Washing liquid delivery device and system

Abstract

A system for applying cleaning liquid to a surface includes a body configured to contain cleaning liquid and an applicator member in fluid communication with the body, the applicator member having at least one nozzle, the system configured to dispense the cleaning liquid with a first fluid flow force and a first fluid flow pattern, the nozzle configured to selectively dispense the cleaning liquid with a second fluid flow force and / or a second fluid flow pattern, the second fluid flow force being different from the first fluid flow force and the second fluid flow pattern being different from the first fluid flow pattern.

Description

[[Technical Field]]

[0001] Cross-Reference to Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 068821, entitled "LAVAGE FLUID DELIVERY DEVICE AND SYSTEMS," filed on August 21, 2020, which is assigned to the assignee of the present application, and the entire contents of which are incorporated herein by reference.

[0002] The present disclosure relates to an apparatus and system for applying a lavage fluid to a surface. [[Background Art]]

[0003] Currently, lavage (i.e., washing a body cavity, surgical cavity or wound with a medically acceptable fluid) is widely used to prevent contamination of surgical wounds caused by various factors such as unexpected entry into or perforation of internal organs, complicated manipulation from gross leakage, deviation from aseptic techniques, and / or existing ongoing clinical infections. Accordingly, lavage procedures are commonly used to disinfect and clean wounds during surgery.

[0004] Currently, current lavage techniques utilize a variety of different approaches depending on the situation (e.g., the size and shape of the body cavity or wound) and the physician performing the lavage procedure (e.g., the physician's technical preferences). No particular lavage technique is currently standard in the art, and thus medical facilities often require many different lavage devices and systems to accommodate various potential approaches. Careless or improper use of such devices and systems (e.g., where the appearance of the device and / or system is similar to intravenous devices and / or systems) can have catastrophic consequences, so the presentation of such devices and systems may also be a concern in some cases.

[0005] Furthermore, current cleaning methods have several drawbacks, including insufficient disinfectant properties (for example, the 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. In addition, the dosage of disinfectant prepared on-site by the physician performing the cleaning may be inappropriate or contaminated.

[0006] Therefore, in this field of technology, there is a need for versatile devices and systems for performing cleaning processes, in particular, devices and systems that enable physicians to safely and effectively reduce contamination of surgical wounds, which are prone to surgical site infections. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] This disclosure relates to an apparatus and system for delivering cleaning solutions, such as disinfectants, to a surface. [Means for solving the problem]

[0008] The apparatus includes a body configured to contain a cleaning solution such as a disinfectant. The body is further configured to be in fluid communication with at least one coating member, the at least one coating member configured to apply the cleaning solution to a surface sufficient for the cleaning process. The apparatus and system are applicable to allow the user to select from two or more different fluid flow rates, fluid flow patterns, and / or fluid flow forces, thereby providing selectable control over the delivery of the cleaning solution to the surface. This disclosure also relates to the method of using the apparatus and system described herein. [Brief explanation of the drawing]

[0009] [Figure 1A] An example of a compressible body relating to the aspects of this disclosure is shown. [Figure 1B] An example of a foldable body relating to an aspect of this disclosure is shown. [Figure 2A]An example of the main body relating to the aspects of this disclosure is shown. [Figure 2B] An example of the main body relating to the aspects of this disclosure is shown. [Figure 3] An example of the connection portion of the main body according to the aspect of this disclosure is shown. [Figure 4] An example of a main body with an external casing according to an aspect of this disclosure is shown. [Figure 5] An exemplary coating member relating to an aspect of this disclosure is shown. [Figure 6] An exemplary system relating to the aspects of this disclosure is shown. [Figure 7A] An exemplary distribution auxiliary unit relating to an aspect of this disclosure is shown. [Figure 7B] An exemplary distribution auxiliary unit relating to an aspect of this disclosure is shown. [Figure 8] An exemplary system relating to the aspects of this disclosure is shown. [Figure 9] An exemplary system relating to the aspects of this disclosure is shown. [Figure 10] An exemplary system relating to the aspects of this disclosure is shown. [Figure 11] An exemplary system relating to the aspects of this disclosure is shown. [Figure 12] An exemplary system comprising multiple nozzles according to an aspect of this disclosure is shown. [Modes for carrying out the invention]

[0010] This disclosure relates to an apparatus and system for delivering a cleaning solution, such as a disinfectant, to a surface. The apparatus includes a body configured to contain the cleaning solution, such as a disinfectant. The body is further configured to be in fluid communication with at least one coating member, the at least one coating member configured to apply the cleaning solution to a surface sufficient for the cleaning process. The apparatus and system can be applied to allow the user to select from two or more different fluid flow rates, fluid flow patterns, and / or fluid flow forces, thereby providing selectable control over the delivery of the cleaning solution. This disclosure also relates to methods of using the apparatus and system described herein.

[0011] As used herein, the term "cleaning solution" refers to a fluid suitable for the cleaning process described herein. As used herein, "irrigation" refers to irrigation of a body cavity, a surgical cavity, and / or a wound.

[0012] According to some embodiments, the cleaning solution may comprise a disinfecting solution. As used herein, "disinfecting solution" refers to a solution comprising at least a solvent and one or more disinfectants. According to some embodiments, the disinfecting solution is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which water accounts for at least half or more of the solvent. It is to be understood that in some examples, the solvent may consist of water. According to some embodiments, the disinfecting solution is an alcohol solution. As used herein, the term "alcohol solution" refers to a solution in which alcohol accounts for at least half or more of the solvent. It is to 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.

