KR20230098185A - Device for reducing bleeding and method of making and using the same - Google Patents

Abstract

In some embodiments, a system includes an applicator pad, an application device (eg, gripper), and a reservoir. The grip portion is releasably engageable to the applicator pad and can be configured to position the applicator pad against the affected area of the subject such that pressure can be transferred to the affected area through the applicator pad to enhance hemostasis. The reservoir may be configured to contain a drug to be released to the affected area via the applicator pad.

Description

Device for reducing bleeding and method of making and using the same

CROSS REFERENCES TO RELATED APPLICATIONS

This application is filed on April 9, 2020, US Provisional Patent Application Serial No. 63/007,543 entitled "Devices for Bleeding Reduction and Methods of Making and Using the International Application No. PCT/US2021/026714, filed on April 9, 2021, claiming priority to "Devices for Bleeding Reduction and Methods of Making and Using The Same" Methods of Making and Using the Same", the disclosures of each of which are incorporated herein by reference in their entirety.

This application also relates to U.S. Provisional Patent Application Serial No. 63/087,532, filed on October 5, 2020, titled "Methods for Self-Treatment or Home Care Provider Treatment of Minor Lesions". Provider Treatment of Minor Wounds" and U.S. Provisional Patent Application Serial No. 63/090,768, filed on October 13, 2020, entitled "Methods for Self-Treatment or Managed Provider Treatment of Minor Wounds" or Care Provider Treatment of Minor Wounds", the disclosures of each of which are incorporated herein by reference in their entirety.

Patients with minor injuries seek medical treatment in primary care clinics, urgent care centers, and hospital emergency departments. Many emergency management centers are not open 24 hours a day and 7 days a week (24/7). Rural areas may have limited access to these emergency management centers. A common type of visit to a hospital emergency room or urgent care center is for patients on a wound requiring cessation of bleeding, especially on anticoagulant or antiplatelet medications. As the population ages, more patients require treatment with these medications for a variety of conditions.

Better methods and devices are needed that enable patients, family members, and/or caregivers to safely treat minor lesions requiring cessation of bleeding at home or at the site of an injury.

This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to identify key features or essential features of the claimed subject matter, and is not intended to be used to limit the scope of the claimed subject matter.

Disclosed herein are devices, methods of using the devices, and methods of making the devices, for the treatment of bleeding, eg from minor lesions. In some embodiments, a system includes an applicator pad, an application device (eg, gripper), and a reservoir. The grip portion is releasably engageable to the applicator pad and can be configured to position the applicator pad against the affected area of the subject, so that pressure can be transferred through the applicator pad to the affected area to enhance hemostasis. The reservoir may be configured to contain a drug to be released to the affected area via the applicator pad.

Additional features, aspects and/or advantages will be recognized and understood upon further review of the detailed description of exemplary embodiments taken in conjunction with the accompanying drawings.

1 is a cross-sectional view of a portion of the skin, showing the structure of the epidermis, dermis, hypodermis and subcutaneous layers.
2 is a schematic diagram of a bleeding treatment system according to an embodiment.
FIG. 3A is a schematic diagram of the bleeding treatment system of FIG. 3 shown with the packaging removed from the bleeding treatment device and placed near an affected area on a patient's skin.
FIG. 3B is a schematic diagram of the bleeding treatment device of FIG. 3A showing a portion of the bleeding treatment device positioned adjacent to a lesion on a patient's skin, with the optional applicator seal removed.
Figure 3c is a schematic diagram of the bleeding treatment device of Figure 3a with the grip portion removed.
FIG. 3D is a schematic diagram of the bleeding treatment device of FIG. 3A, shown separated from a patient's affected area.
FIG. 4 is a flowchart of a method of treating a wound requiring the cessation of bleeding using the bleeding treatment system of FIGS. 2 and 3A to 3D .
5 is a schematic diagram of a bleeding treatment system according to an embodiment.
6A to 6C are schematic diagrams of a bleeding treatment system according to an embodiment.
7A-7D are schematic diagrams of the bleeding treatment system in an initial configuration according to one embodiment.
7E-7H are schematic diagrams of a bleeding treatment system in a wet configuration.
8 is a schematic diagram of a bleeding treatment system according to an embodiment.
9A to 9C are schematic diagrams of a bleeding treatment system according to an embodiment.
10A to 10C are schematic diagrams of a bleeding treatment system according to an embodiment.
11A and 11B are schematic diagrams of a bleeding treatment system according to an embodiment.
12 is a schematic diagram of an applicator pad and a blood absorbent pad according to one embodiment.
13 is a schematic diagram of a bleeding treatment system according to an embodiment.
14 is a flowchart of a method of using the bleeding treatment system according to an embodiment.
15A-15E are schematic diagrams of the bleeding treatment system at various stages of use according to one embodiment.
16A-16C are schematic diagrams of a bleeding treatment system in a wet configuration according to one embodiment.
16D-16F are schematic diagrams of the bleeding treatment system of FIGS. 16A-16C in an isolated configuration.
17A and 17B are schematic diagrams of the bleeding treatment system of FIGS. 16A-16C according to one embodiment.
18 is a schematic diagram of the bleeding treatment system of FIGS. 17A and 17B according to one embodiment.
19A is a schematic diagram of a bleeding treatment system according to one embodiment.
19B is a schematic diagram of a portion of the bleeding treatment system of FIG. 19A.
19C is a schematic diagram of a portion of the bleeding treatment system of FIG. 19A according to one embodiment.
20 is a schematic diagram of a bleeding treatment system according to an embodiment.
21 is a schematic diagram of a bleeding treatment system according to an embodiment.
22A and 22B are schematic diagrams of cross-sectional and top views of a bleeding treatment system according to one embodiment.
23A to 23C are schematic diagrams of a bleeding treatment system according to an embodiment.
24 is a schematic diagram of a bleeding treatment system according to an embodiment.
25A-25C are schematic diagrams of a series of steps performed using a kit, according to one embodiment.
26A-26C are schematic diagrams of a series of steps performed using a kit, according to one embodiment.

The detailed description herein serves to describe non-limiting embodiments or examples incorporating various inventive concepts, and reference numbers are used to facilitate understanding of these examples. Common reference numbers between the drawings indicate common features and structures having the same or similar function, as may be understood. Although the various drawings will have common reference numerals designating these common features and structures, for brevity, the following drawing descriptions will not necessarily repeat the description of these features and structures.

For reference, FIG. 1 shows a cross-sectional view of a skin portion SK of a person, eg a subject to be treated. The skin portion (SK) includes an epidermis (E), a dermis (D), a hypodermis (H), and a subcutaneous layer (S).

The systems and methods disclosed herein treat a wound and/or stop bleeding in a wound that extends through epidermal and/or dermal layers, is non-arterial, does not pulsatile, and has no exposed subcutaneous fat or muscle. may be configured to assist. In some embodiments, the systems and methods disclosed herein may be self-imposed (eg, the donor of the system and/or method is a subject who also has a lesion). In some embodiments, the systems and methods disclosed herein may be given to a subject with an affected condition by someone other than the subject, such as a caregiver (eg, a non-medical home care provider such as a family member) or a clinician. In some embodiments, the systems and methods disclosed herein may be given to a non-human patient, such as a pet dog or pet cat, and the method steps may be performed by the pet owner or veterinarian. In some embodiments, a target lesion treatable by the systems and methods disclosed herein may be less than 3 centimeters in length. In some embodiments, target lesions treatable by the systems and methods disclosed herein in a home setting may be lesions that do not require stitches or sutures for closure. In some embodiments, target lesions treatable by the systems and methods disclosed herein in a clinical setting are treated prior to bleeding using a stitch or suture, if the systems and/or methods disclosed herein are not effective after a single use. It can be a lesion that can be first tried to be stopped using the systems and methods disclosed in .

Potential patient populations that may be treated by the systems and methods disclosed herein include any person with local hemorrhage (ie, bleeding from the skin). For example, the target patient population may include persons with a susceptibility to naturally-induced, drug-induced, or procedure-induced increased bleeding and/or resistance to blood clotting. Sensitivity to spontaneous-induced bleeding and/or resistance to blood coagulation may be associated with hemophilia, von Willebrand disease, vascular disorders (e.g. Osler-Weber-Rendu), coagulation illness, kidney failure, liver failure, bone marrow suppression (pathological or drug-induced) platelet disorders, age (elderly people may have more delicate skin), or conditions that make a person more prone to accidents or difficult to treat (such as eg, genetic conditions) (including age and/or motor or cognitive deficits). Drugs that can cause sensitivity to bleeding and/or resistance to clotting include anticoagulant drugs such as warfarin, heparin, factor Xa inhibitors, thrombin inhibitors, low molecular weight heparin, dabigatran, argatorban, hirudin, rivaroxaban, apixaban, edoxaban, fondaparinux, enoxaparin, dalteparin and bivalirudin; and antiplatelet drugs such as platelet aggregation inhibitors such as aspirin (acetylsalicylic acid or ASA), cangrelor, ticagrelor, lopidogrel, prasugrel, cilostazol, clopidogrel, dipyridamole, ticlopidine, glyco protein platelet inhibitors such as epifibatide, tirofiban, apsiximab, and protease-activated receptor-1 antagonists such as borapasar. Anticoagulant drugs can be taken for a wide range of indications such as deep vein thrombosis, pulmonary embolism, and atrial fibrillation. Medical procedures that can cause susceptibility to bleeding and/or resistance to clotting include renal replacement therapy (eg, hemodialysis), cardiopulmonary bypass, extracorporeal-membrane oxygen therapy (ECMO), chemical thrombolysis (tissue plasminogen activating factor (TPA)), cardiac catheterization, peripheral vascular procedures (eg, popliteal bypass, arterial thrombectomy), mechanical thrombectomy, angiography, and other nerve interventional procedures and interventions.

A bleeding treatment system 100 that can be used to treat a wound requiring cessation of bleeding is schematically illustrated 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 , and an applicator seal 120 coupled to the applicator pad 110 . Optional blood absorbent pad 130, one or more optional reservoirs 150 fluidly coupled to applicator pad 110 via fluid couplings 155 and containing one or more medications, releasable from applicator pad 110 an optional release mechanism 160 coupled to the applicator device 170 and comprising a gripper 140, a reservoir 150, a fluid coupling 155 and a gripper 140, an applicator pad ( optional pad retainer 135 coupled to 110), optional user guide 190 associated with applicator device 170, and optional packaging 195 to contain other components of bleeding treatment system 100. includes The gripping portion 140 may be releasably engageable to the applicator pad 110 via an optional pad connector 148 .

The applicator pad 110 (also referred to as a topical applicator pad) is sized, configured, and formed of a material suitable for covering the affected area treatable by the system 100 . Applicator pad 110 may be formed of any one or more materials having suitable physical properties. For example, it is preferred that the material is capable of absorbing blood. The material may also swell or expand when absorbing fluids such as blood. The material may also contain, absorb, wick, or otherwise deliver one or more drugs for application to the surface of the affected area (WD) and/or to the skin (SK) surrounding the affected area. It must be biologically compatible with the skin (SK) and the affected area (WD). Preferably, the one or more substances are also non-reactive or otherwise compatible with any drug(s) to be delivered by the applicator pad 110, for example, the composition, delivery, or It does not alter the efficacy or degrade or otherwise lose any desired physical properties when exposed to the drug(s) over the maximum period of treatment of the wound. The material is preferably sufficiently rigid, elastic, etc. to be able to apply a sufficient amount of pressure to the affected area to assist in achieving hemostasis, i.e., function as a hemostat. At least the bottom or distal surface of the applicator pad 110 (eg, any surface exposed prior to use of the bleeding treatment system 100) prevents contamination of the applicator pad 110 and/or the applicator. It may be covered or surrounded by a removable applicator seal 120 to prevent unwanted release of any drug(s) that may be contained within the pad 110. The applicator pad 110 may be formed of a spongy material. The applicator seal 120 may be formed as a film or other thin layer of material that is non-reactive with the applicator pad 110 . The applicator seal 120 may be removed from the applicator pad 110 (eg, via peeling) prior to use.

Suitable materials for the applicator pad 110 are polyvinyl alcohol (PVA), polyurethane (hydrophilic or otherwise), polypropylene which may be formed of foam (open or closed cell) (eg, porous expandable foam), natural fibers such as cotton, linen, wool, etc. in woven or non-woven (eg, felt) form and/or polymers or other compositions such as layered matrices of foam and/or gauze packing. The applicator pad 110 may be formed monolithically from a single material, or may be formed as a composite or other aggregate of different materials. For example, the applicator pad 110 may be formed primarily of one material and may have a relatively thin covering of a second material. A material can achieve a desired function in different ways. For example, absorption of blood may occur mechanically, such as by capillary wicking, and/or chemically, such as by absorption into molecular sieves or other desiccants, or in clays such as kaolin, bentonite, It can be achieved by combination with materials such as montmorillonite, saponite, polygorskite, attapulgite, and/or sepiolite. In some embodiments, clay may be dispersed in a liquid medium. In some embodiments, applicator pad 110 may include a hemostatic patch and a flexible insulating or suction device (also referred to as a backing portion or layer). In some embodiments, the hemostatic patch may contain the liquid medication, and a flexible insulating or wicking device may isolate the affected area and the hand applying pressure to the applicator pad 110 from the liquid medication.

As described in more detail below, the applicator pad 110 may contain, incorporate, or embody a reservoir for the drug(s), and different materials may be used to form or border the reservoir. In some embodiments, applicator pad 110 may include a reservoir for a dry or lipophilized drug that may be made flowable through fluid released from a reservoir of applicator device 170 and/or blood from an affected area. there is. In some embodiments, applicator pad 110 may form or include internal structures or passageways to assist in the flow of drug through applicator pad 110 and/or direct current preferentially toward target affected tissue. . In some embodiments, applicator pad 110 may include a colored dye.

Bleeding treatment system 100 is preferably configured to deliver one or more medications to target affected tissue during treatment, eg, via applicator pad 110 . The drug(s) may be contained in one or more reservoirs 150 (which may be separate from or integral to the applicator pad 110, as described above), and may be deposited into the reservoir(s) by one or more release mechanisms 160. It can be selectively released from 150 and transferred from reservoir(s) 150 to applicator pad 110 by one or more fluid couplings 155 . For example, the reservoir 150 may have a volume sufficient to contain a therapeutically effective amount of drug and may include glass, metal, plastic, polymer (e.g., rigid polymers such as polyethylene, polypropylene, polyamide, polycarbonate), and the like. It can be implemented as a container (such as an ampoule) formed of a material that is impermeable and non-reactive to the drug or its components. In some embodiments, reservoir 150 may be formed of a material (eg, plastic or glass) that can be broken or punctured to release the contents of reservoir 150 . Reservoir 150 may have an opening through which a drug may be introduced into and/or selectively released from reservoir 150 . In some embodiments, reservoir 150 may include vents.

