Adapter, system with fluid container and kit with adapter

Abstract

An adapter, a system having a fluid container, and a kit having an adapter are disclosed herein. The adapter includes: a connection portion connectable to a fluid container; a first fluid flow path having a first end configured to provide fluid communication with the fluid container and a second end including a fluid outlet; at least one valve disposed along the first fluid flow path; and a second fluid flow path separate from the first fluid flow path wherein the at least one valve is configured to provide a selection between assisted fluid delivery and manual fluid delivery.

Description

Technical Field

[0001] The present disclosure relates to an adapter that can be used with a fluid container to provide at least two alternative fluid delivery modes. Background Art

[0002] Intraoperative incision irrigation is an acceptable method that helps prevent surgical site infections (SSIs). For such surgeries, irrigation is typically performed in one of two modes: manual (i.e., direct perfusion, bulb syringe, etc.) or assisted (i.e., delivering the solution through a powered lavage device).

[0003] In the assisted delivery method, the solution is typically present in a fluid container hanging on an intravenous pole (IV pole) in a non-sterile area, while the pulsed lavage device operates in the sterile area. The fluid container is stored outside the sterile area mainly because of limited space within the sterile area and to reduce clutter near the surgical cavity.

[0004] In the manual delivery method, healthcare providers typically apply manual pressure to a compressible fluid container to deliver the irrigation fluid to the surgical cavity.

[0005] The choice between manual or assisted delivery is typically determined by the surgeon's preference and the details of the surgery. While some medical practitioners believe that assisted delivery may be harmful to the patient's health (e.g., pushing bacteria deeper into the wound or causing damage to tissue), other surgeons believe that assisted delivery offers advantages such as higher consistency and more thorough debridement of the surgical cavity. Depending on the specific surgical situation, a significant number of surgeons also prefer to use both manual and assisted delivery in their practice.

[0006] Manual delivery is typically accomplished using a device that interfaces with the fluid container by piercing it. These devices typically have a relatively simple design, which is lacking in several respects. For example, after manually compressing the fluid container, the compression force is released and the container is allowed to relax back to its original geometry. During the relaxation phase, air is drawn back into the container, allowing the container to be compressed again to expel more fluid. However, typical devices available for such containers allow air to travel through the fluid passage to restore the container shape, which may introduce contaminants into the irrigation fluid itself or the fluid passage.

[0007] Ancillary delivery is typically performed by piercing a fluid container with a device to form a fluid passage. However, such a device cannot be used without a lavage device, and thus, once the device has pierced the fluid container, the fluid cannot be delivered manually. Accordingly, healthcare providers are required to stock two types of devices (i.e., a device designed for manual delivery and a device designed for ancillary delivery). Current devices also limit fluid delivery from each fluid container to a single delivery mode. SUMMARY OF THE UTILITY MODEL

[0008] Disclosed herein is an adapter having: a connection portion configured to connect to a fluid container; a first fluid flow path having a first end and a second end, the first end being configured to provide fluid communication with the fluid container and the second end including a fluid outlet; at least one valve disposed along the first fluid flow path; and a second fluid flow path separate from the first fluid flow path, wherein the at least one valve is configured to provide a choice between ancillary fluid delivery and manual fluid delivery. Also described herein are kits and systems having the adapter described herein.

[0009] Further, the first end of the first fluid path includes a cannula element.

[0010] Further, the at least one valve includes a cross slit valve.

[0011] Further, the at least one valve is configured to open in two directions.

[0012] Further, the adapter further includes a vent disposed along the second fluid flow path.

[0013] Further, the vent is irreversibly fixed in a vent housing.

[0014] Also disclosed herein is a system having a fluid container, the system including: the fluid container; an adapter, wherein the adapter includes: a connection portion connected to the fluid container; a first fluid flow path having a first end and a second end, the first end being configured to provide fluid communication with the fluid container and the second end including a fluid outlet; at least one valve disposed along the first fluid flow path, wherein the at least one valve is configured to provide a choice between ancillary fluid delivery and manual fluid delivery; and a second fluid flow path separate from the first fluid flow path.

[0015] Further, the first end of the first fluid path includes a cannula element.

[0016] Further, the at least one valve includes a cross slit valve.

[0017] Further, the at least one valve is configured to open in two directions.

[0018] Further, the adapter further includes a vent disposed along the second fluid flow path.

[0019] Further, the fluid container contains a lavage fluid.

[0020] The present disclosure also provides a kit having an adapter, comprising: the adapter, wherein the adapter includes: a connection portion configured to connect to a fluid container; a first fluid flow path having a first end and a second end, the first end being configured to provide fluid communication with the fluid container, the second end including a fluid outlet; at least one valve disposed along the first fluid flow path, wherein the at least one valve is configured to provide a choice between assisted fluid delivery and manual fluid delivery; and a second fluid flow path separate from the first fluid flow path; and instructions for connecting the adapter to the fluid container.

[0021] Further, the first end of the first fluid path includes a cannula element.

[0022] Further, the at least one valve includes a cross slit valve.

[0023] Further, the at least one valve is configured to open in two directions.

[0024] Further, the adapter further includes a vent disposed along the second fluid flow path.

[0025] Further, the vent is irreversibly fixed in a vent housing.

[0026] Further, the kit further includes the fluid container.

[0027] Further, the fluid container contains a lavage fluid. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1A An exemplary adapter in accordance with aspects of the present disclosure is shown.

[0029] Figure 1B An exemplary adapter in accordance with aspects of the present disclosure is shown.

[0030] Figure 1C An exemplary vent housing in accordance with aspects of the present disclosure is shown.

[0031] Figure 2 An exemplary adapter having a valve in accordance with aspects of the present disclosure is shown.