[0013] In one non-limiting example, the disinfectant may comprise 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 biguanide). According to some embodiments, the disinfectant may comprise a bis-(dihydropyridinyl)-decane derivative (i.e., a compound derived from bis-(dihydropyridinyl)-decane). According to some embodiments, the disinfectant may comprise octenidine salts and / or chlorhexidine salts. According to some embodiments, the disinfectant may comprise alexidine, octenidine dihydrochloride, chlorhexidine gluconate, or combinations thereof.

[0014] Additionally or alternatively, the disinfectant may comprise iodine. According to some embodiments, iodine may be provided as an iodine complex such as povidone-iodine (PVPI), nonylphenoxy-(ethyleneoxy)-iodine, polyethyleneoxypolypropyleneoxy-iodine, undecoynium chloride-iodine, iodine povacrylex, and combinations thereof.

[0015] Additionally or alternatively, the disinfectant may comprise 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.

[0016] The disinfectant may have sufficient antimicrobial activity to provide an acceptable log reduction of microorganisms over a specified period of time. It is to be understood that as used herein, the term "microorganism" 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.

[0017] Exemplary bacteria include Streptococcus mutans, Streptococcus pyogenes (Group A β-hemolytic streptococcus), 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-sensitive Staphylococcus aureus (MSSA / OSSA), Enterococcus species (e.g., Enterococcus faecalis, Enterococcus faecium, and Enterococcus hyalae), vancomycin-resistant enterococci (VRE) and vancomycin-sensitive enterococci (VSE). Examples include, but are not limited to, Bacteroides fragilis, Propionibacterium acnes, Clostridium difficile (spores and vegetative cells), Selenomonas, Pseudomonas aeruginosa, Escherichia coli, Bacillus cepacia, Proteus mirabilis, Gardnerella vaginalis, Klebsiella aerogenes, Klebsiella pneumoniae, multidrug-resistant Klebsiella pneumoniae (MDR), Acinetobacter baumannii, Acinetobacter baumannii MDR, Achromobacter xylosoxidance, Micrococcus luteus, Ralstonia picketti, Haemophilus influenzae, and Serratia.

[0018] Examples of fungi include, but are not limited to, Aspergillus niger, Candida albicans, Candida auris, C. dubriniensis, C. glabrata (formerly Tollopsis glabrata), C. guilliermondi, C. kefir (formerly Candida pseudotropicalis), C. crusey, C. lucitanie, C. tropicalis, Epidermophyton floccosum, Microsporum gypsum, Microsporum canis, and Trichophyton folliculoides.

[0019] Examples of viruses include, but are not limited to, viruses that have lipid components in their outer layer or an outer envelope, such as cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2), influenza virus, parainfluenza virus, smallpox virus, vaccinia virus, norovirus, and novel coronavirus.

[0020] In some embodiments, the specific period may be a period of approximately 5 minutes or less, arbitrarily approximately 4 minutes or less, arbitrarily approximately 3 minutes or less, arbitrarily approximately 2 minutes or less, or arbitrarily approximately 1 minute or less.

[0021] In some embodiments, the specific period may be approximately 120 seconds or less, arbitrarily approximately 105 seconds or less, arbitrarily approximately 90 seconds or less, arbitrarily approximately 75 seconds or less, arbitrarily approximately 60 seconds or less, arbitrarily approximately 45 seconds or less, arbitrarily approximately 30 seconds or less, or arbitrarily approximately 15 seconds or less.

[0022] It should be understood that "acceptable logarithmic reduction" may be microorganism-dependent. For example, as described herein, acceptable logarithmic reduction may refer to the acceptable logarithmic reduction of one type of microorganism present on the surface (e.g., present in a body cavity or wound site), a combination of two types of microorganisms present on the surface, or the total number of microorganisms present on the surface.

[0023] According to some embodiments, the acceptable logarithmic decrease is at least about 1.0, arbitrarily at least 1.1, arbitrarily at least 1.2, arbitrarily at least 1.3, arbitrarily at least 1.4, arbitrarily at least 1.5, arbitrarily at least 1.6, arbitrarily at least 1.7, arbitrarily at least 1.8, arbitrarily at least 1.9, arbitrarily at least 2.0, arbitrarily at least 2.1, arbitrarily at least 2.2, arbitrarily at least 2.3, arbitrarily at least 2.4, arbitrarily at least 2.5, arbitrarily at least 2.6, arbitrarily at least 2.7, arbitrarily at least 2.8, arbitrarily at least 2.9, It may be at least approximately 3.0, at least approximately 3.1, at least approximately 3.2, at least approximately 3.3, at least approximately 3.4, at least approximately 3.5, at least approximately 3.6, at least approximately 3.7, at least approximately 3.8, at least approximately 3.9, at least approximately 4.0, at least approximately 4.1, at least approximately 4.2, at least approximately 4.3, at least approximately 4.4, at least approximately 4.5, at least approximately 4.6, at least approximately 4.7, at least approximately 4.8, at least approximately 4.9, or at least approximately 5.0.

[0024] According to some embodiments, the disinfectant may be present in the disinfectant solution at a concentration sufficient to provide an acceptable logarithmic reduction of microorganisms over a specific period, as described herein. According to some embodiments, the disinfectant may be present in the disinfectant solution at concentrations 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, and optionally about 0.5% w / v.

[0025] According to some embodiments, the disinfectant may be present in the disinfectant solution at concentrations of approximately 0.1-0.9% w / v, optionally approximately 0.2-0.8% w / v, optionally approximately 0.3-0.7% w / v, and optionally approximately 0.4-0.6% w / v.