The gripper portion 140 may be formed of any suitable material, at least the distal end (eg, optional plate) being formed of a relatively rigid material capable of applying adequate pressure to the applicator pad 110. do. For example, the grip portion 140 (or at least the body of the first portion of the grip portion 140) may be formed of a rigid polymer such as polyethylene, polypropylene, polyamide, and/or polycarbonate.

The reservoir 150 may be wholly or partially contained within the applicator pad 110 or may be coupled thereto via a fluid fitting 155 such as a tube, wick, or the like. The drug(s) may be selectively released from the reservoir 150 such that the drug(s) may be received within the applicator pad 110, for example by the release mechanism 160. The release mechanism 160 can be a valve that can be opened to establish fluid communication between the reservoir 150 and the applicator pad 110, for example directly or via a fluid coupling 155, and can also be a reservoir ( 150) can be selectively closed to fluidly isolate the drug(s) within. The release mechanism may be a removable or frangible cap or other closure that closes an opening in the reservoir 150 . Reservoir 150 itself may be brittle, for example formed of glass that is easily breakable, or at least partially made of a material that bursts when the contents of reservoir 150 exceed a critical pressure. , and the drug(s) can be released from the reservoir 150 by causing or allowing disruption of the reservoir 150. As described above, in some embodiments, reservoir 150 may be part of applicator pad 110 . For example, the material of the applicator pad 100 is impregnated or saturated with the drug(s), and the applicator seal 120 (e.g., a film of material that is impermeable and non-reactive to the drug(s)) or other thin layers). The drug(s) can be released from the reservoir 150 by removing the applicator seal 120, exposing the surface of the applicator pad 110 whereby the drug(s) is released from the surface of the applicator pad 110. It can be delivered to the affected tissue where the surface is placed in contact.

In some embodiments, the volume and material of the applicator pad 110, whether separate from the applicator pad 110 or integrated into the applicator 110, is the amount of drug(s) contained within the one or more reservoirs 150. The amount or amount of drugs pre-soaked into the applicator pad 110 is such that the applicator pad 110 is saturated by about 35% (i.e., about 35% of the amount of drug(s) it can hold). ) can be selected. In some embodiments, applicator pad 110 may be configured to be saturated between about 67 and about 100% by amount of drug(s). In some embodiments, the applicator pad 110 is configured to be saturated between about 25% and about 50% by the amount of drug(s). In some embodiments, applicator pad 110 may be pre-soaked or filled to hold a metered dose of medication. In some embodiments, the applicator pad 110 allows a volume of drug(s) to be effective in treating the affected area, but allows the drug to flow outside of the treatment area (e.g., down the user's arm or leg) and damage the user's skin. It may be configured not to move across (eg, configured to saturate about 35% or saturate between about 25% and about 50%).

The applicator pad 110 may be of any suitable shape and/or size sufficient to cover the target lesion, preferably. For example, the periphery of the applicator pad 110 may be formed into a circle, oval, oval, square, rounded square, rectangle, rounded rectangle, triangle, pentagon, hexagon, or any other suitable shape. As described above, the target lesion size to be covered by the applicator pad 110 may be less than about 3 centimeters in length and/or width, for example. In some embodiments, for example, applicator pad 110 may have a square perimeter with a side length of about 1.5 inches. In some embodiments, applicator pad 110 may have a smaller area. In some embodiments, applicator pad 110 may have a surface area between about 3.0 cm ² and about 7.0 cm ² . In some embodiments, applicator pad 110 may have a surface area between about 7.0 cm ² and about 12.0 cm ² . In some embodiments, applicator pad 110 may have a surface area between about 2 cm ² and about 25 cm ² . In some embodiments, applicator pad 110 may have a surface area of about 3 cm ² to about 10 cm ² or about 10 cm ² to about 20 cm ² . For example, a surface area of about 2 cm ² , about 3 cm ² , about 4 cm ² , about 5 cm ² , about 6 cm ² , about 7 cm 2 , about 8 cm ² , about 9 cm ^{2 ,} about 10 cm ² , about 11 cm ² , about 12 cm ² , about 13 cm ² , about 14 cm ² , about 15 cm ^{2 , about 16 cm 2} , about 17 cm ² , about 18 cm ² , about 19 ^{cm 2 ,} about 20 cm ² , about 21 cm ² , about 22 cm ² , about 23 cm ² , about 24 cm ² , or about 25 cm ² .

The applicator device 170 may be manipulated by the user to place the applicator pad 110 in a desired location, eg, adjacent to the affected area WD, and to deposit the applicator pad 110 in the desired location. may be any suitable device. For example, applicator device 170 may be a mechanical syringe comprising a barrel having a distal end suitable for attachment to applicator pad 110 and a proximal end grippable by a user. In some embodiments, reservoir 150, release mechanism 160, and/or fluid coupling 155 may be disposed within the barrel (eg, between plunger and applicator pad 110). In some embodiments, the applicator device 170 may include a plunger that is movable relative to the barrel and the user engages the distal end of the plunger relative to the plunger with the reservoir 150 and the contents of the reservoir 150 are transferred to the barrel. to apply a distally directed force to be pushed distally out of the distal end of the barrel and into contact with the applicator pad 110. For example, reservoir 150 may have a breakable neck portion separated from a body portion of reservoir 150 to release liquid from reservoir 150 in response to reservoir 150 being pressed against an internal ramp or ramp. can include Alternatively, the neck portion of the reservoir 150 may break from the reservoir due to engagement between the neck portion and the deformable sidewall of the applicator device 170 due to manipulation of the sidewall by the user.

In some embodiments, reservoir 150 is configured to be preferentially destroyed when a disruptive force is applied to the weakened or pre-scored region (e.g., a circumferential region). or a sidewall region). For example, in some embodiments, the weakened or pre-scored region may be at a mid-point location of the reservoir 150 along the central axis of the reservoir 150, adjacent to the shoulder of the reservoir 150; and/or on or near the first (eg, distal) or second (eg, proximal) end of the reservoir 150 . Reservoir 150 is formed due to (e.g., weakened or pre- in the scored area) may be configured to be destroyed. In some embodiments, this rotational, bending and/or vertical force may be applied through twisting and/or bending the gripping portion 140 on which the reservoir 150 is disposed. In some embodiments, the breaking force contacts a portion of the grip (eg, a deformable sidewall portion) with the sidewall of the reservoir 150 sufficiently forcefully to break the reservoir 150 and expel the contents of the reservoir 150. It can be applied by displacing (eg, squeezing) into one state. In some embodiments, the breaking force may be applied by rotating or translating a second portion of the gripping portion 140 relative to a first portion of the gripping portion 140 to apply a breaking force to the reservoir 150 .

In some embodiments, the ejection mechanism 160 is directed to the inside of the gripping portion 140 to concentrate a crushing force against the sidewall or end of the reservoir 150 and break (eg, crumble) the reservoir 150 . placed on a surface and pressed against the sidewall of the reservoir 150 (e.g., bending the grip 140, squeezing or pushing the outer portion of the grip 140 toward the reservoir 150, or the grip ( A force concentrating component (also referred to as a stress concentrating component) configured as a result of the rotation of the second portion of the gripping portion 140 relative to the first portion of the gripping portion 140 (eg, a ball such as a steel ball or a carbide tip) protrusions such as convex or sharp tipped protrusions). In some embodiments, gripper 140 may include a notched feature in the sidewall of gripper 140 so that gripper 140 can more easily bend about a preferred axis or plane that includes the notched feature. can

In some embodiments, the reservoir 150 and/or the grip 140 is such that, in the initial configuration of the system 100, the reservoir 150 is elongated along a longitudinal axis intersecting a plane containing the applicator pad 110; It may be placed in a vertical orientation while the applicator pad 110 is wetted with the contents of the reservoir 150 and/or while pressure is applied to the applicator pad 110 as it is placed on the affected area of the subject. In some embodiments, the contents of the reservoir 150 may be configured to flow from the reservoir 150 to the applicator pad 110 through the open distal end of the grip 140 . In some embodiments, the reservoir 150 and/or the grip 140 may, in the initial configuration of the system 100, the reservoir 150 along a longitudinal axis disposed substantially parallel to the plane containing the applicator pad 110. placed in a horizontal orientation while the applicator pad 110 is wetted with the contents of the reservoir 150 and/or while pressure is applied to the applicator pad 110 when placed on the affected area of the subject so that the can In some embodiments, the contents of the reservoir 150 may be configured to flow from the reservoir 150 through the sidewall of the grip 140 to the applicator pad 110 .

In some embodiments, the applicator device 170 includes a reservoir 150 and a reservoir 150 to prevent undesirable substances (eg, particles and/or glass fragments over a certain size) from reaching the applicator pad 110 . A filter (not shown) may be included between the applicator pads 110 . In some embodiments, applicator device 170 may not include reservoir 150, ejection mechanism 160, and/or fluid coupling 155, instead allowing the user to hold applicator pad 110 and target Applying the applicator pad 110 against the affected tissue and applying a distributed pressure to the applicator pad 110 may provide a handle capable of maintaining the pressure between the target affected tissue and the applicator pad 110 .

The gripping portion 140 provides a distributed force (eg, uniformly distributed force) to the applicator pad 110 so that the applicator pad 110 can apply to target affected tissue during use, for example. It can be used to increase blood pressure and improve hemostasis. Gripper 140 can be implemented in a variety of ways, including those described in specific embodiments below. For example, the gripping portion 140 is disposed on the distal end of the handle portion of the gripping portion 140 and extends laterally from the handle portion to contact the applicator pad 110 and apply a distributed force thereto. configured plates (also referred to herein as “fixed plates”). In some embodiments, the plate may be shaped and sized such that the plate has a greater length and width than the target affected tissue, such that the plate urges a sufficiently large portion of the applicator pad 110 into contact with the target affected tissue and It is possible to maintain a uniformly distributed pressure between the applicator pad 110 and the target affected tissue for a period of time. Accordingly, the gripping portion 140 may be used to provide sufficient hemostasis to the target affected tissue (eg, sufficient pressure in consideration of the hardness or modulus of the material(s) on which the applicator pad 110 is formed). to generate). In some embodiments, the grip 140 or a portion of the grip is deformable (eg, compressible) to force fluid out of the reservoir 150 disposed within the grip.

In some embodiments, applicator device 170 may selectively release applicator pad 110 . For example, gripping portion 140 is releasable from applicator pad 110 via pad connector 148 to apply applicator pad 110 to a patient's surface (eg, to target affected tissue). can be conjoined. The pad connector 148 is disconnected from the applicator pad 110 such that the grip 140 and pad connector 148 can be disconnected from the applicator pad 110 leaving the applicator pad 110 on the patient's surface. It can be. In some embodiments, the pad connector 148 engages the gripping portion 140 to the applicator pad 110 and allows the applicator pad 110 to be applied to the affected area without displacing the applicator pad 110 relative to the affected area. When placed in contact with the gripper 140 and/or the applicator pad 110 such that the gripper 140 can be released from the applicator pad 110 without displacing the applicator pad 110 relative to the affected area. ) may include one or more adhesive strips configured to be removed from. In some embodiments, pad connector 148 may include complementary hook and loop fastener portions coupled to gripping portion 140 and applicator pad 110 such that gripping portion 140 provides complementary hook and loop fastener portions. It can be releasably coupled to the applicator pad 110 by disengaging the loop fastener portion. In some embodiments, pad connector 148 may include a first engagement feature coupled to applicator pad 110 and a complementary second engagement feature coupled to gripper 140 . Complementary second engagement features (e.g., by receiving a portion of the first engagement feature within an opening of the second engagement feature, e.g., due to relative rotation between the features, or by opposing arms of the second engagement feature ( (by receiving a portion of the first coupling feature between the arms) to releasably engage the first coupling feature. In some embodiments, pad connector 148 may include a latch portion disposed on grip portion 140 configured to engage a hook portion disposed on applicator pad 110 .

In some embodiments, applicator pad 110 may include or be coupled to pad retainer 135 , which may be configured to hold applicator pad 110 in contact with target affected tissue. Pad retainer 135 may include, for example, adhesive on the skin-contacting side of applicator pad 110 (eg, is disposed around at least a portion of the periphery of applicator pad 110). ). In some embodiments, pad retainer 135 may include adhesive foam disposed around the periphery of applicator pad 110 . In some embodiments, the pad retainer 135 has a first portion coupled to an upper surface of the applicator pad 110 and is adapted to the subject's skin to hold the applicator pad 110 in position relative to the affected area on the skin. and an adhesive strip having a second portion configured to be coupled to the adhesive strip. In some embodiments, pad retainer 135 may include a bandage configured to be positioned over at least a portion of applicator pad 110 . In some embodiments, the bandage may be formed as a wrap configured to be wrapped around a portion of a subject's body (eg, arm or leg) that includes the affected area. In some embodiments, the bandage may be formed as a bandage configured to be applied over top of the applicator pad 110 and having an adhesive perimeter that is larger than the perimeter of the applicator pad 110 . In some embodiments, the bandage may include a convex portion configured to align with the affected area and be positioned in contact with an upper surface of the applicator pad 110 such that the applicator pad 110 is placed on the affected area and the bandage is applied to the applicator. When applied over the pad 110, the convex portion may apply a greater target pressure through the applicator pad 110 to the affected area than if the bandage did not include the convex portion. In some embodiments, after a period of time, the bulge can be removed from the subject, leaving the applicator pad 110 in place in contact with the affected area.

In some embodiments, applicator device 170 may be implemented as a pipette. The pipette may be configured in a manner most suitable for the accuracy and precision required for the size and location of the affected area. For example, a pipette may be configured to be placed within a patient's nostril.

The bleeding treatment system 100 may include a user guidance unit 190 . The user guidance unit 190 may include instructions for operating the bleeding treatment system 100 to treat a person experiencing an affected area requiring bleeding to be stopped. Instructions can be in the form of text and/or graphical information that can be presented on a fixed substrate (eg paper) or on a display (eg screen), and/or audible (voiced instructions). and/or other sensory modalities including tactile (haptic feedback to the user). User guide 190 may be any one or more component(s) of bleeding treatment system 100 including applicator device 170, packaging 190, applicator pad 110 and/or reservoir 150. ) or bonded (eg, mechanically attached). User guide 190 may be separate from, or associated with, any component of bleeding treatment system 100, such as packaging 195 with other components of bleeding treatment system 100. can be placed within. In some embodiments, user guide 190 may be wholly or partially implemented in software usable on a device such as a smartphone, for example downloaded onto a smartphone to use bleeding treatment system 100. It may be in the form of an “app” that can be executed by the user in preparation for

In some embodiments, user guide 190 or other information label disposed on or included with system 100 may include an information label that includes user instructions such as:

"Only apply to areas of epidermal bleeding less than 1 inch. Apply downward pressure with a topical applicator pad over the affected area for 5 minutes. Place an adhesive bandage over the affected area. If bleeding does not stop, seek professional medical attention. If If you feel faint or dizzy, call 911 immediately and do not use the device. Not for use by mouth. Not for use on deep wounds. Do not use if you have a history of seizures. Do not use on penetrating wounds or puncture wounds. Do not use (gunshot wounds, knives, etc.)."

