Washing system and device having a flow adjusting member

Abstract

A system for applying a cleaning liquid to a surface, the system having a sealed body for containing the cleaning liquid and a flow regulating member configured to create a breakage part in the sealed body for dispensing the cleaning liquid, wherein the sealed body and the cleaning liquid contained therein are ultimately sterilized.

Description

Technical Field

[0001] Cross - reference to Related Applications This application claims the priority of U.S. Provisional Application No. 63 / 358,401, filed on July 5, 2022, the entire content of which is incorporated herein by reference.

[0002] Technical Field The present disclosure relates to an apparatus and a system for applying a lavage fluid to a surface, the apparatus and the system having at least one flow - adjusting member.

Background Art

[0003] Currently, lavage (i.e., flushing a body cavity, surgical cavity, or wound with a medically acceptable liquid) is often used to prevent contamination of open surgical wounds that can occur for various reasons such as accidental visceral penetration or perforation, complex surgeries due to massive effusion, deviation from sterilization techniques, and / or existing ongoing clinical infections. Thus, the lavage process is often used to provide intraoperative antiseptic wound lavage.

[0004] Lavage techniques currently encompass a wide variety of different approaches based on factors such as the situation (e.g., the size and shape of the cavity or wound) and the healthcare provider performing the lavage process (e.g., the preference of the operator's technique). Currently, no specific lavage technique is standard in the art, and thus, healthcare facilities often need many different lavage devices and systems to accommodate the potential diversity of approaches. (For example, intravenous when the device and / or system has a similar appearance to an intravenous device and / or system) The presentation of such devices and systems is also sometimes a concern because inadvertent inappropriate use of such devices and systems can have a devastating impact.

[0005] Furthermore, there are several drawbacks in current cleaning methods, including inadequacies in the properties of the disinfectant solution (e.g., the time required for the disinfectant solution to achieve an acceptable biological effect, which may be prohibited), the risk of systemic absorption of the disinfectant solution, adverse reactions such as anaphylaxis, peritoneal adhesions, neurotoxicity, and respiratory failure, and sometimes inappropriate dosing or contamination of the disinfectant solution temporarily adjusted by healthcare workers performing the cleaning.

[0006] In addition, current cleaning devices often increase the risk of contamination. For example, some current cleaning devices utilize an elastic hollow body (e.g., a "squeeze bottle", etc.) that discharges the cleaning liquid when pressure is applied to it. To function, such a device requires one or more re - equilibration periods (i.e., periods during which reduced pressure or no pressure is applied to the device) so that gas, such as air, sufficient to re - equilibrate the internal pressure can be drawn into the device. However, by introducing non - sterile gas into the device, the sterility of the cleaning liquid (and thus the surgical wound it contacts) can be put at risk. Furthermore, such a device inhales gas during the re - equilibration period along the same path by which the cleaning liquid is dispensed from the device. However, these paths are generally not optimized for such a function, and thus the re - equilibration periods required by such devices often result in delays unacceptable to the cleaning process, which often leads to an inefficient and / or ineffective cleaning process. Additionally, current cleaning devices provide clinicians with only a limited ability to control and target the flow of the cleaning liquid.

[0007] Accordingly, there is a need in the art for a versatile apparatus and system for performing a cleaning process, particularly an apparatus and system that enables medical personnel to safely and effectively reduce the contamination of surgical wounds that are susceptible to surgical site infections. There is a need in the art for a finally sterilized cleaning apparatus in which the cleaning liquid contained therein is finally sterilized together with the cleaning apparatus without damaging the materials used in the manufacture of the cleaning apparatus. There is also a need in the art for a cleaning apparatus having the ability to deliver large volumes of cleaning liquid in a short time, which allows a clinician to optimally control and aim the flow of the cleaning liquid. SUMMARY OF THE INVENTION

[0008] The present disclosure relates to an apparatus and system for delivering a cleaning liquid, such as an irrigation solution, to a surface. The apparatus has a sealed body configured to contain a cleaning liquid, such as an irrigation solution. Optionally, both the sealed body and the cleaning liquid contained therein are finally sterilized. The system further has at least one flow regulating member, and the at least one flow regulating member is configured to facilitate the process of applying a sufficient amount of cleaning liquid to the surface for the cleaning process.

[0009] The apparatus and system are adaptable such that a user can select from one or more different fluid flow rates, fluid flow designs, and / or fluid flow forces, and thus provide selectable control of the delivery of the cleaning liquid to the surface. The present disclosure also relates to a method of using the apparatus and system described herein.

[0010] The present disclosure also relates to a flow regulating member that can be used with the devices and systems described herein. The flow regulating member is configured to create a disruption in a sealed body that houses a cleaning liquid. The disruption created in the sealed body facilitates the discharge of the cleaning liquid in a flow pattern from the sealed body. The flow regulating member may or may not be in fluid communication with the body during the discharge of the cleaning liquid.

Brief Description of the Drawings

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Modes for Carrying Out the Invention

[0019] The present disclosure relates to an apparatus and system for delivering a cleaning fluid, such as a cleaning solution, to a surface. The system has an apparatus such as a fluid receptacle having a sealed body configured to contain a cleaning fluid such as a cleaning solution. The system further has at least one flow regulating member, and the at least one flow regulating member is configured to facilitate the process of applying a sufficient amount of the cleaning fluid to the surface for a cleaning process. The apparatus and system can be adaptable such that a user can select from one or more different fluid flow rates, fluid flow designs, and / or fluid flow forces, and thus provide selectable control of the delivery of the cleaning fluid to the surface. The present disclosure also relates to a method of using the apparatus and system described herein.