[0026] According to some embodiments, the disinfectant may be present in the disinfectant solution at concentrations of approximately 0.1-1% w / v, optionally approximately 0.2-1% w / v, optionally approximately 0.3-1% w / v, and optionally approximately 0.4-1% w / v.

[0027] It should be understood that, in some embodiments, the cleaning solution may not necessarily be a disinfectant solution 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 solution may include a saline solution. The saline solution may contain water and sodium chloride at medically acceptable concentrations such as about 0.1–1% w / v, optionally about 0.45% w / v, or optionally about 0.9% w / v.

[0028] In some embodiments, cleaning solutions, such as disinfectants, described herein may include visualization aids. As used herein, “visualization aid” refers to a component in the cleaning solution configured to assist in the visualization of the application of the cleaning solution. Examples of visualization aids include, but are not limited to, colorants, dyes, and radiopaque agents. It should be understood that the visualization aid may be the same as, or different from, one of the other components of the cleaning solution. For example, a disinfectant may function as a visualization aid. Additionally or alternatively, the cleaning solution may include a visualization aid other than a disinfectant.

[0029] In some embodiments, the cleaning solution may contain a colorant. As used herein, “colorant” means a component sufficient to provide the fluid with an observable color. The colorant may be sufficient to allow the cleaning solution to be visible when applied to a surface. In some non-limiting examples, the colorant may include anionic colorants, such as anionic dyes. The anionic dye may be any dye suitable for medical use, such as dyes approved by the Food and Drug Administration for use in food, pharmaceuticals, and / or cosmetics (i.e., “D&C” or “FD&C” dyes). Examples of anionic dyes include, but are not limited to, FD&C Blue No. 1 (Brilliant Blue FCF), FD&C Blue No. 2 (Indigo Carmine), FD&C Green No. 3 (Fast Green FCF), FD&C Red No. 3 (Erythrosine), FD&C Red No. 40 (Allura Red), FD&C Yellow No. 5 (Tartrazine), FD&C Yellow No. 6 (Sunset Yellow FCF), D&C Yellow No. 8 (Fluorescein), D&C Orange No. 4, and combinations thereof. They may be combined to achieve a specific color. For example, an orange hue may include both FD&C Red No. 40 and D&C Yellow No. 8. Additionally or alternatively, the colorants may include compounds that become observable when irradiated with visible and / or non-visible light, including, but are not limited to, vitamin B-12, medicinal honey, fluorescent polymer nanoparticles, water-soluble luminescent carbon nanodots, quinine, and combinations thereof.

[0030] In some embodiments, the cleaning solutions, such as disinfectants, described herein may contain dyes. As used herein, the term "dye" refers to components sufficient to temporarily or permanently color the surface being contacted.

[0031] In some embodiments, cleaning solutions such as disinfectants described herein may contain radiopaque agents. As used herein, “radiopaque agent” refers to a component that is impermeable to the radio wave and X-ray portions of the electromagnetic spectrum sufficient for visualization. In some non-limiting examples, radiopaque agents may include barium, iodine, iron oxide nanoparticles, gadolinium composite nanospheres, silica nanospheres, and combinations thereof.

[0032] According to some embodiments, the cleaning solution, such as the disinfectant described herein, may be basic, neutral, or acidic. According to some embodiments, the pH of the cleaning solution may be about 1 to 8, optionally about 1 to 7, optionally about 1 to 6, or optionally about 2 to 5.5.

[0033] In some embodiments, cleaning solutions such as disinfectants described herein may include a buffer system. As used herein, the term "buffer system" refers to a component present in the composition or solution that provides resistance to significant pH changes caused by strong acids or bases. The buffer system may include one or more agents, such as a weak acid and its conjugate base. By interacting with strong acids or bases in the composition or solution, the buffer system provides resistance to significant pH changes, thereby at least partially preventing significant changes in the pH of the composition or solution.

[0034] 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 the addition of equimolar amounts of strong acid or strong base.

[0035] The buffering range of a buffer system is determined by the acid dissociation constant (K) of one or more weak acids contained in the buffer system. a This relates to the term "acid dissociation constant." The term "acid dissociation constant" refers to the equilibrium constant of an acid dissociation reaction. The midpoint of the buffer range of a buffer system is generally approximately the logarithmic value of the acid dissociation constant of the weak acid contained in the buffer system (i.e., pK). a -log 10 Ka (Equivalent to).

[0036] In some embodiments, cleaning solutions such as disinfectants described herein may contain stabilizers. As used herein, the term “stabilizer” means a component that supports the stability of a cleaning solution unless expressly stated herein.

[0037] The apparatus relating to this disclosure includes a body configured to contain the cleaning solution described herein. In some embodiments, the body may be compressible. As used herein, “compressible” means the ability to reversibly reduce in volume without any unacceptable changes, such as unacceptable permanent changes to size, shape, and / or one or more properties described herein. In some embodiments, the body may, when compressed, be configured to dispense at least a portion of the disinfectant contained therein. As used herein, “dispense” (or “dispense”) may mean transferring the cleaning solution to a coating member that is in fluid communication with the body, and / or transferring the cleaning solution from the coating member to a surface.

[0038] In some embodiments, the body may be foldable. As used herein, “foldable” means the ability to permanently reduce its volume. For example, a foldable body described herein may have a first volume when a first volume of fluid is contained within it. When at least a portion of the fluid is distributed, 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 the volume of waste (e.g., the volume of the body after the fluid within it has been distributed). A foldable body can also enable efficient fluid discharge.

[0039] In some embodiments, the body may be configured to allow for a volume reduction of at least 10%, optionally at least 20%, optionally at least 30%, optionally at least 40%, optionally at least 50%, optionally at least 60%, optionally at least 70%, optionally at least 80%, optionally at least 90%, and optionally at least 99% when compressed and / or folded.