In some embodiments, user guide 190 or other information label disposed on or included with system 100 may include an information label that includes user instructions such as:

"Only apply to epidermal hemorrhage lesions less than 3 inches in length. Depress the release device to destroy the drug. Allow the drug to completely cover the topical applicator. Apply downward pressure with the device over the affected area for 10 minutes. Place an adhesive bandage over the affected area. If bleeding does not stop or if you feel dizzy, unconscious, or tired, seek professional medical attention immediately Do not use orally Do not use in deep wounds Do not use if you have a history of seizures Do not use on penetrating wounds or puncture wounds (gunshot wounds, knives, etc.) Do not drink this drug. Keep out of reach of children or infants."

In some embodiments, user guidance 190 or other informational labels disposed on or included with system 100 may include one or more statements indicating one or more of the following:

(i) remove the applicator cap before pressing the device down onto the affected area; and (ii) peel the topical applicator from the rest of the device and use an adhesive bandage to hold the topical applicator on the affected area.

In some embodiments, user guide 190 or other informational label or stamp on system 100 may include an expiration date. For example, system 100 may have a shelf life of 3 years, greater than 3 years, or less than 3 years from the date of manufacture. In some embodiments, a user guide 190 or other informational label or stamp on system 100 may include a lot number and/or date of manufacture. In some embodiments, user guidance 190 or other informational labels or stamps on system 100 may include barcodes and/or quick response (QR) codes.

Packaging 195 is implemented in the same manner as any known medical device packaging to house the other components of bleeding treatment system 100, to protect the components from the environment, and optionally to preserve the sterility of the components. can do. Packaging 195 is preferably configured to be easily opened by a user when the user wishes to access and use bleeding treatment system 100, for example by peeling a cover from a tray. Packaging 195 can be implemented in a number of different ways including, for example, a bag or box. System 100 is preferably intended for single user and single site application. System 100 is preferably intended to be discarded after use, and may optionally include a container for safe disposal. In some embodiments, system 100 may originally be supplied to the user in packaging 195 that may also be used for disposal. In some embodiments, packaging 195 and/or disposal container may be a resealable bag and/or may include a biohazard label and/or disposal instructions.

The drug(s) disclosed herein may be any drug desirable for delivery to a patient experiencing a lesion requiring cessation of bleeding, either in preparation for or as part of treatment of the lesion. Categories of drugs include vasoconstrictors, antifibrinolytics, antibiotics, recombinant clotting factor drugs, local anesthetics, analgesics, buffering agents, calcium, alcohols/disinfectants (e.g., clohexidine and solutions of isopropyl alcohol and/or ethyl alcohol and chlorhexidine solution), or any combination thereof. Vasoconstrictors may be useful to help constrict bleeding vessels prior to or concurrently with the administration of hemostatic drugs such as antifibrinolytic agents, preferably prior to or during application of the applicator pad 110 to the target affected tissue. and/or thereafter delivered to the target affected tissue at or around the bleeding site. Suitable vasoconstrictors may include phenylephrine, oxymetazoline (Afrin), and epinephrine. The antifibrinolytic agent may be useful in preventing clot breakdown, and is also preferably delivered to affected tissue at or around a bleeding site before, during, and/or after application of the applicator pad 110 to the target affected tissue. can Suitable anti-fibrin solubilizing agents may include aminocaproic acid, tranexamic acid (TXA) (e.g., dried or lyophilized TXA or a liquid formulation containing TXA), aprotinin, protabenzobenzoic acid, and fibrinogen. . Protamine, an anticoagulant for the anticoagulant heparin, can be used before, during or after the use of the drug. The drug(s) may include, for example, protamine sulfate. As described above, the bleeding treatment system 100 and drug(s) may be used in patients who are sensitive to bleeding or may find it difficult to achieve hemostasis, such as patients taking anticoagulant and/or antiplatelet drugs (described above). can be particularly helpful in the treatment of

In some embodiments, the drug comprises a therapeutically effective amount of TXA, one or more antibiotic(s), one or more anesthetic(s), one or more non-steroidal anti-inflammatory drug(s), and/or an excipient or carrier that facilitates topical administration. It may include a pharmaceutical composition comprising. For example, in some embodiments, the therapeutically effective amount of tranexamic acid is 1 to 70% by weight of the composition. In some embodiments, the one or more antibiotic(s) include sulfacetamide, mupirocin, erythromycin, clindamycin, sulfadiazine, mafenide, tetracycline, bacitracin, neomycin, and polymyxin B. can do. In some embodiments, the one or more antibiotic(s) may include bacitracin, neomycin, and polymyxin B. In some embodiments, an excipient or carrier allows the composition to remain in contact with the bleeding lesion. In some embodiments, excipients or carriers include ointments, creams, liniments, pastes, lotions, gels, hydrogels, liposomes, sprays, aerosols, solutions, or emulsions. In some embodiments, an excipient or carrier permits instillation of the composition. In some embodiments, the one or more anesthetic agent(s) may include lidocaine, proparacaine, procaine, tetracaine, and combinations thereof. In some embodiments, the one or more non-steroidal anti-inflammatory drug(s) may include ketorolac, ketoprofen, flubiprofen, bromfenac, diclofenac, and/or combinations thereof.

In some embodiments, the drug is an opiate such as codeine, morphine, oxycodone, and the like; acetaminophen; anti-inflammatory agents including non-steroidal anti-inflammatory drugs, aspirin, and the like; with antibiotics or other antibacterial drugs or compounds; antihistamines (eg, cimetidine, chloropheniramine maleate, diphenhydramine hydrochloride, and promethazine hydrochloride); antifungal agents; ascorbic acid; Routine; thrombin; botanicals, etc.; and analgesics including, but not limited to, combinations thereof. Drugs may also include magnesium sulfate, sodium metaphosphate, calcium chloride, dextrins, and combinations thereof.

In some embodiments, the drug may include sterile water (which may be included as a carrier) and/or physiological saline. In some embodiments, the drug may include about 50% to about 100% tranexamic acid and about 50% to about 0% sterile water or physiological saline. In some embodiments, the drug may include about 10% to about 50% tranexamic acid and about 90% to about 50% sterile water or physiological saline. In some embodiments, the drug may include about 50% to about 90% tranexamic acid and about 10% to about 50% sterile water or physiological saline. In some embodiments, the drug may include at least one of a liquid and a gel. In some embodiments, the drug may have a viscosity of between about 0.75 milliPascal-second and about 0.98 milliPascal-second at about 25 degrees Celsius.

In some embodiments, the reservoir 150 may contain an activating liquid, such as sterile water or saline, and the applicator pad 110 may be dried (configured to be activated by the activating liquid upon release of the activating liquid from the reservoir 150). eg, lyophilized) drug. In some embodiments, the applicator pad 110 is adapted to the blood flowing from the affected area when the applicator pad 110 is placed in contact with the affected area such that the activating liquid disposed within the applicator device 170 is not necessary or supplemental. It may include a dried drug configured to be activated by In some embodiments, applicator pad 110 may include a wetting agent to enhance dissolution of the dried drug.

In some embodiments, the drug(s) is 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. antifibrinolytic agent in an amount of about 50 mg/mL to about 300 mg/mL. In some embodiments, the drug(s) may also contain a colored dye to indicate that the drug(s) have been dispensed to the affected area and are of a human-visible composition based on skin color and blood color (pre- and post-coagulation). . In other embodiments, the drug(s) may not contain colored dyes.

In some embodiments, the amount (eg, a therapeutically effective amount) of drug(s) (eg, an antifibrinolytic agent such as TXA) contained in a reservoir and/or provided to a target affected area from the reservoir is about 1 mg to about 20 mg, about 1 mg to about 5 mg, about 5 mg to about 10 mg, about 10 mg to about 15 mg, about 15 mg to about 20 mg, and/or about 10 mg to about 20 mg. . In some embodiments, a larger amount of drug(s) may be included for treatment of a larger target lesion size.

In some embodiments, the reservoir(s) 150 and/or release device 160 are configured such that a metered dose can be dispensed from the reservoir (eg, to the applicator pad 110 and/or to the patient). . A metered dose (eg, of IV TXA) may be an amount of liquid placed into reservoir(s) 150 prior to use of system 100 . In some embodiments, the metered dose is 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, It may be 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, the reservoir 150 can hold about 1 mL, or about 2 mL, or about 3 mL, or about 4 mL, or about 5 mL, or about 6 mL, or about 7 mL, or about 8 mL, or about 9 mL, or about 10 mL, or about 11 mL, or about 12 mL, or about 13 mL, or about 14 mL, or about 15 mL, or about 16 mL, or about 17 mL, or about 18 mL, or about 19 mL, or about 20 mL of metered doses.

A method of using the bleeding treatment system 100 to treat a wound requiring cessation of bleeding is illustrated in FIG. 4 and illustrated with reference to FIGS. 3A-3D. In some embodiments, the bleeding treatment system 100 may be operated with one hand (eg, the hand of a subject having a lesion in need of treatment or the hand of a caregiver). As shown in FIG. 4 and shown in FIG. 3A , in some embodiments, applicator device 170 may be removed from packaging 195 at 202 . User guide 190 can optionally review or initiate at 204 . Optionally, at 206 , the drug(s) may be released from the reservoir(s) 150 and delivered to the applicator pad 110 . The applicator pad 110 may be exposed at 208 for delivery to the lesion WD in the skin SK (eg, via removal of the optional applicator seal 120).

As shown in FIG. 4 and shown in FIG. 3B , the applicator pad 110 may be delivered at 210 to the affected area WD within the skin SK. As shown in FIG. 3A and referenced above, in some embodiments, the applicator pad 110 may be applied to the affected area WD and skin surrounding the affected area SK. It may be delivered to the affected area WD in the skin SK in, extending from, or coupled to the applicator device 170 to contact the area of the skin.

Applicator pad 110 may be pressed against affected area WD in skin SK, at 212 . For example, applicator pad 110 applies pressure (eg, pressure distributed across affected area WD) to applicator pad 110 using gripping portion 140 so as to prevent skin SK. It can be pressed against the affected part WD within. Alternatively or additionally, in some embodiments, the applicator pad 110 is applied to the affected area WD within the skin SK through the applicator pad 110 by applying pressure to the applicator pad 110 with a user's finger. can be pressed against.

The drug(s) may be allowed to be released from the applicator pad 110 at 214 to the affected area WD. For example, in some embodiments, the drug(s) flow through the fluid coupling 155 to the applicator pad 110 and then from the applicator pad 110 to the affected area WD. may be released from the reservoir 150 through interaction with the release mechanism 160 to In some embodiments, as described above, applicator pad 110 may include drug(s) prior to use of system 100 (eg, via pre-soaking), such that applicator seal 120 ) and application of the applicator pad 110 to the affected area WD (and/or the pressure applied to the applicator pad 110 when in contact with the affected area WD) ensures that the drug(s) is not removed from the affected area WD. Allow or cause movement to come into contact with In some embodiments, instead of or in addition to releasing the drug(s) from reservoir 150, an activating liquid, such as saline, is contained within applicator pad 110 (eg, initially dry). To activate the drug(s) can be released from the reservoir 150 so that the combination of drug(s) and activating liquid from the applicator pad can flow into contact with the affected area WD. In some embodiments, blood from the affected area (WD) may contact and activate the drug(s) (eg, initially dry) within the applicator pad 110, such that the drug (s) from the applicator pad ( s) and blood can flow to contact the affected area WD.

The applicator pad 110 may be held against the affected area WD at 216 with the pressure applied by the gripping portion 140 against the affected area WD. At 218, hemostasis may be assessed. For example, the hemostatic status of the affected area WD may be evaluated to determine whether the hemostatic status satisfies a target hemostasis status. The hemostatic status of the affected area (WD) may be assessed through any suitable method. For example, after a preset period of time (eg, 5 or 10 to 30 minutes), the applicator pad 110 may be removed and the wound WD checked to determine whether hemostasis has been achieved. there is.

In some embodiments, after evaluating hemostasis at 218, the applicator pad 110 may be held against the wound WD while continuing to apply pressure to the wound WD at 220, until hemostasis is achieved. may be re-evaluated. For example, if the hemostatic state of the affected area WD does not satisfy the target hemostasis condition, the applicator pad 110 may apply pressure to the affected area WD for a predetermined period of time and may be maintained against the affected area WD. The hemostatic status can then be re-evaluated to determine if the target hemostasis status has been met. This cycle may continue until the target hemostasis condition is met, at which time the applicator pad 110 may be removed from the affected area WD.

In some embodiments, prior to removal of the applicator pad 110 from the affected area WD at 222 , as shown in FIG. 3C , the pressure on the affected area WD may be released. For example, when the gripper 140 is used to apply pressure to the applicator pad 110, the gripper 140 reduces the pressure of the applicator pad 110 on the affected area WD. may be separated from the applicator pad 110 for In some embodiments, applicator pad 110 may be held against affected area WD at 224 after pressure is released (eg, after removal of gripper 140 ). In some embodiments, applicator pad 110 may be held in place relative to affected area WD by pad retainer 135 . In some embodiments, a bandage or wrap may be applied to the applicator pad 110 to hold the applicator pad 110 against the affected area WD for a period of time. In some embodiments, the applicator pad 110 may continue to apply pressure to the affected area WD after removal of the gripping portion 140 (eg, due to maintaining contact with the affected area WD). In some embodiments, the applicator pad 110 applies pressure to the affected area WD at least in part due to expansion of the applicator pad 110 or blood absorption pad 130 due to liquid (eg, blood) absorption. can continue to apply. As shown in FIG. 3D , the applicator pad 110 may be removed from the affected area WD at 226 .

5 is a schematic diagram of a bleeding treatment system 300 . System 300 may be identical or similar in structure and/or function to any of the bleeding treatment systems disclosed herein. System 300 includes an applicator device 370 , an applicator pad 310 and an optional reservoir 350 . The applicator device 370 includes a grip 340 having a first portion 342 (also referred to as a “first section”). The first portion 342 selectively forms an interior space 343 . In some embodiments, first portion 342 optionally defines an open distal end such that interior space 373 can be fluidly coupled to the applicator pad through the distal end of first portion 342 .

First portion 342 can be formed in any suitable shape. For example, first portion 342 can include a cylindrical or tubular housing. In some embodiments, first portion 342 includes or is coupled to plate 341 disposed at the distal end of first portion 342 and configured to apply pressure to applicator pad 310 and thus to a target affected area. It can be. The plate 341 may form the bottom surface of the gripping portion 340 . In some embodiments, for example when grip 340 does not include a reservoir, plate 341 may be formed as a continuous plate. In some embodiments, plate 341 may be formed as a flange extending from the bottom edge of first portion 342 (eg, a circumferential flange).

