CN116490134A - Devices for reducing bleeding and methods of making and using the same - Google Patents

Abstract

In some embodiments, a system includes an applicator pad, an applicator (e.g., a grip), and a reservoir. The grip may be releasably coupled to the applicator pad and configured to position the applicator pad against a wound of a recipient such that pressure may be transferred to the wound via the applicator pad to enhance hemostasis. The reservoir can be configured to contain a drug to be released to the wound via the applicator pad.

Description

Devices for reducing bleeding and methods of making and using the same

Cross Reference to Related Applications

The present application is a continuation of the section of International application PCT/US2021/026714 entitled "device for reducing bleeding and method of making and using same (Devices for Bleeding Reduction and Methods of Making and Using the Same)" filed on 4/9/2021, which claims priority from U.S. provisional patent application Ser. No. 63/007,543 entitled "device for reducing bleeding and method of making and using same (Devices for Bleeding Reduction and Methods of Making and Using the Same)" filed on 9/4/2020, the disclosure of each of which is incorporated herein by reference in its entirety.

The present application also claims priority from U.S. provisional patent application Ser. No. 63/087,532 to Methods for Self-treatment of small wounds or home care provider treatment (Methods for Self-Treatment or Home Care Provider Treatment of Minor Wounds) filed on 5 th 10 th 2020 and U.S. provisional patent application Ser. No. 63/090,768 to Methods for Self-treatment of small wounds or home care provider treatment (Methods for Self-Treatment or Care Provider Treatment of Minor Wounds) filed on 13 th 10 th 2020, the disclosures of each of which are incorporated herein by reference in their entirety.

Background

Light injury patients seek medical care in primary care clinics, emergency centers, and hospital emergency rooms. Many emergency centers are not open twenty four hours per day for seven days per week (24/7). Rural areas may have limited accessibility to these emergency centers. A common type of hospital emergency room or emergency center is where wounds require hemostasis, particularly for patients taking anticoagulants or antiplatelet drugs. As the population ages, an increasing number of patients need these drugs to address various diseases.

Better methods and devices are needed to allow patients, family members and/or caregivers to safely treat small wounds requiring hemostasis at home or at the site of injury.

Disclosure of Invention

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, nor is it intended to be used to limit the scope of the claimed subject matter.

Disclosed herein are devices for treating bleeding, for example, from small wounds, methods of using the devices, and methods of making the devices. In some embodiments, a system includes an applicator pad, an applicator (e.g., a grip), and a reservoir. The grip may be releasably coupled to the applicator pad and configured to position the applicator pad against a wound of a recipient such that pressure may be transferred to the wound via the applicator pad to enhance hemostasis. The reservoir can be configured to contain a drug to be released to the wound via the applicator pad.

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

Drawings

Fig. 1 is a cross-sectional view of a skin portion showing the structure of epidermis, dermis, hypodermis and subcutaneous layers.

Fig. 2 is a schematic diagram of a bleeding treatment system according to an embodiment.

Fig. 3A is a schematic view of the bleeding treatment system of fig. 3 shown disposed adjacent a wound on a patient's skin, with the wrapper removed from the bleeding treatment device.

Fig. 3B is a schematic view of the bleeding treatment device of fig. 3A shown with an optional applicator seal removed as a portion of the bleeding treatment device disposed adjacent a wound on the patient's skin.

Fig. 3C is a schematic view of the bleeding treatment device of fig. 3A, with the grip removed.

Fig. 3D is a schematic view of the bleeding treatment device of fig. 3A shown separated from a wound of a patient.

Fig. 4 is a flow chart of a method of treating a wound in need of hemostasis using the hemorrhage processing system of fig. 2 and 3A-3D.

Fig. 5 is a schematic diagram of a bleeding treatment system according to an embodiment.

Fig. 6A-6C are schematic diagrams of a hemorrhage treatment system according to embodiments.

Fig. 7A-7D are schematic diagrams of a bleeding treatment system in an initial configuration, according to an embodiment.

Fig. 7E-7H are schematic illustrations of a bleeding treatment system in a wet configuration.

Fig. 8 is a schematic diagram of a bleeding treatment system, according to an embodiment.

Fig. 9A-9C are schematic diagrams of a hemorrhage treatment system according to embodiments.

Fig. 10A-10C are schematic diagrams of a hemorrhage treatment system according to embodiments.

Fig. 11A and 11B are schematic diagrams of a hemorrhage treatment system according to embodiments.

Fig. 12 is a schematic view of an applicator pad and a blood-drawing pad according to an embodiment.

Fig. 13 is a schematic diagram of a bleeding treatment system, according to an embodiment.

Fig. 14 is a flow chart of a method of using a hemorrhage processing system according to an embodiment.

Fig. 15A-15E are schematic illustrations of a hemorrhage treatment system at various stages of use, according to an embodiment.

Fig. 16A-16C are schematic illustrations of a bleeding treatment system in a wet configuration, according to an embodiment.

Fig. 16D-16F are schematic illustrations of the hemorrhage processing system of fig. 16A-16C in a separated configuration.

Fig. 17A and 17B are schematic diagrams of the hemorrhage treatment system of fig. 16A-16C according to embodiments.

Fig. 18 is a schematic diagram of the hemorrhage treatment system of fig. 17A and 17B, according to an embodiment.

Fig. 19A is a schematic diagram of a bleeding treatment system, according to an embodiment.

Fig. 19B is a schematic view of a portion of the bleeding treatment system of fig. 19A.

Fig. 19C is a schematic diagram of a portion of the bleeding treatment system of fig. 19A, according to an embodiment.

Fig. 20 is a schematic diagram of a bleeding treatment system, according to an embodiment.

Fig. 21 is a schematic diagram of a bleeding treatment system according to an embodiment.

Fig. 22A and 22B are schematic diagrams of a cross-sectional view and a top view of a bleeding treatment system, according to an embodiment.

Fig. 23A-23C are schematic diagrams of a hemorrhage treatment system according to embodiments.

Fig. 24 is a schematic diagram of a bleeding treatment system, according to an embodiment.

Fig. 25A to 25C are schematic diagrams of a series of steps performed using a kit according to an embodiment.

Fig. 26A to 26C are schematic diagrams of a series of steps performed using a kit according to an embodiment.

Detailed Description

The detailed description herein is intended to describe non-limiting examples or examples that relate to various inventive concepts and use reference numerals to facilitate an understanding of these examples. Common reference numerals between the figures refer to common features and structures having the same or similar functions, as will be understood. While the various figures will have common reference numerals referring to such common features and structures, the description of the figures that follows will not necessarily repeat the discussion of these figures and structures for the sake of brevity.

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

The systems and methods described herein may be configured to treat wounds and/or assist in hemostasis of wounds that extend through the epidermis and/or dermis layers, are non-arterial, do not lead to pulsatile bleeding, and do not expose subcutaneous fat or muscle. In some embodiments, the systems and methods described herein can be self-administered (e.g., the applicator of the systems and/or methods is also the recipient of the wound). In some embodiments, the systems and methods described herein may be administered to a recipient by a person other than the recipient with a wound, such as a caregiver (e.g., a non-medical home care provider, such as a family member) or a clinician. In some embodiments, the systems and methods described herein may be administered to a non-human patient, such as a pet dog or pet cat, and the method steps may be performed by a pet owner or veterinarian. In some embodiments, the length of a target wound that may be treated by the systems and methods described herein may be less than 3 centimeters. In some embodiments, the target wound that may be treated by the systems and methods described herein in a home use environment may be a wound that does not require sutures or sutures to close. In some embodiments, a target wound that may be treated by the systems and methods described herein in a clinical setting may be a wound that may be first attempted to stop bleeding using the systems and methods described herein and then re-use the suture or suture if the systems and/or methods described herein are not effective after one use.

A potential patient population that may be treated by the systems and methods described herein includes any person with localized bleeding (i.e., bleeding from the skin). For example, the target patient population may include a population that increases bleeding susceptibility and/or anticoagulation, either naturally-induced, drug-induced, or program-induced. Naturally induced bleeding susceptibility and/or increased anticoagulation may be caused by chronic diseases such as hemophilia, von willebrand disease, vascular diseases (e.g., osler-Weber-Rendu), coagulopathy, renal failure, liver failure, bone marrow suppression (pathologically or drug induced), platelet diseases, age (the skin of the elderly may be more fragile) or diseases (e.g., genetic diseases) that make the person more prone to accidents or difficult to treat, including age and/or motor or cognitive deficits. Drugs that may induce bleeding susceptibility and/or anticoagulation may include: anticoagulants such as warfarin, heparin, factor Xa inhibitors, thrombin inhibitors, low molecular weight heparin, dabigatran etexilate, argatroban, hirudin, rivaroxaban, apixaban, edoxaban, fondaparinux sodium, enoxaparin, dalteparin sodium and bivalirudin; and anti-platelet drugs such as platelet aggregation inhibitors such as aspirin (acetylsalicylic acid or ASA), cangrelor, ticagrelor, clopidogrel, prasugrel, cilostazol, clopidogrel, dipyridamole, ticlopidine; glycoprotein platelet inhibitors such as eptifibatide, tirofiban, acipimab; and protease activated receptor-1 antagonists such as verapamil. Anticoagulants can be used in a wide variety of indications, such as deep vein thrombosis, pulmonary embolism, and atrial fibrillation. Medical procedures that may induce bleeding susceptibility and/or anticoagulation may include renal replacement therapy (e.g., hemodialysis), cardiopulmonary bypass, epicardial oxygenation (ECMO), chemothrombolysis (using Tissue Plasminogen Activator (TPA)), cardiac catheterization, peripheral vascular procedures (e.g., femoral popliteal bypass, arterial thrombectomy), mechanical thrombectomy, angiography, and other neurointerventional procedures and interventions.

A bleeding treatment system 100 that may be used to treat wounds requiring hemostasis 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, an optional blood-sucking pad 130 coupled to the applicator pad 110, one or more optional reservoirs 150 fluidly coupled to the applicator pad 110 via a fluid coupling 155 and containing one or more drugs, an applicator device 170 releasably coupleable to the applicator pad 110 and including a grip 140, an optional release mechanism 160 coupled to the reservoirs 150, the fluid coupling 155, and the grip 140, an optional pad holder 135 coupled to the applicator pad 110, an optional user guide 190 associated with the applicator device 170, and an optional wrapper 195 containing other components of the bleeding treatment system 100. The grip 140 may be releasably coupled to the applicator pad 110 via an optional pad connector 148.

Applicator pad 110 (also referred to as a topical applicator pad) is sized, configured, and formed of a material suitable for covering a wound that may be treated by system 100. The applicator pad 110 may be formed from any one or more materials having suitable physical properties. For example, the material is preferably capable of absorbing blood. The material may also swell or expand upon absorbing a fluid such as blood. The material may also be capable of containing, absorbing, wicking, or otherwise delivering one or more drugs for application to the wound WD and/or the surface of the skin SK surrounding the wound. It should be biocompatible with skin SK and wound WD. Preferably, the one or more materials are also nonreactive or otherwise compatible with any drug to be delivered by the applicator pad 110, e.g., do not alter the composition, delivery, or efficacy of the drug or degrade or otherwise lose any desired physical properties thereof upon exposure to the drug for the maximum duration of the wound treatment. The material is preferably sufficiently rigid, resilient, etc. so as to be able to apply a sufficient amount of pressure to the wound treatment to assist in achieving hemostasis, i.e., to act as a hemostat. At least a bottom or distal surface of the applicator pad 110 (e.g., any surface exposed prior to use of the bleeding treatment system 100) may be covered or closed by a removable applicator seal 120 to prevent contamination of the applicator pad 110 and/or to prevent undesired release of any drug that may be contained in the applicator pad 110. The applicator pad 110 may be formed of a sponge material. The applicator seal 120 may be formed as a thin layer of film or other material that is non-reactive with the applicator pad 110. The applicator seal 120 may be removed (e.g., via peeling) from the applicator pad 110 prior to use.