[0020] The present disclosure also relates to a flow regulating member that can be used with the apparatus and system described herein. The flow regulating member is configured to create a breakage, such as a cut (incision, cut-out), a small hole (puncture), a hole, or a slit, in a sealed body configured to contain the cleaning fluid. The breakage made in the sealed body facilitates the discharge of the cleaning fluid in a flow pattern from the sealed body. The flow regulating member may or may not be in fluid communication with the sealed body during the discharge of the cleaning fluid.

[0021] As used herein, the term "cleaning fluid" refers to a fluid suitable for the cleaning processes described herein. As used herein, "cleaning" refers to the cleaning of body cavities, surgical cavities, and / or wounds.

[0022] According to some embodiments, the cleaning liquid may include a cleaning solution. As used herein, "cleaning solution" refers to a solution containing at least a solvent and one or more chemical agents. Non-limiting examples of chemical agents include, but are not limited to, preservatives, antibiotics, antibacterial agents, oxidizing agents, and combinations thereof. According to some embodiments, the cleaning solution is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which the solvent contains at least mostly water. In some examples, it should be understood that the solvent may consist of water. According to some embodiments, the cleaning solution is an alcohol solution. As used herein, the term "alcohol solution" refers to a solution in which the solvent contains at least mostly alcohol. In some examples, it should be understood that 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.

[0023] In one non-limiting example, the chemical agent may include a preservative. According to some embodiments, the preservative may include cationic molecules (i.e., molecules having a positive charge) such as cationic surfactants or cationic biguanide derivatives (i.e., compounds derived from biguanide). According to some embodiments, the preservative may include bis-(dihydropyridinyl)-decane derivatives (i.e., compounds derived from bis-(dihydropyridinyl)-decane). According to some embodiments, the preservative may include octenidine salts and / or chlorhexidine salts. According to some embodiments, the preservative may include alexidine, octenidine dihydrochloride, chlorhexidine gluconate, or combinations thereof.

[0024] Additionally or alternatively, the preservative may include iodine. According to some embodiments, iodine may be provided as an iodine complex such as povidone iodine (PVPI), nonylphenoxy(ethyleneoxy)iodine, polyethyleneoxypolypropyleneoxyiodine, undecoylium chloride iodine, iodopovidone, and combinations thereof.

[0025] Additionally or alternatively, the chemical agent 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, Dakin's solution, hypochlorous acid, and combinations thereof.

[0026] In one non-limiting example, the chemical agent may include an antibiotic. Non-limiting examples of antibiotics according to the present disclosure include, but are not limited to, bacitracin, vancomycin, gentamicin, cefazolin, clindamycin, polymyxin, or combinations thereof.

[0027] The chemical agent may have antibacterial activity sufficient to provide an acceptable logarithmic reduction of microorganisms within a specific period. As used herein, it should be understood that the term "microorganism" may refer to any microorganism that is sterilized and / or removed as a result of washing. Examples of microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0028] Examples of bacteria include drug-resistant and drug-sensitive Streptococcus species (e.g., S. mutans, S. pyogenes, S. salivarius, S. sanguis), Staphylococcus species (e.g., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus saprophyticus), Enterococcus species (e.g., E. faecalis, E. faecium, E. hirae), Bacteroides fragilis, Cutibacterium acnes (formerly Propionibacterium acnes), Clostridium difficile (spores and vegetative cells), Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Klebsiella species (e.g., K. aerogenes, K. pneumoniae), Acinetobacter baumannii, Micrococcus luteus, Haemophilus influenzae, and Serratia marcescens, but are not limited thereto.

[0029] Examples of fungi include, but are not limited to, Aspergillus brasiliensis, Candida spp. (C. albicans, C. auris, C. dubliniensis, C. glabrata, C. guilliermondii, C. kefyr (formerly C. pseudotropicalis), C. krusei, C. lusitaniae, C. tropicalis), Epidermophyton floccosum, Microsporum spp. (e.g., M. gypseum, M. canis), and Trichophyton mentagrophytes, which can be drug-resistant or drug-sensitive.

[0030] Examples of viruses include, but are not limited to, single-stranded or double-stranded, sense or antisense oriented, DNA and RNA genomes with protein coats (capsids), with or without lipid envelopes, such as cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2), influenza virus, parainfluenza virus, norovirus, and coronavirus.

[0031] According to some embodiments, a particular period can 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, and optionally about 1 minute or less.

[0032] According to some embodiments, a particular period can 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.

[0033] It should be understood that "acceptable log reduction" can depend on the microorganism. For example, the acceptable log reduction described herein can refer to the acceptable log reduction of one type of microorganism present on a surface (e.g., present in a body cavity or a wound site), a combination of more than two types of microorganisms present on a surface, or all microorganisms present on a surface.

[0034] According to some embodiments, the acceptable logarithmic decrease can be at least about 1.0, optionally at least about 1.1, optionally at least about 1.2, optionally at least about 1.3, optionally at least about 1.4, optionally at least about 1.5, optionally at least about 1.6, optionally at least about 1.7, optionally at least about 1.8, optionally at least about 1.9, optionally at least about 2.0, optionally at least about 2.1, optionally at least about 2.2, optionally at least about 2.3, optionally at least about 2.4, optionally at least about 2.5, optionally at least about 2.6, optionally at least about 2.7, optionally at least about 2.8, optionally at least about 2.9, optionally at least about 3.0, optionally at least about 3.1, optionally at least about 3.2, optionally at least about 3.3, optionally at least about 3.4, optionally at least about 3.5, optionally at least about 3.6, optionally at least about 3.7, optionally at least about 3.8, optionally at least about 3.9, optionally at least about 4.0, optionally at least about 4.1, optionally at least about 4.2, optionally at least about 4.3, optionally at least about 4.4, optionally at least about 4.5, optionally at least about 4.6, optionally at least about 4.7, optionally at least about 4.8, optionally at least about 4.9, and optionally at least about 5.0.