In some embodiments, the grip 340 may be used to contaminate the applicator pad 310 prior to use and optionally to prevent leakage from the applicator pad 310 or drying of the applicator pad 310 . and an applicator seal 310 configured to cover at least the distal or skin contacting surface of 310 . The applicator seal 310 may be formed, for example, as a film (eg, a peelable film). In some embodiments, the applicator seal 310 may be formed of a shrink wrap material covering the distal end of the applicator pad 310 and positioned over at least a portion of the length of the first portion 342 .

Applicator pad 310 may be identical or similar in structure and/or function to any of the applicator pads disclosed herein. For example, the applicator pad 310 may include and/or be coupled to an optional blood absorbent pad 330 and/or an optional pad retainer 335 . Blood absorbent pad 330 and pad retainer 335 may have the same or similar structure and/or function as any blood absorbent pad or pad retainer, respectively, disclosed herein.

As shown in FIG. 5 , reservoir 350 may be disposed within optional interior space 343 . In some embodiments, reservoir 350 is displaced such that liquid (eg, drug and/or an activating liquid such as saline) within reservoir 350 flows from reservoir 350 to applicator pad 310 and/or Or it can be configured to be pressurized. For example, reservoir 350 may include a release mechanism 360 and/or fluid coupling 355, which may be identical or similar in structure and/or function to any release mechanism and/or fluid coupling disclosed herein. may optionally be included. In some embodiments, the fluid coupling 355 provides a portion of the interior space 343 formed by the housing of the first portion 342 through which liquid can flow from the reservoir 350 to the applicator pad 310. may be part of it. In some embodiments, fluid coupling 355 includes a separate tubular member defining a lumen through which liquid can flow from reservoir 350 to applicator pad 310 .

In some embodiments, delivery device 370 may include an optional second portion 344 (also referred to as “second section”). In some embodiments, second portion 344 may be configured to engage reservoir 350 and/or ejection mechanism 360 to initiate delivery of liquid from reservoir 350 to applicator pad 310 . In some embodiments, the second portion 344 is formed as a plunger and is at least partially relative to the first portion 342 to apply pressure to the reservoir 350 (e.g., into the interior space 343 or at least partially). The reservoir 350 may be advanced by a user (eg, a self-administering home user, caregiver, or patient) while in contact with the reservoir 350 to advance itself. In some embodiments, the second portion 344 may be disposed on a sidewall of the first portion 342 and configured to be pushed laterally into the interior space 343 to apply pressure to the reservoir 350. can

In some embodiments, the interior space 343 can be formed at least in part by an inner surface of the sidewall of the gripping portion 340, and can be formed by the first portion 342 and/or the second portion 344. can In some embodiments, the inner and/or outer surfaces of the sidewalls of gripping portion 340 (including first portion 342 and second portion 344) may have a round cylindrical shape, an ovoid cylindrical shape, an elliptical cylindrical shape, 2 Tubular shapes having two opposite flat sides joined together by two opposite curved sides, and/or prisms, including cubes, rounded square prisms, rectangular prisms, rounded rectangular prisms, triangular prisms, pentagonal prisms, hexagonal prisms, etc. It can have any suitable shape, such as a shape. In some embodiments, the inner surface of the gripping portion 340 defining the interior space 343 includes one or more rounded or beveled edges. In some embodiments, the inner surface of the gripping portion 340 defining the inner space 343 includes a rounded rectangular prism shape with one or more rounded edges. In some embodiments, interior space 343 is cylindrical.

In some embodiments, the release mechanism 360 can be coupled to the reservoir 350 and a pressure greater than a threshold pressure within the reservoir 350 (eg, applied by the distal end of the second portion 344). responsive to allow the drug to flow from the reservoir 350 to the applicator pad 310 through the fluid coupling 355 to transition from the closed state to the open state. For example, in some embodiments, release mechanism 360 may include a weakened or weakened portion of the sidewall of reservoir 350 . In some embodiments, release mechanism 360 includes a valve that transitions from a closed state to an open state when the internal pressure of reservoir 350 rises above a threshold pressure. In some embodiments, release mechanism 360 when pushed against an internal obstruction (not shown) such as a lamp portion in interior space 343 such that the drug in reservoir 350 can be released from reservoir 350. It may be a weak part of the reservoir 350 configured to be destroyed. In some embodiments, first portion 372 includes a filter (not shown) between reservoir 350 and applicator pad 310 to prevent unwanted material from reaching applicator pad 310 . can do.

Prior to use, the applicator device 370 may be placed in an initial configuration. In an initial configuration, applicator pad 310 may be coupled to the distal end of gripper 340 . Applicator seal 320 may cover applicator pad 310 . To use the applicator device 370, the applicator seal 320 can optionally be removed and the grip 340 can be used to apply the applicator pad 310 to the affected area. In embodiments that include a reservoir 350, a release mechanism 360, and a fluid coupling 355, a liquid (eg, drug and/or active agent such as saline) is applied to the affected area to apply the applicator pad 310. can be immersed in storage 350 before and optionally after. To release the liquid from the reservoir 350 so that the liquid flows to the applicator pad 310, the second portion 344 is coupled with the first portion 342 to engage the reservoir 350 and/or the ejection mechanism 360. may be configured to move relative to (eg, via translation relative to the first portion 342 , radial movement relative to the first portion 342 , and/or rotational movement relative to the first portion 342 ). .

Applicator pad 310 can be selectively pressed against target affected tissue using gripping portion 340 . Applicator pad 310 is applied to the affected area by coupling applicator pad 310 to the skin via pad retainer 335 (eg, without holding grip 340 against applicator pad 310). can be maintained selectively. Applicator pad 310 may be selectively disconnected from applicator pad 310 by releasing applicator pad 310 from pad connector 348 .

6A and 6B are perspective and cross-sectional views of a bleeding treatment system 400 . 6C is a cross-sectional view of the bleeding treatment system in which the reservoir 450 of the bleeding treatment system 400 is not shown. System 400 may be identical or similar in structure and/or function to any delivery or treatment system disclosed herein. For example, system 400 includes applicator device 470 , reservoir 450 and applicator pad 410 . The applicator device 470 includes a gripping portion 440 defining an interior space 443 and having an open distal end and a closed proximal end and extending along a central longitudinal axis A. The gripping part 440 has a first part 442 and a second part 444 , and the second part 444 is movable relative to the first part 442 . Reservoir 450 may be formed as an ampoule having a neck portion 452 and a body portion 454 . Neck portion 452 may be narrower than body portion 454 (eg, may have a smaller diameter). The reservoir 450 may be disposed within the inner space 443 of the gripping part 440 . The reservoir 450 may be oriented such that the neck portion 452 is distal to the body portion 454 and thus closer to the open end of the grip portion 440 . The interior space 443 may be formed at least in part by the inner surface of the sidewall of the gripping portion 440 and may be formed by the first portion 442 and/or the second portion 444 . The gripping portion 440 (eg, inner surface and/or outer surface) has a tubular shape with two opposing flat sides joined together by two opposing curved sides, as shown in FIG. 6A. can be formed In some embodiments, gripping portion 440 may have any suitable shape as described above with respect to gripping portion 340 .

The first portion 442 may include a plate 431 having a distal or bottom surface extending laterally with respect to the central axis A of the gripping portion 440 . Applicator pad 410 may be disposed on the distal end of first portion 442 (eg coupled to the distal surface of plate 431 ). The first portion 442 partially extends into the interior space 443 of the first portion 442 so that the neck portion 452 can contact the lamp portion 462 (also referred to as the first emission mechanism portion). It may include a lamp portion 462 to be. First portion 442 also extends toward central axis A of first portion 442 and is at a proximal end of reservoir 450 for advancing reservoir 450 relative to one or more retaining portions 447. One or more retaining portions 447 configured to contact the shoulder of the body portion 454 of the reservoir 450 as shown in FIG. 6B to hold the reservoir 450 in the initial proximal position until sufficient force is applied ( For example, a flexible tab or bump portion) may be included. First portion 442 may also include one or more gripping features 445 on an outer surface of the sidewall of first portion 442 to enhance a user's grip during handling of gripper 440 . The gripping features 445 can be any suitable for increasing gripping or friction, such as one or more ridges (as shown in FIG. 6A ), concave and/or convex curvatures, and/or textured or rough surfaces. It may contain surface features.

The second portion 444 can include a protrusion 464 (also referred to as a second ejection 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 . there is. For example, first portion 442 may be coupled to second portion 444 via any suitable coupling mechanism, such as, for example, a flexible portion circumferential portion. The second portion 444 (eg, by pressing the proximal end of the second portion 444) releases the liquid in the reservoir 450 so that the liquid flows to the applicator pad 410. 442) so that the second release mechanism portion 464 applies a force to the proximal end of the reservoir 450 to compress the reservoir 450 distally, thereby distally compressing the neck of the reservoir 450. Contact between portion 452 and lamp portion 462 causes neck portion 452 to separate (eg, break) from the remainder of reservoir 450 and allow liquid to flow from reservoir 450 to the first portion. out of the distal end of 442 and into applicator pad 410, allowing applicator pad 410 to be wetted with liquid from reservoir 450.

In some embodiments, first portion 442 may include a filter to prevent unwanted material (eg, particles and/or glass fragments over a certain size) from reaching applicator pad 410 . there is. Before or after wetting the applicator pad 410 with liquid, the distal surface of the applicator pad 410 may be placed against the affected area of the subject. Grip 440 then presses against applicator pad 410 such that plate 431 applies a distributed pressure to applicator pad 410 for a period of time, as described with respect to method 200 above. can be maintained In some embodiments, first portion 442 and/or second portion 444 may be deformable (eg, compressible) to force fluid (eg, drug) out of reservoir 450 . . In some embodiments, bleeding treatment system 400 may be operated with one hand (eg, the hand of a subject having an affected area in need of treatment). For example, a user may place a thumb on the proximal end of the second portion 444 and move around the sidewall of the gripping portion 440 with at least some of the remaining fingers in contact with the gripping feature 445 ( For example, the remaining fingers of the same hand may be wrapped around the first portion 442 . While gripping the gripper 440 in this configuration, either before or after pressing the applicator pad 410 against the affected area, the user applies with the user's thumb to expel liquid from the reservoir 450 as described above. The second portion 444 may be pressed toward the base pad 410 .

7A to 7D are perspective, front, side, and cross-sectional schematic views of the bleeding treatment system 500 in an initial configuration, respectively. 7E-7H are schematic views, respectively, of a bleeding treatment system 500 in a wet configuration in perspective, front, side, and cross-sectional views. System 500 may be identical or similar in structure and/or function to any delivery or treatment system disclosed herein, such as, for example, bleeding treatment system 400 . For example, system 500 includes applicator device 570 , reservoir 550 and applicator pad 510 . The applicator device 570 includes a gripping portion 540 defining an interior space 543 and having an open distal end and a closed proximal end and extending along a central longitudinal axis D. The gripping portion 540 has a first portion 542 and a second portion 544 , and the second portion 544 is movable relative to the first portion 542 . Reservoir 550 may be formed as an ampoule having a neck portion 552 and a body portion 554 . Neck portion 552 may be narrower (eg, may have a smaller diameter) than body portion 554 . The reservoir 550 may be disposed within the inner space 543 of the gripping part 540 . Reservoir 550 may be oriented such that neck portion 552 is distal to body portion 554 and thus closer to the open end of grip portion 540 . The interior space 543 may be formed in part by the inner surfaces of the sidewalls of the first portion 542 and the second portion 544 .

The first portion 542 may include a plate 531 having a distal or bottom surface extending laterally with respect to the central axis D of the gripping portion 540 . Applicator pad 510 may be disposed on the distal end of first portion 542 (eg coupled to the distal surface of plate 531 ). The first portion 542 partially extends into the interior space 543 of the first portion 542 so that the neck portion 552 can contact the lamp portion 562 (also referred to as the first emission mechanism portion). It may include a lamp portion 562 to be. First portion 542 also extends toward central axis A of first portion 542 and is at a proximal end of reservoir 550 for advancing reservoir 550 relative to one or more retaining portions 547. One or more retaining portions 547 configured to contact the shoulder of the body portion 554 of the reservoir 550 as shown in FIG. 6B to hold the reservoir 550 in the initial proximal position until sufficient force is applied ( For example, a flexible tab or bump portion) may be included. First portion 542 can also include one or more gripping features 545 on an outer surface of the sidewall of first portion 542 to enhance a user's grip during handling of gripper 540 .

The second portion 544 can include a protrusion 564 (also referred to as a second ejection mechanism portion) extending 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 . there is. For example, the second portion 544 can include a slidable engagement portion 544A, and the first portion 542 can include a slideable engagement portion 544A (eg, the second portion 544). The slidable engagement portion (by pressing the proximal end of the second portion 544 and/or gripping opposing sidewalls of the second portion 544 and advancing the second portion 544 distally) so that it can be translated into the receiving portion 544B. 544A) and a receiving portion 544B having a shape corresponding to and a periphery larger than its outer diameter. During translation of the slidable coupling portion 544A to the receiving portion 544B, the second ejection mechanism portion 564 applies a force to the proximal end of the reservoir 550 to engage the neck portion 552 and the reservoir 550. Contact between the lamp portions 562 causes the neck portion 552 to separate (eg break) from the remainder of the reservoir 550 and allow liquid to flow from the reservoir 550 to the distal end of the first portion 542 . The reservoir 550 may be urged distally to cause the flow out and into the applicator pad 510 to wet the applicator pad 510 with the liquid from the reservoir 550 .

In some embodiments, first portion 542 is a filter (eg, to prevent unwanted material (eg, particles over a certain size and/or glass fragments) from reaching applicator pad 510 . , disposed between the ramp 562 and the distal opening of the grip 540). Before or after wetting the applicator pad 510 with the liquid, the distal surface of the applicator pad 510 may be placed against the affected area of the subject. The grip 540 is then directed to the applicator pad 510 such that the plate 531 applies a distributed pressure to the applicator pad 510 for a period of time, as described with respect to method 200 above. can be maintained for In some embodiments, bleeding treatment system 500 may be operated with one hand (eg, the hand of a subject having an affected area in need of treatment). For example, a user may place a thumb on the proximal end of second portion 544 and place the remaining fingers of the same hand on the sidewall of gripping portion 540 such that at least a portion of the remaining fingers contact gripping feature 545 . may be wrapped around (eg, around first portion 542 ). While gripping the gripper 540 in this configuration, either before or after pressing the applicator pad 510 against the affected area, the user presses the second portion 544 with the thumb of the user towards the applicator pad 510. may be pressurized to expel the liquid from the reservoir 550 as described above.

8 is a schematic diagram of a bleeding treatment system 600 . Bleeding treatment system 600 may have the same or similar structure and/or function as any bleeding treatment system disclosed herein, such as bleeding treatment system 400 or bleeding treatment system 500 . For example, bleeding treatment system 600 includes applicator device 670 , reservoir 650 , and applicator pad 610 . The applicator device 670 includes an applicator pad 610 and optionally a sheath 620 configured to be releasably coupled to the distal end of the first portion 642 . The applicator device 670 includes a gripping portion 640 that includes a first portion 642 and a second portion 644 . First portion 642 has an open distal end and an open proximal end such that a reservoir 650 can be inserted into the proximal end of first portion 642 and placed in interior space 643 . The second portion 644 can then be coupled to the proximal end of the first portion 642 . The second portion 644 extends into the interior space 643, contacts the reservoir 650, and directs the reservoir and/or liquid in the reservoir to an applicator pad 610 disposed at the distal end of the first portion 642. and a protrusion 664 configured to press toward.

