WO2025073048A1

WO2025073048A1 - Timed automatic injection device

Info

Publication number: WO2025073048A1
Application number: PCT/CA2024/051311
Authority: WO
Inventors: Emalie Marie LAFRAMBOISE; Jean-Marc Joseph Eugene Andre LAFRAMBOISE
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-10-04
Filing date: 2024-10-03
Publication date: 2025-04-10
Anticipated expiration: 2026-04-04

Abstract

The present disclosure provides a method and apparatus for the automatic injection of multiple doses of a fluid to a target site of a subject. The delivery device generally includes a housing and at least one injection assembly housed in the housing. A controller is configured to control the injection assembly to inject a first dose of a fluid after a first preselected time period has elapsed and to inject a second dose of a fluid after a second preselected time period has elapsed.

Description

TIMED AUTOMATIC INJECTION DEVICE

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/542476 filed on October 4, 2023. The contents of the aforementioned application are incorporated by reference herein.

TECHNICAL FIELD

[0002] The present disclosure generally relates to a delivery device for administering multiple doses of a fluid to a subject. In particular, the present disclosure generally relates to a delivery device and methods of using a delivery device to administer multiple doses of a medication to a subject to combat an opioid overdose.

BACKGROUND

[0003] Opioid overdoses are caused by an excess of opioids in the system of a subject and can lead to symptoms such as nausea, vomiting, loss of consciousness, depressed breathing, confusion and delirium. Depressed breathing, or even respiratory arrest, can be particularly dangerous and can result in hypoxia, where the body is starved of oxygen. Hypoxia can result in permanent neurological damage and organ failure. Left untreated, a subject can easily die due to these life-threatening effects.

[0004] The effects of an opioid overdose can be reduced or even reversed by the timely administration of a suitable medicament, such as Naloxone (marketed as Narcan™). Naloxone is known to be effective in blocking the effects of opioids and can be administered intravenously, intramuscularly, subcutaneously or as a nasal spray. It may be beneficial to administer multiple doses as the duration of action of some opioids is greater than that of Naloxone.

[0005] Autoinjectors are devices that are designed to allow one the ability to predominantly self-administer a set dose of medication intramuscularly or subcutaneously. By providing a secondary route to the patient’s systemic circulation that avoids obtaining an IV, autoinjectors circumvent many of the difficulties that IV’s carry, especially outside of hospital environments. Additionally, while IV lines must be placed by a trained healthcare professional, autoinjectors can be operated by members of the general public due to their simplicity and minimal risk of needlestick injuries or dosing errors.

[0006] Outside of the supervision of a healthcare professional, Naloxone is available for administration as a nasal spray or in a prefilled syringe. The prefilled syringe may require a user to inject manually and may in some cases feature a needle that automatically retracts after injection. However, a large proportion of opioid overdoses occur when a subject is alone. In many of these cases, once the effects of the overdose become apparent, such as loss of consciousness, the subject is unable to administer one or more doses of Naloxone to counteract the effects of the opioid and the chances of survival are greatly reduced.

[0007] Thus, there is a continuing need to provide improved methods and apparatuses for the administration of medicaments to treat opioid overdoses.

SUMMARY

[0008] According to an embodiment of the present disclosure, there is provided a delivery device operable to automatically deliver multiple doses of a fluid to a target site of a subject. The delivery device comprises a housing and an injection assembly housed inside the housing. The injection assembly comprises a syringe assembly configured to hold the fluid and a needle module comprising a needle in fluid communication with the syringe assembly. The needle module is moveable relative to the housing from a first needle module position wherein the needle is housed within the housing, to a second needle module position wherein the needle is inserted into a target site of the subject. The delivery device further comprises a controller in communication with the injection assembly, the controller being configured to: after a first preselected time period has elapsed: release the needle module from the first needle module position to the second needle module position to insert the needle into the target site of the subject and release the syringe assembly from a first syringe assembly configuration to a second syringe assembly configuration, to deliver a first dose of the fluid from the syringe assembly into the needle to inject the first dose into the target site; and after a second preselected time period has elapsed: release the syringe assembly from the second syringe assembly configuration to a third syringe assembly configuration, to deliver a second dose of the fluid from the syringe assembly into the needle to inject the second dose into the target site.

[0009] In some embodiments, the delivery device further comprises a first releasable retainer configured to secure the syringe assembly in the first syringe assembly configuration and to retain the needle module in the first needle module position, whereby the controller causes the first releasable retainer to release the syringe assembly and the needle module after the first preselected time period has elapsed and a second releasable retainer configured to secure the syringe assembly in the second syringe assembly configuration, whereby the controller causes the second releasable retainer to release the syringe assembly after the second preselected time period has elapsed.

[0010] In some embodiments, the first releasable retainer releases the needle module from the first needle position before releasing the syringe assembly from the first syringe assembly configuration.

[0011] In some embodiments, the syringe assembly comprises a fluid container and a plunger disposed within an interior space of the fluid container. As the syringe assembly is released from the syringe assembly configuration, the fluid container moves relative to the plunger from a first fluid container position to a second fluid container position, decreasing an interior volume of the fluid container to expel fluid from the fluid container through the needle; and as the syringe assembly is released from the second syringe assembly configuration, the fluid container moves relative to the plunger from the second fluid container position to a third fluid container position, further decreasing the interior volume of the fluid container to expel fluid from the fluid container through the needle.

[0012] In some embodiments, the fluid container is configured to move relative to the plunger along a longitudinal axis of the delivery device between the first, second and third fluid container positions.

[0013] In some embodiments, the first releasable retainer is configured to prevent movement of the plunger along the longitudinal axis of the delivery device. [0014] In some embodiments, the first releasable retainer comprises a first member to engage the needle module when the needle module is in the first needle module position and a second member to engage the fluid container when the fluid container in is the first fluid container position.

[0015] In some embodiments, the first and second members each comprise a latch mechanism.

[0016] In some embodiments, the second releasable retainer engages the fluid container through a latch mechanism once the fluid container reaches the second fluid container position and the latch mechanism disengaging the fluid container causes the fluid container to move to the second fluid container position.

[0017] In some embodiments, the controller is a mechanical controller. In some embodiments, the mechanical controller comprises a clockwork mechanism. In some embodiments, the controller is an electronic controller.

[0018] In some embodiments, the injection assembly further comprises a first energy storage member operable to release energy to the needle module an displace the needle module from the first needle module position to the second needle module position. In some embodiments, the first energy storage member comprises a spring.

[0019] In some embodiments, the injection assembly further comprises a second energy storage member operable to release energy to the syringe to displace the fluid container from the first syringe assembly configuration to the second syringe assembly configuration and from the second syringe assembly configuration to the third syringe assembly configuration. In some embodiments, the second energy storage member comprises a spring.

[0020] In some embodiments, the needle module is configured to rotate about a transverse axis of the delivery device as the needle module moves from the first needle module position to the second needle module position. [0021] In some embodiments, the needle module is configured to move in a linear direction along a transverse axis of the delivery device as the needle module moves from the first needle module position to the second needle module position.

[0022] In some embodiments, the delivery device further comprises an opening in the housing for the needle to extend through when the needle module moves from the first needle module position to the second needle module position. In some embodiments, the opening is covered by a septum. In some embodiments, the opening is covered by a slidable door.

[0023] In some embodiments, the delivery device further comprises a control interface on an outer surface of the housing to allow a user to set the first and second preselected time periods and to activate the device. In some embodiments, the control interface comprises one or more dials.

[0024] In some embodiments, the first prelected time period is between about 1 and about 90 minutes and the second preselected time period is between about 2 and about 90 minutes. In some embodiments, the second preselected time period is between about 3 minutes and about 5 minutes greater than the first preselected time period.

[0025] In some embodiments, the syringe assembly is configured to hold an amount of the fluid of no more than about 3 mL. In some embodiments, the first dose has a volume of between about 0.5 mL and about 3 mL.

[0026] In some embodiments, the first dose has a volume of about 1 mL. In some embodiments, the second dose has a volume of between about 0.5 mL and about 3 mL. In some embodiments, the second dose has a volume of about 1 mL. In some embodiments, the volume of the first dose is equal to the volume of the second dose.

[0027] In some embodiments, the fluid comprises an opioid antagonist. In some embodiments, the opioid antagonist comprises naloxone.

[0028] In some embodiments, the target site is an intramuscular site. In some embodiments, the target site is a subcutaneous site. [0029] In some embodiments, the delivery device is a wearable delivery device. In some embodiments, the wearable delivery device further comprises an attachment mechanism connected to the housing, the attachment mechanism configured to attach the delivery device to body part of the subject.

[0030] In some embodiments, the attachment mechanism is a strap. In some embodiments, the body part is an upper arm. In some embodiments, the body part is a thigh.

[0031] In some embodiments, the delivery device comprises at least two injection assemblies and the device is operable to automatically deliver multiple doses of a fluid to a target site from each of the at least two injection assemblies.

[0032] According to another embodiment, there is provided a method of operation of a delivery device operable to automatically deliver multiple doses of a fluid to a target site of a subject. The method comprises initiating a controller of the device, determining, using the controller when a first preselected time period has elapsed, and after the first preselected time period has elapsed: releasing a needle module from a first needle module position to a second needle module position to insert a needle into the target site of the subject, releasing a syringe assembly from a first syringe assembly configuration to a second syringe assembly configuration, to deliver a first dose of the fluid from the syringe assembly into the needle to inject the first dose into the target site and determining, using the controller when a second preselected time period has elapsed and after the second preselected time period has elapsed: releasing the syringe assembly from the second syringe assembly configuration to a third syringe assembly configuration, to deliver a second dose of the fluid from the syringe assembly into the needle to inject the second dose into the target site.

[0033] In some embodiments, the first and second preselected time periods are selected by the subject prior to initiating the device. In some embodiments, the first preselected time period is less than the second preselected time period. In some embodiments, the first preselected time period is equal to the second preselected time period.

[0034] In some embodiments, the needle module is released from the first needle position before the syringe assembly is released from the first syringe assembly configuration. [0035] In some embodiments, the method further comprises installing the syringe assembly containing the fluid into a housing of the delivery device prior to initiating the controller.

[0036] In some embodiments, the first prelected time period is between about 1 and about 90 minutes and the second preselected time period is between about 2 and about 90 minutes. In some embodiments, the second preselected time period is between about 3 minutes and about 5 minutes greater than the first preselected time period.

[0037] In some embodiments, the syringe assembly is configured to hold an amount of the fluid of no more than about 3 mL.

[0038] In some embodiments, the first dose has a volume of between about 0.5 mL and about 3 mL. In some embodiments, the first dose has a volume of about 1 mL.

[0039] In some embodiments, the second dose has a volume of between about 0.5 mL and about 3 mL. In some embodiments, the second dose has a volume of about 1 mL.

[0040] In some embodiments, the volume of the first dose is equal to the volume of the second dose.

[0041] In some embodiments, the fluid comprises an opioid antagonist. In some embodiments, the fluid comprises naloxone hydrochloride.

[0042] In some embodiments, the target site is an intramuscular site. In some embodiments, the target site is a subcutaneous site.