Materials suitable for the applicator pad 110 include polymers or other compositions such as polyvinyl alcohol (PVA), polyurethane (hydrophilic or otherwise), polypropylene, which may be formed into a foam (open or closed cell) (e.g., a porous expandable foam); natural fibers in woven or nonwoven (e.g., felt) form, such as cotton, flax, wool, and the like; and/or a layered foam matrix and/or gauze filler. The applicator pad 110 may be integrally formed 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 have a relatively thin covering of a second material. These materials may perform the desired functions in different ways. For example, absorption of blood may be achieved mechanically, e.g., by capillary wicking, and/or chemically, such as by absorption into, e.g., a molecular sieve or other desiccant, or in combination with a material such as clay (e.g., kaolin, bentonite, montmorillonite, saponite, palygorskite, attapulgite, and/or sepiolite). In some embodiments, the clay may be dispersed in a liquid medium. In some embodiments, the applicator pad 110 may include a hemostatic patch and a flexible barrier or wicking mechanism (also referred to as a backing portion or layer). In some embodiments, the hemostatic patch may include a liquid drug, and the flexible isolation or wicking mechanism may isolate the hand applying pressure to the applicator pad 110 from the wound site and the liquid drug.

As explained in more detail below, the applicator pad 110 may include, incorporate, or embody a reservoir for a drug, and different materials may be used to form or define such a reservoir. In some embodiments, the applicator pad 110 may include a reservoir for a dry or lyophilized drug that may become flowable via fluid released from the reservoir of the applicator device 170 and/or the blood of the wound. In some embodiments, the applicator pad 110 may define or include internal structures or channels to assist in the flow of the drug through the applicator pad 110 and/or preferentially direct the flow to the targeted wound tissue. In some embodiments, the applicator pad 110 may include a colored dye.

The bleeding treatment system 100 is preferably configured to deliver one or more drugs to target wound tissue during treatment, for example, via the applicator pad 110. The medicament may be contained in one or more reservoirs 150 (which may be separate from or incorporated into the applicator pad 110 as described above), may be selectively released from the reservoirs 150 by one or more release mechanisms 160, and may be delivered from the reservoirs 150 to the applicator pad 110 by one or more fluid couplings 155. For example, the reservoir 150 may be implemented as a container (ampoule, etc.) having a volume sufficient to hold a therapeutically effective amount of a drug and formed of a material that is impermeable to and non-reactive with the drug or a component thereof, such as glass, metal, plastic, polymer (e.g., rigid polymer such as polyethylene, polypropylene, polyamide, polycarbonate), etc. In some embodiments, the reservoir 150 may be formed of a material (e.g., plastic or glass) that is capable of breaking or puncturing to release the contents of the reservoir 150. The reservoir 150 may have an opening through which the drug may be introduced into and/or selectively released from the reservoir 150. In some embodiments, the reservoir 150 may include a vent.

The gripping portion 140 may be formed of any suitable material, with at least the distal end (e.g., an optional plate) being formed of a relatively rigid material capable of applying a suitable pressure to the applicator pad 110. For example, the grip portion 140 (or at least the body of the first portion of the grip portion 140) may be formed from 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 to the applicator pad via a fluid coupling 155 such as a tube, wick, or the like. The drug may be selectively released from the reservoir 150, for example, by a release mechanism 160, such that the drug may be received in the applicator pad 110. The release mechanism 160 may be, for example, a valve that may be opened to establish fluid communication between the reservoir 150 and the applicator pad 110, either directly or via the fluid coupling 155, and may also be selectively closed to fluidly isolate the medicament in the reservoir 150. The release mechanism may be a removable or frangible cap or other closure that closes the opening in the reservoir 150. The reservoir 150 itself may be frangible, e.g., formed of glass that can be easily broken or at least partially formed of a material that bursts when the contents of the reservoir 150 are above a threshold pressure, and may release the drug from the reservoir 150 by causing or allowing the reservoir 150 to burst. As described above, in some embodiments, the reservoir 150 may be part of the applicator pad 110. For example, the material of the applicator pad 100 may be impregnated or saturated with the drug and closed with an applicator seal 120 (e.g., a thin layer of film or other material that is impermeable to and non-reactive with the drug). Drug may be released from reservoir 150 by removing applicator seal 120 thereby exposing a surface of applicator pad 110 so that drug may be delivered to wound tissue with which the surface of applicator pad 110 is placed.

In some embodiments, the volume and material of the applicator pad 110 may be selected such that the amount of drug or the amount of drug contained in one or more reservoirs 150 (whether separate from the applicator pad 110 or incorporated into the applicator 110) may be pre-impregnated into the applicator pad 110 such that the applicator pad 110 is about 35% saturated (i.e., contains about 35% of the amount of drug it is capable of containing). In some embodiments, the applicator pad 110 may be configured to have an amount of drug that is about 67% to about 100% saturated. In some embodiments, the applicator pad 110 is configured to have an amount of drug that is about 25% to about 50% saturated. In some embodiments, the applicator pad 110 may be pre-impregnated or filled to hold a metered dose of drug. In some embodiments, the applicator pad 110 may be configured such that the volume of the drug is effective to treat the wound, but such that the drug does not travel outside of the treatment area past the skin of the user (e.g., down the arm or leg of the user) (e.g., configured to be about 35% saturated or about 25% to about 50% saturated).

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

The applicator device 170 may be any suitable device that is manipulable by a user to place the applicator pad 110 at a desired location (e.g., adjacent the wound WD) and to place the applicator pad 110 at the desired location. For example, the applicator device 170 may be a mechanical syringe including a barrel having a distal end adapted to be attached to the applicator pad 110 and a proximal end that may be grasped by a user. In some embodiments, the reservoir 150, the release mechanism 160, and/or the fluid coupling 155 may be disposed within the barrel (e.g., between the plunger and the applicator pad 110). In some embodiments, the applicator device 170 may include a plunger that is movable relative to the barrel and to which a user may apply a distally directed force to engage the distal end of the plunger with the reservoir 150 and cause the contents of the reservoir 150 to pass distally through the barrel, out of the distal end of the barrel, and into contact with the applicator pad 110. For example, the reservoir 150 may include a breakable neck portion that separates from a body portion of the reservoir 150 to release liquid from the reservoir 150 in response to the reservoir 150 being pushed against an internal ramp or incline. As another example, the neck portion of the reservoir 150 may be broken from the reservoir by engagement between the deformable side wall and the neck portion of the applicator device 170 due to manipulation of the side wall by the user.

In some embodiments, the reservoir 150 may include a weakened or pre-scored region (e.g., a circumferential region or a sidewall region) configured to preferentially break upon application of a breaking force to the weakened or pre-scored region. For example, in some embodiments, the weakened or pre-scored region may be at a midpoint of the reservoir 150 along a central axis of the reservoir 150, adjacent a shoulder of the reservoir 150, and/or may be on or near a first (e.g., distal) end or a second (e.g., proximal) end of the reservoir 150. The reservoir 150 may be configured to break (e.g., at a weakened or pre-scored area) due to rotational, bending, and/or orthogonal forces applied to the reservoir 150 (relative to or along a central axis of the reservoir 150). In some embodiments, such rotational, bending, and/or orthogonal forces may be applied via twisting and/or bending the grip 140 within which the reservoir 150 is disposed. In some embodiments, the breaking force may be applied via displacing (e.g., squeezing) a portion of the grip (e.g., the deformable sidewall portion) into sufficiently forceful contact with the sidewall of the reservoir 150 to break the reservoir 150 and release the contents of the reservoir 150. In some embodiments, the breaking force may be applied via rotation or translation of the second portion of the grip 140 relative to the first portion of the grip 140 to apply the breaking force to the reservoir 150.

In some embodiments, the release mechanism 160 may include a force concentrating component (also referred to as a stress concentrating component) (e.g., a ball such as a steel ball or a protrusion such as a male or pointed protrusion, such as a carbide head) disposed on an inner surface of the grip 140 and configured to push against a sidewall of the reservoir 150 (e.g., due to bending the grip 140, squeezing or pushing an outer portion of the grip 140 toward the reservoir 150, or rotating a second portion of the grip 140 relative to a first portion of the grip 140) to concentrate a breaking force on a sidewall or end of the reservoir 150 and break (e.g., destroy) the reservoir 150. In some embodiments, the grip 140 may include notch features in the sidewall of the grip 140 such that the grip 140 may more easily bend about a preferential axis or plane that includes the notch features.

In some embodiments, the reservoir 150 and/or the grip 140 may be disposed in a vertical orientation such that the reservoir 150 is elongated along a longitudinal axis intersecting a plane containing the applicator pad 110 in an initial configuration of the system 100 during wetting of the applicator pad 110 with the contents of the reservoir 150 and/or during application of pressure to the applicator pad 110 while the applicator pad 110 is disposed on a recipient's wound. 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 be disposed in a horizontal orientation such that the reservoir 150 is elongated along a longitudinal axis disposed substantially parallel to a plane containing the applicator pad 110 in the initial configuration of the system 100 during wetting of the applicator pad 110 with the contents of the reservoir 150 and/or during application of pressure to the applicator pad 110 while the applicator pad 110 is disposed on a recipient's wound. 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 sidewall of the grip 140.

In some embodiments, the applicator device 170 may include a filter (not shown) between the reservoir 150 and the applicator pad 110 to prevent unwanted material (e.g., particles and/or pieces of glass that exceed a certain size) from reaching the applicator pad 110. In some embodiments, the applicator device 170 may not include the reservoir 150, the release mechanism 160, and/or the fluid coupling 155, but rather merely provide a handle by which a user may hold the applicator pad 110 so as to be able to apply the applicator pad 110 to the target wound tissue and apply a distributed pressure to the applicator pad 110 to maintain the pressure between the applicator pad 110 against the target wound tissue.

The grip 140 may be used to provide a distributed force (e.g., a uniformly distributed force) to the applicator pad 110, for example, to increase the pressure that the applicator pad 110 may apply to target wound tissue during use to enhance hemostasis. The grip 140 may be implemented in a variety of ways, including those described below in particular embodiments. For example, the grip 140 may include a plate (also referred to herein as a "fixation plate") disposed on the distal end of the grip 140 and extending laterally from the handle portion of the grip and configured to contact and apply a distributed force to the applicator pad 110. In some embodiments, the plate may be shaped and sized such that the plate has a length and width that are greater than the target wound tissue, such that the plate may push a sufficient portion of the applicator pad 110 into contact with the target wound tissue and maintain an evenly distributed force between the applicator pad 110 and the target wound tissue for a period of time. Thus, the grip 140 may be used to provide sufficient hemostatic force to the target wound tissue (e.g., to create sufficient pressure in view of the stiffness or modulus of the material forming the applicator pad 110). In some embodiments, the grip 140 or a portion of the grip may be deformable (e.g., squeezable) to facilitate fluid flow from a reservoir 150 disposed within the grip.

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

In some embodiments, the applicator pad 110 may include or be coupled to a pad holder 135, which may be configured to hold the applicator pad 110 in contact with the target wound tissue. The pad retainer 135 may include, for example, an adhesive on the skin contacting side of the applicator pad 110 (e.g., disposed around at least a portion of the perimeter of the applicator pad 110). In some embodiments, pad retainer 135 may comprise an adhesive foam disposed around the perimeter of applicator pad 110. In some embodiments, pad retainer 135 may comprise adhesive strips having a first portion coupled to an upper surface of applicator pad 110 and having a second portion configured to be coupled to the skin of a recipient to hold applicator pad 110 in place relative to a wound on the skin. In some embodiments, pad retainer 135 may comprise a bandage configured to be placed over at least a portion of applicator pad 110. In some embodiments, the bandage may be formed as a wrap configured to wrap around a portion of the recipient's body (e.g., an arm or leg) that includes the wound. In some embodiments, the bandage may be formed with an adhesive perimeter that is greater than the perimeter of the applicator pad 110 and configured to be applied over the top of the applicator pad 110. In some embodiments, the bandage may include a convex portion configured to align with the wound and be placed in contact with an upper surface of the applicator pad 110 such that when the applicator pad 110 is disposed on the wound and the bandage is applied over the applicator pad 110, the convex portion may apply a target force to the wound via the applicator pad 110 that is greater than if the bandage did not include the convex portion. In some embodiments, after a period of time, the male portion may be removed from the recipient, leaving the applicator pad 110 in place in contact with the wound.

In some embodiments, the applicator device 170 may be implemented as a pipette. The pipette may be configured in a manner that best suits the accuracy and precision required for the size and location of the wound. For example, the pipette may be configured to be positioned within a nostril of the patient.

