Device for reducing bleeding and methods of making and using same - Patents.com

Abstract

In some embodiments, the system includes an applicator pad, a pressure device (e.g., a grip), and a reservoir. The grip can be releasably coupleable to the applicator pad and configured to place the applicator pad in contact with a wound of a subject such that pressure can be transmitted through the applicator pad to the wound to promote hemostasis. The reservoir can be configured to contain a drug that is released through the applicator pad to the wound.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and benefit of U.S. Provisional Patent Application No. 63 / 315,915, filed March 2, 2022, entitled "Devices for Bleeding Reduction and Methods of Making and Using the Same," the disclosure of which is incorporated by reference in its entirety into this specification.

[0002]

[0002] This application is a continuation-in-part of International PCT Application No. PCT / US2021 / 026714, filed April 9, 2021, entitled "Devices for Bleeding Reduction and Methods of Making and Using the Same," which claims priority to U.S. Provisional Patent Application No. 63 / 007,543, filed April 9, 2020, entitled "Devices for Bleeding Reduction and Methods of Making and Using the Same," and which claims the benefit of U.S. Provisional Patent Application No. 63 / 007,543, filed April 9, 2020, entitled "Devices for Bleeding Reduction and Methods of Making and Using the Same," and which claims the benefit of U.S. Provisional Patent Application No. No. 17 / 522,736, filed on April 25, 2022, which is a divisional application of U.S. patent application Ser. No. 17 / 522,736, filed on April 25, 2022, entitled "Devices for Bleeding Reduction and Methods of Making and Using the Same," and a continuation-in-part application of U.S. patent application Ser. No. 17 / 728,894, filed on April 25, 2022, entitled "Devices for Bleeding Reduction and Methods of Making and Using the Same," the disclosures of each of which are incorporated herein by reference in their entireties.

[0003]

[0003] International PCT Application No. PCT / US2021 / 053641 also claims priority to U.S. Provisional Patent Application No. 63 / 087,532, entitled "Methods for Self-Treatment or Home Care Provider Treatment of Minor Wounds," filed on October 5, 2020, and U.S. Provisional Patent Application No. 63 / 090,768, entitled "Methods for Self-Treatment or Care Provider Treatment of Minor Wounds," filed on October 13, 2020, the disclosures of each of which are incorporated by reference in their entirety into this specification. [Background technology]

[0004]

[0004] Patients with minor injuries receive medical attention from physicians in primary care clinics, urgent care centers, and hospital emergency rooms. Many urgent care centers are not open 24 hours a day and 7 days a week. Availability of these urgent care centers may be limited in rural areas. A typical visit to a hospital emergency room or urgent care center is for a wound that requires bleeding to be stopped, especially for patients receiving anticoagulant or antiplatelet therapy. With an aging population, more patients require these treatments for a variety of conditions.

[0005]

[0005] Better methods and devices are needed that allow patients, family members, and / or caregivers to safely treat small wounds that require stopping bleeding at home or at the site of the injury. Summary of the Invention

[0006]

[0006] This Summary is provided to introduce some concepts in a simplified form that are detailed below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

[0007]

[0007] Disclosed herein are devices, methods of using the devices, and methods of manufacturing the devices, for example for the treatment of bleeding from small wounds. In some embodiments, the system includes an applicator pad, a pressure device (e.g., a grip), and a reservoir. The grip can be releasably coupleable to the applicator pad and configured to place the applicator pad in contact with a wound of a subject such that pressure is delivered to the wound through the applicator pad to promote hemostasis. The reservoir can be configured to contain a drug that is released to the wound through the applicator pad.

[0008]

[0008] Additional features, aspects and / or advantages will be appreciated and understood upon further consideration of the detailed description of the illustrative embodiments in conjunction with the accompanying drawings. [Brief description of the drawings]

[0009] [Figure 1]

[0009] FIG. 1 is a cross-sectional view of a portion of skin showing the structure of the epidermis, dermis, subcutaneous tissue, and subcutaneous layer. [Diagram 2]

[0010] FIG. 1 is a schematic diagram of a bleeding treatment system according to one embodiment. [Figure 3A]

[0011] 4 is a schematic diagram of the bleeding treatment system of FIG. 3 showing the packaging removed from the bleeding treatment device and placed near a wound on a patient's skin. [Figure 3B]

[0012] 3B is a schematic diagram of the bleeding treatment device of FIG. 3A with any applicator seal removed and showing a portion of the bleeding treatment device disposed adjacent to a wound on the patient's skin. FIG. [Figure 3C]

[0013] FIG. 3B is a schematic diagram of the bleeding treatment device of FIG. 3A with the grip removed. [Figure 3D]

[0014] FIG. 3B is a schematic diagram of the bleeding treatment device of FIG. 3A shown separated from a wound on a patient. [Figure 4]

[0015] 3 is a flowchart of a method of using the bleeding treatment system of FIGS. 2 and 3A-3D to treat a wound in need of stopping bleeding. [Diagram 5]

[0016] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figures 6A-6C]

[0017] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figure 7A-7D]

[0018] FIG. 1 is a schematic diagram of a bleeding treatment system in an initial configuration, according to one embodiment. [Fig. 7E-7H]

[0019] FIG. 1 is a schematic diagram of a bleeding treatment system in a wet configuration. [Figure 8]

[0020] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figure 9A-9C]

[0021] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figure 10A-10C]

[0022] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figure 11A-11B]

[0023] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figure 12]

[0024] FIG. 2 is a schematic diagram of an applicator pad and a blood absorbing pad, according to one embodiment. [Figure 13]

[0025] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figure 14]

[0026] 1 is a flowchart of a method of using a bleeding treatment system, according to one embodiment. [Figures 15A-15E]

[0027] 1A-1D are schematic diagrams of a bleeding treatment system at various stages of use, according to one embodiment. [Figures 16A-16C]

[0028] FIG. 1 is a schematic diagram of a bleeding treatment system in a wet configuration, according to one embodiment. [Fig. 16D-16F]

[0029] FIG. 16C is a schematic diagram of the bleeding treatment system of FIGS. 16A to 16C in a decoupled configuration. [Figure 17A-17B]

[0030] FIG. 16C is a schematic diagram of the bleeding treatment system of FIGS. 16A-16C, according to one embodiment. [Figure 18]

[0031] FIG. 17C is a schematic diagram of the bleeding treatment system of FIGS. 17A and 17B, according to one embodiment. [Figure 19A]

[0032] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figure 19B]

[0033] FIG. 19B is a schematic diagram of a portion of the bleeding treatment system of FIG. 19A. [Figure 19C]

[0034] FIG. 19B is a schematic diagram of a portion of the bleeding treatment system of FIG. 19A, according to one embodiment. [Figure 20]

[0035] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figure 21]

[0036] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Fig. 22A-22B]

[0037] 1A-1D are schematic cross-sectional and top view illustrations of a bleeding treatment system, according to one embodiment. [Figures 23A-23C]

[0038] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Figure 24]

[0039] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Fig. 25A-25C]

[0040] FIG. 1 is a schematic diagram of a sequence of steps performed using a kit, according to one embodiment. [Figures 26A-26C]

[0041] FIG. 1 is a schematic diagram of a sequence of steps performed using a kit, according to one embodiment. [Figure 27]

[0042] FIG. 1 is a schematic diagram of a bleeding treatment system, according to one embodiment. [Fig. 28A-28F]

[0043] 1A-1D are various views of a bleeding treatment system, according to one embodiment; [Fig. 29A-29H]

[0044] 1A-1D are various views of a bleeding treatment system, according to one embodiment; [Fig. 30A-30E]

[0045] 1A-1D are various views of a bleeding treatment system, according to one embodiment; [Fig. 31A-31D]

[0046] 1A-1D are various views of a bleeding treatment system, according to one embodiment; [Fig. 32A-32L]

[0047] 1A-1D are various views of a bleeding treatment system, according to one embodiment; [Fig. 33A-33B]

[0048] FIG. 1 illustrates an applicator pad of a bleeding treatment system, according to one embodiment. [Diagram 34]

[0049] 1 is an example of an applicator pad according to one embodiment. [Fig. 35A-35D]

[0050] 1A-1D are various views of a bleeding treatment system, according to one embodiment; [Figure 36A]

[0051] 1 is an example of an applicator pad including microneedles, according to one embodiment. [Fig. 36B-36D]

[0052] FIG. 2 is a diagram of the area near the microneedles of an applicator pad, according to one embodiment. [Figure 36E]

[0053] FIG. 2 is a schematic diagram of another example of a microneedle, according to one embodiment. [Figure 37]

[0054] FIG. 1 illustrates a perspective view of an embodiment of a bleeding treatment system, according to one embodiment. [Figure 38A]

[0055] FIG. 38 is an exploded view of the embodiment of the bleeding treatment system shown in FIG. 37. [Fig. 38B-38C]

[0056] FIG. 38B is a perspective view of various components of a bleeding treatment system according to the embodiment shown in FIG. 38A. [Fig. 38D-38E]

[0057] FIG. 38B is a top view of various components of a bleeding treatment system according to the embodiment shown in FIG. 38A. [Figure 39-40]

[0058] FIG. 38B is a cross-sectional view of a bleeding treatment system according to the embodiment shown in FIG. 38A prior to use of the bleeding treatment system. [Figure 41-42]

[0059] FIG. 38B is a cross-sectional view of a bleeding treatment system according to the embodiment shown in FIG. 38A during use of the bleeding treatment system. [Figure 43-45]

[0060] 38B illustrates components of a bleeding treatment system according to the embodiment illustrated in FIG. 38A. [Figure 46-47]

[0061] FIG. 38B illustrates a cross-sectional view of the bleeding treatment system after the drive plunger has moved into the reservoir to force the agent out of the reservoir according to the embodiment shown in FIG. 38A. [Figure 48-49]

[0062] 38B is a cross-sectional view of the bleeding treatment system after the applicator cap has been removed from the main portion of the bleeding treatment system according to the embodiment shown in FIG. 38A. [Figure 50]

[0063] 38B illustrates an applicator pad including channels according to the embodiment illustrated in FIG. 38A. [Fig. 51-55]

[0064] 1A-1D are various views of a bleeding treatment system, according to one embodiment; [Fig. 56A-56J]

[0065] 1A-1D are various views of a bleeding treatment system, according to one embodiment; [Fig. 57A-57B] Same as above. [Fig. 58A-58D] Same as above. [Fig. 59A-59D] Same as above. [Figure 60A-60C] Same as above. [Figure 61A-61C] Same as above. [Fig. 62A-62D] Same as above. [Fig. 63A-63F] Same as above. [Fig. 64A-64F] Same as above. [Fig. 65A-65E] Same as above. [Fig. 66A-66F] Same as above. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010]

[0066] The detailed description herein serves to describe non-limiting embodiments or examples incorporating various inventive concepts, and uses reference numbers to facilitate understanding of these examples. It will be understood that reference numbers common to the figures refer to common features and structures having the same or similar functionality. Although various figures have common reference numbers that refer to such common features and structures, for the sake of brevity, the description of subsequent figures will not necessarily repeat a discussion of these features and structures.

[0011]

[0067] For reference, Fig. 1 shows a cross-sectional view of a skin portion SK of a human being, e.g., a subject to be treated. The skin portion SK includes an epidermis E, a dermis D, a subcutaneous tissue H, and a subcutaneous layer S.

[0012]

[0068] The systems and methods described herein may be configured to treat and / or assist in stopping bleeding of wounds that extend through the epidermal and / or dermal layers, are not arterial, do not result in pulsatile bleeding, and do not expose subcutaneous fat or muscle. In some embodiments, the systems and methods described herein may be self-performed (e.g., the practitioner of the system and / or method is also the subject with the wound). In some embodiments, the systems and methods described herein may be performed on the subject with the wound by a person other than the subject, such as a caregiver (e.g., a non-medical home caregiver such as a family member) or a clinician. In some embodiments, the systems and methods described herein may be performed on a non-human patient, such as a pet dog or cat, and the method steps may be performed by the owner or a veterinarian. In some embodiments, the target wound treatable by the systems and methods described herein may be less than 3 centimeters in length. In some embodiments, the target wound treatable by the systems and methods described herein in a home setting may be a wound that does not require sutures to close. In some embodiments, target wounds treatable with the systems and methods described herein in a clinical setting may be wounds in which the systems and methods described herein may be used to initially attempt to stop bleeding prior to utilizing suturing if the systems and / or methods described herein are ineffective after a single use.

[0013]

[0069] Potential patient populations that may be treated with the systems and methods described herein include those with localized bleeding (i.e., bleeding through the skin). For example, the target patient population may include people with naturally induced, drug induced, or treatment induced bleeding susceptibility and / or resistance to blood clotting. Naturally induced bleeding susceptibility and / or resistance to blood clotting may result from chronic diseases such as hemophilia, von Willebrand's disease, vascular disorders (e.g., Osler's disease), coagulation disorders, renal failure, liver failure, bone marrow suppression (pathologically induced or drug induced) platelet disorders, aging (older people may have more fragile skin), or diseases that make people more prone to accidents (including aging and / or motor or cognitive disorders) or are difficult to treat (e.g., genetic diseases). Drugs that may induce bleeding susceptibility and / or resistance to clotting may include anticoagulants such as warfarin, heparin, factor Xa inhibitors, thrombin inhibitors, low molecular weight heparins, dabigatran, argatroban, hirudin, rivaroxaban, apixaban, edoxaban, fondaparinux, enoxaparin, dalteparin, and bivalridine, as well as antiplatelet agents such as aspirin (acetylsalicylic acid or ASA), platelet aggregation inhibitors such as cangrelor, ticagrelor, lopidogrel, prasugrel, cilostazol, clopidogrel, dipyridamole, ticlopidine, glycoprotein platelet inhibitors such as epifibatide, tirofiban, abciximab, and protease-activated receptor-1 antagonists such as vorapaxar. Anticoagulants may be taken for a variety of conditions, such as deep vein thrombosis, pulmonary embolism, and atrial fibrillation. Medical procedures that may induce bleeding susceptibility and / or resistance to clotting may include renal replacement therapy (e.g., hemodialysis), cardiopulmonary bypass, extracorporeal membrane oxygenation (ECMO), chemical thrombolysis (using tissue plasminogen activator (TPA)), cardiac catheterization, peripheral vascular surgery (e.g., femoral-popliteal bypass, arterial thrombectomy), mechanical thrombectomy, angiography, and other neurointerventional procedures and interventions. In some embodiments, any of the systems, methods, or devices herein may be used to treat melasma and / or freckling.Although the systems described herein are referred to as bleeding treatment systems and are described with respect to treating wounds, any of the systems and devices described herein, such as system 100 described below, may also be configured or used as a system or device for locally applying any therapeutic or other substance to any suitable type of target treatment site on a user that may benefit from application of the substance.

[0014]

[0070] A bleeding treatment system 100 that may be used to treat a wound requiring stopping of bleeding is shown diagrammatically in Fig. 2. As shown in Fig. 2, the bleeding treatment system 100 includes an applicator pad 110, an optional applicator seal 120 coupled to the applicator pad 110, an optional blood absorbing pad 130 coupled to the applicator pad 110, one or more optional reservoirs 150 fluidly coupled to the applicator pad 110 via a fluid coupling 155 and containing one or more medicaments, an applicator device 170 releasably coupleable to the applicator pad 110 and including a grip 140, an optional release mechanism 160 coupled to the reservoirs 150, the fluid coupling 155, and the grip 140, an optional pad retainer 135 coupled to the applicator pad 110, an optional user guide 190 associated with the applicator device 170, and an optional package 195 including other components of the bleeding treatment system 100. The grip 140 may be releasably coupleable to the applicator pad 110 via an optional pad connector 148 .

[0015]

[0071] The applicator pad 110 (also referred to as a topical applicator pad) is formed of a size, configuration, and material suitable for covering a wound treatable by the system 100. The applicator pad 110 may be formed of any one or more materials having suitable physical properties. For example, the material is preferably capable of absorbing blood. The material may also swell or expand upon absorbing fluids such as blood. The material may also be capable of containing, absorbing, wicking, or carrying one or more agents to be applied to the wound WD and / or the surface of the skin SK surrounding the wound. The material should be biologically compatible with the skin SK and wound WD. Preferably, the one or more materials are also non-reactive or compatible with the agents carried by the applicator pad 110, e.g., do not alter the composition, delivery, or effectiveness of the agents, or degrade or lose any of their desired physical properties when exposed to the agents for the maximum period of wound treatment. The material is preferably sufficiently stiff and elastic to be able to exert a sufficient amount of pressure on the wound treatment to help achieve hemostasis, i.e., to function as a hemostatic agent. At least a bottom or distal surface of the applicator pad 110 (e.g., the surface that is exposed prior to use of the bleeding treatment system 100) may be covered or surrounded by a removable applicator seal 120 to prevent contamination of the applicator pad 110 and / or to prevent undesired release of a medicinal agent that may be contained in the applicator pad 110. The applicator seal 120 may be formed as a film or other thin layer of a material that is non-reactive with the applicator pad 110. The applicator seal 120 may be removed (e.g., by peeling) from the applicator pad 110 prior to use.

[0016]

[0072] Suitable materials for the applicator pad 110 include polymers or other compositions such as polyvinyl alcohol (PVA), polyurethane (hydrophilic or not), polypropylene, which may be formed into a foam (open or closed cell) (e.g., porous expandable foam), natural fibers such as cotton, linen, wool, in woven or non-woven (e.g., felt) form, and / or layered matrices of foam and / or gauze packings. The applicator pad 110 may be monolithically formed of a single material, or may be formed as a composite or other assembly of various materials. For example, the applicator pad 110 may be formed primarily of one material with a relatively thin coating of a second material. The materials may achieve the desired function in a variety of ways. For example, absorption of blood may be accomplished mechanically, e.g., by capillary wicking, and / or chemically, e.g., by absorption into molecular sieves or other desiccants, or by binding with materials such as clays, e.g., kaolin, bentonite, montmorillonite, saponite, polygorskite, attapulgite, and / or sepiolite. In some embodiments, clays may be dispersed in the liquid medium. In some embodiments, the applicator pad 110 may comprise a hemostatic patch and a flexible insulating or wicking mechanism (also referred to as a backing or backing layer). In some embodiments, the hemostatic patch may contain a liquid agent, and the flexible insulating or wicking mechanism may separate the hand applying pressure to the applicator pad 110 from the wound site and the liquid agent.

[0017]

[0073] As described in more detail below, the applicator pad 110 may comprise, incorporate or integrate a reservoir of drug, and various materials may be used to form or border such reservoir. In some embodiments, the applicator pad 110 may comprise a reservoir of dry or lipophilized drug that may be made flowable by fluid released from the reservoir of the applicator device 170 and / or blood from the wound. For example, the applicator pad 110 and / or a backing layer coupled to the applicator pad 110 may define a recessed or internal area within which a powdered drug may be placed in the initial configuration of the applicator pad 110. In some embodiments, the applicator pad 110 may define or comprise an internal structure or passageway to aid in the flow of drug through the applicator pad 110 and / or to preferentially direct the flow to the target wound tissue. In some embodiments, the applicator pad 110 may include a colored dye.

[0018]

[0074] The bleeding treatment system 100 is preferably configured to deliver one or more drugs to a target wound tissue, for example, via the applicator pad 110. The drugs may be contained in one or more reservoirs 150 (which may be separate from or integrated into the applicator pad 110, as described above), may be selectively released from the reservoirs 150 by one or more release mechanisms 160, and may be conveyed from the reservoirs 150 to the applicator pad 110 by one or more fluid couplings 155. For example, the reservoirs 150 may be embodied as containers (such as ampoules) having a volume sufficient to contain a therapeutically effective amount of the drug and formed of a material that is impermeable to and non-reactive with the drug or its components, such as glass, metal, plastic, polymers (e.g., rigid polymers such as polyethylene, polypropylene, polyamide, polycarbonate, etc.). In some embodiments, the reservoirs 150 may be formed of a material (e.g., plastic or glass) that can be broken or ruptured to release the contents of the reservoirs 150. The reservoir 150 may have an opening through which an agent may be introduced into the reservoir 150 and / or selectively released from the reservoir 150. In some embodiments, the reservoir 150 may include an outlet.

[0019]

[0075] Gripping portion 140 may be formed of any suitable material, with at least the distal end (e.g., any plate) being formed of a relatively rigid material capable of applying suitable pressure to applicator pad 110. For example, gripping portion 140 (or at least the body of a first portion of grip 140) may be formed of a rigid polymer, such as polyethylene, polypropylene, polyamide, and / or polycarbonate.

[0020]

[0076] The reservoir 150 may be contained in whole or in part within the applicator pad 110 or may be coupled to the applicator pad 110 via a fluid coupling 155, such as a tube, a wick, or the like. The medicament may be selectively released from the reservoir 150, for example, by a release mechanism 160, such that the medicament may be received at the applicator pad 110. The release mechanism 160 may be, for example, a valve, which may be opened to establish fluid communication between the reservoir 150 and the applicator pad 110, either directly or via the fluid coupling 155, and may be selectively closed to fluidly isolate the medicament in the reservoir 150. The release mechanism 160 may be a removable or frangible cap or other closure that closes an opening in the reservoir 150. The reservoir 150 may itself be fragile, e.g., made of glass that can be easily broken, or at least partially made of a material that will burst when the contents of the reservoir 150 rise above a threshold pressure, and the drug may be released from the reservoir 150 by breaking or allowing the reservoir 150 to break. As noted above, in some embodiments, the reservoir 150 may be part of the applicator pad 110. For example, the material of the bleeding treatment system 100 may be impregnated or saturated with the drug and encased in an applicator seal 120 (e.g., a film or other thin layer of a material that is impermeable to and unreactive with the drug). The drug may be released from the reservoir 150 by removing the applicator seal 120 and exposing a surface of the applicator pad 110 such that the drug may be delivered to wound tissue against which the surface of the applicator pad 110 is placed.

[0021]

[0077] In some embodiments, the volume and material of the applicator pad 110 may be selected to contain an amount of drug in one or more reservoirs 150, whether separate from or incorporated into the applicator pad 110, or an amount of drug may be pre-impregnated into the applicator pad 110 such that the applicator pad 110 is about 35% saturated (i.e., contains about 35% of the amount of drug that it can contain). In some embodiments, the applicator pad 110 may be configured to be about 67 to about 100% saturated with an amount of drug. In some embodiments, the applicator pad 110 may be configured to be about 25 to about 50% saturated with an amount of drug. In some embodiments, the applicator pad 110 may be pre-impregnated or loaded to hold a measured amount of drug. In some embodiments, the applicator pad 110 can be configured (e.g., configured to be about 35% saturated or about 25% to about 50% saturated) so that the amount of drug is effective to treat the wound, but does not allow the drug to pass across the user's skin outside the treatment area (e.g., down the user's arm or leg).

[0022]

[0078] The applicator pad 110 may be of any suitable shape and / or size, preferably sufficient to cover the target wound. For example, the perimeter of the applicator pad 110 may be formed in a circular, oval, elliptical, square, rounded square, rectangle, rounded rectangle, triangle, pentagon, hexagon, or any other suitable shape. As noted above, the size of the target wound covered by the applicator pad 110 may be, for example, less than about 3 centimeters in length and / or width. In some embodiments, for example, the applicator pad 110 may have a square perimeter with a side length of about 1.5 inches. In some embodiments, the applicator pad 110 may have a smaller area. In some embodiments, the applicator pad 110 may have a square perimeter with a side length of about 3.0 cm. 2 ~Approx. 7.0cm 2 In some embodiments, the applicator pad 110 may have a surface area of ​​about 7.0 cm 2~Approx. 12.0cm 2 In some embodiments, the applicator pad 110 may have a surface area of ​​about 2 cm 2 ~Approx. 25cm 2 In some embodiments, the applicator pad 110 may have a surface area of ​​about 3 cm 2 ~about 10cm 2 , or about 10 cm 2 ~about 20cm 2 For example, the surface area may be approximately 2 cm 2 , about 3cm 2 , about 4cm 2 , about 5cm 2 , about 6cm 2 , about 7cm 2 , about 8cm 2 , about 9cm 2 , about 10cm 2 , about 11cm 2 , about 12cm 2 , about 13cm 2 , about 14cm 2 , about 15cm 2 , about 16cm 2 , about 17cm 2 , about 18cm 2 , about 19cm 2 , about 20cm 2 , about 21cm 2 , about 22cm 2 , about 23cm 2 , about 24cm 2 , or about 25 cm 2 It may be the case.

[0023]

[0079] The applicator device 170 may be any suitable device operable by a user to position the applicator pad 110 at a desired location, e.g., adjacent to the wound WD, and to anchor the applicator pad 110 at the desired location. For example, the applicator device 170 may be a mechanical syringe with a cylinder having a distal end suitable for attachment to the applicator pad 110 and a proximal end that may be grasped by a user. In some embodiments, the reservoir 150, release mechanism 160, and / or fluid coupling 155 may be disposed within the cylinder (e.g., between a plunger and the applicator pad 110). In some embodiments, the applicator device 170 may include a plunger movable relative to the cylinder, such that a user can apply a distal force to the plunger to engage the distal end of the plunger with the reservoir 150 and urge the contents of the reservoir 150 distally within the cylinder and out the distal end of the cylinder into contact with the applicator pad 110. For example, the reservoir 150 may include a breakable neck that separates from a body of the reservoir 150 to release liquid from the reservoir 150 in response to the reservoir 150 being pressed against an internal ramp or slope. In another example, the neck of the reservoir 150 may be broken off from the reservoir by engagement of the neck with a deformable sidewall of the applicator device 170 by a user manipulating the sidewall.

[0024]

[0080] In some embodiments, the reservoir 150 can include a weakened or pre-perforated area (e.g., a circumferential region or a sidewall region) configured to preferentially break when a breaking load is applied. For example, in some embodiments, the weakened or pre-perforated area can be at a midpoint of the reservoir 150 adjacent a shoulder of the reservoir 150 along a central axis of the reservoir 150, and / or on or near a first (e.g., distal) or second (e.g., proximal) end of the reservoir 150. The reservoir 150 can be configured to break (e.g., at a weakened or pre-perforated area) due to a rotational, bending, and / or orthogonal force (relative to or along a central axis of the reservoir 150) applied to the reservoir 150. In some embodiments, such rotational, bending, and / or orthogonal forces can be applied by twisting and / or bending the grip 140 within which the reservoir 150 is disposed. In some embodiments, the break load may be applied to displace (e.g., crush) a portion of the grip (e.g., a deformable sidewall portion) into sufficiently forceful contact with a sidewall of the reservoir 150 to break the reservoir 150 and release the contents of the reservoir 150. In some embodiments, the break load may be applied by rotating or translating a second portion of the grip 140 relative to a first portion of the grip 140 to apply the break load to the reservoir 150.

[0025]

[0081] In some embodiments, the release mechanism 160 may comprise a force concentrating component (also referred to as a stress concentrating component) (e.g., a protrusion, such as a ball, such as a steel ball, or a convex or sharp-pointed protrusion, such as a carbide tip) disposed on an inner surface of the grip 140 and configured to be biased toward a sidewall of the reservoir 150 (e.g., as a result of bending the grip 140, crushing or pushing an exterior of the grip 140 toward the reservoir 150, or rotating a second portion of the grip 140 relative to a first portion of the grip 140) to concentrate a breaking load against the sidewall or end of the reservoir 150 and break (e.g., crush) the reservoir 150. In some embodiments, the grip 140 may comprise a notch feature in a sidewall of the grip 140, which may allow the grip 140 to bend more easily about a preferential axis or plane that includes the notch feature.

[0026]

[0082] In some embodiments, reservoir 150 and / or grip 140 may be disposed in a vertical orientation while wetting applicator pad 110 with the contents of reservoir 150 and / or while applying pressure to applicator pad 110 when reservoir 150 is disposed on a wound of a subject such that reservoir 150 is elongated along a longitudinal axis that intersects a plane that includes applicator pad 110 in the initial configuration of system 100. In some embodiments, the contents of reservoir 150 may be configured to flow from reservoir 150 to applicator pad 110 through the open distal end of grip 140. In some embodiments, reservoir 150 and / or grip 140 may be disposed in a horizontal orientation while wetting applicator pad 110 with the contents of reservoir 150 and / or while applying pressure to applicator pad 110 when reservoir 150 is disposed on a wound of a subject such that reservoir 150 is elongated along a longitudinal axis disposed substantially parallel to a plane containing applicator pad 110 in the initial configuration of system 100. In some embodiments, the contents of reservoir 150 may be configured to flow from reservoir 150 to applicator pad 110 through a sidewall of grip 140.

[0027]

[0083] In some embodiments, applicator device 170 may include a filter (not shown) between reservoir 150 and applicator pad 110 to prevent unwanted material (e.g., particles and / or glass pieces above a certain size) from reaching applicator pad 110. In some embodiments, applicator device 170 may not include reservoir 150, release mechanism 160, and / or fluid coupling 155, and instead may provide only a handle by which a user may hold applicator pad 110 so as to apply distributed pressure to applicator pad 110 against target wound tissue and maintain pressure between applicator pad 110 and target wound tissue.

[0028]

[0084] The grip 140 may be used to provide a distributed force (e.g., an evenly distributed force) to the applicator pad 110 to enhance hemostasis, for example to increase the pressure that the applicator pad 110 may apply to the target wound tissue during use. The grip 140 may be implemented in a variety of ways, including those described in the specific embodiments below. For example, the grip 140 may include a plate (also referred to herein as a "fixation plate") disposed at a distal end of the grip 140, extending laterally from a handle portion of the grip 140, and configured to contact and apply a distributed force to the applicator pad 110. In some examples, the plate may be shaped and sized such that the plate has a length and width larger than the target wound tissue such that the plate can press a sufficiently large portion of the applicator pad 110 against the target wound tissue to maintain an evenly distributed pressure between the applicator pad 110 and the target wound tissue for a period of time. Thus, grip 140 may be used to provide sufficient hemostatic force against the target wound tissue (e.g., generate sufficient pressure given the stiffness or modulus of the material from which applicator pad 110 is formed). In some embodiments, grip 140 or a portion of the grip may be deformable (e.g., crushable) to force fluid from a reservoir 150 disposed within the grip.

[0029]

[0085] In some embodiments, the applicator device 170 can selectively release the applicator pad 110. For example, the grip 140 can be releasably engaged with the applicator pad 110 via the pad connector 148 to apply the applicator pad 110 to a surface of a patient (e.g., against a target wound tissue). The pad connector 148 can be disengaged from the applicator pad 110 such that the grip 140 and the pad connector 148 can be separated from the applicator pad 110 while leaving the applicator pad 110 on the surface of the patient. In some embodiments, the pad connector 148 can comprise one or more adhesive strips configured to couple the grip 140 to the applicator pad 110 when the applicator pad 110 is placed in contact with a wound of a target without displacing the applicator pad 110 relative to the wound, and to be removed from the grip 140 and / or the applicator pad 110 such that the grip 140 can be separated from the applicator pad 110 without displacing the applicator pad 110 relative to the wound. In some embodiments, the pad connector 148 may comprise complementary hook-and-loop fastener portions coupled to the grip 140 and the applicator pad 110, and the grip 140 may be releasably coupled to the applicator pad 110 by disengaging the complementary hook-and-loop fastener portions. In some embodiments, the pad connector 148 may comprise a first engagement feature coupled to the applicator pad 110 and a second complementary engagement feature coupled to the grip 140. The second complementary engagement feature may be configured to releasably engage with the first engagement feature (e.g., by receiving a portion of the first engagement feature within an opening of the second engagement feature by relative rotation between the features or by receiving a portion of the first engagement feature between opposing arms of the second engagement feature). In some embodiments, the pad connector 148 may comprise a latch portion disposed on the grip 140 configured to engage with a hook portion disposed on the applicator pad 110.