[0040] In some embodiments, the body may include a body material 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.

[0041] In some embodiments, the body material may be sufficient to prevent unacceptable loss of vapors or disinfectants from the cleaning solution contained in the body over a specific storage period. “Unacceptable loss of vapors or disinfectants” may mean a loss that renders the cleaning solution unsuitable for its intended use. Loss of vapors or disinfectants may result, for example, from adsorption or absorption of disinfectants by the material (e.g., the body material), evaporation of the solution, evaporation of components of the solution (e.g., disinfectants in the disinfectant solution), or a combination thereof. In one non-limiting example, the cleaning solution contains water and iodine as described herein, and the body material may be sufficient to prevent loss of water vapor and / or iodine over a specific storage period.

[0042] As used throughout this application, the term “storage period” refers to the length of time a product (e.g., disinfectant) can be stored within the specifications required for its form, suitability, and function. Storage period may be determined by measuring certain characteristics of the product that may indicate the product is unsuitable for medical use. For example, storage period can be determined by measuring the concentration of impurities in the product after storage under long-term storage conditions, the color change of the product, the concentration of insoluble particles in the product, the potency of active agents (e.g., disinfectants) contained in the product, the concentration of one or more components of the product, the pH of the product, and / or the sterility of the product. As used herein, “long-term storage conditions” refers to environmental conditions sufficient to store the product for an acceptable period beyond 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, the 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 components of 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, the 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 components of the product, the pH of the product, and / or the sterility of the product after storage at approximately 15°C to 30°C, where temperatures below approximately 40°C are permissible.

[0043] In some embodiments, the storage period may 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, or optionally at least about 40 months.

[0044] In some embodiments, the main material may be sufficiently sterilized using known sterilization techniques useful in accordance with this disclosure, such as moist heat sterilization (i.e., high-pressure steam sterilization), gas sterilization, gamma irradiation, electron beam (e-beam) sterilization, aseptic manufacturing processes (e.g., aseptic filtration and / or blow-fill seal operations), and combinations thereof. In some embodiments, the container containing the main material can be sterilized for at least 10 days after sterilization. -6 If the material has a sterility assurance level (SAL) and provides an acceptable result during the container closure integrity test after sterilization, the main material can be determined to be sufficiently sterilized.

[0045] In some embodiments, the body material may have sufficient mechanical strength to provide the body with an acceptable resistance to shock, vibration, shaking, or a combination thereof. In some embodiments, an acceptable resistance refers to a resistance compliant 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), or a combination thereof. In some embodiments, the body material may be safe for biomedical applications. For example, the body material may comply with the requirements of ISO 10993 and / or REACH. In some embodiments, the main material may be sufficient to exhibit at least some of the properties described herein over a specific storage period of the cleaning solution at a temperature of about 15°C to 30°C, while being tolerable at temperatures below about 40°C. Additionally or alternatively, the main material may be sufficient to exhibit at least some of the properties described herein over a specific storage period of the cleaning solution after being stored at about 25°C and 60% relative humidity. Additionally or alternatively, the main material may be sufficient to exhibit at least some of the properties described herein over a specific storage period of the cleaning solution after being stored at about 37°C and 65% relative humidity.

[0046] The main material may be rigid or flexible. As used herein, "rigidity" means sufficient rigidity to resist deformation under normal operating forces. As used herein, "flexibility" means the ability to be bent or compressed under normal operating forces.

[0047] Examples of body materials include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Examples of plastics useful in accordance with this disclosure include, but are not limited to, high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene, polystyrene, nylon, and any combination thereof. In some embodiments, the body material may be a backing material and / or coating material such as backing paper and / or coated paper.

[0048] In some embodiments, the main body may be provided with an external casing. For example, Figure 4 shows a main body 41 comprising a flexible main body material. The main body 41 may be provided with an external casing 42 that is permanently attached to or removable from the main body 41. In some embodiments, the external casing 42 is rigid and therefore functions to protect the main body 41 during storage and / or use. Additionally or alternatively, the external casing 42 may function to distinguish the main body 41 from similar devices used in a medical setting, such as intravenous (IV) fluid bags. This reduces the risk of unintentional misuse of the main body 41.

[0049] The body according to this disclosure is configured to distribute a cleaning solution, such as a disinfectant, contained within the body via one or more mechanisms. In some embodiments, the body is configured to distribute the cleaning solution when compressed, as described herein. For example, as shown in Figure 1A, body 11 may be configured to distribute at least a portion of the cleaning solution contained within the body in response to compression, such as squeezing. Additionally or alternatively, as shown in Figure 1B, body 12 may be configured to distribute at least a portion of the cleaning solution contained within the body in response to longitudinal compression.

[0050] Additionally or alternatively, the body may be configured to distribute at least a portion of the cleaning fluid contained within it when oriented in a particular direction. For example, as shown in Figure 2A, the body 21 may include an opening 23 from which the cleaning fluid can be distributed. In this example, the body 21 may be configured to distribute at least a portion of the cleaning fluid by gravity when positioned in a particular direction (for example, the opening 23 is located at or near the bottom of the body relative to the ground).

[0051] In the example shown in Figure 2A, the main body 21 may include a positioning component 22 that can position the main body in a specific direction. The positioning component 22 may be any component configured to position and / or fix the main body in a selected direction, such as a hook, strap, snap, button, string, or a combination thereof. The positioning component 22 may be integrated with the main body and / or a separate component configured to interact with the main body, such as a strap that can be attached to the main body. The positioning component 22 may also be configured to interact with a second positioning component, such as an extension arm configured to interact with a hook included in and / or attached to the main body.