To use the bleeding treatment system 600 to treat the 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 can be coupled to the proximal end of the first portion 642 . Cover 620 may be removed from applicator pad 610 . The second portion 644 can then be advanced distally in the direction of arrow A to apply pressure to the reservoir 650 . Liquid is released from the reservoir 650 such that the drug M is disposed on the applicator pad 610 using any suitable reservoir and release mechanism structures, such as any of the reservoir and release mechanism structures disclosed herein. It may flow to the applicator pad 610 .

9A and 9B are perspective and cross-sectional views of a bleeding treatment system 700 . 9C is a cross-sectional view of the bleeding treatment system in which the reservoir 750 of the bleeding treatment system 700 is not shown. System 700 may be identical or similar in structure and/or function to any delivery or treatment system disclosed herein. For example, system 700 may include applicator device 770 , reservoir 750 and applicator pad 710 . The applicator device 770 may have a gripping portion 740 defining an interior space 743 and having an open distal end and a closed proximal end and extending along a central longitudinal axis B. The grip has a first portion 742 and a second portion 744 , the second portion 744 being movable laterally relative to the first portion 742 . Reservoir 750 may be formed as an ampoule having a neck portion 752 and a body portion 754. Neck portion 752 may be narrower than body portion 754 (eg, may have a smaller diameter). The reservoir 750 may be disposed within the inner space 743 of the gripping portion 740 . The reservoir 750 can be oriented such that the neck portion 752 is distal to the body portion 754 and thus closer to the open end of the grip portion 740 . The interior space 743 may be formed at least in part by an inner surface of the sidewall of the gripping portion 740 and may be formed by a combination of the first portion 742 and the second portion 744 . The gripping portion 740 (eg, inner surface and/or outer surface) may be formed as shown in FIG. 8A , comprising two opposing flat sides joined together by two opposing curved sides. It has a tubular shape with In some embodiments, gripping portion 740 may have any suitable shape as described above with respect to gripping portion 340 .

The first portion 742 can include a plate 731 having a distal or bottom surface extending laterally with respect to the central axis B of the gripping portion 740 . Applicator pad 710 may be disposed on the distal end of first portion 742 (eg coupled to the distal surface of plate 431 ). The first portion 742 also extends toward the central axis B of the first portion 742 and contacts the shoulder of the body portion 754 of the reservoir 750 to hold the reservoir 750 in a proximal position. It may include one or more retaining portions (not shown) configured to (eg, flexible tabs or bump portions). In some embodiments, instead of or in addition to including one or more retaining portions in contact with the shoulders of body portion 754 , first portion 742 is such that neck portion 752 interlocks with second portion 744 . It may include retaining portions such as adhesive and/or inner sidewalls in frictional contact with body portion 754 to hold body portion 754 in a radially aligned position.

The second portion 744 can be formed as a deformable sidewall portion disposed within the opening formed by the first portion 742 . The second portion 744 is deformable and/or extends laterally toward the central axis B and toward the neck portion 752 of the reservoir 750 in the initial configuration and includes a protrusion 762 (also referred to as an ejection mechanism portion). referred to) may optionally be included. The second portion 744 will be deformed by being pushed in by a user's finger to force the protrusion 762 into sufficient contact with the neck portion 752 to break the neck portion 752 and expel the liquid in the reservoir 750. can In some embodiments, the second portion 744 intersects the neck portion 752 to break the neck portion 752 such that the second portion 744 does not include the protruding portion 762 and operates as an ejection mechanism portion. The second portion 744 can deform sufficiently so that it can be pressed into sufficient contact. In some embodiments, second portion 744 may be formed of, for example, silicone or a similar elastomeric material. Although not shown, in some embodiments, the gripping portion 740 may include a lamp portion that may have the same or similar structure and/or function as the lamp portion 562 . The lamp portion may be deformed such that the second portion 744 presses the neck portion 552 into the lamp portion such that the neck portion 552 breaks against the body portion 554 ( 744) can be arranged.

As shown in FIG. 8B , first portion 742 can include a closed proximal end and an open distal end. The first portion 742 is coupled to the flexible end of the first portion 742 and, when depressed by a user's finger, contacts the proximal end of the reservoir 750 and urges the reservoir 750 distally. It may optionally include a protruding portion 764 configured (or to force liquid fluidly out of the reservoir 750).

To release the liquid in the reservoir 750 and allow the liquid to flow to the applicator pad 710, the second portion 744 can be deflected laterally relative to the neck portion 752 (e.g., with the thumb and thumb). Contact between the second portion 744 and the neck portion 752 of the reservoir 750 (by pressing the second portion 744 with the same user's finger) is such that the neck portion 752 is the body of the reservoir 750 ( 754) and allow liquid to flow from the reservoir 750, out of the distal end of the first portion 742, and to the applicator pad 710, 410 is wetted with liquid from reservoir 750.

The second portion 744 can include one or more gripping features 745 on an outer surface of the second portion 742 to enhance a user's grip during handling of the gripper 740 . Grip feature 745 can be any suitable surface feature to increase grip or friction, such as one or more ridges (as shown in FIG. 8A ), concave and/or convex curvatures, and/or textured or rough surfaces. can include

In some embodiments, first portion 742 may include a filter to prevent unwanted material (eg, particles and/or glass fragments over a certain size) from reaching applicator pad 710 . there is. Before or after wetting the applicator pad 710 with the liquid, the distal surface of the applicator pad 710 may be placed against the affected area of the subject. The grip 740 is then directed to the applicator pad 710 such that the plate 731 applies a distributed pressure to the applicator pad 710 for a period of time, as described with respect to method 200 above. can be maintained for In some embodiments, first portion 742 and/or second portion 744 are deformable (eg, compressed) (eg, after neck portion 752 is separated from body portion 750 ). possible) to press the drug out of the reservoir 750. In some embodiments, bleeding treatment system 700 may be operated with one hand (eg, the hand of a subject having an affected area in need of treatment). For example, a user may place a thumb on the second portion 744 and wrap the remaining fingers of the same hand around the sidewall of the grip 740 (eg, around the first portion 742 ). there is. While gripping the gripping portion 740 in this configuration, before or after pressing the applicator pad 710 against the affected area, the user applies the second portion 744 with the user's thumb to the neck portion (as described above). 752) to expel the liquid from the reservoir 750.

10A and 10B are perspective and cross-sectional views of a bleeding treatment system 800 . 10C is a cross-sectional view of the bleeding treatment system in which the reservoir 850 of the bleeding treatment system 800 is not shown. System 800 may be identical or similar in structure and/or function to any delivery or treatment system disclosed herein. For example, system 800 may include applicator device 870 , reservoir 850 and applicator pad 810 . The applicator device 870 may include a gripping portion 840 defining an interior space 843 and having an open distal end and a closed proximal end and extending along a central longitudinal axis C. The gripping portion has a first portion 842 and a second portion 844 , the second portion 844 being 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. Neck portion 852 may be narrower (eg, may have a smaller diameter) than body portion 854 . The reservoir 850 may be disposed within the inner space 843 of the gripping portion 840 . The reservoir 850 can be oriented such that the neck portion 852 is distal to the body portion 854 and thus closer to the open end of the grip portion 840 . The interior space 843 may be formed at least in part by an inner surface of the sidewall of the gripping portion 840 and may be formed by the first portion 842 and/or the second portion 844 . The gripping portion 840 (eg, inner surface and/or outer surface) may be formed to have a cylindrical shape as shown in FIG. 9A. In some embodiments, gripping portion 840 may have any suitable shape as described above with respect to gripping portion 340 .

The first portion 842 can include a plate 831 having a distal or bottom surface extending laterally with respect to the central axis C of the gripping portion 840 . Applicator pad 810 may be disposed on the distal end of first portion 842 (eg coupled to the distal surface of plate 831 ). The first portion 842 is a lamp portion 862 (first emission mechanism) partially extending into the inner space 843 of the first portion 842 so that the neck portion 852 can contact the lamp portion 862. Also referred to as parts). The first portion 842 also extends toward the central axis C of the first portion 842 and contacts the shoulder of the body portion 854 of the reservoir 850 as shown in FIG. 9B to form the reservoir 850. One or more retention portions (not shown) configured to hold the reservoir 850 in an initial proximal position until sufficient force is applied to the proximal end of the reservoir 850 to advance the reservoir 850 relative to the one or more retention portions (eg For example, a flexible tab or bump portion). First portion 842 may also include one or more gripping features (not shown) on an outer surface of the sidewall of first portion 842 to enhance a user's grip while handling gripper 840. there is. The gripping features may include any suitable surface feature to increase gripping or friction, such as one or more ridges, concave and/or convex curvatures, and/or textured or rough surfaces.

The second portion 844 can include a distal-facing inner surface 864 (also referred to as a second ejection mechanism portion). The first portion 842 and the second portion 844 can be coupled so that the second portion 844 can be advanced relative to the first portion 842 toward the distal end of the first portion 842 . there is. For example, first portion 842 may be coupled to second portion 844 via any suitable coupling mechanism, such as, for example, a threaded or slidable friction fitting. The second portion 844 can have an inner diameter greater than the outer diameter of the proximal end of the first portion 842 so that the second portion 844 can be placed in contact with an outer surface of the first portion 842 . The reservoir 850 can be placed in an initial position within the interior space 843 such that the proximal end of the reservoir is adjacent to or proximate the distal-facing interior surface 864, as the second portion 844 is displaced distally. It can be advanced in the distal direction. To expel the liquid in the reservoir 850 so that the liquid flows to the applicator pad 810, the second portion 844 forces the inner surface 864 to apply a force to the proximal end of the reservoir 850, causing the reservoir 850 to flow. Contact between the neck portion 852 and the beveled portion 862 of ) causes the neck portion 852 to separate (eg, break) from the remainder of the reservoir 850 (eg, the body 854). and allows liquid to flow from the reservoir 850, out of the distal end of the first portion 842, and into the applicator pad 810, so that the applicator pad 810 is able to drain the liquid from the reservoir 850. may be advanced distally against the first portion 842 (eg, by pressing the proximal end of the second portion 844 ) to urge the reservoir 850 distally to wet it with .

In some embodiments, first portion 842 may include a filter to prevent unwanted material (eg, particles and/or glass fragments over a certain size) from reaching applicator pad 810 . there is. Before or after wetting the applicator pad 810 with the liquid, the distal surface of the applicator pad 810 may be placed against the affected area of the subject. The grip 840 is then directed to the applicator pad 810 such that the plate 831 applies a distributed pressure to the applicator pad 810 for a period of time, as described with respect to method 200 above. can be maintained for In some embodiments, first portion 842 and/or second portion 844 is deformable (eg, compressible) to press medication from reservoir 850 . In some embodiments, bleeding treatment system 800 may be operated with one hand (eg, the hand of a subject having an affected area in need of treatment). For example, a user may place a thumb on the proximal end of second portion 844 and the other fingers of the same hand around the sidewall of grip 840 (eg, around first portion 842 ). can be wrapped While gripping the gripper 840 in this configuration, either before or after pressing the applicator pad 810 against the affected area, the user uses their thumb to expel liquid from the reservoir 850 as described above. The second portion 844 may be pressed against the applicator pad 810 .

11A and 11B are cross-sectional views of a bleeding treatment system 900 with and without a reservoir 950 shown, respectively. System 900 may be identical or similar in structure and/or function to any delivery or treatment system disclosed herein. For example, system 900 may include applicator device 970 , reservoir 950 and applicator pad 910 . The applicator device 970 may include a gripping portion 940 defining an interior space 943 and having an open distal end and a closed proximal end and extending along a central longitudinal axis D. The gripping portion has a first portion 942 and a second portion 944 , the second portion 944 being movable relative to the first portion 942 . Reservoir 950 may be formed as an ampoule having a neck portion 952 and a body portion 954 . Neck portion 952 may be narrower (eg, may have a smaller diameter) than body portion 954 . The reservoir 950 may be disposed within the inner space 943 of the gripping part 940 . The reservoir 950 can be oriented such that the neck portion 952 is distal to the body portion 954 and thus closer to the open end of the grip portion 940 . The interior space 943 may be formed at least in part by an inner surface of the sidewall of the gripping portion 940 and may be formed by the first portion 942 and/or the second portion 944 . The gripping portion 940 (eg, inner surface and/or outer surface) may be formed in a cylindrical shape. In some embodiments, gripping portion 940 may have any suitable shape as described above with respect to gripping portion 340 .

The first portion 942 can include a plate 931 having a distal or bottom surface extending laterally with respect to the central axis D of the gripping portion 940 . Applicator pad 910 may be disposed on the distal end of first portion 942 (eg coupled to the distal surface of plate 931 ). The first portion 942 is a lamp portion 962 (first emission mechanism) extending partially into the inner space 943 of the first portion 942 so that the neck portion 952 can contact the lamp portion 962. Also referred to as a part) may include. The first portion 942 also extends toward the central axis D of the first portion 942 and allows sufficient force at the proximal end of the reservoir 950 to advance the reservoir 950 relative to the one or more retaining portions. One or more retaining portions (not shown) configured to contact the shoulder of the body portion 954 of the reservoir 950 to hold the reservoir 950 in the initial proximal position until applied (e.g., a flexible tab or bump portion) may be provided. First portion 942 may also include one or more gripping features (not shown) on an outer surface of the sidewall of first portion 942 to enhance a user's grip while handling gripper 940 . there is. The gripping features may include any suitable surface feature to increase gripping or friction, such as one or more ridges, concave and/or convex curvatures, and/or textured or rough surfaces.

The gripping portion may include a spring portion 946 . The first portion 942 and the second portion 944 can be coupled such that the second portion 944 can be advanced relative to the first portion 942 toward the distal end of the first portion 942 . For example, first portion 942 may be coupled to second portion 944 via any suitable coupling mechanism, such as, for example, a threaded or slidable friction fitting. The second portion 944 can have an inner diameter greater than the outer diameter of the proximal end of the first portion 942 so that the second portion 944 can be placed in contact with an outer surface of the first portion 942 . Reservoir 950 can be placed in an initial position within interior space 943 such that the proximal end of the reservoir is adjacent to or proximate distally-facing inner surface 964, as second portion 944 is displaced distally. It can be advanced in the distal direction. In some embodiments, spring portion 946 may be configured to transition from an initial configuration to an expansion or compression configuration to bring reservoir 950 into contact with ramp 962 . For example, spring portion 946 may be operable to urge ramp 962 away from applicator pad 910 into breaking contact with neck portion 952 . In some embodiments, spring portion 946 may be operable to pull or push reservoir 950 into contact with lamp 962 . The second portion 944 may be coupled with the spring portion 946 such that depression or twisting of the second portion 944 actuates the spring portion 946 . Thus, to release the liquid in the reservoir 950 so that the liquid flows to the applicator pad 910, the second portion 944 causes the spring portion 946 to be released from its initial configuration (e.g., the second portion 944). It can be twisted or advanced distally relative to the first portion 942 (through rotation or pressing of the proximal end of 944). The spring portion 946 then causes contact between the lamp 962 and the neck portion 952 of the reservoir 950 to prevent the neck portion 952 away from the remainder of the reservoir 950 (e.g., body 954). Allow to separate (eg, break) and allow liquid to flow from the reservoir 950, out of the distal end of the first portion 942, and into the applicator pad 910 so that the applicator pad 910 Reservoir 950 and/or ramp 962 may be translated to wet with liquid from 950 .

