CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63/138,020 filed on January 15, 2021. The content of the aforementioned application is incorporated herein by reference.

FIELD

[0002] The present disclosure generally relates to a delivery device, and more particularly to a delivery device including at least two separate injection assemblies for automatically injecting at least two fluids at different stages of operation into a target site of a subject, such as, but not limited to, a vastus lateralis intramuscular site, after activation of the medical injection device. It also relates to methods for reducing or preventing hemorrhage comprising intramuscularly administering an antifibrinolytic agent.

BACKGROUND

[0003] Trauma amounts to nearly 10% of worldwide deaths and is the leading cause of death under the age of 45. An essential element for treating many life-threatening emergencies, such as shock, trauma, cardiac arrest, drug overdoses, diabetic ketoacidosis, arrhythmias, bums, and status epilepticus, is rapid establishment of an IV line in order to administer drugs and fluids directly into a patient's vascular system. Whether in an ambulance by paramedics, in an emergency room by emergency specialists or on a battlefield by an Army medic, the goal is the same - quickly start an IV in order to administer lifesaving drugs and fluids. To a large degree, the ability to successfully treat most critical emergencies is dependent on the skill and luck of an operator in accomplishing vascular access. Doctors, nurses and paramedics can experience great difficulty in establishing IV access in many patients due to a variety of causes, such as patients with chronic disease or patients that may not have available IV sites due to anatomical scarcity of peripheral veins, obesity, extreme dehydration or previous IV drug use. A further complicating factor in achieving IV access occurs “in the field” e.g. at the scene of an accident, during military combat, or during ambulance transport where it is difficult to see the target and excessive motion makes accessing the venous system difficult.

[0004] Autoinjectors are devices that are designed to allow one the ability to 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 in hectic situations described above, such as ambulance transport and military combat. 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.

[0005] In emergency situations involving massive hemorrhage and hemorrhagic shock, tranexamic acid (TXA) is considered a first-line medication. TXA is an antifibrinolytic drug that stops the breakdown of fibrin clots formed at the site of injury. In doing so, TXA causes a significant reduction in blood loss for the patient thereby decreasing patient mortality rates. TXA is most effective when given immediately after injury, but research has shown that TXA is only given to 3% of trauma victims within the first hour due to the difficulties of securing IV access. However, when TXA is given within an hour of the injury, it is shown to reduce deaths caused by hemorrhagic shock by one-third. Therefore, rapid TXA treatment that may be provided by the trauma patient themselves in the case that they do not have quick access to a trained healthcare professional is crucial to increase the chance of their survival. The ability for a trained healthcare professional or the trauma user to automatically inject TXA intramuscularly would significantly decrease the treatment time and increase the access to the drug without requiring an IV.

[0006] Known devices capable of accessing an IM site and/or administering drugs intramuscularly include, for example, the devices described in:

- US Pat. No. 10,556,067 which discloses a multiple use autoinjector that may be rearmed for multiple injections.

- US Pat. No. 8,961,463 which discloses an autoinjector allowing the automatic delivery of the first dose of a medicament, and the manual administration of the second.

- US Pat. No. 6,575,939 which discloses a single dose autoinjector comprising an inner and outer casing that are slidably arranged in relation to each other.

It would be desirable to improve upon these state-of-the-art devices and provide a user-friendly, multi-dose autoinjector and preferably with an advanced safety mechanism to prevent needlestick injuries.

SUMMARY

[0007] According to one embodiment, the present disclosure provides a delivery device operable to automatically inject and deliver at least two fluids separately to a target site of a subject during at least two different stages of operation comprising: a lower body configured to house at least two injection assemblies; an upper body configured to move over the lower body in a longitudinal direction upon application of a force to the upper body; a first injection assembly positioned within the lower body; a second injection assembly positioned within the lower body adjacent to the first injection assembly; and a movable setting switch operable to select the first injection assembly or the second injection assembly. The first injection assembly and second injection assembly each comprise: an actuator operable for activating the injection assembly; a plunger module moveable between a first position and second position, a first releasable retainer member configured to secure the plunger module in the first position and release the plunger module after activation of the injection assembly, a first energy storage member operable to release energy to the plunger module and displace the plunger module in a proximal direction from the first position to the second position, a fluid container configured to hold a fluid and having a distal end configured to receive the plunger module and a proximal end with an outlet, a driver moveable from a first position to a second position having a proximal end and a distal end, the driver and fluid container operatively coupled at the driver’s distal end and the fluid container’s proximal end, a second energy storage member operable to release energy to the driver and displace the driver in a proximal direction, a needle module moveable between a first position and second position and having a distal end in fluid communication with the outlet of the fluid container and a proximal end configured for insertion into the target site of the subject and delivering the fluid to the subject, a second releasable retainer member configured for securing the needle module to the driver in the first position and releasing the needle module when the plunger module is located at its second position, and a return energy storage member operable to release energy to the needle module and displace the needle module in a distal direction from the first position to the second position after the needle module has been released from the driver.

[0008] According to another embodiment, the present disclosure provides a method for reducing or preventing hemorrhage, comprising intramuscularly administering an antifibrinolytic agent in a dose of 0.1 g to 30 g at a rate of no less than 50 mg/s.

[0009] According to another embodiment, the present disclosure provides a method for reducing or preventing hemorrhage, comprising intramuscularly administering an antifibrinolytic agent with an autoinjector in a dose of 0.1 g to 30 g. [0010] In still another embodiment, the present disclosure provides use of an antifibrinolytic agent for reducing or preventing hemorrhage, wherein the agent is administered intramuscularly in a dose of about 0.1 g to about 30 g at a rate of no less than 50 mg/s.

[0011] In yet another embodiment, the present disclosure provides use of an antifibrinolytic agent for reducing or preventing hemorrhage, wherein the agent is administered intramuscularly with an autoinjector in a dose of about 0.1 g to about 30 g.