[0043] In some embodiments, the delivery device is a wearable delivery device. In some embodiments, the method further comprises attaching the wearable delivery device to a body part of the subject using an attachment mechanism prior to initiating the controller. In some embodiments, the attachment mechanism is a strap. In some embodiments, the body part is an upper arm. In some embodiments, wherein the body part is a thigh.

BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In drawings which illustrate embodiments of the invention, [0045] FIG. 1 is a schematic block diagram of a delivery device according to an embodiment of the present disclosure;

[0046] FIG. 2A is a cross sectional view of a delivery device according to another embodiment, with the delivery device in a first configuration;

[0047] FIG. 2B is a cross-sectional view of the delivery device of FIG. 2A in a second configuration;

[0048] FIG. 20 is a cross-sectional view of the delivery device of FIG. 2A in a third configuration;

[0049] FIG. 2D is a cross-sectional view of the delivery device of FIG. 2A in a fourth configuration;

[0050] FIG. 3 is a schematic view of an embodiment of a first releasable retainer, a second releasable retainer and a controller of the delivery device of FIG. 2A;

[0051] FIG. 4 is a schematic view of the second releasable retainer and controller of FIG. 3;

[0052] FIG. 5 is a perspective view of the delivery device of FIG. 2A, with the delivery device attached to a subject;

[0053] FIG. 6 is a cross sectional view of a delivery device according to another embodiment;

[0054] FIG. 7 is perspective view of the driver and second energy storage member of the delivery device of FIG. 6;

[0055] FIG. 8 is a perspective view of the delivery device of FIG. 6;

[0056] FIG. 9 is a cross sectional view of a delivery device according to another embodiment; and

[0057] FIGS. 10A and 10B are side and top views of the delivery device of FIG. 9. DETAILED DESCRIPTION

[0058] The following terms shall have the following meanings:

[0059] The term "comprising" and derivatives thereof are not intended to exclude the presence of any additional component, step or procedure, whether or not the same is disclosed herein. In order to avoid any doubt, all compositions claimed herein through use of the term "comprising" may include any additional additive or compound, unless stated to the contrary. In contrast, the term, "consisting essentially of" if appearing herein, excludes from the scope of any succeeding recitation any other component, step or procedure, except those that are not essential to operability and the term "consisting of", if used, excludes any component, step or procedure not specifically delineated or listed. The term "or", unless stated otherwise, refers to the listed members individually as well as in any combination.

[0060] The articles "a" and "an" are used herein to refer to one or to more than one (i.e. to at least one) of the grammatical objects of the article. By way of example, "a solvent" means one solvent or more than one solvent. The phrases "in one embodiment", "according to one embodiment" and the like generally mean the particular feature, structure, or characteristic following the phrase is included in at least one embodiment of the present disclosure and may be included in more than one embodiment of the present disclosure. Importantly, such phrases do not necessarily refer to the same aspect. If the specification states a component or feature "may", "can", "could", or "might" be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.

[0061] The term “about” as used herein can allow for a degree of variability in a value or range, for example, it may be within 10%, within 5%, or within 1% of a stated value or of a stated limit of a range.

[0062] Values expressed in a range format should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range, but to also include all of the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. For example, a range such as from 1 to 6, should be considered to have specifically disclosed sub-ranges, such as, from 1 to 3, from 2 to 4, from 3 to 6, etc., as well as individual numbers within that range, for example, 1 , 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0063] As used in this specification and the appended claims, the words “proximal” and “distal” refer to directions closer to and away from, respectively, the desired position of injection and delivery of fluid of the delivery device. The words “upward”, “downward”, “upper”, “lower”, “right” and “left” are relative terms used to designate components and/or directions for convenience and are not intended to be limiting. For example, an upper part could be located below a lower part depending on the direction of view (and vice versa). The words “inward” and “outward” refer to directions toward and away from, respectively.

[0064] The term “intramuscular site” or “IM site” refers to a position where an injection of a fluid can be administered into any muscle of a subject, such as the deltoid, vastus lateralis, rectus femoris or the ventrogluteal and dorsogluteal areas.

[0065] The term “subcutaneous site” refers to a position where an injection of a fluid can be administered beneath the skin of a subject. A subcutaneous injection may be administered into the subcutis, which is the layer of skin directly below the dermis and epidermis.

[0066] The term "operatively coupled" can refer to a direct or indirect coupling engagement between two or more structural component parts.

[0067] The term “fluid” includes any liquid, such as but not limited to, blood, water, saline solutions, IV solutions or plasma, or any mixture of liquids, particulate matter, medicament, dissolved medicament and/or drugs appropriate for injection into the target site of a subject.

[0068] The term “container” refers to a pharmaceutically acceptable container comprising a chamber suitable to house a fluid. Containers can include, but are not limited to vials, barrels, ampoules or bottles and in some embodiments are made of glass, plastic, composites, laminates or metal.

[0069] As used herein, a “subject” may be a human or non-human mammal. Nonhuman mammals include, for example, livestock and pets, such as ovine, bovine, porcine, canine and feline mammals. Preferably, the subject is a human and in some embodiments the operator and the subject are the same (i.e., the delivery device is a self-administering delivery device).

[0070] The terms “preferred” and “preferably” refer to embodiments that may afford certain benefits, under certain circumstances. However, other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the present disclosure.

[0071] The term “optional” or “optionally” means that the subsequently described event or circumstance may or may not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not.

[0072] The term “wt.%” means weight percent.

[0073] In one aspect, embodiments of the present disclosure are generally directed to a delivery device adapted to automatically inject multiple doses of a fluid into a target site, such as an intramuscular (IM) or subcutaneous (SQ) site of a subject. In some embodiments the target site is a portion of a thigh of a subject, such as the vastus lateralis muscle. In other embodiments, the target site is a portion of an arm of a subject, such as the deltoid muscle. In some embodiments, the delivery device is configured to be automatically deliver multiple doses of a fluid to a target site of the subject, where each dose is delivered after a pre-selected time period has elapsed.

[0074] As used herein, the first preselected time period (Ti) may refer to a period of time from the initiation/activation (To) of a delivery device as described herein. The second preselected time period (T2) may refer to a period of time from the initiation/activation of the delivery device (To) that is longer than the first preselected time period (T1). After the first preselected time period (T1) has elapsed, the delivery device is configured to deliver a first dose of fluid and after the second preselected time period (T2) has elapsed, the delivery device is configured to deliver a second dose of the fluid. The timing between the delivery of the first dose and the delivery of the second dose may be determined by (T2-T1). [0075] It has been recognized that by controlling an injection assembly such that once activated, the injection assembly will automatically administer multiple doses of a fluid (for example a medicament) to the target site of the subject, specific timings for the delivery of the medicament may be achieved for a subject that is not capable or qualified to do so themselves. For example, an opioid antagonist such as Naloxone may be automatically administered to a subject that has taken an opioid overdose, where the subject would be unable to administer a single dose of Naloxone to themselves, much less multiple doses. The subject may be able to activate the delivery device prior to losing consciousness and the delivery device will deliver multiple doses of Naloxone a specifically timed intervals. For example, in some embodiments, the subject may set the first and second preselected time periods (Ti and T2), take an opioid and then activate the device (To) By automatically controlling the time of administration of the first dose and the second dose, an optimal dosage schedule of first and second doses relative to the time of taking the opioid may be closely followed, increasing the likelihood of a better outcome for the subject. Further, in some embodiments, the subject or another individual may be able to deactivate the device at any point to prevent the device from delivering any further doses.

[0076] Accordingly, an embodiment relates to a delivery device comprising a housing and an injection assembly housed inside the housing. The injection assembly comprises a syringe assembly configured to hold the fluid and a needle module configured to insert a needle into the target site of the subject. The delivery device also includes a controller in communication with the syringe assembly and operable to, after the first preselected time period has elapsed, cause insertion of the needle of the needle module into the target site of the subject and to cause the delivery of a first dose of fluid from the syringe assembly to and through the needle and into the target site of the subject. The controller is also configured to, after the second preselected time period has elapsed, cause the delivery of a second dose of fluid from the syringe assembly to and through the needle and into the target site of the subject.

[0077] Other embodiments relate to a method for operation of a delivery device operable to automatically deliver multiple doses of a fluid to a target site of a subject.

[0078] An example delivery device 10 for automatically delivering multiple doses of a fluid to a target site of a subject is schematically illustrated in FIG. 1. As depicted, the apparatus 10 includes a housing 12 for housing injection assembly 13 and a controller 18. Injection assembly 13 is configured to deliver multiple doses of the fluid; for example 2, 3, 4, 5, 6 or more doses of the fluid. Each dose of fluid may be same volume, or the volume of some or all of the doses may vary.

[0079] Controller 18 is in communication with injection assembly 13 as is configured to, after the first preselected time period (Ti) has elapsed, cause injection assembly 13 to deliver a first dose of the fluid to the target site of a subject and after the second preselected time period has elapsed, cause injection assembly 13 to deliver a second dose of the fluid to the target site of a subject.

[0080] Injection assembly 13 includes a syringe assembly 14 and a needle module 16. Syringe assembly 16 is configured to hold a volume of a fluid and deliver the fluid to the needle module 16. Needle module 16 is configured to receive the fluid from syringe assembly 16 and deliver the fluid to a target site of the subject.

[0081] Although one injection assembly 13 is shown, the delivery device 10 may include one or more injection assemblies, for example 2, 3, 4, 5, 6 or more injection assemblies. Each injection assembly may be in communication with a shared controller or with separate controllers. Each injection assembly may contain the same fluid or different fluids.

[0082] FIGS 2A-D illustrate cross-sectional views of a delivery device 100, which is an example embodiment of the delivery device 10 in FIG. 1. Delivery device 100 is shown advancing sequentially from a first configuration (FIG. 2A) to a second configuration (FIG. 2B), to third configuration (FIG. 2C) and to a fourth configuration (FIG. 2D).

[0083] The delivery device 100 includes a housing 102 having a chamber 110, sized and configured to receive an injection assembly 103 and controller 108. Injection assembly 103 includes a syringe assembly 104 and a needle module 106. Whilst not shown in the FIGS., in some embodiments, syringe assembly 104 and/or needle module 106 may be mounted on a slidable assembly/internal frame that is slidably movable with respect to housing 102. This may enable syringe assembly 104 and/or needle module 106 to be removed from housing 102, such as for replacement or maintenance purposes. [0084] Chamber 110 may be divided to adjacent chamber sections 110a, 110b by inner wall 110c, where needle module 106 is housed in chamber section 110a and syringe assembly 104 is housed in chamber section 110b.

[0085] Chamber 110 includes openings 112, 114 at respective first and second ends 102a, 102b of housing 102. As will be explained in more detail, opening 112 is configured to allow a needle to pass therethrough and may include a breakable/pierceable seal or septum 116 for sterilization purposes.

[0086] At second end 102b, opening 114 may be sized to allow access to the components of delivery device 100. In some embodiments, opening 114 may permit the removal and replacement of some or all components of syringe assembly 104.

[0087] A cap 118 is disposed at second end of 102b of housing 102 to serve as a cover for opening 114. In some embodiments, cap 118 may be permanently attached to housing 102 or formed as an integral part of housing 102. In other embodiments, cap 118 may be removable from housing 102, such as through a threaded or snap fit connection.

