Cleaning system and device with vented components

Abstract

The present invention provides a system for applying a cleaning liquid to a surface, the system comprising: a body containing a cleaning liquid; an applicator member in fluid communication with the body and configured to distribute the cleaning liquid along a flow path; a fluid passage configured to provide fluid communication between the body and an external environment; and a venting element associated with the fluid passage having at least one filter sufficient to filter gas, such as air, passing through the fluid passage, at least a portion of the fluid passage being separated from the flow path.

Description

[Technical Field]

[0001] This application claims priority to U.S. Provisional Application No. 63 / 092,235, filed October 15, 2020, and U.S. Application No. 17 / 501,768, filed October 14, 2021, the entire disclosures of both of which are expressly incorporated herein by reference.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates to devices and systems for applying cleaning fluid to surfaces, and in particular to devices and systems that include at least one venting component. [Background technology]

[0003] Currently, irrigation (i.e., the cleaning of a body cavity, surgical cavity, or wound with a medically acceptable fluid) is often used to prevent contamination of surgical wounds that can occur for a variety of reasons, including accidental visceral penetration or perforation, complicated procedures due to gross leakage, deviations from aseptic technique, and / or existing ongoing clinical infections. Thus, irrigation processes are often used to disinfect and cleanse wounds during surgery.

[0004] Currently, irrigation techniques utilize a wide variety of approaches that vary depending on the situation (e.g., the size and shape of the body cavity or wound) and the practitioner performing the irrigation process (e.g., the practitioner's technique preferences). Because the field currently lacks a standard, specific irrigation technique, healthcare facilities often require many different irrigation devices and systems to accommodate the various potential approaches. The presentation of such devices and systems can also be a concern, as their careless and improper use (e.g., improper use intravenously when the device and / or system resembles an intravenous device and / or system in appearance) can have devastating effects.

[0005] Furthermore, current irrigation methods have several drawbacks, including inadequate disinfectant properties (e.g., excessive time required for the disinfectant to achieve an acceptable biological effect), the risk of systemic absorption of the disinfectant, and side effects such as anaphylaxis, peritoneal adhesions, neurotoxicity, and respiratory failure, as well as inadequate or contaminated doses of disinfectant prepared extemporaneously by the physician performing the irrigation.

[0006] Current irrigation devices also often increase the risk of contamination. For example, some current irrigation devices utilize a resilient, hollow body (e.g., a "squeeze bottle") that expels irrigation fluid when pressure is applied. To function, such devices require one or more re-equilibration periods (i.e., periods during which the pressure applied to the device is reduced or no pressure is applied) so that sufficient gas, such as air, can be drawn into the device to re-equilibrate its internal pressure. However, introducing non-sterile gas into the device can jeopardize the sterility of the irrigation fluid contained therein (and therefore the surgical wound it contacts). Furthermore, during the re-equilibration period, such devices draw gas along the same pathway through which irrigation fluid is dispensed from the device. However, because these pathways are typically not optimized for such functionality, the re-equilibration periods required by such devices often result in unacceptable delays in the irrigation process, often rendering it inefficient and / or ineffective.

[0007] Therefore, there is a need in the art for versatile devices and systems that perform cleaning processes, particularly devices and systems that allow physicians to safely and effectively reduce contamination of surgical wounds that are prone to surgical site infections. Summary of the Invention [Problem to be solved by the invention]

[0008] The present disclosure relates to devices and systems for delivering cleaning fluids, such as disinfectant fluids, to surfaces. [Means for solving the problem]

[0009] The device includes a body configured to contain a cleaning fluid, such as a disinfectant solution, the body further configured to be in fluid communication with at least one application member configured to apply the cleaning fluid to a surface sufficient for a cleaning process.

[0010] The devices and systems are adaptable to allow a user to select between two or more different fluid flow rates, fluid flow patterns, and / or fluid flow forces, thereby allowing for selectable control of the delivery of cleaning fluid to a surface. The present disclosure also relates to methods of using the devices and systems described herein.

[0011] The present disclosure also relates to a venting component usable in the devices and systems described herein. The venting component includes a fluid passage configured to provide fluid communication between the body and an external environment. The fluid passage may further include at least one filter disposed relative to the fluid passage sufficient to remove contaminants from gas passing through the fluid passage. According to some embodiments, at least a portion of the fluid passage is separated from a fluid flow path through which a cleaning fluid is distributed by the device or system. [Brief explanation of the drawings]

[0012] [Figure 1A] 1 illustrates an example of a compressible body according to aspects of the present disclosure. [Figure 1B] 1 illustrates an example of a foldable body according to aspects of the present disclosure. [Figure 2A] 1 illustrates an example of a body according to aspects of the present disclosure. [Figure 2B] 1 illustrates an example of a body according to aspects of the present disclosure. [Figure 3] 1 illustrates an example of a body connector according to an aspect of the present disclosure. [Figure 4] 1 illustrates an example of a body with an outer casing according to aspects of the present disclosure. [Figure 5] 1 illustrates an exemplary applicator member according to aspects of the present disclosure. [Figure 6] 1 illustrates an exemplary system according to an aspect of the present disclosure. [Figure 7A] 1 illustrates an exemplary dispensing aid according to aspects of the present disclosure. [Figure 7B] 1 illustrates an exemplary dispensing aid according to aspects of the present disclosure. [Figure 8] 1 illustrates an exemplary system according to an aspect of the present disclosure. [Figure 9] 1 illustrates an exemplary system according to an aspect of the present disclosure. [Figure 10] 1 illustrates an exemplary system according to an aspect of the present disclosure. [Figure 11] 1 illustrates an exemplary system according to an aspect of the present disclosure. [Figure 12] 1 illustrates an exemplary system with multiple nozzles, according to aspects of the present disclosure. [Figure 13] 1 illustrates an exemplary vent adapter according to aspects of the present disclosure. [Figure 14A] 1 illustrates an exemplary vent adapter according to aspects of the present disclosure. [Figure 14B] 1 illustrates an exemplary vent adapter with a body, according to aspects of the present disclosure. [Figure 15] 1 illustrates an exemplary vent adapter with a body, according to aspects of the present disclosure. [Figure 16A] 1 illustrates an exemplary body with one or more vent components according to an embodiment of the present disclosure. [Figure 16B] 1 illustrates an exemplary applicator member with one or more venting components, according to an embodiment of the present disclosure. [Figure 17] 1 illustrates an exemplary vent adapter with a body, according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0013] The present disclosure relates to devices and systems for delivering cleaning fluid, such as a disinfectant solution, to a surface. The device includes a body configured to contain a cleaning fluid, such as a disinfectant solution. The body is further configured to be in fluid communication with at least one application member configured to apply the cleaning fluid to a surface sufficient for a cleaning process. The devices and systems are adaptable to allow a user to select from two or more different fluid flow rates, fluid flow patterns, and / or fluid flow forces, thereby allowing selectable control of the delivery of the cleaning fluid. The present disclosure also relates to methods of using the devices and systems described herein.

[0014] The present disclosure also relates to a venting component usable in the devices and systems described herein. The venting component includes a fluid passage configured to provide fluid communication between the body and an external environment, and may further include at least one filter disposed relative to the fluid passage sufficient to filter gases, such as air, passing through the fluid passage. According to some embodiments, at least a portion of the fluid passage is separated from a fluid flow path through which cleaning fluid is distributed by the device or system.

[0015] As used herein, the term "fluid" refers to a substance that does not have a fixed shape, such as a liquid or gas. As used herein, the term "irrigation fluid" refers to a fluid that is suitable for the irrigation processes described herein. As used herein, "irrigation" refers to the irrigation of a body cavity, a surgical cavity, and / or a wound.

[0016] According to some embodiments, the cleaning solution may include a disinfectant solution. As used herein, "disinfectant solution" refers to a solution containing at least one solvent and one or more disinfectants. According to some embodiments, the disinfectant solution is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution containing water as at least half of the solvent. It should be understood that in some examples, the solvent may consist of water. According to some embodiments, the disinfectant solution is an alcohol solution. As used herein, the term "alcohol solution" refers to a solution containing alcohol as at least half of the solvent. It should be understood that in some examples, the solvent may consist of one or more alcohols. Non-limiting examples of alcohols include, but are not limited to, ethanol, isopropyl alcohol, n-propanol, and combinations thereof.

