Self-supporting cleaning system, device, and article

Abstract

An article for applying a cleaning liquid to a surface, the article having a sealed body that houses the cleaning liquid, the sealed body being configured to stand on its own before and during the discharge of the cleaning liquid from the sealed body, and the sealed body and the cleaning liquid contained therein being ultimately sterilized. A system comprising the article of claim 1 and an application member, the application member being configured to rupture the wall of the sealed body to form a fluid supply port and to form a flow path for discharging the cleaning liquid.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 63 / 358,412, filed on July 5, 2022, the entire content of which is incorporated herein by reference.

[0002] The present disclosure relates to self - standing devices, systems, and articles for applying a cleaning fluid to a surface.

Background Art

[0003] Currently, lavage (i.e., the irrigation of body cavities, surgical cavities, or wounds with a medically acceptable liquid) is often used to prevent contamination of open surgical wounds, which can occur for various reasons such as accidental visceral penetration or perforation, surgeries complicated by a large amount of spillage, deviation from aseptic techniques, and / or existing ongoing clinical infections. Thus, the lavage process is often used for intraoperative wound disinfection.

[0004] Lavage techniques currently encompass a wide variety of approaches that vary based on the situation (e.g., the size and shape of the cavity or wound) and the physician performing the lavage process (e.g., the physician's technical preferences). Currently, no specific lavage technique is standardized in this technology, and thus, in medical facilities, it is often necessary to have a number of different lavage devices and systems to accommodate the various potential approaches. The presentation of such devices and systems is also sometimes a concern. This is because improper use of such devices and systems (e.g., intravenously when the device and / or system resembles an intravenous device and / or system) can have devastating effects.

[0005] Furthermore, current cleaning methods have several drawbacks, including the inadequacy of the properties of disinfectants (e.g., the time required for disinfectants to achieve an acceptable biological effect, which can be exorbitant), the risk of systemic absorption of disinfectants, side effects such as anaphylaxis, peritoneal adhesions, neurotoxicity, and respiratory failure, and inappropriate dosages or contamination of disinfectants specially (ad hoc) prepared by the physicians performing the cleaning.

[0006] Furthermore, current cleaning devices often have an increased risk of contamination. For example, some current cleaning devices use an elastic hollow body (e.g., a "squeeze bottle", etc.) that discharges the cleaning liquid when pressure is applied. For such a device to function, it requires one or more rebalancing periods (i.e., periods during which the pressure on the device is reduced or no pressure is applied at all), during which gas such as air is drawn into the device to rebalance the internal pressure of the device. However, introducing non-sterile gas into the device may compromise the sterility of the cleaning liquid (and thus the surgical wound with which the cleaning liquid comes into contact) contained in the device. Furthermore, such devices inhale gas during the rebalancing 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 therefore the rebalancing periods required for such devices often result in unacceptable delays in the cleaning process, and as a result, the cleaning process is often inefficient and / or ineffective.

[0007] Furthermore, current cleaning devices are not self-supporting and require support of the device by specific means separate from the cleaning device itself to perform the intended function. Current cleaning devices typically require specific components to position the device in a specific orientation and maintain the device in a stable position for the cleaning liquid application process. Furthermore, current cleaning devices have a limited ability for clinicians to control the flow of the cleaning liquid to the target.

[0008] Thus, there is a need in the art for self - contained, multi - purpose devices and systems for performing a lavage process, and in particular, for devices and systems that enable a physician to safely and effectively reduce the contamination of surgical wounds that are susceptible to surgical site infections. In the art, there is a need for a self - contained lavage device that does not require another means to position and maintain a stable position of the lavage device. In the art, there is a need for a terminal sterilization lavage device in which the lavage fluid contained therein is ultimately sterilized along with the lavage device without damaging the materials used to manufacture the lavage device. Also needed in the art is a lavage device that has the ability to deliver large volumes of lavage fluid in a short period of time and enables a clinician to optimally control and target the flow of the lavage fluid. SUMMARY OF THE INVENTION

[0009] The present disclosure relates to devices, systems, and articles for delivering a lavage fluid, such as an irrigation fluid, to a surface. The article includes a sealed body configured to contain a lavage fluid, such as an irrigation fluid. The sealed body is further configured to be self - standing before and during the discharge of the lavage fluid from the sealed body. Optionally, both the sealed body and the lavage fluid contained therein are ultimately sterilized.

[0010] The devices, systems, and articles 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 selectively control the delivery of the lavage fluid to the surface. The present disclosure also relates to methods of using the devices, systems, and articles described herein.

[0011] The present disclosure also relates to an application member that can be used with the devices, systems, and articles described herein. The application member is configured to apply a cleaning fluid to a surface sufficient for a cleaning process. The application member includes a fluid channel configured to provide fluid communication between the seal body and the external environment. The application member is configured to cause a disruption in the seal body containing the cleaning fluid. Due to the disruption occurring in the seal body, the cleaning fluid flows from the seal body through the application member and is easily discharged in a flow pattern.

Brief Description of the Drawings

[0012]

Figure 1

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Modes for Carrying Out the Invention

[0013] The present disclosure relates to devices, systems, and articles for delivering a cleaning fluid, such as an irrigation fluid, to a surface. The article includes a device such as a fluid container that includes a seal body configured to contain a cleaning fluid such as an irrigation fluid. The seal body is further configured to stand on its own before and during the discharge of the cleaning fluid from the seal body. Optionally, both the seal body and the cleaning fluid contained therein are ultimately sterilized.

[0014] The present disclosure also relates to an applicator member that can be used with the devices, systems, and articles described herein. The applicator member is configured to apply a cleaning fluid to a surface sufficient for a cleaning process. The applicator member includes a fluid channel configured to provide fluid communication between a seal body and an external environment. The applicator member is configured to form a rupture, such as a cut, puncture, hole, or slit, in the seal body containing the cleaning fluid. The rupture formed in the seal body facilitates the discharge of the cleaning fluid from the seal body through the applicator member in a flow pattern. The devices, systems, and articles 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 selectively control the delivery of the cleaning fluid. The present disclosure also relates to methods of using the devices, systems, and articles described herein.