[0088] The delivery device 100 as shown includes only one injection assembly 103, but in other embodiments, delivery device 100 may include more than one injection assemblies. In such embodiments, the components for the additional injection assemblies and their arrangement and operation would be similar injection assembly 103.

[0089] Syringe assembly 104 is configured to deliver multiple doses of a fluid from syringe assembly 104 to needle module 106. Syringe assembly 104 may have a first syringe assembly configuration, a second syringe assembly configuration (FIG. 2C) and a syringe assembly configuration (FIG. 2D).

[0090] Syringe assembly 104 includes a fluid container 120, plunger 122 and a first energy storage member 124. Fluid container 120 defines an internal volume and is configured to house a fluid and includes a first end 120a comprising an outlet or orifice that is fluidly coupled to needle module 106 through conduit 130, which passes through an opening 133 in internal wall 110c. Conduit 130 may be coupled to first end 120a by any suitable connection such as a Luer connector, threads, a snap-fit, a latch, a lock, a friction fit coupling, an adhesive or any other suitable coupling features. Fluid container 120 also comprises an open second end 120b for receiving plunger 122. In some embodiments, the fluid comprises a medicament, such as, for example, Naloxone or any of the other medicaments as will be further described below.

[0091] When delivery device 100 is in the first configuration shown in FIG. 2A, fluid container 120 is received with a fluid container housing 134, having a complementary size and shape to fluid container 120. Fluid container housing 134 is operable to prevent movement of fluid container 120 in a transverse direction (i.e., perpendicular to axis L in FIG. 2A) whilst still allowing fluid container to move along longitudinal axis L in the direction indicated by arrow 136 in FIG. 2A.

[0092] In the embodiment shown in FIGS. 2A-D, fluid container housing 134 is generally cylindrical and is interconnected to internal wall 110c. In some embodiments, fluid container housing is integrally formed with internal wall 110c and/or housing 102.

[0093] Plunger 122 is received on the open second end 120b of fluid container 120 and is sized and configured such that plunger 122 is moveably disposed within to the fluid container 120 as fluid container 120 is moved. Plunger 122 may have a cylindrical body with a first end 122a and a second end 122b. As shown in FIG. 2A, when syringe assembly 104 is in the first configuration, the first end 122a of plunger 122 may be proximal to the second end 120b of fluid container 120.

[0094] The first end 122a of plunger 122 may include a plunger seal 132 configured to contact the interior surfaces of the sidewalls of the fluid container 120 such that the plunger seal 132 forms a fluid-tight seal with the sidewalls of the fluid container 120, to prevent leakage of the fluid. The plunger seal 132 can be made of an inert and/or biocompatible material. Example materials include rubber, silicone, plastic, polymers, any other suitable material or combination thereof. In some embodiments, the plunger seal 132 can be monolithically formed with the plunger 122.

[0095] The second end 122b of plunger 122 is secured to cap 118 such that plunger 122 does not move relative to cap 118 and housing 102. In various embodiments, plunger may be secured to cap 118 by an interference fit; adhesive, fasteners (such as screws, rivets, clips), interlocking structural elements or any suitable means that restricts the relative motion of plunger 122 relative to housing 102. In other embodiments, plunger 122 may be directly secured to a portion of housing 102.

[0096] Injection assembly 103 also includes a first energy storage member 124, operable to release energy to fluid container 120 and displace fluid container 120 in direction 136. As this occurs, first energy storage member expands along axis L from a first configuration (FIGS. 2A and 2B), to a second configuration (FIG. 2C) to a third configuration (FIG. 2D), thereby displacing fluid container 120 in direction 136 from the first fluid container position (FIGS 2A and 2B), the second fluid container position (FIG. 2C) to the third fluid container position (FIG. 2D). As fluid container 120 moves, fluid container 120 will be displaced relative to the first end 122a of plunger 122. As such the internal volume defined by fluid container 120 will decrease, thereby expelling fluid into conduit 130 and to needle module 106.

[0097] When the first energy storage member 124 is in its first configuration, it has a first potential energy. When the first energy storage member 124 is in its second configuration, it has a second potential energy that is less than the first potential energy. When the first energy storage member 124 is in its third configuration, it has a third potential energy that is less than the second potential energy.

[0098] In the embodiment shown in FIGS. 2A-D, first energy storage member 124 is a mechanical energy storage member comprising a spring, such as, for example, a helical, compression, extension, torsion, constant, variable, variable stiffness or any other type of spring The first energy storage member 124 may be sized to receive fluid container housing 134 therewithin and is operatively coupled to the second end 120b of fluid container 120 and inner wall 110c.

[0099] When the first energy storage member 124 moves from its first configuration to its second configuration, it converts at least a portion of its first potential energy into kinetic energy to displace the fluid container 120 in the direction 136 from the first fluid container position to the second fluid container position. Said another way, the movement of the first energy storage member 124 from its first configuration to its second configuration results in the release of energy that acts upon the fluid container 120 to move the fluid container 120 from the first fluid container position (FIGS 2A and 2B) to the second fluid container position (FIG. 20) and thereby dispense a first dose of fluid contained within fluid container 120.

[00100] When the first energy storage member 124 moves from its second configuration to its third configuration, it converts at least a portion of its second potential energy into kinetic energy to displace the fluid container 120 in the direction 136 from the second fluid container position to the third fluid container position. Said another way, the movement of the first energy storage member 124 from its second configuration to its third configuration results in the release of energy that acts upon the fluid container 120 to move the fluid container 120 from the second fluid container position (FIGS. 20) to the third fluid container position (FIG. 2D) and thereby dispense a second dose of fluid contained within fluid container 120.

[00101] In some embodiments syringe assembly 104 may include a dampener mechanism (not shown in FIGS), operable to control the speed of motion of fluid container 120, thereby controlling the flow rate of the first and/or second dose of fluid from fluid container 120 to the subject.

[00102] In some embodiments, first energy storage member 124 may comprise more than one spring such as, for example, two springs. For example, in some embodiments first energy storage member 124 may comprise two springs wherein a first spring is located within a second spring, wherein the second spring has a larger diameter than the first spring. This may allow first energy storage member 124 to store a larger amount of energy to be used to displace the fluid container 120 as described above.

[00103] In some embodiments, a damper may be placed between fluid container housing 134 and first energy storage member 124 in order to slow the release of energy from first energy storage member 124, thereby slowing the movement of fluid container 120. In some embodiments, the damper may be a friction pad affixed to the inner surface of fluid container housing 134 and configured to contact first energy storage member 124, thereby slowing the expansion of the spring after first and second releasable retainers 126, 129 release fluid container 120. [00104] The dampener may be any suitable mechanism for controlling the speed of motion of fluid container 120 and/or the flow rate of the first and/or second dose of fluid. For example, the dampener may comprise a valve configured to restrict the flow of fluid. The valve may be positioned in or adjacent to fluid container 120, conduit 130 or needle 140. In another embodiment, the dampener may comprise a friction device configured to create friction between one or more moving components of syringe assembly 102, thereby slowing the motion of the one or more components. For example, the friction device may cause friction between fluid container 120 and first energy storage member 124, thereby slowing the motion of fluid container 120.

[00105] Injection assembly 103 also includes a needle module 106. The needle module 106 includes a driver 138, a needle 140 and a second energy storage member 146.

[00106] As shown in FIGS. 2A-D, driver 138 is shown as elongated member operatively coupled needle 140 at a first end 138a. Needle 140 may be removably coupled to driver such as by a snap fit or interference fit such that needle 140 can be removed and replaced between uses of delivery device 100. Needle 140 is also fluidly connected to conduit 130 to receive fluid from syringe assembly 104. Needle 140 may be connected to driver 138 and conduit 130 through a suitable clamping mechanism at first end 138a.

[00107] Driver 138 is rotatably coupled to housing 102 at the approximate mid-point of driver 138 through rotatable connection 142, such that driver 138 and needle 140 are operable to rotate in the direction indicated by arrow 144 from a first needle module position shown in FIG. 2A to a second needle module position shown in FIG. 2B.

[00108] Rotational connection 142 may be any suitable connection or mechanism that allows driver 138 to rotate relative to housing 102. In an embodiment, rotational connection 142 includes a cylindrical shaft that extends through an opening in driver 138 that is retained in opposed sides of housing 102 (not shown in FIGS.). Through this arrangement, driver 138 can pivot about the cylindrical shaft. [00109] In some embodiments, as needle module 106 moves from the first needle module position to the second needle module position, driver 138 will rotate through an angle of about 25 to 60 degrees.

[00110] Second energy storage member 146 is operable to release energy to driver 138 and displace driver 138 in direction 144. As this occurs, second energy storage member moves along an axis X from a first configuration (FIG. 2A) to a second configuration (FIG. 2B), thereby causing driver 138 and needle 140 rotate in the direction indicated by arrow 144 thereby displacing needle module 106 from a first needle module position shown in FIG. 2A to a second needle module position shown in FIG. 2B. When delivery device 100 is placed in proximity to the target site of a subject, this will have the effect of inserting the needle 140 through opening 112 and into the target site of the subject.

[00111] Second energy storage member 146 is operatively coupled to housing 102 though a mounting bracket 148 and is received within an opening at the second end 138b of driver 138. In the embodiment shown in FIGS 2A-D, the second energy storage member 146 is a mechanical energy storage member comprising a spring, such as, for example, a helical, compression, extension, torsion, constant, variable, variable stiffness or any other type of spring.

[00112] When the second energy storage member 146 is in its first configuration (shown in FIG. 2A), it also has a first potential energy. When the second energy storage member 146 is in its second configuration (shown in FIG. 2B), it has a second potential energy that is less than the first potential energy. The second energy storage member 146 is operably coupled to driver 138 such that when the second energy storage member 146 moves from its first configuration to its second configuration, it converts at least a portion of its first potential energy into kinetic energy to displace driver 138 and needle 140 in direction 144 from the first needle module position to the second needle module position.

[00113] The first and second energy storage members 124, 146 each independently can be any device for storing energy. Thus, one or both of the first and second energy storage members 124, 146 may be a mechanical energy storage member, such as a spring, a device containing compressed gas, a device containing a vapor pressure-based propellant or something similar or an electrical energy storage member, such as a battery, a capacitor, a magnetic energy storage member or something similar In yet other embodiments, one or more of the first and second energy storage members 124, 146 can be a chemical energy storage member, such as a container containing two substances that, when mixed, react to produce energy.

[00114] Injection assembly 103 also includes first and second releasable retainers 126, 129, which may be any suitable mechanisms operable to prevent or restrict movement of fluid container 120 along axis L and/or needle module 106 in direction 144.

[00115] As depicted in FIG. 2A, first releasable retainer 126 comprises first and second arms 127, 128. First arm 127 is configured to secure fluid container 120 in the first fluid container position and to release fluid container 120 to allow fluid container 120 to move to the second fluid container position (FIG. 2C). First releasable retainer 126 is also configured to retain needle module 106 in the first needle module position (FIG. 2A) and to release needle module 106 to allow needle module 106 to move from the first needle module position to the second needle module position (FIG. 2B).

[00116] Second releasable retainer 129 comprises a first arm 131 and is configured to secure fluid container 120 in the second fluid container position (FIG. 2C) and to release fluid container 120 to allow fluid container 120 to move to the third fluid container position (FIG. 2D).