[0032] Figure 3An exemplary cross - slit valve in accordance with aspects of the present disclosure is shown. Detailed Description

[0033] The present disclosure relates to an adapter that can be used with a fluid container to provide at least two alternative fluid delivery modes. According to some aspects, the adapter can be configured to provide both assisted fluid delivery and manual fluid delivery through a single fluid container. The adapter can include a connection portion, a first fluid flow path, a second fluid flow path, a fluid outlet, and at least one valve disposed along the first fluid flow path. The present disclosure also relates to kits and systems having an adapter and a fluid container as described herein.

[0034] The adapter of the present disclosure can be used with a fluid container. As used herein, the term "fluid" refers to a substance that does not have a fixed shape, such as a liquid or a gas. In some non - limiting examples, the fluid is an irrigation fluid. As used herein, the term "irrigation fluid" refers to a fluid suitable for the irrigation processes described herein. As used herein, "irrigation" refers to the flushing of a body cavity, a surgical cavity, and / or an external wound.

[0035] According to some aspects, the irrigation fluid can include an antiseptic solution. As used herein, the term "antiseptic solution" refers to a solution that includes at least one solvent and one or more disinfectants. According to some aspects, the antiseptic solution is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which the solvent is at least mostly water. It should be understood that in some examples, the solvent can consist of water. According to some aspects, the antiseptic solution is an alcoholic solution. As used herein, the term "alcoholic solution" refers to a solution in which the solvent is at least mostly alcohol. It should be understood that in some examples, the solvent can consist of one or more alcohols. Non - limiting examples of alcohols include, but are not limited to, ethanol, isopropyl alcohol, n - propyl alcohol, and combinations thereof.

[0036] In a non-limiting example, the disinfectant can include cationic molecules (i.e., molecules with a positive charge), such as cationic surfactants or cationic biguanide derivatives (i.e., compounds derived from biguanide). According to some aspects, the disinfectant can include bis-(dihydropyridinyl)-decane derivatives (i.e., compounds derived from bis-(dihydropyridinyl)-decane). According to some aspects, the disinfectant can include octenidine salt and / or chlorhexidine salt. According to some aspects, the disinfectant can include alexidine, octenidine dihydrochloride, chlorhexidine gluconate, or a combination thereof.

[0037] Additionally or alternatively, the disinfectant can include iodine. According to some aspects, iodine can be provided as an iodine complex, such as povidone iodine (PVPI), nonylphenoxy-(ethyleneoxy)-iodine, polyethylene oxypolypropyleneoxy-iodine, undecoylium-chloride-iodine, iodine povacrylex, and combinations thereof.

[0038] Additionally or alternatively, the disinfectant can include an oxidizing agent (i.e., an oxidation reagent). Non-limiting examples of oxidizing agents according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, hypochlorous acid, and combinations thereof.

[0039] The disinfectant can have sufficient antimicrobial activity to provide an acceptable logarithmic reduction of microorganisms over a specific period of time. It should be understood that the term "microorganism" as used herein can refer to any microorganism that is killed and / or removed due to irrigation. Exemplary microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0040] Exemplary bacteria include, but are not limited to, Streptococcus mutans, Streptococcus pyogenes (Group A β-hemolytic streptococci), Streptococcus salivarius, Streptococcus sanguis, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus saprophyticus, methicillin-resistant Staphylococcus aureus / oxacillin-resistant Staphylococcus aureus (MRSA / ORSA) and methicillin / oxacillin-susceptible Staphylococcus aureus (MSSA / OSSA), Enterococcus spp. (e.g., Enterococcus faecalis, Enterococcus faecium, and Enterococcus hirae), vancomycin-resistant Enterococcus (VRE) and vancomycin-susceptible Enterococcus (VSE), Bacteroides fragilis, Propionibacterium acnes, Clostridium difficile (spores and vegetative cells), Selenomonas, Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Gardnerella vaginalis, Klebsiella aerogenes, Klebsiella pneumoniae, Klebsiella pneumoniae multidrug resistant (MDR), Acinetobacter baumannii, Acinetobacter baumannii MDR, Achromobacter xylosoxidans, Micrococus luteus, Ralstonia pickettii, Haemophilus influenza, and Serratia marcescens.

[0041] Exemplary fungi include, but are not limited to, Aspergillus niger, Candida albicans, Candida auris, Candida dubliniensis, Candida glabrata (formerly Torulopsis glabrata), Candida guillermondii, Candida kefyr (formerly C. pseudotropicalis), Candida krusei, Candida lusitaniae, Candida tropicalis, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis, and Trichophyton mentagrophytes.

[0042] Exemplary viruses include, but are not limited to, viruses having a lipid component in their outer coat or having an outer envelope, such as cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2), influenza virus, parainfluenza virus, smallpox virus, vaccinia virus, norovirus, and coronavirus.

[0043] According to some aspects, the specific time period can be a time period not exceeding about five minutes, optionally not exceeding about four minutes, optionally not exceeding about three minutes, optionally not exceeding about two minutes, and optionally not exceeding about one minute.

[0044] According to some aspects, the specific time period can be a time period not exceeding about 120 seconds, optionally not exceeding about 105 seconds, optionally not exceeding about 90 seconds, optionally not exceeding about 75 seconds, optionally not exceeding about 60 seconds, optionally not exceeding about 45 seconds, optionally not exceeding about 30 seconds, and optionally not exceeding 15 seconds.

[0045] It should be understood that an "acceptable log reduction" can be microbe-dependent. For example, an acceptable log reduction as described herein can refer to an acceptable log reduction of one type of microbe present on a surface (e.g., present in a body cavity or at an external wound site), a combination of two or more types of microbes present on a surface, or all of the microbes present on a surface.