[0015] As used herein, the term "cleaning fluid" refers to a fluid suitable for the cleaning processes described herein. As used herein, the term "cleaning" refers to the cleaning of body cavities, surgical cavities, and / or wounds.

[0016] In some aspects, the cleaning fluid can include an irrigation fluid. As used herein, "cleaning fluid" refers to a solution containing at least a solvent and one or more chemicals. Non-limiting examples of chemicals include, but are not limited to, preservatives, antibiotics, antibacterial agents, oxidizing agents, and combinations thereof. In some aspects, the irrigation fluid is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which the solvent contains at least a majority of water. It should be understood that in some examples, the solvent may consist of water. In some aspects, the irrigation fluid is an alcohol solution. As used herein, the term "alcohol solution" refers to a solution in which the solvent contains at least a majority of alcohol. It should be understood that in some examples, the solvent may consist of one or more alcohols. Non-limiting examples of alcohols include, but are not limited to, ethanol, isopropyl alcohol, n-propanol, and combinations thereof.

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

[0018] In addition to or instead of, the preservative can include iodine. According to some embodiments, the iodine can be provided as an iodine complex such as povidone iodine (PVPI), nonylphenoxy(ethyleneoxy)iodine, polyethyleneoxypolypropyleneoxyiodine, undecoylium chloride iodine, iodine pobaxylate, and combinations thereof.

[0019] In addition to or instead of, the chemical can 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.

[0020] In a non-limiting example, the chemical 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.

[0021] The chemical may have sufficient antibacterial activity to provide an acceptable log reduction of microorganisms within a certain period. It should be understood that the term "microorganisms" as used herein may refer to any microorganisms that are killed and / or removed as a result of cleaning. Examples of microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0022] Examples of bacteria include drug-resistant and drug-susceptible Streptococcus species (e.g., S. mutans, S. pyogenes, S. salivarius, S. sanguis), Staphylococcus species (e.g., S. aureus, S. epidermidis, S. haemolyticus, S. hominis, S. simulans, S. saprophyticus), Enterococcus species (e.g., E. faecalis, E. facecium, and E. hirae), Bacteroides fragilis, Cutibacterium acnes (formerly Propionibacterium acnes), Clostridium difficile (spores and vegetative cells), Pseudomonas aeruginosa, Escherichia coli, Sepacia, Proteus mirabilis, Klebsiella species (e.g., K. aerogenes, K. pneumoniae), Acinetobacter baumannii, Micrococus luteus, Haemophilus influenza, Serratia marcescens, but are not limited thereto.

[0023] Examples of fungi include drug-resistant and drug-susceptible Aspergillus brasiliensis, Candida spp (C. albicans, C. aurus, C. dubliniensis, C. glabrata, C. guillermondii, C. kefyr (formerly C. pseudotropicalis), C. krusei, C. lusitaniae, C. Tropicalis), Epidermophyton floccosum, Microsporum spp (e.g., M. gypseum, M. canis), and Trichophyton mentagrophytes, but are not limited thereto.

[0024] Examples of viruses include 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, etc., including DNA and RNA genomes that are single-stranded or double-stranded, have a sense or antisense orientation, and have a protein coat (capsid) regardless of the presence or absence of a lipid envelope, but are not limited thereto.

[0025] According to some embodiments, a particular period may be a period of about 5 minutes or less, optionally about 4 minutes or less, optionally about 3 minutes or less, optionally about 2 minutes or less, and optionally about 1 minute or less.

[0026] According to some embodiments, a particular period may be about 120 seconds or less, optionally about 105 seconds or less, optionally about 90 seconds or less, optionally about 75 seconds or less, optionally about 60 seconds or less, optionally about 45 seconds or less, optionally about 30 seconds or less, and optionally about 15 seconds or less.

[0027] It should be understood that "acceptable log reduction" may depend on the microorganism. For example, the acceptable log reduction described herein may refer to the acceptable log reduction of one type of microorganism present on a surface (e.g., present in a body cavity or at an external wound site), a combination of two or more types of microorganisms present on a surface, or all of the microorganisms present on a surface.

[0028] According to some embodiments, the acceptable logarithmic reduction may 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.

[0029] According to some embodiments, the chemical may be present in the cleaning solution at a concentration sufficient to provide an acceptable log reduction of microorganisms within a specified period, as described herein. According to some embodiments, the chemical may be present in the cleaning solution at a concentration of about 0.001 to 10% w / v, optionally about 0.001 to 7.5% w / v, optionally about 0.001 to 5% w / v, optionally about 0.001 to 2.5% w / v, optionally about 0.001 to 1% w / v, optionally about 0.001 to 0.1% w / v, optionally about 0.001 to 0.01% w / v, optionally about 0.01 to 10% w / v, optionally about 0.01 to 7.5% w / v, optionally about 0.01 to 5% w / v, optionally about 0.01 to 2.5% w / v, optionally about 0.01 to 2% w / v, optionally about 0.01 to 1.5% w / v, optionally about 0.01 to 1% w / v, and optionally about 0.5% w / v.

[0030] According to some embodiments, the chemical may be present in the perfusion fluid at a concentration of about 0.1 to 0.9% w / v, optionally about 0.2 to 0.8% w / v, optionally about 0.3 to 0.7% w / v, and optionally about 0.4 to 0.6% w / v.

[0031] According to some embodiments, the chemical may be present in the perfusion fluid at a concentration of about 0.1 to 1% w / v, optionally about 0.2 to 1% w / v, optionally about 0.3 to 1% w / v, and optionally about 0.4 to 1% w / v.