[00117] In the embodiment shown in FIGS. 2A-D, retainers 126, 129 include inwardly projecting latch mechanisms 127a, 131a respectively operable to releasably engage the first end 120a of fluid container 120. First releasable retainer 126 also includes latch mechanism 128a operable to releasably engage the second end 138b of driver 138. In other embodiments, first and second releasable retainers 126, 129 may comprise another type of engagement mechanism such as a mechanical linkage, a compressed ring, a spring-loaded rod, a tensioned latch or tab or the like.

[00118] As will be explained in more detail below, the disengagement of latch mechanisms 127a, 128a 131a of first and second releasable retainers 126, 129 is controlled by controller 108, which causes the disengagement of latch mechanism 128a, followed by latch mechanism 127a, followed by latch mechanism 131a. [00119] Whilst not shown in the FIGS., in some embodiments delivery device 100 may include a safety activation mechanism operatively coupled with needle module 106 operable to prevent rotation of driver 138 until the safety activation mechanism is activated. Thus, the safety activation mechanism is configured to prevent the premature or accidental deployment of the delivery device 100. The safety activation mechanism may comprise any suitable mechanism, such as a button, pin, knob or similar mechanism. In such embodiments, regardless of whether latch mechanism 128a has been released from engagement with driver 138, the safety activation mechanism will prevent movement of driver 138.

[00120] In some embodiments, needle 140 may have a safety cap 141 (FIG. 2A) configured to surround at least first end 140a of needle 140. Safety cap 141 may protect a user from needlestick injuries when needle 140 is installed in driver 138. In some embodiments, once needle 140 is installed in driver 138 and safety cap 141 is removed, the device may be considered armed and ready for use.

[00121] In some embodiments, delivery device 100 may include a locking mechanism 115 (FIG. 2A) that that blocks or inhibits any movement of needle 140 through opening 112. Locking mechanism 115 may have a locked configuration, whereby needle 140 is prevented passing through opening 112 and an unlocked configuration, whereby needle 140 is able to pass though opening 112 (as driver 138 and needle 140 rotate to the second needle module position shown in FIG. 2B). Locking mechanism may be, for example, a shearable tab or sliding door that a user can shear/slide such locking mechanism 115 is in the unlocked configuration. In some embodiments, locking mechanism may be formed as part of seal/septum 116.

[00122] Once activated/initiated, controller 108 is configured to measure a first preselected time period and a second preselected time period. Once the first preselected time period (Ti) has elapsed, controller 108 is configured to first cause the first releasable retainer 126 (through disengagement of latch mechanism 128a with the second end 138b of driver 138) to release the needle module 106 from the first needle module position to the second needle module position to insert the needle into the target site of the subject. Once the first preselected time period (Ti) has elapsed (but after the needle module 106 has been released to the second needle module position, controller 108 is also configured to cause the first releasable retainer 126 to release syringe assembly 104 from the first syringe assembly configuration to a second syringe assembly configuration to deliver a first dose of the fluid from the syringe assembly 104 into the needle 140 to inject the first dose into the target site. Once the second preselected time period (T2) has elapsed, controller 108 is configured to configured to cause the second releasable retainer 129 to release the syringe assembly 104 from the second syringe assembly configuration to a third syringe assembly configuration to deliver a second dose of the fluid from the syringe assembly 104 into the needle 140 to inject the second dose into the target site.

[00123] In the embodiment shown in FIGS. 2A-D, controller 108 is configured to control engagement/disengagement of first and second releasable retainers 126, 129.

[00124] In some embodiments, controller 108 may be an entirely mechanical controller. For example, controller 108 may comprise one or more mechanical timers, such as clockwork mechanisms in communication with first and second releasable retainers 126, 129. The clockwork timers will measure one or both of the preselected time periods (T 1 and/or T2) after delivery device 100 is activated/initiated.

[00125] The use of an entirely mechanical mechanism, i.e., without any electronics may beneficially increase reliability, reduce maintenance, lower cost of delivery device 100. For example, an entirely mechanical device may more reliably operate in lower temperatures.

[00126] An example of how mechanical controller 108 may operate first and second releasable retainers 126, 129 is illustrated schematically in FIGS. 3 and 4.

[00127] Controller 108 may include first and second timers 150, 152 respectively. First timer 150 is in communication with first releasable retainer 126 and second timer 152 is in communication with second releasable retainer 129, through respective linkages 154, 156. Linkages 154, 156 may be any suitable type of mechanical linkage.

[00128] In some embodiments, first and second timers 150, 152 and first and second releasable retainers 126, 129 may be mounted on the same slidable assembly/internal frame as the other components of syringe assembly 104 and needle module 106 such that these components are slidably moveable relative to housing 102.

[00129] First and second releasable retainers 126, 129 are illustrated in FIG.3 as positioned when delivery device 100 in the first configuration shown in FIG. 2A, where latch mechanism 127a of first arm 127 is in engagement with second end 120b of fluid container 120 and latch mechanism 128a is in engagement with second end 138b of driver 138. In some embodiments, when delivery device 100 is in the first configuration, first and second arms 127, 128 may be partially retained in the positions shown in FIG. 3 by respective third and fourth energy storage members 166 and 168.

[00130] First and second arms 127, 128 of first releasable retainer 126 may be interconnected to a first rotational member 158. First rotational member 158 is configured to rotate about a central axis 160 in a clockwise direction 162 (as viewed in FIG. 3).

[00131] Once the first preselected time period has elapsed, controller 108 will cause first rotational member 158 to rotate in clockwise direction 162, which causes interconnected second arm 128 to move in the direction indicated by arrow 170, thereby causing latch mechanism 128a to disengage with second end 138b of driver 138. As a result, driver 138 and needle 140 are able to rotate in the direction indicated by arrow 144 in FIG. 2A from the first needle module position shown in FIG. 2A to a second needle module position shown in FIG. 2B.

[00132] As shown in FIG. 3, first arm 127 of first releasable retainer 126 may include a proximal portion 172 and a distal portion 174 rotationally coupled to each other via a rotational joint 176. Distal portion 174 may be supported by a pin 178 which is interconnected at one end to a portion of housing 102 and at the other end to a spiral groove 180 of distal portion 174.

[00133] Rotation of first rotational member 158 in clockwise direction 162 will cause interconnected first arm 127 to be urged in the direction indicated by arrow 182 in FIG.3. This will result in rotation of distal portion 174 relative to proximal portion 172 (via rotational joint 176) via a longitudinal axis of rotation 182. Thus, the linear motion of proximal portion 172 is converted into rotational motion of distal portion 174. Rotation of distal portion 174 about axis 182 will in turn result of rotation of latch mechanism 127a such that latch mechanism 127a is rotated way from second end 120b of fluid container 120 and thereby disengages from engagement with second end 120b. As a result, fluid container 120 is free to move along longitudinal axis L from the first fluid container position shown in FIGS. 2A and 2B to the second fluid container position shown in FIG. 20 as described above, whereby second end 120b engages with latch mechanism 131a of first arm 131 of second releasable retainer 129.

[00134] Third energy storage member 168 may prevent linear motion of second arm 128 (i.e. , movement in direction 170), whilst fourth energy storage member 166 may prevent rotational movement of proximal portion 172 of first arm 127 (via rotational joint 176) via the longitudinal axis of rotation 182.

[00135] In some embodiments, first rotational member 158 may function such that both first and second arms 127, 128 of first releasable retainer 126 are actuated at the same time, thereby allowing needle module 106 to move from the first needle module position to the second needle module position and allowing fluid container 120 to move from the first fluid container position to the second fluid container position at substantially the same time. In other embodiments, there may be a delay between the actuation of first and second arms 127, 128 such that second arm 128 is actuated before first arm 127. This may ensure that needle 140 is inserted into the target site of the subject before the first dose is delivered from fluid container 120 to needle 140.

[00136] As shown in FIG. 3, the mounting point 157 of second arm 128 to first rotational member 158 is closer to the central axis 160 of first rotational member 158 compared to the mounting point 161 of first arm 127. In the embodiment shown in FIG. 3, second arm 128 requires a smaller distance of linear movement in comparison to first arm 127 in order to disengage latch mechanism 128a. As a result, of first rotational member 158 rotates, latch mechanism 128a of second arm 128 will disengage with second end 138b of driver 138 before latch mechanism 127a disengages from engagement with second end 120b of fluid container 120. As a result, needle module 106 will start to move from the first needle module position shown to the second needle module position before fluid container 120 starts to move from the first fluid container position to the second fluid container position. In some embodiments needle module 106 may be in the second needle module position before fluid container 120 starts to move from the first fluid container positions.

[00137] Turning to FIG. 4, second releasable retainer 129 is shown as positioned when delivery device 100 is in the third configuration shown in FIG. 2C, where fluid container 120 is in the second fluid container position and latch mechanism 131a of first arm 131 of second releasable retainer 129 is in engagement with second end 120b of fluid container 120. In some embodiments, first arms 131 may be partially retained in the position shown in FIG. 4 by fifth energy storage member 184.

[00138] First arm 131 of second releasable retainer 129 may be interconnected to a second rotational member 186. Second rotational member 186, may be generally similar to first rotational member 158 and is configured to rotate about a central axis 188 in a clockwise direction 190 (as viewed in FIG. 3).

[00139] Similar to first arm 127 of first releasable retainer 126 described above, first arm 131 of first releasable retainer 129 may include a proximal portion 192 and a distal portion 194 rotationally coupled to each other via a rotational joint 196. Distal portion 194 may be supported by a pin 198 which is interconnected at one end to a portion of housing 102 and at the other end to a spiral groove 200 of distal portion 194.

[00140] Once the second preselected time period has elapsed, controller 108 will cause second rotational member 188 to rotate in clockwise direction 190, causing interconnected first arm 131 to be urged in the direction indicated by arrow 202 in FIG.4.

[00141] This will result in rotation of distal portion 194 relative to proximal portion 192 (via rotational joint 196) via a longitudinal axis of rotation 204. Rotation of distal portion 194 about axis 204 will in turn result of rotation of latch mechanism 131a such that latch mechanism 131a is rotated way from second end 120b of fluid container 120 and thereby disengages from engagement with second end 120b. Thus, the linear motion of proximal portion 192 is converted into rotational motion of distal portion 194. As a result, fluid container 120 is free to move along longitudinal axis L from the second fluid container position shown in FIG. 2C to the third fluid container position shown in FIG. 2D.

[00142] In some embodiments a sixth energy storage member 206 may be interconnected to second rotational member 188 and is configured to prevent rotation of second rotational member 188 until a sufficient rotational force is applied.

[00143] Similar to first energy storage member 124, third, fourth, fifth and sixth energy storage members 166, 168, 184 and 206 may mechanical energy storage members comprising a spring, such as, for example, a helical, compression, extension, torsion, constant, variable, variable stiffness or any other type of spring. Energy storage members 166, 168 and 184 may exert a force sufficient bias their respective latch mechanisms to remain in engagement until a sufficient counter force is applied, for example from rotation of rotational members 158, 186. In other embodiments members 166, 168, 184 and 206 may be any other suitable type of non-permanent retainer, such as a clip, latch or breakable part that is configured to detach/break upon application of a sufficient force.