[0052] Figure 2B shows another example of the system according to this disclosure. In this example, the body 24 is configured to interact with a separate positioning component 22, including a snap 25. This allows the body 24 to be positioned and fixed to the user's arm, such as the arm of a physician performing the cleaning. In this example, the cleaning fluid may be distributed by gravity as described herein and / or by a distribution aid described later.

[0053] In some embodiments, the main body may be configured to communicate with a distribution assist unit, which is configured to provide sufficient force to distribute at least partially the cleaning fluid contained in the main body. For example, the distribution assist unit may include a pump configured to move the cleaning fluid away from the main body. The pump may be a mechanical pump, an electric pump, a vacuum pump, or any combination thereof.

[0054] It should be understood that the body may be configured to distribute cleaning fluid via one or a combination of the mechanisms described herein. For example, the body may be configured to distribute cleaning fluid together with gravity when compressed. Additionally or alternatively, the body may be configured to distribute cleaning fluid by gravity, and / or together with a force generated by a pump (including, but not limited to, a vacuum force generated by a pump) when compressed. According to some embodiments, the body may be configured to selectively distribute cleaning fluid via one or more mechanisms described herein. In one non-limiting example, the body may be configured to distribute cleaning fluid when compressed with or without the force of a pump. This allows the user to select a desired distribution mechanism based on physical constraints (e.g., the user's motor skills), a desired fluid flow force, a desired fluid flow rate, a desired fluid flow pattern (e.g., pulsed or constant), or a combination thereof.

[0055] In some embodiments, the body may be configured to distribute 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 within the body. The body may be configured to distribute the cleaning fluid continuously and / or intermittently. In one non-limiting example, the body may be configured to distribute the cleaning fluid intermittently such that the cleaning fluid is distributed only when the body is compressed and / or when a distribution aid such as a pump is in operation.

[0056] The body may be configured to hold 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 hold about 250 to 2000 mL, optionally about 500 to 1000 mL of fluid. According to some embodiments, the body may be configured to hold about 500 mL of fluid. According to some embodiments, the body may be configured to hold about 1 L of fluid.

[0057] The body relating to this disclosure may include a connecting portion configured to selectively position the body to be in fluid communication with a coating member. As used herein, “connecting portion” means a portion of the body configured to provide a secure connection between the body and the coating member, thereby enabling controllable distribution of a fluid (e.g., disinfectant) from the body to the coating member.

[0058] In one example, the connector is configured to secure the body and the coating member so that a first opening in the body and a second opening in the coating member, sufficient to provide fluid communication between the body and the coating member, are aligned. The connector may include any known type of connector in the art that is useful in accordance with this disclosure.

[0059] Figure 3 shows an example of a connector 33 configured to connect a body 31 and a coating member 32. In this example, the connector 33 includes a projection configured to interact with a corresponding projection included in the coating member to form a threaded connection, thereby allowing the body 31 to be screwed into the coating member 32. In this example, it should be understood that screwing the body 31 into the coating member 32 via the connector 33 aligns the opening 34 of the body 31 with the opening 35 of the coating member 32, providing fluid communication between the body 31 and the coating member 32 when they are connected.

[0060] In some embodiments, the body may be provided with a removable lid, for example, a cap configured to interact with the connection of the body instead of the coating member. It should be understood that the lid can, for example, prevent the fluid from being discharged from the body during storage or transport of the body.

[0061] In some embodiments, a fluid metering device, such as a valve, may be provided at the connection. The fluid metering device may be provided in communication with an opening in the main body (for example, provided in an opening in the main body) and may be sufficient to influence the fluid flow from the main body.

[0062] Furthermore, this disclosure relates to a system comprising the main body described herein and one or more coating members. Each of the one or more coating members may be configured to apply a cleaning solution to a surface sufficient for the cleaning process.

[0063] In some embodiments, the system adapts to the exchange of coating members by including a body with a connector configured to interact with two or more different coating members. For illustrative purposes, in the example shown in Figure 3, the system may include a body 31 having a connector 33 as shown. The system may further include one or more coating members, each having a connector 36, each substantially the same size and shape, so that each of the one or more coating members can be interchangeably connected to the body 31. This allows the user to select from two or more coating members based on their preferences and requirements for the cleaning process, without requiring multiple body types. Thus, the systems according to this disclosure benefit the user in selecting from a variety of different coating members, each of which can provide unique fluid flow rates, fluid flow patterns, and / or fluid flow forces, as will be described in more detail herein.

[0064] Figure 5 shows one exemplary coating member 50 according to the present disclosure. As shown in Figure 5, the coating member 50 may include a connector 51 and a dispensing section 52. As described herein, the connector 51 may be configured to connect the coating member 50 to a body. The dispensing section 52 may include one or more dispensing openings 53 configured to distribute a fluid (e.g., a disinfectant as described herein) to a surface such as a surgical site during a cleaning process.

[0065] In the example shown in Figure 5, the discharge section 52 may include a semi-flexible conduit whose shape and / or direction can be adjusted. This allows the angle and / or direction of fluid discharge to be adjusted before and / or during the cleaning process. As used herein, “semi-flexible” refers to the ability to bend and compress, in addition to the ability to maintain its shape when subjected to operating pressures such as fluid flow and / or pressure from user handling. In some embodiments, the degree of flexibility of the semi-flexible component may depend at least in part on the material of the coating member, the shape of the discharge section, the length of the discharge section, or a combination thereof. It should be understood that the coating member 50 shown in Figure 5 advantageously controls the flow path of the distributed fluid so that the user can direct the fluid (e.g., disinfectant) to irregularly shaped and / or hard-to-reach surfaces, such as irregularly shaped and / or hard-to-reach surgical sites.