[0032] It should be understood that according to some embodiments, the cleaning solution need not be the perfusion fluid described herein and may be any medically acceptable fluid configured to perform the cleaning process described herein. By way of non-limiting example, the cleaning solution may include physiological saline. Physiological saline can include water and sodium chloride at a medically acceptable concentration, such as about 0.1 to 1% w / v, optionally about 0.45% w / v, and optionally about 0.9% w / v.

[0033] In a preferred embodiment, the cleaning solution can contain a formulation. The formulation can contain sodium citrate, citric acid, and sodium lauryl sulfate. The formulation can contain sodium citrate at a medically acceptable concentration, such as about 10 - 50 g / l, optionally about 20 - 40 g / l, and optionally about 30 g / l. The formulation can contain citric acid at a medically acceptable concentration, such as about 10 - 50 g / l, optionally about 20 - 40 g / l, and optionally about 32 g / l. The formulation can contain sodium lauryl sulfate at a medically acceptable concentration, such as about 0.1 - 5 g / l, optionally about 0.5 - 2 g / l, and optionally about 1 g / l.

[0034] In a preferred embodiment, the cleaning solution can contain a formulation. The formulation can contain sodium acetate, acetic acid, benzalkonium chloride, and ethanol. The formulation can contain sodium acetate at a medically acceptable concentration, such as about 10 - 50 g / l, optionally about 20 - 40 g / l, and optionally about 30 g / l. The formulation can contain acetic acid at a medically acceptable concentration, such as about 20 - 100 g / l, optionally about 40 - 80 g / l, and optionally about 50 g / l. The formulation can contain benzalkonium chloride at a medically acceptable concentration, such as about 0.1 - 5 g / l, optionally about 0.5 - 2 g / l, and optionally about 1 g / l. The formulation can contain ethanol at a medically acceptable concentration, such as about 50 - 150 g / l, optionally about 75 - 125 g / l, and optionally about 100 g / l.

[0035] According to some aspects, the cleaning fluid such as the perfusion fluid described herein can include a visualization aid. As used herein, the term "visualization aid" refers to a component in the cleaning fluid configured to assist in visualizing the application of the cleaning fluid. Examples of visualization agents include, but are not limited to, colorants, dyes, and radiopaque agents. It should be understood that the visualization agent may be the same as or different from one of the other components of the cleaning fluid. For example, a chemical may function as a visualization agent. Additionally or alternatively, the cleaning fluid may include a visualization agent different from the chemical.

[0036] According to some aspects, the cleaning fluid may include a colorant. As used herein, the term "colorant" refers to a component sufficient to impart an observable color to a fluid. The colorant may be sufficient to make the cleaning fluid applied to the surface visible. In some non-limiting examples, the colorant may include an anionic colorant such as an anionic dye. The anionic dye may be any dye suitable for medical use, such as a dye approved by the Food and Drug Administration for use in food, 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 (Indigo Carmine), FD&C Green No. 3 (Fast Green FCF), FD&C Red No. 3 (Erythrosine), FD&C Red No. 40 (Allura Red), FD&C Yellow No. 5 (Tartrazine), FD&C Yellow No. 6 (Sunset Yellow FCF), D&C Yellow No. 8 (Fluorescein), D&C Orange No. 4, and combinations thereof. Combinations can also be implemented to obtain a specific color. For example, orange coloring can include both FD&C Red No. 40 and D&C Yellow No. 8. Additionally or alternatively, the colorant can include compounds observable when exposed to visible and / or non-visible light, including, but not limited to, vitamin B-12, medical honey, fluorescent polymer nanoparticles, water-soluble luminescent carbon nanodots, quinine, and combinations thereof.

[0037] According to some aspects, the cleaning liquid such as the perfusion liquid described herein can contain a staining agent. As used herein, the term "staining agent" refers to a component sufficient to temporarily or permanently color the contacting surface.

[0038] According to some aspects, the cleaning liquid such as the perfusion liquid described herein can contain a radiopaque agent. As used herein, the term "radiopaque agent" refers to a component that is opaque to radio waves and X-ray portions of the electromagnetic spectrum sufficient for visualization. In some non-limiting examples, the radiopaque agent can include barium, iodine, iron oxide nanoparticles, gadolinium complex nanospheres, silica nanospheres, and combinations thereof.

[0039] According to some aspects, the cleaning liquid such as the perfusion liquid described herein can be basic, neutral, or acidic. According to some aspects, the pH of the cleaning liquid can be about 1-10, optionally about 1-7, optionally about 1-6, and optionally about 2-5.5.

[0040] According to some aspects, the cleaning liquid such as the perfusion liquid described herein can contain 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 large changes in pH caused by strong acids or strong bases. The buffer system can include a single agent or multiple agents such as a weak acid and its conjugate base. The buffer system can provide resistance to large pH changes by interacting with strong acids or strong bases in the composition or solution, thereby at least partially preventing the pH of the composition or solution from changing significantly.

[0041] Generally, a buffer system has one or more buffer ranges in which the buffer system has the ability to provide resistance to large pH changes. When the pH of a composition or solution containing a buffer system is within the buffer range of the buffer system, the pH of the composition or solution will not change significantly even when an equimolar amount of strong acid or strong base is added.

[0042] 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 approximately the same as the logarithmic measure of the acid dissociation constant of the weak acid contained in the buffer system (i.e., pK a , equal to -log 10 K a ).

[0043] According to some embodiments, a cleaning solution such as the perfusion solution described herein can include a stabilizer. As used herein, the term "stabilizer" refers to any component that supports the stability of the cleaning solution not explicitly described herein.

[0044] According to some embodiments, the cleaning solution can be the cleaning solution described in U.S. Patent Application No. 17 / 152,565, which is hereby incorporated by reference in its entirety.