[0046] According to some aspects, the acceptable log reduction can be at least about 1.0, optionally at least about 1.1, optionally at least about 1.2, optionally at least about 1.3, optionally at least about 1.4, optionally at least about 1.5, optionally at least about 1.6, optionally at least about 1.7, optionally at least about 1.8, optionally at least about 1.9, optionally at least about 2.0, optionally at least about 2.1, optionally at least about 2.2, optionally at least about 2.3, optionally at least about 2.4, optionally at least about 2.5, optionally at least about 2.6, optionally at least about 2.7, optionally at least about 2.8, optionally at least about 2.9, optionally at least about 3.0, optionally at least about 3.1, optionally at least about 3.2, optionally at least about 3.3, optionally at least about 3.4, optionally at least about 3.5, optionally at least about 3.6, optionally at least about 3.7, optionally at least about 3.8, optionally at least about 3.9, optionally at least about 4.0, optionally at least about 4.1, optionally at least about 4.2, optionally at least about 4.3, optionally at least about 4.4, optionally at least about 4.5, optionally at least about 4.6, optionally at least about 4.7, optionally at least about 4.8, optionally at least about 4.9, and optionally at least about 5.0.

[0047] According to some aspects, the disinfectant can be present in the disinfection solution at a concentration sufficient to provide an acceptable microbial log reduction over a specific period of time as described herein. According to some aspects, the disinfectant can be present in the disinfection solution at a concentration between about 0.001 and 15% w / v, optionally between about 0.001 and 10% w / v, optionally between about 0.001 and 5% w / v, optionally between about 0.001 and 2.5% w / v, optionally between about 0.001 and 1% w / v, optionally between about 0.001 and 0.1% w / v, optionally between about 0.001 and 0.01% w / v, optionally between about 0.01 and 5% w / v, optionally between about 0.01 and 2.5% w / v, optionally between about 0.01 and 2% w / v, optionally between about 0.01 and 1.5% w / v, optionally between about 0.01 and 1% w / v, and optionally about 0.5% w / v. According to some aspects, the disinfectant can be present in the disinfection solution at a concentration between about 0.001 and 20% w / v, optionally between about 1.0 and 20% w / v, optionally between about 10 and 20% w / v, and optionally about 15% w / v.

[0048] According to some aspects, the disinfectant can be present in the disinfection solution at a concentration between about 0.1 and 0.9% w / v, optionally between about 0.2 and 0.8% w / v, optionally between about 0.3 and 0.7% w / v, and optionally between about 0.4 and 0.6% w / v.

[0049] According to some aspects, the disinfectant can be present in the disinfection solution at a concentration between about 0.1 and 1% w / v, optionally between about 0.2 and 1% w / v, optionally between about 0.3 and 1% w / v, and optionally between about 0.4 and 1% w / v.

[0050] In some non-limiting examples, after the container holding the disinfection solution is opened, the disinfectant can act as a preservative by reducing or eliminating microbial contamination of the disinfection solution.

[0051] It should be understood that, according to some aspects, the lavage fluid is not necessarily a disinfection solution as described herein and can be any medically acceptable fluid configured to perform the lavage process as described herein. In one non-limiting example, the lavage fluid can include a saline solution. The saline solution can include water and sodium chloride at a medically acceptable concentration (e.g., between about 0.1 and 1% w / v, optionally about 0.45% w / v, and optionally about 0.9% w / v).

[0052] According to some aspects, the lavage fluid (e.g., a disinfection solution as described herein) may include a visualizing aid. As used herein, the term "visualizing aid" refers to a component in the lavage fluid that is configured to assist in visualizing the application of the lavage fluid. Exemplary visualizing agents include, but are not limited to, tinting agents, staining agents, and radiopaque agents. It should be understood that the visualizing agent may be the same as or different from one of the other components of the lavage fluid. For example, a disinfectant may serve as a visualizing agent. Additionally or alternatively, the lavage fluid may include a visualizing agent different from the disinfectant.

[0053] According to some aspects, the lavage fluid may include a tinting agent. As used herein, the term "tinting agent" refers to a component sufficient to provide an observable color to the fluid. The tinting agent may be sufficient to allow the lavage fluid to be visualized when applied to a surface. In some non-limiting examples, the tinting agent may include anionic tinting agents, such as anionic dyes. The anionic dye may be any dye suitable for medical use, such as a dye approved by the Food and Drug Administration for use in food, drugs, and / or cosmetics (i.e., "D&C" or "FD&C" dyes). Exemplary anionic dyes include, but are not limited to, FD&C Blue No. 1 (Brilliant Blue FCF), FD&C Blue No. 2 (Indigo Carmine), FD&C Green No. 3 (Fast Green FCF), FD&C Red No. 3 (Erythrosine), FD&C Red No. 40 (Allura Red), FD&C Yellow No. 5 (Tartrazine), FD&C Yellow No. 6 (Sunset Yellow FCF), D&C Yellow No. 8 (Fluorescein), D&C Orange No. 4, and combinations thereof. Combinations may be implemented to obtain a specific color. For example, an orange tinting agent may include FD&C Red No. 40 and D&C Yellow No. 8. Additionally or alternatively, the tinting agent may include compounds observable upon exposure to visible light and / or non-visible light, including but not limited to vitamin B-12, medical honey, fluorescent polymer nanoparticles, water-soluble luminescent carbon nanodots, quinine, and combinations thereof.

[0054] According to some aspects, the lavage fluid (e.g., a disinfection solution as described herein) may include a staining agent. As used herein, the term "staining agent" refers to a component sufficient to temporarily or permanently color a surface with which it comes into contact.

[0055] According to some aspects, the lavage fluid (e.g., a disinfection solution as described herein) can include a radiopaque agent. As used herein, the term "radiopaque agent" refers to a component that is opaque to the radio wave and x-ray portions of the electromagnetic spectrum and is sufficient to render it visible. In some non-limiting examples, the radiopaque agent can include barium, iodine, iron oxide nanoparticles, gadolinium complex nanospheres, silica nanospheres, and combinations thereof.