[00144] Rotational movement of first and second rotation members 158, 186 may be driven by any suitable method. For example, each member 158, 186 may mechanically connected to a suitable drive mechanism controlled by controller 108. In an embodiment, the drive mechanism may use a suitable clockwork mechanism controlled by controller 108 and configured to drive rotation of members 158, 186. For example, where timer 150 and 152 are clockwork mechanisms, once the respective preselected time period has elapsed, the respective clockwork mechanism could be used to drive rotational movement of first and second rotation members 158, 186 through the respective linkages 154, 156. Each clockwork mechanism may be entirely mechanical and include a torsional spring which may be prewound by a user, such as through a dial on the external surface of housing 102 of delivery device 100.

[00145] In other embodiments, rotational movement of first and second rotation members 158, 186 may be driven by one or more electric motors within housing 102 of delivery device 100. The one or more electric motors may be powered by a suitable power source, such as a battery within housing 102 of delivery device 100. The one or more electric motors may be activated by first timer 150 and/or second timer 152 once the respective preselected time period has elapsed.

[00146] In some embodiments, first and second timers 150, 152 may be replaced by a single integrated timer, operable to measure both the first and second preselected time periods simultaneously.

[00147] In other embodiments, controller 108 may be electronically coupled to first and second releasable retainers 126, 129. In other embodiments, controller 108 may be in wireless communication with first and second releasable retainers 126, 129. [00148] In other embodiments controller 108 may be an electric controller in communication with a solenoid mechanism configured to activate first and second releasable retainers 126, 129.

[00149] With reference to FIG. 5, the exterior delivery of device 100 is shown when placed on a portion of the upper leg 208 of a subject. Housing 102 is generally cuboidal in shape and includes a first end 102a, a second end 102b and an exterior surface 102c. The housing 102 may be a unitary structure (i.e., one-piece) that defines the exterior surface 102c, or it may include a plurality of layers with different layers defining the exterior surface 102c. In other embodiments, housing 102 may have any suitable shape.

[00150] In various embodiments, delivery device 100 may have a length of between about 7 inches to about 11 inches, a width of between about 0.5 inches and about 3 inches and a height of between about 2 inches and about 4 inches. In an embodiment, delivery device 100 may have a length of about 9 inches, a width of about 1.75 inches and a height of between about 3.75 and about 4 inches.

[00151] In some embodiments, housing 102 may be rigid. According to other embodiments, the housing 102 may be flexible, whether according to the nature of the material that defines housing 102 or according to the nature of the structure of the upper housing 102. In some embodiments, housing may be transparent, partially transparent or opaque such that a user may view part or all of the contents of the housing 102. This may be beneficial, for example to assist in determining if the components or delivery device 100 have been correctly installed or to confirm if delivery device 100 has been activated.

[00152] In some embodiments, housing 102 may feature one or more elongated windows sized and configured to allow the operator to view the contents of housing 102. The windows may be any suitable shape for viewing the contents, such as, but not limited to, an arrow, rectangle or a long oval. The windows may comprise a clear material, such as a translucent or transparent material to maintain the sterility of the delivery device 100 whilst allowing the operator to view the contents of housing 102.

[00153] Housing 102 may be made of glass, metal, or polymer, for example. In particular, polymer versions may be made of polycarbonate, polypropylene, polyethylene (such as high density polyethylene), polytetrafluoroethylene, cyclic olefin polymer, cyclic olefin copolymer, crystal zenith olefinic polymer, nylon, or engineering resins. As to flexible versions of the housing 102, butyl rubber, silicon-based rubber, latex-based rubber, coated rubber, as well as multi-layer polymer films, such as polyethylene (such as low density polyethylene) and polypropylene, may be used.

[00154] In order to secure delivery device 100 to a subject, delivery device 100 may include an attachment mechanism, such as strap 210. Strap 210 is configured to wrap around delivery device 100 and a limb of a subject, such as arm 208 to hold the delivery device in place. This is especially important in situations where the subject may be overdosing whereby involuntary movement could undesirably shift the placement of delivery device 100. Strap 210 may have an adjustable length so as to accommodate different subjects and such that delivery device may be secure to different limbs of the subject. Strap 208 may be adjusted and then secured in place in any suitable way, such as Velcro or a buckle. In some embodiments, strap 208 may be permanently secured to a portion of the exterior surface 102c of housing 102, such as by a suitable adhesive.

[00155] The exterior surface 102c of housing 102 may include a user interface, operable to enable a user to select the first and second preselected time period. Still referring to FIG. 5, in some embodiments this may include first and second dials 212 and 214 respectively that form part of controller 108. First dial 212 may be configured to set the first preselected time period of timer 150 and second dial 214 may be configured to set the second preselected time period of timer 152.

[00156] In some embodiments, once the first and second preselected time periods have been programmed into the respective first and second timers 150, 152, the timers may automatically begin counting (i.e. , delivery device is initiated/activated at this point). In other embodiments, the first and respective first and second timers 150, 152 may require a further user input to initiate before beginning counting. This user input may include the activation of a switch or button (not shown in FIGS.) on the exterior surface 102c of housing 102 in order to initiate/activate delivery device 100.

[00157] Delivery device 100 may also include a driver rotation control 216 on the exterior surface 102c of housing 102. Driver rotation control 216 may be interconnected to rotational connection 142 of driver 138 and enables, by rotation of control 216, a user to rotate driver 138 (and interconnected needle 140) manually. This may enable a user to remove needle 140 once needle 140 has been inserted into the target site of a subject, for example once all doses have been delivered to the subject or if it desired to abort any further doses being delivered to the subject.

[00158] To illustrate operation of the delivery device 100, a sequence of events illustrating the injection and delivery of fluid by the device 100, as well as the position of the various components, is discussed progressing from FIGS. 2A-D.

[00159] FIG. 2A illustrates the delivery device 100 in a first configuration, where the delivery device 100 is ready for use and activation. Syringe assembly 104 is in the first syringe assembly configuration, with fluid container 120 in the first fluid container position. Needle module 106 is in the first needle module position. First and second energy storage members 124, 146 are in their first configurations. Fluid container 120 is held in the first fluid container position by first releasable retainer 126. Needle module 106 is held in the first needle module position by first releasable retainer 126.

[00160] An operator may place delivery device 100 on a body part a subject, such that opening 116 is in proximity to the desired target site. Delivery device may then be secured to the target site using strap 210. Prior to or following this a user will program the first and second preselected time periods using dials 212 and 214. Once the time periods have be programmed the timers 150, 152 will begin timing. As described above, in some embodiments, delivery device 100 may require to be initiated/activated by operation of a switch/button before timers 150, 152 will begin timing. It should be noted that the term “user” in this instance may refer to the subject that the device is being placed on, or to another person who is securing and configuring the device on the subject.

[00161] Once delivery device 100 is activated timers 150, 152 of controller 108 will monitor the period of time elapsed. Once timer 150 determines that the first preselected term period (Ti) has elapsed the controller 108 causes an automatic sequence of movements. First, as described above latch mechanism 128a will disengage from second end 138b of driver 138. As this occurs second energy storage member 146 is able to release energy as it moves from its first configuration to its second configuration, exerting a force on driver 138 causing driver 138 to rotate about rotational connection 142 in direction 144. As this occurs interconnected needle 140 will also move and the first end 140a of needle 140 will penetrate seal 116 such that a portion of needle 140 extends outside of housing 102 and is injected into the target site of the subject at the desired depth.

[00162] FIG. 2B illustrates the delivery device 100 in a second configuration. Syringe assembly 104 is still in in the first syringe assembly configuration, with fluid container 120 still in the first fluid container position. Needle module 106 is now in the second needle module position, with second energy storage member 146 in its second configuration. Fluid container 120 is still held in the first fluid container position by first releasable retainer 126. Needle 140 has been inserted into the target site of the subject. Latch mechanism 127a will disengage from second end 120b of fluid container 120. As this occurs first energy storage member 124 is able to release energy as it moves from its first configuration to its second configuration, thereby displacing fluid container 120 in direction 136 along longitudinal axis L from the first fluid container position (FIG. 2B) to the second fluid container position (FIG. 2C). As this occurs, with plunger secured in place relative to housing 102, the movement of fluid container 120 will cause the internal volume of fluid container 120 to decrease, which will cause a first volume (first dose) of fluid to be delivered from/urged out of from fluid container 120 through the outlet at first end 120a and into conduit 130 and through needle 140 and into the target site of the subject. Fluid container 120 will continue to be displaced in direction 136 until second end 120b engages latch mechanism 131a of second releasable retainer 129 (FIG. 2C).

[00163] FIG. 2C illustrates the delivery device 100 in a third configuration. Syringe assembly 104 is now in the second syringe assembly configuration, with fluid container 120 in the second fluid container position and first energy storage member in 124 in its second configuration. Needle module 106 is still in the second needle module position, with needle 140 inserted into the target site of the subject. Displacement of fluid container 120 beyond the second fluid container position is prevented by engagement of latch mechanism 131a with second end 120b of fluid container 120.

[00164] Delivery device 100 will remain in this configuration until the second preselected time period (T2) has elapsed. Once timer 152 determines that the second preselected time period has elapsed, as described above controller 108 will cause latch mechanism 131a to disengage with second end 120a of fluid container 120. As this occurs first energy storage member 124 is able to release energy as it moves from its second configuration (FIG. 20) to its third configuration (FIG. 2D), thereby displacing fluid container 120 in direction 136 along longitudinal axis L from the second fluid container position (FIG. 20) to the third fluid container position (FIG. 2D). As this occurs, with plunger secured in place relative to housing 102, the displacement of fluid container 120 will cause the internal volume of fluid container 120 to further decrease, which will cause a second volume (second dose) of fluid to be delivered from/urged out of fluid container 120 through the outlet at first end 120a and into conduit 130 and through needle 140 and into the target site of the subject.

[00165] Fluid container 120 may continue to be displaced in direction 136 until first energy storage member 124 has expelled all of its energy and/or second end 120b of fluid container 120 contacts the end of housing 102 adjacent to cap 118 or the first end 122a of plunger 122 contacts the first end 120a of fluid container 120.

[00166] Once the second dose of fluid has been delivered, delivery device 100 may be removed from the subject, which will also remove needle 140 from the target site. Prior to or after removal of delivery device 100, needle 140 may be retracted back into housing 102 by rotation of driver rotation control 216. This may assist in preventing needlestick injuries.

[00167] Fluid container 120, plunger 122 and needle 140 may be any suitable commercially available combination of fluid container, plunger and needle.

[00168] Fluid container 120, plunger 122, conduit 130 and needle 140 may all be removal and disposable components of delivery device 100 such that a user may remove, dispose and replace these components such that delivery device 100 may be reused multiple times. The removable components may be accessed by removing cap 118, allowing access to the chamber 110 of housing 102.