[0045] An article 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 its ordinary and general sense and refers to a decrease in volume to create a pressure differential to support optimal fluid flow. In some embodiments, this can include the ability to reversibly decrease the volume without unacceptable changes such as unacceptable permanent changes to the size, shape, and / or one or more properties described herein. According to some embodiments, the sealed body can be configured such that at least a portion of the cleaning solution contained therein is dispensed when compressed. It should be understood that "dispense" (or referred to as "discharge") as used herein may refer to transferring the cleaning solution to an application member in fluid communication with the sealed body and / or transferring the cleaning solution from the application member to a surface.

[0046] According to some aspects, the seal body may be collapsible. As used herein, the term "collapsible" is used in its ordinary and general sense and refers to the ability to permanently reduce volume. For example, a collapsible seal body as described herein may have a first volume when a first volume of fluid is contained therein. When at least a portion of the fluid is dispensed, the collapsible seal body is collapsed to have a second volume, and the second volume is smaller than the first volume. It should be understood that a collapsible seal body advantageously reduces the volume of waste (e.g., the volume of the body after the internal fluid has been dispensed). A collapsible seal body can further provide for more efficient fluid discharge.

[0047] According to some aspects, the seal 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.

[0048] According to some aspects, the seal body can be composed of a body material that is compatible with the cleaning liquid contained therein, i.e., a material that does not react chemically or physically with the cleaning liquid or render the cleaning liquid unsuitable for medical use.

[0049] According to some embodiments, the body material may be sufficient to prevent unacceptable vapor or chemical losses from the cleaning liquid contained therein over a certain storage period. It should be understood that "unacceptable vapor or chemical losses" may be losses that render the cleaning liquid unsuitable for its intended use. Losses of vapor or chemicals may result, for example, from adsorption or absorption of chemicals by the material (e.g., the body material), evaporation of the solution, evaporation of components of the solution (e.g., disinfectants of the disinfecting solution), or combinations thereof. In a non-limiting example where the cleaning liquid contains water and iodine as described herein, the body material may be sufficient to prevent loss of water vapor and / or loss of iodine over a certain storage period.

[0050] As used throughout this application, the term "storage period" refers to the period during which a product (e.g., a disinfecting solution) can be stored while remaining within the specifications required for the shape, fitness, and function of the product. The storage period can be determined by measuring certain characteristics of the product that may indicate that the product is no longer suitable for medical use. For example, the storage period 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., the 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 stored acceptably for more than 72 hours. According to some embodiments, the long-term storage conditions may refer to a temperature of about 25°C and a relative humidity of about 60%. Additionally or alternatively, the storage period 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 of 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 storage period 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 of 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 about 15 - 30°C and fluctuating the temperature to below about 40°C.

[0051] According to some embodiments, the shelf life 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 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.

[0052] According to some embodiments, the body material may 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 may be sufficient for sterilization by gamma irradiation, in which case the body material is compatible with the process of gamma irradiation. According to some embodiments, the body material does not react chemically or physically with the cleaning solution, or the cleaning solution is not suitable for medical use due to the gamma irradiation process. According to some embodiments, when the container containing the body material has a sterility assurance level (SAL) of at least 10 -6 and provides acceptable results in the integrity test of the post-sterilization container closure, the body material can be determined to be sufficient for sterilization.

[0053] According to some aspects, the body material may have sufficient mechanical strength for the body to provide an acceptable response to impact, vibration, shaking, or combinations thereof. According to some aspects, an acceptable response refers to a response compliant with ASTM D4169-16 (Standard Test Methods 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 comply with ISO 10993 and / or REACH requirements. According to some aspects, the body material may be sufficient to exhibit at least some of the characteristics described herein over a certain period of the storage period of the cleaning liquid at a temperature of about 15 - 30 °C and under a condition of temperature variation of about 40 °C or less. Additionally or alternatively, the body material may be sufficient to exhibit at least some of the characteristics described herein over a certain period of the storage period of the cleaning liquid 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 characteristics described herein over a certain period of the storage period of the cleaning liquid after storage at about 37 °C and 65% relative humidity.

[0054] The body material may be rigid or flexible. As used herein, the term "rigid" refers to sufficient rigidity to withstand deformation by normal operating forces. As used herein, the terms "flexible, flexible" refer to the ability to bend or compress with normal operating forces.

[0055] Examples of the body material 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 may be a lined and / or coated material, such as lined and / or coated paper.

[0056] According to some embodiments, the body material may be polypropylene. Preferably, the body material may be radiation-grade polypropylene. Here, when the body material is radiation-grade polypropylene, the body material can undergo terminal sterilization. The body material according to the present disclosure may be configured to receive gamma-ray irradiation as part of terminal sterilization. By using radiation-grade polypropylene plastic as the body material, gamma rays can be irradiated onto the seal body containing the cleaning liquid, and sterilization is performed with the cleaning liquid already present in the seal body.

[0057] The seal body according to the present disclosure can maintain flexibility even when receiving gamma-ray irradiation, and the cleaning liquid contained therein is not significantly affected by gamma-ray irradiation, that is, the stability and integrity of the cleaning liquid can be maintained. Here, the seal body maintains the ability to bend or compress under normal operating forces. The seal body according to the present disclosure is not significantly affected by gamma-ray irradiation even when receiving gamma-ray irradiation, and the stability and integrity of the seal body can be maintained.

[0058] According to some embodiments, when the seal body receives gamma-ray irradiation, it can undergo certain material property changes that can help reduce the elongation of the body when the application member causes the seal body to rupture, as described herein. The reduction in the elongation of the seal body allows the application member to easily cause the seal body to rupture, as described herein.

[0059] As shown in FIG. 1, according to some embodiments, the seal body 11 includes a wall configured to be ruptured to facilitate the discharge of the cleaning liquid contained therein. In some embodiments, the wall is configured to form a fluid supply port when ruptured. According to some embodiments, the application member 14 causes a rupture 18 in the wall of the seal body to facilitate the discharge of the cleaning liquid contained in the seal body. In some embodiments, the application member causes a rupture in the wall of the seal body, such as a cut, puncture, hole, or slit.