[0066] Figure 6 shows another exemplary coating member 60 according to the present disclosure. As shown in Figure 6, the coating member 60 may include a connector 61 and a dispensing section 62. The connector 61 may be configured to connect the coating member 60 to a body 600, as described herein. The dispensing section 62 may include one or more dispensing openings 63 configured to distribute a fluid (e.g., disinfectant) to a surface such as a surgical site during a cleaning process. It should be understood that the dispensing section 62 may include a conduit 64 which may be a semi-flexible conduit, a flexible conduit, or a rigid conduit, as described in relation to Figure 5.

[0067] As shown in Figure 6, the coating member 60 may further include a distribution assist unit 65 as described herein, such as a pump. For example, as shown in Figure 7A, the distribution assist unit may be a mechanical pump. Figure 7A shows a hand pump 71 that moves the fluid when compressed by the user's hand 72. Additionally or alternatively, as shown in Figure 7B, the distribution assist unit may be an electric pump. Figure 7B shows an electric pump 73 that moves the fluid using electrical energy generated by a battery 74 or the like.

[0068] It should be understood that the coating member 60 having a distribution assist unit 65 as described herein can distribute cleaning fluid (e.g., disinfectant) from the body 600 when the distribution assist unit 65 is activated (e.g., when the pump described herein is activated). Additionally or alternatively, the distribution assist unit 65 may function to distribute fluid from the body 600 together with gravity. For example, Figure 6 shows an exemplary body 600 similar to the body shown in Figure 2A, i.e., a body configured to distribute at least a portion of the contained cleaning fluid by gravity when positioned in a particular direction. It should be understood that the distribution assist unit allows the user to advantageously control the fluid flow force, fluid flow rate, and / or fluid flow pattern (e.g., pulsed or constant) of the distributed cleaning fluid.

[0069] The examples shown in Figures 5 and 6 illustrate a discharge section having one discharge opening, but it should be understood that the discharge section may include two, three, four, or more discharge openings. Each discharge opening may have the same or different size as one or more other discharge openings. Additionally or alternatively, each discharge opening may have the same or different shape as one or more other discharge openings. The shape and / or size of one or more discharge openings may be selected to provide a specific 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 as to adjust the fluid flow force, fluid flow rate, and / or flow pattern of the distributed fluid.

[0070] In some embodiments, one or more discharge openings may be provided on the nozzle portion of the discharge section of the coating member. For example, Figure 8 shows a body 800 in fluid communication with a coating member 80 having a connection portion 81 and a discharge portion 82, as described herein. As shown in Figure 8, the discharge portion 82 may include a nozzle 83 having one or more discharge openings 84, as described herein. The nozzle 83 may be removable or replaceable, so that the same coating member 80 may interchangeably include at least two different nozzles 83. Accordingly, the system according to this disclosure may include at least one coating member and two or more replaceable nozzles, as described herein.

[0071] In the example shown in Figure 8, the coating member 80 may further include a distribution assist unit 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 by any mechanism known in the field when the actuator 86 is operated. It should be understood that, additionally or alternatively, the nozzle 83 may be configured to provide a fluid flow, a fluid spray, or a combination thereof.

[0072] Figure 9 shows another example of the system according to the present disclosure. As shown in Figure 9, the coating member 90 may include a connector 91 and a discharge unit 92 as described herein. The discharge unit may include a nozzle 93 and an actuator 94 such as a trigger. In this example, the coating member 90 may further include a conduit 95 that is in fluid communication with a fluid contained in a body 900, as described herein. In this example, the body 900 may be pressurized. When the actuator 94 is activated (e.g., when the trigger is compressed), the pressure in the conduit 95 may fall below the pressure in the body 900, as a result of the fluid being forced from the body 900 into the coating member 90. The nozzle 93 may be configured to provide, for example, a fluid flow, a fluid mist, a fluid spray, or a combination thereof.

[0073] Figure 10 shows another example of the system according to the present disclosure. As shown in Figure 10, the coating member 100 may include a connector 101 and a discharge section 102, as described herein. The discharge section may include a nozzle 103. In this example, the nozzle 103 may also function as an actuator, for example, by being pressed toward the body 1000. The coating member 100 may further include a conduit 104 that is in fluid communication with a fluid contained in the body 1000. The body 1000 may be pressurized, as described in relation to Figure 9. When the nozzle 103 is operated, the pressure in the conduit 104 may fall below the pressure in the body 1000, and as a result, the fluid is forced from the body 1000 to the coating member 100, as described in relation to Figure 9.

[0074] Figure 11 shows another exemplary system according to the disclosure, similar to the example shown in Figure 10, comprising a coating member 110, a connector 111, a discharge unit 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 when the actuator 115 is activated (i.e., by pressing a button), the pressure in the conduit 114 falls below the pressure in the body 1100, and as a result, fluid is forced from the body 1100 to the coating member 110.

[0075] Figure 12 shows another example of the system relating to this disclosure. As shown in Figure 12, the coating member 120 may include a connector 121 and a discharge unit 122, as described herein. The discharge unit may include a first nozzle 123 and an actuator 124. As described in relation to Figures 9, 10 and 11, the body 1200 may be pressurized. Additionally or alternatively, the system may include a cartridge (not shown) containing a propellant configured to provide an aerosol known in the art. The propellant may be any propellant acceptable for the medical applications relating to this disclosure, and may include, but is 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.