[0030]

[0086] In some embodiments, the applicator pad 110 may comprise or be coupled to a pad retainer 135 that may be configured to maintain the applicator pad 110 in contact with the target wound tissue. The pad retainer 135 may comprise, for example, an adhesive on a skin-contacting surface of the applicator pad 110 (e.g., disposed around at least a portion of the perimeter of the applicator pad 110). In some embodiments, the pad retainer 135 may comprise an adhesive foam disposed around the perimeter of the applicator pad 110. In some embodiments, the pad retainer 135 may comprise an adhesive strip having a first portion coupled to a top surface of the applicator pad 110 and having a second portion configured to be coupled to the skin of a subject to hold the applicator pad 110 in place against a wound on the skin. In some embodiments, the pad retainer 135 may comprise a bandage configured to be placed over at least a portion of the applicator pad 110. In some embodiments, the bandage may be formed as a wrap configured to be wrapped around a portion of the subject's body (e.g., an arm or leg) that includes a wound. In some embodiments, the bandage may be formed as a bandage having an adhesive perimeter that is greater than the perimeter of the applicator pad 110 and configured to be applied on top of the applicator pad 110. In some embodiments, the bandage may include protrusions configured to be aligned with the wound and placed in contact with the upper surface of the applicator pad 110, such that when the applicator pad 110 is placed over the wound and the bandage is applied to the applicator pad 110, the protrusions can apply a greater target pressure to the wound through the applicator pad 110 than if the bandage did not include the protrusions. In some embodiments, after a period of time, the protrusions can be removed from the subject leaving the applicator pad 110 in contact with the wound.

[0031]

[0087] In some embodiments, the applicator device 170 may be embodied as a pipette. The pipette may be configured to best suit the accuracy and precision required for the size and location of the wound. For example, the pipette may be configured to be placed within the patient's nostril.

[0032]

[0088] The bleeding treatment system 100 may include a user guide 190. The user guide 190 may include instructions for operating the bleeding treatment system 100 to treat a person experiencing a wound that requires the bleeding to be stopped. The instructions may take the form of textual and / or graphical information that may be presented on a fixed substrate (e.g., paper) or on a display (e.g., a screen) and / or may use other sensory modalities, including audible (audio instructions) and / or tactile (tactile feedback to the user). The user guide 190 may be disposed on (e.g., printed on) or coupled to (e.g., mechanically attached to) any one or more components of the bleeding treatment system 100, including the applicator device 170, the package 190, the applicator pad 110, and / or the reservoir 150. The user guide 190 may be separate from any of the components of the bleeding treatment system 100, but may be associated therewith, for example disposed in a package 195 together with other components of the bleeding treatment system 100. In some embodiments, the user guide 190 may be implemented in whole or in part in software usable on a device such as a smartphone, for example in the form of an "app" that can be downloaded to and launched by a user on a smartphone in preparation for using the bleeding treatment system 100.

[0033]

[0089] In some embodiments, the user guide 190 or another informational label placed on or attached to the system 100 may include an informational label with user instructions such as "Use only on superficial bleeding areas less than 1 inch. Press the topical applicator pad down on the wound for 5 minutes. Place a bandage over the wound. If bleeding does not stop, seek professional medical attention. If you feel weak or dizzy, call 911 immediately and do not use this device. Do not use in the mouth. Do not use on deep wounds. Do not use if you have a history of seizures. Do not use on penetrating or puncture wounds (gunshot, knife, etc.)."

[0034]

[0090] In some embodiments, the user guide 190 or another informational label placed on or attached to the system 100 may include an informational label with user instructions such as "Use only on superficial, bleeding wounds 3 inches or less in length. Press the release mechanism to break up the medication. Allow the medication to completely cover the topical applicator. Hold the device down on the wound for 10 minutes. Place a bandage over the wound. If bleeding does not stop or you feel dizzy, weak, or fatigued, seek immediate professional medical attention. Do not use in the mouth. Do not use on deep wounds. Do not use if you have a history of seizures. Do not use on penetrating or puncture wounds (gunshot, knife, etc.). Do not ingest this medication. Keep out of reach of children and infants."

[0035]

[0091] In some embodiments, the user guide 190 or another informational label placed on or attached to the system 100 may include one or more instructions indicating one or more of the following: (i) to remove the applicator cap before pressing the device down onto the wound, and (ii) to peel the topical applicator off the rest of the device and use a bandage to hold the topical applicator on the wound.

[0036]

[0092] In some embodiments, the user guide 190 or another informational label or stamp affixed to the system 100 may include an expiration date. The system 100 may have a shelf life from the date of manufacture of, for example, 3 years, more than 3 years, or less than 3 years. In some embodiments, the user guide 190 or another informational label or stamp affixed to the system 100 may include a lot number and / or a date of manufacture. In some embodiments, the user guide 190 or another informational label or stamp affixed to the system 100 may include a bar code and / or a quick response (QR) code.

[0037]

[0093] The package 195 may be implemented similarly to any known medical device packaging to contain the other components of the bleeding treatment system 100, to protect them from the environment, and optionally to preserve their sterility. The package 195 is preferably configured so that when the user wishes to access and use the bleeding treatment system 100, the user can easily open it, for example by peeling a cover off the tray. The package 195 may be implemented in many other forms, including, for example, a bag or a box. The system 100 is preferably intended for use with a single user and one wound site. The system 100 is preferably intended to be discarded after use and may optionally include a container for safe disposal. In some embodiments, the system 100 may be initially supplied to the user in the package 195, which may also be used for disposal. In some embodiments, the package 195 and / or the disposal container may be a resealable bag and / or may include a biohazard label and / or disposal instructions.

[0038]

[0094] The agents described herein may be any agent that is desirable to deliver to a patient experiencing a wound that requires bleeding to be stopped in preparation for or as part of the treatment of the wound. Types of agents may include vasoconstrictors, antifibrinolytics, antibiotics, recombinant clotting factor preparations, local anesthetics, analgesics, buffers, calcium, alcohol / antiseptics (e.g., chlorhexidine solutions such as chlorhexidine and solutions of isopropyl and / or ethyl alcohol), or any combination thereof. Vasoconstrictors may be useful in helping bleeding blood vessels to constrict prior to or concurrently with administration of a hemostatic agent such as an antifibrinolytic agent, and may desirably be delivered to the wound tissue at or around the bleeding site before, during, and / or after application of the applicator pad 110 to the target wound tissue. Suitable vasoconstrictors may include phenylephrine, oxymetazoline (Afrin), and epinephrine. Antifibrinolytic drugs may help prevent clot breakdown and may desirably be delivered to wound tissue at or around the bleeding site before, during, and / or after application of the applicator pad 110 to the target wound tissue. Suitable antifibrinolytic drugs may include aminocaproic acid, tranexamic acid (TXA) (e.g., dry or lyophilized TXA or liquids containing TXA), aprotimine, protaminomethylbenzoic acid, and fibrinogen. Protamine, an antagonist of anticoagulant heparin, may be used before, during, or after the use of the above drugs. Drugs may include, for example, protamine sulfate. As noted above, the bleeding treatment system 100 and drugs may be particularly useful in treating patients who are prone to bleeding or in patients in whom hemostasis may be difficult to achieve, such as patients taking anticoagulant and / or antiplatelet drugs (identified above).

[0039]

[0095] In some embodiments, the medicament may comprise a pharmaceutical composition comprising a therapeutically effective amount of TXA, one or more antibiotics, one or more anesthetics, one or more nonsteroidal anti-inflammatory drugs, and / or an excipient or carrier that facilitates topical administration. For example, in some embodiments, the therapeutically effective amount of tranexamic acid is 1-70% by weight of the composition. In some embodiments, the one or more antibiotics may comprise sulfacetamide, mupirocin, erythromycin, clindamycin, sulfadiazine, mafenide, tetracycline, bacitracin, neomycin, and polymyxin B. In some embodiments, the one or more antibiotics may comprise bacitracin, neomycin, and polymyxin B. In some embodiments, the excipient or carrier allows the composition to remain in contact with the bleeding wound. In some embodiments, the excipient or carrier comprises an ointment, cream, liniment, paste, lotion, gel, hydrogel, liposome, spray, aerosol, solution, or emulsion. In some embodiments, the excipient or carrier allows the composition to be instilled. In some embodiments, the one or more anesthetic agents may include lidocaine, proparacaine, procaine, tetracaine, and combinations thereof. In some embodiments, the one or more nonsteroidal anti-inflammatory agents may include ketorolac, ketoprofen, flurbiprofen, bromfenac, diclofenac, and / or combinations thereof.

[0040]

[0096] In some embodiments, the medicament may include a TXA-containing composition. In some embodiments, the TXA-containing composition includes about 200-300 mg / mL of TXA. In embodiments, the TXA-containing composition includes about 200 mg / mL of TXA. In embodiments, the TXA-containing composition includes about 300 mg / mL of TXA. In embodiments, the TXA-containing composition includes about 250 mg / mL of TXA. In embodiments, the TXA-containing composition has a viscosity of about 1-50 cps, and the viscosity is in accordance with USP <912> The viscosity is measured at 21° C. using the rotational viscosity method III (cone and plate rheometer) described in USP 1999. In an embodiment, the viscosity of the TXA-containing composition is about 1-100 cps, and the viscosity is measured using the rotational viscosity method III (cone and plate rheometer) described in USP 1999. <912> The viscosity is measured at 21° C. using the rotational viscosity method III (cone and plate rheometer) described in USP 1999. In an embodiment, the viscosity of the TXA-containing composition is about 5-50 cps, and the viscosity is measured using the rotational viscosity method III (cone and plate rheometer) described in USP 1999. <912> The viscosity is measured at 21° C. using a rotational viscosity method III (cone and plate rheometer) as described in, for example, US Pat. No. 6,399,343, filed Mar. 1, 2023, and having any of the properties described in International Patent Application No. PCT / US2023 / 063500 to M. Powell et al., entitled “Topical Tranexamic Acid Compositions and Methods of Use Thereof,” filed Mar. 1, 2023, the disclosure of which is incorporated herein by reference in its entirety.

[0041]

[0097] In some embodiments, the medicament may include an opiate, such as codeine, morphine, oxycodone, an anti-inflammatory, including acetaminophen, nonsteroidal anti-inflammatory, such as aspirin, an antibiotic or another antibacterial drug or compound, an antihistamine (e.g., cimetidine, chloropheniramine maleate, diphenhydramine hydrochloride, and promethazine hydrochloride), an antifungal, an analgesic, including ascorbic acid, rutin, thrombin, botanicals, and the like, and combinations thereof, etc. The medicament may also include magnesium sulfate, sodium metaphosphate, calcium chloride, dextrin, and combinations thereof, etc.

[0042]

[0098] In some embodiments, the medicament may include sterile water and / or saline (which may be included as a carrier). In some embodiments, the medicament may include about 50% to about 100% tranexamic acid and about 50% to about 0% sterile water or saline. In some embodiments, the medicament may include about 10% to about 50% tranexamic acid and about 90% to about 50% sterile water or saline. In some embodiments, the medicament may include about 50% to about 90% tranexamic acid and about 10% to about 50% sterile water or saline. In some embodiments, the medicament may include at least one of a liquid and a gel. In some embodiments, the medicament may have a viscosity of about 0.75 millipascal seconds to about 0.98 millipascal seconds at about +25 degrees Celsius.

[0043]

[0099] In some embodiments, reservoir 150 may include an activation liquid, such as sterile water or saline, and applicator pad 110 may include a dried (e.g., lyophilized) drug configured to be activated by the activation liquid upon release of the activation liquid from reservoir 150. In some embodiments, applicator pad 110 may include a dried drug configured to be activated by blood flowing from a wound, such that an activation liquid disposed within applicator device 170 is not needed or is supplemental when applicator pad 110 is placed in contact with a wound. In some embodiments, applicator pad 110 may include a wetting agent that facilitates dissolution of the dried drug.

[0044]

[0100] In some embodiments, the medicament may include an antifibrinolytic agent in an amount of about 50 mg / mL to about 300 mg / mL, including about 50 mg / mL, about 100 mg / mL, about 150 mg / mL, about 200 mg / mL, about 250 mg / mL, or about 300 mg / mL. In some embodiments, the medicament may also include a colored dye that indicates that the medicament is administered to a wound and is a composition visible to humans based on skin color (before and after clotting) and blood color. In other embodiments, the medicament may not include a colored dye.

[0045]

[0101] In some embodiments, the amount of agent (e.g., a therapeutically effective amount) contained in the reservoir and / or provided to the target wound from the reservoir (e.g., an antifibrinolytic agent such as TXA) can be from about 1 mg to about 20 mg, from about 1 mg to about 5 mg, from about 5 mg to about 10 mg, from about 10 mg to about 15 mg, from about 15 mg to about 20 mg, and / or from about 10 mg to about 20 mg. In some embodiments, larger amounts of agent can be included to treat target wounds of larger size.

[0046]

[0102] In some embodiments, reservoir 150 and / or release mechanism 160 are configured to provide a metered amount from the reservoir (e.g., to applicator pad 110 and / or to the patient). The metered amount (e.g., of IV TXA) can be the amount of liquid that is placed in reservoir 150 prior to use of system 100. In some embodiments, the metered amount of medication can be about 1.5 mL to about 2.5 mL, about 2.5 mL to about 4.5 mL, about 3 mL to about 10 mL, about 3 mL to about 7 mL, about 1 mL to about 20 mL, about 1 mL to about 1.5 mL, about 2.5 mL to about 5 mL, about 5 mL to about 10 mL, about 10 mL to about 15 mL, or about 15 mL to about 20 mL. For example, reservoir 150 can have a volume of 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.

[0047]

[0103] A method of using the bleeding treatment system 100 to treat a wound that requires stopping bleeding is shown in FIG. 4 and described with reference to FIG. 3A to FIG. 3D. In some embodiments, the bleeding treatment system 100 may be operated with one hand (e.g., the hand of a subject having a wound in need of treatment or the hand of a caregiver). As shown in FIG. 4 and described with FIG. 3A, in some embodiments, the applicator device 170 may be removed from the package 195 at 202. The user guide 190 may be optionally read or started at 204. At 206, a drug may be optionally released from the reservoir 150 and transferred to the applicator pad 110. The applicator pad 110 may be exposed at 208 (e.g., by removing the applicator seal 120) for passing to the wound WD of the skin SK.

[0048]

[0104] As shown in the flowchart of method 200 in Figure 4 and described in Figure 3B, the applicator pad 110 may be presented to the wound WD on the skin SK at 210. As shown in Figure 3A and referenced above, in some embodiments, the applicator pad 110 may be presented to the wound WD on the skin SK within, extending from, or coupled to the applicator device 170 such that the applicator pad 110 contacts the wound WD and an area of ​​the skin SK surrounding the wound WD.

[0049]

[0105] The applicator pad 110 may be pressed against the wound WD on the skin SK at 212. For example, the applicator pad 110 may be pressed against the wound WD on the skin SK by applying pressure (e.g., pressure distributed across the wound WD) to the applicator pad 110 using the grip 140. Alternatively or additionally, in some embodiments, the applicator pad 110 may be pressed against the wound WD on the skin SK by applying pressure to the applicator pad 110 with a user's finger via the applicator pad 110.

[0050]

[0106] The agent may be released from the applicator pad 110 to the wound WD at 214. For example, in some embodiments, the agent may be released from the reservoir 150 by interaction with the release mechanism 160 such that the agent flows to the applicator pad 110 via the fluid coupling 155 and from the applicator pad 110 to the wound WD. In some embodiments, as described above, the applicator pad 110 may contain an agent prior to use of the system 100 (e.g., by being pre-impregnated), so that removal of the applicator seal 120 and placing the applicator pad 110 on the wound WD (and / or pressure applied to the applicator pad 110 when in contact with the wound WD) displaces the agent into contact with the wound WD. In some embodiments, rather than or in addition to releasing drug from reservoir 150, an activation liquid, such as saline, may be released from reservoir 150 to activate drug contained in applicator pad 110 (e.g., in an initially dry state) such that a combination of drug and activation liquid from the applicator pad can flow to contact wound WD. In some embodiments, blood from the wound WD may contact and activate drug in applicator pad 110 (e.g., in an initially dry state) such that a combination of drug and blood from the applicator pad can flow to contact wound WD.

[0051]

[0107] The applicator pad 110 may be maintained in contact with the wound WD with pressure applied to the wound WD by the grips 140 at 216. Hemostasis may be evaluated at 218. For example, the hemostatic status of the wound WD may be evaluated to determine whether the hemostatic status meets a target hemostatic condition. The hemostatic status of the wound WD may be evaluated by any suitable method. For example, after a predetermined time (e.g., 5 minutes or 10-30 minutes), the applicator pad 110 may be removed and the wound WD may be checked to determine whether hemostasis has been achieved.

[0052]

[0108] In some embodiments, after evaluating hemostasis at 218, the applicator pad 110 may continue to be maintained in contact with the wound WD while continuing to apply pressure to the wound WD at 220, and hemostasis may be re-evaluated until achieved. For example, if the hemostasis status of the wound WD does not meet the target hemostasis condition, the applicator pad 110 may be maintained in contact with the wound WD while applying pressure to the wound WD for a period of time. The hemostasis status may then be re-evaluated to determine whether the target hemostasis condition has been met. Such cycles may continue until the target hemostasis condition is met, at which time the applicator pad 110 may be removed from the wound WD.

[0053]

[0109] In some embodiments, as shown in FIG. 3C, pressure on the wound WD may be released at 222 before removing the applicator pad 110 from the wound WD. For example, if a grip 140 is used to apply pressure to the applicator pad 110, the grip 140 may be disengaged from the applicator pad 110 to reduce the pressure of the applicator pad 110 on the wound WD. In some embodiments, the applicator pad 110 may be maintained in contact with the wound WD at 224 after pressure is released (e.g., after removal of the grip 140). In some embodiments, the applicator pad 110 may be maintained in place in contact with the wound WD by a pad retainer 135. In some embodiments, a bandage or wrap may be applied to the applicator pad 110 to maintain the applicator pad 110 in contact with the wound WD for a period of time. In some embodiments, the applicator pad 110 may continue to apply pressure to the wound WD after removal of the grip 140 (e.g., by continuing to contact the wound WD). In some embodiments, the applicator pad 110 may continue to apply pressure to the wound WD, at least in part, due to expansion of the applicator pad 110 or blood absorbing pad 130 due to liquid (e.g., blood) absorption. As shown in FIG. 3D, the applicator pad 110 may be removed from the wound WD at 226.

[0054]

[0110] 5 is a schematic diagram of a bleeding treatment system 300. The system 300 may be the same or similar in structure and / or function to any of the bleeding treatment systems described herein. The system 300 comprises an applicator device 370, an applicator pad 310, and an optional reservoir 350. The applicator device 370 comprises a grip 340 having a first portion 342 (also referred to as a "first section"). The first portion 342 optionally defines an interior space 343. In some embodiments, the first portion 342 may be fluidly coupled to the applicator pad via a distal end of the first portion 342, with the interior space 373.

[0055]

[0111] The first portion 342 may be formed in any suitable shape. For example, the first portion 342 may comprise a cylindrical or tubular housing. The first portion 342 may comprise or be coupled to a plate 341 disposed at a distal end of the first portion 342 and configured to apply pressure to the applicator pad 310 and thus the target wound. The plate 341 may comprise a bottom surface of the grip 340. In some embodiments, the plate 341 may be formed as a continuous plate, such as when the grip 340 does not comprise a reservoir. In some embodiments, the plate 341 may be formed as a flange (e.g., a circumferential flange) extending from a bottom edge of the first portion 342.

[0056]

[0112] In some embodiments, grip 340 includes an applicator seal 320 configured to cover at least a distal or skin-contacting surface of applicator pad 310 to prevent contamination of applicator pad 310 and, optionally, leakage from or drying out of applicator pad 310 prior to use. Applicator seal 320 may be formed, for example, as a film (e.g., a peelable film). In some embodiments, applicator seal 320 may be formed of shrink wrap material that covers a distal end of applicator pad 310 and is disposed over at least a portion of the length of first portion 342.

[0057]

[0113] Applicator pad 310 may be the same as or similar in structure and / or function to any of the applicator pads described herein. For example, applicator pad 310 may include or be coupled with optional blood absorbing pad 330 and / or optional pad retainer 335. Blood absorbing pad 330 and pad retainer 335 may be the same as or similar in structure and / or function to any of the blood absorbing pads or pad retainers described herein, respectively.

[0058]

[0114] As shown in FIG. 5 , the reservoir 350 may be disposed in any of the interior spaces 343. In some embodiments, the reservoir 350 may be configured to be displaced and / or pressurized such that liquid (e.g., a drug and / or an activating liquid such as saline) in the reservoir 350 flows from the reservoir 350 to the applicator pad 310. For example, the reservoir 350 may optionally include a release mechanism 360 and / or a fluid coupling 355, which may be the same or similar in structure and / or function to any of the release mechanisms and / or fluid couplings described herein. In some embodiments, the fluid coupling 355 may be a portion of the interior space 343 defined by the housing of the first portion 342 through which liquid may flow from the reservoir 350 to the applicator pad 310. In some embodiments, the fluid coupling 355 comprises a separate tubular member defining a lumen through which liquid may flow from the reservoir 350 to the applicator pad 310.

[0059]

[0115] In some embodiments, the delivery device 370 may include an optional second portion 344 (also referred to as a "second section"). In some embodiments, the second portion 344 may be configured to engage the reservoir 350 and / or the release mechanism 360 to initiate the transfer of liquid from the reservoir 350 to the applicator pad 310. In some embodiments, the second portion 344 may be formed as a plunger and may be advanced by a user (e.g., a self-care home user, a caregiver, or a patient) relative to the first portion 342 (e.g., to advance the reservoir 350 at least partially into the interior space 343 or itself while contacting the reservoir 350) to apply pressure to the reservoir 350. In some embodiments, the second portion 344 may be disposed on a sidewall of the first portion 342 and configured to be biased laterally into the interior space 343 to apply pressure to the reservoir 350.

[0060]

[0116] In some embodiments, the interior space 343 may be at least partially defined by an inner surface of the sidewall of the grip 340, and may be defined by the first portion 342 and / or the second portion 344. In some embodiments, the inner surface and / or the outer surface of the sidewall of the grip 340 (including the first portion 342 and the second portion 344) may have any suitable shape, such as a cylindrical shape, an oblong cylindrical shape, an elliptical cylindrical shape, a tubular shape having two opposing flat sides joined by two opposing curved sides, and / or a prismatic shape including a cube, a rounded square prism, a rectangular prism, a rounded rectangular prism, a triangular prism, a pentagonal prism, a hexagonal prism, and the like. In some embodiments, the inner surface defining the interior space 343 of the grip 340 includes one or more rounded or chamfered edges. In some embodiments, the inner surface defining the interior space 343 of the grip 340 includes a rounded rectangular prism shape having one or more rounded edges. In some embodiments, the interior space 343 is cylindrical.

[0061]

[0117] In some embodiments, the release mechanism 360 can be coupled to the reservoir 350 and configured to transition from a closed state to an open state that allows medicament to flow from the reservoir 350 to the applicator pad 310 through the fluid coupling 355 in response to pressure in the reservoir 350 above a threshold pressure (e.g., applied by the distal end of the second portion 344). For example, in some embodiments, the release mechanism 360 can include a weak or frangible portion of a sidewall of the reservoir 350. In some embodiments, the release mechanism 360 comprises a valve that transitions from a closed state to an open state when the internal pressure of the reservoir 350 is greater than a threshold pressure. In some embodiments, the release mechanism 360 can be a frangible portion of the reservoir 350 configured to break when pressed against an internal obstacle (not shown), such as a ramp portion in the interior space 343, such that the medicament in the reservoir 350 can be released from the reservoir 350. In some embodiments, the first portion 342 may include a filter (not shown) between the reservoir 350 and the applicator pad 310 to prevent unwanted materials from reaching the applicator pad 310 .

[0062]

[0118] Prior to use, applicator device 370 may be placed in an initial configuration. In the initial configuration, applicator pad 310 may be coupled to a distal end of grip 340. Applicator seal 320 may cover applicator pad 310. To use applicator device 370, applicator seal 320 may be optionally removed and grip 340 may be used to apply applicator pad 310 to a wound. In embodiments including reservoir 350, release mechanism 360, and fluid coupling 355, liquid (e.g., drug and / or activating agent such as saline) may be trapped within reservoir 350 prior to and optionally after application of applicator pad 310 to a wound. To release liquid from reservoir 350 so that the liquid flows to applicator pad 310, second portion 344 may be configured to move relative to first portion 342 (e.g., by translational movement relative to first portion 342, radial movement relative to first portion 342, and / or rotational movement relative to first portion 342) to engage with reservoir 350 and / or release mechanism 360.

[0063]

[0119] Applicator pad 310 may be pressed against target wound tissue, optionally using grip 340. Applicator pad 310 may be maintained against the wound (e.g., without maintaining grip 340 against applicator pad 310), optionally by coupling applicator pad 310 to the skin via pad retainer 335. Applicator pad 310 may be optionally separated from applicator pad 310 by releasing applicator pad 310 from pad connector 348.

[0064]

[0120] 6A and 6B are perspective and cross-sectional views of a bleeding treatment system 400. FIG. 6C is a cross-sectional view of the bleeding treatment system 400 without showing the reservoir 450 of the bleeding treatment system 400. The bleeding treatment system 400 may be the same or similar in structure and / or function to any of the delivery or treatment systems described herein. For example, the system 400 includes an applicator device 470, a reservoir 450, and an applicator pad 410. The applicator device 470 includes a grip 440 that defines an interior space 443, has an open distal end, a closed proximal end, and extends along a central longitudinal axis A. The grip 440 has a first portion 442 and a second portion 444 that is movable relative to the first portion 442. The reservoir 450 may be formed as an ampoule having a neck portion 452 and a body portion 454. The neck portion 452 may be narrower (e.g., may have a smaller diameter) than the body portion 454. The reservoir 450 may be disposed within an interior space 443 of the grip 440. The reservoir 450 may be oriented such that the neck portion 452 is distal to the body portion 454, i.e., closer to the open end of the grip 440. The interior space 443 may be defined at least in part by an interior surface of a sidewall of the grip 440, and may be defined by the first portion 442 and / or the second portion 444. The grip 440 (e.g., the interior and / or exterior surfaces) may be formed to have a tubular shape having two opposing flat surfaces joined by two opposing curved surfaces as shown in FIG. 6A. In some embodiments, the grip 440 may have any suitable shape, such as those described above for the grip 340.

[0065]

[0121] The first portion 442 may include a plate 431 having a distal or bottom surface extending transversely to a central axis A of the grip 440. The applicator pad 410 may be disposed at a distal end of the first portion 442 (e.g., coupled to a distal surface of the plate 431). The first portion 442 may include a ramp portion 462 (also referred to as a first release mechanism portion) that extends partially into the interior space 443 of the first portion 442 such that the neck portion 452 may contact it. The first portion 442 may also include one or more retaining portions 447 (e.g., flexible tabs or bumps) that extend toward the central axis A of the first portion 442 and are configured to contact a shoulder of the body portion 454 of the reservoir 450 as shown in FIG. 6B to retain the reservoir 450 in an initial proximal position until a force sufficient to advance the reservoir 450 against the one or more retaining portions 447 is applied to the proximal end of the reservoir 450. First portion 442 may also include one or more gripping features 445 on an exterior surface of a sidewall of first portion 442 to enhance a user's grip during manipulation of grip 440. Grip features 445 may include any suitable surface features for enhancing grip or friction, such as one or more ridges (as shown in FIG. 6A ), concave and / or convex curvatures, and / or textured or roughened surfaces.

[0066]

[0122] The second portion 444 can include a protrusion 464 (also referred to as a second release mechanism portion). The first portion 442 and the second portion 444 can be coupled such that at least a portion of the second portion 444 can be advanced relative to the first portion 442 toward a distal end of the first portion 442. For example, the first portion 442 can be coupled to the second portion 444 via any suitable coupling mechanism, such as, for example, a flexible circumference. To release the liquid in the reservoir 450 so that the liquid flows to the applicator pad 410, the second portion 444 may be advanced distally relative to the first portion 442 (e.g., by pressing the proximal end of the second portion 444) such that the second release mechanism portion 464 applies a force to the proximal end of the reservoir 450 urging the reservoir 450 distally such that contact between the neck portion 452 of the reservoir 450 and the ramp 462 causes the neck portion 452 to separate (e.g., break) from the remainder of the reservoir 450, thereby allowing liquid to flow from the reservoir 450 out the distal end of the first portion 442 and onto the applicator pad 410, thereby wetting the applicator pad 410 with liquid from the reservoir 450.

[0067]

[0123] In some embodiments, the first portion 442 may include a filter to prevent unwanted material (e.g., particles and / or glass fragments above a certain size) from reaching the applicator pad 410. Before or after wetting the applicator pad 410 with a liquid, the distal surface of the applicator pad 410 may be placed in contact with a wound of a subject. The grip 440 may then be maintained in contact with the applicator pad 410 such that the plate 431 applies distributed pressure to the applicator pad 410 for a period of time, as described for the method 200 above. In some embodiments, the first portion 442 and / or the second portion 444 may be deformable (e.g., crushable) to force fluid (e.g., medication) from the reservoir 450. In some embodiments, the bleeding treatment system 400 may be operated with one hand (e.g., the hand of a subject having a wound in need of treatment). For example, a user can place their thumb on the proximal end of second portion 444 and wrap the remaining fingers of the same hand around the side walls of grip 440 (e.g., around first portion 442) with at least a portion of the remaining fingers contacting gripping feature 445. While holding grip 440 in this configuration, before or after pressing applicator pad 410 against a wound, a user can press second portion 444 with the user's thumb against applicator pad 410 to expel liquid from reservoir 450 as described above.

[0068]

[0124] 7A-7D are schematic perspective, front, side, and cross-sectional views, respectively, of the bleeding treatment system 500 in an initial configuration. FIG. 7E-7H are schematic perspective, front, side, and cross-sectional views, respectively, of the bleeding treatment system 500 in a wetted configuration. The system 500 may be the same or similar in structure and / or function to any of the delivery or treatment systems described herein, such as the bleeding treatment system 400. For example, the system 500 includes an applicator device 570, a reservoir 550, and an applicator pad 510. The applicator device 570 includes a grip 540 that defines an interior space 543, has an open distal end, a closed proximal end, and extends along a central longitudinal axis D. The grip 540 includes a first portion 542 and a second portion 544 that is movable relative to the first portion 542. The reservoir 550 may be formed as an ampoule having a neck portion 552 and a body portion 554. The neck portion 552 may be narrower (e.g., have a smaller diameter) than the body portion 554. The reservoir 550 may be disposed within an interior space 543 of the grip 540. The reservoir 550 may be oriented such that the neck portion 552 is distal to the body portion 554, i.e., closer to the open end of the grip 540. The interior space 543 may be defined in part by the inner surfaces of the sidewalls of the first portion 542 and the second portion 544.

[0069]

[0125] The first portion 542 may include a plate 531 having a distal or bottom surface extending transversely to a central axis D of the grip 540. The applicator pad 510 may be disposed at a distal end of the first portion 542 (e.g., coupled to the distal surface of the plate 531). The first portion 542 may include a ramp portion 562 (also referred to as a first release mechanism portion) extending partially into the interior space 543 of the first portion 542 such that the neck portion 552 may contact it. The first portion 542 may also include one or more retaining portions 547 (e.g., flexible tabs or bumps) extending toward the central axis A of the first portion 542 and configured to contact a shoulder of the body portion 554 of the reservoir 550 as shown in FIG. 6B to hold the reservoir 550 in an initial proximal position until a force sufficient to advance the reservoir 550 against the one or more retaining portions 547 is applied to the proximal end of the reservoir 550. The first portion 542 may also include one or more gripping features 545 on an exterior surface of a sidewall of the first portion 542 to enhance a user's grip during manipulation of the grip 540.

[0070]

[0126] The second portion 544 can include a protrusion 564 (also referred to as a second release mechanism) that extends into the interior space 543. The first portion 542 and the second portion 544 can be coupled such that at least a portion of the second portion 544 can be advanced relative to the first portion 542 toward a distal end of the first portion 542. For example, the second portion 544 can include a slidable engagement portion 544A, and the first portion 542 can include a receiving portion 544B having a corresponding shape and an outer periphery larger than an outer diameter of the slidable engagement portion 544A, such that the slidable engagement portion 544A can be translated into the receiving portion 544B (e.g., by pressing against a proximal end of the second portion 544 and / or by gripping opposing side walls of the second portion 544 and advancing the second portion 544 distally). During translational movement of the slidable engagement portion 544A into the receiving portion 544B, the second release mechanism portion 564 can apply a force to the proximal end of the reservoir 550 urging the reservoir 550 in a distal direction such that contact between the neck portion 552 of the reservoir 550 and the ramp 562 causes the neck portion 552 to separate (e.g., break) from the remainder of the reservoir 550, allowing liquid to flow from the reservoir 550 out the distal end of the first portion 542 and onto the applicator pad 510, thereby wetting the applicator pad 510 with liquid from the reservoir 550.