[0060] According to some aspects, the seal body containing the cleaning liquid may have variations in the thickness of the walls of the seal body. In particular, one or more wall portions of the seal body may have different thicknesses compared to other wall portions or the wall thickness of the seal body. Preferably, the wall configured to form the fluid supply port when ruptured has a wall portion with a different thickness compared to other wall portions or the wall thickness of the seal body. Preferably, the thickness of the wall portion configured to form the fluid supply port when ruptured may be thinner compared to other wall portions or the wall of the seal body. The thickness of the wall portion may be up to 95% of the thickness of other wall portions or the wall, optionally up to 90% of the thickness of other wall portions or the wall, optionally up to 85% of the thickness of other wall portions or the wall, optionally up to 80% of the thickness of other wall portions or the wall, optionally up to 75% of the thickness of other wall portions or the wall, optionally up to 70% of the thickness of other wall portions or the wall, optionally up to 65% of the thickness of other wall portions or the wall, optionally up to 60% of the thickness of other wall portions or the wall, optionally up to 55% of the thickness of other wall portions or the wall, optionally up to 50% of the thickness of other wall portions or the wall, optionally up to 45% of the thickness of other wall portions or the wall, optionally up to 40% of the thickness of other wall portions or the wall, optionally up to 35% of the thickness of other wall portions or the wall, optionally up to 30% of the thickness of other wall portions or the wall, and optionally up to 25% of the thickness of other wall portions or the wall. The wall portion with a thinner thickness as described above may be the upper, lower, or side wall portion of the seal body. Preferably, the wall portion with a thinner thickness as described above may be the bottom wall portion of the seal body with respect to the ground. Due to the thinner thickness of the wall portion, an application member outside the seal body can easily cause rupture of the seal body. Preferably, the confined gas is under a pressure higher than atmospheric pressure. The confined gas may include an inert gas such as air and / or nitrogen.

[0061] According to some embodiments, a wall configured to form a fluid supply port when ruptured includes a first portion and a second portion, and the first portion is thinner than the second portion. As shown in FIG. 1, according to some embodiments, the fluid supply port is formed in the first portion 19 of the wall of the seal body. Here, as shown in FIG. 3, the fluid supply port 31 is formed by the rupture of the first portion of the wall 32 of the seal body, and this rupture is formed by an application member to facilitate the discharge of the cleaning liquid, and the second portion of the wall is indicated by 33. In some embodiments, the rupture of the first portion of the wall of the seal body forms a fluid supply port, thus forming a flow path for discharging the cleaning liquid.

[0062] In some embodiments, the wall configured to form a fluid supply port when ruptured further includes a spike port, and the spike port is located in the first portion of the wall. In some embodiments, the application member ruptures the spike port by forming a cut, puncture, hole, or slit in the spike port to form a fluid supply port for facilitating the discharge of the cleaning liquid. In some embodiments, the rupture of the spike port forms a fluid supply port, thus forming a flow path for discharging the cleaning liquid. In some embodiments, the spike port further includes a flexible membrane. Preferably, the flexible membrane includes an elastomeric disk. In particular, the elastomeric disk is made of a material including, but not limited to, silicone, thermoplastic polyurethane (TPU), nylon, and polyvinylidene fluoride (PVDF).

[0063] As shown in FIG. 6, according to some aspects, the seal body 61 may be self - standing. According to some aspects, one of the walls of the seal body is configured to be placed on a surface in a stable manner. Here, one of the walls of the seal body supports the rest of the seal body when placed on the surface, provides a stable position for an individual using the application member, and causes a rupture in the seal body to facilitate the discharge of the cleaning liquid. For example, an individual can easily place the self - standing seal body on a table and stably cause a rupture with the application member. In some embodiments, the seal body is self - standing before and during the discharge of the cleaning liquid from the seal body.

[0064] According to some aspects, the seal body may be labeled to indicate a position on the seal body configured to be ruptured by an application member, e.g., a position on the seal body configured to be ruptured by an individual using the application member to cause a rupture in the seal body. According to some aspects, the seal body is labeled using a process selected from the group consisting of embossing, engraving, marking, etc.

[0065] The seal body according to the present disclosure is configured to distribute a cleaning liquid, such as an irrigation liquid contained therein, through one or more mechanisms. According to some aspects, the seal body may be configured to distribute the cleaning liquid upon compression, as described herein. For example, the seal body may be configured to distribute at least a portion of the cleaning liquid contained therein in response to compression (e.g., squeezing). Additionally or alternatively, the seal body may be configured to distribute at least a portion of the cleaning liquid contained therein in response to vertical compression.

[0066] Additionally or alternatively, the seal body may be configured to dispense at least a portion of the cleaning liquid contained therein when the seal body is oriented in a particular direction. Preferably, the application member causes a rupture in the seal body, such as a cut, puncture, hole, or slit, from which the cleaning liquid can be dispensed. The seal body may be configured such that when provided in a particular orientation (e.g., when a rupture caused by the application member is provided at or near the bottom of the seal body relative to the substrate), at least a portion of the cleaning liquid is dispensed by gravity.

[0067] It should be understood that the seal body may be configured to dispense the cleaning liquid via one or a combination of the mechanisms as described herein. For example, the seal body may be configured to dispense the cleaning liquid upon compression in conjunction with gravity. According to some aspects, the seal body may be configured to selectively dispense the cleaning liquid via one or more of the mechanisms as described herein. In a non-limiting example, the seal body may 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 dynamics, desired fluid flow rate, desired fluid flow design (e.g., pulsed or constant), or a combination thereof.