[0012] In still another embodiment, the present disclosure provides a delivery device operable to automatically inject and deliver at least two fluids comprising at least 0.1 grams of an antifibrinolytic agent separately to a target site of a subject during at least two different stages of operation comprising: a lower body configured to house at least two injection assemblies; an upper body configured to move over the lower body in a longitudinal direction upon application of a force to the upper body; a first injection assembly positioned within the lower body; a second injection assembly positioned within the lower body adjacent to the first injection assembly; and a movable setting switch operable to select the first injection assembly or the second injection assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1A is a cross-sectional view of a delivery device according to one embodiment in a first configuration;

[0014] FIG. IB is a cross-sectional view of the delivery device of FIG. 1A in a second configuration;

[0015] FIG. 1C is a cross-sectional view of the delivery device of FIG. 1A in a third configuration; [0016] FIG. ID is a cross-section view of the delivery device of FIG. 1A in a fourth configuration; [0017] FIG. 2 is an exploded view of a delivery device according to an embodiment of the present disclosure;

[0018] FIG. 3 is a cross-sectional view of the delivery device of FIG. 2 in a first configuration;

[0019] FIG. 4 is a cross-sectional view of the delivery device of FIG. 2 in a second configuration; [0020] FIG. 5 is a cross-sectional view of the delivery device of FIG. 2 in a third configuration and;

[0021] FIG. 6 is a perspective view of the delivery device of FIG. 2 in a first configuration.

DETAILED DESCRIPTION

[0022] The following terms shall have the following meanings:

[0023] 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 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.

[0024] 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 container" means one container or more than one container. 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.

[0025] 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” designate directions in the drawings to which reference is made. The words “inward” and “outward” refer to directions toward and away from, respectively.

[0026] 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.

[0027] The term “movably coupled” means that one member is directly or indirectly supported by another member to allow movement of the one member.

[0028] The term "operatively coupled" can refer to a direct or indirect coupling engagement between two or more structural component parts.

[0029] 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.

[0030] 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.

[0031] As used herein, a “subject” may be a human or non-human mammal. Non-human 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).

[0032] 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.

[0033] In one aspect, embodiments of the present disclosure are generally directed to a delivery device adapted to automatically inject and deliver at least two fluids separately into a target site, such as an IM site, of a subject during at least two different stages of operation. In some embodiments, the delivery device is sized to be carried in compact spaces such as, but not limited to, military pouches and tactical vests.

[0034] Turning now to the drawings and in particular, to FIGS. 1A-1D, a cross-sectional view of a delivery device 1 is shown according to one embodiment advancing sequentially from a first configuration to a second configuration, to a third configuration and to a fourth configuration, respectively. In general terms, the delivery device 1 includes a lower body 4 which is configured to house at least two injection assemblies (i.e. a first and second injection assembly 2 and 2’), each injection assembly configured to inject and deliver a fluid to the IM site of the subject. In some embodiments, each injection assembly is configured to inject and deliver at least 1 mL or at least 2 mL or at least 3 mL or at least 4 mL or at least 5 mL of the fluid to the IM site of the subject. Although two injection assemblies are shown, the delivery device 1 may include three or more injection assemblies. Lower body further includes a first stop 14 and a second stop 24 which is described further below. [0035] The delivery device 1 also includes an upper body 3 which is movably coupled to the lower body 4. The upper body 3 is configured to be moveable over the lower body 4 in a longitudinal direction L upon application of a force to the upper body 3. The upper body 3 may also include a setting switch 3a moveably coupled thereto in a horizontal direction for the purpose of selecting the desired injection assembly for use.

[0036] The injection assembly 2 generally includes an actuator 5 to activate the injection assembly 2, a plunger module 8 moveable between a first position and second position, a first releasable retainer member 6 configured to secure the plunger module 8 in the first position and release the plunger module 8 after activation of the injection assembly 2, a first energy storage member 7 operable to release energy to the plunger module 8 and displace the plunger module 8 in the proximal direction from the first position to the second position, and a fluid container 9 having a distal end configured to receive the plunger module 8 and a proximal end with an orifice or outlet. The plunger module 8 is sized to be movably disposed within the fluid container 9. The fluid container 9 is configured to hold the fluid. In some embodiments, the fluid comprises a medicament, such as, for example, tranexamic acid or any of the other medicaments further described below.

[0037] The injection assembly 2 also includes a driver 11 moveable from a first position to a second position and having a proximal end and a distal end. The driver 11 and fluid container 9 are operatively coupled at the driver’s distal end and the fluid container’s proximal end. The injection assembly 2 also includes a second energy storage member 10 operable to release energy to the driver 11 and displace the driver 11 in a proximal direction. The first stop 14, which is positioned near the proximal end of the lower body 4, is sized and configured to stop movement of the driver 11 in a proximal direction when the driver’s proximal end contacts the stop 14. The injection assembly 2 also includes a needle module 12 moveable between a first position and second position and having a distal end in fluid communication with the outlet of the fluid container 9 and a proximal end for insertion into the IM site and delivering fluid to the subject. The injection assembly 2 also includes a second releasable retainer member 6a configured to secure the needle module 12 to the driver 11 in the first position and to release the needle module 12 when the plunger module 8 is located at its second position. Finally, the injection assembly 2 includes a return energy storage member 13 operable to release energy to the needle module 12 and displace the needle module 12 in a distal direction from the first position to the second position after the needle module 12 has been released from the driver 11.

[0038] The delivery device 1 further includes at least a second injection assembly 2’ . The injection assembly 2’ generally includes an actuator 15, a first energy storage member 17, a plunger module 18, a first releasable retainer member 16, a fluid container 19 (configured to hold a fluid which may be the same as or different from the fluid in fluid container 9 in the volumes above), a driver 21 (lower body 4 includes a second stop 24 to prevent movement of the driver 21 in the proximal direction once the driver 21 contacts second stop 24), a needle module 22, a second energy storage member 20, a second releasable retainer member 16a and a return energy storage member 23. The components of the second injection assembly 2’ are arranged and operate similarly to those of the first injection assembly 2. Accordingly, the description of the first injection assembly’s components, their arrangement and operation will apply to the second injection assembly 2’.