The hemorrhage processing system 100 can include a user guide 190. The user guide 190 may include instructions for operating the hemorrhage processing system 100 to treat a person whose wound requires hemostasis. The instructions may be in the form of text and/or graphical information that may be presented on a fixed substrate (e.g., paper) or display (e.g., screen), and/or other sensory modalities may be used, including audible (verbal instructions) and/or tactile (tactile feedback to the user). The user guide 190 may be disposed on (e.g., printed on) or coupled to (e.g., mechanically attached to) any one or more components of the blood processing system 100, including the applicator device 170, the wrapper 190, the applicator pad 110, and/or the reservoir 150. The user guide 190 may be separate from, but associated with, any component of the hemorrhage processing system 100, for example, disposed in the package 195 along with other components of the hemorrhage processing system 100. In some embodiments, the user guide 190 may be implemented in whole or in part in software available on a device such as a smart phone, for example, in a form that can be downloaded onto the smart phone and launched by a user preparing to use the bleeding processing system 100.

In some embodiments, the user guide 190 or another information tag disposed on or included with the system 100 may include an information tag having user instructions, such as: "only for superficial bleeding areas of less than 1 inch. The topical applicator pad was pressed against the wound for 5 minutes. An adhesive bandage is placed over the wound. If bleeding does not stop, a specialized medical procedure is sought. If you feel weak or dizziness, please dial 911 immediately, and don't use the device. Do not use in the mouth. Do not apply to deep wounds. If there is a history of seizures, do not use. Do not penetrate wounds or puncture wounds (gunshot wounds, knife wounds, etc.). "

In some embodiments, the user guide 190 or another information tag disposed on or included with the system 100 may include an information tag having user instructions, such as: "only for superficial bleeding of 3 inches or less in length. The release mechanism is pressed to break the drug. Allowing the drug to adequately cover the topical applicator. The device was pressed against the wound for 10 minutes. An adhesive bandage is placed over the wound. If bleeding does not stop or if you feel dizziness, weakness or fatigue, you seek professional medical treatment immediately. Do not use in the mouth. Do not apply to deep wounds. If there is a history of seizures, do not use. Do not penetrate wounds or puncture wounds (gunshot wounds, knife wounds, etc.). The medicine is not drunk. Please keep away from the child or infant. "

In some embodiments, the user guide 190 or another information tag disposed on or included with the system 100 may include one or more statements indicating one or more of the following: (i) Removing the applicator cap prior to pressing the device against the wound; and (ii) peeling the topical applicator from the remainder of the device and retaining the topical applicator on the wound using an adhesive bandage.

In some embodiments, the user guide 190 or another information tag or stamp on the system 100 may include a expiration date. For example, the system 100 may have an expiration date of three years, more than three years, or less than three years from the date of manufacture. In some embodiments, the user guide 190 or another informational tag or stamp on the system 100 may include a lot number and/or a date of manufacture. In some embodiments, the user guide 190 or another information tag or stamp on the system 100 may include a bar code and/or a Quick Response (QR) code.

The package 195 may be implemented in the same manner as any known medical device package to house other components of the blood treatment system 100, to protect the components from the environment, and optionally to maintain sterility of the components. When a user desires to access and use the blood processing system 100, the package 195 is preferably configured to be easily opened by the user, such as by peeling the cover from the tray. The package 195 may be implemented in many other ways including, for example, a bag or a box. The system 100 is preferably intended for single user and one wound site application. The system 100 is preferably intended to be discarded after use and may optionally include a container for safe disposal. In some embodiments, the system 100 may be initially supplied to the user in a package 195 that may also be used for disposal. In some embodiments, the package 195 and/or disposal container may be a resealable bag and/or may include a biohazard label and/or disposal instructions.

The medicament described herein may be any medicament that will be desired to be delivered to a patient whose wound requires hemostasis in preparation for or as part of treating the wound. The class of drugs may include vasoconstrictors, antifibrinolytic drugs, antibiotics, recombinant clotting factor drugs, local anesthetics, analgesics, buffers, calcium, alcohols/antimicrobials (e.g., chlorhexidine solutions such as solutions of chlorhexidine and isopropanol and/or ethanol) or any combination thereof. The vasoconstrictor may be used to aid in vasoconstriction of bleeding prior to or concurrent with administration of a hemostatic drug (such as an anti-fibrinolytic drug), and may desirably be delivered to the target wound tissue at or around the site of bleeding prior to, during, and/or after application of the applicator pad 110 to the target wound tissue. Suitable vasoconstrictors may include phenylephrine, oxymetazoline (alfulin), and epinephrine. The anti-fibrotic solvent may be used to prevent clot lysis and may also desirably be delivered to the wound tissue at or around the site of bleeding prior to, during, and/or after application of the applicator pad 110 to the target wound tissue. Suitable antifibrinolytic agents may include aminocaproic acid, tranexamic acid (TXA) (e.g., dried or lyophilized TXA or a liquid formulation comprising TXA), aprotinin, protamine aminotoluene, and fibrinogen. Protamine (i.e., a reversal agent for anticoagulated heparin) may be used before, during, or after the use of the above-described drugs. The drug may include, for example, protamine sulfate. As described above, the bleeding treatment system 100 and medicaments may be particularly helpful in treating patients who are prone to bleeding or have difficulty achieving hemostasis, such as patients taking anticoagulation and/or antiplatelet medicaments (identified above).

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

In some embodiments, the drug may include an analgesic, including but not limited to opioids, such as codeine, morphine, oxycodone, and the like; acetaminophen; anti-inflammatory agents including non-steroidal anti-inflammatory drugs, aspirin, and the like; an antibiotic or another antibacterial agent or compound; antihistamines (e.g., cimetidine, chlorpheniramine maleate, diphenhydramine hydrochloride, and promethazine hydrochloride); an antifungal agent; ascorbic acid; rutin; thrombin; a plant preparation; etc.; and combinations thereof. The medicament may also include magnesium sulfate, sodium metaphosphate, calcium chloride, dextrin and combinations thereof.

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

In some embodiments, the reservoir 150 may include an activation liquid, such as sterile water or saline, and the applicator pad 110 may include a dry (e.g., lyophilized) drug configured to be activated by the activation liquid after the activation liquid is released from the reservoir 150. In some embodiments, the applicator pad 110 may include a dry drug configured to be activated by blood flowing from the wound when the applicator pad 110 is placed in contact with the wound, such that no activation liquid or replenishment thereof is required to be disposed within the applicator device 170. In some embodiments, the applicator pad 110 may include a wetting agent to facilitate dissolution of the dry medicament.

In some embodiments, the drug may include an anti-fibrinolytic drug in an amount of about 50mg/mL to about 300mg/mL, including about 50mg/mL, about 100mg/mL, about 150mg/mL, about 200mg/mL, about 250mg/mL, or about 300mg/mL. In some embodiments, the medicament may also include a colored dye to indicate that the medicament has been dispensed to the wound and has a composition that is visible to the person based on skin color and blood color (before and after clotting). In other embodiments, the drug may not contain a colored dye.

In some embodiments, an amount (e.g., a therapeutically effective amount) of a drug (e.g., an anti-fibrinolytic drug such as TXA) included in and/or provided from a reservoir to a target wound may be between about 1mg and about 20mg, between about 1mg and about 5mg, between about 5mg and about 10mg, between about 10mg and about 15mg, between about 15mg and about 20mg, and/or between about 10mg and about 20 mg. In some embodiments, a greater amount of drug may be included for treating a larger target wound size.

In some embodiments, the reservoir 150 and/or the release mechanism 160 are configured such that a metered dose may be provided from the reservoir (e.g., to the applicator pad 110 and/or the patient). The metered dose (e.g., the dose of IV TXA) may be the amount of liquid disposed within the reservoir 150 prior to use of the system 100. In some embodiments, the metered dose may be between about 1.5mL and about 2.5mL, between about 2.5mL and about 4.5mL, between about 3mL and about 10mL, between about 3mL and about 7mL, between about 1mL and about 20mL, between about 1mL and about 1.5mL, between about 2.5mL and about 5mL, between about 5mL and about 10mL, between about 10mL and about 15mL, or between about 15mL and about 20 mL. For example, reservoir 150 may include a metered dose of about 1mL, or about 2mL, or about 3mL, or about 4mL, or about 5mL, or about 6mL, or about 7mL, or about 8mL, or about 9mL, or about 10mL, or about 11mL, or about 12mL, or about 13mL, or about 14mL, or about 15mL, or about 16mL, or about 17mL, or about 18mL, or about 19mL, or about 20 mL.

A method of treating a wound in need of hemostasis using the hemorrhage treatment system 100 is shown in fig. 4 and described with reference to fig. 3A-3D. In some embodiments, the hemorrhage treatment system 100 can be operated with one hand (e.g., the hand of the recipient or the hand of a caregiver whose wound requires treatment). As shown in fig. 4 and in fig. 3A, in some embodiments, the applicator device 170 may be removed from the package 195 at 202. At 204, the user guide 190 may optionally be checked or understood. At 206, optionally, the drug may be released from the reservoir 150 and transferred to the applicator pad 110. At 208, the applicator pad 110 may be exposed for delivery to the wound WD in the skin SK (e.g., via removal of the optional applicator seal 120).

As shown in fig. 4 and in fig. 3B, at 210, the applicator pad 110 may be delivered to a wound WD in the skin SK. As shown in fig. 3A and referenced above, in some embodiments, the applicator pad 110 may be delivered to the wound WD in the skin SK in a manner that extends from, or is coupled to, the applicator device 170 such that the applicator pad 110 is in contact with the wound WD and an area of the skin SK surrounding the wound WD.

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

At 214, the drug may be allowed to release from the applicator pad 110 to the wound WD. For example, in some embodiments, the drug may be released from the reservoir 150 via interaction with the release mechanism 160 such that the drug flows to the applicator pad 110 via the fluid coupling 155 and then from the applicator pad 110 to the wound WD. In some embodiments, as described above, the applicator pad 110 may include a drug (e.g., by pre-dipping) prior to use of the system 100, such that removal of the applicator seal 120 and application of the applicator pad 110 to the wound WD (and/or pressure applied to the applicator pad 110 while in contact with the wound WD) allows or causes the drug to travel into contact with the wound WD. In some embodiments, rather than releasing the drug from the reservoir 150 or as a supplement, an activation liquid, such as saline, may be released from the reservoir 150 to activate the drug included in the applicator pad 110 (e.g., in an initial dry state) such that the combination of drug and activation liquid from the applicator pad may flow into contact with the wound WD. In some embodiments, blood from the wound WD may activate the drug in the applicator pad 110 (e.g., in an initial dry state) such that the combination of drug and blood from the applicator pad may flow into contact with the wound WD.

At 216, the applicator pad 110 may be held against the wound WD by pressure applied to the wound WD by the grip 140. At 218, hemostasis may be assessed. For example, the hemostatic condition of the wound WD may be evaluated to determine whether the hemostatic condition meets a target hemostatic condition. Hemostatic conditions of wound WD may be assessed via any suitable method. For example, after a preset period of time (e.g., five minutes or ten minutes to thirty minutes), the applicator pad 110 may be removed and the wound WD checked to determine whether hemostasis has been achieved.

In some embodiments, after hemostasis is assessed at 218, at 220, the applicator pad 110 may continue to be held against the wound WD while pressure is applied to the wound WD, and hemostasis may be re-assessed until achieved. For example, if the hemostatic condition of the wound WD fails to meet the target hemostatic condition, the applicator pad 110 may be held against the wound WD, thereby applying pressure to the wound WD for a period of time. The hemostatic condition may then be re-evaluated to determine whether the target hemostatic condition has been met. Such a cycle may continue until the target hemostatic condition has been met, at which point the applicator pad 110 may be removed from the wound WD.

In some embodiments, as shown in fig. 3C, the pressure on the wound WD may be released at 222 before the applicator pad 110 is removed from the wound WD. For example, in the event that pressure is applied to the applicator pad 110 using the grip 140, the grip 140 may be disengaged from the applicator pad 110 to reduce the pressure of the applicator pad 110 against the wound WD. In some embodiments, at 224, the applicator pad 110 may remain against the wound WD after the pressure is released (e.g., after the grip 140 is removed). In some embodiments, the applicator pad 110 may be held in place against the wound WD by a 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 wound WD for a period of time. In some embodiments, the applicator pad 110 may continue to apply pressure to the wound WD after the grip 140 is removed (e.g., because contact with the wound WD is maintained). In some embodiments, the applicator pad 110 may continue to apply pressure to the wound WD due, at least in part, to the inflation of the applicator pad 110 or the blood-drawing pad 130 due to the absorption of liquid (e.g., blood). As shown in fig. 3D, at 226, the applicator pad 110 may be removed from the wound WD.