[00169] In various embodiments fluid container 120 may be configured to hold an amount of fluid in the range of about 0.5 milliliter (mL) to about 20 mL, or about 2 mL to about 15 mL, or about 3 mL to about 10 mL, or about 4 mL to about 6 mL. In some embodiments the fluid container holds 1 mL of fluid. [00170] In other embodiments, delivery device 100 may not be a wearable device. In some embodiments, delivery device 100 may only need to held in place at the target site when the first and second doses are delivered. Delivery device 100 may be configured to produce an indication/notification when a dose of fluid is about to be delivered, such that a user (who may or may not be the individual receiving the dose) may place the device in proximity to the target site. The indication/notification may an audible warning (such as a chime or buzzer) or a visible warning (such as a light) originating form delivery device 100. In some embodiments, the indication/notification may comprise a signal that is sent from delivery device 100 to another device, such as a mobile phone, where the other device displays/relays the signal to the user.

[00171] The fluid may comprise a medicament such as, but not limited to, an analgesic, anti-inflammatory agent, anthelmintic, anti-arrhythmic agent, antibiotic (including penicillin), anticoagulant, antidepressant, antidiabetic agent, antiepileptic, antihistamine, antihypertensive agent, antimuscarinic agent, anti mycobacterial agent, antineoplastic agent, antifibrinolytic, immunosuppressant, antithyroid agent, antiviral agent, anxiolytic sedative (hypnotics and neuroleptics), astringent, beta-adrenoceptor blocking agent, blood product and substitutes, cardiac inotropic agent, corticosteroid, cough suppressant (expectorants and mucolytics), diagnostic agent, diuretic, dopaminergic (antiparkinsonian agents), haemostatic, immunological agent, lipid regulating agent, muscle relaxant, parasympathomimetic, parathyroid calcitonin and biphosphonate, prostaglandin, radiopharmaceutical, sex hormone (including steroids), anti-allergic agent, stimulant and anorexic, sympathomimetic, thrombolytic, thyroid agent, PDE IV inhibitor, NK3 inhibitor, ppar agent, NK-2 inhibitor, CSBP/RK/p38 inhibitor, antipsychotic, vasodilator, xanthine, and antidote (e.g., to a toxin or to a biological, chemical, or radiological weapon).

[00172] In some embodiments, the fluid may further comprise a suitable solvent, such as water.

[00173] In some embodiments, the fluid comprises an opioid antagonist or opioid receptor antagonist, that is, a receptor antagonist that acts on one or more opioid receptors. In some embodiments the opioid antagonist comprises Naloxone, Naltexone, Nalmefene or Samidorphan. [00174] In some embodiments the fluid comprises a Naloxone Hydrochloride solution (Narcan™) having a concentration of 400 pg/mL

[00175] In some embodiments the fluid comprises Epinepherine.

[00176] In some embodiments, the first dose is equal to the second dose. In other embodiments, the first dose is greater or smaller than the second dose.

[00177] In various embodiments, the first and/or second dose the dose is provided in an amount of fluid in the range of about 0.5 mL to about 5 mL, about 1 mL to about 4.5 mL, about 1.5 mL to about 4.0 mL, about 2 mL to about 3.5 mL or about 2.5 mL to about 3.0 mL. In various embodiments, the first and/or second dose the dose is provided in an amount of fluid of about 0.1 mL, about 0.2 mL, about 0.3 mL, about 0.4 mL, about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, about 1 .0 mL, about 1.1 mL, about 1 .2 mL, about 1.3 mL, about 1.4 mL, about 1.5 mL, about 1.6 mL, about 1.7 mL, about 1.8 mL, about 1.9 mL, about 2.0 mL, about 2.5 mL, about 3.0 mL, about 3.5 mL, about 4.0 mL, about 4.5 mL or about 5.0 g. In some embodiments the first dose is about 1 mL and the second dose is about 1 mL

[00178] It will be appreciated that the volume of the first and/or second dose is influenced by a number of factors such as the relative sizes of fluid container 120 and plunger 122, and the relative placing of latch mechanisms 127a, 131a of first and second releasable retainers 127, 129 respectively. For example, is the spacing between latch mechanisms 127a, 131a (in the longitudinal direction L) were to be increased, then the size of the first dose would also be increased as fluid container 120 would be displaced a further distance between the first fluid container position and the second fluid container position.

[00179] As will be appreciated, the respective lengths of first arm 127 of first releasable retainer 126 and first arm 131 of second releasable retainer 129 will influence the volume of the first and/or second doses. For example, increasing the length of first arm 131 relative to first arm 127 will increase the size of the first dose as fluid container 120 will move a greater distance in direction 136 when released by first releasable retainer 126. Similarly, decreasing the length of first arm 131 will increase the size of the second dose as fluid container 120 will move a greater distance in direction 136 when released by second releasable retainer 129. [00180] In some embodiments, the first preselected time period (Ti) is less than the second preselected time period (T2).

[00181] In various embodiments the first and/or the second preselected time period is in the range of about 1 to 90 minutes, about 5 to 85 minutes, about 10 to 80 minutes, about 15 to 75 minutes, about 20 to 70 minutes, about 25 to 65 minutes, about 30 to 60 minutes, about 35 to 55 minutes, or about 40 to 50 minutes.

[00182] In various embodiments, the second preselected time period is greater than the first preselected time period (T2-T1) by between about 1 to 90 minutes, about 5 to 85 minutes, about 10 to 80 minutes, about 15 to 75 minutes, about 20 to 70 minutes, about 25 to 65 minutes, about 30 to 60 minutes, about 35 to 55 minutes, or about 40 to 50 minutes. In some embodiments, the second preselected time period is about 5 minutes greater, about 10 minutes greater, about 15 minutes greater, about 20 minutes greater, about 25 minutes greater, about 30 minutes greater, about 35 minutes greater, about 40 minutes greater, about 45 minutes greater, about 50 minutes greater, about 55 minutes greater, about 60 minutes greater, about 65 minutes greater, about 70 minutes greater, about 75 minutes greater, about 80 minutes greater, about 85 minutes greater or about 90 minutes greater. In an embodiment the second preselected time period is 3-5 minutes greater than the first preselected time period

[00183] In some embodiments, the first and second preselected time periods may be fixed when delivery device 10 is manufactured and may not be adjustable.

[00184] In some embodiments, the fluid comprises a Naloxone Hydrochloride solution having a concentration of 400 pg/mL and the first dose is about 1 mL (containing about 400 pg of Naloxone) and the second dose is about 1 mL (containing about 400 pg of Naloxone).

[00185] In an embodiment, the fluid comprises a Naloxone Hydrochloride solution having a concentration of 400 pg/mL, the first preselected time period (T1) is 1 minutes, the first dose is about 1 mL (containing about 400 pg of Naloxone), the second preselected time period (T2) is 2 minutes, and the second dose is about 1 mL (containing about 400 pg of Naloxone). [00186] In some embodiments, the opioid comprises oxycodone, hydrocodone, codeine, morphine, fentanyl, heroin, methadone or any mixture thereof.

[00187] In some embodiments, delivery device 100 may also include a component for providing feedback to the operator once the injection and delivery of one or both dose of fluid is complete, such as, but not limited to, one or more viewing windows, or an audible cue, such as a click, buzzer or chime. The audible cue may be heard, for example once timer 152 of controller 108 determines that the second preselected time period has elapsed.

[00188] A GPS notification system can be configured onto the device to alert emergency health services that the device delivered naloxone and to the individual’s location. The notification system may form part of controller 108 and may be activated once the first and/or second preselected time periods have elapsed. In some embodiments, the GPS notification system may be configured to transmit further information, such as the dosage administered and the time between administration of dosing.

[00189] In some embodiments the delivery device 100 may be in wireless communication (such as via Bluetooth™ or a wifi connection) with an electronic device, such as a cell phone, tablet or computer and is configured to send a signal to the electronic device that delivery device 100 has be used. The electronic device may then transmitthat information (along with any other relevant parameters), for example via a text message, e-mail or another form of communication.

[00190] In another aspect, embodiments of the present disclosure are directed to a method for operation of a delivery device operable to automatically deliver multiple doses of a fluid to a target site of a subject. A user (who may be the same person as the subject or a different individual) initiates a controller of the device and the controller determines when a first preselected time period (Ti) has elapsed. After the first preselected time period has elapsed (according to the controller) a needle module is released from a first needle module position to a second needle module position to insert a needle into the target site of the subject. Also, after the first preselected time period has elapsed, a syringe assembly is released from a first syringe assembly configuration to a second syringe assembly configuration to deliver a first dose of the fluid from the syringe assembly into the needle to inject the first dose into the target site. The controller will also determine when a second preselected time period (T2) has elapsed. After the second preselected time period has elapsed (according to the controller) the syringe assembly is released from the second syringe assembly configuration to a third syringe assembly configuration, to deliver a second dose of the fluid from the syringe assembly into the needle to inject the second dose into the target site.

[00191] The delivery device in the above described method may be any of the delivery devices described herein.

[00192] In some embodiments, the user may attach the delivery device to a body part of the user prior to or shortly after initiating the delivery device, for example by using strap 210 of delivery device 100.

[00193] In some embodiments, a user may set the first and second preselected time periods prior to or after attaching a delivery device (such as delivery device 100) to a body part of the user. The user may then take an opioid and then initiate/activate the delivery device prior. This will ensure that the user will receive first and second doses of fluid (for example Naloxone) from the delivery device regardless of the condition (for example state of consciousness) of the user. As discussed above, the delivery device may be stopped/deactivated at any point after initiation/activation, such that no further doses of fluid are delivered. In some embodiments, the first and second preselected time periods may be preset and the user may not need to set the first and second preselected time periods.

[00194] In some embodiments, delivery device 100 may be configured to deliver more than two doses of a fluid to a subject. A skilled person would understand that by the inclusion of additional timers and releasable retainers similar to those described above such that fluid container 120 moves through additional fluid container positions, addition doses of fluid may be delivered to the subject. For example, fluid container 120 may be retained in a position between the second fluid container position and the third fluid container position (shown in FIG. 2D) by a third releasable retainer, which may be generally similar to second releasable retainer described above. Operation of the third releasable retainer may be controlled by a third timer of controller 108, which measures a third preselected time period. Once the third preselected time period has elapsed, the fluid container 120 is released to move in direction 136 and a third dose of fluid is delivered to the subject. [00195] With reference to FIGS. 6-8, a delivery device 300 according to another embodiment is shown. Delivery device 300 may generally be similar to delivery device 100 and includes a housing 302 having a chamber 310, sized and configured to receive an injection assembly 303 and a controller 108. Injection assembly 303 includes a syringe assembly 104, needle module 306, a first releasable retainer 126 and a second releasable retainer 129. Although one injection assembly 303 is shown, the housing 302 may house more than one injection assembly.

[00196] Chamber 310 may be divided to adjacent chamber sections 310a, 310b by inner wall 310c where needle module 306 is housed in chamber section 310a and syringe assembly 104 is housed in chamber section 310b.

[00197] Chamber section 310a may include opening 312. Opening 312 is configured to allow a needle to pass therethrough and may include a slidable door 313 configured to cover opening 312. Slidable door 313 can be seen in more detail in FIG. 8. Prior to use of delivery device 300, a user may slide door 313 to the open position shown in FIG. 6. In some embodiments, movement (e.g., opening) of slidable door 313 may cause activation/initiation of delivery device 300. In some embodiments, closing of slidable door 313 may stop/deactivate delivery device 300 and prevent delivery device 300 from delivery any further doses of fluid.