[0039] The delivery device 1 can generally be operated by moving the setting switch 3a to select the desired injection assembly for use, for example injection assembly 2 as shown in FIG. 1A, and applying a force to the upper body 3 in the proximal direction to move the upper body 3 in a proximal direction over at least a portion of the lower body 4 which activates the actuator 5. Activation of actuator 5 causes an automatic sequence of movements. First, the plunger module 8 is released from the first releasable retainer member 6 and displaced in a proximal direction by the first energy storage member 7. When the plunger module 8 is released, the driver 11, fluid container 9, needle module 12 and second releasable retainer member 6a are also displaced in the proximal direction by the second energy storage member 10 until movement in the proximal direction is prevented by the engagement of driver 11 with stop 14. Movement of the plunger module 8 in the proximal direction will continue until reaching the second position at the distal end of the fluid container 9. Accordingly, it will be in cooperative engagement with the fluid container 9 and second releasable retainer member 6a at its second position. The first energy storage member 7 is operable to continue to apply energy to the plunger module 8 that is sufficient to movably displace the second releasable retainer member 6a (but not the fluid container 9 since its movement is prevented by driver 11 and stop 14) in a proximal direction. Such movement by the second releasable retainer member 6a releases the needle module 12 from the driver 11. The needle module 12 is then displaced in the distal direction by the return energy storage member 13. [0040] It should be noted that when the setting switch 3a is located over the second injection assembly 2’, activation of actuator 15 will begin a similar automatic sequence of movements since the components of the second injection assembly 2’ and their arrangement and operation are similar to those of the first injection assembly 2.

[0041] Referring to FIGS. 1A and IB, the delivery device 1 is shown in a first configuration and a second configuration. To move from the first configuration to second configuration, the upper body 3 is displaced over the lower body 4, as indicated by arrow A in FIG. IB, along a longitudinal axis L between a first position (FIG. 1A) and a second position (FIG. IB). As illustrated, when the upper body 3 is displaced in a proximal direction from the first position to second position, the setting switch 3a is also displaced in the proximal direction from a first position to second position which activates actuator 5. The actuator 5 may be any suitable device for activating the delivery device 1, such as, for example, a handle, a lever, a push button, a slidable button or a trigger.

[0042] Prior to activation, the plunger module 8 is held in a secure position by the first releasable retainer member 6. The first releasable retainer member 6 is configured to release the plunger module 8 and deploy the first energy storage member 7 from its first configuration to second configuration after the actuator 5 has been activated by the movement of the upper body 3 and setting switch 3a in the proximal direction from their first position to second position. The first releasable retainer member 6 can be any suitable mechanism for releasably retaining the plunger module 8 and deploying the first energy storage member 7, such as, for example, a mechanical linkage, a compressed ring, a spring-loaded rod, a tensioned latch or tab or a gear collar/helical plunger mechanism (which uses static friction to hold the plunger module before releasing it) or the like.

[0043] Upon activation of the actuator 5 and release of the plunger module 8 by the first releasable retainer member 6, the second energy storage member 10 is deployed from its first configuration to second configuration. As described above and illustrated in FIGS. 1A and IB, the fluid container 9 and driver 11 are operatively coupled and each move in a proximal direction, as indicated by arrow A in FIG. IB, along a longitudinal axis L from a first position (FIG. 1A) to second position (FIG. IB) by second energy storage member 10 where further movement in the proximal direction is prevented by stop 14. The needle module 12 is still held in a secure position to the driver 11 by the second releasable retainer member 6a and both remain in their first position. [0044] When the delivery device 1 is in the first configuration, the needle module 12 is positioned entirely within the lower body 4. When the delivery device 1 moves to the second configuration, the fluid container 9 and driver 11 have been displaced (or advanced) to the second position by the second energy storage member 10 and at least a portion of the needle module 12 extends outside the lower body 4 for insertion into the target site of the subject at a desired depth. Thus, movement of the delivery device 1 from the first configuration to second configuration will extend a portion of the needle module 12 outside of the lower body 4 for insertion into, for example, the IM site of the subject.

[0045] With reference to FIGS. 1A and 1C (which depicts the delivery device 1 in a third configuration), the plunger module 8 is further displaced in a proximal direction, as indicated by arrow B, along a longitudinal axis L between a first position (FIG. 1A) and second position (FIG. 1C) by deployment of the first energy storage member 7. When the plunger module 8 is in the first position, a portion of the plunger module 8 at its proximal end is positioned at the distal end of the fluid container 9. In this first position, the plunger module 8 is in fluid communication with the fluid contained within fluid container 9. When the plunger module 8 is displaced (or advanced) to the second position, the plunger module 8 is advanced from the distal end of the fluid container 9 to the proximal end of the fluid container 9. In this manner, as the plunger module 8 is displaced (or advanced) between the first and second positions, fluid is conveyed from within fluid container 9 through the needle module 12 and into the IM site of the subject. Thus, movement of the delivery device 1 from the second configuration to third configuration delivers fluid into the IM site of the subject.

[0046] With reference now to FIG. ID (which depicts the delivery device 1 in a fourth configuration), prior to the plunger module 8 reaching its second position, the needle module 12 is held in a secure position to the driver 11 by the second releasable retainer member 6a. The second releasable retainer member 6a is configured to release the needle module 12 and deploy the return energy storage member 13 from its first configuration to second configuration once the plunger module 8 reaches its second position. The second releasable retainer member 6a can be any suitable mechanism for releasably retaining the needle module 12 and deploying the return energy storage member 13, such as, for example, a mechanical linkage, a compressed ring, a spring-loaded rod, a tensioned latch or tab or the like.