Fig. 5 is a schematic diagram of a bleeding treatment system 300. The system 300 may be identical or similar in structure and/or function to any of the bleeding treatment systems described herein. The 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 optionally defines an interior space 343. In some embodiments, the first portion 342 optionally defines an open distal end such that the interior space 373 can be fluidly coupled to the applicator pad through the distal end of the first portion 342.

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

In some embodiments, the grip 340 includes an applicator seal 310 configured to cover at least a distal or skin contacting surface of the applicator pad 310 to prevent contamination of the applicator pad 310 and optionally to prevent the applicator pad 310 from leaking or drying out prior to use. The applicator seal 310 may be formed, for example, as a film (e.g., a peelable film). In some embodiments, the applicator seal 310 may be formed from 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.

The applicator pad 310 may be the same or similar in structure and/or function as any of the applicator pads described herein. For example, the applicator pad 310 may include and/or be coupled to an optional blood-drawing pad 330 and/or an optional pad holder 335. The blood drawing pad 330 and pad retainer 335 may be identical or similar in structure and/or function to any of the blood drawing pads or pad retainers, respectively, described herein.

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

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

In some embodiments, the interior space 343 may be at least partially defined by an interior surface of a sidewall of the grip 340 and may be defined by the first portion 342 and/or the second portion 344. In some embodiments, the inner and/or outer surfaces of the sidewalls of the grip 340 (including the first and second portions 342, 344) may have any suitable shape, such as a circular cylindrical shape, an oval cylindrical shape, an elliptical cylindrical shape, a tubular shape with two opposing flat sides coupled together by two opposing curved sides, and/or a prismatic shape, including cubes, rounded square prisms, rectangular prisms, rounded rectangular prisms, triangular prisms, pentagonal prisms, hexagonal prisms, and the like. In some embodiments, the inner surface of the grip 340 defining the interior space 343 includes one or more rounded or beveled edges. In some embodiments, the inner surface of the grip 340 defining the interior space 343 comprises a rounded rectangular prismatic shape with one or more rounded edges. In some embodiments, interior space 343 is cylindrical.

In some embodiments, the release mechanism 360 may be coupled to the reservoir 350 and configured to transition from the closed state to the open state to allow the drug to flow from the reservoir 350 to the applicator pad 310 via the fluid coupling 355 in response to a pressure within the reservoir 350 being above a threshold pressure (e.g., applied by the distal end of the second portion 344). For example, in some embodiments, the release mechanism 360 may include weakened or frangible portions of the side walls of the reservoir 350. In some embodiments, the release mechanism 360 includes a valve that transitions from a closed state to an open state when the internal pressure of the reservoir 350 rises above a threshold pressure. In some embodiments, the release mechanism 360 may be a frangible portion of the reservoir 350 that is configured to break when pushed against an internal obstruction (not shown), such as a ramp portion within the interior space 343, so that the drug within the reservoir 350 may be released from the reservoir 350. In some embodiments, the first portion 372 may include a filter (not shown) between the reservoir 350 and the applicator pad 310 to prevent unwanted material from reaching the applicator pad 310.

The applicator device 370 may be set in an initial configuration prior to use. In an initial configuration, the applicator pad 310 may be coupled to the distal end of the grip 340. The applicator seal 320 may cover the applicator pad 310. To use the applicator device 370, the applicator seal 320 may optionally be removed, and the grip 340 may be used to apply the applicator pad 310 to the wound. In embodiments including reservoir 350, release mechanism 360, and fluid coupling 355, a liquid (e.g., a drug and/or an activator, such as saline) may be contained within reservoir 350 before and optionally after applicator pad 310 is applied to the wound. To release the liquid from the reservoir 350 such that the liquid flows to the applicator pad 310, the second portion 344 may be configured to move relative to the first portion 342 (e.g., 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) to engage with the reservoir 350 and/or the release mechanism 360.

The grip 340 may optionally be used to press the applicator pad 310 against the target wound tissue. The applicator pad 310 may optionally be held relative to the wound by coupling the applicator pad 310 to the skin via the pad holder 335 (e.g., without the grip 340 being held against the applicator pad 310). The applicator pad 310 may optionally be separated from the applicator pad 310 by releasing the applicator pad 310 from the pad connector 348.

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

The first portion 442 may include a plate 431 having a distal or bottom surface extending transversely with respect to the central axis a of the grip 440. The applicator pad 410 may be disposed on a distal end of the first portion 442 (e.g., coupled to a distal surface of the plate 431). The first portion 442 may include a ramp portion 462 (also referred to as a first release mechanism portion) that extends partially into the interior space 443 of the first portion 442 such that the neck portion 452 may contact the ramp portion 462. The first portion 442 may also include one or more retaining portions 447 (e.g., flexible tabs or raised portions) that extend toward the central axis a of the first portion 442 and are configured to contact a shoulder of the body portion 454 of the reservoir 450, as shown in fig. 6B, to retain the reservoir 450 in an initial proximal position until sufficient force is applied to the proximal end of the reservoir 450 to advance the reservoir 450 relative to the one or more retaining portions 447. The first portion 442 may also include one or more gripping features 445 on an outer surface of the sidewall of the first portion 442 to improve the grip of the user during manipulation of the grip 440. Gripping features 445 may include any suitable surface features to increase grip or friction, such as one or more ridges (as shown in fig. 6A), concave and/or convex curves, and/or textured or roughened surfaces.

The second portion 444 may include a protrusion 464 (also referred to as a second release mechanism portion). The first portion 442 and the second portion 444 can be coupled such that at least a portion of the second portion 444 can be advanced relative to the first portion 442 toward the distal end of the first portion 442. For example, the first portion 442 may be coupled to the second portion 444 via any suitable coupling mechanism (e.g., such as a flexible portion circumferential portion). To release the liquid within the reservoir 450 such that the liquid flows to the applicator pad 410, the second portion 444 may be advanced distally relative to the first portion 442 (e.g., by pressing on the proximal end of the second portion 444) such that the second release mechanism portion 464 applies a force to the proximal end of the reservoir 450 to push the reservoir 450 distally such that contact between the neck portion 452 and the ramp 462 of the reservoir 450 causes the neck portion 452 to separate (e.g., break) from the remainder of the reservoir 450 and allows the liquid to flow from the reservoir 450 out of the distal end of the first portion 442 and to the applicator pad 410, thereby causing the applicator pad 410 to be wetted by the liquid from the reservoir 450.

In some embodiments, the first portion 442 may include a filter to prevent unwanted material (e.g., particles and/or glass flakes exceeding a certain size) from reaching the applicator pad 410. The distal surface of the applicator pad 410 may be placed against the recipient's wound either before or after wetting the applicator pad 410 with liquid. The grip 440 may then be held against the applicator pad 410 such that the plate 431 applies a distributed pressure to the applicator pad 410 over a period of time, as described with respect to the method 200 above. In some embodiments, the first portion 442 and/or the second portion 444 may be deformable (e.g., squeezable) to facilitate the flow of fluid (e.g., drug) out of the reservoir 450. In some embodiments, the hemorrhage processing system 400 can be operated with one hand (e.g., the hand of the recipient whose wound requires treatment). For example, the user may place a thumb on the proximal end of the second portion 444 and wrap the remaining fingers of the same hand around the sidewall of the grip 440 (e.g., around the first portion 442), with at least some of the remaining fingers in contact with the gripping features 445. When grasping the grip 440 in this configuration, the user may press the second portion 444 against the applicator pad 410 with the user's thumb to release the liquid from the reservoir 450, either before or after pressing the applicator pad 410 against the wound, as described above.

Fig. 7A-7D are schematic diagrams of perspective, front, side and cross-sectional views, respectively, of a hemorrhage treatment system 500 in an initial configuration. Fig. 7E-7H are schematic diagrams of a perspective view, a front view, a side view, and a cross-sectional view, respectively, of a bleeding treatment system 500 in a wetted configuration. The system 500 may be identical or similar in structure and/or function to any of the delivery or treatment systems described herein (e.g., such as the hemorrhage treatment system 400). For example, the system 500 includes an applicator device 570, a reservoir 550, and an applicator pad 510. The applicator device 570 includes a grip 540 defining an interior space 543 and having an open distal end, a closed proximal end, and extending along a central longitudinal axis D. The grip 540 has a first portion 542 and a second portion 544, the second portion 544 being movable relative to the first portion 542. The reservoir 550 may be formed as an ampoule having a neck portion 552 and a body portion 554. The neck portion 552 may be narrower (e.g., may have a smaller diameter) than the body portion 554. The reservoir 550 may be disposed within the interior space 543 of the grip 540. The reservoir 550 may be oriented such that the neck portion 552 is distal of the body portion 554 and thus closer to the open end of the grip 540. The interior space 543 may be defined in part by the interior 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 that extends transversely relative to the central axis D of the grip 540. The applicator pad 510 may be disposed on a distal end of the first portion 542 (e.g., coupled to a distal surface of the plate 531). The first portion 542 may include a ramp portion 562 (also referred to as a first release mechanism portion) that extends partially into the interior space 543 of the first portion 542 such that the neck portion 552 may contact the ramp portion 562. The first portion 542 may also include one or more retaining portions 547 (e.g., flexible tabs or raised portions) that extend toward the central axis a of the first portion 542 and are configured to contact a shoulder of the body portion 554 of the reservoir 550, as shown in fig. 6B, to retain the reservoir 550 in an initial proximal position until sufficient force is applied to the proximal end of the reservoir 550 to advance the reservoir 550 relative to the one or more retaining portions 547. The first portion 542 may also include one or more gripping features 545 on an outer surface of the sidewall of the first portion 542 to improve the grip of the user during manipulation of the grip 540.

The second portion 544 may include a protrusion 564 (also referred to as a second release mechanism portion) that extends into the interior space 543. The first portion 542 and the second portion 544 may be coupled such that at least a portion of the second portion 544 may be advanced relative to the first portion 542 toward the distal end of the first portion 542. For example, the second portion 544 may include a slidable engagement portion 544A, and the first portion 542 may include a receiving portion 544B having a corresponding shape and a diameter that is greater than an outer diameter of the slidable engagement portion 544A, such that the slidable engagement portion 544A may translate into the receiving portion 544B (e.g., by pressing on a proximal end of the second portion 544 and/or grasping an opposing sidewall of the second portion 544 and advancing the second portion 544 distally). During translation of the slidable engagement portion 544A into the receiving portion 544B, the second release mechanism portion 564 may apply a force to the proximal end of the reservoir 550 to push the reservoir 550 distally such that contact between the neck portion 552 of the reservoir 550 and the ramp 562 causes the neck portion 552 to separate (e.g., break) from the remainder of the reservoir 550 and allow liquid to flow from the reservoir 550 out of the distal end of the first portion 542 and to the applicator pad 510, thereby causing the applicator pad 510 to be wetted by liquid from the reservoir 550.

In some embodiments, the first portion 542 may include a filter (e.g., disposed between the ramp 562 and the distal opening of the grip 540) to prevent unwanted material (e.g., particles and/or glass flakes exceeding a certain size) from reaching the applicator pad 510. The distal surface of the applicator pad 510 may be placed against the recipient's wound either before or after wetting the applicator pad 510 with liquid. The grip 540 may then be held against the applicator pad 510 such that the plate 531 applies a distributed pressure to the applicator pad 510 over a period of time, as described with respect to the method 200 above. In some embodiments, the hemorrhage processing system 500 can be operated with one hand (e.g., the hand of the recipient whose wound requires treatment). For example, the user may place a thumb on the proximal end of the second portion 544 and wrap the remaining fingers of the same hand around the sidewall of the grip 540 (e.g., around the first portion 542), with at least some of the remaining fingers in contact with the gripping features 545. When grasping the grip 540 in this configuration, the user may press the second portion 544 against the applicator pad 510 with the user's thumb to release the liquid from the reservoir 550, either before or after pressing the applicator pad 510 against the wound, as described above.