[0056] According to some aspects, the lavage fluid (e.g., a disinfection solution as described herein) can be alkaline, neutral, or acidic. According to some aspects, the pH value of the lavage fluid can be between about 1 and 8, optionally between about 1 and 7, optionally between about 1 and 6, and optionally between about 2 and 5.5.

[0057] According to some aspects, the lavage fluid (e.g., a disinfection solution as described herein) can include a buffer system. As used herein, the term "buffer system" refers to components present in a composition or solution that can provide resistance to significant pH changes caused by strong acids or strong bases. The buffer system can contain a single reagent or more than one reagent, such as a weak acid and its conjugate base. The buffer system can provide resistance to significant pH changes by interacting with strong acids or strong bases in the composition or solution, thereby at least partially preventing significant pH changes in the composition or solution.

[0058] Generally, a buffer system has one or more buffer ranges in which the buffer system has the ability to resist significant pH changes. When the pH value of a composition or solution having a buffer system is within the buffer range of the buffer system, the pH value of the composition or solution does not change significantly with the addition of an equimolar amount of a strong acid or strong base.

[0059] The buffer range of a buffer system is related to the acid dissociation constant (Ka) of one or more weak acids contained in the buffer system. The term "acid dissociation constant" refers to the equilibrium constant of an acid dissociation reaction. The midpoint of the buffer range of a buffer system is typically approximately the logarithm measure of the acid dissociation constant (i.e., pKa, equal to -log10Ka) of the weak acid contained in the buffer system.

[0060] According to some aspects, the lavage fluid (a flushing solution as described herein) can contain a stabilizer. As used herein, the term "stabilizer" refers to any component that supports the stability of the lavage fluid and is not explicitly described herein.

[0061] According to some aspects, a fluid container according to the present disclosure can include a body configured to contain a fluid as described herein. According to some aspects, the body can be compressible. As used herein, the term "compressible" refers to the ability to reversibly reduce in volume without undergoing unacceptable changes (e.g., unacceptable permanent changes in size, shape, and / or one or more properties as described herein). According to some aspects, the body can be configured such that upon compression, at least a portion of the fluid contained therein is dispensed. It should be understood that "dispensed" (or "expelled") as used herein can refer to delivering the fluid to an adapter in fluid communication with the fluid container, and / or can refer to delivering the fluid to a surface.

[0062] According to some aspects, the body can be collapsible. As used herein, the term "collapsible" refers to the ability to permanently reduce in volume. For example, a collapsible body as described herein can have a first volume when a first volume of fluid is contained therein. When at least a portion of the fluid is dispensed, the collapsible body can collapse to have a second volume that is less than the first volume. It should be understood that a collapsible body will advantageously reduce the volume of waste (e.g., the volume of the body after the fluid therein has been dispensed). A collapsible body can also provide more efficient fluid expulsion.

[0063] According to some aspects, the body can be configured to allow a volume reduction of at least 10%, optionally at least 20%, optionally at least 30%, optionally at least 40%, optionally at least 50%, optionally at least 60%, optionally at least 70%, optionally at least 80%, optionally at least 90%, and optionally at least 99% when compressed and / or collapsed.

[0064] According to some aspects, the body can include a body material that is compatible with the fluid contained therein, i.e., a material that does not chemically or physically react with the fluid or otherwise render the fluid unsuitable for medical use.

[0065] According to some aspects, the body material can be sufficient to prevent unacceptable vapor or disinfectant loss of the fluid contained therein over a certain shelf life. It should be understood that "unacceptable vapor or disinfectant loss" can be a loss that causes the fluid to become unsuitable for its intended use. Vapor or disinfectant loss can be caused by, for example, adsorption or absorption of the disinfectant by the material (e.g., the body material), evaporation of the solution, evaporation of solution components (e.g., the disinfectant of a disinfecting solution), or a combination thereof. In a non-limiting example, where the fluid includes water and iodine as described herein, the body material can be sufficient to prevent water vapor loss and / or iodine loss over a certain shelf life.

[0066] As used in this application, the term "shelf life" refers to the length of time that a product (e.g., a disinfecting solution) can be stored while maintaining its form, suitability, and functionality within the required specifications. The shelf life can be determined by measuring certain properties of the product that may indicate that the product is no longer suitable for medical use. For example, the shelf life can be determined by measuring the following properties: the concentration of impurities in the product, the color change of the product, the concentration of insoluble particles in the product, the potency of the active agent (e.g., disinfectant) contained in the product, the concentration of one or more components in the product, the pH value of the product, and / or the sterility of the product after storage under long-term storage conditions. The term "long-term storage conditions" as used herein refers to environmental conditions that are sufficient to allow the product to be acceptably stored for more than 72 hours. According to some aspects, the long-term storage conditions can refer to a temperature of about 25°C and a relative humidity of about 60%. Additionally or alternatively, the shelf life can be determined by measuring the following properties: the concentration of impurities in the product, the color change of the product, the concentration of insoluble particles in the product, the potency of the active agent of the product, the concentration of one or more components in the product, the pH value of the product, and / or the sterility of the product after storage at 37°C and 65% relative humidity. Additionally or alternatively, the shelf life can be determined by measuring the following properties: the concentration of impurities in the product, the color change of the product, the concentration of insoluble particles in the product, the potency of the active agent of the product, the concentration of one or more components in the product, the pH value of the product, and / or the sterility of the product after storage between about 15°C and 30°C (with a temperature deviation of no more than about 40°C).