[0017] In one non-limiting example, the antiseptic may include a cationic molecule (i.e., a molecule having a positive charge) such as a cationic surfactant or a cationic biguanide derivative (i.e., a compound derived from a biguanide). According to some embodiments, the antiseptic may include a bis-(dihydropyridinyl)-decane derivative (i.e., a compound derived from bis-(dihydropyridinyl)-decane). According to some embodiments, the antiseptic may include an octenidine salt and / or a chlorhexidine salt. According to some embodiments, the antiseptic may include alexidine, octenidine dihydrochloride, chlorhexidine gluconate, or a combination thereof.

[0018] Additionally or alternatively, the antiseptic may include iodine. According to some embodiments, the iodine may be provided as an iodine complex, such as povidone-iodine (PVPI), nonylphenoxy-(ethyleneoxy)-iodine, polyethyleneoxypolypropyleneoxy-iodine, undecoilium iodide chloride, povacrilex iodide, and combinations thereof.

[0019] Additionally or alternatively, the disinfectant may include an oxidant (i.e., an oxidizing agent). Non-limiting examples of oxidants according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, and combinations thereof.

[0020] A disinfectant may have sufficient antimicrobial activity to allow for an acceptable log reduction of microorganisms over a specified period of time. It should be understood that the term "microorganisms" as used herein may refer to any microorganism that is killed and / or removed as a result of cleaning. Exemplary microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0021] Examples of bacteria include Streptococcus mutans, Streptococcus pyogenes (group A beta-hemolytic streptococci), S. salivarius, S. sanguis, Staphylococcus aureus, Staphylococcus epidermidis, S. haemolyticus, S. hominis, S. simulans, Staphylococcus saprophyticus, methicillin / oxacillin-resistant Staphylococcus aureus (MRSA / ORSA) and methicillin / oxacillin-susceptible Staphylococcus aureus (MSSA / OSSA), Enterococcus faecalis (e.g., Enterococcus faecalis, Enterococcus faecalis, and Enterococcus hirae), vancomycin-resistant enterococci (VRE) and vancomycin-susceptible enterococci (VSE), Bacteroides furunculosis, and Enterococcus faecalis. radilis, Propionibacterium acnes, Clostridium difficile (spores and vegetative cells), Selenomonas, Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Gardnerella vaginalis, Klebsiella aerogenes, Klebsiella pneumoniae, multidrug-resistant Klebsiella pneumoniae (MDR), Acinetobacter baumannii, Acinetobacter baumannii MDR, Achromobacter xylosoxidans, Micrococcus luteus, Ralstonia pickettii, Haemophilus influenzae, and Serratia marcescens.

[0022] Exemplary fungi include, but are not limited to, Aspergillus niger, Candida albicans, Candida auris, C. dubliniensis, C. glabrata (formerly Torulopsis glabrata), C. guilliermondii, C. kefir (formerly C. pseudotropicalis), C. krusei, C. lusitaniae, C. tropicalis, Epidermophyton floccosum, Microsporum gypsum, Microsporum canis, and Trichophyton mentagrophytes.

[0023] Exemplary viruses include, but are not limited to, viruses that have a lipid component in their coat or have 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 (variola virus), vaccinia virus, norovirus, and coronavirus.

[0024] According to some embodiments, the specified period of time may be a period of about 5 minutes or less, optionally about 4 minutes or less, optionally about 3 minutes or less, optionally about 2 minutes or less, optionally about 1 minute or less.

[0025] According to some embodiments, the specified period of time may be about 120 seconds or less, optionally about 105 seconds or less, optionally about 90 seconds or less, optionally about 75 seconds or less, optionally about 60 seconds or less, optionally about 45 seconds or less, optionally about 30 seconds or less, and optionally about 15 seconds or less.

[0026] It is understood that an "acceptable log reduction" can be microorganism-dependent. For example, an acceptable log reduction as described herein may refer to an acceptable log reduction of one microorganism present on a surface (e.g., present in a body cavity or trauma site), a combination of two microorganisms present on a surface, or all microorganisms present on a surface.

[0027] According to some embodiments, an acceptable log reduction is 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, optionally at least about 5.0.

[0028] According to some embodiments, the disinfectant can be present in the disinfecting solution at a concentration sufficient to allow an acceptable log reduction of microorganisms over a specified period of time, as described herein. According to some embodiments, the disinfectant can be present in the disinfecting solution at a concentration of about 0.001-5% w / v, optionally about 0.001-2.5% w / v, optionally about 0.001-1% w / v, optionally about 0.001-0.1% w / v, optionally about 0.001-0.01% w / v, optionally about 0.01-5% w / v, optionally about 0.01-2.5% w / v, optionally about 0.01-2% w / v, optionally about 0.01-1.5% w / v, optionally about 0.01-1% w / v, or optionally about 0.5% w / v.

[0029] According to some embodiments, the disinfectant may be present in the disinfectant solution at a concentration of about 0.1-0.9% w / v, optionally about 0.2-0.8% w / v, optionally about 0.3-0.7% w / v, optionally about 0.4-0.6% w / v.

[0030] According to some embodiments, the disinfectant may be present in the disinfectant solution at a concentration of about 0.1-1% w / v, optionally about 0.2-1% w / v, optionally about 0.3-1% w / v, optionally about 0.4-1% w / v.

[0031] It should be understood that, according to some embodiments, the cleaning fluid is not necessarily a disinfectant fluid as described herein, but may be any medically acceptable fluid configured to perform the cleaning process described herein. In one non-limiting example, the cleaning fluid may include a saline solution. The saline solution may include water and sodium chloride at a medically acceptable concentration, such as about 0.1-1% w / v, optionally about 0.45% w / v, and optionally about 0.9% w / v.

[0032] According to some embodiments, cleaning solutions, such as the disinfectant solutions described herein, can include a visualization aid. As used herein, the term "visualization aid" refers to a component in a cleaning solution configured to aid in visualizing the application of the cleaning solution. Exemplary visualization agents include, but are not limited to, colorants, stains, and radiopaque agents. It should be understood that the visualization agent can be the same as or different from one of the other components of the cleaning solution. For example, a disinfectant can function as a visualization agent. Additionally or alternatively, the cleaning solution can include a visualization agent that is different from the disinfectant.

[0033] According to some embodiments, the cleaning fluid may include a colorant. As used herein, the term "colorant" refers to a component sufficient to provide a visible color to the fluid. The colorant may be sufficient to allow visualization of the cleaning fluid upon application to a surface. In some non-limiting examples, the colorant may include an anionic colorant, such as an anionic dye. 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., a "D&C" or "FD&C" dye). 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 AC), 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. They can be combined to achieve a specific color. For example, an orange hue can include both FD&C Red No. 40 and D&C Yellow No. 8. Additionally or alternatively, the colorant can include a compound that becomes observable upon irradiation with visible and / or non-visible light, including, but not limited to, vitamin B-12, medical honey, fluorescent polymeric nanoparticles, water-soluble luminescent carbon nanodots, quinine, and combinations thereof.

[0034] According to some aspects, cleaning solutions, such as the disinfecting solutions described herein, may include a staining agent. As used herein, the term "staining agent" refers to a component sufficient to temporarily or permanently stain a surface with which it comes into contact.

[0035] According to some embodiments, cleaning solutions, such as the disinfecting solutions described herein, can include a radiopaque agent. As used herein, the term "radiopaque agent" refers to a component that is opaque to radio waves and x-ray portions of the electromagnetic spectrum sufficient for visualization. In some non-limiting examples, radiopaque agents can include barium, iodine, iron oxide nanoparticles, gadolinium composite nanospheres, silica nanospheres, and combinations thereof.

[0036] According to some embodiments, cleaning solutions, such as the disinfecting solutions described herein, can be basic, neutral, or acidic. According to some embodiments, the pH of the cleaning solution can be about 1-8, optionally about 1-7, optionally about 1-6, and optionally about 2-5.5.

[0037] According to some embodiments, cleaning solutions, such as the disinfectant solutions described herein, may include a buffer system. As used herein, the term "buffer system" refers to components present in a composition or solution that provide resistance to significant changes in pH caused by strong acids or strong bases. A buffer system may include a single agent or multiple agents, such as a weak acid and its conjugate base. A buffer system may provide resistance to significant pH changes by interacting with a strong acid or strong base in the composition or solution, thereby at least partially preventing significant changes in pH of the composition or solution.

[0038] Generally, a buffer system has one or more buffer ranges that provide resistance to significant pH changes. If a composition or solution containing a buffer system has a pH within the buffer range of the buffer system, the pH of the composition or solution will not change significantly upon addition of an equimolar amount of a strong acid or strong base.

[0039] The buffer range of a buffer system is determined by the acid dissociation constant (K a The term "acid dissociation constant" refers to the equilibrium constant for the dissociation reaction of an acid. The midpoint of the buffer range of a buffer system is generally approximately the logarithmic measure of the acid dissociation constant of the weak acid included in the buffer system (i.e., -log 10 K a pK equals a ).