[0047] Upon release of the needle module 12 by the second releasable retainer member 6a, the return energy storage member 13 is also deployed from its first configuration to second configuration. Energy released from the return energy member 13 to the needle module 12 displaces the needle module 12 in a distal direction, as indicated by arrow C in FIG. ID, along a longitudinal axis L between a first position (FIG. 1C) and second position (FIG. ID) within the proximal end of the fluid container 9 and is fully retracted back into the lower body 4. The setting switch 3a can then be moved in a horizontal direction to select the second injection assembly 2’ for use. Thus, movement of the delivery device 1 from the third configuration to fourth configuration fully retracts the needle module 12 back into the lower body 4 and readies the delivery device 1 for the second insertion and delivery of a second fluid by the second injection assembly 2’. The operator may then repeat the previous steps to insert and deliver the second fluid from the second injection assembly 2’ to the same or different IM site.

[0048] The first, second and return energy storage members 7, 10 and 13 each independently can be any device for storing energy. Thus, one or more of the first, second and return energy storage members 7, 10 and 13 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 the like or an electrical energy storage member, such as a battery, a capacitor, a magnetic energy storage member or the like. In yet other embodiments, one or more of the first, second and return energy storage members 7, 10 and 13 can be a chemical energy storage member, such as a container containing two substances that, when mixed, react to produce energy.

[0049] As shown, each energy storage member defines a longitudinal axis L. The first energy storage member 7 can be moved within the lower body 4 along L between a first configuration (FIG. 1A) and a second configuration (FIG. 1C). When the first energy storage member 7 is in its first configuration, it has a first potential energy. When the first energy storage member 7 is in its second configuration, it has a second potential energy that is less than the first potential energy. The first energy storage member 7 is operably coupled to the plunger module 8 such that when the first energy storage member 7 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 plunger module 8 in the proximal direction from its first position to second position. Said another way, the movement of the first energy storage member 7 from its first configuration to its second configuration results in the release of energy that acts upon the plunger module 8 to move the plunger module 8 from its first position to second position and thereby dispense fluid contained within the fluid container 9. Moreover, the energy released is also sufficient to displace the second releasable retainer member 6a from its first position to second position when the plunger module is in its second position and release the needle module 12 from driver 11.

[0050] Similarly, the second energy storage member 10 can be moved within the lower body 4 along L between a first configuration (FIG. 1A) and a second configuration (FIG. IB). When the second energy storage member 10 is in its first configuration, it also has a first potential energy. When the second energy storage member 10 is in its second configuration, it has a second potential energy that is less than the first potential energy. The second energy storage member 10 is operably coupled to the driver 11 such that when the second energy storage member 10 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 driver 11 and fluid container 9 which is operatively coupled to the driver 11 in the proximal direction from their first position and second position (needle module 12 which is secured to the driver 11 by the second releasable retainer member 6a in its first position also moves with the driver 11). In particular, the movement of the second energy storage member 10 from its first configuration to its second configuration results in the release of energy that acts upon driver 11 and fluid container 9 to move them from their first position to second position at stop 14. The needle module 12 which is secured to the driver 11 by the second releasable retainer member 6a partially extends outside the lower body 4 as the driver moves between its first and second position to insert into the target site of the subject at the desired depth (i.e. depending upon where the stop 14 is positioned and/or the length of the needle module 12).

[0051] Finally, the return energy storage member 13 can be moved within the lower body 4 along L between a first configuration (FIG. 1A) and a second configuration (FIG. ID). When the return energy storage member 13 is in its first configuration, it has a first potential energy. When the return energy storage member 13 is in its second configuration, it has a second potential energy that is less than the first potential energy. The return energy storage member 13 is operably coupled to the needle module 12 such that when the return energy storage member 13 moves from its first configuration to its second configuration, it converts at least a portion of its first potential energy into kinetic energy to move the needle module 12 from its first position to second position in a distal direction. Said another way, the movement of the return energy storage member 13 from its first configuration to its second configuration results in the release of energy that acts upon the needle module 12 to move the needle module 12 from its first position to second position and thereby fully retracts the needle module 12 back into the lower body 4. [0052] With reference now to FIGS. 2, 3 and 6 a delivery device according to an embodiment is shown and generally designated by reference numeral 100. The delivery device 100 generally includes a lower body 110 and an upper body 120 movably coupled to the lower body 110. The lower body 110 is generally shaped and dimensioned to fit within an operator’s hand and includes a distal end 110a, a proximal end 110b and an exterior surface 111. The lower body 110 may be a unitary structure (i.e., one-piece) that defines the exterior surface 111, or it may include a plurality of layers with different layers defining the exterior surface 111. The lower body 110 may further include a safety switch 112 movably coupled thereto which may be operated by the operator and an opening 113 to accommodate the safety switch 112. The safety switch 112 is adapted and configured to prevent the premature or accidental activation of the delivery device 100. In one embodiment, the safety switch 112 shown in FIG. 6 is a lever in engagement with the opening 113 and the lower slot 126 of upper body 120 and must be turned counter clockwise to release it from engagement, but it may also be a switch, a button, or similar mechanism to prevent accidental activation.

[0053] In some embodiments, the lower body 110 may be rigid. According to other embodiments, the lower body 110 may be flexible, whether according to the nature of the material that defines the lower body 110 or according to the nature of the structure of the lower body 110. The lower body 110 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 lower body 110, 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. [0054] The lower body 110 further houses two chambers 114 and 116 that extend from the distal end 110a to the proximal end 110b of the lower body 110 and that are sized and configured to support injection assembly 102 and 104, respectively. Although two chambers and two injection assemblies are shown, the lower body 110 may include more than two chambers for holding more than two injection assemblies if desired. Chamber 114 includes an opening at its distal end 114a and proximal end 114b. Similarly, chamber 116 includes an opening at its distal end 116a and proximal end 116b. Such openings may include a breakable or removable seal or cover (not shown) for sterilization purposes prior to use. Chambers 114 and 116 also include stops 115 and 117 which are sized and configured to engage the driver 170 and prevent movement of the driver 170 in the proximal direction as will be described below.