In some embodiments, first portion 942 may include a filter to prevent unwanted material (eg, particles and/or glass fragments over a certain size) from reaching applicator pad 910 . there is. Before or after wetting the applicator pad 910 with the liquid, the distal surface of the applicator pad 910 may be placed against the affected area of the subject. The grip 940 is then directed to the applicator pad 910 such that the plate 931 applies a distributed pressure to the applicator pad 910 for a period of time, as described with respect to method 200 above. can be maintained for In some embodiments, first portion 942 and/or second portion 944 is deformable (eg, compressible) to force the drug out of reservoir 950 . In some embodiments, bleeding treatment system 900 may be operated with one hand (eg, the hand of a subject having an affected area in need of treatment). For example, a user may place a thumb on the proximal end of second portion 944 and the other fingers of the same hand around the sidewall of grip 940 (eg, around first portion 942 ). can be wrapped While gripping the gripper 940 in this configuration, before or after pressing the applicator pad 910 against the affected area, the user points the applicator pad 910 with the user's thumb toward the second, as described above. Portion 944 may be pressurized to expel liquid from reservoir 950 .

12 is a schematic diagram of an applicator pad 1010 in combination with a blood absorbent pad 1030, which may be identical or similar in structure and/or function to any of each of the applicator pad and blood absorbent pad disclosed herein. . As shown, applicator pad 1010 may be surrounded by blood absorbent pad 1030 such that applicator pad 1010 and absorbent pad 1030 are concentric. Accordingly, in some embodiments, the applicator pad 1010 is shaped, sized, and shaped such that only the applicator pad 1010 contains or contacts liquid (eg, drug) from the reservoir and not the blood absorbent pad 1030. It can be set up and positioned (eg, relative to the grip). In some embodiments, a liquid impermeable partition 1032 may be disposed between the applicator pad 1010 and the blood absorbent pad 1030 . In some embodiments, instead of surrounding the applicator pad 1010 , the blood absorbent pad 1030 may only partially surround or be placed 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 applicator pad 110, in some embodiments the applicator pad 1010 is circular, It can have any suitable shape, such as oval, or square.

In some embodiments, instead of including a reservoir within the grip of the applicator device, an applicator pad, such as any of the applicator pads disclosed herein, may be pre-filled with drug. For example, FIG. 13 is a schematic diagram of a bleeding treatment system 1100 . Bleeding treatment system 1100 may be identical or similar in structure and/or function to any of the other bleeding treatment systems disclosed herein. For example, the bleeding treatment system 1100 includes 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. can include In some embodiments, the applicator pad 1110 may be a porous applicator (eg, a sponge-type material) configured to hold the liquid drug M and apply the liquid drug M only to the affected area upon physical contact. there is. The applicator pad 1110 may be pre-filled (eg, pre-soaked) with liquid or dry drug M. The gripping portion 1140 may be the same as the applicator pad 1110 or the same as the applicator pad 1110 such that the gripping portion 1140 may be used to apply a distributed pressure to the applicator pad 1110 when the applicator pad 1110 contacts the affected area. It may include a plate 1141 having a larger diameter. The plate 1141 can be rigid or semi-rigid, or can have a surface that opposes the surface that contacts the applicator pad 1110, so that it can apply uniform pressure to the applicator pad 1110. In some embodiments, plate 1141 may be flexible. The plate 1141 may serve as an isolation mechanism configured to isolate the hand applying pressure from the affected area and the drug within the applicator pad 1110 . To use the system 1100, the applicator seal 1120 can be removed from the applicator pad 1110, and the grip 1110 applies the applicator pad 1110 to the affected area to allow the drug to flow to the affected area. It can be used to apply and maintain pressure against the affected area by applying pressure to the applicator pad 1110.

14 is a flow diagram of a method 1200 of using a bleeding treatment system, such as any of the bleeding treatment systems disclosed herein. The method 1200 may be for reducing bleeding at an affected site in a subject taking a medication that causes increased and/or prolonged bleeding. In some embodiments, steps of method 1200 may be implemented by a subject, caregiver, medical practitioner, veterinary caregiver, or the like. At step 1202, the affected area may be washed and elevated (eg, by a subject with the affected area and/or by a caregiver or clinician) to reduce bleeding. In some embodiments, the affected area is washed (eg, with soap and water). In some embodiments, the affected area is elevated above the level of the patient's heart.

At step 1204, it may be determined whether the subject (eg, patient) is taking medications (eg, anticoagulant medications or antiplatelet medications) that cause the subject to experience increased and/or prolonged bleeding. For example, a caregiver or clinician may check to see if such medications have been taken by the subject within a relevant time period (eg, by checking medical records or querying the subject). 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 if the affected area is still bleeding after step 1206, and the steps of method 1200 may proceed from there.

In step 1206, if it is determined that the subject is not taking medications that cause increased and/or prolonged bleeding within the relevant time period, strong pressure is applied (eg, by the subject or caregiver) to the affected area using a sterile gauze pad. may be authorized. In some embodiments, the strong pressure may be applied for a first period of time (eg, a predetermined period of time). In some embodiments, for example, the first period of time can be about 5 minutes, about 4 minutes to about 6 minutes, less than about 4 minutes, greater than about 5 minutes, greater than about 6 minutes. After the first period, the pressure may be removed. Once the wound has stopped bleeding, the subject or caregiver can apply a bandage to the wound. If the wound is still bleeding, step 1208 may be performed as described below and/or medical treatment may be sought.

In step 1208, if it is determined that the subject has been taking medications that cause increased and/or prolonged bleeding within the relevant period of time, or applying strong pressure for a first period of time as described in step 1206 is not recommended. If it does not cause cessation of bleeding, a metered dose of the drug (eg, 5 minutes) for a second period (eg, a second predetermined period) to allow the drug to contact the affected area (eg, 5 minutes). Strong pressure may be applied to the affected area using a topical applicator pad containing TXA, such as intravenous (IV) TXA. 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 less than the first period of time. In some embodiments, a metered dose can be 3 to 10 mL and/or contain about 300 to about 1000 mg of drug.

At step 1210, pressure may be removed by the subject or caregiver (eg, by removing the applicator pad) and the affected area may be checked to see if the affected area is still bleeding. In step 1212, once the wound has stopped bleeding, a bandage may be applied to the wound by the subject or caregiver. At step 1214, if the wound is still bleeding, the subject or caregiver may re-apply firm pressure to the wound using a topical applicator pad for an additional predetermined period of time (eg, for an additional 5 minutes). there is. In some embodiments, a new topical applicator pad (either containing a metered dose or not containing a metered dose of drug) may be used. In step 1216, the pressure may be removed and the wound may be checked to see if it is still bleeding. In step 1218, once the wound has stopped bleeding, a bandage may be applied to the wound if needed. At step 1220, if the wound is still bleeding, the subject may seek medical treatment (with help from a caregiver if needed).

15A-15E are schematic diagrams of a bleeding treatment system 1300 in various stages of use. System 1300 may be identical or similar in structure and/or function to any of the systems disclosed herein. For example, system 1300 may include an applicator device 1370 , a reservoir (not shown) and an applicator pad 1310 . As shown in FIG. 15A , applicator pad 1310 may be coupled to applicator device 1370 via pad connector 1348 . Pad connector 1348 may include any suitable mating mechanism, such as any of the mating mechanisms and pad connectors disclosed herein. For example, the applicator device 1370 may be released from the applicator device 1370 before or after engagement features associated with the applicator pad 1310 are applied to the affected area WD, as shown in FIG. 15B. may include a sliding mechanism or latch capable of disengaging engagement features associated with the applicator pad 1310.

In some embodiments, applicator pad 1310 may act as an ejection mechanism to allow adhesive strip 1303 to contact the patient's skin, for example to secure pad connector 1348 to wound WD. It can be coupled to the applicator device 1370 through an adhesive strip 1303 that is releasable from the applicator device 1370 through a pad connector 1348 that can be releasable. Thus, in the first configuration shown in FIG. 15C , applicator pad 1310 may be coupled to applicator device 1370 . As shown in FIG. 15D , applicator pad 1310 and adhesive strip 1303 may be disengaged from applicator device 1370 . The applicator pad 1310 can then be secured to the subject at the site of the affected area via the adhesive strip 1303.

16A-16C are schematic views, respectively, of a bleeding treatment system 1400 in a perspective, front and cross-sectional view in a wet configuration in which the reservoir 1450 has been breached to release the contents of the reservoir 1450. 16D-16F are perspective, front, and cross-sectional schematic views, respectively, of a bleeding treatment system 1400 in a decoupled configuration with the grip 1440 of the system 1400 disengaged from the applicator pad 1450. System 1400 may be identical or similar in structure and/or function to any delivery or treatment system described herein, such as, for example, bleeding treatment system 500 . For example, system 1400 includes an applicator device 1470 , a reservoir 1450 and an applicator pad 1410 . The applicator device 1470 has a gripping portion 1440 that defines an interior space 1443 and has an open distal end and a closed proximal end and extends along a central longitudinal axis. The applicator device 1470 includes a filter 1471 (eg, a filter) to prevent unwanted material (eg, particles over a certain size and/or glass fragments) from reaching the applicator pad 1410. disposed between the ramp 1462 of the branch 1450 and the distal opening of the grip 1440).

As shown in FIGS. 16A-16F , system 1400 may include a bandage 1412 coupled to a portion of the top surface of applicator pad 1410 and extending beyond the outer periphery of applicator pad 1410 . can Although shown surrounding the periphery of applicator pad 1410, in some embodiments the bandage may extend beyond opposing portions or sides of applicator pad 1410, but not in all directions. The bandage 1412 may define one or more apertures 1412A adjacent the top surface of the applicator pad 1450 such that fluid may flow through the apertures and wet contact with the applicator pad 1450 . In some embodiments, one or more openings 1412A may collectively have a surface area and perimeter equal to or smaller than the surface area and perimeter of the distal opening of gripping portion 1440 . In some embodiments, bandage 1412 may include a liquid permeable layer or portion covering one or more openings 1412A. In some embodiments, bandage 1412 may be adhesively bonded to the top surface of applicator pad 1450 via one or more adhesive portions.

System 1400 has applicator pad 1410 and bandage 1412 in contact with a surface, applicator pad 1410 in contact with the affected area of the subject and bandage 1412 surrounding applicator pad 1410. and can be located on the surface of an object. Applicator device 1470 can be transitioned from the initial configuration to the wet configuration shown in FIGS. 16A-16C through the same steps as described with respect to system 500 . After the contents of the reservoir 1450 are expelled from the reservoir 1450 as shown in FIG. 16C, the contents pass through the filter 1471, through one or more openings 1412A in the bandage 1412, and through the applicator pad ( 1410) to contact the affected area. The gripper 1440 is applied by applying downward pressure to the gripper 1440 with the distal end of the gripper 1440 and/or plate 1431 in contact with the applicator pad 1410 (e.g., applying It can be used to apply pressure to the applicator pad 1410 (before and/or after wetting the pad 1410) and thereby apply pressure to the affected area.

In some embodiments, the applicator pad 1410 and bandage 1412 can be left on the subject's skin such that the applicator pad 1410 remains in contact with the affected area, and the grip 1440 is applied to the applicator pad 1410. ) can be disengaged from the applicator pad 1410 and bandage 1412 such that it is not displaced relative to the affected area during disengagement. 16D-16F, after disengaging the gripper 1440 from the applicator pad 1410 and/or bandage 1412, the gripper 1440 is discarded and the applicator pad 1410 and the bandage 1412 can be left in place on the affected area and skin of the subject.

Gripper 1440 may be coupled to and/or disengaged from applicator pad 1410 and/or bandage 1412 via any suitable disengagement method disclosed herein.

For example, as shown in FIGS. 17A and 17B, which are two different perspective views of system 1400 that include two adhesive strips 1414 (also referred to as pad connectors), applicator device 1470 is It may be coupled to the bandage 1412 via a removable adhesive strip 1414 . Adhesive strips 1414 may be placed in contact with the upper surface of the plate 1431 on either side of the grip 1440, the adhesive strips 1414 passing through the plate 1431 and holding the grip 1440 to the bandage 1412. ), each having an end in contact with the bandage 1412. In some embodiments, adhesive strip 1414 can be flexible, but has low or no elasticity. To separate grip 1440 from bandage 1412 and applicator pad 1410, each adhesive strip 1414 is peeled off from bandage 1412 to release bandage 1412 from plate 1431. can

In some embodiments, instead of including a peelable, low- or no-elastic adhesive strip, as shown in FIG. 18 , system 1400 includes a high-elastic adhesive strip 1416 . adhesive to the bandage 1412 and/or plate 1431 such that the adhesive strip 1416 is deformed and the adhesive contact between the adhesive strip 1416 and the bandage 1412 and/or plate 1431 is destroyed. By stretching the free end of each adhesive strip 1416 away from, but in or near the plane that contains the portion of the adhesive strips 1416 (also referred to as pad connectors) bonded to the bandage 1412 and/or Or it can be disengaged from plate 1431. For example, adhesive strip 1416 may include synthetic rubber resin adhesive.

In some embodiments, the applicator pad may include or be coupled to a rigid or semi-rigid backing portion 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 have the same or similar structure and/or function as any other system disclosed herein. The system 1500 can include a gripper 1540 , an applicator pad 1510 , and a reservoir (not shown) within the applicator pad 1510 and/or contained within the gripper 1540 . As shown in FIG. 19B , applicator pad 1510 may be coupled (eg, via adhesive) to backing portion 1518 , which may be rigid or more rigid than applicator pad 1510 . The backside portion 1518 defines one or more openings (not shown in FIGS. 19A and 19B ) to allow fluid to flow from a reservoir in the grip 1540 to the applicator pad 1510 to wet the applicator pad 1510 . can do. Backing portion 1518 is such that gripping portion 1540 is capable of being adhered, clipped, latched, friction fitted, hook-and-loop fastened, buttoned, or otherwise released to backside portion 1518 via any suitable engagement mechanism. It may include one or more pad retainer portions 1535 configured to be received by or otherwise engaged by a complementary pad retainer portion (not shown) of the gripping portion 1540 such that it can be securely engaged. After applying pressure to the backing portion 1518 to push the applicator pad 1510 against the affected area, the gripping portion 1540 may be disengaged from the backing portion 1518 by disengaging the complementary pad retainer portion. there is. As shown in FIG. 19A , gripping portion 1540 is convex distal configured to apply a targeted and increased pressure to the affected area when a user presses gripping portion 1540 into applicator pad 1510 coupled to the affected area. surface 1536. Convex distal surface 1536 can include one or more apertures that allow fluid flow through convex distal surface 1536 .