[0035] According to some embodiments, the chemical agent may be present in the cleaning solution at a concentration sufficient to provide an acceptable log reduction of microorganisms over a specified period described herein. According to some embodiments, the chemical agent may be present in the cleaning solution at a concentration between about 0.001 and 10% w / v, optionally between about 0.001 and 7.5% w / v, optionally between about 0.001 and 5% w / v, optionally between about 0.001 and 2.5% w / v, optionally between about 0.001 and 1% w / v, optionally between about 0.001 and 1% w / v, optionally between about 0.001 and 0.1% w / v, optionally between about 0.001 and 0.01 w / v, optionally between about 0.01 and 10% w / v, optionally between about 0.01 and 7.5% w / v, optionally between about 0.01 and 5% w / v, optionally between about 0.01 and 2.5% w / v, optionally between about 0.01 and 2% w / v, optionally between about 0.01 and 1.5% w / v, optionally between about 0.01 and 1% w / v, and optionally at a concentration of about 0.5% w / v.

[0036] According to some embodiments, the chemical agent may be present in the cleaning solution at a concentration between about 0.1 and 0.9% w / v, optionally between about 0.2 and 0.8% w / v, optionally between about 0.3 and 0.7% w / v, and optionally between about 0.4 and 0.6% w / v.

[0037] According to some embodiments, the chemical agent may be present in the cleaning solution at a concentration between about 0.1 and 1% w / v, optionally between about 0.2 and 1% w / v, optionally between about 0.3 and 1% w / v, and optionally between about 0.4 and 1% w / v.

[0038] It should be understood that according to some embodiments, the cleaning liquid may not necessarily be the cleaning solution as described herein, but can be any medically acceptable fluid configured to perform the cleaning process as described herein. In one non-limiting example, the cleaning liquid may include physiological saline. Physiological saline may include water and sodium chloride at medically acceptable concentrations such as between about 0.1 and 1% w / v, optionally about 0.45% w / v, and optionally about 0.9% w / v.

[0039] In a preferred embodiment, the cleaning solution may contain a formulation. The formulation may contain sodium citrate, citric acid, and sodium lauryl sulfate. The formulation may contain sodium citrate at a medically acceptable concentration between about 10 to 50 g / l, optionally between about 20 to 40 g / l, and optionally about 30 g / l. The formulation may contain citric acid at a medically acceptable concentration between about 10 to 50 g / l, optionally between about 20 to 40 g / l, and optionally about 32 g / l. The formulation may contain sodium lauryl sulfate at a medically acceptable concentration between about 0.1 to 5 g / l, optionally between about 0.5 to 2 g / l, and optionally about 1 g / l.

[0040] In a preferred embodiment, the cleaning solution may contain a formulation. The formulation may contain sodium acetate, acetic acid, benzalkonium chloride, and ethanol. The formulation may contain sodium acetate at a medically acceptable concentration between about 10 to 50 g / l, optionally between about 20 to 40 g / l, and optionally about 30 g / l. The formulation may contain acetic acid at a medically acceptable concentration between about 20 to 100 g / l, optionally between about 40 to 80 g / l, and optionally about 50 g / l. The formulation may contain benzalkonium chloride at a medically acceptable concentration between about 0.1 to 5 g / l, optionally between about 0.5 to 2 g / l, and optionally about 1 g / l. The formulation may contain ethanol at a medically acceptable concentration between about 50 to 150 g / l, optionally between about 75 to 125 g / l, and optionally about 100 g / l.

[0041] According to some aspects, a cleaning fluid such as the cleaning solution described herein may include a visualizing aid. As used herein, the term "visualizing aid" refers to a component in a cleaning fluid configured to assist in visualizing the application of the cleaning fluid. Examples of visualizing agents include, but are not limited to, colorants, dyes, and radiopaque agents. It should be understood that the visualizing agent may be the same as or different from one of the other components of the cleaning fluid. For example, a detergent may function as a visualizing agent. Additionally or alternatively, the cleaning fluid may include a visualizing agent different from the chemical agent.

[0042] According to some aspects, the cleaning fluid may include a colorant. As used herein, the term "colorant" refers to a component sufficient to provide an observable color to a fluid. The colorant may be sufficient to enable 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 U.S. Food and Drug Administration for use in food, pharmaceuticals, and / or cosmetics (i.e., a "D&C" or "FD&C" dye). Examples of anionic dyes include, but are not limited to, FD&C Blue No. 1 (Brilliant Blue FCF), FD&C Blue No. 2 (Indigocarmine), FD&C Green No. 3 (Fast Green FCF), FD&C Red No. 3 (Erythrosine), FD&C Red No. 40 (Allura Red), FD&C Yellow No. 5 (Tartrazine), FD&C Yellow No. 6 (Sunset Yellow FCF), D&C Yellow No. 8 (Fluorescein), D&C Orange No. 4, and combinations thereof. Combinations may be implemented to achieve a particular color. For example, the orange hue may include both FD&C Red No. 40 and D&C Yellow No. 8. Additionally or alternatively, the colorant may include chemicals observable upon exposure to 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.

[0043] According to some aspects, cleaning fluids such as the cleaning solutions described herein may include a dye. As used herein, the term "dye" refers to a component sufficient to temporarily or permanently color the contacting surface.