[0055] The upper body 120 includes a distal end 120a and a proximal end 120b and is generally shaped and dimensioned to be slidably disposed over the lower body 110 in a proximal direction from a first position to a second position upon application of a force in the proximal direction and in a distal direction from the second position to the first position upon application of a force in the distal direction. The upper body 120 includes an exterior surface 121. The upper body 120 may be a unitary structure (i.e., one-piece) that defines the exterior surface 121, or it may include a plurality of layers with different layers defining the exterior surface 121. The upper body 120 may further include a setting switch 122 movably coupled thereto which may be operated by the operator and an opening 123 to accommodate the setting switch 122. Opening 123 is configured to allow the setting switch 122 to be movably displaced in a horizontal direction due to the presence of two opposing rails 123a and 123b positioned on the walls of the opening 123. The rails 123a and 123b lead into internal stop ends 123c and 123d limiting the distance the setting switch 122 can travel in the horizontal direction within the opening 123. When the setting switch 122 is positioned at stop end 123d, the setting switch 122 is lined up in a longitudinal direction L with chamber 114 of lower body 110 and when the setting switch 122 is positioned at stop end 123c, the setting switch 122 is lined up in a longitudinal direction L with chamber 116 of lower body 110. The setting switch 122 may include a ridge 122a on its lower surface which is sized and configured to activate actuator 130 when a force is applied to move the upper body 120 in a proximal direction, thus activating a sequence of movements for an injection assembly to inject and deliver a first fluid to the target site of the subject. Once the delivery of the first fluid to the subject has been completed, the operator may move the setting switch 122 to the opposite stop end to position the setting switch 122 over the other injection assembly for insertion into the same or different target site and delivery of a second fluid to the subject.

[0056] The upper body 120 may further include a landmarking system 125 for the purpose of indicating where the chambers 114 and 116, and therefore the injection assemblies 102 and 104, are positioned. The landmarking system 125 includes markings on the exterior surface 121 of the upper body 120 such that the operator can visually determine the location of the injection assemblies relative to the anatomical features of the subject. The upper body 120 may also include lower slot 126 to accommodate and engage the safety switch 112 of lower body 110 to prevent accidental activation.

[0057] In some embodiments, upper body 120 may feature one more elongated windows (not shown) sized and configured to allow the operator to view the contents within the lower body 110, and in particular, the chambers 114 and 116. The windows may be covered with a clear material, such as a translucent or transparent material, to maintain sterility of the delivery device 100 while allowing the operator to view the contents of the lower body 110. The windows may be any suitable shape for viewing the contents, such as, but not limited to, an arrow or a long oval. [0058] With continued reference to FIGS. 2 and 3, the delivery device 100 includes a first injection assembly 102 and a second injection assembly 104 positioned within chambers 114 and 116 of lower body 110. The components for each injection assembly and their arrangement and operation are similar and accordingly only the first injection assembly 102 will be described below.

[0059] The first injection assembly 102 includes an actuator 130, a first releasable retainer member 132, a first energy storage member 134, a plunger module 140, a fluid container 150, a second energy storage member 152, a second releasable retainer member 154, a return energy storage member 156, a needle module 160 and a driver 170.

[0060] With reference to FIGS. 2 and 3, actuator 130, in the form of a slidable button having an opening at its proximal end with an expanded inner cavity 131, is positioned at the distal end 114a of chamber 114. The actuator 130 is shown in a first position in FIG. 3 and is advanced in the proximal direction to its second position shown in FIG. 4 by movement of the upper body 120 and setting switch 122 from their first position shown in FIG. 3 to second position shown in FIG. 4 during operation of the delivery device 100. As will be described in detail below, such movement by the actuator 130 from its first position to second position activates the delivery device 100 to cause a sequence of movements of the injection assembly 102 that subsequently leads to the injection and delivery of fluid contained within the injection assembly 102.

[0061] The first releasable retainer member 132 engages the surface of the opening at the proximal end of the actuator 130 and the exterior surface 141 of the plunger module 140. The first releasable retainer member 132 is inherently biased outwardly, with the exterior surface 141 of the plunger module 140 being shaped and configured so as to interferingly engage the first releasable retainer member 132 under force of movement of the first energy storage member 134 when the delivery device 100 is in the initial position (first configuration). In addition, the opening of the proximal end of the actuator 130 is shaped and configured so as to interferingly engage the first releasable retainer member 132 when the delivery device 100 is in the first configuration. With this arrangement, movement of the plunger module 140 and actuator 130 in the L direction is limited due to inter engagement with the first releasable retainer member 132. Thus, both the plunger module 140 and actuator 130 are retained before use. Once the upper body 120 and setting switch 122 have moved in a proximal direction from their first position to second position (and upon activation of actuator 130), the first releasable retainer member 132 will have also moved to a position within the expanded inner cavity 131 of actuator 130 thus allowing the first releasable retainer member 132 to spring outwards thereby releasing the plunger module 140 from engagement.