[00198] Syringe assembly 104 may be as described above with respect to delivery device 100 and includes fluid container 120 and plunger 122. First energy storage member 124, a first releasable retainer 126 and a second releasable retainer 129 may also be as described above.

[00199] The injection assembly 303 also includes a needle module 306. Needle module 306 and includes a driver 338 and a needle 340. Driver 338 is shown in isolation in FIG. 7 and includes a needle retainer 339 configured to receive a portion of needle 340 therewithin, such as through a snap fit or interference fit. Needle retainer 339 is slidably coupled to driver base 341.

[00200] Fluid container 120 is fluidly coupled to needle module 306 through conduit 330, which passed through an opening 333 in internal wall 310c. Similar to conduit 130 described above conduit 330 may be coupled to first end 120a by any suitable connection such as a Luer connector, threads, a snap-fit, a latch, a lock, a friction fit coupling, an adhesive or any other suitable coupling features.

[00201] Driver base 341 is rigidly connected to housing 302 such that needle retainer 339 is slidably moveable relative to driver base 341 from a first injection assembly configuration (designated A and shown in dashed lines in FIG. 6) to a second injection assembly configuration (designated B in and shown in solid lines FIG. 6). When in the first injection assembly configuration, needle 340 is fully inside housing 302 and when in the second injection assembly configuration, needle 340 protrudes from housing 302 through opening 312.

[00202] Needle module 104 also includes a second energy storage member 346 (FIG. 7) operable to release energy to driver 338 and displace needle retainer 339 in direction 344. Second energy storage member 346 is operable to expand, thereby displacing that driver 338 and interconnected needle 340 in direction 344 thereby displacing needle module 306 from a first needle module position (shown in dashed lines in FIG. 6) to a second needle module position (shown in solid lines in FIG. 6). When delivery device 300 is placed in proximity to the target site of a subject, this will have the effect of inserting the needle 340 into the target site of the subject.

[00203] In the embodiment shown in FIG 6, the second energy storage member 346 is a mechanical energy storage member comprising a spring, such as a torsion spring. In other embodiments, second energy storage member 346 may be a helical, compression, extension, constant, variable, variable stiffness or any other type of spring.

[00204] When the second energy storage member 346 is in its first configuration (designated A and shown in dashed lines in FIG. 6 and also shown in FIG. 7) it also has a first potential energy. When the second energy storage member 346 is in its second configuration, it has a second potential energy that is less than the first potential energy. The second energy storage member 346 is operably coupled to driver 338 such that when the second energy storage member 346 moves from its first configuration to its second configuration, it converts at least a portion of its first potential energy into kinetic energy to displace needle retainer 339 and needle 340 in direction 344. [00205] The first and second energy storage members 124, 346 each independently can be any device for storing energy. Thus, one or both of the first and second energy storage members 124, 346 may be a mechanical energy storage member, such as a spring, a device containing compressed gas, a device containing a vapor pressure-based propellant or something similar or an electrical energy storage member, such as a battery, a capacitor, a magnetic energy storage member or something similar In yet other embodiments, one or more of the first and second energy storage members 124, 346 can be a chemical energy storage member, such as a container containing two substances that, when mixed, react to produce energy.

[00206] As described above, first releasable retainer 126 is configured to retain needle module 306 in the first needle module position (dashed lines in FIG. 6) and to release needle module 306 to allow needle module 306 to move from the first needle module position to the second needle module position (solid lines in FIG. 6). First releasable retainer 126 is also configured to secure fluid container 120 in the first fluid container position and to release fluid container 120 to allow fluid container 120 to move to the second fluid container position after releasing needle module 306 from the first needle module position. In the embodiment shown in FIG. 6, second arm 128 of first releasable retainer 126 engages a c-shaped cut out portion 343 (shown in FIG. 7) of needle retainer 339 to retain needle module 306 in the first needle module position.

[00207] The disengagement of first releasable retainer 126 and second releasable retainer 129 is controlled by controller 108 in a similar manner to as described above for delivery device 100.

[00208] With reference to FIG. 8, the exterior of delivery device 300 is shown. Housing 302 is generally cuboidal in shape and includes a first end 302a, a second end 302b and an exterior surface 302c. First end 302a of housing 302 may include an enlarged region 302d, sized to accommodate injection assembly 303.

[00209] Housing 302 may be constructed in a similar manner and from similar materials to housing 102 described above. Similar to delivery device 100, delivery device 300 may include an attachment mechanism, such as strap 210. [00210] The exterior surface 302c of housing 302 may include a user interface, operable to enable a user to select the first and second preselected time period. In some embodiments this may include first and second dials 212 and 214 respectively, in a similar manner to as described above for delivery device 100. In some embodiments, the exterior surface may include a start/stop button or switch to initiate/activate and/or stop/deactivate delivery device 300.

[00211] The sequence of events for the operations for delivery device 300 may be generally similar to those described with respect to delivery device 100 and illustrated in FIGS. 2A-2D, such that once activated, delivery device 300 is operable to deliver first and second doses of a fluid to a target site of a subject.

[00212] With reference to FIGS. 9 and 10, a delivery device 400 according to another embodiment is shown. Delivery device 400 is configured to house two injection assemblies, 403a, 403b, which are each configured to inject a single dose of fluid to the target site of a subject.

[00213] Delivery device 400 includes a housing 402 having a chamber 410, sized to receive injection assemblies 403a, 403b and a controller 408. Injection assembly 403a includes a syringe assembly 404a and a needle module 406a. Injection assembly 403b includes a syringe assembly 404b and a needle module 406b.

[00214] Chamber 410 may include a pair of openings 412a, 412b, each configured to allow a needle of respective needle modules 406a, 406b to pass through. Openings 412a. 412b may be covered by a slidable door or suitable cover prior to use of delivery device 400.

[00215] Syringe assembly 404a and needle module 406a may be substantially identical to syringe assembly 404b and needle module 406b and as such only syringe assembly 404a will be described below.

[00216] Syringe assembly 404a includes a fluid container 420a, plunger 422a, a first energy storage member 424a and a first releasable retainer 426a.

[00217] Fluid container 420a and plunger 422a may be generally similar to fluid container 120 and 122 described above. Fluid container 420a may be pre-filed with a first dose of a fluid. Needle module 406a includes a needle 440a which may be attached to and fluidly connected to the interior of fluid container 420a. In the embodiment shown in FIGS. 9 and 10, fluid containers 420a is slidably moveable within chamber 410 in the direction indicated by arrow 436.

[00218] In some embodiments, components injection assemblies 403a, 403b or components thereof may be mounted on a substructure or frame that is slidably moveable within housing 402, such that injection assemblies 403a, 403b or components thereof) may be removed from housing 402, for example though a door or opening ing housing 402.

[00219] First energy storage member 424a is operable to release energy to fluid container 420a and plunger 422a and displace fluid container 420a and plunger 422a in direction 436. First energy storage member 424a may be similar to first energy storage member 124 described above and is movable from a first configuration (the position shown for first energy storage member 424a) to a second configuration (the position shown for first energy storage member 424b).

[00220] As first energy storage member 424a moves from its first configuration to its second configuration, fluid container 420a will be displaced in direction 436 from a first fluid container position (the position shown for fluid container 420a) to a second fluid container position (the position shown for fluid container 420a). As this occurs, needle module 406a will move from a first needle module position (the position shown for needle module 406a) to a second needle module position (the position shown for needle module 406b) such that needle 440a will protrude through opening 412a. When delivery device 400 is placed in proximity to a target site, such as a thigh 413 shown in FIG. 9, needle 440a will be inserted into the target site to a sufficient depth.

[00221] When fluid container 420a has reached the second fluid container position (such as when the proximal end 421a of fluid container 420a comes into contact with an inner surface of housing 402), plunger 424a will continue to move in direction 436 relative to fluid container 420a from a first plunger position (shown for plunger 422a) to a second plunger position. As this occurs, the internal volume defined by fluid container 420a will be decreased, expelling into and through needle module 440a and into the target site of the subject. [00222] First releasable retainer 426a may be any suitable mechanism operable to prevent movement of fluid container 420a, plunger 422a and/or first energy storage member 424a. For example, first releasable retainer 426 may include one or more latch mechanisms similar to as described above for first releasable retainer 126.

[00223] Syringe assembly 404b and needle module 406b may be configured in a similar manner and operate similarly to syringe assembly 404a and needle module 406a describe above. Syringe assembly includes a second releasable retainer 426b, which may be any suitable mechanism operable to prevent movement of fluid container 420b, plunger 422b and/or first energy storage member 424b. For example, second releasable retainer 426b may include one or more latch mechanisms similar to as described above for first releasable retainer 426a.

[00224] The disengagement of first and second releasable retainers 426a, 426b is controlled by controller 408. In some embodiments, the disengagement of first and second releasable retainers 426a, 426b may be similar to as described above with respect to first and second releasable retainers 126, 129. Controller 408 may be a single controller in communication with first and second releasable retainers 426a, 426b or delivery device 400 may include a separate controller for each of first and second releasable retainers 426a, 426b.

[00225] Controller 408 may be similar to and operate in a similar manner to controller 108 described above and may be configured to measure a first preselected time period (Ti) and a second preselected time period (T2). In some embodiments, controller 408 may be an entirely mechanical controller. For example, controller 408 may comprise one or more mechanical timers similar to as described above with respect to controller 108.

[00226] Once the first preselected time period (T1) has elapsed, controller 408 is configured to release the needle module 406a of injection assembly 403a from the first needle module position to the second needle module position to insert the needle 440a into the target site of the subject and to release the fluid container 420a from the first fluid container position to the second fluid container position and release plunger 422a from the first plunger position to the second plunger position, to deliver a first dose of the fluid from the syringe assembly 404a into the needle 440a to inject the first dose into the target site. [00227] Once the second preselected time period (T2) has elapsed, controller 408 is configured to release the needle module 406b of injection assembly 403b from the first needle module position to the second needle module position to insert the needle 440b into the target site of the subject, to release the fluid container 420b from the first fluid container position to the second fluid container position and to release plunger 422b from the first plunger position to the second plunger position, to deliver a first dose of the fluid from the syringe assembly 404b into the needle 440b to inject the first dose into the target site.

[00228] With reference to FIGS. 10A and 10B, the exterior delivery of device 400 is shown. Housing 402 is generally cuboidal in shape and includes a first end 402a, a second end 402b and an exterior surface 402c. The housing 402 may be a unitary structure (i.e., one-piece) that defines the exterior surface 402c, or it may include a plurality of layers with different layers defining the exterior surface 402c. In other embodiments, housing 402 may have any suitable shape.

[00229] In some embodiments, housing 402 may be rigid. According to other embodiments, the housing 402 may be flexible, whether according to the nature of the material that defines housing 402 or according to the nature of the structure of the housing 402. In some embodiments, housing may be transparent, partially transparent, or opaque such that a user may view part or all of the contents of the housing 402. This may be beneficial, for example to assist in determining if the components or delivery device 400 have been correctly installed or to confirm if delivery device 400 has been activated.