[0068] According to some aspects, the seal body may be configured to dispense at least about 75%, optionally at least about 80%, optionally at least about 85%, optionally at least about 90%, optionally at least about 95%, and optionally about 100% of the cleaning liquid contained therein. The seal body may be configured to dispense the cleaning liquid continuously and / or to dispense the cleaning liquid intermittently. In a non-limiting example, the seal body may be configured to dispense the cleaning liquid intermittently such that the cleaning liquid is dispensed only upon compression of the seal body.

[0069] The seal body can be configured to contain a sufficient amount of cleaning liquid to perform at least a part of the cleaning process. According to some embodiments, the seal body can be configured to contain about 250 to 2000 mL (milliliters) of fluid, and optionally can be configured to contain about 500 to 1000 mL. According to some embodiments, the seal body may be configured to contain about 500 mL of fluid. According to some embodiments, the seal body may be configured to contain about 1 L of fluid.

[0070] According to some embodiments, the application member causes a rupture in the seal body to facilitate the discharge of the cleaning liquid through the flow path. Here, the cleaning liquid is discharged in a specific flow pattern through the flow path. According to some embodiments, the flow pattern of the cleaning liquid from the seal body is determined by the shape and size of the rupture caused by the application member.

[0071] According to some embodiments, the flow pattern of the cleaning liquid is described as the cleaning liquid being discharged at a specific pressure. According to some embodiments, the cleaning liquid is discharged from the seal body at a pressure of less than 15 psi, less than 12 psi, less than 10 psi, less than 8 psi, or less than 5 psi.

[0072] According to some embodiments, the flow pattern of the cleaning liquid is described as the cleaning liquid being discharged in a spray wave of a specific area. According to some embodiments, the cleaning liquid is discharged from the seal body in a spray wave of 10 square inches, 9 square inches, 8 square inches, 7 square inches, 6 square inches, 5 square inches, 4 square inches, 3 square inches, 2 square inches, or 1 square inch. In particular, the spray wave may be of any shape.

[0073] According to some embodiments, the flow pattern of the cleaning liquid is described as substantially all of the cleaning liquid being discharged from the seal 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.

[0074] As shown in FIG. 1, the article according to the present disclosure further includes an application member 14 configured to cause a rupture 18 in the seal body 11 to facilitate the discharge of the cleaning liquid through the flow path. According to some aspects, the application member includes a tubular structure 15 including a first end and a second end. According to some aspects, the first end of the application member includes a spike 16 that causes a rupture 18 in the seal body. According to some aspects, the second end of the application member includes an injection gun 17 to facilitate the discharge of the cleaning liquid.

[0075] As shown in FIG. 2, in some embodiments, the application member 24 further includes a connector 21 to facilitate connecting a single application member 24 to a plurality of seal bodies 22 and 23. In some embodiments, the first end of the application member 24 includes a plurality of spikes 25 and 26 to facilitate connecting a single application member 24 to a plurality of seal bodies 22 and 23. For example, the application member 24 includes two spikes 25 and 26 at the first end of the application member, spike A 25 causes a rupture in seal body A 22, spike B 26 causes a rupture in seal body B 23, and the connector 21 facilitates connecting a single application member 24 to two seal bodies 22 and 23 containing the cleaning liquid.

[0076] As shown in FIG. 4, according to some embodiments, the application member includes a spike cap 41. The spike cap is configured to rupture the wall of the seal body and facilitate the discharge of the cleaning liquid contained in the seal body. Here, the spike of the spike cap causes a rupture in the wall of the seal body when the spike cap is attached to the seal body, ensuring that the cleaning liquid is discharged through the flow path 43 thus formed. According to some embodiments, the spike cap includes a spike shape 42. The spike shape determines the spike shape that causes a rupture in the wall of the seal body. As shown in FIG. 8, according to some embodiments, the spike shape includes a bevel tip 82 or an aligned tip 81. Here, the spike shape determines the flow pattern of the cleaning liquid discharged from the seal body through the flow path, as described herein. The spike shape also determines the force required by the individual spiking the seal body by attaching the spike cap to the wall of the seal body to facilitate the discharge of the cleaning liquid.

[0077] As shown in FIG. 7, according to some embodiments, the seal body may further include buttress threads 71 on a wall configured to form a fluid supply port when ruptured. According to some embodiments, the spike cap may further include buttress threads at a first end of the spike cap. Here, the buttress threads forming the wall of the seal body and the buttress threads forming the end of the spike cap are attached to each other, screwed together, or screwed together to ensure that the spike cap causes a rupture in the wall of the seal body for the discharge of the cleaning liquid.

[0078] According to some embodiments, a spike cap having a bevel tip facilitates the process of causing a rupture in the wall of the seal body when the spike cap is attached to the wall of the seal body, and the bevel tip pierces a selected position on the wall of the seal body to form a fluid supply port. According to some embodiments, a spike cap using an alignment tip aligns the rupture process and the threading process when the spike cap is attached to the wall of the seal body.

[0079] According to some embodiments, a plurality of spike caps may be provided. According to some embodiments, spike caps having different spike shapes are provided, and different flow patterns of the cleaning liquid are realized as needed.

[0080] According to some embodiments, the spikes of the application member include a specific material, and the material has the ability to utilize its own sharp edge, thus eliminating metallic sharp objects that pose a risk in a medical environment. According to some embodiments, the spikes of the application member are made of a plastic material. In particular, the flow rate 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).

[0081] According to some embodiments, the flow rate adjustment member can be made of a metallic material or an alloy material. In particular, the flow rate adjustment member can be made of metals or alloys including, but not limited to, stainless steel, cobalt-chromium alloy, titanium, nickel-titanium alloy, gold, platinum, silver, iridium, tantalum, tungsten, aluminum, copper, and magnesium.

[0082] According to some aspects, the spike of the application member further includes a vent hole, and thus the spike can be provided with a vent hole. In some embodiments, the application member includes a spike with a vent hole that allows the seal body to be compressible, and the seal body is configured such that when the seal body is compressed, the cleaning liquid is discharged.