[0044] According to some aspects, cleaning fluids such as the cleaning solutions described herein may include a radiopaque agent. As used herein, the term "radiopaque agent" refers to a component that is sufficiently opaque to radio waves and the X-ray portion of the electromagnetic spectrum for visualization. In some non-limiting examples, radiopaque agents may include barium, iodine, iron oxide nanoparticles, gadolinium composite nanospheres, silica nanospheres, and combinations thereof.

[0045] According to some aspects, cleaning fluids such as the cleaning solutions described herein may be basic, neutral, or acidic. According to some aspects, the cleaning fluid may have a pH between about 1 and 10, optionally between about 1 and 7, optionally between about 1 and 6, and optionally between about 2 and 5.5.

[0046] According to some aspects, cleaning fluids such as the cleaning solutions described herein may include a buffer system. As used herein, the term "buffer system" refers to a component present in a composition or solution that can provide resistance to significant pH changes 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. The buffer system may interact with strong acids or strong bases in the composition or solution to provide resistance to significant pH changes, thereby at least partially preventing the pH of the composition or solution from changing significantly.

[0047] Generally, a buffer system has one or more buffer ranges and the buffer system has the ability to provide resistance to significant pH changes. When 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.

[0048] The buffering range of a buffer system is related to the acid dissociation constant (K a ) of one or more weak acids contained in the buffer system. The term "acid dissociation constant" refers to the equilibrium constant of the dissociation reaction of an acid. The midpoint of the buffering range of a buffer system is generally related to the logarithmic scale of the acid dissociation constant (i.e., -log 10 K a , equal to pK a ) of the weak acid contained in the buffer system.

[0049] According to some embodiments, a cleaning solution such as the cleaning solution described herein may contain a stabilizer. As used herein, the term "stabilizer" refers to any component that supports the stability of the cleaning solution not otherwise explicitly described herein.

[0050] According to some embodiments, the cleaning solution may be the cleaning solution described in U.S. Patent Application No. 17 / 152,565, which is hereby incorporated by reference in its entirety.

[0051] The system according to the present disclosure includes a sealed body configured to contain the cleaning solution described herein. According to some embodiments, the sealed body may be compressible. As used herein, the term "compressible" is used in a normal and general way and refers to a reduction in volume to form a pressure difference to support an optimal fluid flow. In some embodiments, this may include the ability to reversibly reduce the volume without unacceptable changes such as unacceptable size, shape, and / or one or more of the characteristics described herein. According to some embodiments, the sealed body may be configured such that at least a portion of the cleaning solution contained therein is dispensed when compressed. It should be understood that as used herein, "dispense" (alternatively referred to as "discharge") may refer to transferring the cleaning solution to a surface.

[0052] According to some aspects, the sealed body can be foldable. As used herein, the term "foldable" is used in its ordinary and general sense and refers to the ability to permanently reduce volume. For example, a foldable body as described herein can have a first volume when a first volume of fluid is contained therein. When at least a portion of the fluid is dispensed, the foldable body can be folded to have a second volume, where the second volume is smaller than the first volume. It should be understood that the foldable body advantageously reduces the volume of waste (e.g., the volume of the body after the fluid therein has been dispensed). The foldable body can further provide for more efficient fluid release.

[0053] According to some aspects, the sealed body can 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 an 80% volume reduction, and optionally at least a 90% volume reduction when compressed and / or folded.

[0054] According to some aspects, the sealed body can include a body material that is compatible with the cleaning fluid contained therein, i.e., a material that does not react chemically or physically with the cleaning fluid or otherwise render the cleaning fluid medically inappropriate.

[0055] According to some aspects, the body material may be sufficient to prevent unacceptable loss of vapor or chemicals from the cleaning solution contained therein over a certain shelf life period. It should be understood that "unacceptable loss of vapor or chemicals" can be a loss that results in the cleaning solution becoming inappropriate for its intended use. Loss of vapor or chemicals can occur, for example, by adsorption or absorption of chemicals by the material (e.g., by the body material), evaporation of the solution, evaporation of components of the solution (e.g., disinfectant of a disinfecting solution), or combinations thereof. In one non-limiting example where the cleaning solution contains water and iodine as described herein, the body material may be sufficient to prevent water vapor loss and / or iodine loss over a certain shelf life period.

[0056] When used throughout this application, the term "shelf life" refers to the length of time a product (e.g., a disinfectant solution) can be stored while remaining within the specifications required for the product's shape, fitness, and function. The shelf life can be determined by measuring specific product characteristics that may indicate the product is unsuitable for medical use. For example, the shelf life can be determined by measuring the concentration of impurities in the product, a change in the color of the product, the concentration of insoluble particles in the product, the potency of the active agent contained in the product (e.g., disinfectant), the concentration of one or more components of the product, the pH of the product, and / or the sterility of the product after storage under long-term storage conditions. As used herein, the term "long-term storage conditions" refers to environmental conditions sufficient for the product to be acceptably stored for more than 72 hours. According to some embodiments, the long-term storage conditions can refer to about 25°C and about 60% relative humidity. Additionally or alternatively, the shelf life can be determined by measuring the concentration of impurities in the product, a change in the color of the product, the concentration of insoluble particles in the product, the potency of the 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, a change in the color 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 between about 15°C and 30°C with a temperature variation of about 40°C or less.

[0057] According to some embodiments, the shelf life 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 about 36 months, optionally at least about 37 months, optionally at least about 38 months, optionally at least about 39 months, and optionally at least about 40 months.