[0062] In some embodiments, the injection assembly 102 may further include a safety activation mechanism operatively coupled with actuator 130 which prevents the actuator 130 from moving in a proximal direction thus preventing the first releasable retainer member 132 from moving into the expanded inner cavity 131 of actuator 130 and releasing the plunger module 140 from engagement until the safety activation mechanism is activated. Thus, safety activation mechanism is configured to prevent the premature or accidental deployment of the delivery device 100. The safety activation mechanism can be comprised of any suitable mechanism, such as an energy storage member described above, a button, a pin, or similar mechanism. In such embodiments, once the safety switch 112 is released from engagement, the safety activation mechanism will prevent the actuator 130 from activation until the safety activation mechanism is activated. The safety activation mechanism therefore acts as a second safety mechanism and will prevent the premature or accidental activation of the delivery device irrespective of the release of safety switch

112. [0063] The injection assembly 102 also includes a fluid container 150. The fluid container 150 is configured to hold a fluid. The fluid container 150 includes an open distal end 150a and a proximal end 150b comprising an outlet or orifice that is fluidly coupled to the needle module 160, such as by a luer connector, threads, a snap-fit, a latch, a lock, a friction fit coupling, an adhesive or any other suitable coupling features (not shown). The fluid container 150 may have a length of between about 10 millimeters (mm) to about 70 mm. The distal end 150a and proximal end 150b may have a diameter of between about 10 mm to about 25 mm. The orifice at the proximal end 150b may have a diameter of between about 0.05 mm to about 1.6 mm.

[0064] The fluid container 150 defines an internal volume configured to house a fluid. In some embodiments the fluid container 150 may be configured to hold an amount of fluid in the range of about 1 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. 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, antimycobacterial 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).

[0065] The injection assembly 102 also includes a first energy storage member 134. In the embodiment shown in FIG. 3, the first energy storage member 134 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 having a spring constant ranging between about 1 N/m to about 500 N/m. The first energy storage member 134 is operatively coupled to the plunger module 140 and releases energy to the plunger module 140 to displace the plunger module 140 in the proximal direction when the first energy storage member 134 moves from its first configuration to second configuration after the actuator 130 has been activated.

[0066] As shown in FIGS. 2 and 3, the plunger module 140 comprises a plunger rod 142, a plunger tip 144 movably coupled to the plunger rod 142 and a plunger seal 146. In some embodiments, the plunger module 140 may be formed as a single piece or as modular components. The modular components may be affixed to one another or located adjacently, but not connected, so as to move together. The plunger module 140 is sized and configured to be movably disposed within the fluid container 150 when it moves between its first position and second position.

[0067] The plunger rod 142 is shown as a cylindrical body having a distal end 142a, a proximal end 142b, an exterior surface 143 and an inner cavity 143a. The inner cavity 143a may extend from the plunger rod’s distal end 142a towards the proximal end 142b for a distance that is less than the length of the plunger rod 142, although in some embodiments it may extend for a distance equal to about the length of the plunger rod 142. The plunger rod 142 further includes an upper rim 145a and a lower rim 145b. The plunger module 140 and first energy storage member 134 are operatively coupled at upper rim 145a. The lower rim 145b is positioned inside of fluid container

150.

[0068] The plunger tip 144 is located at the proximal end 142b of plunger rod 142 in a first position. The plunger tip 144 is sized and configured to move in a distal direction within inner cavity 143a to a second position when the needle sleeve 162 is displaced from its first position to second position by the energy released from the return energy storage member 156 as it moves from its first configuration to second configuration as will be described below.

[0069] The proximal end 142b of the plunger rod 142 can be coupled to and/or in contact with the plunger seal 146 which is configured to be in fluid communication with the fluid disposed within the internal volume defined by the fluid container 150. The proximal end 142b of the plunger rod 142 is configured to be movably displaced within the internal volume defined by the fluid container 150 by the energy released by the first energy storage member 134 when the first energy storage member 134 moves from its first configuration to second configuration. In this manner, the first energy storage member 134 acting on the plunger rod 142 can displace the plunger seal 146 within the fluid container 150 to expel the fluid through the orifice at proximal end 150b of fluid container 150. The sidewalls of the plunger seal 146 can be configured to contact the interior surfaces of the sidewalls of the fluid container 150 such that the plunger seal 146 forms a fluid-tight seal with the sidewalls of the fluid container 150, for example, to prevent leakage of the fluid. The plunger seal 146 can be made of an inert and/or biocompatible material which is rigid but soft. Example materials include rubber, silicone, plastic, polymers, any other suitable material or combination thereof. In some embodiments, the plunger seal 146 can be monolithically formed with the plunger module 140. In some embodiments, the plunger module 140 may also include one-way bendable tabs (not shown) to prevent movement of the plunger rod 142 in the distal direction once the plunger module 140 has advanced to the second position.

[0070] With continued reference to FIGS. 2 and 3, the injection assembly 102 includes driver 170. The driver 170 is shown as a cylindrical plug having a distal end 170a and a proximal end 170b and is sized and configured to be movably disposed within chamber 114 in a proximal direction from a first position to a second position. The driver 170 further includes an inner cavity 171 sized and configured to support the needle module 160. The inner cavity 171 further includes an expanded region 172. The driver 170 also includes groove 173 at its distal end 170a that is sized and configured to hold and support the fluid container 150. The driver 170 and fluid container 150 are therefore operatively coupled.

[0071] The injection assembly 102 also includes a second energy storage member 152. In the embodiment shown in FIGS 2 and 3, the second energy storage member 152 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 having a spring constant ranging between about 1 N/m to about 500 N/m. The second energy storage member 152 is operatively coupled to the driver 170 at distal end 170a and releases energy to the driver 170 to displace the driver 170 when the second energy storage member 152 moves from its first configuration to second configuration after the actuator 130 has been activated.

[0072] Referring to FIGS. 2 and 3, the injection assembly 102 also includes a second releasable retainer member 154 which secures the needle module 160 to the driver 170 at a first position and is configured to release the needle module 160 when the plunger module 140 moves to its second position. The second releasable retainer member 154 engages the surface of the inner cavity 171 of driver 170 and the exterior surface of the needle module 160. The second releasable retainer member 154 is inherently biased outwardly, with the exterior surface of the needle module 160 being shaped and configured so as to interferingly engage the second releasable retainer member 154 under force of movement of the return energy storage member 156. With this arrangement, movement of the needle module 160 within the inner cavity 171 of driver 170 in the L direction is prevented. Once the plunger module 140 has moved in a proximal direction from the first position to the second position, the second releasable retainer member 154 will then move from a first position to a second position within the expanded region 172 of inner cavity 171 thus allowing it to spring outwards thereby releasing the needle module 160 from engagement with driver 170 (i.e. the energy released from the first energy member 134 is translated to the second releasable retainer member 154 when the plunger module 140 is displaced to its second position, the energy being sufficient to displace the second releasable retainer member 154 in a proximal direction from a first position to a second position).