[0083] According to some aspects, the application member includes a spike without a vent hole that allows the seal body to be foldable, and the seal body is configured such that when the cleaning liquid is discharged from the seal body, the seal body is folded.

[0084] According to some aspects, the application member is integrated with an article including the seal body. According to some aspects, the application member is in fluid communication with the seal body while discharging the cleaning liquid from the seal body, and the application member forms a fluid supply port and a flow path for discharging the cleaning liquid.

[0085] According to some aspects, the application member includes a specific material. According to some aspects, the application member is made of a plastic material. In particular, the flow rate 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 rate adjustment member can be made of a metal material or an alloy material. In particular, the flow rate adjustment member can be made of metals or alloys 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] As shown in FIG. 1, according to some embodiments, the seal body may further include a recess 13 at the first end 12 of the seal body 11. According to some embodiments, FIG. 5 further shows a recess 51 that covers the entire length of the seal body. The recess in the seal body can assist in the foldability of the seal body. For example, the presence of the recess in the seal body promotes the seal body to fold itself when the cleaning liquid is discharged, and the recess promotes the seal body to fold itself evenly. According to some embodiments, the recess in the seal body can help provide a grip for the individual holding the seal body to perform the operations required for the cleaning process. For example, the presence of the recess in the seal body provides a grip for an individual who holds the seal body and places it on a surface, an individual who holds the seal body and ruptures the seal body by an application member, and an individual who holds the seal body together with the application member when applying the cleaning liquid to the selected surface.

[0088] According to some embodiments, the seal body may be provided with a removable lid to prevent the outflow of fluid from the seal body during storage or transportation of the seal body.

[0089] According to some embodiments, the article may further include a framework separate from the article of the present invention. This framework can help maintain the shape of the seal body when filling the seal body with the cleaning liquid, when the seal body contains the cleaning liquid, and when the cleaning liquid is dispensed from the seal body. According to one embodiment of the present invention, this framework is foldable and can be folded when the cleaning liquid is discharged from the seal body. Thus, the framework can help the seal body to fold gradually and completely when the cleaning liquid is discharged from the seal body. According to one embodiment of the present invention, the framework can help maintain the integrity of the seal body, particularly to support the bottom or edges / corners of the seal body. According to another embodiment of the present invention, this framework is separate from the article and the seal body of the present invention, and the framework may be present either outside or inside the seal body.

[0090] According to some aspects, the article can be configured to provide a fluid flow rate acceptable for the 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 the cleaning process. The fluid flow rate can depend at least in part on the characteristics of the delivery mechanism and / or the application member, as described herein. According to some aspects, the fluid flow rate can be related to the fluid flow force. For example, an increase in the fluid flow rate can correspond to an increase in the fluid flow force, and vice versa. The articles according to the present disclosure can be configured to provide different selectable fluid flow rates.

[0091] According to some aspects, the article can be configured to impart an acceptable fluid flow force to the 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 the cleaning process. The acceptable fluid flow force can be determined based on the requirements of the cleaning process.

[0092] It should be understood that the fluid flow force provided by the articles described herein can depend at least in part on the characteristics of the delivery mechanism and / or the application member described herein. The articles according to the present disclosure can be configured to impart different selectable fluid flow forces. It should be understood that each of the selectable fluid flow forces can correspond, for example, to a particular delivery mechanism, a particular application member, or a combination thereof, as described herein.

[0093] According to some aspects, the article is configured to provide a fluid flow design that is acceptable for the cleaning process. As used herein, the term "fluid flow design" refers to a design in which fluid is dispensed from the device and / or applied to a surface such as a human subject during the cleaning process. In some non-limiting examples, the fluid flow design can include a fluid mist (i.e., a suspension of finely divided fluid in a gas), a fluid stream (i.e., a stable and continuous fluid), a fluid spray (i.e., a finely divided fluid), or a combination thereof. The fluid flow design can be constant (e.g., fluid is continuously dispensed from the device and / or applied to the surface) or pulsed (e.g., fluid is intermittently dispensed from the device and / or applied to the surface).

[0094] Additionally or alternatively, the fluid flow design can 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 can have a fluid flow design that is substantially orthogonal to the longitudinal axis of the seal body, as described herein.

[0095] In addition or instead, the fluid flow design 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 the cross-section of the flow path in any of the x, y, and z directions. It should be understood that the fluid flow design can depend at least in part on the delivery mechanism and / or flow rate adjustment member described herein.

[0096] According to some aspects, one or more components of the articles 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 thermoforms, sterile bags, sterile plastic molded trays with lids, and combinations thereof. It should be understood that one or more components of the article may be provided in the same sterile package and / or a different sterile package than at least one other component of the article. For example, a first component of the article may be included in a first sterile package and a second component of the article may be included in a second sterile package. In a non-limiting example, the article may include a seal body included in a first sterile package and an application member included in a second sterile package. By providing one or more components of the article in different sterile packages, each component of the article can be removed immediately before use, thus preventing 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 article can be achieved.

[0097] According to some aspects, the present invention includes a method of applying a cleaning liquid to a surface, the method including providing a seal body containing the cleaning liquid and providing an application member including a spike, wherein the seal body and the cleaning liquid contained therein are terminally sterilized. The method further includes rupturing the wall of the seal body with the spike of the application member, which facilitates the discharge of the cleaning liquid from the seal body by a specific force. The discharged cleaning liquid is then applied to the surface selected by the application member.

[0098] According to some aspects, the specific forces that facilitate the discharge of the cleaning liquid from the seal body include pressure, gravity, internal force, external force, vacuum, and the like.