[0058] According to some embodiments, the body material can be sufficient for sterilization by any known sterilization technique 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., aseptic filtration and / or blow-fill-seal operations), and combinations thereof. Preferably, the body material can be sufficient for sterilization by gamma irradiation, and the body material is compatible with the gamma irradiation process. According to some embodiments, the gamma irradiation process causes the body material not to react chemically or physically with the cleaning solution or, if so, not to render the cleaning solution medically unqualified. According to some embodiments, if a container containing the body material has a sterility assurance level (SAL) of at least 10 -6 and provides acceptable results in the integrity test for post-sterilization container closure, the body material can be determined to be sufficient for sterilization.

[0059] According to some aspects, the body material may have sufficient mechanical strength such that the body provides an acceptable response to impact, vibration, shake, or combinations thereof. According to some aspects, an acceptable response refers to a response that conforms to ASTM D4169-16 (Standard Practice for Performance Testing of Shipping Containers and Systems), ASTM D4728-06 (Standard Test Method for Random Vibration Testing of Shipping Containers), ASTM D642-15 (Standard Test Method for Determining the Compressive Resistance of Shipping Containers, Components, and Unit Loads), or any combination thereof. According to some aspects, the body material may be safe for biomedical use. For example, the body material may conform to ISO10993 and / or REACH requirements. According to some aspects, the body material may be sufficient to exhibit at least some of the properties described herein over a storage life of a cleaning solution for a specified period at a temperature between about 15°C and 30°C with variations at temperatures 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 storage life of a cleaning solution for a specified period 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 storage life of a cleaning solution for a specified period after storage at about 37°C and 65% relative humidity.

[0060] The body material may be rigid or flexible. As used herein, the term "rigid" means having sufficient stiffness to resist deformation under normal operating forces. As used herein, the term "flexible" means the ability to bend or compress under normal operating forces.

[0061] Examples of body materials include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Examples of useful plastics according to 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 aspects, the body material can be a lined and / or coated material such as lined and / or coated paper.

[0062] According to some aspects, the body material can be polypropylene. Preferably, the body material can be radiation grade polypropylene. Here, when the body material is radiation grade polypropylene, the body material can be terminally sterilized. The body material according to the present disclosure can be configured to receive gamma irradiation as part of terminal sterilization. Radiation grade polypropylene plastic as the body material allows a sealed body containing the cleaning liquid to receive gamma irradiation, and sterilization is performed with the cleaning liquid already present inside the sealed body.

[0063] The sealed body according to the present disclosure can maintain flexibility during gamma irradiation, and the cleaning liquid contained therein is not significantly affected by gamma irradiation, i.e., the stability and integrity of the cleaning liquid can be maintained. Here, the sealed body maintains the ability to bend or compress under normal operating forces. The sealed body according to the present disclosure can be not significantly affected by gamma irradiation during gamma irradiation, where the stability and integrity of the sealed body can be maintained.

[0064] According to some aspects, when the sealed body is subjected to gamma rays, it can undergo certain material property changes that can help reduce the elongation of the sealed body when the flow regulating member creates a break in the sealed body, as described herein. The reduction in the elongation of the sealed body allows the flow regulating member to easily create a break in the sealed body, as described herein.

[0065] According to some embodiments, the system has a flow regulating member configured to create a breakage in a sealed body and facilitate the discharge of the cleaning liquid contained therein. In some embodiments, the flow regulating member creates a cut in the sealed body to facilitate the discharge of the cleaning liquid. In some embodiments, the flow regulating member creates a cut in the wall of the sealed body.

[0066] According to some embodiments, the sealed body containing the cleaning liquid may have variations in the thickness of the wall of the sealed body. In particular, one or more wall portions of the sealed body may have a different thickness compared to other portions or walls of the sealed body. Preferably, the thickness of a particular wall portion may be smaller compared to other portions or walls of the sealed body. The thickness of such a particular wall portion can be up to 95% of the thickness of other portions or walls, optionally up to 90%, optionally up to 85%, optionally up to 80%, optionally up to 75%, optionally up to 70%, optionally up to 65%, optionally up to 60%, optionally up to 55%, optionally up to 50%, optionally up to 45%, optionally up to 40%, optionally up to 35%, optionally up to 30%, optionally up to 25% of the thickness of other portions or walls. The wall portion having a smaller thickness as described above may be located on the upper wall, bottom wall or side wall of the sealed body. Preferably, the wall portion having a smaller thickness as described above may be the bottom wall of the sealed body with respect to the ground. As seen in FIG. 4, the reduction in the thickness of the wall portion 43 allows the flow regulating member 42 outside the sealed body 41 to easily create a breakage (such as a cut) in the sealed body. In related embodiments, the change in wall thickness and the trapped gas in the sealed body cooperate in the ventilation of the sealed body by allowing the flow regulating member to create a breakage in the sealed body. Preferably, the trapped gas is under a pressure higher than atmospheric pressure. The trapped gas may include an inert gas such as air and / or nitrogen.

[0067] According to some aspects, the sealed body can be self - supported. According to some aspects, one of the walls of the sealed body is configured to be placed on a surface in a stable manner. Here, one of the walls of the sealed body, when placed on a surface, supports the rest of the sealed body and provides a stable position for an individual to use a flow adjustment member to create a breakage in the sealed body to facilitate the discharge of the cleaning liquid. For example, an individual can easily place the sealed body on a table and stably make a cut using the flow adjustment member.

