chamber, wherein the powder and the liquid are maintained separately from each other in a first configuration before use.

13. The reconfigurable automatic syringe according to claim 12, wherein the step of activating the reconfigurable automatic syringe includes pressing the reconfigurable automatic syringe against the patient's skin to automatically initiate the reconfiguration and the injection.

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

15. The reconfigurable automatic syringe 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 by the second spring, the liquid moves to the first chamber.

16. The reconstituted automatic syringe according to claim 15, wherein the method further comprises the steps of adding gas through the flow path to stir the liquid after the liquid has moved from the second chamber to the first chamber, reconstituting the powder with the liquid to prepare a reconstituted mixture, and closing the flow path with a second plunger.

17. The reconfigurable automatic syringe according to claim 15, further comprising the steps of filling the first chamber with the liquid from the second chamber and moving the first plunger within the first chamber to actuate a first compressed spring, thereby releasing the first compressed spring and applying force to the first plunger to move the first plunger away from the first spring and toward the injection site.

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

19. The reconfigurable auto-injector 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 stopper and the end of the needle is in a gap formed by the end cap and the end of the needle enters the patient's skin.

20. The reconstituted automatic syringe according to claim 19, wherein the method further comprises the step of moving the needle into the injection site of the patient and injecting the reconstituted mixture into the patient.

21. A first chamber configured to store the powder inside; 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; A first actuator configured to operate the first power source; A second chamber configured to store liquid; The second plunger in the second chamber; and A body having a second power source configured to push the second plunger to reduce the volume in the second chamber, and A reconfigurable automatic syringe comprising a flow path between a first chamber and a second chamber, such that when the second plunger is moved by the second power source, the liquid can flow into the first chamber, The reconfigurable automatic syringe, comprising a first plunger, a first actuator, and a first power source, wherein when liquid from the second chamber flows into the first chamber and the plunger moves in a first direction, increasing the volume of the first chamber, the actuator automatically activates the first power source, and once activated, the first power source 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 occur when the liquid in the second container is compressed by the second plunger after the operation of the second power source.

23. The step of providing a reconfigurable auto-injector comprising a first chamber containing powder, a second chamber containing liquid, a first power source, and a second power source; The steps of activating the second power source to start the first power source, compressing the liquid, and flowing the liquid from the second chamber to the first chamber; The step of reconstituting a drug in powder form into a recomposed drug mixture; and The step of automatically activating the first power source to inject the reconstituted drug mixture into the patient. The reconfigurable auto-injector for use in a method including the following.

24. The reconfigurable automatic syringe according to claim 23, wherein the automatic operation of the first power source is by the movement of the first plunger in a first direction, and the first power source is configured to move the first plunger in a second direction opposite to the first direction once activated.

25. The reconfigurable auto-injector according to claim 24, wherein the activation of the second power source is achieved by pressing the reconfigurable auto-injector against the patient's skin to activate the second power source.

26. The reconfigurable automatic syringe according to claim 25, wherein the method further includes the steps of maintaining the first chamber and the second chamber so as not to be in fluid contact via 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.

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