[0067] According to some aspects, the shelf life can be at least about 15 months, optionally at least about 16 months, optionally at least about 17 months, optionally at least about 18 months, optionally at least about 19 months, optionally at least about 20 months, optionally at least about 21 months, optionally at least about 22 months, optionally at least about 23 months, optionally at least about 24 months, optionally at least about 25 months, optionally at least about 26 months, optionally at least about 27 months, optionally at least about 28 months, optionally at least about 29 months, optionally at least about 30 months, optionally at least about 31 months, optionally at least about 32 months, optionally at least about 33 months, optionally at least about 34 months, optionally at least about 35 months, optionally at least about 36 months, optionally at least about 37 months, optionally at least about 38 months, optionally at least about 39 months, and optionally at least about 40 months.

[0068] In accordance with some aspects, the bulk material is sufficiently sterilized by any known sterilization technique applicable to the present disclosure, including moist heat sterilization (i.e., autoclaving), gas sterilization, gamma radiation, electron beam (e-beam) sterilization, aseptic manufacturing processes (such as aseptic filtration and / or blow-fill-seal operations), and combinations thereof. In accordance with some aspects, if the container containing the bulk material has a sterility assurance level (SAL) of at least 10 -6 and provides acceptable results when an integrity test is performed on the container closure after sterilization, then the bulk material can be determined to be sufficiently sterilized. In accordance with some aspects, if the container containing the bulk material has a sterility assurance level (SAL) of at least 10 -3 and provides acceptable results when an integrity test is performed on the container closure after sterilization, then the bulk material can be determined to be sufficiently sterilized.

[0069] In accordance with some aspects, the bulk material can have sufficient mechanical strength such that the bulk provides an acceptable response to shock, vibration, shaking, or combinations thereof. In accordance with some aspects, an acceptable response means a response that complies with ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems), ASTM D4728-06 (Standard Test Method for Random Vibration Testing of Shipping Containers), ASTM D642-15 (Standard Test Method for Determining the Compressive Strength and Unit Load of Shipping Containers and Components), or any combination thereof. In accordance with some aspects, the bulk material can be safely used for biomedical applications. For example, the bulk material can meet the requirements of ISO10993 and / or REACH. In accordance with some aspects, at a temperature between about 15 °C and 30 °C (with a temperature deviation not exceeding about 4 °C), for a certain period of the fluid shelf life, the bulk material can be sufficient to exhibit at least a portion of the characteristics described herein. Additionally or alternatively, after storage at about 25 °C and 60% relative humidity, for a certain period of the fluid shelf life, the bulk material can be sufficient to exhibit at least a portion of the characteristics described herein. Additionally or alternatively, after storage at about 37 °C and 65% relative humidity, for a certain period of the fluid shelf life, the bulk material can be sufficient to exhibit at least a portion of the characteristics described herein.

[0070] The bulk material can be rigid or flexible. As used herein, the term "rigid" refers to a stiffness sufficient to resist deformation under normal operating forces. As used herein, the term "flexible" refers to the ability to bend or compress under normal operating forces.

[0071] Exemplary body materials include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Exemplary plastics suitable for use in accordance with the present disclosure include, but are not limited to, high density polyethylene (HDPE), low density polyethylene (LDPE), polypropylene, polystyrene, nylon, and any combination thereof. In some aspects, the body material may be a lined and / or coated material, such as lined and / or coated paper.

[0072] The present disclosure relates to an adapter that can be used with the fluid containers described herein. In some aspects, the adapter may include a connection portion configured to interact with a corresponding connection portion of the fluid container to provide a secure connection.

[0073] Figure 1A An exemplary adapter 100 according to aspects of the present disclosure is shown. As Figure 1A shown, the adapter 100 may include a connection portion 101. In some non-limiting examples, the connection portion 101 may include one or more protrusions configured to interact with corresponding protrusions of the fluid container to form a threaded connection, thereby allowing the adapter 100 to be screwed onto the fluid container.

[0074] However, it should be understood that the present disclosure is not necessarily limited to Figure 1A the example shown. For example, in addition to or instead of protrusions, the connection portion 101 may include any connection component sufficient to provide a secure connection between the adapter and the fluid container. In some non-limiting examples, the connection portion 101 may be configured to provide a snap connection, a friction connection, or a combination thereof. In some aspects, the connection portion 101 may be configured to provide a secure connection with commercially available fluid containers known in the art.

[0075] As Figure 1A shown, the adapter 100 may also include at least one spike element 104 at a first end of a first fluid flow path 102a. In some aspects, the spike element 104 may be configured to pierce a membrane of the fluid container sufficient to provide fluid communication between the fluid container and the first fluid flow path 102a of the adapter 100. In some non-limiting examples, the spike element 104 may include one or more features of a spike interface as described in U.S. Provisional Patent Application No. 63 / 366,588, the disclosure of which is incorporated herein by reference in its entirety.

[0076] However, it should be understood that the adapter 100 is not necessarily limited in this manner. For example, the adapter 100 may not have a spike element 104 as long as the corresponding end of the first fluid flow path 102a terminates in at least one hole sufficient to provide fluid communication between the first fluid flow path 102a and the fluid containers described herein.

[0077] As Figure 1A shown, the adapter 100 may also include a second fluid flow path 102b configured to provide fluid communication between the fluid container, as described herein, and the atmosphere outside the fluid container when the fluid container is pierced, for example, by the lancet element 104 as described above. In this way, when fluid is dispensed from the fluid container, the pressure within the fluid container can be balanced.

[0078] According to some aspects and as Figure 1A shown, the second fluid flow path 102b may include at least one vent 106 that may have one or more features described in U.S. Provisional Patent Application No. 63 / 366,588. For example, the vent 106 may be configured to prevent contaminants from entering the fluid container when air or gas flows into the second fluid flow path 102b and thus into the fluid container. In one non-limiting example, the vent 106 may include a one-way valve or a membrane (e.g., a membrane configured to prevent a liquid solution from passing therethrough but allowing air to freely enter and exit the container). According to some aspects, the vent 106 may include at least one material having a polarity opposite to that of the fluid contained in the fluid container as described herein. For example, in the case where the fluid container contains a predominantly aqueous fluid, the vent 106 may include at least one hydrophobic material to reduce the likelihood of the aqueous fluid passing therethrough. In some examples, the vent 106 may include a sterile filter, a sterile porous foam, or a sterile membrane to reduce or prevent contaminants from entering the second fluid flow path 102b.