[0076] The exemplary system shown in Figure 12 also shows a plurality of interchangeable nozzles 125 as described herein. As described herein, each of the plurality of interchangeable nozzles 125 is configured to be interchangeable with nozzle 123, so it should be understood that a single coating member 120 and body 1200 are provided configured to distribute fluid to a surface through various nozzles to provide a variety of selectable fluid flow rates, fluid flow patterns, and / or fluid flow forces.

[0077] The systems described herein may include at least a body configured to be in fluid communication with one or more different coating members as described herein, each of which has at least one discharge opening, and the at least one discharge opening may optionally be included in a removable and replaceable nozzle. Thus, the systems described herein may be configured to deliver cleaning fluid to a surface by one or more selectable different fluid flow rates, fluid flow patterns, and / or fluid flow forces as described herein.

[0078] For example, the system may include at least two different coating members and / or at least two different nozzles, each of the at least two different coating members and / or each of the at least two different nozzles, configured to provide a unique fluid flow rate, fluid flow pattern, and / or fluid flow force. According to some embodiments, a single coating 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 by, for example, providing one or more discharge openings with adjustable shapes and / or sizes, as described herein.

[0079] In some embodiments, the system may be configured to provide an acceptable fluid flow rate for the cleaning process. As used herein, “fluid flow rate” refers to the flow rate at which the 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., compression of a body, orientation of a body, use of a distribution aid, or a combination thereof, as described herein), and / or the properties of the application member and / or nozzle. In some embodiments, the fluid flow rate may be related to the fluid flow force. For example, an increase in the fluid flow rate may correspond to an increase in the fluid flow force, and vice versa. The systems according to this 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.

[0080] In some embodiments, the system may be configured to provide an acceptable fluid flow force for the cleaning process. As used herein, “fluid flow force” refers to the force exerted by the fluid on a surface, such as a human tester, during the cleaning process. An acceptable fluid flow force can be determined based on the requirements of the cleaning process. Illustrative fluid flow forces useful according to this disclosure are, but are not limited to, about 10–50 g, and optionally about 15–45 g. In some embodiments, the fluid flow force may be about 15 g. In some embodiments, the fluid flow force may be about 30–45 g. Other illustrative fluid flow forces useful according to this disclosure are, 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”).

[0081] 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 coating member and / or nozzle, as described herein. The systems relating to this 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 of the selectable fluid flow forces may correspond to, for example, a particular delivery mechanism, a particular coating member, a particular nozzle, or a combination thereof, as described herein. For example, one or more selectable flow forces may correspond to a coating member having an actuator as described herein, such as a trigger, 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 one or more discharge openings.

[0082] In some embodiments, the system is configured to provide an acceptable fluid flow pattern for the cleaning process. As used herein, “fluid flow pattern” refers to the pattern in which a fluid is dispensed from the apparatus and / or applied to a surface such as a human tester during the cleaning process. In some non-limiting examples, the fluid flow pattern may include a fluid mist (i.e., fine fluid suspended in a gas), a fluid flow (i.e., a steady, continuous fluid), a fluid spray (i.e., fine fluid), or a combination thereof. The fluid flow pattern may be constant (e.g., for a fluid continuously dispensed from the apparatus and / or applied to a surface) or pulsed (e.g., for a fluid intermittently dispensed from the apparatus and / or applied to a surface).

[0083] Additionally or alternatively, the fluid flow pattern may refer to the angle at which the fluid channel is distributed from the device and / or applied to the surface. For example, the fluid channel may have a fluid flow pattern substantially perpendicular to the longitudinal axis of the body, as described herein.

[0084] Additionally or alternatively, the fluid flow pattern may refer to the geometric shape of the flow path. It should be understood that the geometric shape of the flow path refers to the shape defined by a cross-sectional view of the fluid flow path in any of the X, Y, and Z directions.

[0085] It should be understood that the fluid flow pattern may depend at least partially on the delivery mechanism and / or the coating member and / or nozzle, as described herein. The systems relating to this 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 distribution 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, one or more selectable flow patterns may correspond to a discharge section of a coating member, such as a discharge section including a semi-flexible conduit, as described herein. In this example, 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.

[0086] In some embodiments, one or more components of the systems described herein may be contained in sterile packaging. As used herein, “sterile packaging” refers to packaging that provides a sterile environment to maintain the sterility of the contained sterile product. Examples of sterile packaging include, but are not limited to, sterile blister packaging, sterile safe-edge trays, sterile surgical trays, customized sterile thermoformed packaging, and combinations thereof. It should be understood that one or more components of a system may be contained 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 a system may be contained in a first sterile packaging, and a second component of a system may be contained in a second sterile packaging. In one non-limiting example, a system may include a main body contained in a first sterile packaging and a coating member contained in a second sterile packaging. It should be understood that by containing one or more components of a system in different sterile packaging, each component of the system can be removed immediately before use, thus preventing one or more components from being exposed to a non-sterilized environment for extended periods. This makes it possible to fully assemble the system and present it in a sterile condition.

[0087] This disclosure also relates to methods of using the apparatus and systems described herein. For example, the method may include providing a body containing a cleaning fluid, including a connector. The method may include arranging the body to be in fluid communication with a coating member and distributing a sufficient amount of cleaning fluid to perform the cleaning process described herein.

[0088] While the embodiments described herein are described in conjunction with the exemplary embodiments outlined above, various substitutes, variations, modifications, improvements, and / or substantial equivalents, whether known or currently unpredictable, will become apparent to those skilled in the art. Therefore, the exemplary embodiments described above are intended to be illustrative and not limiting. Various modifications can be made without departing from the spirit and scope of this disclosure. Accordingly, this disclosure is intended to encompass all known or future-developed substitutes, variations, modifications, improvements, and / or substantial equivalents.