[0068] According to some aspects, as shown in FIG. 1, the sealed body 11 can be labeled with a label 12 to indicate a position on the sealed body that is configured to be broken by a flow adjustment member, for example, by an individual using the flow adjustment member to create a breakage in the sealed body. According to some aspects, the sealed body is labeled using a process selected from the group consisting of embossing, engraving, marking, etc.

[0069] The sealed body according to the present disclosure is configured to distribute a cleaning liquid, such as a cleaning solution, contained therein via one or more mechanisms. According to some aspects, the body can be configured to distribute the cleaning liquid upon compression as described herein. For example, the sealed body can be configured to distribute at least a portion of the cleaning liquid contained therein in response to compression such as squeezing. Additionally or alternatively, the sealed body can be configured to distribute at least a portion of the cleaning liquid contained therein in response to longitudinal compression.

[0070] Additionally or alternatively, the sealed body may be configured to distribute at least a portion of the cleaning liquid contained therein when the body is oriented in a particular direction. Preferably, the flow regulating member forms a breakage portion such as a cut, a small hole, a hole, or a slit in the sealed body, and the sealed body through which the cleaning liquid can be distributed is provided in a particular orientation (e.g., the breakage portion generated by the flow regulating member is provided at or near the bottom of the body sealed with respect to the ground), at least a portion of the cleaning liquid can be configured to be distributed by gravity.

[0071] The sealed body may further have a positioning component that enables the sealed body to be arranged in a particular orientation. The positioning component can be any component configured to position and / or fix the sealed body in a selected orientation, such as a hook, a strap, a snap, a button, a tie, or a combination thereof. The positioning component may be integral with the sealed body and / or a separate component configured to interact with the body, such as a strap attachable to the body. The positioning component may be configured to interact with a second positioning component, such as an extension arm configured to interact with a hook formed by and / or attached to the sealed body.

[0072] It should be understood that the sealed body can be configured to dispense the cleaning liquid via one or a combination of the mechanisms described herein. For example, the sealed body can be configured to dispense the cleaning liquid upon compression in relation to gravity. According to some aspects, the sealed body can be configured to selectively dispense the cleaning liquid via one or more of the mechanisms described herein. In one non-limiting example, the sealed body can be configured to dispense the cleaning liquid upon compression, regardless of the presence or absence of an external force. In this way, the user can select a desired delivery mechanism based on physical limitations (e.g., the user's physical capabilities), desired fluid flow force, desired fluid flow rate, desired fluid flow design (e.g., pulsed or constant), or a combination thereof.

[0073] According to some aspects, the flow regulating member creates a breakage portion in the sealed body to facilitate the discharge of the cleaning liquid through the breakage portion. Here, the cleaning liquid is discharged in a specific flow pattern. According to some aspects, as shown in FIG. 3, the shape and size of the breakage portion 33 created by the flow regulating member determine the flow pattern 32 of the cleaning liquid from the sealed body 31.

[0074] According to some aspects, the flow pattern of the cleaning liquid is described as the cleaning liquid being discharged at a specific pressure. According to some aspects, the cleaning liquid is discharged from the sealed body at a pressure less than 15 psi (1.03×10 5 Pa), less than 12 psi (8.27×10 4 Pa), less than 10 psi (6.89×10 4 Pa), less than 8 psi (5.52×10 4 Pa), or less than 5 psi (3.45×10 4 Pa).

[0075] According to some aspects, the flow pattern of the cleaning liquid is described as the cleaning liquid being discharged in a spray wave in a specific area. According to some aspects, the cleaning liquid is discharged from the sealed body at a pressure less than 15 psi (1.03×10 -3square meters), 9 square inches (5.81×10 -3 square meters), 8 square inches (5.16×10 -3 square meters), 7 square inches (4.52×10 -3 square meters), 6 square inches (3.87×10 -3 square meters), 5 square inches (3.23×10 -3 square meters), 4 square inches (2.58×10 -3 square meters), 3 square inches (1.94×10 -3 square meters), 2 square inches (1.29×10 -3 square meters) or 1 square inch (6.45×10 -4 square meters) and is discharged from the body sealed by the spray wave. In particular, the spray wave can be of any shape.

[0076] According to some embodiments, the flow pattern of the cleaning fluid is described as being such that substantially all of the cleaning fluid is discharged from the sealed body within 20 seconds, less than 20 seconds, within 15 seconds, less than 15 seconds, within 10 seconds, less than 10 seconds, or within 5 seconds.

[0077] According to some embodiments, the sealed body can 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 sealed body can be configured to dispense the cleaning fluid continuously and / or intermittently. In one non-limiting example, the sealed body can be configured to dispense the cleaning fluid intermittently such that the cleaning fluid is dispensed only when the sealed body is compressed.

[0078] The sealed body can be configured to contain an amount of cleaning liquid sufficient to perform at least part of the cleaning process. According to some aspects, the sealed body can be configured to contain a fluid between about 250 mL and 2000 mL, optionally between about 500 mL and 1000 mL. According to some aspects, the sealed body can be configured to contain about 500 mL of fluid. According to some aspects, the sealed body can be configured to contain about 1 L of fluid.

[0079] The system according to the present disclosure has a flow regulating member configured to create a breakage in the sealed body to facilitate the discharge of the cleaning liquid. According to some aspects, as shown in FIG. 2, the flow regulating member 21 has a tool provided in the sealed body as a system to create a breakage in the sealed body. The tool 21 preferably has a tapered end 22 that creates a breakage in the sealed body. Non-limiting examples of tools are tools with a tapered end that can be used to create a breakage such as a cut, a small hole, a hole, or a slit, or a tool that can drill or spike (spike and damage) a hole in the sealed body at a selected location. The tool can be selected from the group consisting of generally cylindrical tools with a tapered end, knives, screws, pins, blades, tapered rods, spikes, or any tool with a tapered first end 22 and a hand grip 23 leading to a second end for creating a breakage in the sealed body. As shown in FIG. 5, various flow regulating members 53 can be used to create a breakage 52 in the sealed body 51.