[00230] In some embodiments, one side of housing 402 may be openable such that the contents of housing 402 may be accessed, for example such that injection assemblies 403a, 403b can be installed and/or replaced. For example, housing 402 may include a pair of doors 402d, 402e that are secured in a closed position by one or more latches 405

[00231] Housing 402 may be made of similar materials as described above with respect to housing 102 of delivery device 100.

[00232] In order to secure delivery device 400 to a subject, delivery device 400 may include an attachment mechanism, such as strap 510. Strap 510 may be configured in a similar manner to strap 210 described above and is configured to wrap around delivery device 100 and a limb of a subject to hold the delivery device 400 in place.

[00233] Similar to delivery device 100, the exterior surface 402c of housing 402 may include a user interface, operable to enable a user to select the first and second preselected time period. In some embodiments this may include first and second dials 512 and 514 respectively which operate in a similar manner to first and second dials 212 and 214 described above.

[00234] In some embodiments, the delivery devices described herein may be reusable.

For example, in some embodiments, some or all components of delivery device 100 may be reusable. In some embodiments, components that contact the medicament and/or the patient may be replaceable between uses. For example, for delivery device 100, fluid container 120, conduit 130 and needle 140 may be replaced between uses whilst the remaining components of delivery device 100 may be reused.

[00235] Although making and using various embodiments of the present disclosure have been described in detail above, it should be appreciated that the present disclosure provides many applicable inventive concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed herein are merely illustrative of specific ways to make and use the invention, and do not delimit the scope of the invention.

Claims

What is claimed is:

1 . A delivery device operable to automatically deliver multiple doses of a fluid to a target site of a subject, the delivery device comprising: a housing; an injection assembly housed inside the housing, the injection assembly comprising: a syringe assembly configured to hold the fluid; a needle module comprising a needle in fluid communication with the syringe assembly, wherein the needle module is moveable relative to the housing from a first needle module position wherein the needle is housed within the housing, to a second needle module position wherein the needle is inserted into the target site of the subject; a controller in communication with the injection assembly, the controller being configured to: after a first preselected time period has elapsed: release the needle module from the first needle module position to the second needle module position to insert the needle into the target site of the subject; release the syringe assembly from a first syringe assembly configuration to a second syringe assembly configuration, to deliver a first dose of the fluid from the syringe assembly into the needle to inject the first dose into the target site; and after a second preselected time period has elapsed: release the syringe assembly from the second syringe assembly configuration to a third syringe assembly configuration, to deliver a second dose of the fluid from the syringe assembly into the needle to inject the second dose into the target site.

2. The delivery device of claim 1 , further comprising: a first releasable retainer configured to secure the syringe assembly in the first syringe assembly configuration and to retain the needle module in the first needle module position, whereby the controller causes the first releasable retainer to release the syringe assembly and the needle module after the first preselected time period has elapsed; and a second releasable retainer configured to secure the syringe assembly in the second syringe assembly configuration, whereby the controller causes the second releasable retainer to release the syringe assembly after the second preselected time period has elapsed.

3. The delivery device of claim 2, wherein the first releasable retainer releases the needle module from the first needle position before releasing the syringe assembly from the first syringe assembly configuration.

4. The delivery device of claim 2 or claim 3, wherein the syringe assembly comprises a fluid container and a plunger disposed within an interior space of the fluid container, wherein: as the syringe assembly is released from the syringe assembly configuration, the fluid container moves relative to the plunger from a first fluid container position to a second fluid container position, decreasing an interior volume of the fluid container to expel fluid from the fluid container through the needle; and as the syringe assembly is released from the second syringe assembly configuration, the fluid container moves relative to the plunger from the second fluid container position to a third fluid container position, further decreasing the interior volume of the fluid container to expel fluid from the fluid container through the needle.

5. The delivery device of claim 4 wherein the fluid container is configured to move relative to the plunger along a longitudinal axis of the delivery device between the first, second and third fluid container positions.

6. The delivery device of claim 4 or claim 5, wherein the first releasable retainer is configured to prevent movement of the plunger along the longitudinal axis of the delivery device.

7. The delivery device of any one of claims 4 to 6, wherein the first releasable retainer comprises a first member to engage the needle module when the needle module is in the first needle module position and a second member to engage the fluid container when the fluid container in is the first fluid container position.

8. The delivery device of claim 7, wherein the first and second members each comprise a latch mechanism.

9. The delivery device of claim 4, wherein the second releasable retainer engages the fluid container through a latch mechanism once the fluid container reaches the second fluid container position and the latch mechanism disengaging the fluid container causes the fluid container to move to the second fluid container position.

10. The delivery device of any one of claims 1 to 9, wherein the controller is a mechanical controller.

11. The delivery device of claim 10, wherein the mechanical controller comprises a clockwork mechanism.

12. The delivery device of claim 1 , wherein the controller is an electronic controller.

13. The delivery device of any one of claims 1 to 12, wherein the injection assembly further comprises a first energy storage member operable to release energy to the needle module an displace the needle module from the first needle module position to the second needle module position.

14. The delivery device of claim 13, wherein the first energy storage member comprises a spring.

15. The delivery device of any one of claims 4 to 14, wherein the injection assembly further comprises a second energy storage member operable to release energy to the syringe to displace the fluid container from the first syringe assembly configuration to the second syringe assembly configuration and from the second syringe assembly configuration to the third syringe assembly configuration.

16. The delivery device of claim 15, wherein the second energy storage member comprises a spring.

17. The delivery device of any one of claims 1 to 16, wherein the needle module is configured to rotate about a transverse axis of the delivery device as the needle module moves from the first needle module position to the second needle module position.

18. The delivery device of claims 1 to 16, wherein the needle module is configured to move in a linear direction along a transverse axis of the delivery device as the needle module moves from the first needle module position to the second needle module position.

19. The delivery device of any one of claims 1 to 18, further comprising an opening in the housing for the needle to extend through when the needle module moves from the first needle module position to the second needle module position.

20. The delivery device of claim 19, wherein the opening is covered by a septum.

21. The delivery device of claim 19, wherein the opening is covered by a slidable door.

22. The delivery device of any one of claims 1 to 21 , further comprising a control interface on an outer surface of the housing to allow a user to set the first and second preselected time periods and to activate the device.

23. The delivery device of claim 22, wherein the control interface comprises one or more dials.

24. The delivery device of any one of claims 1 to 23, wherein the first prelected time period is between about 1 and about 90 minutes and the second preselected time period is between about 2 and about 90 minutes.

25. The delivery device of any one of claims 1 to 23, wherein the second preselected time period is between about 3 minutes and about 5 minutes greater than the first preselected time period.

26. The delivery device of any one of claims 1 to 25, wherein the syringe assembly is configured to hold an amount of the fluid of no more than about 3 mL.

27. The delivery device of any one of claims 1 to 26, wherein the first dose has a volume of between about 0.5 mL and about 3 mL.

28. The delivery device of claim 27, wherein the first dose has a volume of about 1 mL.

29. The delivery device of claims 1 to 28, wherein the second dose has a volume of between about 0.5 mL and about 3 mL.

30. The delivery device of claim 29, wherein the second dose has a volume of about 1 mL.

31. The delivery device of any one of claims 1 to 30, wherein the volume of the first dose is equal to the volume of the second dose.

32. The delivery device of any one of claims 1 to 31 , wherein the fluid comprises an opioid antagonist.

33. The delivery device of claim 32, wherein the opioid antagonist comprises naloxone.

34. The delivery device of any one of claims 1 to 33, wherein the target site is an intramuscular site.

35. The delivery device of any one of claims 1 to 33, wherein the target site is a subcutaneous site.

36. The delivery device of any one of claims 1 to 35, wherein the delivery device is a wearable delivery device.

37. The delivery device of claim 36, wherein the wearable delivery device further comprises an attachment mechanism connected to the housing, the attachment mechanism configured to attach the delivery device to body part of the subject.

38. The delivery device of claim 37, wherein the attachment mechanism is a strap.

39. The delivery device of claim 37 or claim 38, wherein the body part is an upper arm.

40. The delivery device of claim 37 or claim 38, wherein the body part is a thigh.

41. The delivery device of any one of claims 1 to 40, wherein the delivery device comprises at least two injection assemblies and the device is operable to automatically deliver multiple doses of a fluid to a target site from each of the at least two injection assemblies.

42. A method of operation of delivery device operable to automatically deliver multiple doses of a fluid to a target site of a subject, the method comprising: initiating a controller of the device determining, using the controller when a first preselected time period has elapsed, and after the first preselected time period has elapsed: releasing a needle module from a first needle module position to a second needle module position to insert a needle into the target site of the subject; releasing a syringe assembly from a first syringe assembly configuration to a second syringe assembly configuration, to deliver a first dose of the fluid from the syringe assembly into the needle to inject the first dose into the target site; determining, using the controller when a second preselected time period has elapsed and after the second preselected time period has elapsed: releasing the syringe assembly from the second syringe assembly configuration to a third syringe assembly configuration, to deliver a second dose of the fluid from the syringe assembly into the needle to inject the second dose into the target site.

43. The method of claim 42, wherein the first and second preselected time periods are selected by the subject prior to initiating the device.

44. The method of claim 42 or claim 43, wherein the first preselected time period is less than the second preselected time period.

45. The method of claim 42 or claim 43, wherein the first preselected time period is equal to the second preselected time period.

46. The method of any one of claims 41 to 45, wherein the needle module is released from the first needle position before the syringe assembly is released from the first syringe assembly configuration.

47. The method of any one of claims 42 to 46, wherein the method further comprises: installing the syringe assembly containing the fluid into a housing of the delivery device prior to initiating the controller.

48. The method of any one of claim 42 to 47, wherein the first prelected time period is between about 1 and about 90 minutes and the second preselected time period is between about 2 and about 90 minutes.

49. The method of any one of claims 42 to 47, wherein the second preselected time period is between about 3 minutes and about 5 minutes greater than the first preselected time period.

50. The method of any one of claims 42 to 49, wherein the syringe assembly is configured to hold an amount of the fluid of no more than about 3 mL.

51. The method of any one of claims 42 to 50, wherein the first dose has a volume of between about 0.5 mL and about 3 mL.

52. The method of claim 51, wherein the first dose has a volume of about 1 mL.

53. The method of any one of claims 42 to 52, wherein the second dose has a volume of between about 0.5 mL and about 3 mL.

54. The method of claim 53, wherein the second dose has a volume of about 1 mL.

55. The delivery device of any one of claims 42 to 54, wherein the volume of the first dose is equal to the volume of the second dose.

56. The method of any one of claim 42 to 55, wherein the fluid comprises an opioid antagonist.

57. The method of claim 56, wherein the fluid comprises naloxone hydrochloride.

58. The method of any one of claims 42 to 57, wherein the target site is an intramuscular site.

59. The method of any one of claims 42 to 57, wherein the target site is a subcutaneous site.

60. The method of any one of claims 42 to 59, wherein the delivery device is a wearable delivery device.

61. The method of claim 60, further comprising: attaching the wearable delivery device to a body part of the subject using an attachment mechanism prior to initiating the controller.

62. The method of claim 61, wherein the attachment mechanism is a strap.

63. The method of claim 61 or claim 62, wherein the body part is an upper arm.

64. The method of claim 61 or claim 62, wherein the body part is a thigh.