[0040] According to some aspects, cleaning solutions, such as the disinfecting solutions described herein, may include a stabilizer. As used herein, the term "stabilizer," unless expressly stated otherwise, refers to any component that supports the stability of the cleaning solution.

[0041] A device according to the present disclosure includes a body configured to contain a cleaning fluid as described herein. According to some embodiments, the body may be compressible. As used herein, the term "compressible" refers to the ability to reversibly reduce in volume without unacceptable changes, such as unacceptable permanent changes in size, shape, and / or one or more properties described herein. According to some embodiments, the body may be configured to dispense at least a portion of the cleaning fluid contained therein when compressed. It should be understood that "dispensing" (or "dispensing") as used herein may refer to transferring the cleaning fluid to an application member in fluid communication with the body and / or transferring the cleaning fluid from the application member to a surface.

[0042] According to some embodiments, the body may be foldable. As used herein, the term "foldable" refers to the ability to permanently reduce volume. For example, the foldable body described herein can have a first volume when containing a first volume of fluid. Upon dispensing at least a portion of the fluid, the foldable body may be folded to have a second volume smaller than the first volume. It should be understood that a foldable body advantageously reduces waste volume (e.g., the volume of the body after the fluid within the body has been dispensed). A foldable body can further enable efficient fluid dispensing.

[0043] According to some embodiments, the body may be configured to allow for at least a 10% volume reduction, optionally at least a 20% volume reduction, optionally at least a 30% volume reduction, optionally at least a 40% volume reduction, optionally at least a 50% volume reduction, optionally at least a 60% volume reduction, optionally at least a 70% volume reduction, optionally at least a 80% volume reduction, optionally at least a 90% volume reduction, optionally at least a 99% volume reduction when compressed and / or folded.

[0044] According to some embodiments, the body may comprise a body material that is compatible with the cleaning solution contained therein, i.e., a material that does not chemically or physically react with the cleaning solution or render the cleaning solution unsuitable for medical use.

[0045] According to some embodiments, the body material may be sufficient to prevent unacceptable vapor or disinfectant loss from a cleaning solution contained therein over a specified shelf life. It should be understood that "unacceptable vapor or disinfectant loss" may be loss that renders the cleaning solution unsuitable for its intended use. Vapor or disinfectant loss may result, for example, from adsorption or absorption of disinfectant by a material (e.g., the body material), evaporation of the solution, evaporation of a component of the solution (e.g., a disinfectant in the disinfectant solution), or a combination thereof. In one non-limiting example, the cleaning solution includes water and iodine, as described herein, and the body material may be sufficient to prevent water vapor loss and / or iodine loss over a specified shelf life.

[0046] As used throughout this application, the term "shelf life" refers to the length of time a product (e.g., a disinfectant solution) can be stored within the required specifications for form, fit, and function. Shelf life may be determined by measuring certain product characteristics that may indicate that the product is unsuitable for medical use. For example, shelf life may be determined by measuring the concentration of impurities in the product, the color change of the product, the concentration of insoluble particles in the product, the potency of an active agent (e.g., a disinfectant) contained in the product, the concentration of one or more ingredients of the product, the pH of the product, and / or the sterility of the product after storage at long-term storage conditions. As used herein, the term "long-term storage conditions" refers to environmental conditions sufficient to acceptably preserve a product for more than 72 hours. According to some embodiments, long-term storage conditions may refer to a temperature of about 25°C and a relative humidity of about 60%. Additionally or alternatively, shelf life can be determined by measuring 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 in the product, the concentration of one or more ingredients in the product, the pH of the product, and / or the sterility of the product after storage at 37° C. and 65% relative humidity. Additionally or alternatively, shelf life can be determined by measuring 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 in the product, the concentration of one or more ingredients in the product, the pH of the product, and / or the sterility of the product after storage at a temperature range of about 15° C. to 30° C., up to about 40° C.

[0047] According to some embodiments, the storage period can be 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 36 months, optionally at least about 37 months, optionally at least about 38 months, optionally at least about 39 months, optionally at least about 40 months.

[0048] According to some embodiments, the body material is capable of being sterilized using known sterilization techniques useful according to the present disclosure, including moist heat sterilization (i.e., autoclaving), gas sterilization, gamma irradiation, electron beam (e-beam) sterilization, aseptic manufacturing processes (e.g., sterile filtration and / or blow-fill-seal operations), and combinations thereof. According to some embodiments, a container comprising the body material remains at least 10% sterilized after sterilization. -6 A body material can be determined to be sufficient for sterilization if it has a Sterility Assurance Level (SAL) of 0.1 or greater and provides acceptable results when tested for container closure integrity after sterilization.

[0049] According to some embodiments, the body material can have sufficient mechanical strength so that the body provides acceptable resistance to shock, vibration, shaking, or a combination thereof. According to some embodiments, acceptable resistance refers to a resistance in accordance 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 Compressive Resistance of Shipping Containers, Components, and Unit Loads), and combinations thereof. According to some embodiments, the body material can be safe for biomedical applications. For example, the body material may comply with ISO 10993 and / or REACH requirements. According to some embodiments, the body material may be sufficient to exhibit at least some of the properties described herein over a specified shelf life of the cleaning solution at temperatures between about 15° C. and 30° C., within a temperature range of about 40° C. or less. Additionally or alternatively, the body material may be sufficient to exhibit at least some of the properties described herein over a specified shelf life of the cleaning solution after storage at about 25° C. and 60% relative humidity. Additionally or alternatively, the body material may be sufficient to exhibit at least some of the properties described herein over a specified shelf life of the cleaning solution after storage at about 37° C. and 65% relative humidity.

[0050] The body material can be rigid or flexible. As used herein, the term "rigid" refers to sufficient stiffness 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.

[0051] Exemplary body materials include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Exemplary plastics useful 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. According to some embodiments, the body material may be a backing and / or coating material, such as a backing and / or coated paper.

[0052] According to some embodiments, the body material may be polypropylene. Preferably, the body material may be radiation-grade polypropylene. Here, if the body material is radiation-grade polypropylene, the body material may be capable of undergoing terminal sterilization. The body material according to the present disclosure may be configured to undergo gamma irradiation as part of terminal sterilization. Using radiation-grade polypropylene plastic as the body material allows the body containing the cleaning fluid to undergo gamma irradiation, with sterilization occurring using the cleaning fluid already present inside the sealed body.

[0053] The body of the present disclosure, upon exposure to gamma radiation, can maintain its flexibility, and the cleaning fluid contained therein is not significantly affected by the gamma radiation, i.e., the stability and integrity of the cleaning fluid can be maintained. Here, the body maintains its ability to bend and compress under normal operating forces. The body of the present disclosure, upon exposure to gamma radiation, undergoes changes in certain material properties that serve to reduce the elongation of the body when penetrated by a vent adapter including protrusions configured to insert into the wall of the body, as described herein. As described herein, the reduced elongation of the body allows the vent adapter to more easily penetrate the wall of the body.

[0054] According to some embodiments, the body containing the cleaning fluid may have varying wall thicknesses. In particular, certain walls of the body may have different thicknesses compared to other walls of the body. Preferably, certain walls may be thinner than other walls of the body. Such certain wall thicknesses may be up to 95% of the thickness of the other walls, optionally up to 90% of the thickness of the other walls, optionally up to 85% of the thickness of the other walls, optionally up to 80% of the thickness of the other walls, optionally up to 75% of the thickness of the other walls, optionally up to 70% of the thickness of the other walls, and optionally up to 65% of the thickness of the other walls. The thinner wall may be a top wall, bottom wall, or side wall of the body. Preferably, the thinner wall may be a bottom wall of the body that faces the ground. Preferably, the thinner wall may be a wall opposite a wall of the body configured to be in fluid communication with an applicator member, as described herein. As described herein, the thinner wall thickness allows a vent adapter on the outside of the body to easily penetrate the wall of the body. In a related embodiment, the vent adapter allows for easy penetration of the wall of the body, whereby the change in wall thickness and the trapped gas within the body cooperate to vent the body. Preferably, the trapped gas is under pressure greater than atmospheric pressure. The trapped gas may include air and / or an inert gas such as nitrogen.

[0055] According to some embodiments, the body may be provided with an outer casing. For example, FIG. 4 shows a body 41 including a flexible body material. The body 41 may be provided with an outer casing 42 that may be permanently attached to the body 41 or may be removable. According to some embodiments, the outer casing 42 may be rigid and thus function to protect the body 41 during storage and / or use. Additionally or alternatively, the outer casing 42 may function to distinguish the body 41 from similar devices used in medical settings, such as intravenous (IV) fluid bags. In this way, the outer casing 42 may reduce the risk of inadvertent misuse of the body 41.