[0071]

[0127] In some embodiments, the first portion 542 may include a filter (e.g., disposed between the lamp 562 and the distal opening of the grip 540) to prevent unwanted material (e.g., particles and / or glass fragments above a certain size) from reaching the applicator pad 510. Before or after wetting the applicator pad 510 with liquid, the distal surface of the applicator pad 510 may be placed in contact with a wound of a subject. The grip 540 may then be maintained in contact with the applicator pad 510 such that the plate 531 applies distributed pressure to the applicator pad 510 for a period of time, as described for the method 200 above. In some embodiments, the bleeding treatment system 500 may be operated with one hand (e.g., the hand of a subject having a wound in need of treatment). For example, a user may place a thumb on the proximal end of the second portion 544 and wrap the remaining fingers of the same hand around the side walls of the grip 540 (e.g., around the first portion 542) with at least a portion of the remaining fingers in contact with the gripping mechanism 545. While holding the grip 540 in this configuration, before or after pressing the applicator pad 510 against the wound, the user can press the second portion 544 with the user's thumb toward the applicator pad 510 to release liquid from the reservoir 550 as described above.

[0072]

[0128] 8 is a schematic diagram of a bleeding treatment system 600. The bleeding treatment system 600 may be the same or similar in structure and / or function to any of the bleeding treatment systems described herein, such as the bleeding treatment system 400 or the bleeding treatment system 500. For example, the bleeding treatment system 600 includes an applicator device 670, a reservoir 650, and an applicator pad 610. The applicator device 670 includes the applicator pad 610, and optionally a cover 620 configured to be releasably coupled to the first portion 642. The applicator device 670 includes a grip 640 including a first portion 642 and a second portion 644. The first portion 642 has an open distal end and an open proximal end such that the reservoir 650 can be inserted into the proximal end of the first portion 642 and disposed in the interior space 643. The second portion 644 may then be coupled to the proximal end of the first portion 642. The second portion 644 extends into the interior space 643 and includes a protrusion 664 configured to contact the reservoir 650 and urge the reservoir and / or liquid therein toward an applicator pad 610 disposed at the distal end of the first portion 642.

[0073]

[0129] To use the bleeding treatment system 600 to treat a wound and stop the bleeding of the wound, the reservoir 650 may be inserted into the interior space 643 of the first portion 642. The second portion 644 may be coupled to a proximal end of the first portion 642. The cover 620 may be removed from the applicator pad 610. The second portion 644 may then be advanced distally in the direction of arrow A to apply pressure to the reservoir 650. Using any suitable reservoir and release mechanism structure, such as any of the reservoir and release mechanism structures described herein, liquid may be released from the reservoir 650 and flow to the applicator pad 610 such that the medication M is disposed on the applicator pad 610.

[0074]

[0130] 9A and 9B are perspective and cross-sectional views of a bleeding treatment system 700. FIG. 9C is a cross-sectional view of the bleeding treatment system 700 without showing the reservoir 750 of the bleeding treatment system 700. The system 700 may be the same or similar in structure and / or function to any of the delivery or treatment systems described herein. For example, the system 700 includes an applicator device 770, a reservoir 750, and an applicator pad 710. The applicator device 770 includes a grip 740 that defines an interior space 743, has an open distal end, a closed proximal end, and extends along a central longitudinal axis B. The grip has a first portion 742 and a second portion 744 that is laterally movable relative to the first portion 742. The reservoir 750 may be formed as an ampoule having a neck portion 752 and a body portion 754. The neck portion 752 may be narrower (e.g., have a smaller diameter) than the body portion 754. The reservoir 750 may be disposed within an interior space 743 of the grip 740. The reservoir 750 may be oriented such that the neck portion 752 is distal to the body portion 754, i.e., closer to the open end of the grip 740. The interior space 743 may be defined at least in part by an interior surface of a sidewall of the grip 740 and may be defined by the union of the first portion 742 and the second portion 744. The grip 740 (e.g., the interior and / or exterior surfaces) may be formed to have a tubular shape having two opposing flat surfaces joined by two opposing curved surfaces as shown in FIG. 8A. In some embodiments, the grip 740 may have any suitable shape as described above for the grip 340.

[0075]

[0131] The first portion 742 may include a plate 731 having a distal or bottom surface extending transversely to a central axis B of the grip 740. The applicator pad 710 may be disposed at a distal end of the first portion 742 (e.g., coupled to a distal surface of the plate 731). The first portion 742 may also include one or more retainers (not shown) (e.g., flexible tabs or bumps) extending toward the central axis B of the first portion 742 and configured to contact a shoulder of the body portion 754 of the reservoir 750 to retain the reservoir 750 in a proximal position. In some embodiments, rather than or in addition to including one or more retainers that contact a shoulder of the body portion 754, the first portion 742 may include a retainer, such as an adhesive and / or an inner sidewall that frictionally contacts the body portion 754 to retain the body portion 754 in a position where the neck portion 752 is radially aligned with the second portion 744.

[0076]

[0132] The second portion 744 may be formed as a deformable sidewall disposed in an opening defined by the first portion 742. The second portion 744 may optionally include a protrusion 762 (also referred to as a release mechanism) that extends laterally toward the central axis B and toward the neck 752 of the reservoir 750 in the initial configuration and / or may be deformable. The second portion 744 may be deformed by being pressed by a user's finger such that the protrusion 762 is urged into sufficient contact to break the neck 752 and release the liquid within the reservoir 750. In some embodiments, the second portion 744 may be sufficiently deformable such that the second portion 744 is urged into sufficient contact to break the neck 752 such that the second portion 744 functions as a release mechanism even without the protrusion 762. In some embodiments, the second portion 744 may be formed of an elastomeric material, for example, silicone or a similar type. Although not shown, in some embodiments, grip 740 may include a ramp portion that may be the same as or similar in structure and / or function to ramp portion 562. The ramp portion may be disposed relative to neck portion 552 and second portion 744 such that second portion 744 may deform and urge neck portion 552 toward the ramp portion such that neck portion 552 breaks relative to body portion 554.

[0077]

[0133] 9B, first portion 742 can include a closed proximal end and an open distal end. First portion 742 can optionally include a protrusion 764 coupled to a flexible end of first portion 742 and configured to contact the proximal end of reservoir 750 when pressed by a user's finger and urge reservoir 750 in a distal direction (i.e., urging liquid to flow from reservoir 750).

[0078]

[0134] To release the liquid in the reservoir 750 so that the liquid flows to the applicator pad 710, the second portion 744 may be deformed laterally relative to the neck 752 (e.g., by pressing the second portion 744 with a finger, such as a user's thumb) such that contact between the second portion 744 and the neck 752 of the reservoir 750 causes the neck 752 to separate (e.g., break) from the body 754 of the reservoir 750, allowing liquid to flow from the reservoir 750 out the distal end of the first portion 742 and onto the applicator pad 710, thereby wetting the applicator pad 410 with liquid from the reservoir 750.

[0079]

[0135] The second portion 744 may include one or more gripping features 745 on an exterior surface of the second portion 744 to enhance a user's grip during manipulation of the grip 740. The gripping features 745 may include any suitable surface features for enhancing grip or friction, such as one or more ridges (as shown in FIG. 8A ), concave and / or convex curvatures, and / or textured or roughened surfaces.

[0080]

[0136] In some embodiments, the first portion 742 may include a filter to prevent unwanted material (e.g., particles and / or glass fragments above a certain size) from reaching the applicator pad 710. Before or after wetting the applicator pad 710 with a liquid, the distal surface of the applicator pad 710 may be placed in contact with a wound of a subject. The grip 740 may then be maintained in contact with the applicator pad 710 such that the plate 731 applies distributed pressure to the applicator pad 710 for a period of time, as described for the method 200 above. In some embodiments, the first portion 742 and / or the second portion 744 may be deformable (e.g., crushable) to force the agent from the reservoir 750 (e.g., after the neck portion 752 is separated from the body portion 750). In some embodiments, the bleeding treatment system 700 may be operated with one hand (e.g., the hand of a subject having a wound in need of treatment). For example, a user can place their thumb on second portion 744 and wrap the remaining fingers of the same hand around a side wall of grip 740 (e.g., around first portion 742). While holding grip 740 in this configuration, before or after pressing applicator pad 710 against a wound, a user can press second portion 744 with the user's thumb towards neck 752 to expel liquid from reservoir 750 as described above.

[0081]

[0137] 10A and 10B are perspective and cross-sectional views of a bleeding treatment system 800. FIG. 10C is a cross-sectional view of the bleeding treatment system 800 without showing the reservoir 850 of the bleeding treatment system 800. The system 800 may be the same or similar in structure and / or function to any of the delivery or treatment systems described herein. For example, the system 800 may include an applicator device 870, a reservoir 850, and an applicator pad 810. The applicator device 870 may include a grip 840 that defines an interior space 843, has an open distal end, a closed proximal end, and extends along a central longitudinal axis C. The grip has a first portion 842 and a second portion 844 that is movable relative to the first portion 842. The reservoir 850 may be formed as an ampoule having a neck portion 852 and a body portion 854. The neck portion 852 may be narrower (e.g., may have a smaller diameter) than the body portion 854. The reservoir 850 may be disposed within an interior space 843 of the grip 840. The reservoir 850 may be oriented such that the neck portion 852 is distal to the body portion 854, i.e., closer to the open end of the grip 840. The interior space 843 may be defined at least in part by an interior surface of a sidewall of the grip 840, and may be defined by the first portion 842 and / or the second portion 844. The grip 840 (e.g., the interior and / or exterior surfaces) may be formed to have a cylindrical shape, as shown in FIG. 9A. In some embodiments, the grip 840 may have any suitable shape, such as those described above for the grip 340.

[0082]

[0138] The first portion 842 may include a plate 831 having a distal or bottom surface extending transversely to a central axis C of the grip 840. The applicator pad 810 may be disposed at a distal end of the first portion 842 (e.g., coupled to a distal surface of the plate 831). The first portion 842 may include a ramp portion 862 (also referred to as a first release mechanism portion) that extends partially into the interior space 843 of the first portion 842 such that the neck portion 852 may contact it. The first portion 842 may also include one or more retainers (not shown) (e.g., flexible tabs or bumps) extending toward the central axis C of the first portion 842 and configured to contact a shoulder of the body portion 854 of the reservoir 850 as shown in FIG. 9B to retain the reservoir 850 in an initial proximal position until a force sufficient to advance the reservoir 850 against the one or more retainers is applied to the proximal end of the reservoir 850. First portion 842 may also include one or more gripping features (not shown) on an exterior surface of a sidewall of first portion 842 to enhance a user's grip during manipulation of grip 840. The gripping features may include any suitable surface features for enhancing grip or friction, such as one or more ridges, concave and / or convex curvatures, and / or textured or rough surfaces.

[0083]

[0139] The second portion 844 can include a distally facing inner surface 864 (also referred to as a second release mechanism portion). The first portion 842 and the second portion 844 can be coupled such that the second portion 844 can be advanced relative to the first portion 842 toward a distal end of the first portion 842. For example, the first portion 842 can be coupled to the second portion 844 via any suitable coupling mechanism, such as, for example, threads or a slidable friction fit. The second portion 844 can have an inner diameter that is larger than an outer diameter of a proximal end of the first portion 842 such that the second portion 844 is disposed in contact with an outer surface of the first portion 842. The reservoir 850 can be disposed in an initial position within the interior space 843 such that a proximal end of the reservoir is near or adjacent the distally facing inner surface 864, and can be advanced distally by displacing the second portion 844 distally. To release the liquid in the reservoir 850 so that the liquid flows to the applicator pad 810, the second portion 844 may be advanced distally relative to the first portion 842 (e.g., by pressing the proximal end of the second portion 844) such that the inner surface 864 applies a force to the proximal end of the reservoir 850 urging the reservoir 850 distally such that contact between the neck 852 of the reservoir 850 and the ramp 862 causes the neck 852 to separate (e.g., break) from the remainder of the reservoir 850 (e.g., the body 854) and allow liquid to flow from the reservoir 850 out the distal end of the first portion 842 and onto the applicator pad 810, thereby wetting the applicator pad 810 with liquid from the reservoir 850.

[0084]

[0140] In some embodiments, the first portion 842 may include a filter to prevent unwanted material (e.g., particles and / or glass fragments above a certain size) from reaching the applicator pad 810. Before or after wetting the applicator pad 810 with liquid, the distal surface of the applicator pad 810 may be placed in contact with a wound of a subject. The grip 840 may then be maintained in contact with the applicator pad 810 such that the plate 831 applies distributed pressure to the applicator pad 810 for a period of time, as described for the method 200 above. In some embodiments, the first portion 842 and / or the second portion 844 may be deformable (e.g., crushable) to force the agent from the reservoir 850. In some embodiments, the bleeding treatment system 800 may be operated with one hand (e.g., the hand of a subject having a wound in need of treatment). For example, a user can place their thumb on the proximal end of second portion 844 and wrap the remaining fingers of the same hand around a side wall of grip 840 (e.g., around first portion 842). While holding grip 840 in this configuration, before or after pressing applicator pad 810 against a wound, a user can press second portion 844 with the user's thumb against applicator pad 810 to expel liquid from reservoir 850 as described above.

[0085]

[0141] 11A and 11B are cross-sectional views of a bleeding treatment system 900 with and without a reservoir 950 shown, respectively. The system 900 may be the same or similar in structure and / or function to any of the delivery or treatment systems described herein. For example, the system 900 may include an applicator device 970, a reservoir 950, and an applicator pad 910. The applicator device 970 may include a grip 940 that defines an interior space 943, has an open distal end, a closed proximal end, and extends along a central longitudinal axis D. The grip has a first portion 942 and a second portion 944 that is movable relative to the first portion 942. The reservoir 950 may be formed as an ampoule having a neck portion 952 and a body portion 954. The neck portion 952 may be narrower (e.g., have a smaller diameter) than the body portion 954. The reservoir 950 may be disposed within the interior space 943 of the grip 940. The reservoir 950 may be oriented such that the neck portion 952 is distal to the body portion 954, i.e., closer to the open end of the grip 940. The interior space 943 may be at least partially defined by an inner surface of a sidewall of the grip 940, and may be defined by the first portion 942 and / or the second portion 944. The grip 940 (e.g., the inner and / or outer surfaces) may be formed to have a cylindrical shape. In some embodiments, the grip 940 may have any suitable shape, such as those described above for the grip 340.

[0086]

[0142] The first portion 942 may include a plate 931 having a distal or bottom surface extending transversely to a central axis D of the grip 940. The applicator pad 910 may be disposed at a distal end of the first portion 942 (e.g., coupled to a distal surface of the plate 931). The first portion 942 may include a ramp portion 962 (also referred to as a first release mechanism portion) that extends partially into the interior space 943 of the first portion 942 such that the neck portion 952 may contact it. The first portion 942 may also include one or more retainers (not shown) (e.g., flexible tabs or bumps) extending toward the central axis D of the first portion 942 and configured to contact a shoulder of the body portion 954 of the reservoir 950 to retain the reservoir 950 in an initial proximal position until a force sufficient to advance the reservoir 950 against the one or more retainers is applied to the proximal end of the reservoir 950. First portion 942 may also include one or more gripping features (not shown) on an exterior surface of a sidewall of first portion 942 to enhance a user's grip during manipulation of grip 940. The gripping features may include any suitable surface features for enhancing grip or friction, such as one or more ridges, concave and / or convex curvatures, and / or textured or rough surfaces.

[0087]

[0143] The grip may include a spring portion 946. The first portion 942 and the second portion 944 may be coupled such that the second portion 944 may be advanced relative to the first portion 942 toward a distal end of the first portion 942. For example, the first portion 942 may be coupled to the second portion 944 via any suitable coupling mechanism, such as, for example, threads or a slidable friction fit. The second portion 944 may have an inner diameter that is greater than an outer diameter of a proximal end of the first portion 942 such that the second portion 944 is disposed in contact with an outer surface of the first portion 942. The reservoir 950 may be disposed in an initial position within the interior space 943 such that a proximal end of the reservoir is near or adjacent a distally facing inner surface 964, and may be advanced distally by displacing the second portion 944 distally. In some embodiments, the spring portion 946 may be configured to transition from an initial configuration to an expanded or compressed configuration to bring the reservoir 950 into contact with the ramp 962. For example, the spring portion 946 can be actuable to urge the ramp 962 away from the applicator pad 910 and into destructive contact with the neck portion 952. In some embodiments, the spring portion 946 can be actuable to pull or push the reservoir 950 into contact with the ramp 962. The second portion 944 can be engaged with the spring portion 946 such that pushing down or twisting the second portion 944 actuates the spring portion 946. Thus, to expel liquid within the reservoir 950 such that the liquid flows to the applicator pad 910, the second portion 944 can be twisted or advanced distally relative to the first portion 942 (e.g., by rotating or pushing a proximal end of the second portion 944) such that the spring portion 946 is released from the initial configuration.The spring portion 946 may then translate the reservoir 950 and / or the ramp 962 such that contact between the neck 952 of the reservoir 950 and the ramp 962 causes the neck 952 to separate (e.g., break) from the remainder of the reservoir 950 (e.g., the body 954), allowing liquid to flow from the reservoir 950 out the distal end of the first portion 942 and onto the applicator pad 910, thereby wetting the applicator pad 910 with liquid from the reservoir 950.

[0088]

[0144] In some embodiments, the first portion 942 may include a filter to prevent unwanted material (e.g., particles and / or glass fragments above a certain size) from reaching the applicator pad 910. Before or after wetting the applicator pad 910 with a liquid, the distal surface of the applicator pad 910 may be placed in contact with a wound of a subject. The grip 940 may then be maintained in contact with the applicator pad 910 such that the plate 931 applies distributed pressure to the applicator pad 910 for a period of time, as described for the method 200 above. In some embodiments, the first portion 942 and / or the second portion 944 may be deformable (e.g., crushable) to force the agent from the reservoir 950. In some embodiments, the bleeding treatment system 900 may be operated with one hand (e.g., the hand of a subject having a wound in need of treatment). For example, a user can place their thumb on the proximal end of second portion 944 and wrap the remaining fingers of the same hand around a side wall of grip 940 (e.g., around first portion 942). While holding grip 940 in this configuration, before or after pressing applicator pad 910 against a wound, a user can press second portion 944 with the user's thumb against applicator pad 910 to expel liquid from reservoir 950 as described above.

[0089]

[0145] 12 is a schematic diagram of a combination of an applicator pad 1010 and a blood absorbing pad 1030, each of which may be the same or similar in structure and / or function to any of the applicator pads and blood absorbing pads described herein. As shown, the applicator pad 1010 may be surrounded by the blood absorbing pad 1030 such that the applicator pad 1010 and the blood absorbing pad 1030 are concentric. Thus, in some embodiments, the applicator pad 1010 may be shaped, sized, and positioned (e.g., relative to the grip) such that only the applicator pad 1010, and not the blood absorbing pad 1030, contains or contacts liquid (e.g., medication) from a reservoir. In some embodiments, a liquid impermeable partition 1032 may be disposed between the applicator pad 1010 and the blood absorbing pad 1030. In some embodiments, rather than surrounding the applicator pad 1010, the blood absorbing pad 1030 may only partially surround or be disposed adjacent to the applicator pad 1010. Although the applicator pad 1010 is shown as having a rectangular shape with curved edges as described above for the applicator pad 110, in some embodiments, the applicator pad 1010 may have any suitable shape, such as a circle, an oval, or a square.

[0090]

[0146] In some embodiments, rather than having a reservoir in the grip of the applicator device, an applicator pad, such as any of the applicator pads described herein, may be preloaded with a medicament. For example, FIG. 13 is a schematic diagram of a bleeding treatment system 1100. The bleeding treatment system 1100 may be the same or similar in structure and / or function to any of the other bleeding treatment systems described herein. For example, the bleeding treatment system 1100 may comprise an applicator device 1170 having a grip 1140, an applicator pad 1110 (also referred to as a topical applicator pad), and an applicator seal 1120. In some embodiments, the applicator pad 1110 may be a porous applicator (e.g., a sponge-type material) configured to hold a liquid agent M and apply the liquid agent M to a wound site only upon physical contact. The applicator pad 1110 may be preloaded (e.g., pre-impregnated) with a liquid or dry agent M. The grip 1140 may include a plate 1141 having a diameter equal to or greater than the applicator pad 1110 such that the grip 1140 may be used to apply distributed pressure to the applicator pad 1110 when the applicator pad 1110 contacts the wound. The plate 1141 may be rigid or semi-rigid or have a rigid or semi-rigid surface opposite the surface that contacts the applicator pad 1110 to apply uniform pressure to the applicator pad 1110. In some embodiments, the plate 1141 may be flexible. The plate 1141 may function as an isolation mechanism configured to keep the hand applying pressure away from the wound site and the agent within the applicator pad 1110. To use the system 1100, the applicator seal 1120 may be removed from the applicator pad 1110, and the grip 1110 may be used to place the applicator pad 1110 against the wound and maintain pressure against the wound by applying pressure to the applicator pad 1110 so that the medication flows to the wound.

[0091]

[0147] 14 is a flow chart of a method 1200 of using a bleeding treatment system, such as any of the bleeding treatment systems described herein. Method 1200 may be for reducing bleeding at a wound site in a subject taking a medication that subjects the subject to increased and / or prolonged bleeding. In some embodiments, the steps of method 1200 may be performed by the subject, a caregiver, a medical provider, a veterinary medical provider, etc. In step 1202, the wound may be cleaned and elevated (e.g., by the subject receiving the wound and / or by a caregiver or clinician) to reduce bleeding. In some embodiments, the wound is cleaned (e.g., with soap and water). In some embodiments, the wound is elevated above the level of the patient's heart.

[0092]

[0148] In step 1204, it may be determined whether the subject (e.g., patient) is taking medications (e.g., anticoagulants or antiplatelet medications) that expose the subject to increased and / or prolonged bleeding. For example, a caregiver or clinician may verify (e.g., by reviewing medical records or questioning the subject) whether such medications have been taken by the subject within the relevant time period. In some embodiments, step 1204 may not be included and the user may proceed directly to step 1206, described below. In some embodiments, step 1204 may be performed after step 1206 if the wound is still bleeding, and the steps of method 1200 may proceed from there.

[0093]

[0149] If, in step 1206, it is determined that the subject has not taken a medication within the relevant time period that would subject the subject to increased and / or prolonged bleeding, firm pressure may be applied (e.g., by the subject or a caregiver) to the wound using a sterile gauze pad. In some embodiments, firm pressure may be applied for a first period of time (e.g., a predetermined period of time). In some embodiments, for example, the first period of time may be about 5 minutes, about 4 minutes to about 6 minutes, less than about 4 minutes, more than about 5 minutes, more than about 6 minutes. After the first period of time, pressure may be removed. If the wound is no longer bleeding, the subject or a caregiver may apply a dressing to the wound. If the wound is still bleeding, step 1208 may be performed as described below and / or treatment may be sought.

[0094]

[0150] If, in step 1208, it is determined that the subject has taken a medication within the relevant time period that subjects the subject to increased and / or prolonged bleeding, or if applying firm pressure for the first period of time as described in step 1206 does not result in hemostasis, firm pressure may be applied to the wound using a topical applicator pad containing a metered dose of medication (e.g., TXA, such as intravenous (IV) TXA) for a second period of time (e.g., a second predetermined period of time) (e.g., 5 minutes) such that the medication contacts the wound. In some embodiments, the second period of time may be longer than the first period of time. In some embodiments, the second period of time may be shorter than the first period of time. In some embodiments, the metered dose may be between 3 and 10 mL and / or may include between about 300 and about 1000 mg of medication.

[0095]

[0151] In step 1210, pressure may be removed by the subject or caregiver (e.g., by removing the applicator pad) and the wound may be checked to see if it is still bleeding. In step 1212, if the wound is no longer bleeding, a bandage may be applied to the wound by the subject or caregiver. In step 1214, if the wound is still bleeding, the subject or caregiver may reapply firm pressure to the wound using a topical applicator pad for an additional period of time (e.g., an additional 5 minutes). In some embodiments, a new topical applicator pad (containing or not containing a metered dose of drug) may be used. In step 1216, pressure may be removed and the wound may be checked to see if it is still bleeding. In step 1218, if the wound is no longer bleeding, a bandage may be applied to the wound as needed. In step 1220, if the wound is still bleeding, the subject may seek medical attention (with the help of a caregiver, if necessary).

[0096]

[0152] 15A to 15E are schematic diagrams of a bleeding treatment system 1300 at various stages of use. The system 1300 may be the same or similar in structure and / or function to any of the systems described herein. For example, the system 1300 may comprise an applicator device 1370, a reservoir (not shown), and an applicator pad 1310. As shown in FIG. 15A, the applicator pad 1310 may be coupled to the applicator device 1370 via a pad connector 1348. The pad connector 1348 may include any suitable coupling mechanism, such as any of the coupling mechanisms and pad connectors described herein. For example, the applicator device 1370 may comprise a sliding mechanism or latch that is disengageable from an engagement mechanism associated with the applicator pad 1310 such that the engagement mechanism associated with the applicator pad 1310 may be released from the applicator device 1370 before or after application to the wound WD as shown in FIG. 15B.

[0097]

[0153] In some embodiments, the applicator pad 1310 may be coupled to the applicator device 1370 via an adhesive strip 1303 that is releasable from the applicator device 1370 via, for example, a pad connector 1348, which may operate as a release mechanism to allow the adhesive strip 1303 to contact the patient's skin to secure the pad connector 1348 to the wound WD. Thus, in a first configuration shown in FIG. 15C, the applicator pad 1310 may be coupled to the applicator device 1370. As shown in FIG. 15D, the applicator pad 1310 and the adhesive strip 1303 may be separated from the applicator device 1370. The applicator pad 1310 may then be secured to the subject at the wound location via the adhesive strip 1303.

[0098]

[0154] 16A-16C are schematic perspective, front, and cross-sectional views, respectively, of the bleeding treatment system 1400 in a wetted configuration in which the reservoir 1450 has been broken to release the contents of the reservoir 1450. FIGs. 16D-16F are schematic perspective, front, and cross-sectional views, respectively, of the bleeding treatment system 1400 in a separated configuration in which the grip 1440 of the bleeding treatment system 1400 has been separated from the applicator pad 1410. The system 1400 may be the same or similar in structure and / or function to any of the delivery or treatment systems described herein, such as the bleeding treatment system 500. For example, the system 1400 includes an applicator device 1470, a reservoir 1450, and an applicator pad 1410. The applicator device 1470 includes a grip 1440 that defines an interior space 1443, has an open distal end, a closed proximal end, and extends along a central longitudinal axis. The applicator device 1470 includes a filter 1471 (e.g., disposed between the ramp 1462 of the grip 1440 and the distal opening of the grip 1440) to prevent unwanted material (e.g., particles and / or glass pieces above a certain size) from reaching the applicator pad 1410.

[0099]

[0155] As shown in FIGS. 16A-16F, the system 1400 can include a dressing 1412 coupled to a portion of an upper surface of the applicator pad 1410 and extending beyond the outer perimeter of the applicator pad 1410. Although shown surrounding the perimeter of the applicator pad 1410, in some embodiments, the dressing can extend beyond opposing portions or sides of the applicator pad 1410 in less than all directions. The dressing 1412 can define one or more openings 1412A adjacent the upper surface of the applicator pad 1410 to allow fluid to pass therethrough to wet contact the applicator pad 1410. In some embodiments, the one or more openings 1412A can have a surface area and perimeter that is generally equal to or less than the surface area and perimeter of the distal opening of the grip 1440. In some embodiments, the dressing 1412 can include a liquid-permeable layer or portion covering the one or more openings 1412A. In some embodiments, the bandage 1412 may be adhesively coupled to the upper surface of the applicator pad 1410 via one or more adhesives.

[0100]

[0156] The system 1400 may be placed on a surface of a subject with the applicator pad 1410 and the dressing 1412 in contact with the surface, with the applicator pad 1410 in contact with a wound on the subject and the dressing 1412 surrounding the applicator pad 1410. The applicator device 1470 may be transitioned from an initial configuration to a wet configuration shown in Figures 16A-16C through the same steps as described for the system 500. After the contents of the reservoir 1450 are released from the reservoir 1450 as shown in Figure 16C, the contents may flow through the filter 1471 and through one or more openings 1412A in the dressing 1412 to the applicator pad 1410 to contact the wound. The grip 1440 may be used to apply pressure to the applicator pad 1410 and thus the wound (e.g., before and / or after wetting the applicator pad 1410) by applying downward pressure to the grip 1440 with the distal end and / or plate 1431 of the grip 1440 in contact with the applicator pad 1410.

[0101]

[0157] In some embodiments, the applicator pad 1410 and bandage 1412 may be left on the subject's skin such that the applicator pad 1410 remains in contact with the wound, and the grip 1440 may be separated from the applicator pad 1410 and bandage 1412 so as not to displace the applicator pad 1410 relative to the wound during separation. After separating the grip 1440 from the applicator pad 1410 and / or bandage 1412, the grip 1440 may be discarded leaving the applicator pad 1410 and bandage 1412 in place on the subject's wound and skin, as shown in Figures 16D-16F.

[0102]

[0158] The grips 1440 may be coupled and / or detached from the applicator pad 1410 and / or the bandage 1412 by any suitable detachment method described herein. For example, as shown in Figures 17A and 17B, which are two different perspective views of a system 1400 with two adhesive strips 1414 (also referred to as pad connectors), the applicator device 1470 may be coupled to the bandage 1412 via a removable adhesive strip 1414. The adhesive strips 1414 may be disposed in contact with the top surface of the plate 1431 on either side of the grips 1440, each having an end in contact with the bandage 1412 such that the adhesive strips 1414 secure the grips 1440 to the bandage 1412 via the plate 1431. In some embodiments, the adhesive strips 1414 may be flexible but have low or no elasticity. To separate the grips 1440 from the bandage 1412 and the applicator pad 1410 , each of the adhesive strips 1414 may be peeled away from the bandage 1412 to release the bandage 1412 from the plate 1431 .

[0103]

[0159] 18, instead of comprising a releasable adhesive strip with low or no elasticity, the system 1400 may comprise a highly elastic adhesive strip 1416 that may be separated from the bandage 1412 and / or plate 1431 by stretching each free end of the adhesive strip 1416 away from but in or near a plane that includes a portion of the adhesive strip 1416 (also referred to as a pad connector) adhesively bonded to the bandage 1412 and / or plate 1431 such that the adhesive strip 1416 is deformed and adhesive contact between the adhesive strip 1416 and the bandage 1412 and / or plate 1431 is broken. For example, the adhesive strip 1416 may comprise a synthetic rubber resin adhesive.

[0104]

[0160] In some embodiments, the applicator pad may comprise or be coupled to a rigid or semi-rigid backing configured to be releasably engaged by a portion of the applicator device. For example, FIG. 19A is a schematic diagram of a system 1500 that may be the same as or similar to any of the other systems described herein. The system 1500 may comprise a grip 1540, an applicator pad 1510, and an applicator device 1570 that includes a reservoir (not specified) that is comprised within the applicator pad 1510 and / or within the grip 1540. As shown in FIG. 19B, the applicator pad 1510 may be coupled (e.g., by an adhesive) to a backing 1518 that may be rigid or more rigid than the applicator pad 1510. The backing portion 1518 can define one or more openings (not shown in FIGS. 19A and 19B ) through which fluid can flow from a reservoir in the grip 1540 to the applicator pad 1510 to wet the applicator pad 1510. The backing portion 1518 can include one or more pad retainer portions 1535 configured to be received by or coupled to a complementary pad retainer portion (not shown) of the grip 1540 such that the grip 1540 is releasably coupled to the backing portion 1518 via adhesive, clip-on, latch, friction fit, hook-and-loop fastening, button fastening, or any suitable coupling mechanism. After pressure is applied to the backing portion 1518 to press the applicator pad 1510 against the wound, the grip 1540 can be separated from the backing portion 1518 by disengaging the complementary pad retainer portion. 19A, the grip 1540 can include a convex distal surface 1536 configured to apply targeted elevated pressure to the wound when a user presses the grip 1540 into an applicator pad 1510 coupled to the wound. The convex distal surface 1536 can include one or more openings that allow fluid to flow through the convex distal surface 1536.