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

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

Fig. 9A and 9B are perspective and cross-sectional views of a hemorrhage treatment system 700. Fig. 9C is a cross-sectional view of a hemorrhage processing system, wherein reservoir 750 of hemorrhage processing system 700 is not shown. The system 700 may be identical or similar in structure and/or function to any of the delivery or processing systems described herein. For example, the system 700 may include an applicator device 770, a reservoir 750, and an applicator pad 710. The applicator device 770 includes a graspable portion 740 defining an interior space 743 and having an open distal end, 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 laterally movable relative to the first portion 742. The reservoir 750 may be formed as an ampoule having a neck portion 752 and a body portion 754. The neck portion 752 may be narrower (e.g., may have a smaller diameter) than the body portion 754. The reservoir 750 may be disposed within the interior space 743 of the grip 740. The reservoir 750 may be oriented such that the neck portion 752 is distal to the body portion 754 and thus closer to the open end of the grip 740. The interior space 743 may be at least partially defined by an interior surface of a sidewall of the grip 740 and may be defined by a combination of the first portion 742 and the second portion 744. As shown in fig. 8A, the grip 740 (e.g., inner and/or outer surface) may be formed to have a tubular shape with two opposing flat sides coupled together by two opposing curved sides. In some embodiments, the grip 740 may have any suitable shape, such as described above with respect to the grip 340.

The first portion 742 may include a plate 731 having a distal or bottom surface that extends transversely relative to the central axis B of the grip 740. The applicator pad 710 may be disposed on a distal end of the first portion 742 (e.g., coupled to a distal surface of the plate 431). The first portion 742 may also include one or more retaining portions (not shown) (e.g., flexible tabs or raised portions) that extend toward the central axis B of the first portion 742 and are configured to contact a shoulder of the body portion 754 of the reservoir 750 to retain the reservoir 750 in a proximal position. In some embodiments, rather than or in addition to including one or more retaining portions that contact the shoulder of the body portion 754, the first portion 742 may include a retaining portion such as an adhesive and/or an inner sidewall in frictional contact with the body portion 754 to retain the body portion 754 in a position in which the neck portion 752 is radially aligned with the second portion 744.

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

As shown in fig. 8B, the first portion 742 can include a closed proximal end and an open distal end. The first portion 742 may optionally include a tab portion 764 coupled to the flexible end of the first portion 742 and configured to contact the proximal end of the reservoir 750 and push the reservoir 750 distally (or cause fluid to flow from the reservoir 750) when pressed by a user's finger.

To release the liquid within the reservoir 750 such that the liquid flows to the applicator pad 710, the second portion 744 may be deformed distally relative to the neck portion 752 (e.g., by pressing on the second portion 744 with a user's finger (such as a thumb)) such that contact between the second portion 744 and the neck portion 752 of the reservoir 750 causes the neck portion 752 to separate (e.g., break) from the body 754 of the reservoir 750 and allow the liquid to flow from the distal end of the reservoir 750 out of the first portion 742 and to the applicator pad 710, thereby causing the applicator pad 410 to be wetted by the liquid from the reservoir 750.

The second portion 744 may include one or more gripping features 745 on an outer surface of the second portion 742 to improve the grip of the user during manipulation of the grip 740. Gripping features 745 may include any suitable surface features to increase grip or friction, such as one or more ridges (as shown in fig. 8A), concave and/or convex curves, and/or textured or roughened surfaces.

In some embodiments, the first portion 742 may include a filter to prevent unwanted material (e.g., particles and/or glass flakes exceeding a certain size) from reaching the applicator pad 710. The distal surface of the applicator pad 710 may be placed against the recipient's wound either before or after wetting the applicator pad 710 with liquid. The grip 740 may then be held against the applicator pad 710 such that the plate 731 applies a distributed pressure to the applicator pad 710 over a period of time, as described with respect to the method 200 above. In some embodiments, the first portion 742 and/or the second portion 744 may be deformable (e.g., squeezable) to facilitate the flow of the drug out of the reservoir 750 (e.g., after the neck portion 752 has been separated from the body portion 750). In some embodiments, the hemorrhage processing system 700 can be operated with one hand (e.g., the hand of the recipient whose wound requires treatment). For example, the user may place a thumb on the second portion 744 and wrap the remaining fingers of the same hand around the side wall of the grip 740 (e.g., around the first portion 742). When grasping the grip 740 in this configuration, the user may press the second portion 744 against the neck portion 752 with the user's thumb to release liquid from the reservoir 750, either before or after pressing the applicator pad 710 against the wound, as described above.

Fig. 10A and 10B are perspective and cross-sectional views of a hemorrhage treatment system 800. Fig. 10C is a cross-sectional view of a hemorrhage processing system, wherein reservoir 850 of hemorrhage processing system 800 is not shown. The system 800 may be identical or similar in structure and/or function to any of the delivery or processing systems described herein. For example, the system 800 may include an applicator device 870, a reservoir 850, and an applicator pad 810. The applicator device 870 includes a graspable portion 840 defining an interior space 843 and having an open distal end, a closed proximal end, and extending along a central longitudinal axis C. The grip has a first portion 842 and a second portion 844, the second portion 844 being movable relative to the first portion 842. Reservoir 850 may be formed as an ampoule having a neck portion 852 and a body portion 854. The neck portion 852 may be narrower (e.g., may have a smaller diameter) than the body portion 854. The reservoir 850 may be disposed within the interior space 843 of the grip 840. The reservoir 850 may be oriented such that the neck portion 852 is distal to the body portion 854 and thus closer to the open end of the grip 840. The interior space 843 may be at least partially defined by an interior surface of a sidewall of the grip 840 and may be defined by the first portion 842 and/or the second portion 844. As shown in fig. 9A, the grip 840 (e.g., inner and/or outer surfaces) may be formed to have a cylindrical shape. In some embodiments, the grip 840 may have any suitable shape, such as described above with respect to the grip 340.

The first portion 842 may include a plate 831 having a distal or bottom surface that extends transversely with respect to the central axis C of the grip 840. The applicator pad 810 may be disposed on a distal end of the first portion 842 (e.g., coupled to a distal surface of the plate 831). The first portion 842 may include a ramp portion 862 (also referred to as a first release mechanism portion) that extends partially into the interior space 843 of the first portion 842 such that the neck portion 852 may contact the ramp portion 862. The first portion 842 may also include one or more retaining portions (not shown) (e.g., flexible tabs or raised portions) that extend toward the central axis C of the first portion 842 and are configured to contact a shoulder of the body portion 854 of the reservoir 850, as shown in fig. 9B, to retain the reservoir 850 in an initial proximal position until sufficient force is applied to the proximal end of the reservoir 850 to advance the reservoir 850 relative to the one or more retaining portions. The first portion 842 may also include one or more gripping features (not shown) on an outer surface of the sidewall of the first portion 842 to improve the grip of the user during manipulation of the grip 840. The gripping features may include any suitable surface features to increase grip or friction, such as one or more ridges, concave and/or convex curves, and/or textured or roughened surfaces.

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

In some embodiments, the first portion 842 may include a filter to prevent unwanted material (e.g., particles and/or glass flakes exceeding a certain size) from reaching the applicator pad 810. The distal surface of the applicator pad 810 may be placed against the recipient's wound either before or after wetting the applicator pad 810 with liquid. The grip 840 may then be held against the applicator pad 810 such that the plate 831 applies a distributed pressure to the applicator pad 810 over a period of time, as described with respect to the method 200 above. In some embodiments, first portion 842 and/or second portion 844 may be deformable (e.g., squeezable) to facilitate flow of medicament from reservoir 850. In some embodiments, the hemorrhage processing system 800 can be operated with one hand (e.g., the hand of the recipient whose wound requires treatment). For example, the user may place a thumb on the proximal end of the second portion 844 and wrap the remaining fingers of the same hand around the side wall of the grip 840 (e.g., around the first portion 842). When grasping the grasping portion 840 in this configuration, the user may press the second portion 844 against the applicator pad 810 with the user's thumb to release liquid from the reservoir 850, either before or after pressing the applicator pad 810 against the wound, as described above.

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

The first portion 942 may include a plate 931 having a distal or bottom surface that extends transversely relative to the central axis D of the grip 940. The applicator pad 910 may be disposed on a distal end of the first portion 942 (e.g., coupled to a distal surface of the plate 931). The first portion 942 may include a ramp portion 962 (also referred to as a first release mechanism portion) that extends partially into the interior space 943 of the first portion 942 such that the neck portion 952 may contact the ramp portion 962. The first portion 942 may also include one or more retaining portions (not shown) (e.g., flexible tabs or raised portions) that extend toward the central axis D of the first portion 942 and are configured to contact a shoulder of the body portion 954 of the reservoir 950 to retain the reservoir 950 in an initial proximal position until sufficient force is applied to the proximal end of the reservoir 950 to advance the reservoir 950 relative to the one or more retaining portions. The first portion 942 may also include one or more gripping features (not shown) on an outer surface of the sidewall of the first portion 942 to improve the grip of the user during manipulation of the grip 940. The gripping features may include any suitable surface features to increase grip or friction, such as one or more ridges, concave and/or convex curves, and/or textured or roughened surfaces.

The grip 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 toward a distal end of the first portion 942 relative to the first portion 942. For example, the first portion 942 may be coupled to the second portion 944 via any suitable coupling mechanism (e.g., such as a screw thread or a slidable friction fit). The second portion 944 may have an inner diameter that is greater than an outer diameter of the proximal end of the first portion 942 such that the second portion 944 may be disposed in contact with an outer surface of the first portion 942. The reservoir 950 may be disposed in an initial position within the interior space 943 such that a proximal end of the reservoir is near or adjacent to the distally facing inner surface 964 and may be advanced distally as a result of the distal displacement of the second portion 944. In some embodiments, the spring portion 946 may be configured to transition from an initial configuration to an extended or compressed configuration to bring the reservoir 950 into contact with the ramp 962. For example, the spring portion 946 may be activatable to push the ramp 962 away from the applicator pad 910 and into breaking contact with the neck portion 952. In some embodiments, the spring portion 946 may be activatable to pull or push the reservoir 950 into contact with the ramp 962. The second portion 944 may be engaged with the spring portion 946 such that depressing or twisting the second portion 944 causes the spring portion 946 to activate. Thus, to release the liquid within the reservoir 950 such that the liquid flows to the applicator pad 910, the second portion 944 may be twisted or advanced distally relative to the first portion 942 (e.g., via rotation or pressing on the proximal end of the second portion 944) such that the spring portion 946 is released from the initial configuration. The spring portion 946 may then translate the reservoir 950 and/or the ramp 962 such that contact between the neck portion 952 and the ramp 962 of the reservoir 950 causes the neck portion 952 to separate (e.g., break) from the remainder of the reservoir 950 (e.g., the body 954) and allow liquid to flow from the reservoir 950 out of the distal end of the first portion 942 and to the applicator pad 910, thereby causing the applicator pad 910 to be wetted by liquid from the reservoir 950.

In some embodiments, the first portion 942 may include a filter to prevent unwanted material (e.g., particles and/or glass flakes exceeding a certain size) from reaching the applicator pad 910. The distal surface of the applicator pad 910 may be placed against the recipient's wound either before or after wetting the applicator pad 910 with liquid. The grip 940 may then be held against the applicator pad 910 such that the plate 931 applies a distributed pressure to the applicator pad 910 over a period of time, as described with respect to the method 200 above. In some embodiments, the first portion 942 and/or the second portion 944 may be deformable (e.g., squeezable) to facilitate flow of the drug from the reservoir 950. In some embodiments, the hemorrhage processing system 900 can be operated with one hand (e.g., the hand of the recipient whose wound requires treatment). For example, the user may place a thumb on the proximal end of the second portion 944 and wrap the remaining fingers of the same hand around the side wall of the grip 940 (e.g., around the first portion 942). When grasping the grip 940 in this configuration, the user may press the second portion 944 against the applicator pad 910 with the user's thumb to release the liquid from the reservoir 950, either before or after pressing the applicator pad 910 against the wound, as described above.