As shown in FIG. 19C , in some embodiments, the backing portion 1518 prevents the convex distal surface 1536 of the gripping portion 1540 from wetting the applicator pad 1510 and/or the applicator pad 1510. and may be curved and rigid so as to be seated within the concave upper surface of the back portion 1518 during application of pressure to the affected area accordingly. As shown in FIG. 19C , the backing portion 1518 has one or more openings 1519 to allow fluid to flow from a reservoir in the grip 1540 to the applicator pad 1510 to wet the applicator pad 1510. can form

20, which is a schematic diagram of system 1600, in some embodiments, backing portion 1618 is hook-and-loop fastener 1635 (e.g., Velcro® or a releasable adhesive (not shown)). It can be releasably coupled to the applicator pad 1610 via an attachment such as (not shown). ) may include a convex distal surface 1636 configured to apply pressure to the portion of the applicator pad 1610 that contacts the affected area when coupled to the affected area After hemostasis has occurred, the back portion 1618 may include an applicator pad ( 1610 may be removed, leaving the applicator pad 1610 in place relative to the affected area.

21 is a schematic diagram of a system 1700. System 1700 may be identical or similar in structure and/or function to any of the systems disclosed herein. For example, system 1700 includes gripper 1740 and applicator pad 1710 . Applicator pad 1710 may be coupled to back portion 1718, which may be configured as a bandage. Backing portion 1718 can include adhesive covered by a peel-away adhesive liner disposed on a distal surface of the backing portion. Prior to placing the backing portion 1718 on the subject's skin, the adhesive liner may be peeled off so that the backing portion 1718 may be adhered to the skin via an adhesive. In some embodiments, backing portion 1718 may extend laterally from gripper 1740 prior to placement on the skin, as shown in FIG. 21 . In some embodiments, backing portion 1718 is collinear with grip portion 1740 (eg, extends upward along a sidewall of grip portion 1740 ) and can then be folded to adhere to the skin. In some embodiments, backing portion 1718 may completely surround and/or extend circumferentially away from applicator pad 1710 . In some embodiments, backside portion 1718 may extend along one axis of applicator pad 1710 .

The backing portion 1718 and/or the applicator pad 1710 extends away from the applicator pad 1710 and is configured to be releasably gripped by the pad retainer portion 1735A of the gripping portion 1740 ( 1735B) or may be combined therewith. The pad retainer portion 1735A of the gripping portion 1740 is such that the gripping portion 1740 and the applicator pad 1710 are engaged (e.g., during wetting and/or application of pressure to the affected area), such as a pad and a flexible arm configured to engage the recess of retainer portion 1735B. To separate the grip 1740 from the applicator pad 1710, the flexible arm can (eg, through pulling a tab extending from the outer surface of the grip 1740 or the pad retainer portion 1735B is can be pulled away from the recess of the pad retainer portion 1735B by squeezing an engagement mechanism (e.g., a semicircular button) near or adjacent to the distal end of the gripping portion 1740 to activate the release mechanism to release; The gripping portion 1740 can be removed from the pad retainer portion 1735B.

22A and 22B are schematic cross-sectional and plan views of a system 1800. System 1800 may be identical or similar in structure and/or function to any of the systems disclosed herein. For example, system 1800 includes a semi-rigid backing portion 1818 and an applicator pad 1810 that may be configured as a bandage. As shown, a semi-rigid backing portion 1818 is positioned against a top surface of the applicator pad 1810 and a foam ring 1818A surrounding the applicator pad 1810 and coupled to the foam ring 1818A. It may include a backing layer 1818B. The foam ring 1818A can adhesively bond the backing portion 1818 and the applicator pad 1810 to the surface of the subject's skin, and the applicator pad 1810 to press the applicator pad 1810 against the affected area. ) can be applied with compression pressure. In some embodiments, pressure applied to the applicator pad 1810 may activate release of the drug(s) from the applicator pad 1810.

In some embodiments, the contents of the reservoir may be configured to flow from the reservoir through the sidewall of the grip containing the reservoir to the applicator pad. For example, FIGS. 23A-23C are schematic diagrams of system 1900 at various stages of operation. System 1900 may be identical or similar in structure and/or function to any of the systems disclosed herein. For example, system 1900 includes an applicator device 1970 , a reservoir 1940 and an applicator pad 1910 . The applicator device 1970 may include a grip 1940 defining an interior space in which the reservoir 1950 may be disposed. As shown, gripper 1940 is applied in the initial configuration shown in FIG. 23A where applicator pad 1910 is coupled to the sidewall of gripper 1940 and gripper 1940 and/or reservoir 1950 are It may be arranged horizontally so as to extend along a longitudinal axis disposed substantially parallel to the base pad 1910 .

The gripper 1940 may include a first part 1942 and a second part 1944 that collectively form an inner space in which the reservoir 1950 is disposed. The first part 1942 is attached to the second part 1944 as shown in FIG. 23B so that the reservoir 1950 is broken and the contents of the reservoir 1950 flow from the reservoir 1950 to the applicator pad 1910. It can be configured to bend about. For example, the gripping portion 1940 can be configured such that a first end of the gripping portion 1940 rotates relative to a second end of the gripping portion 1940 so that the inner surface of the gripping portion 1940 applies pressure to the reservoir 1950. may be bent to cause the reservoir 1950 to snap, crush, or otherwise break. In some embodiments, the gripping portion 1940 is positioned on the gripping portion 1940 such that the first portion 1942 is rotated relative to the second portion 1944 about a hinge or notch to break the reservoir 1950. It may include a bendable hinge or notched feature near the midpoint. In some embodiments, the gripping portion 1940 can be broken such that bending of the gripping portion 1940 can force the force concentration element 1909 into breaking contact with a portion of the reservoir 1950, causing the reservoir 1950 to break. It may include a force concentration element 1909, such as a protrusion or steel ball with a tip that may protrude from the inner surface of the support 1940. In some embodiments, the force concentration element 1909 may be aligned with a weakened or pre-scored portion of the reservoir such that the reservoir is preferentially destroyed by the force concentration element 1909 at the weakened or pre-scored portion. . In some embodiments, the subject or caregiver may use both hands to bend the first portion 1942 relative to the second portion 1944 to break the reservoir 1950. In some embodiments, a subject or caregiver places the system 1900 on a hard surface (eg, table) and applies a downward orthogonal force against the grip 1940 so that the reservoir 1950 causes the force concentration element ( 1909) and the contents of the reservoir 1950 can be ejected. In some embodiments, a subject or caregiver may place the system 1900 directly against the affected area with the applicator pad 1910 applied to the affected area, with the reservoir 1950 in destructive contact with the force concentration element 1909. A force orthogonal to the affected area may be applied to the gripping portion 1940 to cause compression and expel the contents of the reservoir 1950. Accordingly, in some embodiments, the user may apply pressure to the grip 1940 using the palm of the user, and the pressure may be applied to the reservoir 1950 by the force concentration element 1909 to break the reservoir 1950. It can be concentrated in a specific location on the image.

After the reservoir 1950 is broken, the contents of the reservoir 1950 may flow from the reservoir 1950 to the applicator pad 1910 through the sidewall of the grip 1940 . For example, gripper 1940 may form one or more apertures through which fluid may flow to applicator pad 1910 that may be coupled or releasably coupled to a sidewall of gripper 1940 and aligned with the aperture. can In some embodiments, gripping portion 1940 may be applied with reservoir 1950 to prevent unwanted material (eg, particles over a certain size and/or glass fragments) from reaching applicator pad 1910 . A filter (not shown) disposed between the base pads 1910 may be included. For example, a filter may be disposed within or adjacent to one or more openings formed by gripping portion 1940 .

In some embodiments, the gripping portion 1940 is provided herein such that the gripping portion 1940 can be disengaged from the applicator pad 1910 after the gripping portion 1940 has wet the applicator pad 1910, as shown in FIG. 23C. It can be releasably coupled to the applicator pad 1910 using any one of the disclosed releasable coupling mechanisms. For example, before or after breaking the reservoir 1950 to wet the applicator pad 1910, the applicator pad 1910 can be placed in contact with the target affected area. After applying pressure to the grip 1940 to break the reservoir 1950 and wet the applicator pad 1910, the grip 1940 presses against the applicator pad 1910 to apply pressure to the affected area. It can be. After a period of time, the gripping portion 1940 can be disengaged from the applicator pad 1910, leaving the applicator pad 1910 positioned in contact with the affected area. In some embodiments, the applicator pad 1910 is placed on the skin contacting surface of the applicator pad 1910 to hold the applicator pad 1910 in place relative to the affected area (e.g., the periphery of the skin contacting surface). Adjacent to) may include an adhesive portion. In some embodiments, adhesive tabs may be applied to the applicator pad 1910 and the subject's skin to hold the applicator pad 1910 in place relative to the affected area. In some embodiments, as shown in FIG. 23C , a back portion 1918, which may be the same as or similar to any back portion or bandage disclosed herein, applies compressive pressure to the applicator pad 1910 and thus to the affected area and and/or placed over top of the applicator pad 1910 to hold the applicator pad 1910 in place relative to the affected area.

In some embodiments, the force concentration element may be disposed on either the first portion or the second portion of the gripping portion, and the second portion of the gripping portion may cause the reservoir to break due to contact between the reservoir and the force concentration element. It can be moved (eg, rotated and/or translated) with respect to the first portion of the gripping portion that comprises it. 24 is a schematic diagram of system 2000, for example. System 2000 may be identical or similar in structure and/or function to any of the systems disclosed herein. For example, system 2000 includes a reservoir 2050, an applicator device 2070, and an applicator pad (not shown). The applicator device 2070 includes a gripping portion 2040 comprising a first portion 2042 and a second portion 2044 . The first portion 2042 may form an internal space in which the reservoir 2050 may be disposed. The second portion 2044 can be configured to rotate and advance relative to the first portion 2042 . For example, the second portion 2044 can be coupled to the first portion 2042 via a threaded connection. The first force concentration element 2009A may be disposed on the reservoir facing surface of the second portion 2044 and/or the second force concentration element 2009B may be disposed on the reservoir facing surface of the first portion 2042 ( eg on a side wall or a ramp or protrusion extending from the side wall). In some embodiments, rotation of the second portion 2044 causes the second portion 2044 to advance toward the reservoir and engage the reservoir 2050 with the first force concentration element 2009A until the reservoir 2050 is destroyed. pressure can be applied. In some embodiments, rotation of the second portion 2044 causes the second portion 2044 to advance toward the reservoir and/or advances the reservoir so that the reservoir 2050 moves until the reservoir 2050 is destroyed. It can be pressed against the second force concentration element 2009B. In some embodiments, the second force concentration element 2009B may be positioned such that the second force concentration element 2009B contacts the shoulder of the reservoir 2050 and breaks the reservoir 2050 at the shoulder. In some embodiments, air vents (not shown) may be included to facilitate movement of fluid from reservoir 2050 towards an applicator pad (not shown).

In some embodiments, the applicator pad may be prepared (eg, wetted) in a tray included in the kit prior to application to the target affected area of the subject. For example, FIGS. 25A-25C are schematic diagrams of a series of steps performed using kit 2100 . Kit 2100 may include any system used in accordance with any of the methods disclosed herein. For example, kit 2100 may include an applicator pad 2110 and a reservoir 2150 containing a fluid. As shown in FIG. 25A , the kit 2100 may include a tray 2101 containing an applicator pad 2110 and a reservoir 2150 . Fluids in reservoir 2150 may include drugs and/or drug actives 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 is supplied from the reservoir 2150 to the applicator pad 2110 to deliver the drug to the applicator pad 2110 and/or combine with the dry drug pre-placed within the applicator pad 2110. ) can be transmitted. Reservoir 2150 may be similar to any reservoir disclosed herein. Fluid may also be delivered from the reservoir 2150 using any of the applicator devices disclosed herein. As shown in FIG. 25C , backing portion 2118 (eg, bandage) may be coupled (eg, via adhesive) to applicator pad 2110 . The backside portion 2118 can include a convex distal surface 2136 configured to couple to the applicator pad 2110 to apply targeted and increased pressure to the affected area via the applicator pad 2110 . The applicator pad 2110 can then be placed in contact with the affected area, and the backing portion 2118 is bonded to the skin surrounding the affected area. In some embodiments, backing portion 2118 may be removed after a predetermined period of time (eg, 4, 5, 6, or 10 minutes).

In some embodiments, an applicator device, such as any of the applicator devices disclosed herein, may be included in kit 2100 and used to eject the contents of the reservoir. The applicator device may then be used to apply the applicator pad 2110 to the affected area and apply pressure to the affected area, or the applicator pad 2110 may optionally be applied (e.g., within the tray 2101) to the applicator device. , the applicator pad 2110 can be applied to the affected area and pressed against the affected area using the subject's or caregiver's fingers and/or palm. Optionally, the back portion 2118 can be applied to the applicator pad 2110 before or after applying the applicator pad 2110 to the affected area.

26A-26C are schematic diagrams of a series of steps performed using kit 2200. Kit 2200 may include any system used in accordance with any of the methods disclosed herein. For example, kit 2200 can include an applicator pad 2210 and a reservoir 2250 containing a fluid. As shown in FIG. 26A , the kit 2200 may include a tray 2201 containing an applicator pad 2210 and a reservoir 2250 . Fluids in reservoir 2250 may include drugs and/or drug actives such as saline. As shown in FIG. 26B , fluid is supplied from the reservoir 2250 to the applicator pad 2210 to deliver the drug to the applicator pad 2210 and/or combine with the dry drug pre-placed within the applicator pad 2210. ) can be transmitted. Reservoir 2250 may be similar to any reservoir disclosed herein. Fluid may also be delivered from the reservoir 2250 using any of the applicator devices disclosed herein. As shown, for example, kit 2200 can be disposed over at least a portion (eg, neck portion or half portion) of reservoir 2250, as shown in FIG. 26B, and grip portion 2240 ) the center of the reservoir 2250 such that a portion of the reservoir 2250 disposed therein is broken (e.g., separated from the remainder of the reservoir 2250 that is outside the grip 2240) and fluid is released. It may include a gripping portion 2240 that can be rotated away from the axis.

As shown in FIG. 26C , backing portion 2118 (eg, bandage) may be coupled (eg, via adhesive) to applicator pad 2210 . The back portion 2218 can include a convex distal surface configured to couple to the applicator pad 2210 to apply targeted and increased pressure to the affected area via the applicator pad 2210 . The applicator pad 2210 can then be placed in contact with the affected area with the backing portion 2218 engaged to the skin surrounding the affected area. In some embodiments, backside portion 2218 may be removed after a predetermined period of time (eg, 4, 5, 6, or 10 minutes).