[0105]

[0161] 19C, in some embodiments, the backing 1518 can be curved and rigid such that the convex distal surface 1536 of the grip 1540 can be seated against a concave upper surface of the backing 1518 while wetting the applicator pad 1510 and / or while applying pressure to the applicator pad 1510 and thus the wound. As shown in FIG. 19C, the backing 1518 can define one or more openings 1519 through which fluid can flow from a reservoir in the grip 1540 to the applicator pad 1510 to wet the applicator pad 1510.

[0106]

[0162] 20, which is a schematic diagram of the system 1600, in some embodiments, the backing 1618 may be releasably coupled to the applicator pad 1610 via an attachment such as a hook-and-loop fastener 1635 (e.g., Velcro®) or a peel-off adhesive (not shown). The backing 1618 may include a convex distal surface 1636 configured to apply pressure to a portion of the applicator pad 1610 that contacts the wound when the applicator pad 1610 contacts the wound and the backing 1618 is coupled to the applicator pad 1610. After hemostasis has been achieved, the backing 1618 may be removed from the applicator pad 1610 and the applicator pad 1610 may be placed against the wound.

[0107]

[0163] FIG. 21 is a schematic diagram of a system 1700. The system 1700 may be the same or similar in structure and / or function to any of the systems described herein. For example, the system 1700 includes a grip 1740 and an applicator pad 1710. The applicator pad 1710 may be coupled to a backing 1718, which may be configured as a bandage. The backing 1718 may include an adhesive covered with a peel-off adhesive liner disposed on a distal surface of the backing. The adhesive liner may be peeled off before placing the backing 1718 on the subject's skin so that the backing 1718 may be attached to the skin via the adhesive. In some embodiments, the backing 1718 may extend laterally from the grip 1740 before being placed on the skin as shown in FIG. 21. In some embodiments, the backing 1718 may be flush with the grip 1740 (e.g., extending upward along a sidewall of the grip 1740) and then folded over to adhere to the skin. In some embodiments, the backing portion 1718 can completely surround the applicator pad 1710 and / or extend circumferentially away from the applicator pad 1710. In some embodiments, the backing portion 1718 can extend along one axis of the applicator pad 1710.

[0108]

[0164] The backing portion 1718 and / or the applicator pad 1710 may include or be coupled to a pad retainer portion 1735B that extends away from the applicator pad 1710 and is configured to be releasably grasped by a pad retainer portion 1735A of the grip 1740. The pad retainer portion 1735A of the grip 1740 may include, for example, a flexible arm configured to engage with a recess in the pad retainer portion 1735B such that the grip 1740 and the applicator pad 1710 are coupled (e.g., during wetting and / or applying pressure to a wound). To separate the grip 1740 from the applicator pad 1710, the flexible arm can be pulled away from the recess in the pad retainer portion 1735B (e.g., by pulling a tab extending from the outer surface of the grip 1740 or by pressing an engagement feature (e.g., a semicircular button) near or adjacent to the distal end of the grip 1740 to activate a release mechanism so that the pad retainer portion 1735B is released) and the grip 1740 can be removed from the pad retainer portion 1735B.

[0109]

[0165] 22A and 22B are schematic cross-sectional and top views of a system 1800. The system 1800 may be the same or similar in structure and / or function to any of the systems described herein. For example, the system 1800 includes a semi-rigid backing 1818 that may be configured as a dressing and applicator pad 1810. As shown, the semi-rigid backing 1818 may include a foam ring 1818A that surrounds the applicator pad 1810 and a backing layer 1818B that is disposed in contact with an upper surface of the applicator pad 1810 and is coupled to the foam ring 1818A. The foam ring 1818A may adhesively couple the backing 1818 and the applicator pad 1810 to a surface of the subject's skin and may apply a compressive pressure to the applicator pad 1810 to urge the applicator pad 1810 against the wound. In some embodiments, pressure applied to the applicator pad 1810 may activate the release of the agent from the applicator pad 1810 .

[0110]

[0166] In some embodiments, the contents of the reservoir can be configured to flow from the reservoir to the applicator pad through a sidewall of the grip that includes the reservoir. For example, FIGS. 23A-23C are schematic diagrams of a system 1900 at various stages of operation. The system 1900 can be the same as or similar in structure and / or function to any of the systems described herein. For example, the system 1900 includes an applicator device 1970, a reservoir 1950, and an applicator pad 1910. The applicator device 1970 can include a grip 1940 that defines an interior space within which the reservoir 1950 can be disposed. As shown, the grip 1940 can be horizontally disposed such that the applicator pad 1910 is coupled to a sidewall of the grip 1940 and the grip 1940 and / or the reservoir 1950 are elongated along a longitudinal axis that is disposed substantially parallel to the applicator pad 1910 in the initial configuration shown in FIG. 23A.

[0111]

[0167] The grip 1940 can include a first portion 1942 and a second portion 1944 that collectively define an interior space within which the reservoir 1950 is disposed. The first portion 1942 can be configured to bend relative to the second portion 1944, as shown in FIG. 23B , such that the reservoir 1950 breaks and the contents of the reservoir 1950 flow from the reservoir 1950 to the applicator pad 1910. For example, the grip 1940 can be rotated such that the first end of the grip 1940 is rotated relative to the second end of the grip 1940 such that an interior surface of the grip 1940 applies pressure to the reservoir 1950 causing it to fold, crush, or break. In some embodiments, the grip 1940 may include a bendable hinge or notch feature near the midpoint of the grip 1940 such that the first portion 1942 may be rotated relative to the second portion 1944 about the hinge or notch such that the reservoir 1950 breaks. In some embodiments, the grip 1940 may include a force concentrating component 1909, such as a sharp pointed protrusion or steel ball that may protrude from an inner surface of the grip 1940 such that bending the grip 1940 pushes the force concentrating component 1909 into destructive contact with a portion of the reservoir 1950, causing the reservoir 1950 to break. In some embodiments, the force concentrating component 1909 may be aligned with a weakened or pre-perforated portion of the reservoir such that the reservoir will be preferentially broken by the force concentrating component 1909 at the weakened or pre-perforated portion. In some embodiments, the subject or caregiver can use both hands to bend the first portion 1942 against the second portion 1944 to break the reservoir 1950. In some embodiments, the subject or caregiver can place the system 1900 on a hard surface (e.g., a table) and apply a downward orthogonal force to the grip 1940 such that the reservoir 1950 is forced into destructive contact with the force concentrating component 1909, releasing the contents of the reservoir 1950.In some embodiments, the subject or caregiver can place the system 1900 in direct contact with the wound with the applicator pad 1910 in contact with the wound, and can apply a force to the grip 1940 perpendicular to the wound such that the reservoir 1950 is urged into destructive contact with the force concentrating component 1909, releasing the contents of the reservoir 1950. Thus, in some embodiments, a user can apply pressure to the grip 1940 using the palm of the user's hand, which pressure can be concentrated by the force concentrating component 1909 at a specific location on the reservoir 1950 to disrupt the reservoir 1950.

[0112]

[0168] After the reservoir 1950 is ruptured, the contents of the reservoir 1950 may flow from the reservoir 1950 to the applicator pad 1910 through a sidewall of the grip 1940. For example, the grip 1940 may define one or more openings through which fluid may flow to the applicator pad 1910, which may be coupled or releasably coupled to a sidewall of the grip 1940 and aligned with the openings. In some embodiments, the grip 1940 may include a filter (not shown) disposed between the reservoir 1950 and the applicator pad 1910 to prevent unwanted material (e.g., particles and / or glass pieces above a certain size) from reaching the applicator pad 1910. For example, the filter may be disposed within or adjacent to one or more openings defined by the grip 1940.

[0113]

[0169] In some embodiments, the grip 1940 may be releasably coupled to the applicator pad 1910 using any of the releasable coupling mechanisms described herein such that the grip 1940 may be separated from the applicator pad 1910 after moistening the applicator pad 1910, as shown in FIG. 23C. For example, the applicator pad 1910 may be placed in contact with a target wound before or after disrupting the reservoir 1950 to moisten the applicator pad 1910. After applying pressure to the grip 1940 to disrupt the reservoir 1950 and moisten the applicator pad 1910, the grip 1940 may be pressed against the applicator pad 1910 to apply pressure to the wound. After a period of time, the grip 1940 may be separated from the applicator pad 1910 leaving the applicator pad 1910 in contact with the wound. In some embodiments, the applicator pad 1910 may include an adhesive on the skin-contacting surface of the applicator pad 1910 (e.g., adjacent the periphery of the skin-contacting surface) to hold the applicator pad 1910 in place against the wound. In some embodiments, an adhesive tab may be attached to the applicator pad 1910 and the subject's skin to hold the applicator pad 1910 in place against the wound. In some embodiments, as shown in FIG. 23C, a backing 1918, which may be the same as or similar to any of the backings or bandages described herein, may be placed over the top of the applicator pad 1910 to apply compressive pressure to the applicator pad 1910 and thus the wound and / or to maintain the applicator pad 1910 in place against the wound.

[0114]

[0170] In some embodiments, the force concentrating component may be disposed on the first or second portion of the grip, and the second portion of the grip may be moved (e.g., rotated and / or translated) relative to the first portion of the grip containing the reservoir to break the reservoir by contacting the reservoir with the force concentrating component. For example, FIG. 24 is a schematic diagram of a system 2000. The system 2000 may be the same or similar in structure and / or function to any of the systems described herein. For example, the system 2000 includes a reservoir 2050, an applicator device 2070, and an applicator pad (not shown). The applicator device 2070 includes a grip 2040 including a first portion 2042 and a second portion 2044. The first portion 2042 may define an interior space within which the reservoir 2050 may be disposed. The second portion 2044 may be configured to rotate and advance relative to the first portion 2042. For example, second portion 2044 may be coupled to first portion 2042 via a threaded connection. A first force concentrating component 2009A may be disposed on a reservoir-facing surface of second portion 2044 and / or a second force concentrating component 2009B may be disposed on a reservoir-facing surface of first portion 2042 (e.g., on a sidewall or a ramp or protrusion extending from a sidewall). In some embodiments, rotation of second portion 2044 may cause second portion 2044 to advance toward the reservoir and apply pressure to reservoir 2050 via first force concentrating component 2009A until reservoir 2050 breaks. In some embodiments, rotation of second portion 2044 may cause second portion 2044 to advance toward and / or advance reservoir such that reservoir 2050 is biased against second force concentrating component 2009B until reservoir 2050 breaks. In some embodiments, the second force concentrating component 2009B may be disposed such that the second force concentrating component 2009B will contact a shoulder of the reservoir 2050 and cause the reservoir 2050 to break at the shoulder.In some embodiments, vents (not shown) may be provided to facilitate fluid movement from the reservoir 2050 towards the applicator pad (not shown).

[0115]

[0171] In some embodiments, the applicator pad may be prepared (e.g., moistened) in a tray included in the kit before being applied to a target wound or treatment site on a subject. For example, FIGS. 25A-25C are schematic diagrams of a series of steps performed using the kit 2100. The kit 2100 may comprise any of the systems used according to any of the methods described herein. For example, the kit 2100 may comprise an applicator pad 2110 and a reservoir 2150 containing a fluid. As shown in FIG. 25A, the kit 2100 may comprise a tray 2101 that contains the applicator pad 2110 and the reservoir 2150. The fluid in the reservoir 2150 may include a drug and / or a drug activator, such as saline. As shown in FIG. 25A, the applicator pad 2110 may optionally include or be coupled to an adhesive strip 2103 configured to adhere the applicator pad 2110 to the skin of a subject. As shown in FIG. 25B, fluid may be transferred from a reservoir 2150 to the applicator pad 2110 to transfer medication to the applicator pad 2110 and / or to combine with dry medication pre-disposed on the applicator pad 2110. The reservoir 2150 may be similar to any of the reservoirs described herein. Furthermore, fluid may be transferred from the reservoir 2150 using any of the applicator devices described herein. As shown in FIG. 25C, a backing 2118 (e.g., a dressing) may be coupled (e.g., via an adhesive) to the applicator pad 2110. The backing 2118 may comprise a convex distal surface 2136 configured to be coupled to the applicator pad 2110 to apply targeted elevated pressure to the wound via the applicator pad 2110. The applicator pad 2110 may then be placed in contact with the wound with the backing 2118 coupled to the skin surrounding the wound. In some embodiments, the backing 2118 may be removed after a predetermined period of time (eg, 4 minutes, 5 minutes, 6 minutes, or 10 minutes).

[0116]

[0172] In some embodiments, an applicator device, such as any of the applicator devices described herein, may be included in the kit 2100 and used to release the contents of the reservoir. The applicator device may then be used to apply the applicator pad 2110 to the wound and apply pressure to the wound, or the applicator pad 2110 may optionally be separated from the applicator device (e.g., in the tray 2101) and the applicator pad 2110 may be applied to the wound and pressed against the wound using the subject's or caregiver's fingers and / or palm. Optionally, a backing portion 2118 may be applied to the applicator pad 2110 before or after the applicator pad 2110 is applied to the wound.

[0117]

[0173] 26A-26C are schematic diagrams of a series of steps performed using the kit 2200. The kit 2200 may comprise any of the systems used according to any of the methods described herein. For example, the kit 2200 may comprise an applicator pad 2210 and a reservoir 2250 containing a fluid. As shown in FIG. 26A, the kit 2200 may comprise a tray 2201 that contains the applicator pad 2210 and the reservoir 2250. The fluid in the reservoir 2250 may comprise a drug and / or a drug activator such as saline. As shown in FIG. 26B, the fluid may be transferred from the reservoir 2250 to the applicator pad 2210 to transfer the drug to the applicator pad 2210 and / or to combine with a dry drug pre-disposed on the applicator pad 2210. The reservoir 2250 may be similar to any of the reservoirs described herein. Additionally, the fluid may be transferred from the reservoir 2250 using any of the applicator devices described herein. As shown, for example, kit 2200 can include a grip 2240 that can be disposed over at least a portion (e.g., a neck or half) of reservoir 2250 as shown in FIG. 26B, and that can be rotated away from a central axis of reservoir 2250 such that a portion of reservoir 2250 disposed within grip 2240 can be broken (e.g., separated from the remainder of reservoir 2250 outside grip 2240) and fluid can be released.

[0118]

[0174] 26C, a backing 2118 (e.g., a bandage) may be coupled (e.g., via an adhesive) to an applicator pad 2210. The backing 2218 may comprise a convex distal surface configured to be coupled to the applicator pad 2210 to apply targeted elevated pressure to the wound via the applicator pad 2210. The applicator pad 2210 may then be placed in contact with the wound with the backing 2218 coupled to the skin surrounding the wound. In some embodiments, the backing 2218 may be removed after a predetermined period of time (e.g., 4 minutes, 5 minutes, 6 minutes, or 10 minutes).

[0119]

[0175] In some embodiments, an applicator device, such as any of the applicator devices described herein, may be included in the kit 2200 and used to release the contents of the reservoir. The applicator device may then be used to apply the applicator pad 2210 to the wound and apply pressure to the wound, or the applicator pad 2210 may optionally be separated from the applicator device (e.g., in the tray 2201) and the applicator pad 2210 may be applied to the wound using the subject's or caregiver's fingers and / or palm and pressed against the wound. Optionally, a backing portion 2218 may be applied to the applicator pad 2210 before or after the applicator pad 2210 is applied to the wound.

[0120]

[0176] 27 is a schematic diagram of a bleeding treatment system 2300. Although the system 2300 is referred to as a bleeding treatment system and is described with respect to treating a wound, the system 2300 (and any of the systems and devices described herein) may also be a system or device for locally applying any therapeutic or other substance to any suitable type of target treatment site that may benefit from application of the substance. The system 2300 may be the same or similar in structure and / or function as any of the bleeding treatment systems described herein. The system 2300 includes an applicator device 2370, an applicator pad 2310, and a reservoir 2350 with a release mechanism 2360. The applicator device 2370 comprises a grip 2340 having a first portion 2342 defining an interior space 2343 configured to receive a reservoir 2350 and a second portion 2344 configured to initiate transfer of liquid from the reservoir 2350 to the applicator pad 2310 (e.g., via engagement or disengagement with an activation mechanism 2398, the reservoir 2350, the first portion 2343, and / or intermediate components). The applicator device 2370 comprises a piercing member 2399 configured to pierce the release mechanism 2360 to release liquid from the reservoir 2350 such that liquid can flow from the reservoir 2350 to the applicator pad 2310 via a fluid coupling 2355 contained in or defined by the grip 2340. The applicator device 2370 includes the above-mentioned activation mechanism 2398, which is configured to activate liquid from the reservoir 2350 (e.g., when released via engagement or disengagement with the second portion 2344, or in response to being activated by the second portion 2344).

[0121]

[0177] In some embodiments, the reservoir 2350 may be configured such that liquid within the reservoir 2350 (e.g., a drug such as TXA and / or an activating liquid such as saline) may be displaced and / or pressurized to initiate a flow of liquid from the reservoir 2350 to the applicator pad 2310. For example, the reservoir 2350 may be closed at a distal end by a release mechanism 2360, which may be the same or similar in structure and / or function as any of the release mechanisms described herein. The release mechanism 2360 may be formed as a pierceable or breakable membrane, such as a rubber membrane (e.g., a resealable membrane), or a frangible membrane, such as a film or foil, that may be pierced by a piercing member 2399 to allow fluid to flow from the reservoir 2350. The reservoir 2350 may be configured to move (e.g., translate) into piercing contact with the piercing member 2399 such that fluid is released and / or forced from the reservoir 2350. The reservoir 2350 may comprise a rigid housing that at least partially defines an interior space in which a liquid is disposed. In some embodiments, the reservoir 2350 may be formed as a cartridge with a housing having a distal open end that is closed in an initial configuration by a pierceable release mechanism 2360 (e.g., a cap, a lined cap, or a cover) and a proximal open end that is closed by a moveable piston or plunger. In some embodiments, the reservoir 2350 may be formed as a vial with a housing having a distal open end that is closed in an initial configuration by a pierceable release mechanism 2360 (e.g., a cap, a lined cap, or a cover) and a closed proximal end. In some embodiments, the reservoir 2350 may be formed as a syringe with a housing having a distal open end that is closed in an initial configuration by a pierceable release mechanism 2360 (e.g., a cap, a lined cap, or a cover) and a proximal end configured to receive a plunger such that a distal piston end of the plunger is translatable within the housing and creates a fluid seal with an inner wall of the housing to prevent liquid within the housing from flowing proximally beyond the piston end of the plunger.In some embodiments, the reservoir 2350 (e.g., formed as a vial) may be pre-filled with compressed gas (e.g., compressed argon gas) in addition to liquid such that by puncturing or otherwise breaking the release mechanism 2360, the liquid is automatically forced from the reservoir 2350 under the force of the expanding gas. In some embodiments, the reservoir 2350 may be shaped and sized to hold and dispense 10 ml of fluid. In some embodiments, the reservoir 2350 may be shaped and sized to hold and dispense any suitable amount of fluid in an initial configuration, such as, for example, 3 ml of fluid, 5 ml of fluid, 7 ml of fluid, or 7.5 ml of fluid.

[0122]

[0178] In some embodiments, the combination of the applicator device 2370 and the reservoir 2350, or any of the combinations of any of the applicator devices and the reservoir described herein, may be configured to contain a liquid. In some embodiments, the combination of the applicator device 2370 and the reservoir 2350, or any of the combinations of any of the applicator devices and the reservoir described herein, may be configured to contain any suitable substance, such as any suitable flowable substance or any suitable high viscosity substance (e.g., a drug). For example, the combination of the applicator device 2370 and the reservoir 2350, or any of the combinations of any of the applicator devices and the reservoir described herein, may be configured to contain a high viscosity drug, such as an ointment, cream, paint, paste, lotion, gel, hydrogel, liposome, spray, aerosol, solution, salve, or any of the substances described herein.

[0123]

[0179] In some embodiments, rather than comprising a piercing member 2499, the release mechanism 2360 can be configured to rupture as a result of the pressure of the liquid in the reservoir increasing above a threshold pressure. For example, the release mechanism 2360 can include a pressure seal, a silicone flapper seal, or a dismantling adhesive. Liquid can then flow through an opening at the distal end of the first portion 2342 and / or through the fluid fitting 2355 to the applicator pad 2310.

[0124]

[0180] The activation mechanism 2398 may include any suitable activation mechanism 2398 configured to bias the reservoir 2350 and / or liquid within the reservoir 2350 toward the applicator pad 2310 (e.g., via interaction with a piston and / or plunger of the reservoir 2350). In some embodiments, the activation mechanism 2398 may include a spring, a plunger configured to move a piston of the reservoir 2350, a plunger assembly configured to force air into the reservoir 2350 to displace liquid from the reservoir 2350, a compressed gas pre-loaded with liquid in the reservoir 2350 as described above, an activation reservoir configured to expand in response to a chemical reaction to propel the reservoir 2350 and / or liquid within the reservoir 2350 distally, and / or any other suitable activation mechanism.

[0125]

[0181] The second portion 2344 of the grip 2340 may be formed as any suitable component configured to be manipulated (e.g., by a self-care home user, a caregiver, or a patient) to release and / or move the activation mechanism 2398. For example, the second portion 2344 may be formed as a retaining pin configured to engage the first portion 2342, the reservoir 2350, and / or the activation mechanism 2398 to prevent expansion of the activation mechanism 2398 from a spring initial configuration to an expanded configuration. In some embodiments, the retaining pin can be configured to be disengaged or detached from the spring (e.g., by being detached from a retaining member coupled to a distal end of the spring and / or the piston of the reservoir 1250) so that the spring can expand and apply pressure to the reservoir 2350 (e.g., to urge the reservoir 2350 distally so that the release mechanism 2360 is pierced by the piercing member 2399 and / or to urge the piston and / or plunger of the reservoir 2350 distally to force liquid out of the reservoir 2350). In some embodiments, the second portion 2344 can be formed as a plunger that the user can advance relative to the first portion 2342 (e.g., contacting the reservoir 2350 and advancing the reservoir 2350 itself and / or the plunger of the reservoir 2350) to apply pressure to the reservoir 2350. In some embodiments, the second portion 2344 may include threads configured to mate with the threads of the first portion 2342 and may be configured to rotate relative to the first portion 2342 such that the second portion 2344 moves distally and applies pressure to the reservoir 2350 to urge the reservoir 2350 distally and / or urges a piston and / or plunger of the reservoir 2350 distally to push liquid out of the reservoir 2350.In some embodiments, the second portion 2344 may be formed as a distal housing portion configured to accommodate the applicator pad 2310 within an open distal end and configured to move translationally relative to the first portion 2342 (e.g., into the interior of the first portion 2342) by applying a force to the first portion 2342 in the direction of the wound in contact with the applicator pad 2310.

[0126]

[0182] In some embodiments, the fluid fitting 2355 can be a portion of the interior space 2343 defined by the housing of the first portion 2342 through which liquid may flow from the reservoir 2350 to the applicator pad 2310. In some embodiments, the fluid fitting 2355 comprises a separate tubular member defining a lumen through which liquid may flow from the reservoir 2350 to the applicator pad 2310. In some embodiments, the fluid fitting 2355 can be a distal opening formed in the grip 2340. In some embodiments, the fluid fitting 2355 can be formed as a tubular portion coupled to the applicator pad 2310 configured to be coupled to the grip 2340 and / or as a portion of the reservoir 2350 projecting distally from the grip 2340. For example, the fluid fitting 2355 can comprise a connector, such as a luer connector, or a friction fit connector configured to be coupled to the grip 2340 and / or reservoir 2350 such that fluid flowing from the reservoir 2350 can pass through the fluid fitting 2355 to the applicator pad 2310. After the transfer of liquid, the fluid fitting 2355 can be decoupled from the grip 2340 and / or reservoir 2350 and the applicator pad 2310 can remain in place (e.g., on the patient's skin). In some embodiments, the fluid fitting 2355 can be a lumen defined by a piercing member 2399 (e.g., the piercing member 2399 can be a hollow needle).

[0127]

[0183] In some embodiments, the piercing member 2399 may be disposed at a distal end of the grip 2340 (coupled to or included in the first portion 2342) and may protrude into the interior space 2343 towards the reservoir 2350. In some embodiments, the piercing member 2399 may be coupled to the applicator pad 2310 (e.g., disposed in the fluid fitting 2355, or in or adjacent to another fluid fitting or connector), which may be coupleable and / or separable from the grip 2340. In some embodiments, the piercing member 2399 may be coupled to the second portion 2344. In some embodiments, the piercing member 2399 may comprise one or more lumens configured to allow flow of liquid from the reservoir 2350 to the applicator pad 2310. In some embodiments, the piercing member 2399 or additional piercing members may comprise one or more lumens configured to allow flow of fluid (e.g., gaseous fluid) into the reservoir 2350 to displace liquid from the reservoir 2350. In some embodiments, the piercing member 2399 does not define a lumen. In some embodiments, the activation mechanism 2398 is configured to bias the release mechanism 2360 of the reservoir 2350 towards the piercing member 2399 such that the piercing member 2399 penetrates the release mechanism 2360 to initiate the transfer of liquid from the reservoir 2350. In some embodiments, the first portion 2342 is configured to translate distally relative to the piercing member 2399, the reservoir 2350 may be in a fixed location relative to the first portion 2342 such that the release mechanism 2360 translates into piercing contact with the piercing member 2399 to initiate transfer of liquid from the reservoir 2350, and the activation mechanism 2398 is configured to bias a portion of the reservoir 2350 (e.g., a piston) towards the piercing member 2399 to bias fluid from the reservoir 2350. The piercing member 2399 may be formed of any suitable material, such as metal or plastic.

[0128]

[0184] In some embodiments, the grip 2340 is positioned relative to the applicator pad 2310 such that a central axis of the grip 2340 (or of a first portion 2342 of the grip 2340) is perpendicular to a wound-facing surface of the applicator pad 2310 (e.g., when the applicator pad 2310 is in contact with a wound). In some embodiments, the grip 2340 is positioned relative to the applicator pad 2310 such that a central axis of the grip 2340 (or of a first portion 2342 of the grip 2340) is disposed at an angle (e.g., a 45 degree angle) relative to a wound-facing surface of the applicator pad 2310 (e.g., when the applicator pad 2310 is in contact with a wound).

[0129]

[0185] In some embodiments, the system 2300 may include any suitable number of reservoirs and piercing members rather than one reservoir 2350 and one piercing member 2399. For example, the system 2300 may include two reservoirs 2350 and two piercing members 2399, three reservoirs 2350 and three piercing members 2399, four reservoirs 2350 and four piercing members 2399, etc. In some embodiments, the system 2300 may include an activation mechanism 2398 (e.g., a spring) associated with each reservoir 2350 and a single second portion 2344 configured to simultaneously activate each of the activation mechanisms 2398. In some embodiments, the system 2300 includes one common activation mechanism 2398 configured to be activated by the second portion 2344.

[0130]

[0186] The first portion 2342 may be formed in any suitable shape. For example, the first portion 2342 may comprise a cylindrical or tubular housing. In some embodiments, the first portion 2342 may comprise or be coupled to a plate 2341 disposed at a distal end of the first portion 2342 and configured to apply pressure to the applicator pad 2310 and thus the target wound. In some embodiments, the plate 2341 may form a bottom surface of the grip 2340. In some embodiments, the plate 2341 may be formed as a flange (e.g., a circumferential flange) extending from a bottom edge of the first portion 2342. In some embodiments, the plate 2341 may be separable from the grip 2340 (e.g., by decoupling the fluid coupling 2355 when the fluid coupling 2355 is coupled to the applicator pad 2310 or by decoupling the plate 2341 from the first portion 2342).

[0131]

[0187] In some embodiments, the grip 2340 and / or the applicator pad 2310 comprises an applicator seal 2320 configured to cover at least a distal or skin-contacting surface of the applicator pad 2310 to prevent contamination of the applicator pad 2310 prior to use, and optionally leakage from the applicator pad 2310 or drying out of the applicator pad 2310. The applicator seal 2320 may be formed, for example, as a film (e.g., a peelable film). In some embodiments, the applicator seal 2320 may be formed of shrink wrap material covering a distal end of the applicator pad 2310 and disposed over at least a portion of the length of the first portion 2342.

[0132]

[0188] The applicator pad 2310 may be the same as or similar in structure and / or function to any of the applicator pads described herein. For example, the applicator pad 2310 may include and / or be coupled with an optional blood absorbing pad 2330 and / or an optional pad retainer 2335. The blood absorbing pad 2330 and the pad retainer 2335 may be the same as or similar in structure and / or function to any of the blood absorbing pads or pad retainers described herein, respectively. In some embodiments, the applicator pad 2310 may have a cylindrical or conical shape.

[0133]

[0189] In some embodiments, the applicator pad 2310 may be coupled (e.g., via an adhesive) to a backing (e.g., a bandage or a flexible or rigid cup). The backing may be the same or similar in structure and / or function as any of the backings described herein and may be configured to couple to the applicator pad 2310 to apply high pressure to the wound via the applicator pad 2310 to hold the applicator pad 2310 in place against the wound. The applicator pad 2310 may then be placed in contact with the wound with the backing coupled to the skin surrounding the wound. In some embodiments, the backing may be removed after a predetermined time (e.g., 4 minutes, 5 minutes, 6 minutes, or 10 minutes, 8 hours). In some embodiments, the backing may be applied to the applicator pad 2310 before or after application of the applicator pad 2310 to the wound. In some embodiments, the backing is coupled to the applicator pad 2310 before the applicator pad 2310 is wetted with liquid from the reservoir 2350. Thus, in some embodiments, the backing may extend laterally from the grip 2340 or fold upward against an outer surface of the grip 2340 when the applicator pad 2310 is coupled to the grip 2340 to receive liquid from the reservoir 2350. In some embodiments, the backing may be coupled to the applicator pad 2310 such that the user can grasp it and separate the applicator pad 2310 from the grip 2340 by pulling on the backing.

[0134]

[0190] Prior to use, the applicator device 2370 can be disposed in an initial configuration. In some embodiments, in the initial configuration, the applicator pad 2310 can be coupled to a distal end of the grip 2340. The applicator seal 2320 can cover the applicator pad 2310. To use the applicator device 2370, the applicator seal 2320 can be optionally removed and the grip 2340 can be used to apply the applicator pad 2310 to a wound. To release liquid from the reservoir 2350 such that the liquid flows to the applicator pad 2310, the second portion 2344 can be configured to move relative to the first portion 2342 (e.g., by translational movement relative to the first portion 2342, disengagement from the first portion 2342, and / or rotational movement relative to the first portion 2342) to engage or disengage with the reservoir 2350 and / or the release mechanism 2360.

[0135]

[0191] The applicator pad 2310 may be pressed against the target wound tissue, optionally using grip 2340. The applicator pad 2310 may be maintained against the wound (e.g., without maintaining grip 2340 in contact with the applicator pad 2310), optionally by coupling the applicator pad 2310 to the skin via pad retainer 2335. The applicator pad 2310 may be separated from the applicator pad 2310, optionally by releasing the applicator pad 2310 from grip 2340 (e.g., by releasing pad connector 2348, which may be the same or similar in structure and / or function as any of the pad connectors described herein, optionally included in applicator device 2370). In some embodiments, the applicator pad 2310 may be configured to move away from the first portion 2342 without manual intervention or without significant manual intervention upon saturation (e.g., by the applicator pad 2310 expanding from a recess in which it is at least partially disposed, by an increase in weight that causes the applicator pad 2310 to fall out of the recess when wet, and / or by a decrease in friction between the applicator pad and the first portion 2342 when the applicator pad is saturated).

[0136]

[0192] Figures 28A to 28F show various views of an embodiment of a bleeding treatment system 2400. Figures 28A and 28D are isometric views of the bleeding treatment system 2400, Figures 28B and 28E to 28F are cross-sectional views (along line AA in Figure 28C) of the bleeding treatment system 2400, and Figure 28C is a side view of the bleeding treatment system 2400. The bleeding treatment system 2400 may be the same or similar in structure and / or function to any of the bleeding treatment systems described herein. As shown in Figure 28B, the bleeding treatment system 2400 includes an applicator device 2470, an applicator pad 2410, and a reservoir 2450 with a release mechanism 2460. The applicator device 2470 comprises a first portion 2442 defining an interior space configured to receive the reservoir 2450, and a second portion 2444 engaging the first portion 2442 in an initial configuration to prevent initiation of transfer of liquid from the reservoir 2450 to the applicator pad 2410. The first portion 2442 may be formed in any suitable shape. For example, the first portion 2442 may comprise a cylindrical or tubular housing 2442A, as shown in FIGS. 28A-F. The first portion 2442 comprises a plate 2441 disposed at a distal end of the first portion 2442 and configured to apply pressure to the applicator pad 2410 and, therefore, to the target wound. In some embodiments, the plate 2441 may be included in a distal end portion 2442B that is separable from the housing 2442A of the first portion 2442 (e.g., may be attached to the first portion after the reservoir 2450 is disposed within the first portion 2442 and / or may be detached from the first portion 2442 after transfer of liquid from the reservoir 2450 to the applicator pad 2410). As shown in FIG. 28B, the distal end portion 2442B may define a receptacle configured to receive at least a portion of the applicator pad 2410. The first portion 2442 also includes a piercing member 2499 that may protrude from the plate 2441 into the interior space toward the reservoir 2450.