Fig. 12 is a schematic view of an applicator pad 1010 in combination with a blood-drawing pad 1030, which may be identical or similar in structure and/or function to any of the applicator pads and blood-drawing pads described herein, respectively. As shown, the applicator pad 1010 may be surrounded by the blood-sucking pad 1030 such that the applicator pad 1010 and the blood-sucking pad 1030 are concentric. Thus, in some embodiments, the applicator pad 1010 may be shaped, sized, and configured (e.g., with respect to the grip) such that only the applicator pad 1010, but not the blood-drawing pad 1030, includes or is in contact with liquid (e.g., a drug) from the reservoir. In some embodiments, a liquid impermeable separator 1032 may be disposed between the applicator pad 1010 and the blood-drawing pad 1030. In some embodiments, rather than surrounding the applicator pad 1010, the blood-drawing pad 1030 may only partially surround or be disposed adjacent to the applicator pad 1010. Although the applicator pad 1010 is shown as having a rectangular shape with curved edges, as described above with respect to the applicator pad 110, in some embodiments the applicator pad 1010 may have any suitable shape, such as circular, oval, or square.

In some embodiments, rather than including a reservoir within the grip of the applicator device, an applicator pad (such as any of the applicator pads described herein) may be pre-filled with a drug. For example, fig. 13 is a schematic diagram of a hemorrhage processing system 1100. The hemorrhage processing system 1100 may be identical or similar in structure and/or function to any of the other hemorrhage processing systems described herein. For example, the hemorrhage treatment system 1100 can include an applicator device 1170 having a grip 1140, an applicator pad 1110 (also referred to as a topical applicator pad), and an applicator seal 1120. In some embodiments, the applicator pad 1110 may be a porous applicator (e.g., a sponge-like material) configured to hold the liquid drug M and apply the liquid drug M only to the wound site in physical contact. The applicator pad 1110 may be pre-filled (e.g., pre-impregnated) with a liquid or dry drug M. The grip 1140 may include a plate 1141 having a diameter equal to or greater than the applicator pad 1110 such that the grip 1140 may be used to apply a distributed pressure to the applicator pad 1110 when the applicator pad 1110 is in contact with a wound. The plate 1141 may be rigid or semi-rigid or have a rigid or semi-rigid surface opposite the surface contacting the applicator pad 1110 to apply uniform pressure to the applicator pad 1110. In some embodiments, the plate 1141 may be flexible. The plate 1141 may serve as an insulating mechanism configured to insulate the pressurized hand from the wound site and the medicament in the applicator pad 1110. To use the system 1100, the applicator seal 1120 may be removed from the applicator pad 1110 and the grip 1110 may be used to apply the applicator pad 1110 to the wound such that the drug flows to the wound and pressure is maintained on the wound by applying pressure to the applicator pad 1110.

Fig. 14 is a flow chart of a method 1200 of using a hemorrhage processing system, such as any of the hemorrhage processing systems described herein. Method 1200 may be used to reduce bleeding at a wound site of a recipient who is taking a medicament that is susceptible to increased and/or prolonged bleeding in the recipient. In some embodiments, the steps of method 1200 may be performed by a recipient, a caregiver, a healthcare provider, a veterinary care provider, or the like. In step 1202, the wound may be cleaned and lifted (e.g., by the recipient and/or caregiver or clinician) to reduce bleeding. In some embodiments, the wound is cleaned (e.g., with soap and water). In some embodiments, the wound is raised to a level above the heart of the patient.

In step 1204, it may be determined whether the recipient (e.g., patient) is taking a drug (e.g., an anticoagulant or an antiplatelet drug) that is susceptible to increased and/or prolonged bleeding in the recipient. For example, a caregiver or clinician can check to see if the recipient has taken such a medication within the relevant time period (e.g., by checking a chart or asking the recipient). In some embodiments, step 1204 may not be included, and the user may proceed directly to step 1206, described below. In some embodiments, if the wound is still bleeding, step 1204 may be performed after step 1206, and the steps of method 1200 may continue therefrom.

In step 1206, if it is determined that the recipient has not taken a medication that is susceptible to increased and/or prolonged bleeding in the recipient within a relevant period of time, a strong pressure may be applied to the wound (e.g., by the recipient or caregiver) using a sterile gauze pad. In some embodiments, the strong pressure may be applied for a first period of time (e.g., a predetermined period of time). In some embodiments, for example, the first period of time may be between about five minutes, between about four minutes and about six minutes, less than about four minutes, greater than about five minutes, greater than about six minutes. After the first period of time, the pressure may be removed. If the wound is no longer bleeding, the recipient or caregiver may apply the bandage to the wound. If the wound is still bleeding, step 1208 may be performed and/or medical care may be sought as described below.

In step 1208, if it is determined that the recipient has taken a medicament that is susceptible to an increase and/or prolongation of bleeding in the recipient for the relevant period of time, or if applying a strong pressure for a first period of time as described in step 1206 does not stop bleeding, a local applicator pad containing a metered dose of the medicament (e.g., TXA, such as Intravenous (IV) TXA) may be used to apply a strong pressure to the wound for a second period of time (e.g., a second predetermined period of time) (e.g., five minutes) such that the medicament contacts the wound. In some embodiments, the second time period may be greater than the first time period. In some embodiments, the second period of time may be less than the first period of time. In some embodiments, the metered dose may be between 3mL and 10mL, and/or include between about 300mg and about 1000mg of drug.

In step 1210, pressure may be removed by the recipient or caregiver (e.g., by removing the applicator pad) and the wound may be inspected to see if the wound is still bleeding. In step 1212, if the wound is no longer bleeding, a bandage may be applied to the wound by the recipient or caregiver. In step 1214, if the wound is still bleeding, the recipient or caregiver may reapply the forceful pressure to the wound for an additional predetermined period of time (e.g., for an additional five minutes) using the topical applicator pad. In some embodiments, a new topical applicator pad (containing a metered dose or no metered dose of drug) may be used. In step 1216, the pressure may be removed and checked to see if the wound is still bleeding. In step 1218, if the wound is no longer bleeding, a bandage may be applied to the wound if desired. In step 1220, if the wound is still bleeding, the recipient may seek medical care (with the assistance of a caregiver, if needed).

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

In some embodiments, the applicator pad 1310 may be coupled to the applicator device 1370 via adhesive strips 1303, which may be released from the applicator device 1370 via, for example, a pad connector 1348, which may operate as a release mechanism to allow the adhesive strips 1303 to contact the skin of a patient to secure the pad connector 1348 to the wound WD. Thus, in the first configuration shown in fig. 15C, the applicator pad 1310 may be coupled to an applicator device 1370. As shown in fig. 15D, the applicator pad 1310 and the adhesive tape 1303 can be detached from the applicator device 1370. The applicator pad 1310 may then be secured to the recipient at the location of the wound via adhesive tape 1303.

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

As shown in fig. 16A-16F, the system 1400 may include a bandage 1412 that is coupled to a portion of the upper surface of the applicator pad 1410 and extends beyond the outer perimeter of the applicator pad 1410. Although shown as surrounding the perimeter of the applicator pad 1410, in some embodiments the bandage may extend beyond opposite portions or sides of the applicator pad 1410 rather than in all directions. The bandage 1412 may define one or more openings 1412A adjacent the upper surface of the applicator pad 1450 such that fluid may flow through the openings and into wetting contact with the applicator pad 1450. In some embodiments, the one or more openings 1412A may collectively have a surface area and circumference that is equal to or less than the surface area and circumference of the distal opening of the grip 1440. In some embodiments, the bandage 1412 may include a liquid permeable layer or portion covering one or more openings 1412A. In some embodiments, the bandage 1412 may be adhesively coupled to the upper surface of the applicator pad 1450 via one or more adhesive portions.

The system 1400 may be placed on a body surface of a recipient with the applicator pad 1410 and the bandage 1412 in contact with the body surface, the applicator pad 1410 in contact with the recipient's wound and the bandage 1412 surrounding the applicator pad 1410. The applicator device 1470 may be transitioned from the initial configuration to the wetted configuration shown in fig. 16A-16C via the same steps as described with respect to the system 500. After the contents of the reservoir 1450 are released from the reservoir 1450, as shown in fig. 16C, the contents may flow through the filter 1471, through one or more openings 1412A in the bandage 1412, to the applicator pad 1410, and into contact with the wound. The grip 1440 may be used to apply pressure to the applicator pad 1410, and thus the wound, by applying downward pressure to the grip 1440 (e.g., before and/or after wetting the applicator pad 1410), wherein the distal end of the grip 1440 and/or the plate 1431 contact the applicator pad 1410.

In some embodiments, the applicator pad 1410 and the bandage 1412 may remain on the recipient's skin such that the applicator pad 1410 remains in contact with the wound, and the grip 1440 may be disengaged from the applicator pad 1410 and the bandage 1412 such that the applicator pad 1410 does not shift relative to the wound during disengagement. As shown in fig. 16D-16F, after disengaging the grip 1440 from the applicator pad 1410 and/or the bandage 1412, the grip 1440 may be discarded, leaving the applicator pad 1410 and the bandage 1412 in place on the recipient's wound and skin.

The grip 1440 may be coupled to and/or disengaged from the applicator pad 1410 and/or the bandage 1412 via any suitable disengagement method described herein. For example, as shown in fig. 17A and 17B, which are two different perspective views of the system 1400 including two adhesive strips 1414 (also referred to as cushion connectors), the applicator device 1470 may be coupled to the bandage 1412 via the removable adhesive strips 1414. The adhesive strips 1414 may be disposed in contact with the upper surface of the plate 1431 on both sides of the grip 1440 and may each have an end in contact with the bandage 1412 such that the adhesive strips 1414 secure the grip 1440 to the bandage 1412 via the plate 1431. In some embodiments, the adhesive tape 1414 may be flexible, but have low or no elasticity. To separate the grip 1440 from the bandage 1412 and the applicator pad 1410, each of the adhesive strips 1414 may be peeled away from the bandage 1412 to release the bandage 1412 from the plate 1431.

In some embodiments, as shown in fig. 18, rather than including an adhesive tape that is releasable and has low or no elasticity, the system 1400 may include an adhesive tape 1416 that has high elasticity and may be detached from the bandage 1412 and/or plate 1431 via adhesive coupling to portions of the bandage 1412 and/or plate 1431 away from the adhesive tape 1416 (also referred to as a cushion connector) but stretching the free end of each of the adhesive tapes 1416 in or near the plane containing the portions such that the adhesive tape 1416 deforms and the adhesive contact between the adhesive tape 1416 and the bandage 1412 and/or plate 1431 is broken. For example, the adhesive tape 1416 may include a 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 releasably engage with a portion of the applicator device. For example, fig. 19A is a schematic diagram of a system 1500, which may be identical or similar in structure and/or function to any other system described herein. The system 1500 can include a grip 1540, an applicator pad 1510, and a reservoir (not identified) included within the applicator pad 1510 and/or within the grip 1540. As shown in fig. 19B, the applicator pad 1510 may be coupled (e.g., via an adhesive) to a backing portion 1518, which may be rigid or more rigid than the applicator pad 1510. The backing portion 1518 may define one or more openings (not shown in fig. 19A and 19B) such that fluid may flow from the reservoir within the grip 1540 to the applicator pad 1510 to wet the applicator pad 1510. The backing portion 1518 may include one or more pad holder portions 1535 configured to be received by or otherwise coupled with complementary pad holder portions (not shown) of the grip 1540 such that the grip 1540 may be adhered, clamped, latched, friction fit, hook and loop fastened, or otherwise releasably coupled to the backing portion 1518 via any suitable coupling mechanism. After applying pressure to the backing portion 1518 to push the applicator pad 1510 against the wound, the grip 1540 can be disengaged from the backing portion 1518 by disengaging the complementary pad holder portion. As shown in fig. 19A, grip 1540 may include a convex distal surface 1536 configured to apply a targeted and increased pressure to a wound when a user presses grip 1540 to applicator pad 1510 coupled to the wound. The convex distal surface 1536 may include one or more openings to allow fluid flow through the convex distal surface 1536.

As shown in fig. 19C, in some embodiments, the backing portion 1518 may be curved and rigid such that the convex distal surface 1536 of the grip 1540 may sit in the concave upper surface of the backing portion 1518 during wetting of the applicator pad 1510 and/or during application of pressure to the applicator pad 1510 and thus the wound. As shown in fig. 19C, the backing portion 1518 may define one or more openings 1519 such that fluid may flow from the reservoir within the grip 1540 to the applicator pad 1510 to wet the applicator pad 1510.