[0079] Figure 1B An exploded view shows an exemplary adapter 100 having at least one vent (provided in the form of vent halves 106a, 106b). As shown, the vent halves 106a, 106b may be disposed within a vent housing 107 of the adapter 100. The vent halves 106a, 106b may be irreversibly fixed within the vent housing 107 in a manner sufficient to withstand pressures associated with dispensing fluid from the fluid container as described herein, e.g., pressures associated with balancing the fluid container (e.g., by manual and / or assisted fluid delivery). For example, the vent halves 106a, 106b may be welded and / or glued into the vent housing 107.

[0080] Figure 1C An exemplary vent housing 107 is shown without a filter, porous foam, or membrane.

[0081] As Figure 1AAs shown, the adapter 100 further includes an outlet 103 disposed at an end of the first fluid flow path 102a opposite the stylet element 104. The outlet 103 is configured to distribute fluid onto a surface (such as a surgical site) during a lavage process. It should be understood that although Figure 1A the outlet 103 of the exemplary adapter 100 shown has a single discharge hole, the outlet 103 is not necessarily limited to this configuration. For example, the outlet 103 may include multiple discharge holes, such as two, three, four, or more discharge holes. Each discharge hole may be the same size or different from one or more other discharge holes. Additionally or alternatively, each discharge hole may have the same shape or a different shape from one or more other discharge holes.

[0082] The adapter 100 may further include at least one valve 105 disposed along the first fluid flow path 102a and particularly between the stylet element 104 and the outlet 103. According to some aspects, the valve 105 is configured such that the adapter 100 can provide at least two alternative fluid delivery modes. In some non-limiting examples, the at least two alternative fluid delivery modes include assisted fluid delivery and manual fluid delivery.

[0083] As used herein, "assisted fluid delivery" refers to the delivery of fluid using at least one pumping device. Non-limiting examples of pumping devices include electric pumps, electromechanical devices, pneumatic devices, and syringes. As is known in the art, a pumping device may be configured to provide a continuous fluid flow from a fluid device. Additionally or alternatively, a pumping device may be configured to provide an intermittent fluid flow, also referred to herein as a "pulsatile" flow.

[0084] As used herein, "manual fluid delivery" refers to the delivery of fluid without a pumping device. For example, in the case where a fluid container includes a compressible body, manual fluid delivery may include compressing the body such that at least a portion of the fluid contained therein is dispensed.

[0085] Figure 2 An example of an adapter 200 having a valve 201 as described herein is shown. Figure 2Three different positions of the valve 201 are also shown. Specifically, in the first position 2001, the valve 201 is closed to prevent fluid from passing therethrough. The second position 2002 shows an example of manual fluid delivery. In this position, the pressure from the fluid stream 202, for example generated by compressing the fluid container described herein, forces the valve 201 into the open position. In this way, the fluid from the fluid stream 202 can pass therethrough. In this example, when the pressure from the fluid stream 202 ends (e.g., when the fluid container is no longer compressed), the valve 201 can return to the closed position, i.e., the first position 2001. In this way, air from the external environment can be prevented from entering the fluid container through the valve 201. Additionally, in the closed position, the fluid in the fluid container can be prevented from accidentally passing through the valve 201. Instead, air from the external environment will enter the fluid container via a second fluid flow path (e.g., the second fluid flow path 102b, as shown and described with respect to Figure 1A shown and described) and thus pass through at least one vent and prevent contaminants from entering the fluid container.

[0086] The third position 2003 shows an example of assisted fluid delivery. In this example, a part of the pumping device (e.g., the stylet 203) can be inserted through the valve 201. Thus, the valve 201 remains in the open position to allow the fluid 205 to flow therethrough. According to some aspects, the valve 201 is configured to prevent the pumping device (e.g., the stylet 203) from accidentally moving out therefrom. For example, the valve 201 can be configured such that sufficient friction is generated between the valve 201 and the stylet 203 to reduce or prevent the sliding of the stylet 203 relative to the valve 201. This friction can be provided by selecting a specific valve material and / or by providing a valve with one or more textural features configured to interact with a part of the pumping device (e.g., the stylet 203). The textural features can include, but are not limited to, ridges, ribs, protrusions, and combinations thereof.

[0087] As Figure 2 shown, the valve 201 can have a structure that allows for the manual fluid delivery and the assisted fluid delivery as described above. For example, the valve 201 can include a cross-slit valve 300 as Figure 3 shown. As Figure 3 shown, the cross-slit valve 300 can include two slits that form a substantially "x-shaped". It should be understood that the cross valve 300 can open in two directions. For example, as Figure 2As shown, the valve 201 is open in the first direction (e.g., towards the outlet 204 of the adapter 200) at position 2002 and open in the second direction (i.e., in the direction opposite to the first direction) at position 2003. However, it should be understood that the present disclosure is not necessarily limited to this example. Specifically, the valve can have any structure capable of providing at least two alternative fluid delivery modes as described herein. For example, the valve can have a single slit or three slits, four slits, five slits or more slits. In some non-limiting examples, the valve is a duckbill valve. In some non-limiting examples, the valve is a check valve, such as a mechanical or pneumatic check valve.

[0088] In some non-limiting examples, the valve can be configured to provide a specific fluid flow force, fluid flow rate, and / or fluid flow pattern. As used herein, the term "fluid flow force" refers to the force exerted by the fluid on a surface (e.g., on a human subject) during irrigation. It should be understood that the fluid flow force according to the present disclosure is acceptable for use in the irrigation processes described herein.