[0056] Bodies according to the present disclosure are configured to dispense cleaning fluid, such as disinfectant fluid, contained therein via one or more mechanisms. According to some embodiments, the bodies may be configured to dispense cleaning fluid upon compression, as described herein. For example, as shown in FIG. 1A, body 11 may be configured to dispense at least a portion of the cleaning fluid contained therein in response to compression, such as squeezing. Additionally or alternatively, as shown in FIG. 1B, body 12 may be configured to dispense at least a portion of the cleaning fluid contained therein in response to longitudinal compression.

[0057] Additionally or alternatively, the body may be configured to dispense at least a portion of the cleaning fluid contained therein when oriented in a particular direction. For example, as shown in FIG. 2A, the body 21 may include an opening 23 through which the cleaning fluid may be dispensed. In this example, the body 21 may be configured to dispense at least a portion of the cleaning fluid by gravity when oriented in a particular direction (e.g., the opening 23 is at or near the bottom of the body relative to the ground).

[0058] In the example shown in FIG. 2A , the body 21 can include a positioning component 22 that allows the body to be positioned in a particular orientation. The positioning component 22 can be any component configured to position and / or secure the body in a selected orientation, such as a hook, strap, snap, button, string, or combination thereof. The positioning component 22 can be integral with the body and / or a separate component configured to interact with the body, such as a strap attachable to the body. The positioning component 22 can also be configured to interact with a second positioning component, such as an extension arm configured to interact with a hook included in the body and / or attached to the body.

[0059] 2B shows another example of a system according to the present disclosure. In this example, body 24 is configured to interact with a separate positioning element 22, which may include a snap 25 or the like, so that body 24 may be positioned and secured relative to a user's arm, such as the arm of a physician performing the irrigation. In this example, irrigation fluid may be dispensed by gravity as described herein and / or by a dispensing aid as described below.

[0060] According to some aspects, the body may be configured in communication with a dispensing aid configured to provide sufficient force to at least partially dispense the cleaning fluid contained in the body. For example, the dispensing aid may include a pump configured to move the cleaning fluid from the body. The pump may be a mechanical pump, an electric pump, a vacuum pump, or any combination thereof.

[0061] It should be understood that the body may be configured to dispense irrigation fluid via one or a combination of the mechanisms described herein. For example, the body may be configured to dispense irrigation fluid in conjunction with gravity when compressed. Additionally or alternatively, the body may be configured to dispense irrigation fluid in conjunction with force generated by a pump (including, but not limited to, vacuum force generated by a vacuum pump) when compressed and / or by gravity. According to some embodiments, the body may be configured to selectively dispense irrigation fluid via one or more of the mechanisms described herein. In one non-limiting example, the body may be configured to dispense irrigation fluid in conjunction with pump force when compressed, with or without pump force. This allows a user to select a desired delivery mechanism based on physical constraints (e.g., the user's athletic ability), desired fluid flow force, desired fluid flow rate, desired fluid flow pattern (e.g., pulsed or constant), or combinations thereof.

[0062] According to some embodiments, the body may be configured to dispense at least about 75%, optionally at least about 80%, optionally at least about 85%, optionally at least about 90%, optionally at least about 95%, and optionally about 100% of the cleaning fluid contained therein. The body may be configured to continuously dispense cleaning fluid and / or to intermittently dispense cleaning fluid. In one non-limiting example, the body may be configured to intermittently dispense cleaning fluid such that cleaning fluid is dispensed only upon compression of the body and / or activation of a dispensing aid, such as a pump.

[0063] The body may be configured to contain a volume of cleaning fluid sufficient to perform at least a portion of the cleaning process. According to some embodiments, the body may be configured to contain approximately 250-2000 mL of fluid, optionally approximately 500-1000 mL of fluid. According to some embodiments, the body may be configured to contain approximately 500 mL of fluid. According to some embodiments, the body may be configured to contain approximately 1 L of fluid.

[0064] A body according to the present disclosure may include a body interface configured to selectively place the body in fluid communication with an applicator member and / or a vent adapter, as described herein. As used herein, the term "body interface" refers to a portion of the body configured to provide a secure connection between the body and the application member and / or the body and the vent adapter to controllably dispense fluid (e.g., cleaning solution) from the body to the application member.

[0065] In one example, the body connector is configured to secure the body and the applicator member such that a first opening included in the body aligns with a second opening included in the applicator member sufficient to provide fluid communication between the body and the applicator member. In another example, the body connector is configured to secure the body and the vent adapter such that a first opening included in the body aligns with a second opening included in the vent adapter. The vent adapter may be further configured to interface with an applicator member having a third opening such that the first opening included in the body aligns with a third opening included in the applicator member sufficient to provide fluid communication between the body and the applicator member via the vent adapter. The body connector may include any connection type known in the art useful in accordance with the present disclosure.

[0066] 3 shows one example of a body connection portion 33 configured to connect a body 31 and an applicator member 32. In this example, the body connection portion 33 includes protrusions configured to interact with corresponding protrusions included on the applicator member (or alternatively, a vent adapter, not shown in FIG. 3 ) to form a threaded connection, thereby allowing the body 31 to be threaded onto the applicator member 32. It should be understood that in this example, threading the body 31 onto the applicator member 32 via the body connection portion 33 aligns the opening 34 of the body 31 with the opening 35 of the applicator member 32 to provide fluid communication between the body 31 and the applicator member 32 when they are connected.

[0067] According to some embodiments, the body may be provided with a removable lid, e.g., a cap, configured to interact with the body connection portion of the body in place of the application member and / or vent adapter. It should be appreciated that the lid may prevent fluid from being expelled from the body, for example, during storage or transport of the body.

[0068] According to some embodiments, the body connection may be provided with a fluid metering device, e.g., a valve, that is provided in communication with (e.g., at) the opening in the body and sufficient to affect the flow of fluid from the body.

[0069] The present disclosure also relates to a system including a body as described herein and one or more application members, each of which may be configured to apply a cleaning fluid to a surface sufficient for a cleaning process.

[0070] According to some embodiments, the main body includes a main body connector configured to interface with two or more different application members, thereby accommodating interchangeability of the application members. For illustrative purposes, taking the example shown in FIG. 3 , the system may include a main body 31 having a main body connector 33 as shown. The system may further include one or more application members, each having a main body connector 36 having substantially the same size and shape, such that each of the one or more application members can be interchangeably connected to the main body 31. This allows a user to select from two or more application members based on their cleaning process preferences and requirements without requiring multiple main body types. Thus, systems according to the present disclosure beneficially allow a user to select from a variety of different application members, each of which can provide a unique fluid flow rate, fluid flow pattern, and / or fluid flow force, as described in more detail herein.

[0071] 5 illustrates one exemplary applicator member 50 according to the present disclosure. As shown in FIG. 5, applicator member 50 may include a connecting portion 51 and a discharge portion 52. As described herein, connecting portion 51 may be configured to connect applicator member 50 to a main body. Discharge portion 52 may include one or more discharge openings 53 configured to dispense a fluid (e.g., an antiseptic solution as described herein) onto a surface, such as a surgical site, during a cleaning process.

[0072] In the example shown in FIG. 5 , the discharge portion 52 may include a semi-flexible conduit with adjustable conduit shape and / or direction. This allows the angle and / or direction of fluid discharge to be adjusted before and / or during the cleaning process. As used herein, the term “semi-flexible” refers to the ability to bend or compress in addition to maintaining shape when subjected to fluid flow and / or operational pressures, such as those from user handling. According to some embodiments, the degree of flexibility of a semi-flexible component may depend, at least in part, on the material of the applicator member, the shape of the discharge portion, the length of the discharge portion, or a combination thereof. It should be appreciated that the applicator member 50 shown in FIG. 5 advantageously provides control over the flow path of the dispensed fluid, allowing a user to direct the fluid (e.g., antiseptic solution) onto irregularly shaped and / or hard-to-reach surfaces, such as an irregularly shaped and / or hard-to-reach surgical site.

[0073] FIG. 6 illustrates another exemplary applicator member 60 according to the present disclosure. As shown in FIG. 6, applicator member 60 may include a connecting portion 61 and a discharge portion 62. Connecting portion 61 may be configured to connect applicator member 60 to a main body 600 as described herein. Discharge portion 62 may include one or more discharge openings 63 configured to dispense a fluid (e.g., antiseptic solution) onto a surface, such as a surgical site, during a cleaning process. It should be understood that discharge portion 62 may include a conduit 64, which may be a semi-flexible conduit, a flexible conduit, or a rigid conduit, as described in connection with FIG. 5.