As shown in fig. 20, which is a schematic diagram of system 1600, in some embodiments, the backing portion 1618 can be secured to the base via a fastener such as hook-and-loop fastener 1635 (e.g.,) Or an attachment of releasable adhesive (not shown) is releasably coupled to the applicator pad 1610. The backing portion 1618 may include a convex distal surface 1636 configured to apply pressure to the portion of the applicator pad 1610 that contacts the wound when the applicator pad 1610 contacts the wound and the backing portion 1618 is coupled to the applicator pad 1610. After hemostasis occurs, the backing portion 1618 may be removed from the applicator pad 1610, leaving the applicator pad 1610 in place relative to the wound.

Fig. 21 is a schematic diagram of a system 1700. The system 1700 may be identical or similar in structure and/or function to any of the systems described herein. For example, the system 1700 includes a grip 1740 and an applicator pad 1710. The applicator pad 1710 may be coupled to a backing portion 1718, which may be configured as a bandage. The backing portion 1718 may include adhesive covered by a release adhesive liner disposed on a distal surface of the backing portion. The adhesive backing layer may be peeled away prior to placing the backing portion 1718 on the skin of the recipient so that the backing portion 1718 may be adhered to the skin via the adhesive. In some embodiments, the backing portion 1718 may extend laterally from the grip 1740 prior to placement on the skin, as shown in fig. 21. In some embodiments, the backing portion 1718 may be flush with the grip 1740 (e.g., extending upward along the sidewalls of the grip 1740) and then folded downward to adhere to the skin. In some embodiments, the backing portion 1718 may completely surround the applicator pad 1710 and/or extend circumferentially away from the applicator pad. In some embodiments, the backing portion 1718 may extend along one axis of the applicator pad 1710.

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

Fig. 22A and 22B are cross-sectional and top views of a schematic diagram of a system 1800. The system 1800 may be identical or similar in structure and/or function to any of the systems described herein. For example, the system 1800 includes a semi-rigid backing portion 1818, which may be configured as a bandage, and an applicator pad 1810. As shown, the semi-rigid backing portion 1818 may include a foam ring 1818A surrounding the applicator pad 1810 and a backing layer 1818B disposed against the upper surface of the applicator pad 1810 and coupled to the foam ring 1818A. The foam ring 1818A may adhesively couple the backing portion 1818 and the applicator pad 1810 to the skin surface of the recipient and apply a compressive force to the applicator pad 1810 to push the applicator pad 1810 against the wound. In some embodiments, pressure applied to the applicator pad 1810 may activate release of the drug from the applicator pad 1810.

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

The grip 1940 may include a first portion 1942 and a second portion 1944 that collectively define an interior space within which the reservoir 1950 is disposed. The first portion 1942 may be configured to bend relative to the second portion 1942, as shown in fig. 23B, to cause the reservoir 1950 to break and the contents of the reservoir 1950 to flow from the reservoir 1950 to the applicator pad 1910. For example, the grip 1940 may be bendable such that a first end of the grip 1940 may rotate relative to a second section of the grip 1940, causing an inner surface of the grip 1940 to apply pressure to the reservoir 1950 to break, crush, or otherwise break the reservoir 1950. In some embodiments, the grip 1940 may include a bendable hinge or notch feature near a midpoint of the grip 1940 such that the first portion 1942 may rotate about the hinge or notch relative to the second portion 1942 to cause the reservoir 1950 to break. In some embodiments, the grip 1940 may include a force concentrating feature 1909, such as a pointed protrusion or a steel ball, that may protrude from an inner surface of the grip 1940 such that bending the grip 1940 will push the force concentrating feature 1909 into breaking contact with a portion of the reservoir 1950, causing the reservoir 1950 to break. In some embodiments, the force concentrating feature 1909 may be aligned with a weakened or pre-scored portion of the reservoir such that the reservoir will be broken by the force concentrating feature 1909 preferentially at the weakened or pre-scored portion. In some embodiments, the recipient or caregiver may use two hands to bend first portion 1942 relative to second portion 1942 to break reservoir 1950. In some embodiments, the recipient or caregiver may place the system 1900 on a hard surface (e.g., a table) and apply a downward normal force to the grip 1940 such that the reservoir 1950 is urged into breaking contact with the force concentrating component 1909 and the contents of the reservoir 1950 are released. In some embodiments, the recipient or caregiver may place the system 1900 directly against the wound with the applicator pad 1910 against the wound and may apply a force normal to the wound to the grip 1940 such that the reservoir 1950 is urged into breaking contact with the force concentrating component 1909 and the contents of the reservoir 1950 are released. Thus, in some embodiments, a user may apply pressure to grip 1940 using the palm of the user's hand, and the pressure may be concentrated by force concentrating component 1909 to a particular location on reservoir 1950 to break reservoir 1950.

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

In some embodiments, the grip 1940 may be releasably coupled to the applicator pad 1910 using any of the releasable coupling mechanisms described herein, such that the grip 1940 may be disengaged from the applicator pad 1910 after wetting the applicator pad 1910, as shown in fig. 23C. For example, the applicator pad 1910 may be placed in contact with the target wound before or after breaking the reservoir 1950 to wet the applicator pad 1910. After applying pressure to grip 1940 to break reservoir 1950 and wet applicator pad 1910, grip 1940 may be pressed against applicator pad 1910 to apply pressure to the wound. After a period of time, grip 1940 may be disengaged from applicator pad 1910, leaving applicator pad 1910 disposed in contact with the wound. In some embodiments, the applicator pad 1910 may include an adhesive portion on the skin-contacting surface of the applicator pad 1910 (e.g., adjacent to the perimeter of the skin-contacting surface) to hold the applicator pad 1910 in place relative to the wound. In some embodiments, an adhesive tab may be applied to the applicator pad 1910 and the skin of the recipient to hold the applicator pad 1910 in place relative to the wound. In some embodiments, as shown in fig. 23C, a backing portion 1918, which may be the same or similar to any of the backing portions or bandages described herein, may be placed on top of the applicator pad 1910 to apply a compressive force to the applicator pad 1910 and thus the wound and/or to hold the applicator pad 1910 in place relative to the wound.

In some embodiments, the force concentrating member may be disposed on either the first portion or the second portion of the grip, and the second portion of the grip may be movable (e.g., rotational and/or translational) relative to the first portion of the grip housing the reservoir in order to break the reservoir due to contact between the reservoir and the force concentrating member. For example, fig. 24 is a schematic diagram of a system 2000. The system 2000 may be identical or similar in structure and/or function to any of the systems described herein. For example, the system 2000 includes a reservoir 2050, an applicator device 2070, and an applicator pad (not shown). The applicator device 2070 includes a grip 2040 that includes a first portion 2042 and a second portion 2044. The first portion 2042 may define an interior space within which a reservoir 2050 may be disposed. The second portion 2044 may be configured to rotate and advance relative to the first portion 2042. For example, the second portion 2044 may be coupled to the first portion 2042 via a threaded connection. The first force concentrating member 2009A may be disposed on a reservoir-facing surface of the second portion 2044 and/or the second force concentrating member 2009B may be disposed on a reservoir-facing surface of the first portion 2042 (e.g., on a sidewall or on a ramp or protrusion extending from a sidewall). In some embodiments, rotation of the second portion 2044 may cause the second portion 2044 to advance toward the reservoir and apply pressure to the reservoir 2050 with the first force concentrating member 2009A until the reservoir 2050 breaks. In some embodiments, rotation of the second portion 2044 may cause the second portion 2044 to advance toward the reservoir and/or advance the reservoir such that the reservoir 2050 is pushed against the second force concentrating member 2009B until the reservoir 2050 breaks. In some embodiments, the second force concentrating member 2009B may be disposed such that the second force concentrating member 2009B will contact a shoulder of the reservoir 2050 and break the reservoir 2050 at the shoulder. In some embodiments, a vent (not shown) may be included to facilitate fluid travel from the reservoir 2050 toward the applicator pad (not shown).

In some embodiments, the applicator pad may be prepared (e.g., wetted) in a tray included in the kit prior to application to the recipient's target wound. For example, fig. 25A to 25C are schematic diagrams of a series of steps performed using the kit 2100. Kit 2100 may include any system for use according to any of the methods described herein. For example, the kit 2100 may include an applicator pad 2110 and a reservoir 2150 containing fluid. As shown in fig. 25A, the kit 2100 may include a tray 2101 that houses an applicator pad 2110 and a reservoir 2150. The fluid in reservoir 2150 may include a drug and/or a drug activator, such as saline. As shown in fig. 25A, the applicator pad 2110 may optionally include or be coupled to an adhesive tape 2103 configured to attach the applicator pad 2110 to the skin of a recipient. As shown in fig. 25B, fluid may be transferred from reservoir 2150 to applicator pad 2110 to transfer drug to applicator pad 2110 and/or combined with dry drug pre-disposed in applicator pad 2110. Reservoir 2150 may be similar to any reservoir described herein. Further, any of the applicator devices described herein may be used to transfer fluid from reservoir 2150. As shown in fig. 25C, a backing portion 2118 (e.g., a bandage) may be coupled to the applicator pad 2110 (e.g., via an adhesive). Backing portion 2118 can include a convex distal surface 2136 configured to couple to applicator pad 2110 to apply a targeted and increased pressure to a wound via applicator pad 2110. The applicator pad 2110 may then be placed in contact with the wound with the backing portion 2118 coupled to the skin surrounding the wound. In some embodiments, backing portion 2118 may be removed after a predetermined period of time (e.g., four minutes, five minutes, six minutes, or ten minutes).

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

Fig. 26A to 26C are schematic views of a series of steps performed using the kit 2200. Kit 2200 can include any system for use according to any of the methods described herein. For example, the kit 2200 may 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. The fluid in the reservoir 2250 may include a drug and/or a drug activator, such as saline. As shown in fig. 26B, fluid may be transferred from the reservoir 2250 to the applicator pad 2210 to transfer the drug to the applicator pad 2210 and/or in combination with a dry drug pre-disposed in the applicator pad 2210. The reservoir 2250 may be similar to any of the reservoirs described herein. Further, any of the applicator devices described herein may be used to transfer fluid from the reservoir 2250. As shown, for example, the kit 2200 may include a grip 2240 that may be disposed over at least a portion (e.g., a neck portion or half) of the reservoir 2250, as shown in fig. 26B, and rotated away from a central axis of the reservoir 2250 such that a portion of the reservoir 2250 disposed within the grip 2240 is broken (e.g., separated from the remainder of the reservoir 2250 that is external to the grip 2240) and fluid released.

As shown in fig. 26C, a backing portion 2118 (e.g., a bandage) may be coupled to the applicator pad 2210 (e.g., via an adhesive). The backing portion 2218 may include a convex distal surface configured to be coupled to the applicator pad 2210 to apply a targeted and increased pressure to the wound via the applicator pad 2210. The applicator pad 2210 may then be placed in contact with the wound with the backing portion 2218 coupled to the skin surrounding the wound. In some embodiments, the backing portion 2218 may be removed after a predetermined period of time (e.g., four minutes, five minutes, six minutes, or ten minutes).

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

While various embodiments have been described herein in terms of text and/or graphics, it should be understood that they have been presented by way of example only, and not limitation. It is also to be understood that the specific terminology used herein is for the purpose of describing particular embodiments and/or features or components thereof only and is not intended to be limiting. Various modifications, changes, enhancements and/or variations in form and/or detail can be made without departing from the scope of the disclosure and/or without altering the function and/or advantages thereof unless explicitly stated otherwise. Functionally equivalent examples, implementations, and/or methods, in addition to those enumerated herein, will be apparent to those skilled in the art from the foregoing description, and are intended to be within the scope of the present disclosure.

The schematic, examples, and/or implementations described above indicate that the arrangement of components may be modified, adapted, optimized, etc. with certain components arranged and/or configured in certain orientations or positions. The particular sizes and/or particular shapes of the various components may be different from the illustrated embodiments and/or may be otherwise modified while still providing the functionality as described herein. More specifically, the size and shape of the various components may be specifically selected for the intended or anticipated use. Thus, it is to be understood that the size, shape and/or arrangement of the embodiments and/or components thereof may be adapted for a given use unless the context clearly dictates otherwise. By way of example, in some embodiments, a treatment device intended to provide treatment to an adult user may have a first size and/or shape, while a treatment device intended to provide treatment to a child user may have a second size and/or shape that is smaller than the first size and/or shape. Further, for example, the smaller size and/or shape of the child handling device may cause certain components to be moved, redirected, and/or rearranged while maintaining the desired functionality of the device.