[0073] With continued reference to FIGS. 2 and 3, the injection assembly 102 also includes a needle module 160. The needle module 160 includes a needle sleeve 162 affixed to a needle 164 operable for intramuscular injection. The needle sleeve 162 is configured to be displaced in the distal direction when released from engagement with the driver 170 by movement of the second releasable retainer member 154 from its first position to second position. Thus, the needle sleeve 162 will be in cooperative engagement with driver 170 and move in a proximal direction with driver 170 as driver 170 moves from its first position to second position and will be released from the driver 170 when the second releasable retainer member 154 moves from its first position to second position. The needle sleeve 162 and needle 164 are sized to be movably disposed within the inner cavity 143a of the plunger module 140 as will be described below. In some embodiments, the needle module 160 may further include a needle cover (not shown). The needle cover is configured to prevent needlestick injuries and maintain the sterility of the needle 164 by providing a protective barrier around the needle 164. The needle cover can be manually removed before operation of the delivery device 100 or may be operable to automatically remove itself during the insertion of needle 164 into the subject then and re-cover the needle 164 after retraction of the needle 164.

[0074] The injection assembly 102 also includes a return energy storage member 156. The return energy storage member 156 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 having a spring constant ranging between about 1 N/m to about 500 N/m. In other embodiments, the return energy storage member 156 may be a mechanical linkage, a spring- loaded rod, a tensioned latch or tab or collet / conical taper mechanism which utilizes static friction. The return energy storage member 156 is operatively coupled to the needle sleeve 162 and releases energy to the needle sleeve 162 to move it in a distal direction from its first position to second position when the return energy member 156 moves from its first configuration to second configuration (which is after the second releasable retainer member 154 has moved from its first position to second position to release the needle sleeve 162 from the driver 170).

[0075] 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. 3-5.

[0076] FIG. 3 illustrates the delivery device 100 in an initial position (i.e. first configuration), where the delivery device 100 is ready for use and activation. Upper body 120 is in a first position. Setting switch 122 is in a first position and located over injection assembly 102 and chamber 114. Actuator 130 is in its first position. First, second and third energy storage members 134, 152 and 156 are in their first configurations. The plunger module 140 is held in place by the first releasable retainer member 132, the first releasable retainer member 132 being in tension between the plunger rod 142 and the actuator 130. The driver 170 and fluid container 150 are cooperatively engaged and in their first position. The needle module 160 is held in place within driver 170 by the second releasable retainer member 154, the second releasable retainer member 154 being in tension between the needle sleeve 162 and driver 170. The needle 164 is fully within lower body 110. The landmarking system 125 on the exterior surface 121 of the upper body 120 may be used to place the injection assembly that is to be used over the desired target site, such as an IM site (for e.g. the vastus lateralis muscle) of the subject. Once the desired point of insertion is determined, the activation of the delivery device 100 can begin.

[0077] FIG. 4 illustrates the delivery device 100 in a second configuration. In one embodiment, a 2-step activation mechanism may be required to activate the actuator 130. First, the safety switch 112 (shown in FIG. 6) is released from engagement and then the safety activation mechanism which is configured to oppose the downward motion of the upper body 120 is released from engagement. In other embodiments, activation may be a 1-step activation where either the safety switch 112 or safety activation mechanism is present and must be released, while in still other embodiments the delivery device 100 does not include the safety switch 112 or safety activation mechanism. The delivery device 100 can be activated by applying a force in the proximal direction to the upper body 120 to move the upper body 120 and setting switch 122 in the proximal direction from their first position to second position and to move the actuator 130 from its first to second position. As the actuator 130 moves to its second position, the first releasable retainer member 132 expands in the inner cavity 131 of the actuator 130 to release the plunger module 140. Energy from the first energy storage member 134 as it moves from its first configuration to second configuration is released to the plunger module 140 to begin its movement in the proximal direction within the fluid container 150 towards its second position. Concurrently, energy from the second energy storage member 152 is released as it moves from its first configuration to second configuration to the driver 170 to move the driver 170, needle module 160, second releasable retainer member 154 and fluid container 150 in the proximal direction until driver 170 has moved to its second position at engagement with stop 115. Movement of the driver 170 to its second position extends needle 164 outside of the lower body 110 to inject the target site of the subject at a desired depth. Movement by the plunger module 140 in the proximal direction towards its second position begins delivery of fluid from the fluid container 150 to the needle module 160 (i.e. through the needle sleeve 162 and the needle 164 which are coupled) and into the subject. The return energy storage member 156 remains in its first configuration.

[0078] FIG. 5 illustrates the delivery device 100 in a third configuration. The plunger module 140 has further moved in the proximal direction within fluid container 150 to its second position to deliver substantially all of the fluid within the fluid container 150 to the needle 164 and into the subject. The proximal end of the plunger module 140 (plunger tip 144 and plunger seal 146) is now in cooperative engagement with the second releasable retainer member 154. Energy released by the first energy storage member 134 to the plunger module 140 is transferred to the second releasable retainer member 154 in an amount that is sufficient to move the second releasable retainer member 154 from its first position to second position to release the needle sleeve 162 from engagement with the driver 170. Energy from the return energy storage member 156 as it moves from its first configuration to second configuration is released to the needle sleeve 162 to move the needle sleeve 162 and needle 164 in the distal direction. As the needle sleeve 162 moves in the distal direction it contacts the plunger tip 144. The needle sleeve 162 (which is sized to be movably disposed within the inner cavity 143a of the plunger module 140) and plunger tip 144 move to their second positions within the inner cavity 143a. The needle 164 is fully retracted back into the lower body 110. The driver 170 and fluid container 150 remain in their second position. The setting switch 122 can then be moved so that it is located over injection assembly 104 and chamber 116 for injection and delivery of the second fluid using the sequence above.