[0137]

[0193] Similar to the embodiment of the bleeding treatment system 2300, the bleeding treatment system 2400 may comprise an applicator seal (not shown) (similar to the applicator seal 2320 of the bleeding treatment system 2300) configured to cover at least a distal or skin-contacting surface of the applicator pad 2410 to prevent contamination of the applicator pad 2410 prior to use, and optionally leakage from or drying out of the applicator pad 2410. The applicator seal may be formed, for example, as a film (e.g., a peelable film), such as a shrink wrap material. The applicator pad 2410 may be the same or similar in structure and / or function as any of the applicator pads described herein.

[0138]

[0194] The reservoir 2450 may be formed as a cartridge with a rigid housing defining an interior configured to be pre-filled with a medicament (e.g., liquid). The reservoir 2450 may have a distal open end closed by a release mechanism 2460 (e.g., a cap or cover) and a proximal open end closed by a movable piston 2451. The release mechanism 2460 may be the same or similar in structure and / or function to any of the release mechanisms described herein (e.g., release mechanism 2360). In an initial configuration of the system 2400, the movable piston 2451 is located at a proximal end PE of the reservoir 2450 housing and is at least partially disposed within the reservoir 2450 housing, as shown in FIG. 28B. The movable piston 2451 is configured to translate from a proximal end PE of the reservoir 2450 to a distal end DE of the reservoir 2450 to urge fluid from the reservoir 2450 when the release mechanism 2460 is pierced by the piercing member 2499 to allow flow from the reservoir 2450. The piercing member 2499 defines a lumen through which liquid may flow from the reservoir towards the applicator pad 2410.

[0139]

[0195] The applicator device 2470 includes an activation mechanism 2498 configured as a spring and arranged to exert pressure on the piston 2451 to bias the piston 2451 in a distal direction. When the activation mechanism 2498 is released, the activation mechanism 2498 can transition from a compressed state to an expanded state. Initially, because liquid disposed within the reservoir 2450 is substantially incompressible, the expansion of the activation mechanism 2498 toward (e.g., relative to) the piston 2451 biases the entire reservoir 2450 toward the piercing member 2499 such that the piercing member 2499 pierces the release mechanism 2460 and releases liquid from the reservoir 2450. Liquid can flow from the reservoir 2450 to the applicator pad 2410 via a lumen of the piercing member 2499.

[0140]

[0196] 28A-28F, the second portion 2444 is formed as a retaining pin 2444. The retaining pin 2444 may comprise an extension member 2444E and a handle portion 2444H. Although the handle portion 2444H is shown as being ring-shaped, the handle portion 2444H may have any suitable shape. Or, although the handle portion 2444H is shown extending perpendicularly away from a central axis of the first portion 2444, in some embodiments the handle portion 2444H may extend in any suitable direction relative to the extension member 2444E (e.g., parallel to the central axis, adjustably relative to the extension member 2444E about a hinge joint). The first portion 2444 and the piston 2451 are configured to receive the extension member 2444E of the retaining pin 2444 in an initial configuration of the system such that the retaining pin 2444 retains the activation mechanism 2498 in the initial configuration and prevents movement of the activation mechanism 2498 and the piston 2451 relative to the first portion 2442. The first portion 2442 defines an opening 2453A in the housing 2442A configured to receive the extension member 2444E of the retaining pin 2444. In some embodiments, the housing 2442A defines a second opening or recess opposite the opening 2453A into which the free end of the extension member 2444E may be disposed in the initial, retained configuration. In some embodiments, the extension member 2444E is visually identifiable (e.g., by a user) within the second opening to confirm proper engagement of the extension member 2444E with the first portion 2442 and the piston 2451. The piston 2451 also defines a through hole or socket 2452 configured to receive the extension member 2444E such that the piston 2451 may be held in place relative to the opening 2453A and the optional second opening by the extension member 2444E. In some embodiments, the piston 2451 may comprise a piston portion and a retainer coupled to a proximal end of the piston portion, and the through hole or socket 2452 may be defined between the piston portion and the retainer. The piston 2451 (e.g., the retainer) may comprise a flat proximal surface against which the activation mechanism 2498 may apply uniform pressure to the piston 2451.

[0141]

[0197] The reservoir 2450 may be held in a position with the release mechanism 2460 spaced from the piercing member 2499 by the engagement of the extension member 2444E with the through hole 2452. Removal of the retaining pin 2444 from the through hole 2452 and the opening 2453A allows the reservoir 2450 to be translated distally by the activation mechanism 2498, which releases the activation mechanism. The activation mechanism 2498 may then push the reservoir 2450 into sufficient engagement with the piercing member 2499 such that the tip of the piercing member 2499 pierces the release mechanism 2460. Once the release mechanism 2460 is pierced, the activation mechanism 2498 pushes the piston 2451 from the proximal end PE towards the distal end DE of the reservoir 2450, allowing delivery of fluid from the reservoir 2450 through the lumen of the piercing member 2499.

[0142]

[0198] In some embodiments, the inner diameter of the first portion 2442 at a distal region of the first portion 2442 (where the housing of the reservoir 2450 is disposed in the initial configuration of the system 2400) can be larger than the inner diameter of the first portion 2442 at a proximal region of the first portion 2442 (where the activation mechanism 2498 is disposed in the initial configuration of the system 2400) so that the piston 2451 and the activation mechanism 2498 do not stick during the expansion of the activation mechanism 2498. In some embodiments, the piston 2451 can be partially disposed between the distal and proximal regions of the first portion 2442. The distal and proximal regions of the first portion 2442 can be separated by, for example, the first opening 2453A and the second opening. In some embodiments, the inner diameter of the cartridge housing can be the same as or larger than the inner diameter of the proximal region of the first portion 2442.

[0143]

[0199] In some embodiments, rather than the retaining pin 2444 preventing release of the activation mechanism 2498 by engaging the piston 2451 and preventing translational movement of the piston 2451, the retaining pin 2444 may directly engage the activation mechanism 2498 or another component coupled to the distal end of the activation mechanism to prevent expansion of the activation mechanism 2498.

[0144]

[0200] In an exemplary embodiment, the activation mechanism 2498 can be a coil spring in compression, as shown, for example, in FIG 28B. In various embodiments, the parameters of the coil spring (e.g., coil elasticity, coil thickness, number of coil turns, diameter of the coil turns, etc.) are selected such that the force generated by the activation mechanism 2498 at the proximal end PE of the reservoir 2450 is sufficient to urge the release mechanism 2460 into contact with the piercing member 2460 causing rupture of the release mechanism 2460 and forcing the movable piston 2451 towards the distal end DE of the reservoir 2450. Further, in some embodiments, the coil spring that comprises the activation mechanism 2498 is configured to expand the distance H+h (shown in FIG. 28B ) to an equilibrium position (e.g., a position where the movable piston 2451 is not under pressure) so that the movable piston 2451 substantially reaches the distal end DE of the reservoir 2450 (a dashed outline of the movable piston is shown at the distal end DE of the reservoir in FIG. 28B simply to show where the movable piston would be when pushed all the way to the distal end DE). Note that the distance H is the distance that the movable piston 2451 has traveled and the distance h is the distance that the reservoir 2450 has traveled after being pushed by the activation mechanism 2498. In some cases, even after expanding the distance H+h, the coil spring may not reach the equilibrium position (thereby continuing to apply pressure to the movable piston 2451 when it is at the distal end DE of the reservoir 2450).

[0145]

[0201] As described above and shown in FIG. 28B, the piercing member 2499 is disposed on the plate 2441 opposite the applicator pad 2410. The piercing member 2499 may include or be coupled to the plate 2441 and have a hub 2449 having an interior in fluid communication with the lumen of the piercing member 2499. The plate 2441 defines an opening 2447 through which fluid from the reservoir 2450 may flow towards the applicator pad 2410. Thus, the hub 2449 and the opening 2447 may individually or collectively constitute a fluid coupling 2455. Additionally or alternatively, in some embodiments, the fluid coupling may be achieved by fluid flowing outside the piercing member 2499. For example, the fluid may flow outside the member 2499, through one or more openings in the plate 2441 to the applicator pad 2410.

[0146]

[0202] To use the applicator device 2470, the optional applicator seal can be removed and the applicator device 2470 can be placed so that the applicator pad 2410 contacts a wound on the user's skin surface. For example, if a user has a wound on one arm, the user can use one hand on the opposite arm to place the applicator device 2470 over the wound so that the applicator pad 2410 contacts the wound. The user can release the activation mechanism 2498 by pulling the retaining pin 2444 with the fingers of one hand (i.e., the hand holding the applicator device 2470) to initiate the release of liquid from the reservoir 2450 to the absorbent pad 2410 and thus the wound. The user can maintain pressure against the wound by applying the applicator device 2470 to the absorbent pad 2410 and thus the wound, as described herein. Alternatively, the user can withdraw the retaining pin 2444 before using the applicator device 2470, and while the applicator pad 2410 is saturated with fluid from the reservoir 2450 or after the saturation operation is completed, the user can place the applicator pad 2410 in contact with the wound and maintain the applicator device 2470 in contact with the applicator pad 2410 to apply pressure to the wound via the plate 2441 and the applicator pad 2410.

[0147]

[0203] In some cases, as described above, the applicator pad 2410 saturated with fluid from the fluid reservoir 2450 may be releasable from the first portion 2442 and may be configured to remain coupled to the wound by being attached (e.g., via an adhesive) to the skin surrounding the wound for continued compression of the wound (e.g., by compression by a user's hand and / or the applicator pad 2410 itself against the applicator pad 2410). The applicator pad 2410 may also be used to prevent contamination of the wound and continue wound treatment with medicinal agents. In some embodiments, the applicator pad 2410 may be coupled to the first portion 2442 by a mucoadhesive layer and may be removable by separating the applicator pad 2410 (e.g., manually) from the first portion 2442 (e.g., after the applicator pad 2410 is coupled to the user's wound). Alternatively, the applicator pad 2410 may be coupled to the first portion 2442 by a pad retainer, such as any of the pad retainers described herein. For example, the pad retainer may include one or more hooks, clamps, etc. In some embodiments, the applicator pad 2310 may be disposed within a receptacle defined by the distal end portion 2442B by compression or friction fit and may expand and move away from the distal end portion 2442B upon wetting with liquid from the reservoir 2450.

[0148]

[0204] In some embodiments, the applicator pad 2410 may not be separated from the first portion 2442 and may be configured to be applied to the wound for a period of time required for wound treatment (e.g., the applicator pad 2410 may be applied to the wound for a minute, several minutes, 10 minutes, tens of minutes, hours, etc. to promote blood clotting in the wound). The applicator pad 2410 may be pressed against the wound by a user pressing the applicator device 2470 against the wound. The applicator pad may be left on the wound with the bandage for several hours (e.g., up to 24 hours).

[0149]

[0205] The applicator pads described herein, such as applicator pad 2410, can be of any suitable shape and size. For example, Figures 29A-29H show an exemplary embodiment of a bleeding treatment system 2500 with an applicator device 2570 that can be similar to applicator device 2470 of bleeding treatment system 2400, with the difference that diameter 2510d of applicator pad 2510 is larger than diameter 2542d of first portion 2542, as shown in Figure 29B. 29A is a perspective view, FIG. 29B is a side view, FIG. 29C is a cross-sectional view along line BB of FIG. 29B, FIG. 29D is a cross-sectional view, FIG. 29E is a perspective view with the first portion 2542 shown in transparency, FIG. 29F is a perspective view with the second portion 2544 separated from the first portion 2542, FIG. 29G is a perspective view with the first portion 2542 shown in transparency, and FIG. 29H is a perspective view of a portion of the system 2500 with the first portion 2542 not shown. Similar to the bleeding treatment system 2400 described above, the applicator device 2570 may comprise a plate 2541, a second portion 2544, and an activation mechanism 2598, and may be configured to house a reservoir 2550 comprising a piston 2551 and coupled to a release mechanism 2560. In some embodiments, the applicator pad 2510 can be of any suitable size, such as being dimensioned to be at least 3.5 cm wide in at least one direction so as to be able to cover a wound approximately 3 cm wide.

[0150]

[0206] The first portion 2542 and the second portion 2544 may be the same or similar in structure and / or function as the first portion 2442 and the second portion 2444 described above. For example, the second portion 2544 may be formed as a retaining pin 2544. The retaining pin 2544 may include an extension member 2544E and a handle portion 2544H. The first portion 2544 and the piston 2551 are configured to receive the extension member 2544E of the retaining pin 2544 in an initial configuration of the system such that the retaining pin 2544 retains the activation mechanism 2598 in the initial configuration and prevents movement of the activation mechanism 2598 and the piston 2551 relative to the first portion 2542. The first portion 2542 defines a first opening 2553A and a second opening 2553B on opposite sides of the housing 2542. Each of the first opening 2553A and the second opening 2553B is configured to receive an extension member 2544E of the retention pin 2544 in an initial retaining configuration. In some embodiments, a free end of the extension member 2544E may be visually discernible (e.g., by a user) in the second opening 2553B to confirm that the extension member 2544E is properly engaged with the first portion 2542 and the piston 2551. The piston 2551 also defines a through hole or socket 2552 configured to receive the extension member 2544E such that the piston 2551 may be held in place relative to the openings 2553A, 2553B by the extension member 2544E. In some embodiments, the piston 2551 can include a piston portion 2551A and a retaining portion 2551B coupled to a proximal end of the piston portion 2551, and the through hole or socket 2552 can be defined between the piston portion 2551A and the retaining portion 2551B. The piston 2551 (e.g., the retaining portion 2551B) can include a flat proximal surface (shown in FIG. 29H) against which the activation mechanism 2598 can apply uniform pressure to the piston 2551.

[0151]

[0207] The reservoir 2550 may be held in a position with the release mechanism 2560 spaced from the piercing member 2599 by the engagement of the extension member 2544E with the through hole 2552. Removal of the retaining pin 2544 from the second opening 2443B, the through hole 2552, and the first opening 2553A allows the reservoir 2550 to be translated distally by the activation mechanism 2598, which releases the activation mechanism. The activation mechanism 2598 may then push the reservoir 2550 into sufficient engagement with the piercing member 2599 such that the tip of the piercing member 2599 pierces the release mechanism 2560. Once the release mechanism 2560 is pierced, the activation mechanism 2598 pushes the piston 2551 from the proximal end PE towards the distal end DE of the reservoir 2550, allowing delivery of fluid from the reservoir 2550 through the lumen of the piercing member 2599.

[0152]

[0208] Figures 30A to 30E show an exemplary embodiment of a bleeding treatment system 2600. Figure 30A shows an isometric view of the bleeding treatment system 2600, Figure 30B shows a front view of the bleeding treatment system 2600, Figure 30C shows a rear view of the bleeding treatment system 2600, Figure 30D shows a side view of the bleeding treatment system 2600, and Figure 30E shows a cross-sectional view of the bleeding treatment system 2600 along section AA shown in Figure 30D. The bleeding treatment system 2600 may be the same or similar in structure and / or function to any of the bleeding treatment systems described herein, such as the bleeding treatment system 2400. For example, the bleeding treatment system 2600 includes an applicator device 2670. The bleeding treatment system 2600 also includes multiple reservoirs, such as reservoirs 2650a-2650c (each of which may be similar to reservoir 2450, as shown in Figures 28A-28G), and an applicator pad 2610, which may be the same or similar in structure and / or function to any of the applicator pads described herein. The applicator device 2670 includes a grip 2640 having a plurality of first portions, e.g., first portions 2642a-2642c (each of first portions 2642a-2642c may be similar to first portion 2442, as shown in FIGS. 28A-28F), a plurality of activation mechanisms, e.g., activation mechanisms 2698a-2698c (each of activation mechanisms 2698a-2698c may be similar to activation mechanism 2498, as shown in FIGS. 28A-28G), a plurality of piercing members, e.g., piercing members 2699a-2699c (each of piercing members 2699a-2699c may be similar to piercing mechanism 2499, as shown in FIGS. 28A-28G), and a fluid coupling (e.g., hub, opening in plate 2641) between the piercing mechanisms 2699a-2699c and the applicator pad 2610. Providing multiple first portions, reservoirs, actuating members, and piercing mechanisms may allow the size of the bleeding treatment system 2600 to be easily adjusted to fit a selected size wound and may allow a particular volume of liquid to be dispensed regardless of whether a cartridge of that particular volume is available.

[0153]

[0209] The activation mechanisms 2698a-2698c may be released upon a user pulling out the retaining clip 2644 (retaining clip 2644 is shown, for example, in FIG. 30A ). The retaining clip 2644 may comprise a flap 2644f configured for a user to grasp, and a body portion 2644b having an extension element that may be inserted into a suitable socket to secure the reservoir 2650a-2650c in place relative to the first portion 2642a-2642c to prevent release of the activation mechanisms 2698a-2698c in some embodiments. When the retaining clip 2644 is removed from the first portion 2642a-2642c, the activation mechanism 2698a-2698c is released, thereby moving the reservoir 2650a-2650c toward the associated piercing member 2699a-2699c, piercing the release mechanism of the reservoir 2650a-2650c (which may be similar to the release mechanism 2460, e.g., as shown in Figures 28A-28G) and moving a piston within the reservoir 2650a-2650c to urge fluid to flow from the reservoir toward the applicator pad 2610 through a fluid coupling (e.g., a lumen and hub) associated with the piercing mechanism 2699a-2699c.

[0154]

[0210] The applicator pad 2610 may be coupled to a backing 2618, which may be configured as a bandage. The backing 2618 may include an adhesive covered with a peel-off adhesive liner disposed on a distal surface of the backing 2618. The adhesive liner may be peeled off prior to placing the backing 2618 on the skin of a subject so that the backing 2618 may be attached to the skin via the adhesive. The backing 2618 may be similar or the same as any of the backings described herein.

[0155]

[0211] In some embodiments, rather than the reservoir being formed as a cartridge, the reservoir may be formed as a vial. For example, Figures 31A-31C show an embodiment of a bleeding treatment system 2700. Figure 31A shows a side view of the treatment system 2700, Figure 31B shows a cross-sectional view of the treatment system 2700 along section line AA of Figure 31A, and Figure 31C shows a perspective view of the treatment system 2700. Figure 31D shows a cross-sectional view of a distal portion of the system 2700. The bleeding treatment system 2700 may be the same or similar in structure and / or function to any of the bleeding treatment systems described herein, such as the bleeding treatment system 2400. For example, the bleeding treatment system 2700 includes an applicator device 2770, an applicator pad 2710, and a reservoir 2750, each of which may be the same or similar in structure and / or function to any of the applicator devices, applicator pads, and reservoirs described herein. 31B, the reservoir 2750 may be formed as a vial with a housing defining an interior configured to contain a liquid and a release mechanism 2760 (e.g., a cap or cover) that is pierceable to access the contents of the reservoir 2750. The reservoir 2750 may include any suitable vial having any suitable volume. For example, the reservoir 2750 may be formed as a glass vial, a plastic vial, etc. The volume may include, for example, 10 mL of fluid, or enough fluid to allow the 10 mL of fluid to be dispensed by the system 2700 (e.g., if some liquid remains in the reservoir 2750 after the applicator device 2870 has been transitioned to a fully dispensed configuration).

[0156]

[0212] The applicator device 2770 comprises a grip 2740 having a first portion 2742 and a second portion 2744 configured to move (e.g., translate) relative to the first portion 2742. As shown in FIG. 31B, the second portion 2744 is formed as a piston configured to move (e.g., translate) within an interior space defined by the first portion 2742. The second portion 2744 defines a cavity 2744c that receives and holds (e.g., via any suitable coupling mechanism, such as a friction fit and / or adhesive) a portion of the reservoir 2750. The applicator device 2770 comprises a piercing member 2799 coupled to a distal end of the first portion 2722, the piercing member 2799 projecting distally such that the reservoir 2750 can be moved toward the piercing member 2799 and the piercing member 2799 can pierce the release mechanism 2760 of the reservoir 2750. As shown in FIG. 31B, the distal end of the first portion 2722 may be formed, at least in part, by a plate 2741 configured to contact a proximal surface of the applicator pad 2710 and compress the applicator pad 2710 (and thus a wound in contact with the applicator pad 2710). The plate 2741 may have a continuous distal surface except for fluid through holes that allow liquid from the reservoir 2750 to flow to the applicator pad 2710. The piercing member 2799 may protrude distally from the plate 2741 and may define a lumen 2799f (also referred to as a fluid channel) in fluid communication with an opening in the plate 2741. The piercing member 2799 may also define a lumen 2799g (also referred to as a gas channel) fluidically separated from the lumen 2799f. The lumen 2799g may be disposed parallel to the lumen 2799f. In some embodiments, rather than including a single piercing member 2799 defining two lumens, the applicator device 2770 may include two piercing members 2799 arranged close enough to each other that either can pierce the release mechanism 2760, one of the piercing members 2799 defining lumen 2799g and the other piercing member defining lumen 2799f.The applicator device 2770 also includes a storage hub 2773 configured to receive a distal end of the vial 2750 and stabilize the vial 2750 against the piercing member 2799 as the vial 2750 translates distally. The storage hub 2773 can include, for example, a set of tabs (e.g., four tabs) configured to bend relative to a base of the storage hub 2773 such that when the distal end of the vial 2750 is in contact with the storage hub 2773, the distal end of the vial 2750 can bias the tabs outwardly, and the tabs can bend back to secure the distal end (e.g., cap-like release mechanism 2360) to a distal portion of the storage hub 2773 distal to the protrusions of the tabs.

[0157]

[0213] The applicator device 2770 also includes an activation mechanism 2798 (also referred to as an actuation assembly) configured to initiate the forcing of liquid from the reservoir 2750. The activation mechanism 2708 includes a plunger 2771 and a barrel 2772 defining a gas reservoir. The gas reservoir of the barrel 2772 is fluidly coupled to a lumen 2799g of the pierceable member 2799 via a fluid coupling 2772a, which may include any suitable combination of fluid couplings, such as a tubular fluid connector, and may include any suitable filter or valve (e.g., a one-way valve). The plunger 2771 is configured to translate relative to the barrel 2772 to forcibly force gas initially disposed within the barrel 2772 into the lumen 2799g via the fluid coupling 2772a. As shown in FIG. 31B, the second portion 2744 can define a plunger cavity 2744d configured to accommodate a portion of the plunger 2771 such that distal translation of the second portion 2744 advances the plunger 2771 distally relative to the barrel 2772 upon contact of a proximal end of the plunger with the second portion 2774.

[0158]

[0214] In use, a user can apply pressure to second portion 2744 to advance second portion 2744 distally relative to first portion 2742. Because reservoir 2750 is held within cavity 2744c and plunger 2771 is disposed within cavity 2744d, as second portion 2744 moves distally towards piercing member 2799, both plunger 2771 and reservoir 2750 move distally under the control of second portion 2744. Once the release mechanism 2760 has been pierced by the piercing member 2799 and the proximal or free end of the piercing member 2799 (including the proximal ends of lumens 2799g and lumens 2799f) is disposed within the reservoir 2750 (by the second portion 2744 having sufficiently advanced the reservoir 2750), further distal translational movement of the second portion 2744 causes the plunger 2771 to apply pressure to the gas within the barrel 2772, thereby releasing at least some amount of gas from the barrel 2772, through the fluid coupling 2772a, and through the lumen 2799g of the piercing member 2799 into the interior of the reservoir 2750. The gaseous fluid moving into the interior of the reservoir 2750 displaces liquid fluid within the reservoir 2750, forcing the liquid fluid through lumen 2799f and onto the applicator pad 2710.

[0159]

[0215] In some embodiments, the length of the plunger 2771, barrel 2772, and piercing member 2799 and the diameter of the barrel 2772, respectively, may be selected to optimize liquid fluid transfer from the vial 2750 to the absorbent pad 2710. For example, the length and diameter may be selected to be short enough that the piercing member 2799 can receive liquid from the bottom of the vial 2750, while the barrel 2772 may have a large enough diameter to allow sufficient gas to be introduced into the vial 2750 to urge liquid out of the vial 2750, even with a shorter barrel and / or plunger length. In some embodiments, the proximal end of the plunger 2798 may be spaced from the contact wall of the cavity 2744d such that the second portion 2744 does not begin to translate the plunger 2771 until or shortly after the release mechanism 2760 is pierced by the piercing member 2799. To avoid creating a low pressure region (e.g., a partial vacuum) within the interior of the reservoir 2750, the remainder of the applicator device 2770 and the components of the activation mechanism 2798 for the reservoir 2750 can be configured to supply an appropriate amount of gas at an appropriate flow rate to the interior of the reservoir 2750 to sufficiently displace liquid from the reservoir 2750 for fluid flow without interruption due to negative pressure.

[0160]

[0216] In some embodiments, the reservoir may not be formed as a vial or cartridge, but as a syringe. Figures 32A-32L show an embodiment of a bleeding treatment system 2800 in a partially dispensed configuration (Figures 32A-32D), a fully dispensed configuration (Figures 32E-32H), and an uncoupled configuration (Figures 32I-32L). Figures 32A, 32E, and 32I are front views of the bleeding treatment system 2800, Figures 32B, 32F, and 32J are side views of the bleeding treatment system 2800, and Figures 32C, 32G, and 32K are cross-sectional views of the bleeding treatment system 2800 along lines GG in Figure 32A, HH in Figure 32E, and II in Figure 32J, respectively. Figures 32D, 32H, and 32L are perspective views of the bleeding treatment system 2800.

[0161]

[0217] The bleeding treatment system 2800 may be the same or similar in structure and / or function to any of the bleeding treatment systems described herein, such as the bleeding treatment system 2400. For example, the bleeding treatment system 2800 includes an applicator device 2870, a pad assembly 2880 including an applicator pad 2810, and a reservoir 2850, each of which may be the same or similar in structure and / or function to any of the applicator devices, applicator pads, and reservoirs described herein. As shown in FIG. 32C, the reservoir 2850 may be formed as a syringe with a plunger 2858, a barrel 2854 defining an interior configured to contain a liquid, and an ejection mechanism 2860 (e.g., a cap or cover) pierceable to access or eject the contents of the reservoir 2850. The reservoir 2850 may include any suitable barrel 2854 having any suitable volume. For example, the reservoir 2850 may be formed as a glass syringe, a plastic syringe, or the like. The capacity may include, for example, 10 mL of fluid, or enough fluid to allow 10 mL of fluid to be ejected by the system 2800 (e.g., if some liquid remains in the reservoir 2850, e.g., in the neck 2852 of the reservoir 2850, after the plunger has transitioned to the fully ejected configuration).

[0162]

[0218] The applicator device 2870 comprises a first portion 2842 and a second portion 2844. The first portion 2842 and the second portion 2488 may be the same or similar in structure and / or function to any of the first and second portions described herein. The first portion 2842 and the second portion 2844 collectively form an interior space within which at least a portion of the reservoir 2850 may be disposed. As shown in FIG. 32C, the first portion 2842 may define a distal opening through which a portion of the reservoir 2850 (e.g., the neck 2852) may extend. The barrel 2854 of the reservoir 2850 may have at least a portion having a larger outer diameter than the distal opening of the first portion 2842 such that the barrel 2854 is prevented from moving distally relative to the first portion 2842 while the neck 2852 extends beyond the distal end of the first portion 2842. The barrel 2850 may be coupled to the first portion 2824 via any suitable coupling mechanism such that rotation of the first portion 2824 by a user causes corresponding rotation of the barrel 2850. For example, the barrel 2850 may be coupled via adhesive, a friction fit, a mating interlocking mechanism, or protrusions or features on the barrel 2850 and / or an interior wall of the first portion 2824 that prevent rotation of the barrel 2850 relative to the first portion 2824.

[0163]

[0219] The first portion 2842 and the second portion 2844 include mating threads such that the second portion 2844 can be twisted relative to the first portion 2842 to advance the second portion 2844 distally relative to the first portion 2842. Although not shown, in some embodiments, the second portion 2844 includes a mechanism (e.g., a laterally extending tab) to assist a user in rotating the second portion 2844 relative to the first portion 2842. When the reservoir 2850 is disposed in an interior space defined by the first portion 2842 and the second portion 2844, an interior proximal surface of the second portion 2844 can contact and / or urge the plunger 2858 of the reservoir 2850 distally as the second portion 2844 is advanced relative to the first portion 2842. Thus, the plunger 2858 and / or a portion of the second portion 2844 configured to contact the plunger 2858 can function as an activation mechanism 2898 that can be activated by rotating the second portion 2844 relative to the first portion 2842. In some embodiments, rather than being coupled via mating threads, the second portion 2844 and the first portion 2842 can be coupled via any suitable mechanism such that the second portion 2844 can be translated or rotated to advance the plunger 2858 relative to the barrel 2854. In some embodiments, the applicator device 2870 can include a spring, similar to that described with respect to the applicator device 2470, configured such that rotation of the second portion 2844 or movement of another element (e.g., a latch, pin, and / or button) releases the spring, allowing the spring to apply a distal force to the plunger 2858.

[0164]

[0220] The pad assembly 2880 includes a piercing member 2899. The pad assembly 2880 can also include a plate 2841 coupled to at least a portion of a proximal surface of the applicator pad 2810. The pad assembly 2880 can also include a backing portion 2818, which can be configured as a bandage. The piercing member 2899 can protrude distally from the applicator pad 2810 such that the release mechanism 2860 can be aligned with the piercing member 2899 (e.g., by manipulating the grip 2840) and pressed against the piercing member 2899 to pierce the release mechanism 2860 and allow fluid to flow from the reservoir 2850 through a lumen of the piercing member 2899 and / or outside the piercing member and through one or more openings defined in the plate 2841 to the applicator pad 2810. In some embodiments, the piercing member 2899 can be coupled to the plate 2841. In some embodiments, the piercing member 2899 may be monolithically formed with the plate 2841. The backing 2818 may be disposed in contact with a proximal surface of the plate 2841 and may extend in two or more opposite directions away from the plate 2841 and the applicator pad 2810. The backing 2818 may include an adhesive that is covered prior to use with a peel-off adhesive liner disposed on a distal surface of the backing 2818. The adhesive liner may be peeled off prior to placing the backing 2818 on the skin of a subject so that the backing 2818 can be adhered to the skin via the adhesive. The piercing member 2899, the plate 2841, and the backing 2818 may each be the same or similar in structure and / or function to any of the piercing members, plates, and backings described herein.

[0165]

[0221] In some embodiments, the reservoir 2850 can include a connector 2881 disposed outside the neck 2852 and configured to releasably engage with a fluid fitting 2855 (also referred to as a connector) of the pad assembly 2880 disposed outside the piercing member 2899. The fluid fitting 2855 can be formed as a cylindrical structure that surrounds the piercing member 2899 and protrudes beyond the plate 2841 to prevent contact between the piercing member 2899 and a user (e.g., a user's finger). The fluid fitting 2855 can optionally be formed monolithically with the plate 2841 and / or the piercing member 2899. The connector 2881 and the fluid fitting 2855 can be configured as mating connectors, such as luer connectors (as shown in FIGS. 32A-32L), threaded connectors, or connectors configured to mate via a friction fit. The connector 2881 and the fluid fitting 2855 may be configured such that the rotational direction in which the first portion 2842 rotates relative to the fluid fitting 2855 to securely engage the connector 2881 with the fluid fitting 2855 is the same rotational direction in which the second portion 2844 rotates relative to the first portion 2842 to advance the plunger 2858 to prevent the reservoir 2850 from inadvertently separating from the pad assembly 2880 during an ejection operation.