[0074] As shown in FIG. 6, the application member 60 may further include a dispensing aid 65 as described herein, such as a pump. For example, as shown in FIG. 7A, the dispensing aid may be a mechanical pump. FIG. 7A shows a hand pump 71 that moves fluid when compressed by a user's hand 72. Additionally or alternatively, as shown in FIG. 7B, the dispensing aid may be an electric pump. FIG. 7B shows an electric pump 73 that moves fluid using electrical energy generated by, for example, a battery 74.

[0075] It should be appreciated that the application member 60 having the dispensing aid 65 described herein can dispense cleaning fluid (e.g., disinfectant solution) from the body 600 upon actuation of the dispensing aid 65 (e.g., actuation of a pump described herein). Additionally or alternatively, the dispensing aid 65 can function to dispense fluid from the body 600 in conjunction with gravity. For example, FIG. 6 illustrates an exemplary body 600 similar to that shown in FIG. 2A, i.e., a body configured to dispense at least a portion of the contained cleaning fluid by gravity when oriented in a particular direction. It should be appreciated that the dispensing aid advantageously allows a user to control the fluid flow force, fluid flow rate, and / or fluid flow pattern (e.g., pulsed or constant) of the dispensed cleaning fluid.

[0076] While the examples shown in Figures 5 and 6 depict a discharge portion having one discharge opening, it should be understood that the discharge portion may include two, three, four, or more discharge openings. Each of the discharge openings may have the same or a different size as one or more of the other discharge openings. Additionally or alternatively, each of the discharge openings may have the same or a different shape as one or more of the other discharge openings. The shape and / or size of one or more discharge openings may be selected to provide a particular fluid flow force, fluid flow rate, and / or fluid flow pattern. According to some embodiments, the shape and / or size of one or more discharge openings may be adjustable so that the fluid flow force, fluid flow rate, and / or flow pattern of the dispensed fluid can be adjusted.

[0077] According to some embodiments, one or more discharge openings may be provided in a nozzle portion of a discharge portion of an application member. For example, FIG. 8 illustrates a body 800 in fluid communication with an application member 80 having a connection portion 81 and a discharge portion 82, as described herein. As shown in FIG. 8, the discharge portion 82 may include a nozzle 83 having one or more discharge openings 84, as described herein. It should be understood that the nozzle 83 may be removable or replaceable, such that the same application member 80 may include at least two different interchangeable nozzles 83. Thus, a system according to the present disclosure may include at least one application member and two or more interchangeable nozzles, as described herein.

[0078] 8, the application member 80 may further include a dispensing aid including a pump shaft 85 and an actuator 86, such as a button. In this example, the nozzle 83 may be adapted to provide a fluid mist in conjunction with the pump shaft 85 when the actuator 86 is actuated by any mechanism known in the art. It should be understood that, additionally or alternatively, the nozzle 83 may be configured to provide a fluid stream, a fluid spray, or a combination thereof.

[0079] FIG. 9 illustrates another example of a system according to the present disclosure. As shown in FIG. 9 , an application member 90 may include a connection portion 91 and a discharge portion 92, as described herein. The discharge portion may include a nozzle 93 and an actuator 94, such as a trigger. In this example, the application member 90 may further include a conduit 95 in fluid communication with a fluid contained in the body 900, as described herein. In this example, the body 900 may be pressurized. Upon actuation of the actuator 94 (e.g., upon compression of the trigger), the pressure in the conduit 95 may fall below the pressure in the body 900, thereby forcing fluid from the body 900 into the application member 90. The nozzle 93 may be configured to provide, for example, a fluid stream, a fluid mist, a fluid spray, or a combination thereof.

[0080] FIG. 10 illustrates another example of a system according to the present disclosure. As shown in FIG. 10 , an application member 100 may include a connection portion 101 and a discharge portion 102, as described herein. The discharge portion may include a nozzle 103. In this example, the nozzle 103 may also function as an actuator, for example, by being pressed toward the main body 1000. The application member 100 may further include a conduit 104 in fluid communication with a fluid contained in the main body 1000. As described in connection with FIG. 9 , the main body 1000 may be pressurized. As described in connection with FIG. 9 , upon actuation of the nozzle 103, the pressure in the conduit 104 may fall below the pressure in the main body 1000, thereby forcing fluid from the main body 1000 into the application member 100.

[0081] Figure 11 shows another exemplary system according to the present disclosure, similar to the example shown in Figure 10, including an applicator member 110, a connection portion 111, an outlet portion 112 including a nozzle 113, and a conduit 114. Figure 11 shows that the nozzle 113 may further include an actuator 115, such as a button. As described in relation to Figures 9 and 10, the body 1100 may be pressurized such that upon actuation of the actuator 115 (i.e., by pressing the button), the pressure in the conduit 114 may fall below the pressure in the body 1100, thereby forcing fluid from the body 1100 into the applicator member 110.

[0082] FIG. 12 illustrates another example of a system according to the present disclosure. As shown in FIG. 12, the application member 120 may include a connection portion 121 and a discharge portion 122, as described herein. The discharge portion may include a first nozzle 123 and an actuator 124. As described in connection with FIGS. 9, 10, and 11, the main body 1200 may be pressurized. Additionally or alternatively, the system may include a cartridge (not shown) containing a propellant configured to provide an aerosol as known in the art. The propellant may be any propellant acceptable for medical use according to the present disclosure, including, but not limited to, carbon dioxide, nitrous oxide, nitrogen, helium, argon, air, and any combination thereof. As used herein, the term "air" refers to the Earth's natural atmosphere.

[0083] 12 also illustrates a plurality of interchangeable nozzles 125, as described herein. It should be appreciated that each of the plurality of interchangeable nozzles 125 is configured to be interchangeable with nozzle 123, as described herein, thereby providing a single application member 120 and body 1200 configured to dispense fluid onto a surface through the various nozzles to provide a variety of selectable fluid flow rates, fluid flow patterns, and / or fluid flow forces.

[0084] According to some embodiments, one or more components of the devices and / or systems described herein may include one or more restrictive features that prevent impermissible fluid passage. For example, at least one restrictive feature may be provided at a location along the flow path of the dispensed fluid, such as a location proximate or adjacent to the discharge portion of an application member described herein. In one non-limiting example, the restrictive feature may include a one-way valve having a first closed position that prevents fluid passage and a second open position that allows fluid passage. In this example, the one-way valve may be provided in the first position when subjected to pressure from one direction (i.e., gas pressure from the ambient environment, such as during a re-equilibration period described herein). The one-way valve may be readily moved to the second position when subjected to pressure from a different direction (i.e., gas pressure from within the body upon compression of the body and / or liquid pressure from cleaning fluid contained in the body). This allows the discharge portion to dispense cleaning fluid as described herein while preventing gas from the external environment from entering the body via the flow path of the dispensed fluid.

[0085] The present disclosure also relates to a venting component configured for use with the devices and / or systems described herein. The venting component according to the present disclosure includes a fluid passageway, at least a portion of which is separated from a fluid flow path through which a cleaning fluid is dispensed (also referred to herein as a dispensed fluid flow path). According to some aspects, the fluid passageway is configured to provide fluid communication between the body and an external environment.

[0086] In one example, a device or system according to the present disclosure may include a compressible body as described herein, configured to dispense at least a portion of the cleaning fluid contained within the body upon compression. In this example, complete distribution of the cleaning fluid contained within the compressible body may require one or more re-equilibration periods during which gas from the external environment is drawn into the body sufficient to re-equilibrate the internal pressure of the body prior to subsequent compression. According to some embodiments, a fluid passage included in the venting component may provide a path for gas from the external environment to rapidly enter the compressible body during one or more re-equilibration periods.

[0087] In another example, the body may be configured to dispense cleaning fluid when compressed and / or by gravity, along with a force generated by a pump, as described herein. In this example, the pump requires fluid (e.g., gas from the external environment) to enter the body between the pump and the body. In this example, a fluid passage included in the venting component can provide a path for gas from the external environment to quickly enter the body, sufficient for the pump to function.