In some embodiments, an applicator device, such as any of the applicator devices disclosed herein, may be included in kit 2200 and used to eject the contents of the reservoir. The applicator device can then be used to apply the applicator pad 2210 to the affected area and apply pressure to the affected area, or the applicator pad 2210 can optionally be applied (e.g., within the tray 2201). Detached from the device, the applicator pad 2210 can be applied to the affected area and pressed against the affected area using the subject's or caregiver's fingers and/or palm. Optionally, the backing portion 2218 can be applied to the applicator pad 2210 before or after applying the applicator pad 2210 to the affected area.

Although various embodiments have been described herein textually and/or graphically, it should be understood that they are presented by way of example only and not limitation. Likewise, it should be understood that specific terminology used herein is intended to describe specific embodiments and/or features or components thereof and is not intended to be limiting. Unless expressly stated otherwise, various modifications, changes, enhancements, and/or changes in form and/or detail may be made without departing from the scope of the disclosure and/or altering its function and/or advantage. . In addition to those listed herein, functionally equivalent embodiments, implementations and/or methods will be apparent to those skilled in the art from the above description, and are intended to be within the scope of this invention.

Where the schematics, embodiments, and/or implementations described above show particular components arranged and/or configured in a particular orientation or position, the arrangement of the components may be modified, adjusted, optimized, or the like. The specific size and/or specific shape of the various components may differ from the illustrated embodiment and/or may be modified in other ways while still providing the functionality disclosed herein. More specifically, the size and shape of the various components may be specifically selected for a desired or intended use. Accordingly, it should be understood that the size, shape and/or arrangement of the embodiments and/or their components may be adapted for a particular use unless the context clearly dictates otherwise. As an example, in some embodiments, a treatment device intended to provide treatment to an adult user can have a first size and/or shape, and a treatment device intended to provide treatment to a pediatric user can have a first size and/or shape. It may have a second size and/or shape smaller than the shape. Also, for example, the smaller size and/or shape of the pediatric treatment device may allow certain components to be moved, reoriented, and/or repositioned while maintaining the desired functionality of the device.

Although various embodiments have been described as having particular features, functions, components, elements, and/or characteristics, features from any embodiment disclosed herein, except in mutually exclusive combinations or where expressly stated otherwise; Other embodiments are possible having any combination and/or sub-combination of functions, components, elements, and/or features. In addition, unless expressly indicated otherwise herein, any particular combination of elements, functions, features, elements, etc. may be separated and/or divided into independent elements, functions, features, elements, etc., single or single It can be integrated into components, functions, features, elements, etc.

Where the method described above indicates that specific events occur in a specific order, the order of specific events may be changed. Additionally, certain events may not only be carried out sequentially, as discussed above, but also concurrently, where possible, in a parallel process. Although a method has been described as having particular steps and/or combinations of steps, except in mutually exclusive combinations and/or unless the context clearly dictates otherwise, other methods having any combination of steps from any method disclosed herein way is possible

Claims (77)

is a system,
applicator pad
a grip releasably engageable to the applicator pad and configured to position the applicator pad against the affected area of a subject such that pressure is transferred to the affected area via the applicator pad to enhance hemostasis;
A reservoir configured to contain a drug to be released to the affected area via the applicator pad.
system. According to claim 1,
the reservoir is a first reservoir contained within the applicator pad;
Further comprising a second reservoir and a fluid coupling,
wherein the fluid coupling is configured to allow liquid to flow from the second reservoir through the fluid coupling to the applicator pad.
system. According to claim 1,
wherein the applicator pad comprises a pad retainer configured to maintain contact of the affected portion and the applicator pad after the gripping portion is disengaged from the applicator pad.
system. According to claim 1,
The holding part includes a first part and a second part,
wherein the second portion is configured to be moved relative to the first portion to release liquid from the reservoir to the applicator pad.
system. According to claim 1,
The reservoir contains the drug,
system. According to claim 1,
The drug includes an antifibrin solubilizing agent,
system. According to claim 5,
The drug includes a vasoconstrictor and an antifibrinolytic agent,
system. According to claim 5,
The drug includes at least one of an antifibrinolytic agent, a vasoconstrictor, an antibiotic, an antiinfective agent, or a steroid.
system. According to claim 5,
The drug is tranexamic acid (TXA),
system. According to claim 9,
wherein the applicator pad comprises a material that is non-reactive with TXA;
system. According to claim 9,
wherein the applicator pad comprises a foamed polymer;
system. According to claim 9,
wherein the applicator pad comprises natural fibers;
system. According to claim 1,
A release coupled to the reservoir and configured to transition from a closed state to an open state to allow drug to flow through the fluid coupling from the reservoir and to the applicator pad in response to a pressure greater than a threshold pressure within the reservoir. further comprising the apparatus,
system. According to claim 13,
wherein the side wall portion of the delivery device is configured to be urged towards the reservoir to transition the reservoir from a closed state to an open state.
system. According to claim 1,
wherein the applicator pad is configured to expand in response to absorbing blood from the affected area.
system. According to claim 1,
The holding part includes a plate,
wherein the plate is disposed on the distal end of the gripping portion and is configured to apply a distributed uniform force to the applicator pad when pressed toward the affected area with a force perpendicular to the skin.
system. According to claim 1,
The gripping portion includes a force concentration component,
wherein the force concentration component protrudes from the inner surface of the gripping portion and is configured to be urged toward the reservoir to break the sidewall of the reservoir and release the drug to the applicator pad;
system. According to claim 1,
wherein the applicator pad includes the reservoir and is pre-soaked with a drug to a saturation within a range of about 25% to about 50% of the saturation point of the applicator pad.
system. According to claim 1,
wherein the applicator pad includes the reservoir and is pre-soaked with a drug to a saturation of about 35% of the saturation point of the applicator pad.
system. According to claim 1,
further comprising a backing material having a convex distal surface coupled to the applicator pad such that the applicator pad has a convex distal surface;
wherein the backing material is stiffer than the applicator pad;
system. According to claim 1,
wherein the gripping portion comprises a convex distal surface configured to contact the proximal surface of the applicator pad and urge at least a portion of the applicator pad toward the affected area.
system. According to claim 1,
further comprising a bandage engageable to the proximal surface of the applicator pad;
wherein the bandage has a convex distal surface configured to contact the proximal surface of the applicator pad and urge at least a portion of the applicator pad toward the affected area.
system. is a system,
an applicator pad pre-soaked with liquid medication;
an applicator seal coupled to a surface of the applicator pad and configured to be removed from the applicator pad prior to placement of the applicator pad on an affected area of a subject;
releasably engageable to the applicator pad and configured to position the applicator pad against the affected area such that pressure can be transferred to the affected area through the applicator pad and the liquid drug can contact the affected area. Including a gripping part,
system. According to claim 23,
wherein the applicator pad comprises a pad retainer configured to hold the applicator pad in contact with the affected area.
system. According to claim 24,
The pad retainer is an adhesive,
system. According to claim 23,
The liquid drug includes an antifibrin solubilizing agent,
system. The method of claim 26,
The liquid drug includes a vasoconstrictor,
system. According to claim 23,
The drug includes at least one of an antifibrinolytic agent, a vasoconstrictor, an antibiotic, an antiinfective agent, or a steroid.
system. According to claim 23,
wherein the liquid drug is tranexamic acid (TXA);
system. According to claim 29,
wherein the applicator pad comprises a material that is non-reactive with TXA;
system. According to claim 29,
wherein the applicator pad comprises a foamed polymer;
system. According to claim 29,
wherein the applicator pad comprises natural fibers;
system. According to claim 23,
wherein the applicator pad is pre-soaked with liquid drug to a saturation within a range of about 25% to about 50% of the saturation point of the applicator pad.
system. According to claim 23,
wherein the applicator pad is pre-soaked with liquid drug to a saturation of about 35% of the saturation point of the applicator pad;
system. is a method,
delivering the applicator pad to the affected area with one hand using a grip coupled to the applicator pad;
pressing the applicator pad against the affected portion by applying force to the gripping portion using only the one hand;
allowing release of the drug from the applicator pad into the affected area;
holding the applicator pad against the affected area such that the applicator pad applies pressure against the affected area to enhance hemostasis.
method. The method of claim 35,
Evaluating whether the state of hemostasis in the affected area satisfies the goal of hemostasis;
removing the applicator pad with the one hand from the affected area in response to the hemostasis condition meeting the hemostasis goal.
method. The method of claim 35,
The step of delivering the applicator pad to the affected area using the gripping portion is such that a central axis of the gripping portion is substantially parallel to the surface of the skin surrounding the affected area and the applicator pad is in contact with the affected area. Including the step of arranging the gripping part,
method. The method of claim 35,
holding the applicator pad against the affected area comprises applying a force to the gripping portion such that the gripping portion applies pressure to the applicator pad;
releasing the applicator pad from the grip so that the applicator pad remains in contact with the affected area.
method. 39. The method of claim 38,
after removing the applicator pad, maintaining pressure with the one hand against the applicator pad, such that the applicator pad applies pressure against the affected area to enhance hemostasis.
method. The method of claim 35,
The step of allowing the release of the drug may include moving the first part of the grip part to the second part of the grip part using only the one hand so that the liquid contained in the reservoir of the grip part flows from the reservoir to the applicator pad. Including the step of moving with respect to,
method. The method of claim 35,
The step of allowing the drug to be released may include pressing a force concentration component protruding from an inner surface of the gripping portion toward a reservoir in the gripping portion to break a sidewall of the reservoir and distributing the drug to the applicator pad and the affected area. Pressing against the gripping portion with the palm of the one hand to release,
method. 41. The method of claim 40,
wherein the applicator pad contains a drug that is activated through contact with the liquid from the reservoir.
method. The method of claim 35,
The applicator pad contains a drug that is activated through contact with blood from the affected area.
method. 41. The method of claim 40,
wherein the liquid in the reservoir is a drug;
method. The method of claim 35,
wherein allowing release of the drug comprises removing the film from the applicator pad.
method. The method of claim 35,
wherein the applicator pad is an applicator pad pre-soaked with the drug;
wherein allowing release of the drug comprises allowing the drug to flow from the pre-soaked applicator pad.
method. 47. The method of claim 46,
wherein the applicator pad is pre-soaked with the drug to a degree of saturation in the range of about 25% to about 50% of the saturation point of the applicator pad.
method. 47. The method of claim 46,
wherein the applicator pad is pre-soaked with the drug to a saturation of about 35% of the saturation point of the applicator pad.
method. The method of claim 35,
The drug includes an antifibrin solubilizing agent,
method. The method of claim 49,
The drug includes a vasoconstrictor,
method. The method of claim 35,
The drug includes at least one of an antifibrinolytic agent, a vasoconstrictor, an antibiotic, an antiinfective agent, or a steroid.
method. The method of claim 35,
The drug is tranexamic acid (TXA),
method. The method of claim 35,
wherein holding the applicator pad against the affected area comprises applying a force to the gripping portion using only the one hand and not moving the gripping portion laterally relative to the affected area. is a method,
delivering the applicator pad to a location on the affected area on the person that is resistant to coagulation using a grip coupled to the applicator pad;
pressing the applicator pad against the affected area by applying force to the gripping portion;
allowing release of a therapeutically effective amount of drug from the applicator pad to the affected area to enhance coagulation;
holding the applicator pad against the affected area such that the applicator pad applies pressure against the affected area to enhance hemostasis.
method. 54. The method of claim 54,
wherein the person resistant to coagulation has drug-induced susceptibility resulting from taking anticoagulant drugs;
method. 54. The method of claim 54,
wherein the person resistant to coagulation has procedure-induced susceptibility resulting from a medical procedure that the person has undergone;
method. 57. The method of claim 56,
Wherein the medical procedure includes at least one of renal replacement therapy, cardiopulmonary bypass, extracorporeal membrane oxygen therapy (ECMO), chemical clot lysis, cardiac catheterization, peripheral vascular surgery, mechanical thrombectomy, or angiography.
method. 54. The method of claim 54,
A person resistant to clotting has a naturally-induced susceptibility arising from a chronic disease, age or genetic condition,
method. 54. The method of claim 54,
The drug is an antifibrin solubilizing agent,
method. The method of claim 59,
The drug is tranexamic acid (TXA),
method. 61. The method of claim 60,
wherein the therapeutically effective amount of TXA is between about 1 mg and about 20 mg;
method. is a kit,
tray,
an applicator pad displaceable within the tray;
a reservoir configured to rupture to release fluid from the reservoir to the applicator pad;
Wherein the applicator pad is configured to release the drug to the affected area after receiving the fluid from the reservoir.
kit. 63. The method of claim 62,
wherein the drug is configured to enhance hemostasis in the affected area,
kit. 63. The method of claim 62,
The fluid contains the drug,
kit. 63. The method of claim 62,
wherein the applicator pad contains the drug in dry form prior to receiving the fluid from the reservoir.
kit. 63. The method of claim 62,
further comprising a backing material having a convex distal surface coupled to the applicator pad such that the applicator pad has a convex distal surface;
wherein the backing material is stiffer than the applicator pad;
kit. 63. The method of claim 62,
further comprising a bandage configured to be coupled to the applicator pad to secure the applicator pad to the affected subject.
kit. 68. The method of claim 67,
the bandage comprising at least a portion having a convex distal surface coupled to the applicator pad such that the applicator pad has a convex distal surface;
wherein the portion with the convex distal surface is stiffer than the applicator pad;
kit. 63. The method of claim 62,
The drug includes an antifibrin solubilizing agent,
kit. 63. The method of claim 62,
The drug includes tranexamic acid (TXA),
kit. is a system,
an applicator pad pre-soaked with a liquid drug that enhances coagulation;
an applicator seal coupled to a surface of the applicator pad and configured to be removed from the applicator pad prior to placement of the applicator pad on the affected area of the subject;
system. 71. The method of claim 71,
releasably engageable to the applicator pad and configured to position the applicator pad against the affected area such that pressure can be transferred to the affected area through the applicator pad and the liquid drug can contact the affected area. Further comprising a gripping portion,
system. 71. The method of claim 71,
A gripping portion coupled to the applicator pad and configured to position the applicator pad against the affected area such that pressure can be transferred to the affected area via the applicator pad and the liquid drug can contact the affected area. including,
system. 71. The method of claim 71,
The liquid drug includes an antifibrin solubilizing agent,
system. 75. The method of claim 74,
The antifibrin solubilizing agent is tranexamic acid (TXA),
system. 71. The method of claim 71,
wherein the applicator pad is pre-soaked with the liquid drug to a degree of saturation in the range of about 25% to about 50% of the saturation point of the applicator pad.
system. 71. The method of claim 71,
wherein the applicator pad is pre-soaked with the liquid drug to about 35% of the saturation point of the applicator pad;
system.

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