[0166]

[0222] In use, a user may start with the system 2800 in an initial configuration (e.g., packaged configuration) in which the applicator device 2870 is decoupled from the pad assembly 2880. In the initial configuration, the reservoir 2850 may be filled with liquid (e.g., medication and / or saline) and the plunger 2858 may be in an initial retracted configuration relative to the barrel 2854. To wet the applicator pad 2810, a user may hold the grip 2840 (e.g., with one hand), align the release mechanism 2860 with the piercing member 2899 of the pad assembly 2880, and press the release mechanism 2860 against the piercing member 2899 such that the piercing member 2899 breaks the release mechanism 2860. Simultaneously or thereafter, the connector 2881 may optionally be engaged with the fluid coupling 2855 (e.g., by rotating the first luer mating connector relative to the second luer mating connector). The second portion 2844 can then be rotated (e.g., by the user's thumb) relative to the first portion 2842 to advance the second portion 2844 distally and force the plunger 2858 distally relative to the first portion 2842 and barrel 2854 to force liquid from the barrel 2854 through the neck 2852, the fluid coupling 2855 and / or optional lumens of the piercing member 2899 and onto the applicator pad 2810. The pad assembly 2880 may be coupled to a patient such that the applicator pad 2810 is positioned in contact with the patient's wound before or after coupling the pad assembly 2880 to the applicator device 2870 and before or after rotating the second portion 2844 to advance the plunger 2858 and wet the applicator pad 2810. After the fluid has been expelled from the reservoir 2850, the grip 2840 and reservoir 2850 may optionally be disconnected from the pad assembly 2880 as shown in Figures 32I-L by disconnecting the fluid coupling 2855 from the connector 2881. The applicator device 2870 may be discarded and the pad assembly 2880 may remain in place in contact with the wound for a period of time.In some embodiments, the user can apply additional pressure to the pad assembly 2880 using the grip 2840 and / or the user's hand to the pad assembly 2880 after the grip 2840 is separated from the pad assembly 2880, such that compression is applied to the wound by the applicator pad 2810, as described with respect to other embodiments herein.

[0167]

[0223] In some embodiments, rather than the piercing member 2899 being coupled to the applicator pad 2810 and being releasably coupleable to the reservoir 2850, the piercing member 2899 may be coupled to the first portion 2842, similar to that shown in other applicator devices described herein, such as applicator device 2570 or applicator device 2770. The applicator device 2870 may engage the applicator pad 2810 via any suitable connector or via contact between a distal end of the first portion 2842 and the applicator pad 2810.

[0168]

[0224] In some embodiments, the bleeding treatment system may include an applicator pad loaded with a medicament. FIGS. 33A and 33B show top and bottom perspective views of a bleeding treatment system 2900. The bleeding treatment system 2900 includes an applicator pad 2910 and a backing 2912. The applicator pad 2910 is loaded with a medicament M (e.g., any of the medicaments described herein) and the backing 2912 is configured to adhere to the tissue of a user. The backing 2912 may form a circumferential ring around the applicator pad 2910 as shown in FIGS. 33A and 33B. The backing 2912 may be similar to the bandage 1412 as shown in FIGS. 16A-16C. Also, in some cases, a distal side of the applicator pad 2910 may be configured to adhere to the skin of a user while transferring the medicament M from the distal side of the applicator pad 2910 towards the tissue. Agent M may be any suitable agent for treating a wound or skin surface of a user, such as any of the agents described herein (e.g., TXA, antibiotics, etc., or combinations thereof).

[0169]

[0225] In some embodiments, the agent M may be stored in an applicator pad 2910, which may be formed from a material that contains, absorbs, wicks up, or stores the agent M to be applied to the wound surface. The applicator pad 2910 may include a sponge, flexible enclosure, and / or the like, that contains the agent M. In some examples, the applicator pad 2910 may be formed from soft plastic, rubber, gauze, sponge, and / or the like that is soaked with the agent M.

[0170]

[0226] In some embodiments, the applicator pad 2910 may have a saturation level (e.g., may be pre-soaked to a saturation level) intended for a particular application of the bleeding treatment system 2900. In some embodiments, the volume and material of the applicator pad 2910 may be selected such that the applicator pad 2910 is about 35% saturated (i.e., contains about 35% of the amount of drug by volume or weight). In some embodiments, the applicator pad 2910 may be configured to be about 30% to about 60% saturated with the amount of drug by volume or weight. In some embodiments, the applicator pad 2910 is configured to be about 25% to about 50% saturated with the amount of drug by volume or weight. In some embodiments, the applicator pad 2910 may be pre-soaked with drug to about 40% of the saturation point of the applicator pad 2910. Alternatively, in some embodiments, the applicator pad may be pre-soaked with agent to about 50%, about 60%, about 70%, about 80%, or about 90% of the saturation point of the applicator pad 2910.

[0171]

[0227] In some embodiments, the applicator pad 2910 may be pre-soaked or pre-loaded to hold a measured amount of drug. In some embodiments, the applicator pad 2910 may be configured such that the amount of drug is effective to treat the wound, but the drug does not travel across the user's skin outside the treatment site (e.g., down the user's arm or leg). For example, the applicator pad 2910 may be formed from a material that is spatially (e.g., radially) variable in saturation with drug. In an illustrative example, the applicator pad 2910 may be more saturated at the center of the applicator pad 2910 and less saturated near the periphery of the applicator pad 2910.

[0172]

[0228] In the embodiment illustrated in FIGS. 33A and 33B, the backing 2912 forms a ring-like perimeter surrounding the applicator pad 2910. The backing 2912 may be impermeable to fluids (e.g., to the drug M in the applicator pad 2910) so that the drug does not leak through the backing 2912 when released from the applicator pad 2910 (e.g., the drug is contained within the applicator pad 2910 or released onto a wound or skin surface of a patient). In some cases, the backing 2912 may only partially surround the applicator pad or may have a shape other than a ring shape as shown in FIGS. 33A and 33B. For example, the backing 2912 may have an extended portion and a short portion, the extended portion configured to extend further away from the applicator pad 2910 than the short portion. As described above, the distal side of the applicator pad 2910 (i.e., the side of the applicator pad 2910 configured to contact the patient's wound or skin surface) may include an adhesive or may have a portion including an adhesive (e.g., the portion may be located close to the periphery of the applicator pad) so that the applicator pad 2910 can be adhesively bonded to the patient's target wound area (e.g., the skin surface surrounding the wound).

[0173]

[0229] The bleeding treatment system 2900 is convenient because it can be easily used in a variety of settings (e.g., at home, in a hospital, etc.) and during and after a variety of procedures (e.g., the bleeding treatment system 2900 may be applied after surgery, including skin procedures such as Mohs micrographic surgery, punch biopsy, shave biopsy, etc.). The bleeding treatment system 2900 may be used after a tracheotomy, after laceration repair with sutures as a means to protect the wound and stop bleeding, or after other procedures that may cause tissue to bleed. Additionally, the bleeding treatment system 2900 may be used to treat a variety of skin disorders (e.g., melasma, or other suitable skin disorders). The bleeding treatment system 2900 may be used in patients who are at high risk of bleeding.

[0174]

[0230] Although the bleeding treatment system 2900 is shown having a substantially circular surface of the applicator pad 2910, in some embodiments, other shapes of the applicator pad 2910 may be used (e.g., the bleeding treatment system 2900 may be configured to have a different shape for use on mucous membranes, including membranes within orifices such as the mouth, nose, ear, rectum, or vagina). The bleeding treatment system 2900 may be used as a therapeutic dressing having different shapes (e.g., circular, rectangular, oval, square, cross, etc.) and may be placed on the user's forehead, cheek, bridge of the nose, etc.

[0175]

[0231] In some embodiments, the top surface of the bleeding treatment system 2900 (e.g., the backing portion 2912) can be impermeable to the agent M contained within the applicator pad 2910. In some embodiments, the top surface of the bleeding treatment system 2900 can prevent drying or evaporation of the agent M from the applicator pad 2910.

[0176]

[0232] In some embodiments, the applicator pad 2910 may not be pre-soaked with the agent M, but instead, the bleeding treatment system 2900 may comprise a bladder pre-filled with the agent M and adjacent (or proximate) to the applicator pad 2910 (e.g., the bladder may be disposed between the backing 2912 and the applicator pad 2910 of the bleeding treatment system 2900). The bladder may be configured to selectively release the agent M to the applicator pad 2910. In some embodiments, the bladder may release the agent M to the applicator pad 2910 when it ruptures due to pressure applied to the bladder being greater than a threshold pressure (e.g., by a user pressing on the bladder when the system 2900 is coupled to a wound). In some embodiments, the bladder may comprise a valve configured to open when pressure greater than a threshold pressure is applied to the bladder, thereby releasing the agent M to the applicator pad 2910.

[0177]

[0233] In some embodiments, at least a lower portion of the applicator pad 2910 (e.g., the surface of the applicator pad 2910 that is placed in contact with a user's wound) may be covered or surrounded by a removable applicator seal to prevent contamination of the applicator pad 2910 and / or to prevent undesired release of a medicinal agent that may be contained in the applicator pad 2910. The applicator seal may be formed as a film or other thin layer of material that is non-reactive with the applicator pad 2910. The applicator seal may be removed from the applicator pad 2910 prior to use (e.g., by peeling) so that the medicinal agent M may be delivered to wound tissue with which the surface of the applicator pad 2910 is placed.

[0178]

[0234] 34 shows a variation of a bleeding treatment system 3000 that may be similar to the bleeding treatment system 2900. The bleeding treatment system 3000 includes an applicator pad 3010, an applicator seal 3020, and a backing 3012 that may be similar to the corresponding applicator pad 2910 and backing 2912 (with the difference that the applicator pad 3010 and backing 3012 are rectangular). In an exemplary embodiment, the applicator pad 3010 may be formed from a material that contains, absorbs, wicks, or transports one or more medicaments to be applied to the surface of the wound (e.g., the applicator pad 3010 may be a sponge). The applicator pad 3010 may be soaked (e.g., pre-soaked) with a medicament (e.g., TXA, an antibiotic, or other suitable medicament for treating tissue). Further, to prevent drying and / or evaporation of the medicament from the applicator pad 3010, the applicator seal 3020 can be used to contain the applicator pad 3010 (e.g., seal the applicator pad 3010) in a space defined between the applicator seal 3020 and the backing 3012. In some embodiments, the applicator seal 3020 can be formed as a rigid or flexible cover that can be removably coupled to the backing 3012 and can surround the applicator pad 3010.

[0179]

[0235] 35A to 35D show an exemplary embodiment of a bleeding treatment system 3100 that may be similar to any of the bleeding treatment systems described herein, such as the bleeding treatment system 2500. FIG. 35A is a perspective view, FIG. 35B is a side view showing the internal components of the bleeding treatment system 3100, FIG. 35C is a cross-sectional view along line BB shown in FIG. 35D, and FIG. 35D is a side view of the bleeding treatment system 3100. In this exemplary embodiment, various parts, components, etc. of the bleeding treatment system 3100 may be the same as or similar to corresponding parts, components, etc. of any of the bleeding treatment systems described herein, such as the bleeding treatment system 2500. For example, the bleeding treatment system 3100 comprises an applicator device 3170 having a first portion 3142. A reservoir 3150 is located within the first portion 3142. The reservoir 3150 and the first portion 3142 may be the same as the reservoir 2550 and the first portion 2542 of the applicator device 2570, respectively. The applicator device 3170 comprises a piercing member 3199 and a release mechanism 3160, as shown in Figures 35B-35C. Furthermore, the bleeding treatment system 3100 comprises an activation mechanism 3198, a retaining pin 3144 for releasably retaining the activation mechanism 3198, and a piston 3151 configured to be moved by the activation mechanism 3198 and to move the reservoir 3150 towards the piercing member 3199 to pierce the release mechanism 3160 when the retaining pin 3144 is removed. These components may be the same as the corresponding components of the bleeding treatment system 2500, for example, the bleeding treatment system 3100 may comprise an applicator pad 3110 with an array of microneedles 3111.

[0180]

[0236] An example of a portion of a bleeding treatment system 3100 is shown in FIG. 36A. The bleeding treatment system 3100 includes an applicator pad 3110, which may be formed from a material that contains, absorbs, wicks, or transports one or more agents to be applied to the surface of a wound (e.g., the applicator pad 3110 may be a sponge). The applicator pad 3110 may be similar to the applicator pad 2510 of the bleeding treatment system 2500. Furthermore, the microneedles 3111 may be attached, secured, or coupled to the applicator pad 3110 using any suitable coupling element. In one embodiment, the microneedles 3111 may be directly secured to the distal end (DE) of the applicator pad 3110 via coupling element 3115. Alternatively, the microneedles 3111 may be attached to the material forming the applicator pad 3110 via coupling element 3116, as shown in FIG. 36A. In some optional embodiments, the applicator pad 3110 may be adjacent to an enclosure 3117 containing a drug (e.g., drug M) such that the drug M flows from the enclosure 3117 toward the applicator pad 3110 through a proximal opening 3122 of the enclosure 3117.

[0181]

[0237] In some embodiments, the DE of the applicator pad 3110 may be configured to be impermeable to the drug M in at least some areas (e.g., areas between the microneedles 3111), but may be configured to be permeable to the drug M in the vicinity of the microneedles 3111. Alternatively, the entire DE may be configured to be permeable to the drug M. Further, in some embodiments, the DE may be configured to be entirely impermeable to the drug M, which may be channeled through the microneedles 3111 to the user's tissue (e.g., the user's skin) as described further below.

[0182]

[0238] In various embodiments, using the bleeding treatment system 3100 includes pressing the applicator pad 3110 against the tissue requiring treatment (e.g., the bleeding treatment system 3100 can be pressed against the outer surface of the tissue (e.g., skin) such that the microneedles pierce the skin). The bleeding treatment system 3100 can then be activated (before or after penetrating the microneedles to the tissue surface) such that the agent M flows through the applicator pad 3110, into the pierced holes in the patient, and into a tissue layer (e.g., dermis layer) deeper than the tissue surface (e.g., skin surface). Activation includes releasing the activation mechanism 3198 by removing the retaining pin 3144.

[0183]

[0239] After releasing the agent M into the tissue, the applicator pad 3110 may be, for example, detached, cut, detached, or removed from the bleeding treatment system 3100 at the proximal end PE while still coupled (e.g., attached, adhered, etc.) to the surface of the user's tissue. In one embodiment, similar to the various applicator pads described above, the applicator pad 3110 may be adhered to the top surface of the tissue (e.g., the top surface of the user's skin) using any suitable adhesive element (e.g., bandage). While attached to the tissue, the microneedles 3111 of the applicator pad 3110 remain attached to the patient (as a patch) for a period of time after initial attachment / activation.

[0184]

[0240] The applicator pad 3110 may comprise any suitable number of microneedles 3111 that facilitates the transport of the agent M to the tissue of the user. For example, the applicator pad 3110 may comprise dozens of microneedles, or even hundreds or hundreds of microneedles. In one example, the number of microneedles may be selected such that the characteristic distance between adjacent microneedles is a fraction of a millimeter, about a millimeter, a few millimeters, etc. In some cases, the distance between adjacent microneedles may be on the order of the diameter of the microneedles, on the order of several times the diameter of the microneedles, or on the order of tens of times the diameter of the microneedles.

[0185]

[0241] The microneedles 3111 may be arranged in any suitable manner. For example, the microneedles may be arranged in a rectangular grid, a triangular grid, a hexagonal array, in the form of concentric circles, a checkerboard array, or any other suitable periodic or non-periodic array. In an exemplary embodiment, as shown in FIG. 35A, the microneedles 3111 are arranged in concentric circles, with approximately the same number of microneedles in each circle (except for a single microneedle in the center of the applicator pad 3110). Alternatively, the microneedles 3111 may be arranged in concentric circles, with the number of microneedles in each circle being proportional to the radius of the circle (e.g., the separation distance between the microneedles 3111 in any particular circle may be approximately constant). It should be understood that other suitable arrangements of the microneedles 3111 may also be selected. The microneedles 3111 may be made of any suitable material (e.g., fluoropolymers, plastics, metals, glasses, ceramics, etc.) and may have any length suitable for extending into the dermis and / or epidermis. In some examples, the microneedles may be a fraction of a millimeter in length, or may be as long as several millimeters (e.g., 4 millimeters (mm)). In some examples, the microneedles may be 0.2 mm, 0.4 mm, 0.6 mm, 0.8 mm, 1 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2 mm, 2.2 mm, 2.4 mm, 2.6 mm, 2.8 mm, 3 mm, 3.2 mm, 3.4 mm, 3.6 mm, 3.8 mm, 4 mm, etc. The microneedles may have any suitable shape (e.g., conical, cylindrical with a sharp tip, or any other suitable shape).

[0186]

[0242] 36B and 36C show a first embodiment of a microneedle 3111A for the bleeding treatment system 3100. In the first embodiment, the microneedle 3111A may be a solid protrusion with a sharp tip. As shown in FIG. 36B, an opening 3111O is formed on the bottom side of the applicator pad 3110 around the microneedle 3111A. The opening 3111O is configured to allow the drug M to flow from the applicator pad 3110 along the outer surface of the microneedle 3111A. The applicator pad 3110 may be filled with the drug M when the retaining pin 3144 is released and the activation mechanism 3198 moves the reservoir 3150 towards the piercing member 3199, so that the drug M is released from the reservoir 3150 into the enclosure 3110.

[0187]

[0243] 36C illustrates an exemplary embodiment in which the opening 3111O comprises a nozzle element 3113 configured to direct the medication M along the outer surface of the microneedle 3111A. The nozzle element 3113 is configured to surround the microneedle 3111A (e.g., the microneedle 3111A is positioned in the middle of the nozzle element 3113). In this exemplary embodiment, the microneedle 3111A is attached to the bottom surface of the applicator pad 3110 via a coupling element 3116.

[0188]

[0244] FIG. 36D illustrates an embodiment of a bleeding treatment system 3100 similar to the embodiment illustrated in FIG. 36B and FIG. 36C including an applicator pad 3110. The applicator pad 3110 includes a distal end DE through which the medicament M may not (or may not) penetrate. Additionally, the applicator pad 3110 includes an opening 3111O through which the medicament M may flow from the applicator pad 3110 toward the outer wall of the microneedle 3111A (e.g., the medicament M may flow from the applicator pad 3110 through a passageway formed by the nozzle 3113, as illustrated in FIG. 36D). The microneedle 3111A may be attached to the applicator pad 3118 using any suitable coupling element (e.g., a coupling element similar to the coupling element 3116 illustrated in FIG. 36C). For example, such coupling elements may be configured to attach the microneedle 311A ​​to the proximal end PE of the applicator pad 3110, to the distal end DE of the applicator pad 3110, or to material within the applicator pad 3110. In some cases, a portion of the outer surface of the microneedle 3111A may be glued or otherwise adhered to the material of the applicator pad 3110.

[0189]

[0245] In some cases, the applicator pad 3110 may be deformable / compressible such that when the microneedle (e.g., the microneedle 3111) is forced through the patient's tissue and the applicator pad 3110 contacts the surface of the user's tissue (e.g., the surface of the user's skin), the applicator pad 3110 retracts relative to the microneedle, thereby exposing more of the length of the microneedle 3111 (so that the microneedle 3111 can be urged deeper into the tissue). In such a configuration, the microneedle 3111 may be attached to the applicator pad 3110 at the top of the applicator pad 3110, such that the bottom of the applicator pad 3110 can move relative to the microneedle 3111.

[0190]

[0246] When the bleeding treatment system 3100 is activated to soak the applicator pad 3110 before pushing the microneedles through the tissue surface, and when the applicator pad 3110 is compressible, retraction of the applicator pad 3110 against the microneedles 3111 may cause the drug M within the soaked applicator pad 3110 to be released (e.g., squeezed out) from the applicator pad 3110 and contact the tissue surface and flow into channels formed by the microneedles 3111 piercing the user's tissue.

[0191]

[0247] Alternatively, in some embodiments, the applicator pad 3110 may be substantially rigid and / or incompressible such that the distance the microneedles 3111 extend beyond the applicator pad 3110 does not change when the bleeding treatment system 3100 is pressed against a user's tissue. In such embodiments, the distance the microneedles 3111 extend beyond the applicator pad 3110 prior to use of the bleeding treatment system 3100 is equal to the insertion depth of the microneedles 3111.

[0192]

[0248] FIG. 36E shows another embodiment of the microneedle 3111B. The microneedle 3111B may be a hollow structure (e.g., a protrusion including a lumen that forms a channel between the applicator pad 3110 and the outflow opening 3111C of the microneedle 3111B). The formed channel is configured to allow the agent M to flow from the applicator pad 3110 into the epidermis and possibly into the dermis of the patient. In some cases, the applicator pad 3110 may be configured to not allow the agent M to be rapidly transported out of the applicator pad 3110 through a bottom surface of the applicator pad 3110 such that the agent M is flowed through a microneedle coupled to the bottom of the applicator pad 3110 rather than through the bottom surface of the applicator pad 3110 upon activation of the bleeding treatment system 3100 (e.g., the bottom surface of the applicator pad 3110 may be configured to not allow the agent M to move toward the wound of the user and may be in contact with the wound).

[0193]

[0249] 37 to 50 are various views of an exemplary embodiment of a bleeding treatment system 3200. FIG. 37 and FIG. 38A are perspective and exploded views, respectively, of the bleeding treatment system 3200. The bleeding treatment system 3200 may be the same or similar in structure and / or function to any of the bleeding treatment systems described herein. For example, the bleeding treatment system 3200 comprises an applicator device 3270 comprising a grip 3240 (also referred to as or including a housing or outer housing) and an applicator pad 3210, which may be the same or similar in structure and / or function to any of the grips and applicator pads described herein. For example, the applicator pad 3210 may be structurally or functionally similar to the applicator pad 2310, as shown diagrammatically in FIG. 27. The grip 3240 comprises a first portion 3242 and a second portion 3244. As shown, the first portion 3242 (also referred to as the first housing portion) may be formed as an elongated housing portion having an open distal end and may define an interior space 3243. The second portion 3244 (also referred to as the second housing portion or the lower housing portion) may be at least partially disposed within the interior space 3243. The applicator pad 3210 may be coupled to the second portion 3244 (e.g., coupled to a distally facing surface of the second portion 3244 and / or disposed within the interior space defined by the second portion 3244) such that at least a portion of the applicator pad 3210 is disposed distal to the second portion 3244 and distal to the first portion 3244. The applicator pad 3210 may include or be coupled to a backing 3212 such that the applicator pad 3210 is coupled to the second portion 3244 via the backing 3212.

[0194]

[0250] In some embodiments, the bleeding treatment system 3200 is configured to be used with one hand of a user (e.g., a wounded subject or a caregiver of the subject). For example, the bleeding treatment system 3200 may be picked up by the user's left or right hand at the first portion 3242 (e.g., wrapping the user's fingers around the first portion 3242 and around a central axis of the first portion) and the applicator pad 3210 may be placed in contact with the wound. The user may translate the first portion 3242 towards the wound by pushing or pulling the first portion 3242 with the user's hand. Sufficient translation of the first portion 3242 relative to the second portion 3244 resulting from translating the first portion 3242 towards the wound compresses the applicator pad 3210 against the wound, providing compression to the wound and transitioning the system 3200 from an initial non-actuated configuration to an actuated configuration such that fluid (e.g., medication) is delivered to the applicator pad 3210. As the user continues to maintain the applicator pad 3210 in contact with the wound (e.g., by compressing the applicator pad 3210), fluid is transferred to the wound and / or blood from the wound is absorbed into the applicator pad 3210. In some embodiments, the applicator pad 3210 comprises a seal that can be removed from the applicator pad 3210 prior to placing the applicator pad 3210 in contact with the wound of a subject.

[0195]

[0251] FIG. 38A shows an exploded view of the bleeding treatment system 3200 showing various components of the bleeding treatment system 3200. In addition to the applicator pad 3210, the first portion 3242 and the second portion 3244 as previously shown in FIG. 37, the interior space 3243 defined by the first housing part 3242 includes components for facilitating the release of fluid to the applicator pad 3210. Additionally, various coupling components and elements are also shown in FIG. 38A. The bleeding treatment system 3200 includes a proximal cap 3297, an applicator release mechanism 3274 (also referred to as an applicator pad release mechanism) located at the top within the interior space 3243, a cap 3225 (also referred to as an ejector button), an activation mechanism 3298 formed by springs 3298A and 3298B, a drive plunger 3227, an inner housing 3228 (also referred to as an inner support frame), reservoirs 3250A and 3250B, and a housing window 3226. The fluid coupler carrier 3244 (also referred to as the second or lower housing part) is coupled to the actuator slider 3275 via a coupler 3278, and includes fluid coupler carrier 3244, actuator slider 3275, actuator slider 3275, actuator cap 3212 (also referred to as the backing or backing part) configured to at least partially accommodate the applicator pad 3210.

[0196]

[0252] The bleeding treatment system 3200 comprises an applicator release mechanism 3274 located at an upper portion within the interior space 3243. The applicator release mechanism 3274 may be configured to move distally (i.e., toward the applicator pad 3210) relative to the first portion 3242 and the second portion 3244 to push the applicator cap 3212 and the applicator pad 3210 coupled thereto from the remainder of the system 3200 (e.g., from the first portion 3242 and the second portion 3244). In some embodiments, the applicator release mechanism 3274 may be moved distally by distal movement of the cap 3225 (e.g., by a user pushing the cap 3225). As shown in FIG. 38E, the applicator release mechanism 3274 may comprise elongate members 3226C and 3226D extending distally from a proximal end of the applicator release mechanism 3274 toward the applicator cap 3212. These elongate members 3226 are configured to push the applicator cap 3212 out of engagement with the second portion 3244 when the applicator release mechanism 3274 moves relative to the first portion 3242 and the second portion 3244.

[0197]

[0253] The inner housing 3228 is located within the interior space 3243 of the first portion 3242 and is configured to house the springs 3298A and 3298B, the drive plunger 3227, and the reservoirs 3250A and 3250B. FIGS. 38B-E show further details of the inner housing 3228 and various elements proximate the inner housing 3228 without showing the first portion 3242. For example, FIG. 38B shows a perspective view of the inner housing 3228, FIG. 38C shows elements located within the inner housing 3228 without showing the inner housing 3228, and FIG. 38D shows a top view of the system 3200 without showing the first portion 3242, the cap 3297, and the applicator release mechanism 3274. FIG. 38E shows a top view of the system 3200 including the applicator release mechanism 3274, but without showing the first portion 3242.

[0198]

[0254] Prior to actuation, the drive plunger 3227 is disposed on top of the inner housing 3228, for example as shown in FIG 38B. The drive plunger 3227 includes a plunger 3227A disposed over and aligned with the piston 3251A of the reservoir 3250A, and a plunger 3227B (shown in FIG 39) disposed over and aligned with the piston 3251B of the reservoir 3250B. Each of the plungers 3227A and 3227B is configured to translate relative to the reservoir housing (e.g., barrel) of the corresponding reservoir 3250A and 3250B, and to engage with the corresponding piston 3251A and 3251B to urge the piston 3251A and 3251B distally such that the contents of the reservoirs 3250A and 3250B are urged distally out through the distal end of the reservoir housing (e.g., via the corresponding piercing members 3299A and 3299B) to reach the applicator pad 3210.

[0199]

[0255] The drive plunger 3227 houses at least a portion of the springs 3298A and 3298B, as shown in, for example, FIG. 38C. In some embodiments, the springs 3298A and 3298B may be held in a compressed state in an initial, unactuated configuration of the bleeding treatment system 3200 and may be configured to expand upon release from the compressed state to move the drive plunger 3227 downward (e.g., distally towards the applicator pad 3210). In some embodiments, rather than using the springs 3298A and 3298B as an activation mechanism for expelling and / or driving fluid from the reservoirs 3250A and 3250B, other activation mechanisms may be used that store mechanical or electrical energy to selectively translate the drive plunger 3227 distally. Such activation mechanisms may include, for example, a flexible element (e.g., a flexible membrane), a string under tension, a wound spring, an electric battery coupled to an electric motor, a pneumatic device (e.g., an air pressure chamber containing compressed gas), or any other suitable electrical or mechanical device that can cause movement of the drive plunger 3227.

[0200]

[0256] The top cap 3228B can be fixedly coupled to a proximal end of the inner housing 3228. The inner housing 3228 holds the reservoirs 3250A and 3250B within the interior of the inner housing 3228 such that the reservoirs 3250A and 3250B are in a fixed position relative to the inner housing 3228 (and thus in a fixed position relative to the first portion 3242). In some embodiments, rather than including two reservoirs, the system 3200 can include only one reservoir. Each reservoir 3250A and 3250B has an open distal end closed by a release mechanism 3260 (e.g., a pierceable membrane such as a cap or cover). In an initial configuration of the system 3200, the release mechanism 3260 can be disposed proximal to the piercing member 3299. In an activated configuration of the system 3200 , the piercing member 3299 can pierce the release mechanism 3260 to release fluid from the reservoir 3250 .

[0201]

[0257] The reservoirs 3250A and 3250B may be made from a transparent material (e.g., glass, clear plastic, etc.) and the inner housing 3228 may include transparent windows 3241A and 3241B through which the reservoirs 3250A and 3250B may be viewed to observe the operation of the system 3200 (e.g., to measure the amount of fluid remaining in the reservoirs 3250A and 3250B). In some cases, the windows 3241A and 3241B may include markings that indicate the amount of drug remaining in the reservoirs 3250A and 3250B based on the visible location of the pistons 3251A and 3251B. Alternatively, the reservoirs 3250A and 3250B may include markings and the windows 3241A and 3241B may be openings defined by the inner housing 3228. The windows 3241A and 3241B may be disposed within openings 3242A and 3242B defined in the first portion 3242, as shown in FIG. 38A.

[0202]

[0258] The inner housing 3228 may include a flexible detent (e.g., flexible detent 3271F shown in FIG. 38B) that may move from an initial position to a second position in response to movement of the actuator slider 3275 and associated protrusions 3275A and 3275B. In some embodiments, a single flexible detent may be used. Alternatively, multiple flexible detents may be used. For example, in an implementation with protrusions 3275A and 3275B, two flexible detents may be used. In some embodiments, the system 3200 may include a flexible detent associated with each protrusion.

[0203]

[0259] The protrusions 3275A and 3275B are configured to translate along the wall of the inner housing 3228 in response to distal translation of the first portion 3242 relative to the second portion 3244, causing an actuation action of the springs 3298A and 3298B. For example, proximal sliding of the protrusions 3275A and 3275B relative to the first portion 3242 causes movement of a flexible detent (further described below in connection with FIGS. 43-45 ) and release of the drive plunger 3227 and the springs 3298A and 3298B.

[0204]

[0260] The actuator slider 3275 is coupled to the fluid coupler carrier 3244 via coupling elements 3278, which may be screws, rivets, or other suitable coupling elements for fixedly attaching the actuator slider 3275 to the fluid coupler carrier 3244. In some embodiments, the actuator slider 3275 and the fluid coupler carrier 3244 may be monolithically formed from any suitable material (e.g., plastic, metal, composite, ceramic, glass, etc.) rather than being separate components.

[0205]

[0261] The fluid coupler carrier 3244 is disposed within the distal end of the first portion 3242 and is configured to slide proximally relative to the first portion 3242 and the inner housing 3228 when a user presses the applicator pad 3210 against a wound. Additionally, an actuator slide 3275, which is fixedly attached to the fluid coupler carrier 3244, is also configured to slide proximally the same distance as the fluid coupler carrier 3244.

[0206]

[0262] The second portion 3244 includes fixedly attached piercing members 3299A and 3299B. In some examples, the piercing members 3299A and 3299B can form a fluid coupling, and the piercing members 3299A and 3299B can be formed as hollow needles that define channels between the corresponding reservoirs 3250A and 3250B and the applicator pad 3210 when the second portion 3244 is translated proximally relative to the first portion 3242. In some examples, the distal ends of the piercing members 3299A and 3299B may be disposed within openings defined in the backing 3212 and / or may be coupled to the applicator pad 3210, and the proximal ends of the piercing members 3299A and 3299B may be configured to pierce the release mechanisms of the corresponding reservoirs 3250A and 3250B when the fluid coupler carrier 3244 slides proximally relative to the first portion 3242 (e.g., the piercing members 3299A and 3299B may be positioned below the release mechanisms 3260 of the corresponding reservoirs 3250A and 3250B, respectively). In some embodiments, the number of fluid couplings may correspond to the number of fluid reservoirs. For example, if a single reservoir is used in an example, a single fluid coupling (e.g., a piercing member) may be used to form a channel between the reservoir and the applicator pad 3210. If more than two reservoirs are used, more than two fluid couplings (eg, piercing members) may be used.