[0088] According to some embodiments, the venting component may include at least one filter disposed relative to the fluid passageway sufficient to filter a gas, such as air, passing through the fluid passageway. As used herein, the act of filtering refers to the removal of contaminants, such as biological and / or chemical contaminants, from the gas. Preferably, the filter removes an acceptable level of contaminants so that the gas is sufficient for contact with a cleaning solution, as described herein. According to some embodiments, a gas may be sufficient for contact with a cleaning solution if it has adequate purity (e.g., oil-free) and has microbiological and particulate qualities after filtration that are equivalent to or better than the air in the environment into which the gas is introduced, as described, for example, in "Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing - Current Good Manufacturing Practice," published in September 2004 by the U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Office of Regulatory Affairs (ORA), the entire disclosure of which is expressly incorporated herein by reference.

[0089] Exemplary biological contaminants that may be removed by the at least one filter include, but are not limited to, bacteria, fungi, and viruses. Exemplary chemical contaminants that may be removed by the at least one filter include, but are not limited to, environmental pollutants, chemical irritants, particulate matter, environmental allergens, and / or debris.

[0090] Useful materials for the at least one filter include, but are not limited to, nylon, polyvinylidene fluoride (PVDF), polyethersulfone (PES), polycarbonate, polypropylene, polytetrafluoroethylene, cellulose, and combinations thereof.

[0091] Exemplary filters useful in accordance with the present disclosure include filters having an average pore size between about 0.01 μm and 20 μm, optionally between about 0.1 μm and 10 μm, optionally about 0.1 μm, optionally about 0.2 μm, optionally about 0.22 μm, and optionally about 10 μm. Additional exemplary filters useful in accordance with the present disclosure include filters having an average pore size of up to about 10 μm, optionally up to about 9 μm, optionally up to about 8 μm, optionally up to about 7 μm, optionally up to about 6 μm, optionally up to about 5 μm, optionally up to about 4 μm, optionally up to about 3 μm, optionally up to about 2 μm, optionally up to about 1.0 μm, optionally up to about 0.5 μm, optionally up to about 0.4 μm, optionally up to about 0.3 μm, optionally up to about 0.2 μm, and optionally up to about 0.1 μm.

[0092] According to some embodiments, the fluid passageway may include one or more restrictive features described herein, configured to prevent impermissible fluids, such as cleaning fluid, from passing through the fluid passageway. For example, the fluid passageway may include a one-way valve having a first closed position that prevents the passage of fluid and a second open position that allows the passage of fluid. In this example, the one-way valve may be positioned in the first position when subjected to pressure from one direction (e.g., air pressure from within the body upon compression of the body and / or hydraulic pressure from cleaning fluid contained in the body). The one-way valve may be easily moved to the second position when subjected to pressure from a different direction (i.e., air pressure from the ambient environment, such as during a re-equilibration period described herein).

[0093] Additionally or alternatively, the fluid passageway may include a selective membrane that allows only selected fluids to pass through. For example, the selective membrane may allow the passage of gases (e.g., air) while substantially preventing the passage of liquids (e.g., cleaning fluids). Exemplary membranes according to the present disclosure include, but are not limited to, hydrophobic membranes. Non-limiting examples of hydrophobic membranes include those comprising expanded PTFE (ePTFE), electrospun (i.e., nanospun) polymers (e.g., electrospun polyurethane), or combinations thereof. Additionally or alternatively, the membrane may include a material that has been surface-modified to be hydrophobic, such as a nanoporous alumina membrane. According to some embodiments, the selective membrane may include a membrane that has been treated with an electrical charge to provide selective porosity (e.g., to allow the passage of air and prevent the passage of liquids).

[0094] According to some embodiments, a vent component according to the present disclosure may be provided as part of a vent adapter. FIG. 13 illustrates an exemplary vent adapter according to the present disclosure. In particular, FIG. 13 illustrates a vent adapter 130 including a first connector 136 configured to connect with a body connector (not shown) of a body described herein. The vent adapter 130 may further include a second connector 131 configured to connect with an application member (not shown). In this non-limiting example, the second connector 131 may include an application member interface 132 configured to fit snugly over an application member sufficient to provide fluid communication as described herein, for example, via an opening 137 included in the application member interface 132.

[0095] 13 may be configured to provide fluid communication between the body and the application member, as described herein, and it should be understood that the vent adapter thus includes at least a portion of the flow path through which the cleaning fluid is dispensed.

[0096] The second connecting portion 131 may further include an applicator member fastening portion 133 having one or more features configured to interact with corresponding features on the applicator member to provide a secure connection between the vent adapter and the applicator member. For example, as shown in FIG. 13 , the applicator member fastening portion 133 may include a helical ridge 134 extending along at least a portion of the circumference of the applicator member mating portion 132, the helical ridge 134 configured to interact with corresponding features (e.g., protrusions and / or grooves) on the applicator member. This allows the applicator member to be threaded onto the second connecting portion 131 of the vent adapter 130. The applicator member fastening portion 133 may further include a locking gap 135 sufficient to securely and / or reversibly lock the applicator member to the second connecting portion 131 when the applicator member is fully threaded onto the second connecting portion 131, thereby preventing the applicator member from being inadvertently removed from the vent adapter 130. According to some embodiments, the second connection 131 may be configured to emit an audible signal, such as a click, indicating locking.

[0097] However, it should be understood that the first connection 136 and second connection 131 of the vent adapter 130 shown in FIG. 13 are not particularly limited, so long as the vent adapter 130 is configured to securely connect and / or lock to the main body and the applicator member, as described herein. According to some embodiments, the secure and / or locked connection may include an airtight seal between the vent adapter and the main body and / or between the vent adapter and the applicator member, thereby configuring the vent adapter to prevent unfiltered and / or unsterilized air from entering the main body and / or to prevent the unintended discharge of irrigation solution.

[0098] As shown in FIG. 13 , the vent adapter 130 can include a fluid passageway 138 as described herein. The fluid passageway 138 can include, for example, a conduit having a first end 139 in fluid communication with the external environment and a second end 1310 that can communicate with the interior of the body (not shown), as described herein. As shown in FIG. 13 , the first end 139 can be located near an opening 1311 in the vent adapter 130. In this example, the opening 1311 is provided with a filter 1312 as described herein. However, it should be understood that the configuration shown in FIG. 13 is not particularly limiting. For example, the filter 1312 can be located at a different position relative to the fluid passageway 138, as described herein, so long as the air traveling along the fluid passageway 138 passes through the filter sufficiently to remove contaminants from the gas. Additionally or alternatively, a second filter, a third filter, or more filters can be provided in addition to the filter 1312. It should be understood that a second, third, or more filters may be provided to prevent failure of one filter from resulting in unacceptable filtration of air passing through fluid passageway 138 or to provide filtration of different contaminants. For example, one filter may be selected to preferentially filter one or more biological contaminants and another filter may be selected to preferentially filter one or more chemical contaminants. Or, one filter may be selected to preferentially filter a particular type of biological contaminant and another filter may be selected to preferentially filter a different type of biological contaminant.

[0099] According to some embodiments, the fluid passages 138 and / or openings 1311 can be large enough to provide an acceptable velocity of fluid advancing along the fluid passages 138. For example, the fluid passages 138 and / or openings 1311 can have an average diameter and / or length such that gas entering the body from the external environment through the fluid passages 138 travels quickly, thereby providing a minimal re-equilibration period as described herein.

[0100] FIG. 14A illustrates another example of a vent adapter 140 according to an embodiment of the present disclosure. In this example, the vent adapter 140 includes a fluid passageway 141 having a first end 142 and a second end 143. The first end 142 may include a protrusion 146 configured for insertion into a wall of a body 144, as described herein and shown, for example, in FIG. 14B . It should be understood that the protrusion 146 should be sharp enough to penetrate the wall of the body 144 so that the fluid passageway 141 can provide fluid communication between the body 144 and the external environment, as described herein. Also, while FIG. 14B illustrates the vent adapter 140 disposed near a bottom wall 148 of the body 144, it should be understood that the vent adapter 140 may be inserted at any position relative to the body 144 as long as the functionality described herein is achieved. The vent adapter 140 may further include one or more filters, as described herein, for example, at or near the second end 143 of the fluid passageway 141.

[0101] 14A, fluid passage 141 may include a restrictive feature, such as one-way valve 147, as described herein, which may allow air to move from the external environment into body 144 while preventing the passage of cleaning fluid, as described herein.

[0102] According to some embodiments, the protrusion 146 of the vent adapter 140 has a thickness that is at least 1.5 times, optionally at least 2 times, optionally at least 2.5 times, optionally at least 3 times, optionally at least 3.5 times, optionally at least 4 times, optionally 4.5 times, and optionally at least 5 times the thickness of any wall of the body 144. The wall having a thinner thickness relative to the protrusion 146 can be a top wall, a bottom wall, or a side wall of the body 144. Preferably, the wall having a thinner thickness can be the bottom wall 148 of the body 144 that faces the ground. Preferably, the wall having a thinner thickness can be a wall opposite a wall of the body 144 configured to be in fluid communication with an applicator member, as described herein.