[0089] In some non-limiting examples, the acceptable fluid flow force can be between 1 and 100 psi, optionally between 1 and 90 psi, optionally between 1 and 80 psi, optionally between about 1 and 70 psi, optionally between 1 and 60 psi, optionally between 1 and 50 psi, optionally between 1 and 40 psi, optionally between 1 and 30 psi, optionally between 1 and 20 psi, and optionally between 1 and 10 psi. In some non-limiting examples, the acceptable fluid flow force can be between 1 and 20 psi, optionally between 1 and 15 psi, and optionally between about 4 and 15 psi. In some non-limiting examples, the acceptable fluid flow force can be about 70 psi, optionally about 65 psi, optionally about 60 psi, optionally about 55 psi, optionally about 50 psi, optionally about 45 psi, optionally about 40 psi, optionally about 35 psi, optionally about 30 psi, optionally about 25 psi, optionally about 20 psi, optionally about 15 psi, optionally about 10 psi, and optionally about 5 psi.

[0090] As used herein, the term "fluid flow rate" refers to the rate at which the fluid is applied to a surface (e.g., applied to a human subject) during irrigation. As used herein, the term "fluid flow pattern" refers to the pattern in which the fluid is dispensed and / or applied from the device to a surface (e.g., applied to a human subject) during irrigation.

[0091] In some non - limiting examples, a valve can have a specific number of slits to provide a specific fluid flow force, fluid flow rate, and / or fluid flow pattern as described herein. For example, as is known in the art, a valve can have one slit, two slits, three slits, four slits, five slits, or more slits. It should be understood that the number of slits can also affect the magnitude of the force required to open the valve (e.g., increasing the number of slits can reduce the force required for the fluid flow to open the valve). Additionally or alternatively, the number of slits can also correspond to the size of the orifice created by the open valve, which can affect the fluid flow force, fluid flow rate, and / or fluid flow pattern.

[0092] In some non - limiting examples, a valve can have one or more slits with a specific length and / or geometry. It should be understood that the length of the one or more slits affects the magnitude of the force required to open the valve (e.g., increasing the slit length reduces the force required for the fluid flow to open the valve). Additionally or alternatively, the one or more slits can have a specific geometric pattern configured to provide a specific fluid flow force, fluid flow rate, and / or fluid flow pattern.

[0093] Additionally or alternatively, one or more other features of the valve can be selected to provide a specific fluid flow force, fluid flow rate, and / or fluid flow pattern. Exemplary valve characteristics include valve size (e.g., valve diameter), valve shape, valve material, valve thickness, valve orientation in the adapter, the valve's position along the first fluid flow path, and combinations thereof.

[0094] According to some aspects, the valve can include a valve material selected to provide a specific fluid flow force, fluid flow rate, and / or fluid flow pattern. Exemplary valve materials include, but are not limited to, silicone, rubber, laminates, elastic materials. In some non - limiting examples, the valve material can include polyisoprene, polybutadiene, polyethers, polysulfides, polyethylene, polyvinyl chloride, polyetheretherketone, polypropylene, nitrile, neoprene, ethylene - propylene - diene monomer rubber, rigid plastics, metallic steel, glass, or combinations thereof. The valve can include one or more check balls and / or springs. In some non - limiting examples, a more flexible valve material (e.g., silicone) may require less force to open than a more rigid material (e.g., vulcanized rubber). In some non - limiting examples, the molecular weight, degree of cross - linking, and / or specific additives contained in the valve material can affect the magnitude of the force required to open the valve.

[0095] According to some aspects, the thickness of the valve affects the magnitude of the force required to open the valve (e.g., increasing the thickness increases the force required for the fluid flow to open the valve).

[0096] According to some aspects, the shape of the valve can affect the magnitude of the force required to open the valve. For example, the valve can include a duckbill valve, which may require a different magnitude of force to open than that required to open a cross-slit valve.

[0097] According to some aspects, the orientation of the valve in the adapter and / or the position of the valve along the first fluid flow path can affect the magnitude of the force required to open the valve. In some non-limiting examples, the orientation of the valve affects the force required for a portion of the pumping device to pass therethrough.

[0098] In some non-limiting examples, instead of or in addition to the valve 105 described herein, the adapter 100 can further include a burst disc. For example, the burst disc can be configured to rupture when a specific pressure is applied to the fluid container. Once the burst disc ruptures, the fluid can be manually delivered as described herein. Optionally, the burst disc can be ruptured by the stylet 203 of the pumping device as described herein.

[0099] According to some aspects, one or more components of the adapter 100 can include a transparent material. As used herein, "transparent material" refers to a material that allows light to pass through sufficiently to enable an observer to see an object on the opposite side. In this way, the adapter 100 can reduce the risk associated with incorrect insertion of the stylet 203 of the pumping device described herein and thus reduce the risk of accidental removal of the stylet 203.

[0100] The present disclosure also relates to a kit having the adapter described herein. In some examples, the kit can include the adapter and an instructions for use, such as instructions for securing the adapter described herein to a fluid container. In some non-limiting examples, the kit can include the adapter described herein, a fluid container, and optionally an instructions for use.

[0101] The present disclosure also relates to a system having a fluid container, at least a first connection portion of which is connected to a second connection portion of the adapter as described herein.

[0102] The present disclosure also discloses a method of using the adapter described herein. The method can include: providing a fluid container; securely connecting the adapter to the fluid container; and dispensing fluid from the fluid container via the adapter by manual or assisted delivery. The method can further include performing a lavage process, i.e., flushing a body cavity, surgical cavity, and / or external wound with fluid from the device.