[0089] Accordingly, the claims are not intended to be limited to the embodiments shown herein, but to give the full scope consistent with the language of the claims, and references to singular elements are intended to mean "one or more" and not "one and only" unless otherwise specified. All structural and functional equivalents to elements of various embodiments described throughout this disclosure, whether known to those skilled in the art or to become known thereafter, are expressly incorporated by reference herein and are intended to be included in the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, whether such disclosure is expressly stated in the claims or not. Elements of the claims should not be construed as means plus function unless they are expressly referred to using the phrase "means for".

[0090] The word “exemplary” is used herein to mean “serving as an example, illustration, or representation.” Any embodiment described herein as “exemplary” should not necessarily be construed as being preferable or more advantageous than other embodiments. Unless otherwise specified, the term “some” means one or more. Combinations such as “at least one of A, B, or C,” “at least one of A, B, and C,” and “A, B, C, or any combination thereof” may include any combination of A, B, and / or C, and may 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,” and “A, B, C, or any combination thereof” may be A only, B only, C only, A and B, A and C, B and C, or A and B and C, and any of these combinations may include one or more of A, B, or C. Nothing disclosed herein, whether such disclosure is expressly stated in the claims or not, is intended to be made available to the public.

[0091] The word "approximately" is used to mean within ±5% of a specified value, arbitrarily within ±4%, arbitrarily within ±3%, arbitrarily within ±2%, arbitrarily within ±1%, arbitrarily within ±0.5%, arbitrarily within ±0.1%, and arbitrarily within ±0.01%.

Claims

1. A main body configured to contain cleaning solution, The coating member includes the main body and is in fluid communication with it, The coating member includes one or more discharge openings configured to distribute the cleaning liquid, At least one of the discharge openings is configured to distribute the cleaning fluid with a first fluid flow force and a first fluid flow pattern, The coating member further A connecting portion configured to connect the coating member and the main body, and providing fluid communication between the coating member and the main body, A discharge section including one or more discharge openings, A system for applying a cleaning solution to a surface, wherein the discharge section includes a semi-flexible conduit that can maintain its shape, bend and compress when subjected to operating pressure, and whose shape and / or direction can be adjusted.

2. Unlike the aforementioned coating member, it further comprises a second coating member that is replaced by the aforementioned coating member and is in fluid communication with the main body, The second coating member is, A nozzle configured to distribute the cleaning solution, Conduits and A connecting portion configured to connect the second coating member and the main body, and providing fluid communication between the second coating member and the main body via the conduit, Includes a discharge section connectable to the nozzle, The system according to claim 1, wherein the nozzle is configured to distribute the cleaning fluid with a second fluid flow force and a second fluid flow pattern.

3. The nozzle is configured to selectively distribute the cleaning liquid with a second fluid flow force and / or a second fluid flow pattern, wherein the second fluid flow force is different from the first fluid flow force, and the second fluid flow pattern is different from the first fluid flow pattern, for a system for applying a cleaning liquid to a surface according to claim 2.

4. The nozzle includes one or more nozzle discharge openings of adjustable size, The first size of the one or more nozzle discharge openings corresponds to the flow force of the first fluid and the flow pattern of the first fluid. The system according to claim 3, wherein the second size of the one or more nozzle discharge openings corresponds to the flow force and / or flow pattern of the second fluid.

5. The nozzle includes one or more nozzle discharge openings whose shape can be adjusted. The first shape of the one or more nozzle discharge openings corresponds to the flow force of the first fluid and the flow pattern of the first fluid. The system according to claim 3, wherein the second shape of the one or more nozzle discharge openings corresponds to the flow force and / or flow pattern of the second fluid.

6. The system according to claim 3, wherein the nozzle is configured to selectively distribute the cleaning liquid as at least two of the following: a fluid flow, a fluid mist, and a fluid spray.

7. The system according to claim 1, wherein the main body is compressible.

8. The invention further includes a pump configured to provide sufficient force to distribute the cleaning fluid, at least partially. The system according to claim 7, wherein the main body is configured to distribute the cleaning liquid when compressed, regardless of the force of the pump.

9. The system according to claim 1, wherein the main body is configured to distribute at least a portion of the cleaning solution when directed in a first direction.

10. The invention further includes a pump configured to provide sufficient force to distribute the cleaning fluid, at least partially. The system according to claim 9, wherein the main body is configured to distribute the cleaning liquid when directed in the first direction, regardless of whether or not the pump is working.

11. The system according to claim 1, wherein the main body is foldable.

12. The system according to claim 1, wherein the cleaning solution comprises a disinfectant and water, and the disinfectant comprises iodine, octenidine salt, chlorhexidine salt, alexidine, an oxidized form, or a combination thereof.

13. The second coating member includes at least two replaceable nozzles configured to dispense the cleaning liquid, The at least two interchangeable nozzles include a first nozzle configured to distribute the cleaning fluid with a second fluid flow force, and a second nozzle configured to distribute the cleaning fluid with a third fluid flow force different from the first fluid flow force. The system according to claim 2, wherein the discharge unit is selectively connectable to at least two interchangeable nozzles.

14. The second coating member described above is further Includes actuator, The system according to claim 13, wherein the system is configured to distribute the cleaning fluid when the actuator is operated.

15. The system according to claim 14, comprising a cartridge for containing propellant.

16. The system according to claim 2, wherein the cleaning solution comprises a disinfectant containing iodine and water.

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