[0103] FIG. 15 shows another example of a vent adapter 150 having a body 151. In this example, the vent adapter 150 includes a fluid passageway 153 having a first end 154 and a second end 155, and at least one filter 156, e.g., located at or near the second end 155. The vent adapter 150 may further include a seal to prevent fluid communication between the body 151 and the external environment. The seal may include an actuation member 152, such as a pull tab or screw top, configured to break the seal, thereby providing fluid communication between the body 151 and the external environment, as described herein. The fluid passageway 153 may further include restrictive features (not shown) as described herein.

[0104] 13-15 show a vent element provided as part of a vent adapter, it should be understood that a vent element according to the present disclosure may be provided as part of any portion of the devices and systems described herein. For example, FIG. 16A shows a device according to the present disclosure including a body 160 and an applicator member 161 described herein. In this example, a vent element 162 may be integrated with the body 160 at any suitable location thereon, such as any of the representative locations shown in FIG. 16A.

[0105] Additionally or alternatively, as shown in Figure 16B, applicator member 161 may include an integral venting element 162 at any suitable location thereon, such as the representative location shown in Figure 16B. As described herein, at least a portion of venting element 162 is separate from the fluid flow path through which cleaning fluid travels and is dispensed, and may include one or more discharge openings 163 as described herein.

[0106] FIG. 17 illustrates another example of a vent adapter 170 according to an embodiment of the present disclosure. In this example, the vent adapter 170 includes a fluid passageway 171 having a first end 172 and a second end 173. The first end 172 may include a protrusion 176 configured to penetrate the wall of the body 174. It should be understood that the protrusion 176 should be sharp enough to penetrate the wall of the body 174 so that the fluid passageway 171 can provide fluid communication between the body 174 and the external environment, as described herein. FIG. 17 also illustrates the vent adapter 170 disposed near a bottom wall 178 of the body 174. The vent adapter 170 may further include a film 179 that encapsulates the vent adapter 170 within itself, i.e., between the bottom wall 178 of the body 174 and the external environment. Film 179 functions as an actuation member configured to be biased against a rigid (preferably sterile) surface 180 with sufficient pressure to allow vent adapter 170 to penetrate bottom wall 178 of body 174, thereby providing fluid communication between body 174 and the external environment via vent adapter 170. As shown in FIG. 17 , vent adapter 170 is initially enclosed within film 179 and will not penetrate bottom wall 178 of body 174 until actuated as desired by biasing film 179 against rigid (preferably sterile) surface 180 with sufficient pressure to allow vent adapter 170 to penetrate bottom wall 178. Preferably, film 179 is made of a breathable material known in the art, i.e., film 179 is made of a material that allows air to move through film 179. In another embodiment, film 179 may be air impermeable, and after vent adapter 170 penetrates bottom wall 178, film 179 may be removed to allow air to reach vent adapter 170. In yet another embodiment, body 174 includes a separate one-way valve (preferably including a filter as described herein) that regulates the flow of air into body 174.

[0107] Vent adapter 170 may be inserted at any position relative to body 174 so long as the functionality described herein is achieved. Vent adapter 170 may further include one or more filters as described herein, for example, at or near second end 173 of fluid passageway 171. In the example shown in FIG. 17 , fluid passageway 171 may include a restrictive feature, such as one-way valve 177 as described herein, which allows fluid passageway 171 to prevent the passage of cleaning fluid while allowing air (preferably filtered air as described herein) to move from the external environment into body 174 as described herein.

[0108] According to some embodiments, the protrusion 176 of the vent adapter 170 has a thickness that is at least 1.5 times, optionally at least 2 times, optionally at least 2.5 times, optionally at least 3 times, optionally at least 3.5 times, optionally at least 4 times, optionally 4.5 times, and optionally at least 5 times the thickness of any wall of the body 174. The wall having a thinner thickness relative to the protrusion 176 can be a top wall, a bottom wall, or a side wall of the body 174. Preferably, the wall having a thinner thickness can be the bottom wall 178 of the body 174 that faces the ground. Preferably, the wall having a thinner thickness can be a wall opposite the wall of the body 174 that is configured to be in fluid communication with an applicator member, as described herein.

[0109] Although not shown, one or more of the nozzles described herein may include a venting component as an integral part thereof.

[0110] It should be understood that the systems described herein may include at least a body configured to be in fluid communication with one or more different application members, as described herein, each having at least one discharge opening, with at least one discharge opening optionally included in a removable and replaceable nozzle. Accordingly, it should be understood that the systems described herein may be configured to deliver cleaning fluid to a surface with one or more selectable different fluid flow rates, fluid flow patterns, and / or fluid flow forces, as described herein. The systems of the present disclosure may further include at least one venting component, as described herein, provided as an integral part of the system's body, application member, and / or nozzle, or as part of a vent adapter, as described herein.

[0111] For example, a system can include at least two different application members and / or at least two different nozzles, as described herein, where each of the at least two different application members and / or each of the at least two different nozzles is configured to provide a unique fluid flow rate, fluid flow pattern, and / or fluid flow force. According to some embodiments, a single application member and / or a single nozzle may be configured to provide at least two unique fluid flow rates, fluid flow patterns, and / or fluid flow forces, as described herein, for example, by providing one or more discharge openings with adjustable shapes and / or sizes.

[0112] According to some embodiments, the system may be configured to provide an acceptable fluid flow rate for the cleaning process. As used herein, the term "fluid flow rate" refers to the rate at which a fluid is applied to a surface, such as a human subject, during the cleaning process. The fluid flow rate may depend, at least in part, on the delivery mechanism (e.g., body compression, body orientation, use of a dispensing aid, or a combination thereof, as described herein) and / or the characteristics of the application member and / or nozzle, as described herein. According to some embodiments, the fluid flow rate may be related to the fluid flow force. For example, an increase in fluid flow rate can correspond to an increase in fluid flow force, and vice versa. Systems according to the present disclosure may be configured to provide at least two, optionally at least three, optionally at least four, and optionally at least five different selectable fluid flow rates.

[0113] According to some embodiments, the system may be configured to provide an acceptable fluid flow force for the cleaning process. As used herein, the term "fluid flow force" refers to the force that a fluid exerts on a surface, such as a human subject, during the cleaning process. The acceptable fluid flow force may be determined based on the requirements of the cleaning process. Exemplary fluid flow forces useful in accordance with the present disclosure include, but are not limited to, about 10-50 g, optionally about 15-45 g. According to some embodiments, the fluid flow force may be about 15 g. According to some embodiments, the fluid flow force may be about 30-45 g. Other exemplary fluid flow forces useful in accordance with the present disclosure include, but are not limited to, about 1-15 psi (referred to herein as "low pressure") and about 35-70 psi (referred to herein as "high pressure").

[0114] It should be understood that the fluid flow forces provided by the systems described herein may depend, at least in part, on the characteristics of the delivery mechanism and / or the application member and / or nozzle, as described herein. Systems according to the present disclosure may be configured to provide at least two, optionally at least three, optionally at least four, and optionally at least five different selectable fluid flow forces. It should be understood that each selectable fluid flow force may correspond, for example, to a particular delivery mechanism, a particular application member, a particular nozzle, or a combination thereof, as described herein. For example, one or more selectable flow forces may correspond to an application member having an actuator, such as a trigger, as described herein, and each of the one or more selectable flow forces may correspond to a degree of trigger compression. In another example, one or more selectable flow forces may correspond to a nozzle having one or more discharge openings, and each of the one or more selectable flow forces may correspond to the shape and / or size of the one or more discharge openings.

[0115] According to some embodiments, the system is configured to provide an acceptable fluid flow pattern for the cleaning process. As used herein, the term "fluid flow pattern" refers to the pattern in which a fluid is dispensed from a device and / or applied to a surface, such as a human subject, during a cleaning process. In some non-limiting examples, the fluid flow pattern may include a fluid mist (i.e., fine fluid particles suspended in a gas), a fluid stream (i.e., a steady, continuous stream of fluid), a fluid spray (i.e., fine fluid particles), or a combination thereof. The fluid flow pattern may be constant (e.g., in the case of fluid dispensed from a device and / or applied to a surface in a continuous manner) or pulsed (e.g., in the case of fluid dispensed from a device and / or applied to a surface in an intermittent manner).

[0116] Additionally or alternatively, a fluid flow pattern may refer to the angle at which a fluid flow path is dispensed from a device and / or applied to a surface. For example, a fluid flow path, as described herein, can have a fluid flow pattern that is generally perpendicular to the longitudinal axis of the body.