[0103] While the aspects described herein have been described in connection with the above exemplary aspects, various alternatives, modifications, variations, improvements and / or substantial equivalents, whether known or currently unforeseeable, will become apparent to those of ordinary skill in the art at least. Accordingly, the exemplary aspects described above are intended to be illustrative and not restrictive. Various changes can be made without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to cover all known or later-developed alternatives, modifications, variations, improvements and / or substantial equivalents.

[0104] Accordingly, the claims are not intended to be limited to the aspects shown herein, but are intended to afford the full scope consistent with the language of the claims, wherein, unless specifically stated otherwise, an element recited in the singular does not mean "one and only one" but means "one or more". All structural and functional equivalents of the elements of the various aspects described in this disclosure, known or later learned by those of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be covered by the claims. Moreover, nothing disclosed herein is dedicated to the public, whether or not such disclosure is expressly recited in the claims. No claim element shall be construed as a means-plus-function unless the phrase "means for" is expressly recited with respect to that element.

[0105] In this document, numerical ranges expressed by endpoints (e.g., between about 50:1 and 1:1, between about 100 °C and 500 °C, between about 1 minute and 60 minutes) include all values falling within that range. For example, between about 1 minute and 60 minutes includes 21, 22, 23, and 24 minutes as endpoints within a specific range. Thus, for example, ranges such as 22 - 36, 25 - 32, 23 - 29, etc. are also ranges formed by endpoints falling within the 1 - 60 range, depending on the starting materials used, temperature, specific application, specific embodiment, or claim limitations (if required). The examples and methods disclosed herein demonstrate that the stated ranges encompass every point within those ranges because different synthetic products result from varying one or more reaction parameters. In addition, the methods and examples disclosed herein describe various aspects of the disclosed ranges, as well as the effects when these ranges are varied alone or in combination with other recited ranges.

[0106] In addition, the term "exemplary" as used herein is used to mean "serving as an example, instance, or illustration". Any aspect described herein as "exemplary" is not necessarily to be construed as preferred or superior to other aspects. Unless specifically stated otherwise, the term "some" means one or more. Combinations such as "at least one of A, B, or C", "at least one of A, B, and C", and "any combination of A, B, C, or any combination thereof" include any combination of A, B, and / or C, and may include multiple A's, multiple B's, or multiple C's. Specifically, combinations such as "at least one of A, B, or C", "at least one of A, B, and C", and "any combination of A, B, C, or any combination thereof" can be only A, only B, only C, A and B, A and C, B and C, or A and B and C, where any such combination can include one or more components of A, B, or C. Nothing disclosed herein is intended to be dedicated to the public, whether or not such disclosure is explicitly recited in the claims.

[0107] The terms "about" and "approximately" as used herein are defined as being close to what is understood by a person of ordinary skill in the art. In a non-limiting embodiment, the terms "about" and "approximately" are defined to be within 10%, preferably within 5%, more preferably within 1%, and most preferably within 0.5%.

Claims

1. An adapter, characterized in that: include: A connecting portion capable of connecting to a fluid container; a first fluid flow path having a first end and a second end, the first end being configured to provide fluid communication with the fluid container, the second end comprising a fluid outlet; at least one valve disposed along the first fluid flow path; as well as a second fluid flow path, separate from the first fluid flow path, Wherein, the at least one valve is configured to provide a selection between assisted fluid delivery and manual fluid delivery.

2. The adapter according to claim 1, characterized in that: The first end of the first fluid flow path includes a lancet element.

3. The adapter according to claim 1, characterized in that: The at least one valve comprises a cross-slit valve.

4. The adapter according to claim 1, characterized in that: The at least one valve is configured to open in two directions.

5. The adapter according to claim 1, characterized in that: The adapter also includes a vent disposed along the second fluid flow path.

6. The adapter according to claim 5, characterized in that: The vent is irreversibly fixed in the vent housing.

7. A system having a fluid container, characterized in that: include: The fluid container ； An adapter, wherein the adapter comprises: a connecting portion connected to the fluid container; a first fluid flow path having a first end and a second end, the first end being configured to provide fluid communication with the fluid container, the second end comprising a fluid outlet; at least one valve disposed along the first fluid flow path, wherein the at least one valve is configured to provide a selection between assisted fluid delivery and manual fluid delivery; and A second fluid flow path is separate from the first fluid flow path.

8. The system according to claim 7, characterized in that The first end of the first fluid flow path includes a lancet element.

9. The system according to claim 7, characterized in that The at least one valve comprises a cross-slit valve.

10. The system according to claim 7, characterized in that The at least one valve is configured to open in two directions.

11. The system according to claim 7, characterized in that The adapter also includes a vent disposed along the second fluid flow path.

12. The system according to claim 7, characterized in that The fluid container contains irrigation fluid.

13. A kit having an adapter, characterized in that: include: The adapter, wherein the adapter comprises: A connecting portion capable of connecting to a fluid container; a first fluid flow path having a first end and a second end, the first end being configured to provide fluid communication with the fluid container, the second end comprising a fluid outlet; at least one valve disposed along the first fluid flow path, wherein the at least one valve is configured to provide a selection between assisted fluid delivery and manual fluid delivery; and a second fluid flow path separate from the first fluid flow path; and For connecting the adapter to the indicating portion of the fluid container.

14. The kit according to claim 13, characterized in that The first end of the first fluid flow path includes a lancet element.

15. The kit according to claim 13, characterized in that The at least one valve comprises a cross-slit valve.

16. The kit according to claim 13, characterized in that The at least one valve is configured to open in two directions.

17. The kit according to claim 13, characterized in that The adapter also includes a vent disposed along the second fluid flow path.

18. The kit according to claim 17, characterized in that The vent is irreversibly fixed in the vent housing.

19. The kit of claim 13, wherein: The kit also includes the fluid container.

20. The kit of claim 19, wherein: The fluid container contains irrigation fluid.

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