[0080] According to some embodiments, as shown in FIG. 6, the flow regulating member has a spike cap 61. The spike cap is configured to be attached to the end of the sealed body to facilitate the discharge of the cleaning liquid contained in the sealed body. Here, the spike of the spike cap creates a breakage part in the sealed body when the spike cap is attached to the sealed body so as to ensure that the cleaning liquid is discharged through its cut part. According to some embodiments, the spike cap includes a spike-shaped part 62. The spike-shaped part determines the shape of the spike that will create a breakage part in the sealed body. According to some embodiments, as seen in FIG. 8, the spike-shaped part includes an inclined tip 82 or an aligned tip 81. Here, the spike-shaped part determines the flow pattern of the cleaning liquid discharged from the sealed body as described herein. The spike-shaped part also determines the force required by the person spiking the sealed body in order to spike the sealed body by attaching the spike cap to the sealed body to facilitate the discharge of the cleaning liquid.

[0081] According to some embodiments, the sealed body may further have a buttress thread part at the first end of the sealed body. According to some embodiments, the spike cap may further have a buttress thread part at the first end of the spike cap. Here, the buttress threads at the ends of the sealed body and the spike cap are attached to each other, screwed together, or screwed together to ensure that the spike cap makes a cut in the sealed body for the discharge of the cleaning liquid.

[0082] According to some aspects, as shown in FIG. 7, a spike cap 71 having an inclined tip 72 facilitates the process of creating a break in a sealed body 73 when the spike cap is attached to the sealed body, and the inclined tip creates a hole at a selected location of the sealed body. According to some aspects, a spike cap having an aligned tip aligns the drilling process with a screwing process when the spike cap is attached to the sealed body.

[0083] According to some aspects, more than one spike cap is provided with the sealed body. According to some aspects, spike caps having different spike shapes are provided with the sealed body to achieve different flow patterns of the cleaning fluid as desired.

[0084] According to some aspects, a flow adjustment member is essential to a system having a sealed body. According to some aspects, the flow adjustment member may or may not be in fluid communication with the sealed body during the discharge of the cleaning fluid from the sealed body.

[0085] According to some aspects, the flow adjustment member includes a specific material that has the ability to utilize its own sharp edges and thus eliminates the sharpness of metal that poses a risk in a medical environment. According to some aspects, the flow adjustment member is made of a plastic material. In particular, the flow adjustment member can be made of plastics including, but not limited to, high density polyethylene (HDPE), low density polyethylene (LDPE), polypropylene, polystyrene, acrylic, nylon, polycarbonate, polymethyl methacrylate (PMMA), polyacrylonitrile (PAN), polyester, acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC), and polyvinylidene fluoride (PVDF).

[0086] According to some aspects, the flow regulating member can be made of a metallic material or an alloy material. In particular, the flow regulating member can be made of a metal or an alloy including, but not limited to, stainless steel, cobalt-chromium alloy, titanium, nickel-titanium alloy, gold, platinum, silver, iridium, tantalum, tungsten, aluminum, copper, and magnesium.

[0087] According to some aspects, the sealed body can include a removable lid to prevent fluid discharge from the sealed body, for example, during storage or transportation of the sealed body.

[0088] According to some aspects, the system can be configured to provide an acceptable fluid flow rate for a cleaning process. As used herein, the term "fluid flow rate" refers to the rate at which fluid is applied to a surface, such as a human subject, during a cleaning process. The fluid flow rate can depend at least in part on the characteristics of the delivery mechanism and / or the flow regulating member, as described herein. According to some aspects, the fluid flow rate can be related to the fluid flow force. For example, an increased fluid flow rate can correspond to an increased fluid flow force, and vice versa. The system according to the present disclosure can be configured to provide different selectable fluid flow rates.

[0089] According to some aspects, the system can be configured to provide an acceptable fluid flow force for a cleaning process. As used herein, the term "fluid flow force" refers to the force of the fluid acting on a surface, such as a human subject, during a cleaning process. The acceptable fluid flow force can be determined based on the requirements of the cleaning process.

[0090] 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 mechanisms and / or flow adjustment members described herein. The systems according to the present disclosure may be configured to provide different selectable fluid flow forces. Each of the selectable fluid flow forces may, as described herein, correspond to, for example, a particular delivery mechanism, a particular flow adjustment member, or a combination thereof.

[0091] According to some aspects, the system is configured to provide an acceptable fluid flow design for a cleaning process. As used herein, the term "fluid flow design" refers to the design by which 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 design may include a fluid mist (i.e., a suspension of finely divided fluid in a gas), a fluid stream (i.e., a stable continuous fluid), a fluid spray (i.e., a finely divided fluid), or a combination thereof. The fluid flow design may be constant (e.g., fluid continuously dispensed from a device and / or applied to a surface) or pulsed (e.g., fluid intermittently dispensed from a device and / or applied to a surface).

[0092] The fluid flow design may additionally or alternatively refer to the angle at which the fluid flow path is dispensed from the device and / or applied to the surface. For example, the fluid flow path may have a fluid flow design that is substantially perpendicular to the longitudinal axis of the sealed body, as described herein.

[0093] Additionally or alternatively, the fluid flow design may refer to the geometric shape of the fluid path. It should be understood that the geometric shape of the fluid 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.