[0099] According to some aspects, the application member includes spikes with ventilation holes, and the presence of ventilation holes in the spikes of the application member enables the seal body to be compressible. Here, the compressible seal body is configured such that when the seal body is compressed, the cleaning liquid is discharged from the seal body. In some embodiments, due to the presence of ventilation holes in the spikes of the application member, the seal body stands on its own before, during, and after the discharge of the cleaning liquid.

[0100] According to some aspects, the application member includes spikes without ventilation holes, and since there are no ventilation holes in the spikes of the application member, the seal body can be folded. Here, the foldable seal body is configured such that when the cleaning liquid is discharged from the seal body, the seal body is folded. In some embodiments, due to the absence of ventilation holes in the spikes of the application member, the seal body stands on its own before and after the discharge of the cleaning liquid.

[0101] The aspects described herein will be described in conjunction with the exemplary aspects outlined above. However, various alternatives, modifications, changes, improvements, and / or substantial equivalents may become apparent to those skilled in the art, whether known, currently unforeseeable, or potentially unforeseeable. Accordingly, the exemplary aspects described above are intended to be illustrative rather than limiting. Various changes can be made without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to encompass all alternatives, modifications, changes, improvements, and / or substantial equivalents, whether known or later developed.

[0102] Accordingly, the claims are not intended to be limited to the aspects shown herein, but rather are to give the full scope consistent with the claim language, and references to elements in the singular are not to be construed as meaning "only one" unless explicitly stated otherwise, but rather "one or more." All structural and functional elements equivalent to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are hereby expressly incorporated by reference and intended to be included within the scope of the claims. Further, nothing disclosed herein is intended to be dedicated to the public whether or not such disclosure is expressly recited in the claims. A claim element is not to be construed as a means-plus-function unless the element is expressly recited using the phrase "means."

[0103] Moreover, as used herein, the term "example" is used in the sense of "an example, instance, or illustration." Aspects described as "examples" herein are not to be construed as necessarily being more preferred or advantageous than other aspects. Unless otherwise specified, the term "part" 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" include any combination of A, B, and / or C and may include multiple A's, multiple B's, or multiple C's. Specifically, combinations such as "at least one of A, B, or C," "at least one of A, B, and C," and "A, B, C, or any combination thereof" are A only, B only, C only, A and B, A and C, B and C, or A and B and C, and such combinations may include one or more members of A, B, or C. Nothing disclosed herein is intended to be provided to the public whether or not such disclosure is expressly recited in the claims.

[0104] As used herein, the term "about" is used to mean within ±5% of the stated value, optionally within ±4% of the stated value, optionally within ±3% of the stated value, optionally within ±2% of the stated value, optionally within ±1% of the stated value, optionally within ±0.5% of the stated value, optionally within ±0.1% of the stated value, and optionally within ±0.01% of the stated value.

Claims

1. A system, the system comprising: an article comprising a seal body containing a cleaning liquid; and an application member comprising a spike without a vent hole, wherein the seal body and the cleaning liquid contained therein are terminally sterilized; the seal body includes a wall configured to form a fluid supply port when ruptured by the application member such that the cleaning liquid is easily discharged in a flow pattern; the seal body stands on its own before and during discharge of the cleaning liquid; the seal body folds itself when the cleaning liquid is discharged from the seal body; A system.

2. The system according to claim 1, wherein the wall includes a first portion and a second portion, the first portion is thinner than the second portion, and the fluid supply port is formed in the first portion.

3. The system according to claim 1, wherein the application member is configured to rupture the wall of the seal body to form the fluid supply port and to form a flow path for discharging the cleaning liquid.

4. A spike port is located in the first portion, The system according to claim 2, wherein the spike port is configured to rupture to form the fluid supply port.

5. The system according to claim 4, wherein the spike port includes a flexible membrane.

6. The system according to claim 5, wherein the flexible membrane includes an elastomeric disk.

7. The application member includes a tubular structure having a first end and a second end, the first end of the tube includes a spike, The system according to claim 3, wherein the second end of the tube includes an injection gun.

8. The system according to claim 7, wherein the application member further includes a connector for connecting to a plurality of seal bodies, and the first end of the tube includes at least two spikes.

9. The system according to claim 3, wherein the application member includes a spike cap, and the spike cap includes a spike shape.

10. The system according to claim 9, wherein the seal body includes buttress threads on the wall of the seal body.

11. The system according to claim 10, wherein the spike cap includes buttress threads that are attached to the buttress threads on the wall of the seal body.

12. The system according to claim 9, wherein the spike shape includes a bevel tip.

13. The spike shape is the system according to claim 9, including aligned chips.

14. The application member is in fluid communication with the seal body during discharge of the cleaning liquid, the system according to claim 3.

15. The cleaning liquid includes chemicals and water, and the chemicals include iodine, the system according to claim 1.

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

17. The flow pattern includes that the cleaning liquid is discharged at a pressure of less than 15 psi, the system according to claim 1.

18. The flow pattern includes that the cleaning liquid is discharged in a spray pattern of 6 square inches, the system according to claim 1.

19. The application member is made of a material selected from the group consisting of plastic, metal, and alloy, the system according to claim 3.

20. The seal body includes a gamma-ray compatible plastic, the system according to claim 1.

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

22. The application member makes a hole in the wall, and the flow pattern of the cleaning liquid is determined by the shape and size of the hole, the system according to claim 3.

23. The seal body further includes a depression at a first end of the seal body, the system according to claim 1.

24. A method of applying a cleaning liquid to a surface, the method comprising: providing a seal body containing a cleaning liquid and an application member including a spike without a vent hole; rupturing the wall of the seal body with the spike without a vent hole of the application member, the force facilitating discharge of the cleaning liquid from the seal body including a vacuum; applying the discharged cleaning liquid to a surface selected by the application member, the seal body being foldable and configured to fold itself when the cleaning liquid is discharged from the seal body; the seal body being self-standing before and during discharge of the cleaning liquid; the seal body and the cleaning liquid contained therein are finally sterilized.

Images