[0117] Additionally or alternatively, the fluid flow pattern may refer to the geometry of the fluid flow path, which should be understood to refer to the shape defined by a cross-section of the fluid flow path in any of the x-, y-, and z-directions.

[0118] It should be understood that the fluid flow pattern may depend, at least in part, on the delivery mechanism and / or application member and / or nozzle, as described herein. Systems according to the present disclosure may be configured to provide at least two, optionally at least three, optionally at least four, and optionally at least five different selectable fluid flow patterns. For example, one or more selectable flow patterns may correspond to a dispensing aid, such as a pump, which may be configured to provide a constant fluid flow from the body and / or a pulsed fluid flow from the body. In another example, the one or more selectable flow patterns may correspond to an application member outlet, such as an outlet including a semi-flexible conduit, as described herein. In this example, the one or more selectable flow patterns may include one or more fluid delivery angles corresponding to the shape and / or orientation of the semi-flexible conduit, as described herein.

[0119] Additionally or alternatively, the systems described herein may be configured to provide a rapid re-equilibration period. Additionally or alternatively, the systems described herein may ensure that only filtered and / or sterilized gas contacts the cleaning fluid contained within the body.

[0120] According to some embodiments, one or more components of the systems described herein may be provided in sterile packaging. As used herein, the term "sterile packaging" refers to packaging that provides a sterile environment to maintain the sterility of the contained sterile product. Exemplary sterile packaging includes, but is not limited to, sterile blister packaging, sterile safe-edge trays, sterile surgical trays, customized sterile thermoform packaging, and combinations thereof. It should be understood that one or more components of the system may be provided in the same sterile packaging as at least one other component of the system and / or in separate sterile packaging. For example, a first component of the system may be contained in a first sterile packaging, and a second component of the system may be contained in a second sterile packaging. In one non-limiting example, the system may include a body contained in a first sterile packaging and an applicator member contained in a second sterile packaging. It should be understood that providing one or more components of the system in different sterile packaging allows each component of the system to be removed immediately prior to use, thereby preventing prolonged exposure of one or more components to an unsterile environment. This allows the system to be presented fully assembled and sterile.

[0121] The present disclosure also relates to a venting component usable in the devices and systems described herein. The venting component includes a fluid passage configured to provide fluid communication between the body and an external environment, and further includes at least one filter disposed relative to the fluid passage sufficient to filter gas passing through the fluid passage. According to some embodiments, at least a portion of the fluid passage is separated from a fluid flow path through which cleaning fluid is distributed by the device or system.

[0122] The present disclosure also relates to methods of using the devices and systems described herein. For example, the method may include providing a body containing a cleaning fluid, the body including a body connection. The method may include placing the body in fluid communication with an application member and dispensing a cleaning fluid described herein sufficient to perform a cleaning process.

[0123] While the embodiments described herein have been described in conjunction with the exemplary embodiments outlined above, various alternatives, variations, modifications, improvements, and / or substantial equivalents, whether known or presently unforeseen, will become apparent to those skilled in the art. Accordingly, the exemplary embodiments as set forth above are intended to be illustrative rather than limiting. Various modifications can be made without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to embrace all known or later-developed alternatives, variations, modifications, improvements, and / or substantial equivalents.

[0124] Accordingly, the claims are not intended to be limited to the embodiments set forth herein, but are to be accorded full scope consistent with the language of the claims, and reference to an element in the singular is intended to mean "one or more," and not "one and only one," unless expressly stated otherwise. All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed as a means-plus-function unless the element is expressly recited using the phrase "means for."

[0125] The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects. Unless otherwise specified, the term "some" refers to one or more. Combinations such as "at least one of A, B, or C," "at least one of A, B, and C," "A, B, C, or any combination thereof" can include any combination of A, B, and / or C, and can include multiples of A, multiples of B, and multiples of C. Specifically, combinations such as "at least one of A, B, or C," "at least one of A, B, and C," "A, B, C, or any combination thereof" can be A only, B only, C only, A and B, A and C, B and C, or A, B, and C, and any of these combinations can include one or more of A, B, or C. Nothing disclosed herein is intended to be made available to the public, whether or not such disclosure is expressly recited in the claims.

[0126] The word "about" is used herein to mean within ±5%, optionally within ±4%, optionally within ±3%, optionally within ±2%, optionally within ±1%, optionally within ±0.5%, optionally within ±0.1%, optionally within ±0.01% of the stated value.

Claims

1. 1. A system for applying a cleaning fluid to a surface, comprising: a compressible body configured to contain a cleaning fluid and configured to dispense at least a portion of the cleaning fluid upon compression; an applicator member in fluid communication with the body, the applicator member configured to distribute the cleaning fluid along a flow path; a fluid passageway configured to provide fluid communication between the body and an external environment; and a venting element provided for the fluid passage, the venting element including at least one filter sufficient to filter gas passing through the fluid passage; the vent piece is provided as part of a vent adapter; the ventilation adapter includes a first connection portion configured to connect to a main body connection portion of the main body and a second connection portion configured to connect to the application member; the vent adapter includes at least a portion of the flow path through which the cleaning fluid is distributed; At least a portion of the fluid passage is separated from the flow path; The system wherein the filter is configured to remove contaminants from the gas.

2. the applicator member includes a restrictive feature at a position along the flow path; The system of claim 1 , wherein the restrictive feature is configured to prevent gas from the external environment from entering the body via the flow passage.

3. The restrictive feature includes a one-way valve, the one-way valve comprising: a first closed position; a second open position; the one-way valve is configured to be in a first position when subjected to pressure from a first direction; the one-way valve is configured to move to a second position when pressure is applied from a second direction; The system of claim 2 , wherein the second direction is different from the first direction.

4. The system of claim 1 , wherein the fluid passage includes at least one restrictive feature that prevents the cleaning fluid from passing through the fluid passage.

5. The system of claim 4 , wherein the at least one restrictive feature includes a one-way valve.

6. The one-way valve is a first closed position; a second open position; the one-way valve is configured to be in a first position when subjected to pressure from a first direction; the one-way valve is configured to move to a second position when pressure is applied from a second direction; The system of claim 5 , wherein the second direction is different from the first direction.

7. The system of claim 4 , wherein the at least one limiting feature comprises a selective membrane.

8. A system for applying a cleaning solution to a surface, comprising: a compressible body configured to contain a cleaning fluid and configured to dispense at least a portion of the cleaning fluid upon compression; an applicator member in fluid communication with the body, the applicator member configured to distribute the cleaning fluid along a flow path; a fluid passageway configured to provide fluid communication between the body and an external environment; and a venting element provided for the fluid passage, the venting element including at least one filter sufficient to filter gas passing through the fluid passage; the vent piece is provided as part of a vent adapter; At least a portion of the fluid passage is separated from the flow path; the filter is configured to remove contaminants from the gas; The system wherein the vent adapter includes a protrusion configured to penetrate a wall of the body such that the fluid passage provides fluid communication between the body and the external environment.

9. A system for applying a cleaning solution to a surface, comprising: a compressible body configured to contain a cleaning fluid and configured to dispense at least a portion of the cleaning fluid upon compression; an applicator member in fluid communication with the body, the applicator member configured to distribute the cleaning fluid along a flow path; a fluid passageway configured to provide fluid communication between the body and an external environment; and a venting element provided for the fluid passage, the venting element including at least one filter sufficient to filter gas passing through the fluid passage; the vent piece is provided as part of a vent adapter; At least a portion of the fluid passage is separated from the flow path; the filter is configured to remove contaminants from the gas; The vent adapter is configured to provide fluid communication between the body and the external environment upon activation of an actuation member including a pull tab or a screw top.

10. The system of claim 1 , wherein the filter has an average pore size of up to 0.2 μm.

11. 10. The system of claim 1, wherein the filter has an average pore size of about 0.2 μm.

12. The system of claim 1 , wherein the filter has an average pore size of up to 10 μm.

13. a first connecting portion connectable to a body of the device and having one or more protrusions having a sharpness configured to penetrate a wall of the body; a second connection portion having an application member joining portion and an application member fixing portion; a fluid flow path; a fluid passageway separated from the fluid flow path; at least one filter disposed relative to the fluid passage for filtering gas passing through the fluid passage.

14. a fluid passageway having a first end and a second end; a filter adjacent the second end for filtering gas passing through the fluid passage; The first end includes a sharpened protrusion configured to penetrate a wall of a body of the device.

15. 15. The vent adapter of claim 14, wherein the fluid passage further includes a one-way valve.

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