[0094] It should be understood that the fluid flow design may depend at least in part on the delivery mechanisms and / or flow adjustment members described herein.

[0095] According to some aspects, one or more components of the systems described herein may be provided in a sterile package. As used herein, the term "sterile package" refers to a package that provides a sterile environment to maintain the sterility of the sterile product contained therein. Examples of sterile packages include, but are not limited to, sterile blister packages, sterile safe-edge trays, sterile surgical trays, sterile custom thermoformed articles, sterile bags, sterile plastic molded trays with upper lids, and combinations thereof. It should be understood that one or more components of the system may be provided in the same sterile package and / or in a sterile package separate from at least one other component of the system. For example, a first component of the system may be housed in a first sterile package, and a second component of the system may be housed in a second sterile package. In one non-limiting example, the system may include a sealed body housed in a first sterile package and a flow regulating member housed in a second sterile package. Providing one or more components of the system in different sterile packages allows for the removal of each component of the system immediately prior to its use and, thus, prevents one or more components from being exposed to a non-sterile environment for an extended period of time. In this way, a fully assembled sterile presentation of the system can be achieved.

[0096] The aspects described herein are described in connection with the exemplary aspects outlined above, but various alternatives, modifications, variations, improvements, and / or substantial equivalents may become apparent to at least one person of ordinary skill in the art, whether known or currently unpredictable. Accordingly, the above exemplary aspects are intended to be illustrative rather than limiting. Various changes may 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, modifications, variations, improvements, and / or substantial equivalents.

[0097] Accordingly, the claims are not intended to be limited to the aspects shown herein, but rather are intended to cover the full scope consistent with the claim language, where references to singular elements are not intended to mean "only one" unless specifically stated otherwise, but rather are intended to mean "one or more." All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those of ordinary skill in the art are hereby expressly incorporated by reference and are intended to be encompassed by the claims. Further, what is disclosed herein is not intended to be made available to the public whether or not such disclosure is expressly recited in the claims. An element of a claim should not be construed as a means-plus-function unless the element is expressly recited using the phrase "means."

[0098] Furthermore, the word "example" as used herein means "an example, instance, or illustration." Any aspect described herein as an "example" should not necessarily 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," and "A, B, C, or any combination thereof" can include any combination of A, B, and / or C and can include multiple A's, multiple B's, or multiple C's. Specifically, combinations such as "at least one of A, B, or C," "at least one of A, B, and C," and "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 and B and C, and such combinations can include one or more members of A, B, or C. What is disclosed herein is not intended to be made available to the public whether or not such disclosure is expressly recited in the claims.

[0099] The term "about" is used herein to mean within ±5% of the recited value, optionally within ±4% of the recited value, optionally within ±3% of the recited value, optionally within ±2% of the recited value, optionally within ±1% of the recited value, optionally within ±0.5% of the recited value, optionally within ±0.1% of the recited value, and optionally within ±0.01% of the recited value.

Claims

1. A system for applying a cleaning liquid to a surface, comprising: A sealed body for containing the cleaning liquid, wherein the sealed body and the cleaning liquid contained therein are ultimately sterilized, the sealed body, and A flow regulating member configured to create a breakage portion in the sealed body to facilitate the discharge of the cleaning liquid in a flow pattern, the flow regulating member, and A system having the above components.

2. The flow regulating member has a tool with a tapered end, The system according to Claim 1.

3. The flow regulating member has a spike cap configured to be attached to a first end of the sealed body, the spike cap having a spike-shaped portion, The system according to Claim 1.

4. The sealed body has a buttress thread portion at a first end of the sealed body, The system according to Claim 3.

5. The spike cap further has a buttress thread portion configured to be attached to the buttress thread portion at the first end of the sealed body, The system according to Claim 4.

6. The spike-shaped portion has an inclined tip, The system according to Claim 3.

7. The spike-shaped portion has aligned tips, The system according to Claim 3.

8. The flow regulating member separates from the sealed body during the discharge of the cleaning liquid, The system according to Claim 1.

9. The flow regulating member is in fluid communication with the sealed body during the discharge of the cleaning liquid, The system according to Claim 1.

10. The flow regulating member makes a cut in the sealed body, and the shape and size of the cut determine the flow pattern of the cleaning liquid, The system according to Claim 1.

11. The sealed body is compressible, and the sealed body is configured such that when the sealed body is compressed, at least a portion of the cleaning liquid is discharged through the breakage portion, The system according to Claim 1.

12. The sealed body is configured such that at least a portion of the cleaning liquid is discharged through the breakage portion regardless of whether the sealed body is compressed, The system according to Claim 1.

13. The sealed body is foldable, The system according to Claim 1.

14. The flow regulating member is integral with the sealed body, The system according to claim 1.

15. The cleaning liquid contains a chemical agent and water, and the chemical agent contains iodine, The system according to claim 1.

16. The flow pattern includes that substantially all of the cleaning liquid is discharged from the sealed body within 20 seconds, The system according to claim 1.

17. The flow pattern includes discharging the cleaning liquid at a pressure of less than 15 psi (1.03×10 5 Pa). The system according to claim 1.

18. The flow pattern includes discharging the cleaning liquid in a spray wave of 6 square inches (3.87×10 -3 square meters). The system according to claim 1.

19. The flow regulating member includes a material selected from the group consisting of plastic, metal, and alloy, The system according to claim 1.

20. The sealed body includes a plastic compatible with gamma ray irradiation, The system according to claim 1.

21. The sealed body and the cleaning liquid contained therein are finally sterilized by gamma ray irradiation, The system according to claim 1.

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