[0207]

[0263] The second portion 3244 may comprise a first set of detents configured to couple (e.g., by a snap fit) to the inner housing 3228 after sliding proximally relative to the first portion 3242, thereby preventing the second portion 3244 from sliding distally back relative to the first portion 3242. Additionally or alternatively, the second portion 3244 may comprise another (e.g., a second) set of detents for coupling (e.g., by a snap fit) to a distal portion of the first portion 3242, thereby preventing the second portion 3244 from sliding distally back relative to the first portion 3242. Further, after moving the second portion 3244 proximally relative to the first portion 3242 and engaging the first set of detents to couple to the inner housing 3228 and / or engaging the second set of detents to couple to the distal portion of the first portion 3242, tactile and audio feedback may be provided to the user indicating that the bleeding treatment system 3200 is activated.

[0208]

[0264] The second portion 3244 may be coupled to the applicator cap 3212. The applicator cap 3212 may be snap-fitted to the second portion 3244. The applicator cap 3212 comprises a proximal side adjacent the second portion 3244 and a distal side adjacent the applicator pad 3210. Additionally, the applicator cap 3212 defines an opening in which the piercing members 3299A and 3299B may be disposed and / or aligned, such that fluid may flow from the reservoir 3250 to the applicator pad 3210 through the opening in the applicator cap 3212. The applicator cap 3212 may be separated from the second portion 3244 by applying sufficient force to the proximal side of the applicator cap 3212, thereby pushing the applicator cap 3212 from the second portion 3244. In some embodiments, the second portion 3244 can be coupled to a slider 3275 that includes a base plate with openings 3276C and 3276D configured for corresponding protrusions 3274C and 3274D to translate into contact with a proximal side of the applicator cap 3212 when the applicator release mechanism 3274 moves distally relative to the first portion 3242. The force applied by the protrusions 3274C and 3274D can cause the applicator cap 3212 to separate from the second portion 3244.

[0209]

[0265] Figures 39 and 40 show cross-sectional views of the bleeding treatment system 3200 in an initial, unactuated configuration, and Figures 41 and 42 show the same cross-sectional views of the bleeding treatment system 3200 after activation (e.g., after the applicator pad 3210, the applicator cap 3212, and the second part 3244 have been moved proximally relative to the first part 3242, such that the piercing members 3299A and 3299B penetrate the release mechanisms 3260 of the corresponding reservoirs 3250A and 3250B and the springs 3298A and 3298B are released to drive the drive plunger 3227 and bias the pistons 3251A and 3251B of the reservoirs 3250A and 3250B in a distal direction). For example, FIG. 39 shows a cross-sectional view along cross-sectional plane AA shown in FIG. 38D including all components of system 3200, and FIG. 40 shows a cross-sectional view along cross-sectional plane BB shown in FIG. 38D including all components of system 3200.

[0210]

[0266] 39 and 40 show the bleeding treatment system 3200 before the first portion 3242 is translated distally relative to the second portion 3244. For example, as shown in FIG 39, the proximal ends of the piercing members 3299A and 3299B are a distance H away from the distal ends (e.g., release mechanisms 3260) of the corresponding reservoirs 3250A and 3250B. As shown in FIG 39 and 40, the drive plunger 3227 is in an initial plunger position such that the distal ends of the plungers 3227A and 3227B are disposed within or near the proximal portions of the corresponding reservoirs 3250A and 3250B.

[0211]

[0267] As shown in FIG. 41, after the first portion 3242 and the inner housing 3228 are slid distally relative to the second portion 3244, the piercing members 3299A and 3299B are configured to penetrate the release mechanisms 3260 of the corresponding reservoirs 3250A and 3250B, thereby forming channels between these reservoirs and the applicator pad 3210 through which fluid can flow from the reservoirs 3250A and 3250B to the applicator pad 3210.

[0212]

[0268] FIG. 42 further illustrates details of detents 3276A and 3276B configured to couple (e.g., snap-fit) to the housing 3228. In some cases, more than two detents may be used. For example, FIG. 42 illustrates the use of a third detent 3279B to couple to the housing 3228. FIG. 42 also illustrates that detents 3228J and 3228K may be used to couple the inner housing 3228 to the first portion 3228. It should be noted that FIGS. 41 and 42 illustrate the drive plunger 3227 in a first plunger position prior to moving to the second plunger position, as discussed further below.

[0213]

[0269] 43-45 show the flexible detent 3271F configured to bend to a first position or a second position based on the movement of the actuator slider 3275 and the associated protrusion 3275A. In the exemplary embodiment shown in FIG. 43, the flexible detent 3271F is in a first position to hold the drive plunger 3227 and prevent the drive plunger 3227 from moving downward (e.g., distally, toward the applicator pad 3210) under the action of the compressed spring 3298A. As shown in FIG. 43, the flexible detent 3271F is prevented from moving to the second position (e.g., bending laterally, as shown by arrow Ar2) by the protrusion 3275A. Meanwhile, the flexible detent 3271F is configured to move to the second position when the protrusion 3275A slides upward (e.g., proximally, away from the applicator pad 3210), as shown by arrow Ar1 in FIG. 43. For example, the flexible detent 3271F is configured to bend as shown by arrow Ar2 in FIG. 44. When the flexible detent 3271F moves to the second position, it removes support for the driving plunger 3227, which causes the driving plunger 3227 to move downward (e.g., toward the applicator pad 3210) under the action of the compressed spring 3298A. In an exemplary embodiment, the driving plunger 3227 is configured to move from a first plunger position, shown in FIGS. 43 and 39-40, to a second plunger position, shown in FIG. 45. FIG. 45 illustrates that in the second plunger position, the driving plunger 3227 is moved downward such that the proximal end 3272P of the driving plunger 3227 is located distal to the end of the flexible detent 3271F. When the driving plunger 3227 is in the second plunger position, the flexible detent 3271F is configured to return to the first position, thereby securing the driving plunger 3227 in the second plunger position. It is understood that multiple flexible detents may be used and that such flexible detents may be structurally and / or functionally similar or the same as the flexible detent 3271F.

[0214]

[0270] 46 and 47 show cross-sectional views of the bleeding treatment system 3200 after the driving plunger 3272 has been moved to the second plunger position. FIG. 46 shows a cross-sectional view along section plane AA shown in FIG. 38D including all components of the system 3200, and FIG. 47 shows a cross-sectional view along section plane BB shown in FIG. 38D including all components of the system 3200. Note that the driving plunger 3227 is in the second plunger position such that the distal ends of the corresponding plungers 3227A and 3227B are disposed in contact with the pistons 3251A and 3251B at the distal ends of the corresponding reservoirs 3250A and 3250B, thereby driving fluid from the reservoirs 3250A and 3250B to the applicator pad 3210 (e.g., via the piercing members 3299A and 3299B). In some embodiments, when the drive plunger 3227 is in the second plunger position, most or all of the fluid initially disposed in the reservoirs 3250A and 3250B is displaced by the plungers 3272A and 3272B and transferred to the applicator pad 3210.

[0215]

[0271] 48 and 49 show cross-sectional views of the bleeding treatment system 3200 after the applicator cap 3212 and the applicator pad 3210 have been removed from the distal ends of the first and second portions 3242, 3244. FIG. 48 shows a cross-sectional view along section plane AA shown in FIG. 38D with all components of the system 3200, and FIG. 49 shows a cross-sectional view along section plane BB shown in FIG. 38D with all components of the system 3200. As shown in FIG. 48 and 49, the applicator cap 3212 is configured to be cut from the second portion 3244 and separated from the first portion 3242. As shown in FIG. 49, the applicator cap 3212 may include a detent 3272D (or multiple detents similar to detent 3272D) that may be used to releasably couple the applicator cap 3212 to the second portion 3244 (e.g., by a snap fit). The applicator cap 3212 may be formed from a flexible material such that when pressure is applied to the proximal side of the applicator cap 3212 (e.g., by movement of the applicator release mechanism 3274), a detent of the applicator cap 3212 is configured to separate from the second portion 3244.

[0216]

[0272] 50 shows a perspective view of the distal side of the applicator cap 3212 when engaged with the second portion 3244. The applicator cap 3212 defines openings that function as fluid couplings 3255A and 3255B through which fluid from the reservoirs 3250A and 3250B may flow to the applicator pad 3210. The distal surface of the applicator cap 3212 also defines a fluid channel 3212C configured to allow fluid from the reservoirs 3250A and 3250B to flow and disperse laterally to the proximal surface of the applicator pad 3210. In some embodiments, the fluid channels 3212C may be designed to span the top surface area of ​​the applicator pad 3210 such that when a larger amount of fluid is dispensed onto the applicator pad 3210 than can be immediately absorbed or dispensed by the applicator 3210, fluid may flow into the channels 3212C and migrate into the applicator pad 3210 at various locations. For example, as shown in FIG. 50, the cap 3212 may define three channels extending laterally in a first direction, one channel extending laterally in a second direction perpendicular to the first direction, and two curved channels. It should be understood that other suitable channels may be used (e.g., any other number of channels of different shapes and orientations may be used).

[0217]

[0273] In some embodiments, the applicator pad 3210 can be configured to fit within an interior space defined by the applicator cap 3212. In some embodiments, the applicator pad 3210 can be formed as or comprise a sponge that can be compressed when inserted into the applicator cap 3212 and / or when the applicator pad 3210 is pressed against a patient's surface using the system 3200.

[0218]

[0274] 51 is an exploded view of a bleeding treatment system 3300. The bleeding treatment system 3300 may be the same or similar in structure and / or function to any of the bleeding treatment systems described herein. The bleeding treatment system 3300 may comprise an outer housing 3342 (also referred to as an outer housing portion, a first housing, or a first housing portion), at least one reservoir 3350, a drainage subassembly 3306, an inner housing subassembly 3305, a lower actuator subassembly 3304, a sponge cup subassembly 3302, and an optional distal cap 3320.

[0219]

[0275] As shown in FIG. 52, the inner housing subassembly 3305 can include an inner support frame 3328 defining an enclosure with one or more channels configured to receive and hold the reservoirs 3350 (e.g., a pair of channels each with one of the pair of reservoirs 3350) and configured to receive at least a portion of the drive plunger 3327. In some embodiments, the inner support frame 3328 can be formed of two or more separate components that can be fixedly coupled to each other and / or to the outer housing 3342. In some embodiments, the inner support frame 3328 can be of one piece construction (e.g., monolithically formed). In some embodiments, the drive plunger 3327 can be formed of two separate components that can be coupled to each other and / or to the inner support frame 3328. In some embodiments, the drive plunger 3327 can be of one piece construction (e.g., monolithically formed). The reservoir 3350 may be included in the inner housing subassembly 3305 and may be held in a fixed position relative to the inner support frame 3328. The reservoir 3350 may also be held in a fixed position relative to the outer housing 3342 since the inner support frame 3328 is coupled to and held in a fixed position relative to the outer housing 3342 along a central axis of the outer housing 3342, respectively.

[0220]

[0276] The drive plunger 3327 may comprise a pair of plunger members 3327A (also referred to as plunger elements), each configured to translate within a channel defined by the inner support frame 3328 to engage a respective reservoir 3350 of the pair of reservoirs 3350. For example, the reservoirs may be formed as a cartridge with a reservoir housing (e.g., a barrel), a piston 3351 closing a proximal end of the reservoir housing, and a release mechanism 3360 (e.g., a pierceable membrane in the form of a cap or cover) closing a distal end of the reservoir housing. The drive plunger 3327 may translate distally (e.g., within the inner support frame 3328) to engage each plunger member 3327A with the piston 3351 of each reservoir 3350 to advance the piston 3351 relative to the housing of each reservoir 3350 and force fluid from the reservoir 3350.

[0221]

[0277] 53, the lower actuator subassembly 3304 can include a second housing portion 3344 (also referred to as a lower housing portion), a pair of piercing members 3399 (e.g., needles), and a pair of elongate members 3329. The second housing portion 3344 can include an exterior engagement mechanism 3344A (e.g., a latch) and a proximally extending retention element 3344B (e.g., a latch). The proximally extending retention element 3344B is configured to engage the inner support frame 3328 in an initial, unactuated configuration of the system 3300 to retain the second housing portion 3344 relative to the first housing portion 3342 via the inner support frame 3328. The external engagement mechanism 3344A is configured to fit within an opening or recess 3342Y defined in the outer housing 3342 and hold the second housing portion 3344 relative to the first housing portion 3342 after the second housing portion 3344 is translated proximally relative to the first housing portion 3342 during operation of the system 3300.

[0222]

[0278] The second housing portion 3344 also defines a pair of openings configured to receive the piercing members 3399 such that the needles are secured within and extend proximally from the openings. Each of the piercing members 3399 can have a sharp proximal end and a blunt distal end that does not contact any components other than the second housing portion 3344 during operation of the system 3300. The second housing portion 3344 is also configured to be coupled to the pair of elongated members 3329 such that the pair of elongated members 3329 extend proximally from the second housing portion 3344 and are secured relative to the second housing portion 3344 such that translational movement of the lower actuator subassembly 3304 causes translational movement of the pair of elongated members 3329. Each of the elongated members defines a recess 3329A.

[0223]

[0279] 54, the sponge cup subassembly 3302 (also referred to as a pad subassembly) may comprise an absorbent pad 3310 and a backing 3312 (also referred to as a backing portion, cup, or sponge cup). The backing 3312 may comprise one or more retention elements 3312C (e.g., latches) and one or more outwardly extending protrusions 3312E. The retention elements 3312C may be configured to mate with an inwardly directed retention flange or rim disposed on an inner surface of a sidewall of the second housing portion 3344 to prevent the backing 3312 from inadvertently separating from the second housing portion 3344 prior to the optional draining step. The outwardly extending protrusion 3312E may be configured to mate with a recess or groove defined in the inwardly facing surface of the second housing portion 3344 such that when a proximal force is applied to the backing portion 3312 (e.g., by the applicator pad 3310 to urge the first housing portion 3342 distally toward the surface while pressing the applicator pad 3310 against the surface of a target), the backing portion 3312 urges the second housing portion 3344 proximally, toward the interior of the first housing portion 3342.

[0224]

[0280] 55, the ejection subassembly 3306 includes an ejection button 3325 coupled to or included in an applicator pad release mechanism 3374. The applicator pad release mechanism 3374 includes a pair of pad biasing elongated members 3326 coupled to the ejection button 3325 (e.g., via a base portion 3374A) and extending distally a sufficient distance such that when the ejection button 3325 is depressed, the elongated members 3326 contact and distally bias the backing 3312, a pair of spring receiving elongated members 3339, and an actuation mechanism 3398 (also referred to as an energy storage element) formed by a pair of spring elements 3398 configured to be threaded onto the spring receiving elongated members 3339. In some embodiments, the actuation mechanism 3398 may be included separately from the ejection subassembly 3306. The elongate members 3326 include a retaining element 3326A disposed near a distal end of each elongate member 3326 and configured to selectively engage the second housing portion 3344. The elongate members 3326 also include a distal end configured to engage a portion of the backing 3312 such that when the elongate members 3326 are advanced relative to the second housing portion 3344 by a force applied to the button 3325 (e.g., by translation through one or more openings in the second housing portion 3344), the distal end of the elongate member 3326 can apply a force to the backing 3312 to remove the backing 3312 from the second housing portion 3344 and separate the backing 3312 and applicator pad 3310 from the remainder of the system 3300. In some embodiments, the elongate member 3326, the elongate member 3339, the base portion 3374A, and / or the button 3325 may be formed of two, three, or more separate components that may be fixedly coupled to one another. For example, as shown in FIG. 55, the elongate member 3325, the elongate member 3339, and the base portion 3374A may be formed as a unitary structure. In some embodiments, the elongate member 3326, the elongate member 3339, the base portion 3374A, and / or the button 3325 may be formed as a unitary structure (e.g., monolithically formed).

[0225]

[0281] The spring elements 3398 may be arranged such that a proximal end of each spring contacts a distal-facing surface of the base portion 3374A and a distal end of each spring element 3398 contacts a proximal-facing surface of the drive plunger 3327, such that actuation of the system 3300 (e.g., by translating the second housing part 3344 proximally relative to the first housing part 3342 to release the drive plunger 3327 from its initial position) causes the spring elements 3398 to transition from a stored energy configuration to an activated configuration (e.g., from a compressed configuration to an expanded and / or expanded configuration) to drive the drive plunger 3327 in a distal direction (e.g., urging the piston 3351 of the reservoir 3350 in a distal direction). In some embodiments, similarly, actuation of the system 3300 may cause the button 3325 to transition from an initial position to an actuated position (e.g., translate proximally relative to the first housing portion 3342) by the proximal end of the spring element 3398 applying a proximal force to the base portion 3374A and / or the button 3325 such that (e.g., simultaneously with or immediately before or after) the button 3325 is pressed distally by a user, biasing the elongate member 3398 into contact with the backing 3312 and biasing the applicator pad 3310 and backing 3312 away from the second housing portion 3344.

[0226]

[0282] In some embodiments, the cap 3320 can include two cap halves connected via a flexible or living hinge such that the cap 3320 can be separated from the distal end of the remainder of the system 3320 by bending or rotating one half of the cap 3320 relative to the other half.

[0227]

[0283] Figures 56A to 62D are various views of the bleeding treatment system 3400. Figures 56A to 56E are perspective, front, side, bottom, and top views, respectively, of the bleeding treatment system 3400 in an initial, non-activated configuration. Figures 56F to 56J are perspective, front, side, bottom, and top views, respectively, of the bleeding treatment system 3400 in an activated configuration. Figures 57A and 57B are exploded views of the bleeding treatment system 3400. Figures 58A to 58D are front, right, 45°, and 135° cross-sectional views of the system 3400 in an initial, non-activated configuration. Figures 59A to 59D are front, right, 45°, and 135° cross-sectional views of the system 3400 in an activated configuration. 60A-60C are front 45 degree cross-sectional views of the system 3400 at various stages of ejection of the applicator pad 3410 and backing 3412 of the system 3400 from the grip 3440 of the system 3400. FIGS. 61A and 61B are schematic illustrations of perspective views of the system 3400 with the cap 3420 of the system 3400 in locked and unlocked configurations, respectively. FIG. 61C is a schematic illustration of a side view of the system 3400 with the cap 3420 separated from the remainder of the system 3400.

[0228]

[0284] The bleeding treatment system 3400 may be the same or similar in structure and / or function to any of the bleeding treatment systems disclosed herein. For example, the bleeding treatment system 3400 may comprise a grip 3440 comprising a first housing 3442 (also referred to as a first housing part) and a second housing 3444 (also referred to as a second housing part). The bleeding treatment system 3400 may also comprise an applicator pad 3410, a pair of reservoirs 3450, and an actuation mechanism 3498 (also referred to as an energy storage member or element).

[0229]

[0285] 57A and 57B, the bleeding treatment system 3400 also includes an optional removable distal cap 3420, a backing portion 3412 (also referred to as a cup or sponge cup), a pair of elongate members 3429 coupled to and extending proximally from the second housing portion 3444, and a pair of piercing members 3499 fixedly coupled to the second housing portion 3444. In some embodiments, the second housing portion 3444, the piercing member 3499, and the pair of elongate members 3429 may be included in a lower actuator subassembly 3404. The bleeding treatment system 3400 also includes an optional evacuation subassembly 3406 including an evacuation button 3425, a pair of pad biasing elongate members 3426, and a pair of spring loaded elongate members 3439 (also referred to as spring loaded elongate members 3439). In some embodiments, the ejection button 3425 may be coupled to or included in an applicator pad release mechanism 3474 (also referred to as an ejector mechanism or ejection mechanism) comprising a pair of pad biasing elongate members 3426 and a spring-loaded elongate member 3439 coupled to and extending distally from a base portion 3474A of the applicator pad release mechanism 3474. The bleeding treatment system 3400 also comprises an inner housing subassembly 3405 comprising an inner frame 3428 (also referred to as an inner housing or inner support frame) and a drive plunger 3427 comprising a pair of elongate plunger members 3427A configured to engage each of the pair of reservoirs 3450 to eject fluid from the reservoirs 3450 upon activation of the activation mechanism 3498.

[0230]

[0286] The applicator pad 3410 may be the same or similar in structure and / or function to any of the applicator pads described herein. In some embodiments, the applicator pad may have a thickness of about ⅛ inch to about 1 inch, about ¼ inch to about 6 / 8 inch, about ¼ inch to about ½ inch, about 5 / 8 inch, and / or about ¼ inch. In some embodiments, the applicator pad 3410 may have any suitable diameter, such as about 42 mm. In some embodiments, the applicator pad 3410 may be configured to have any suitable fluid capacity (e.g., about 36 mL, about 30 mL, about 40 mL, about 30-40 mL, about 20-50 mL, about 20-20 mL, and / or about 10-30 mL) in the uncompressed configuration of the applicator pad 3410. In some embodiments, the applicator pad 3410 may be configured to be about 80%, about 70%, about 60%, about 90%, about 70-90%, and / or other suitable percentage saturated with fluid when compressed (e.g., against a user's surface or wound), and fluid is fully dispensed onto the applicator pad 3410. In some embodiments, when compressed, the applicator pad 3410 may be configured to have a suitable range of fluid capacity, such as, for example, 3 mL, 4 mL, 5 mL, 6 mL, 7 mL, 8 mL, 9 mL, 10 mL, and / or a range limited by or including these exemplary amounts. For example, in some embodiments, the applicator pad 3410 may have a capacity of 7 mL when 100% saturated, and / or a capacity of 6 mL when 85% compressed saturated or 17% uncompressed saturated. The applicator pad 3410 may be configured to receive, contain, and / or dispense fluid from the reservoir 3450 to the wound while absorbing blood from the wound.

[0231]

[0287] The first housing portion 3442 can define an interior space and an open distal end. As shown, in some embodiments, the first housing portion 3442 can have a central axis, an elongated portion 3442X, and a base portion 3442W disposed distally of the elongated portion 3442X and having a greater lateral extent relative to the central axis than the elongated portion 3442X. The base portion 3442W can define the open distal end, the elongated portion 3442X can define a first portion of the interior space, and the base portion 3442W can define a second portion of the interior space. The first housing portion 3442 can also define an open proximal end, or an opening at the proximal end in which the ejection button 3425 can be disposed. The first housing portion 3442 (e.g., the elongated portion 3442X) can define at least one sidewall opening 3441A (e.g., two sidewall openings) such that at least one of the reservoirs 3450 can be viewed by a user through the sidewall opening 3441A. The first housing portion 3442 can include a transparent window segment disposed within each of the sidewall openings 3441A. In some examples, the sidewall openings 3441A can be sufficiently long such that a majority or entire length of each reservoir 3450 and / or the travel path of the piston of each reservoir 3450 can be viewed through the sidewall opening 3441A. The first housing portion 3442 can optionally include gripping texture, such as ribs, disposed on an exterior surface of the first housing portion 3442 (e.g., an exterior surface of the elongated portion 3442X) to enhance a user's grip.

[0232]

[0288] In some embodiments, each of the components of the system 3400 disposed within the interior space of the first housing portion 3442 may optionally include a stabilizing portion (e.g., an elongated member) to guide, stabilize, and / or support the movement of the component within the interior space of the first housing portion 3442 (e.g., within a void formed by other components of the system 3400). For example, the applicator pad release mechanism 3474 may include a stabilizing portion 3474z. Also, in some embodiments, the base portion 3442W, a proximal surface of the base portion 3442W, a portion (e.g., a flat surface or flat surface) of the second housing portion 3444, a distal surface of the inner housing 3428, and / or a proximal or substantially flat surface of the backing portion 3412 may function individually or collectively as a force distribution plate as described with respect to other embodiments herein.

[0233]

[0289] The second housing portion 3444 can be configured to be at least partially disposed in an interior space of the first housing portion 3442 (e.g., at least partially disposed in an interior space of the base portion 3442W). FIGS. 63A-63F are top perspective, bottom perspective, top, bottom, front, and side views, respectively, of the second housing portion 3444. The second housing portion 3444 can have a distal end disposed distally of the distal end of the first housing portion (e.g., of the base portion 3442W) in an initial configuration of the second housing portion 3444 relative to the first housing portion (e.g., the initial, non-actuated configuration of the system 3400 shown in FIGS. 56A-56E). In an actuated configuration of the system 3400, the distal end of the second housing portion 3444 can be disposed distally of or coplanar with the distal end of the first housing portion. The second housing portion 3444 can include a proximal wall and a sidewall having a perimeter similar in shape (e.g., substantially circular) to the perimeter of the applicator pad 3410 and / or the backing portion 3412. Thus, the second housing portion 3444 can define an interior space configured to accommodate at least a portion of the applicator pad 3410 and / or the backing portion 3412. A portion of the interior space defined by the base portion 3442W of the first housing portion 3442 can have a shape that is substantially complementary to an outer surface of the second housing portion 3444. The applicator pad 3410 can be disposed distal to (e.g., coupled to) a distal facing surface of the second housing portion 3444 and can extend distally of a distal-most surface of the second housing portion 3444 in an initial, unactuated configuration of the system 3400. In some embodiments, the applicator pad 3410 may also be disposed distal to the distal-most surface of the second housing portion 3444 in the operative configuration of the system 3400 (e.g., when pressed against the surface of the subject and / or after being removed from the surface of the subject).

[0234]

[0290] As shown in FIG. 58B, the second portion 3444 may include a proximally extending retaining element 3444B (e.g., a latch) configured to engage a portion (e.g., a distal surface) of the inner housing 3427 to retain the second housing portion 3444 relative to the inner housing 3427 and the first housing portion 3442 to prevent the second housing portion 3444 from inadvertently separating from the first housing portion 3442 (e.g., prior to use of the system 3400). The second housing portion 3444 may include one or more latch elements 3444A configured to be received within corresponding latch openings 3442Y defined by the first housing portion 3442 (e.g., the base portion 3442W) such that when the first housing portion 3442 is translated in a fully distal direction relative to the second housing portion 3444 (e.g., from a first position to a second position that is sufficiently distal to the first position such that the system 3400 is activated and fluid is ejected onto the actuator pad 3410), the latch elements 3444A can be received within the latch openings 3442Y such that the second housing portion 3444 is held in a position proximal to the first housing portion 3442 relative to the first housing portion 3442 relative to the initial position of the second housing portion 3444. For example, the latch element 3444A may be biased outwardly, but may be urged inwardly by an inner surface of the base portion 3442W when the system 3400 is in an initial, unactuated configuration and as the first housing portion 3442 moves distally relative to the second housing portion 3444. The latch element 3444A may mate with the latch opening 3442Y such that when the first housing portion 3442 reaches its fully distal position relative to the second housing portion 3444, the latch element 3444A is no longer held in an inward configuration by the inner surface of the base portion 3442W, and the latch element 3444A may expand outwardly into the latch opening 3442Y to prevent the second housing portion 3444 from translating distally relative to the first housing portion 3442.The second housing portion 3444 may have any suitable number of latch elements 3444A and the first housing portion 3442 may have any suitable number of complementary latch openings 3442Y, such as, for example, one, two, three, four, five or more.

[0235]

[0291] The backing portion 3412 can include a proximal wall and side walls that collectively define an interior space configured to accommodate at least a portion of the applicator pad 3410. As shown in FIGS. 62A-D, which are proximal, distal, side, and cross-sectional views of the backing portion 3412 and the applicator pad 3410, the applicator pad 3410 can be partially disposed in the interior space of the backing portion 3412 and can extend distally of the backing portion 3412 in an uncompressed state and / or in a compressed state (e.g., when pressed against a surface of a subject). The backing portion 3412 can define openings 3412A through the proximal wall (e.g., one opening 3412A per reservoir 3450) through which fluid can flow from the reservoirs 3450 to the applicator pad 3410. The backing portion 3412 may also be provided with a retaining element 3412C (e.g., a pair of oppositely disposed retaining elements 3412C) configured to mate with an inwardly facing retaining flange, rim, recess, or groove 3444G disposed on the inner surface of the side wall of the second housing portion 3444 to prevent the backing portion 3412 from inadvertently separating from the second housing portion 3444 prior to the optional ejection step. The backing portion 3412 can also include a set of outwardly extending protrusions 3412E configured to mate with recesses or grooves 3444H defined in an inwardly facing surface of the second housing portion 3444 such that when a proximal force is applied to the backing portion 3412 (e.g., by the applicator pad 3410 urging the first housing portion 3442 distally toward the surface while pressing the applicator pad 3410 against the surface of the subject), the backing portion 3412 urges the second housing portion 3444 proximally into the first housing portion 3442. As shown in FIG. 62D, the backing portion 3412 can include a circumferential seal portion 3412F disposed about each opening 3412A and configured to form a fluid seal when engaged with a distal extension of the second portion 3444 that defines an opening 3499K in which the piercing member 3499 is disposed, as shown in FIG.Thus, fluid ejected through the piercing member 3499 and the opening 3412A can form a fluid bolus disposed between the distal-facing surface 3412B of the backing portion 3412 and the proximal surface of the applicator pad 3410 and / or within the opening 3412A as the fluid is absorbed into the applicator pad 3410.

[0236]

[0292] The backing portion 3412 may be coupled to the applicator pad 3410 via any suitable coupling mechanism. For example, the applicator pad 3410 may be coupled to the backing portion 3412 via a friction fit and / or an adhesive. In some embodiments, an adhesive may be disposed between the applicator pad 3410 and an inner surface of a sidewall of the backing portion 3412. In some embodiments, alternatively or additionally, an adhesive may be disposed between a proximal surface of the applicator pad 3410 and a distal surface of the backing portion 3412.

[0237]

[0293] In some embodiments, the distal surface of the proximal wall of the backing portion 3412 can be smooth, as shown in FIG. 62B. In some embodiments, the distal surface of the proximal wall of the backing portion 3412 can include fluid flow channels, as shown and described with respect to other embodiments. In some embodiments, the distal surface of the proximal wall of the backing portion 3412 can be convex, as shown in the figures. In some embodiments, the distal surface of the proximal wall of the backing portion 3412 can be flat or concave.

[0238]

[0294] The backing portion 3412 may be formed of any suitable material and may be flexible or rigid. For example, the backing portion 3412 may include a webbing feature (e.g., disposed around a periphery of a proximal surface of the backing portion 3412) to improve structural integrity, and optionally may have less or no webbing feature in a central area of ​​the backing portion 3412 to improve flexibility of the backing portion 3412. In some embodiments, the backing portion 3412 may be formed of thermoplastic polyurethane (TPU) and / or polypropylene (PP). In some embodiments, some portions of the backing portion 3412 can be moved relative to other portions by pressing the proximal side of the backing portion 3412 so that when the backing portion 3412 and applicator pad 3410 are separated from the rest of the system 3400, the user can control the compression of the backing portion 3412 and applicator pad 3410 against the wound (e.g., greater compression of certain portions of the applicator pad than other portions of the applicator pad).

[0239]

[0295] Each reservoir 3450 may be formed as a cartridge with a rigid housing (e.g., barrel) defining an interior configured to be pre-filled with a medicament (e.g., liquid). Each reservoir 3450 may have a distal open end closed by a release mechanism 3460 (e.g., a pierceable membrane formed as a cap or cover) and a proximal open end closed by a movable piston 3451. The release mechanism 3460 may be the same or similar in structure and / or function to any of the release mechanisms described herein (e.g., release mechanism 2360). In an initial configuration of the system 3400, the movable piston 3451 is located at a proximal end of the reservoir 3450 housing and is at least partially disposed within the reservoir 3450 housing, as shown in FIG. 58A. The movable piston 3451 is configured to translate from a proximal end of the reservoir 3450 to a distal end of the reservoir 3450 to force fluid from the reservoir 3450 (e.g., when the release mechanism 3460 is pierced by the piercing member 3499 to allow flow from the reservoir 3450).

[0240]

[0296] Each piercing member 3499 defines a lumen through which liquid may flow from the reservoir towards the applicator pad 3410. As shown in FIG. 58A, each piercing member 3499 is fixedly coupled to the second housing portion 3444 and aligned with the release mechanism 3460 of the reservoir 3450 without piercing contact. Each piercing member 3499 can have a sharp proximal end and a blunt distal end. Each piercing member 3499 can be coupled to the second housing portion 3444 such that each piercing member 3499 has a distal end that is proximal to a distal portion of the second housing portion 3444 that defines an opening in which each piercing member 3499 is disposed. Thus, each piercing member 3499 is disposed and sized so as not to contact the applicator pad 3410 or the backing portion 3412 during operation of the system 3400.