[0079] In some embodiments, the delivery device 100 may also include a component for providing feedback to the operator once the injection and delivery of fluid is complete and the needle 164 has been fully retracted back into the lower body 110, such as, but not limited to, a viewing window indicating that the injection and delivery of fluid has been completed or an audible click.

[0080] In another aspect, embodiments of the present disclosure are directed to a method for reducing or preventing hemorrhage, comprising intramuscularly administering an antifibrinolytic agent in a dose of about 0.1 g to about 30 g at a rate of no less than 50 mg/s; or use of an antifibrinolytic agent for reducing or preventing hemorrhage, wherein the agent is administered intramuscularly in a dose of about 0.1 g to about 30 g at a rate of no less than 50 mg/s. Without being limited by theory, it is believed that intramuscular injection of an antifibrinolytic agent at a rate of no less than 50 mg/s may facilitate the rapid absorption of the agent into the bloodstream of a bleeding patient. In some embodiments, the dose is administered at a rate of no less than 100 mg/s, no less than 150 mg/s, or no less than 200 mg/s, or no less than 250 mg/s. In some embodiments, the dose is administered at a rate of about 250 mg/s. In some embodiments, the dose is administered within about 5 seconds, within about 10 seconds, or within about 15 seconds. In some embodiments, the dose is administered within about 10 seconds.

[0081] In another aspect, embodiments of the present disclosure are directed to a method for reducing or preventing hemorrhage, comprising intramuscularly administering an antifibrinolytic agent with an autoinjector in a dose of about 0.1 g to about 30 g; or use of an antifibrinolytic agent for reducing or preventing hemorrhage, wherein the agent is administered intramuscularly with an autoinjector in a dose of about 0.1 g to about 30 g. Without being limited by theory, it is believed that intramuscular injection of an antifibrinolytic agent with an autoinjector achieves deeper penetration and better distribution of the agent than with a pre-loaded syringe. In some embodiments, the autoinjector a multi-dose autoinjector.

[0082] In some embodiments, the antifibrinolytic agent is tranexamic acid (TXA) or e- aminocaproic acid (EACA). In some embodiments, the antifibrinolytic agent is TXA. In some embodiments, the antifibrinolytic agent is EACA.

[0083] In some embodiments, the dose is about 0.1 g to about 20 g, about 0.1 g to about 10 g, about 0.1 g to about 5 g, about 0.1 g to about 4 g, about 0.1 g to about 3 g, about 0.1 to about 2 g, about 0.1 to about 1.5 g, about 0.1 g to about 1 g, about 0.5 g to about 30 g, about 0.5 g to about 20 g, about 0.5 g to about 10 g, about 0.5 g to about 5 g, about 0.5 g to about 4 g, about 0.5 g to about 3 g, about 0.5 to about 2 g, about 0.5 to about 1.5 g, about 0.5 g to about 1 g, or about 1 g to about 2 g. In some embodiments, the dose is at least 0.1 g, 0.5 g, at least 1 g, at least 1.5 g, or at least 2 g. In some embodiments, the dose is about 0.1 g, about 0.2 g, about 0.3 g, about 0.4 g, about 0.5 g, about 0.6 g, about 0.7 g, about 0.8 g, about 0.9 g, about 1.0 g, about 1.1 g, about 1.2 g, about 1.3 g, about 1.4 g, about 1.5 g, about 1.6 g, about 1.7 g, about 1.8 g, about 1.9 g, about 2.0 g, about 2.5 g, about 3.0 g, about 3.5 g, about 4.0 g, about 4.5 g, about 5.0 g, about 6.0 g, about 7.0 g, about 8.0 g, about 9.0 g, about 10 g, about 11 g, about 12 g, about 13 g, about 14 g, about 15 g, about 16 g, about 17 g, about 18 g, about 19 g, about 20 g, about 21 g, about 22 g, about 23 g, about 24 g, about 25 g, about 26 g, about 27 g, about 28 g, about 29 g, or about 30 g. [0084] In some embodiments, the dose is provided in an amount of fluid in the range of about 5 mL to about 20 mL, about 5 mL to about 10 mL, about 1 mL to about 20 mL, about 1 mL to about

10 mL, or about 1 mL to about 5 mL. In some embodiments, the dose is provided in about 1 mL, about 2 mL, about 3 mL, about 4 mL, about 5 mL, about 6 mL, about 7 mL, about 8 mL, about 9 mL, about 10 mL, about 11 mL, about 12 mL, about 13 mL, about 14 mL, about 15 mL, about 16 mL, about 17 mL, about 18 mL, about 19 mL, or about 20 mL of fluid. In some embodiments, the dose is administered at a rate of no less than 0.1 mL/s, no less than 0.2 mL/s, no less than 0.3 mL/s, no less than 0.4 mL/s, no less than 0.5 mL/s, no less than 0.6 mL/s, no less than 0.7 mL/s, no less than 0.8 mL/s, no less than 0.9 mL/s, or no less than 1 mL/s.

[0085] In some embodiments, the hemorrhage is posttraumatic hemorrhage, postpartum hemorrhage, or postoperative hemorrhage. In some embodiments, the hemorrhage is external. In some embodiments, the hemorrhage is internal. In some embodiments, the antifibrinolytic agent is administered within 5 hours, within 4 hours, within 3 hours, within 2 hours, within 1 hour, within 45 min, within 30 min, or within 15 min of the onset of the hemorrhage.

[0086] While the foregoing is directed to embodiments of the present disclosure, other and further embodiments of the disclosure may be devised without departing from the basic scope thereof, and the scope thereof is determined by the claims that follow.