Although various embodiments have been described as having particular features, functions, components, elements and/or characteristics, other embodiments are possible with any combination and/or subcombination of features, functions, components, elements and/or characteristics from any embodiment described herein, unless a mutually exclusive combination or clearly stated otherwise. Furthermore, unless expressly stated otherwise herein, any particular combination of parts, functions, features, elements, etc. may be separated and/or separated into individual parts, functions, features, elements, etc. or may be integrated into a single or unitary part, function, feature, element, etc.

In the case where the method described above indicates certain events occurring in a particular order, the ordering of certain events may be modified. Additionally, certain events may be performed concurrently in a parallel process, where possible, and in sequence as described above. Although methods have been described as having particular steps and/or combinations of steps, other methods are possible having any combination of steps from any of the methods described herein, unless a mutually exclusive combination and/or context clearly dictates otherwise.

Claims (77)

1. A system, the system comprising:

an applicator pad;

a grip releasably coupleable to the applicator pad and configured to position the applicator pad against a recipient's wound such that pressure can be transmitted to the wound via the applicator pad to enhance hemostasis; and

a reservoir configured to hold a drug to be released to the wound via the applicator pad.

2. The system of claim 1, wherein the reservoir is a first reservoir included in the applicator pad, the system further comprising a second reservoir and a fluid coupling configured to enable liquid to flow from the second reservoir to the applicator pad via the fluid coupling.

3. The system of claim 1, wherein the applicator pad comprises a pad holder configured to hold the applicator pad in contact with the wound after the grip is disengaged from the applicator pad.

4. The system of claim 1, wherein the grip comprises a first portion and a second portion configured to move relative to the first portion to cause release of liquid from the reservoir to the applicator pad.

5. The system of claim 1, wherein the reservoir contains the drug.

6. The system of claim 1, wherein the drug comprises an anti-fibrinolytic drug.

7. The system of claim 5, wherein the drug comprises a vasoconstrictor and an anti-fibrinolytic drug.

8. The system of claim 5, wherein the drug comprises at least one of an anti-fibrinolytic drug, a vasoconstrictor, an antibiotic, an anti-infective agent, or a steroid.

9. The system of claim 5, wherein the drug is tranexamic acid (TXA).

10. The system of claim 9, wherein the applicator pad comprises a material that is non-reactive with TXA.

11. The system of claim 9, wherein the applicator pad comprises a foamed polymer.

12. The system of claim 9, wherein the applicator pad comprises natural fibers.

13. The system of claim 1, further comprising a release mechanism coupled to the reservoir and configured to transition from a closed state to an open state to allow drug to flow from the reservoir to the applicator pad via the fluid coupling in response to a pressure within the reservoir being above a threshold pressure.

14. The system of claim 13, wherein a sidewall portion of a delivery device is configured to be pushed toward the reservoir to transition the reservoir from a closed state to an open state.

15. The system of claim 1, wherein the applicator pad is configured to expand in response to absorbing blood from the wound.

16. The system of claim 1, wherein the grip comprises a plate disposed on a distal end of the grip and configured to apply a distributed uniform force to the applicator pad when the applicator pad is pressed against the wound with a force normal to the skin.

17. The system of claim 1, wherein the grip comprises a force concentrating member protruding from an inner surface of the grip and configured to be pushed toward the reservoir to break a sidewall of the reservoir and release the drug to the applicator pad.

18. The system of claim 1, wherein the applicator pad contains the reservoir and is pre-impregnated with the drug to a saturation level in the range of about 25% to about 50% of the saturation point of the applicator pad.

19. The system of claim 1, wherein the applicator pad contains the reservoir and is pre-impregnated with the drug to a saturation of about 35% of a saturation point of the applicator pad.

20. The system of claim 1, further comprising a backing having a convex distal surface coupled to the applicator pad such that the applicator pad has a convex distal surface, the backing being more rigid than the applicator pad.

21. The system of claim 1, wherein the grip comprises a convex distal surface configured to contact a proximal surface of the applicator pad and push at least a portion of the applicator pad toward the wound.

22. The system of claim 1, further comprising a bandage coupleable to a proximal surface of the applicator pad, the bandage having a convex distal surface configured to contact the proximal surface of the applicator pad and push at least a portion of the applicator pad toward the wound.

23. A system, the system comprising:

an applicator pad pre-impregnated with a liquid drug;

An applicator seal coupled to a surface of the applicator pad and configured to be removed from the applicator pad prior to disposing the applicator pad against a recipient's wound;

a grip releasably coupleable to the applicator pad and configured to position the applicator pad against the wound such that pressure can be transferred to the wound via the applicator pad and the liquid drug can contact the wound.

24. The system of claim 23, wherein the applicator pad comprises a pad holder configured to hold the applicator pad in contact with the wound.

25. The system of claim 24, wherein the pad retainer is an adhesive.

26. The system of claim 23, wherein the liquid drug comprises an anti-fibrinolytic drug.

27. The system of claim 26, wherein the liquid drug comprises a vasoconstrictor.

28. The system of claim 23, wherein the drug comprises at least one of an anti-fibrinolytic drug, a vasoconstrictor, an antibiotic, an anti-infective agent, or a steroid.

29. The system of claim 23, wherein the liquid drug is tranexamic acid (TXA).

30. The system of claim 29, wherein the applicator pad comprises a material that is non-reactive with TXA.

31. The system of claim 29, wherein the applicator pad comprises a foamed polymer.

32. The system of claim 29, wherein the applicator pad comprises natural fibers.

33. The system of claim 23, wherein the applicator pad is pre-impregnated with the liquid drug to a saturation level in the range of about 25% to about 50% of the saturation point of the applicator pad.

34. The system of claim 23, wherein the applicator pad is pre-impregnated with the liquid drug to a saturation of about 35% at a saturation point of the applicator pad.

35. A method, the method comprising:

delivering an applicator pad to a wound site with one hand using a grip coupled to the applicator pad;

pressing the applicator pad against the wound by applying a force to the grip using only the one hand;

allowing drug to be released from the applicator pad to the wound; and

The applicator pad is held against the wound such that the applicator pad applies pressure to the wound to enhance hemostasis.

36. The method of claim 34, the method further comprising:

assessing whether a hemostatic condition of the wound meets a hemostatic target; and

the applicator pad is removed from the wound with the one hand in response to the hemostatic condition meeting the hemostatic target.

37. The method of claim 34, wherein delivering the applicator pad to the location of the wound using the grip portion comprises positioning the grip portion such that a central axis of the grip portion is substantially parallel to a skin surface surrounding the wound and the applicator pad is in contact with the wound.

38. The method of claim 34, wherein holding the applicator pad against the wound comprises applying a force to the grip such that the grip applies pressure to the applicator pad, and the method further comprises releasing the applicator pad from the grip such that the applicator pad remains in contact with the wound.

39. The method of claim 37, the method further comprising:

After removing the applicator pad, pressure is maintained on the applicator pad with the one hand such that the applicator pad applies pressure to the wound to enhance hemostasis.

40. The method of claim 34, wherein allowing release of the drug comprises moving a first portion of the grip relative to a second portion of the grip using only the one hand such that liquid contained within a reservoir of the grip flows from the reservoir to the applicator pad.

41. The method of claim 34, wherein allowing release of the drug comprises pressing with a palm of the one hand against the grip such that a force concentrating feature protruding from an inner surface of the grip is pushed toward a reservoir within the grip to break a sidewall of the reservoir and release the drug to the applicator pad and the wound.

42. The method of claim 39, wherein the applicator pad comprises a drug activated via contact with liquid from the reservoir.

43. The method of claim 34, wherein the applicator pad comprises a drug activated via contact with blood from the wound.

44. The method of claim 39, wherein the liquid in the reservoir is a drug.

45. The method of claim 34, wherein allowing release of the drug comprises removing a membrane from the applicator pad.

46. The method of claim 34, wherein the applicator pad is a pre-impregnated applicator pad with the drug, and allowing release of the drug comprises allowing drug to flow from the pre-impregnated applicator pad.

47. The method of claim 45, wherein the applicator pad is pre-impregnated with the drug to a saturation level in the range of about 25% to about 50% of the saturation point of the applicator pad.

48. The method of claim 45, wherein the applicator pad is pre-impregnated with the drug to a saturation of about 35% at the saturation point of the applicator pad.

49. The method of claim 34, wherein the drug comprises an anti-fibrinolytic drug.

50. The method of claim 48, wherein said drug comprises a vasoconstrictor.

51. The method of claim 34, wherein the drug comprises at least one of an antiplasmin, a vasoconstrictor, an antibiotic, an anti-infective agent, or a steroid.

52. The method of claim 34, wherein the drug is tranexamic acid (TXA).

53. The method of claim 34, wherein holding the applicator pad against the wound comprises applying a force to the grip using only the one hand without moving the grip laterally relative to the wound.

54. A method, the method comprising:

delivering an applicator pad to a site of a wound of an anticoagulated human using a grip coupled to the applicator pad;

pressing the applicator pad against the wound by applying a force to the grip;

allowing a therapeutically effective amount of a drug for enhancing coagulation to be released from the applicator pad to the wound; and

the applicator pad is held against the wound such that the applicator pad applies pressure to the wound to enhance hemostasis.

55. The method of claim 53, wherein the anticoagulated human is susceptible to drug induction by administration of an anticoagulant drug.

56. The method of claim 53, wherein the anticoagulated human produces a procedure-induced susceptibility due to a medical procedure experienced by the human.

57. The method of claim 55, wherein the medical procedure comprises at least one of renal replacement therapy, cardiopulmonary bypass, epicardial oxygenation (ECMO), chemothrombolysis, cardiac catheterization, peripheral vascular procedure, mechanical thrombectomy, or angiography.

58. The method of claim 53, wherein the anticoagulated human is subject to a naturally induced susceptibility due to chronic disease, age, or genetic disease.

59. The method of claim 53, wherein the drug is an anti-fibrinolytic drug.

60. The method of claim 58, wherein the drug is tranexamic acid (TXA).

61. The method of claim 59 wherein the therapeutically effective amount of TXA is between about 1 mg and about 20 mg.

62. A kit, the kit comprising:

a tray;

an applicator pad disposable in the tray; and

a reservoir configured to break to release fluid from the reservoir to the applicator pad, the applicator pad configured to release drug to a wound after receiving the fluid from the reservoir.

63. The kit of claim 61, wherein the drug is configured to enhance hemostasis of a wound.

64. The kit of claim 61, wherein the fluid comprises the drug.

65. The kit of claim 61, wherein the applicator pad comprises the drug in dry form prior to receiving the fluid from the reservoir.

66. The kit of claim 61, further comprising a backing having a convex distal surface coupled to the applicator pad such that the applicator pad has a convex distal surface, the backing being more rigid than the applicator pad.

67. The kit of claim 61, further comprising a bandage configured to be coupled to the applicator pad to secure the applicator pad to a recipient having the wound.

68. The kit of claim 66, wherein the bandage comprises at least a portion having a convex distal surface coupled to the applicator pad such that the applicator pad has a convex distal surface, the portion having the convex distal surface being more rigid than the applicator pad.

69. The kit of claim 61, wherein the drug comprises an anti-fibrinolytic drug.

70. The kit of claim 61, wherein the drug comprises tranexamic acid (TXA).

71. A system, the system comprising:

an applicator pad pre-impregnated with a clotting enhancing liquid drug; and

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 against a recipient's wound.

72. The system of claim 70, the system further comprising:

a grip releasably coupleable to the applicator pad and configured to position the applicator pad against the wound such that pressure can be transferred to the wound via the applicator pad and the liquid drug can contact the wound.

73. The system of claim 70, the system further comprising:

a grip coupled to the applicator pad and configured to position the applicator pad against the wound such that pressure can be transmitted to the wound via the applicator pad and the liquid drug can contact the wound.

74. The system of claim 70, wherein the liquid drug comprises an anti-fibrinolytic drug.

75. The system of claim 73, wherein the anti-fibrinolytic drug is tranexamic acid (TXA).

76. The system of claim 70, wherein the applicator pad is pre-impregnated with the liquid drug to a saturation level in the range of about 25% to about 50% of the saturation point of the applicator pad.

77. The system of claim 70, wherein the applicator pad is pre-impregnated with the liquid drug to a saturation of about 35% at the saturation point of the applicator pad.