[0241]

[0297] 65A-65C are perspective, top, and bottom views, respectively, of the inner support frame 3428. FIG. 65D is a perspective view of the inside of an elongated half of the inner support frame 3428. FIG. 65E is a close-up view of a portion of the outer surface of the inner support frame 3428. The inner support frame 3428 may be disposed within an interior space defined by the first housing portion 3442 and may be fixedly coupled to the first housing portion 3442 such that the inner support frame 3428 and the first housing portion 3442 translate together. The inner support frame includes a pair of outwardly extending tabs 3428Z configured to be received in recesses defined in the first housing portion 3442 such that the inner support frame 3428 is coupled to the first housing portion 3442. The inner support frame 3428 defines parallel channels within which each of the two reservoirs 3450 is disposed and held such that the inner support frame 3428 and the reservoirs 3450 translate together.

[0242]

[0298] 66A-66F are bottom perspective, top perspective, top, bottom, front, and side views, respectively, of the drive plunger 3427. The drive plunger 3427 is disposed within an interior space defined by the first housing portion 3442 and includes a pair of plunger members 3427A configured to translate within channels in the inner support frame 3428 to bias the piston 3451 distally relative to the reservoir housing of the reservoir 3450. Prior to actuation, the drive plunger 3427 is held in an unbiased position relative to the reservoir 3450 and the actuation mechanism 3498 is held in an energy stored configuration by the drive plunger 3427. For example, each spring 3498 of the actuation mechanism 3498 may be biased toward an extended configuration and may be disposed in a compressed configuration between a surface 3427B of the drive plunger 3427 and a proximal face of the system 3400 (e.g., a surface of the first housing portion 3442 and / or a surface of the ejection subassembly) in an initial, unactuated configuration of the system 3400. Each spring 3498 may be at least partially disposed within a spring channel 3427C defined in the drive plunger 3427. The drive plunger 3427 is retained in an initial configuration by a pair of retention features 3428A on the inner support frame 3428 that are biased toward an outward position but are retained in an inward position that prevents distal movement of the drive plunger 3427 by engaging a distal face of the drive plunger 3427 and by an elongate member 3429 coupled to the second housing portion 3444 being disposed between the retention features 3428A on the inner support frame 3428 and an inner surface of the first housing portion 3442 to prevent outward movement of the pair of retention features 3428A (e.g., relative to a central axis of the first housing portion 3442). Each of the elongate members 3429 defines an inwardly facing recess 3429A.When the first housing part 3442 is translated distally relative to the second housing part 3444 to an actuated position, the recess in the elongate member 3429 mates with the retention feature 3428A, allowing the retention feature 3428A to expand outward from the retention position to a non-retention position so that the drive plunger 3427 can be driven distally by the expansion spring and the plunger member 3427A can urge the piston 3451 distally within the reservoir housing of the reservoir 3450.

[0243]

[0299] Because the piercing member 3499 is fixedly coupled to the second housing part 3444 and the reservoir 3450 is held in a fixed position relative to the first housing part 3442, distal translational movement of the first housing part 3442 relative to the second housing part 3444 brings the piercing member 3499 into piercing contact with the release mechanism 3460 of the reservoir 3450, allowing fluid to flow from the reservoir 3450 to the applicator pad 3410 through the piercing member 3499 and the opening in the backing part 3412.

[0244]

[0300] 64A-64C are perspective, bottom, and top views, respectively, of the exhaust subassembly 3406. FIGs. 64D-64F are side views of the exhaust subassembly 3406 from various angles. As shown, the exhaust subassembly 3406 can include a base portion 3474A from which the elongate member 3426 and the spring receiver elongate member 3439 extend distally (e.g., forming the applicator pad release mechanism 3474). The springs 3498 can be configured to receive the spring receiver elongate member 3429 within an internal lumen of the springs 3498 such that a proximal end of each of the springs 3498 contacts or is attached to the base portion 3474A of the exhaust subassembly 3406 and each of the springs 3498 is wound around the elongate member 3429 in the initial configuration of the system 3400.

[0245]

[0301] A pair of pad biasing elongate members 3426 may be coupled to and extend distally from the ejection button 3425 (e.g., via a base portion 3474A of the ejection subassembly 3406). Each elongate member 3426 may include a retaining element 3426A (e.g., a hook or latch) configured to selectively mate with a complementary retaining element 3444K of the second housing portion 3444. In some embodiments, as shown, the retaining elements 3426A may be formed with a reduced thickness portion of the elongate member 3426 and a hook or latch element disposed at a distal end of the reduced thickness portion of the elongate member 3426 such that a recess is formed in the elongate member 3426. 58C , in an initial, unactivated configuration of the system 3400, the retaining element 3426A of each elongate member 3426 can be mated with the retaining element 3444K of the second housing part 3444 such that the ejection button 3425 is retained in a depressed position (e.g., an initial, unactivated position) relative to the proximal end of the first housing part 3442 (e.g., substantially flush with the proximal end of the first housing part 3442 and / or a side wall of the ejection button 3425 is not visible). Thus, a user of the system 3400 is prevented from mistaking the ejection button 3425 for an activation button.

[0246]

[0302] The distal end 3426B of each elongate member 3426 (e.g., the distal end 3426B of the retaining element 3426A) can be configured to mate with an ejection feature 3412F of the backing portion 3412 (e.g., a recess or opening in the hub periphery and / or a raised or non-raised portion on the proximal face 3412D of the backing portion 3412). Thus, as shown in FIG. 60A , as the first housing portion 3442 translates distally relative to the second housing portion 3444, the retaining element 3426A of the elongate member 3426 will advance distally out of contact with the retaining element 3444K of the second housing portion 3444 and into engagement with the ejection feature 3412F of the backing portion 3412. 60A, expansion of the spring 3498 may also bias the ejection button 3425 and the proximal end of the elongate member 3426 in a proximal direction (e.g., via the base portion 3474A of the ejection subassembly 3406) such that the ejection button 3425 translates to a position proximal to an initial position (e.g., an actuated configuration) of the ejection button 3425 and protrudes from the proximal end of the first housing portion 3442. In some embodiments, in the actuated configuration of the ejection button 3425, a side wall of the ejection button 3425 and / or a portion of the pad release mechanism 3474 may be visible by a user. The ejection button 3425 may then be pushed distally as shown in FIG. 60B, causing the elongate member 3426 to translate distally relative to the second housing portion 3444 (e.g., through an opening in the second housing portion 3442) and biasing the backing portion 3412 in a distal direction. The force applied by the elongate member 3426 to the backing portion 3412 due to the button 3425 being pressed distally can overcome the retention force between the backing portion 3412 and the second housing portion 3442 such that the backing portion 3412 and the applicator pad 3410 separate from the second housing portion 3444 and become disconnected from the remainder of the system 3400. The applicator pad 3410 and backing portion 3412 may then be used separately from the remainder of the system 3400 (e.g., by manually applying the applicator pad 3410 and backing portion 3412 to a subject or by using a bandage or wrap to keep the applicator pad 3410 and backing portion 3412 in contact with the subject).

[0247]

[0303] As shown in FIGS. 61A-61C , a distal cap 3420 may be optionally included in the system 3400 and removed from the first housing portion 3442 prior to operation of the system 3400. In some embodiments, the cap 3420 may be formed of a transparent material. The cap 3420 may be configured to prevent movement of the first housing portion 3442 relative to the second housing portion 3444 prior to removal of the cap 3420. The cap 3420 may include a set of openings or slots 3421 configured to receive an outwardly projecting retention feature 3444J of the second housing portion 3444 in a locked configuration of the cap 3420. The outwardly projecting retention feature 3444J may project from an outer surface (e.g., a bottom edge) of the second housing portion 3444 away from a central axis of the second housing portion 3444 and the first housing portion 3442. Although four of each are shown, any suitable number of retention features 3444J and slots 3421 may be included, such as one, two, three, five, six, etc. As shown in FIG. 61A, when the cap 3420 is in the locked configuration, the retention features 3444J protrude from the slots 3421 and contact between the retention features 3444J and portions of the cap 3420 proximal to the slots 3421 prevents the cap 3420 from translating distally relative to the first and second housing portions 3444, 3442. To unlock the cap 3420, the cap can be rotated (e.g., 45 degrees) such that the slots 3421 are out of alignment with the retention features 3444J and the retention features 3444J are disposed in an interior region of the cap rather than passing through the slots 3421. In this manner, the retention features 3444J do not impede distal translation of the cap 3420. As shown in FIG. 61C, the cap can then be translated distally (e.g., in the direction of arrow A) relative to the first housing portion 3442 and the second housing portion 3444 to separate the cap 3420 from the second housing portion 3444 and expose the applicator pad 3410 for use on a subject.As shown, the cap 3420 may optionally include an arrow or other identifier visible on a surface of the cap 3420 to inform the user which way the cap needs to be rotated to go from the locked to the unlocked configuration. Optionally, the cap 3420 may include a blocking portion at one end of each slot 3421 to prevent rotation of the cap 3420 relative to the second housing portion 3444 in a non-unlocked direction by blocking further rotation of the retention mechanism 3444J. In some embodiments, rather than including the cap 3420 shown in the figures (e.g., a twist-off cap), the system 3400 may include other suitable caps, such as a cap that couples to the first housing portion 3442 via mating threads, a pressure fit, and / or includes a hinge.

[0248]

[0304] In use, a user (e.g., a subject or a caregiver) can use the system 3400 using the same or similar method steps as described with respect to any of the other systems and methods herein. For example, a user can remove the optional cap 3420 and contact the absorbent pad 3410 with a wound on the subject in an initial, unactuated state. The user can then translate the first housing portion 3442 distally toward the wound a sufficient distance to compress the absorbent pad 3410 against the wound and advance the first housing portion 3442 a sufficient distance (e.g., from a first position to a second position) relative to the second housing portion 3444 to actuate the system 3400. In some embodiments, the amount of actuation force applied to actuate the system 3400 (e.g., to translate the first housing portion 3442 from the first position to the second position) can be less than 2 N, between about 5 N and about 15 N, between about 2 N and about 20 N, or any other suitable amount of force. Relative translational movement of the first and second housing parts 3442 can actuate the actuation mechanism 3498 such that the spring applies pressure to the piston of the reservoir 3450, and (e.g., simultaneously or immediately before or after) the piercing member 3499 can pierce the release mechanism 3460 of the reservoir 3450 such that a fluid coupling is established from the reservoir 3450 to the applicator pad 3410 and fluid is urged through the fluid coupling by the drive plunger 3427 under control of the actuation mechanism 3498 (e.g., spring). In some embodiments, simultaneously with actuation of the actuation mechanism 3498 and piercing of the release mechanism 3460, or immediately before or after, the ejection button 3425 can also be urged proximally as a result of the relative movement of the first and second housing parts 3442 and 3444. The user can maintain the applicator pad 3410 in contact with the wound for a sufficient time for fluid to be ejected onto the applicator pad 3410 by continuing to grasp the first housing portion 3442 (e.g., by wrapping their fingers around the elongated portion 3442X) and pressing or pulling the first housing portion 3442 against the wound so that the applicator pad 3410 remains compressed.In some embodiments, fluid may be dispensed onto the applicator pad 3410 for about 5 seconds, about 10 seconds, about 15 seconds, about 20 seconds, about 25 seconds, about 30 seconds, about 35 seconds, about 40 seconds, about 3-10 seconds, about 10-30 seconds, about 20-30 seconds, about 20-30 seconds, about 5 seconds to about 30 seconds, about 10 seconds to about 60 seconds, or any suitable amount or range of time. In some embodiments, a user can observe the movement of the piston 3451 and / or the plunger 3427A relative to the reservoir housing of the reservoir 3450 through the window 3441A of the first housing portion 3442 to assess whether the system 3400 is functioning properly and / or determine when the fluid has been fully dispensed.

[0249]

[0305] Similar to what is described with respect to other method steps described herein, the user can maintain the applicator pad 3410 in contact with the wound for a period of time (e.g., a period of time sufficient to achieve hemostasis) by continuing to grip the first housing portion 3442 (e.g., by wrapping fingers around the elongated portion 3442X) and pressing or pulling the first housing portion 3442 against the wound so that the applicator pad 3410 remains compressed. The period of time can optionally be based on when complete expulsion of fluid is observed through the window 3441A. After the period of time, the user can check the wound and / or remove the applicator pad 3410 from the wound and discontinue use of the grip 3440. Optionally, the user can eject the applicator pad 3410 and backing portion 3412 from the remainder of the system 3400 (e.g., from the grip 3440) by pressing the eject button 3425 distally (e.g., toward the second housing portion) causing the elongate member 3426 to exert a force on the backing portion 3412 and applicator pad 3410 urging it to separate from the second housing portion 3444 and release from the grip 3440. Optionally, the applicator pad 3410 and backing portion 3412 are then applied to the wound for a period of time (e.g., by manually applying the applicator pad 3410 and backing portion 3412 to the subject, or by placing the applicator pad 3410 against the wound and applying a bandage or wrap to the backing portion 3412 to secure the applicator pad 3410 and backing portion 3412 to the wound).

[0250]

[0306] While various embodiments have been described herein in the text and / or figures, it should be understood that they are presented by way of example only and not limitation. Likewise, it should be understood that specific terms used herein are for the purpose of describing particular embodiments and / or their features or components, and are not intended to be limiting. Various modifications, changes, enhancements, and / or variations in form and / or details may be made without departing from the scope of the present disclosure and / or without altering its function and / or advantages, unless expressly stated otherwise. Functionally equivalent embodiments, examples, and / or methods, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing description and are intended to be within the scope of the present disclosure.

[0251]

[0307] Where the above summary, embodiments, and / or examples show particular components arranged and / or configured in particular orientations or positions, the arrangement of the components may be modified, adjusted, optimized, etc. The specific size and / or specific shape of the various components may differ from the illustrated embodiments and / or may be otherwise modified while still providing the functionality described herein. More specifically, the size and shape of the various components may be specifically selected for a desired or intended application. Thus, it should be understood that the size, shape, and / or arrangement of the embodiment and / or its components may be suitable for a particular application unless the context clearly indicates otherwise. By way of example, in some embodiments, a treatment device intended to provide treatment to an adult user may have a first size and / or shape, while a treatment device intended to provide treatment to a pediatric user may have a second size and / or shape that is smaller than the first size and / or shape. Additionally, the smaller size and / or shape of, for example, a pediatric treatment device may cause certain components to be moved, reoriented, and / or repositioned while still maintaining the desired functionality of the device.

[0252]

[0308] Although various embodiments have been described as having certain features, functions, components, elements, and / or characteristics, other embodiments are possible having any combination and / or sub-combination of the features, functions, components, elements, and / or characteristics from any of the embodiments described herein, unless expressly stated in mutually exclusive combinations or otherwise. Further, unless expressly stated otherwise herein, any particular combination of components, functions, features, elements, etc. may be separated into separate components, functions, features, elements, etc., or may be incorporated into a single or unified component, function, feature, element, etc.

[0253]

[0309] Where the methods above indicate that certain events occur in a particular order, the order of the certain events may be changed. Also, some of the events may occur simultaneously, where possible, in addition to occurring sequentially as described above. Although methods have been described as having certain steps and / or combinations of steps, other methods are possible having any combination of steps from any of the methods described herein, except for mutually exclusive combinations and / or unless the context clearly indicates otherwise.

Claims

1. a first housing portion defining an interior space and an open distal end; a second housing portion configured to be at least partially disposed in the interior space, the second housing portion having a distal end disposed distally of the distal end of the first housing portion in an initial configuration of the second housing portion relative to the first housing portion; an applicator pad coupled to a distal-facing surface of the second housing portion; a reservoir configured to contain a fluid; an energy storage member configured to be actuated to urge the fluid from the reservoir to the applicator pad; the first housing portion is configured to be translated distally relative to the second housing portion to cause actuation of the energy storage member. system.

2. 2. The system of claim 1, wherein the second housing portion is configured to cause actuation of the energy storage member in response to the applicator pad being placed in contact with a wound of a user and the first housing portion being translated distally toward the wound and relative to the applicator pad and the second housing portion.

3. The system of claim 1 , wherein the applicator pad is disposed distal to the distal end of the first housing portion in the initial configuration of the second housing portion relative to the first housing portion.

4. The system of claim 1 , wherein at least a portion of the applicator pad is disposed distal to the distal end of the second housing portion in the initial configuration of the second housing portion relative to the first housing portion.

5. The system of claim 1 , wherein the reservoir is disposed in the interior space of the first housing portion.

6. 2. The system of claim 1, wherein the reservoir comprises a cartridge having a barrel with an open distal end and an open proximal end, a piston translatable within the barrel, and a pierceable membrane coupled to the distal end of the barrel.

7. The system of claim 1 , wherein the energy storage member is disposed in the interior space of the first housing portion.

8. the energy storage member includes a spring member; The system of claim 1 , wherein the actuation of the energy storage member includes releasing the spring member such that the spring member transitions from an energy stored configuration to an activated configuration.

9. A drive plunger is further included, The system of claim 1 , wherein the energy storage member is configured to bias the drive plunger against the reservoir to expel the fluid in the reservoir onto the applicator pad.

10. the at least one reservoir comprises a cartridge having a barrel having an open distal end and an open proximal end, a piston translatable within the barrel, and a pierceable membrane coupled to the distal end of the barrel; the energy storage member includes a spring member in contact with a proximally facing surface of the drive plunger; The system of claim 9 , wherein the spring member is configured to translate the drive plunger distally such that the drive plunger biases the piston distally within the barrel of the cartridge.

11. The system of claim 1 , wherein the applicator pad comprises a backing portion and a pad portion coupled to a distal-facing surface of the backing portion.

12. The system of claim 11 , wherein the backing portion defines an interior space within which a portion of the pad portion is disposed in the initial configuration of the second housing portion relative to the first housing portion.

13. The system of claim 11 , wherein the pad portion is fixedly coupled to the backing portion.

14. The system of claim 11 , wherein the backing portion defines at least one opening through which the fluid can be transferred to the pad portion.

15. The system of claim 11 , wherein the backing portion is releasably coupled to the second housing portion such that the applicator pad can be separated from the second housing portion.

16. 16. The system of claim 15, further comprising an ejection mechanism releasably coupleable to the backing portion and configured to urge the applicator pad distally to detach the applicator pad from the second housing portion.

17. 17. The system of claim 16, wherein the ejection mechanism comprises an elongate member translatable through an opening defined by the second housing portion to urge the applicator pad distally relative to the second housing portion to separate the applicator pad from the second housing portion.

18. 18. The system of claim 17, wherein the ejection mechanism comprises an ejection button disposed in a first unactuated position when the second housing portion is in the initial configuration relative to the first housing portion, configured to transition from the first position to a second actuated position in response to the first housing portion being translated distally relative to the second housing portion causing actuation of the energy storage member, and configured to be depressed to the second actuated position to translate the elongate member of the ejection mechanism to bias the applicator pad distally relative to the second housing portion.

19. 20. The system of claim 18, wherein the ejection button is configured to be transitioned from the first position to the second position by a force applied to the ejection mechanism by a proximal end of the energy storage member.

20. 2. The system of claim 1, wherein the translational movement of the first housing portion relative to the second housing portion causes translational movement of the reservoir that brings the reservoir into piercing engagement with a piercing member such that the fluid flows from the reservoir to the applicator pad.

21. The system of claim 18 , wherein the piercing member is fixedly attached to the second housing portion.

22. the applicator pad comprises a backing portion and a pad portion; 22. The system of claim 21, wherein the backing defines an opening that is aligned with the piercing member such that the fluid travels through the opening in the backing to the pad portion.

23. The system of claim 1 , further comprising an applicator backing coupled to the applicator pad and disposed between the applicator pad and the second housing portion.

24. the first housing portion having a central axis, an elongated portion, and a base portion disposed distally of the elongated portion and having a greater lateral extent relative to the central axis than the elongated portion; the base of the housing defines the open distal end; the elongated portion defines a first portion of the interior space; The system of claim 1 , wherein the base defines a second portion of the interior space such that the base is configured to at least partially accommodate the applicator pad.

25. 25. The system of claim 24, wherein the first housing portion can be translated distally relative to the second housing portion by a user wrapping the user's finger around the central axis of the elongated portion and applying a distal force to at least one of the elongated portion or the base portion.

26. the reservoir is a first reservoir, The system of claim 1 further comprising a second reservoir.

27. The system of claim 1 , wherein the fluid comprises a drug.

28. 28. The system of claim 27, wherein the drug comprises tranexamic acid (TXA).

29. a first housing portion defining an interior space and an open distal end; a second housing portion configured to be at least partially disposed in the interior space, the second housing portion defining an opening; a needle disposed within the opening of the second housing portion and fixedly attached to the second housing portion; an applicator pad coupled to a distal-facing surface of the second housing portion; a reservoir having a pierceable membrane configured to be pierced by the needle, the reservoir configured to contain a fluid; an energy storage member configured to be actuated to force fluid from the reservoir to the applicator pad; the first housing portion is configured to be translated distally from a first position to a second position relative to the second housing portion to bring the pierceable membrane of the reservoir into contact with the needle such that the needle pierces the pierceable membrane and the fluid flows from the reservoir through the needle to the applicator pad. system.

30. 30. The system of claim 29, wherein the first housing portion is configured to be translated distally relative to the second housing portion by placing the applicator pad in contact with a wound of a user and translating the first housing portion toward the wound and distally relative to the applicator pad and the second housing portion.

31. 30. The system of claim 29, wherein the applicator pad is disposed distal to the distal end of the first housing portion at the first location of the first housing portion.

32. 30. The system of claim 29, wherein at least a portion of the applicator pad is disposed distal to the distal end of the second housing portion at the first location of the first housing portion.

33. 30. The system of claim 29, wherein the reservoir is disposed in the interior space of the first housing portion.

34. the reservoir comprises a cartridge including a barrel having an open distal end and an open proximal end and a piston translatable within the barrel; 30. The system of claim 29, wherein the pierceable membrane is coupled to the distal end of the barrel.

35. 30. The system of claim 29, wherein the energy storage member is disposed in the interior space of the first housing portion.

36. the energy storage member includes a spring member; 30. The system of claim 29, wherein the actuation of the energy storage member includes releasing the spring member such that the spring member transitions from an energy stored configuration to an activated configuration.

37. 37. The system of claim 36, wherein the spring member is released in response to the first housing portion being translated from the first position to the second position relative to the second housing portion.

38. A drive plunger is further included, 30. The system of claim 29, wherein the energy storage member is configured to bias the drive plunger against the reservoir to cause the fluid in the reservoir to flow to the applicator pad.

39. the at least one reservoir comprises a cartridge including a barrel having an open distal end and an open proximal end and a piston translatable within the barrel; the piercable membrane is coupled to the distal end of the barrel; the energy storage member includes a spring member in contact with a proximally facing surface of the drive plunger; 40. The system of claim 38, wherein the spring member is configured to translate the drive plunger distally such that the drive plunger biases the piston distally within the barrel of the cartridge.

40. 30. The system of claim 29, wherein the applicator pad comprises a backing portion and a pad portion coupled to a distal-facing surface of the backing portion.

41. 41. The system of claim 40, wherein the backing portion defines an interior space within which a portion of the pad portion is disposed when the first housing portion is in the first position relative to the second housing portion.

42. 41. The system of claim 40, wherein the pad portion is fixedly coupled to the backing portion.

43. 41. The system of claim 40, wherein the backing portion defines at least one opening through which the fluid can flow to the pad portion.

44. 41. The system of claim 40, wherein the backing portion is releasably coupled to the second housing portion such that the applicator pad can be separated from the second housing portion.

45. 45. The system of claim 44, further comprising an ejection mechanism releasably coupleable to the backing portion and configured to urge the applicator pad in a distal direction to detach the applicator pad from the second housing portion.

46. 46. ​​The system of claim 45, wherein the ejection mechanism comprises an elongate member translatable through an opening defined by the second housing portion to urge the applicator pad distally relative to the second housing portion to separate the applicator pad from the second housing portion.

47. 47. The system of claim 46, wherein the ejection mechanism comprises an ejection button disposed in a first inactivated position when the first housing portion is in the first position, configured to transition from the first position to a second activated position in response to the first housing portion being translated to the second position, and configured to be depressed to the second activated position to translate the elongated member of the ejection mechanism and bias the applicator pad distally relative to the second housing portion.

48. 48. The system of claim 47, wherein the ejection button is configured to be transitioned from the first position to the second position by a force applied to the ejection mechanism by a proximal end of the energy storage member.

49. the applicator pad comprises a backing portion and a pad portion; 30. The system of claim 29, wherein the backing defines an opening aligned with the needle such that the fluid passes through the opening in the backing to the pad.

50. 30. The system of claim 29, further comprising an applicator backing coupled to the applicator pad and disposed between the applicator pad and the second housing portion.

51. the first housing portion having a central axis, an elongated portion, and a base portion disposed distally of the elongated portion and having a greater lateral extent relative to the central axis than the elongated portion; the base of the housing defines the open distal end; the elongated portion defines a first portion of the interior space; 30. The system of claim 29, wherein the base defines a second portion of the interior space such that the base is configured to at least partially accommodate the applicator pad.

52. 52. The system of claim 51, wherein the first housing portion can be translated distally relative to the second housing portion by a user wrapping the user's finger around the central axis of the elongated portion and applying a distal force to at least one of the elongated portion or the base portion.

53. the reservoir is a first reservoir, 30. The system of claim 29, further comprising a second reservoir.

54. 30. The system of claim 29, wherein the fluid comprises a drug.

55. 56. The system of claim 55, wherein the drug comprises tranexamic acid (TXA).

56. a first housing portion defining an interior space and an open distal end; a second housing portion defining a plurality of openings, the second housing portion having a distal end disposed distally of the distal end of the first housing portion in an initial configuration of the second housing portion relative to the first housing portion; a plurality of needles, each needle of the plurality of needles disposed within a corresponding one of the plurality of openings of the second housing portion and fixedly attached to the second housing portion; a backing portion releasably coupleable to the second housing portion; an applicator pad coupled to the backing; a plurality of reservoirs disposed in the interior space of the first housing portion, each reservoir of the plurality of reservoirs comprising a pierceable membrane; a plurality of springs disposed in the interior space of the first housing portion; the first housing portion is configured to be translated distally from a first position to a second position relative to the second housing portion to contact the pierceable membrane of each reservoir of the plurality of reservoirs with a corresponding needle of the plurality of needles such that each pierceable membrane is pierced, and the plurality of springs are simultaneously actuated to bias fluid from each reservoir of the plurality of reservoirs such that fluid simultaneously flows from each reservoir through the plurality of needles to the applicator pad. system.

57. 57. The system of claim 56, wherein the first housing portion is configured to be translated from the first position to the second position by placing the applicator pad in contact with a wound of a user and translating the first housing portion toward the wound and in a distal direction relative to the applicator pad and the second housing portion.

58. 57. The system of claim 56, wherein the applicator pad is disposed distal to the distal end of the first housing portion at the first location of the first housing portion.

59. 57. The system of claim 56, wherein at least a portion of the applicator pad is disposed distal to the distal end of the second housing portion at the first location of the first housing portion.

60. A drive plunger is further included, 57. The system of claim 56, wherein the plurality of springs are configured to bias the drive plunger against the reservoir of the plurality of reservoirs to bias the fluid from each reservoir of the plurality of reservoirs.

61. 57. The system of claim 56, wherein the backing portion defines an interior space within which a portion of the applicator pad is disposed when the first housing portion is in the first position relative to the second housing portion.

62. 57. The system of claim 56, wherein the applicator pad is fixedly coupled to the backing.

63. 57. The system of claim 56, wherein the backing defines at least one opening through which the fluid can flow to the applicator pad.

64. 57. The system of claim 56, further comprising an ejection mechanism releasably coupleable to the backing portion and configured to urge the backing portion in a distal direction to decouple the applicator pad from the second housing portion.

65. 65. The system of claim 64, wherein the ejection mechanism comprises an elongate member translatable through an opening defined by the second housing portion to urge the backing portion distally relative to the second housing portion to separate the backing portion and the applicator pad from the second housing portion.

66. 66. The system of claim 65, wherein the ejection mechanism comprises an ejection button disposed in a first inactivated position when the first housing portion is in the first position, configured to transition from the first position to a second activated position in response to the first housing portion being translated to the second position, and configured to be depressed to the second activated position to translate the elongate member of the ejection mechanism and bias the backing portion distally relative to the second housing portion.

67. 67. The system of claim 66, wherein the ejection button is configured to be transitioned from the first position to the second position by a force applied to the ejection mechanism by proximal ends of the plurality of springs.

68. The backing portion has a plurality of openings, 57. The system of claim 56, wherein each opening of the plurality of openings defines a plurality of openings aligned with one of the plurality of needles such that the fluid travels through the plurality of openings in the backing portion to the pad portion.

69. the first housing portion having a central axis, an elongated portion, and a base portion disposed distally of the elongated portion and having a greater lateral extent relative to the central axis than the elongated portion; the base of the housing defines the open distal end; the elongated portion defines a first portion of the interior space; 57. The system of claim 56, wherein the base defines a second portion of the interior space such that the base is configured to at least partially accommodate the applicator pad.

70. 57. The system of claim 56, wherein the first housing portion can be translated distally relative to the second housing portion by a user wrapping the user's finger around the central axis of the elongated portion and applying a distal force to at least one of the elongated portion or the base portion.

71. 57. The system of claim 56, wherein the fluid comprises a drug.

72. 72. The system of claim 71, wherein the agent comprises tranexamic acid (TXA).

73. an outer housing defining an interior space and an open distal end; a reservoir having a release mechanism; an inner housing subassembly including an inner support frame and a plunger element configured to hold the reservoir and defining a channel within which at least a portion of the plunger element may translate to engage the reservoir, the inner support frame fixedly coupled to the outer housing such that translational movement of the outer housing translates the inner housing subassembly; an activation mechanism coupled to the plunger element and configured to be activated to bias the plunger element against the reservoir; a lower actuator subassembly including a lower housing portion, a piercing member fixedly coupled to the lower housing portion, and an elongate member extending proximally from the lower housing portion; a pad subassembly including an applicator pad; the outer housing is configured to be translated distally from a first position to a second position relative to the lower actuator subassembly to pierce the release mechanism of the reservoir with the piercing member and to activate the activation mechanism by a release interaction between the elongated member of the lower actuator subassembly and the plunger element of the inner housing subassembly caused by distal translation of the plunger element within the inner support frame. system.

74. 74. The system of claim 73, wherein the pad subassembly comprises a pad backing configured to partially contain the applicator pad in its uncompressed configuration.

75. 75. The system of claim 74, wherein the pad backing defines an opening through which fluid can flow from the reservoir to the applicator pad.

76. 74. The system of claim 73, wherein the lower actuator subassembly has a distal-most portion disposed distally of a distal-most portion of the outer housing at the first position of the outer housing relative to the lower actuator subassembly.

77. disposing a distal end of a grip in an initial configuration in which a distal end of a first housing portion of the grip is disposed proximal to a distal end of a second housing portion of the grip, and applying an applicator pad disposed distally of the second housing portion of the grip against a wound surface; pressing the applicator pad against the wound surface; an actuation mechanism is actuated to translate the first housing portion distally relative to a second housing portion of the grip to force fluid from a reservoir disposed within the first housing portion onto the applicator pad; maintaining compression of the applicator pad against the wound surface by continuing to urge the first housing portion toward the wound surface such that the fluid contacts the wound surface and pressure is applied by the applicator pad to the wound surface for a period of time; A method comprising:

78. 80. The method of claim 77, wherein the translating comprises gripping the first housing portion by wrapping a user's fingers around the first housing portion and biasing the first housing portion along a central axis of the first housing portion.

79. 78. The method of claim 77, wherein the period of time comprises a period during which the fluid is expelled from the reservoir.

80. 80. The method of claim 78, further comprising continuing to maintain pressure of the applicator pad against the wound surface for a period of time after the fluid has been expelled from the reservoir.

81. 80. The method of claim 77, further comprising: decoupling the applicator pad from the second housing portion via engaging an ejection mechanism coupled to the first housing portion.

82. 82. The method of claim 81, further comprising maintaining pressure of the applicator pad against the wound surface after separating the applicator pad from the second housing portion.

83. the applicator pad comprises a flexible backing portion and a pad portion; 83. The method of claim 82, wherein the backing portion is stiffer than the pad portion.

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