Universal adapter for auxiliary and manual feeding

Abstract

An adapter comprising a connector connectable to a fluid container, a first fluid passage having a first end and a second end, the first end configured to provide fluid communication with the fluid container and the second end having a fluid outlet, at least one valve provided along the first fluid passage, and a second fluid passage separate from the first fluid passage, wherein at least one valve is configured to provide a choice between auxiliary fluid supply and manual fluid supply. Systems, kits, and methods including the adapter are also described.

Description

Technical Field

[0001] The present disclosure relates to an adapter that can be used with a fluid container that provides at least two selectable fluid supply modes.

Background Art

[0002] Intraoperative incision wound irrigation is an established method to assist in preventing surgical site infection (SSI). In such procedures, irrigation is typically performed via one of two modes: manual (i.e., direct injection, bulb syringe, etc.) or assisted (i.e., supply of solution via a powered irrigation device).

[0003] In the assisted supply method, while a pulsed irrigation device is operating within the sterile field, a solution is typically present within a fluid container suspended from an IV pole within the non-sterile field. Due mainly to the limited space within the sterile field and to reduce clutter in the immediate vicinity of the surgical cavity, the fluid container is stored outside the sterile field.

[0004] In the manual supply method, medical personnel typically apply manual pressure to a compressible fluid container to supply irrigation fluid to the surgical cavity.

[0005] The choice of manual or assisted supply generally depends on the preference of the surgeon and the details of the procedure. Some medical personnel consider assisted supply to be potentially harmful to the patient's health (e.g., by forcing bacteria deeper into the wound or damaging tissue), while some surgeons see advantages such as higher consistency and more thorough wound debridement of the surgical cavity. There are also quite a number of surgeons who prefer to utilize both manual and assisted supply in practice, depending on the specific surgical case.

[0006] Manual supply is typically achieved using a device that connects to the cleaning fluid container by puncturing it. These devices generally have a relatively simple design and lack some features. For example, after manual compression of the fluid container, the compressive force is released and the container relaxes towards its original shape. During this relaxation phase, air is drawn back into the container, thereby compressing it again and discharging more fluid. However, typical devices usable with such containers allow the container shape to be restored by air passing through the fluid channel, which can lead to contamination of the cleaning fluid itself or the fluid channel with contaminants.

[0007] Auxiliary supply is typically performed by creating a fluid passage by puncturing a fluid container with a device. However, such devices cannot be used without a cleaning device, and once the device has punctured the fluid container, the fluid cannot be supplied manually. Therefore, healthcare professionals are required to stock both types of devices (i.e., devices designed for manual supply and devices designed for auxiliary supply). Even with current devices, the supply of fluid from each fluid container is limited to a single supply mode. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Provisional Patent Application No. 63 / 366,588 [Overview of the Initiative] [Means for solving the problem]

[0009] Disclosed herein is an adapter comprising a connector connectable to a fluid container, a first fluid passage having a first end and a second end, the first end configured to provide fluid communication with the fluid container and the second end including a fluid outlet, at least one valve provided along the first fluid passage, and a second fluid passage separate from the first fluid passage, wherein the at least one valve is configured to provide a choice between auxiliary fluid supply and manual fluid supply. Kits and systems having adapters such as those described herein are also disclosed herein. [Brief explanation of the drawing]

[0010] [Figure 1A] An example of an adapter according to this disclosure is shown. [Figure 1B] An example of an adapter according to this disclosure is shown. [Figure 1C] An example of a vent housing according to an aspect of this disclosure is shown. [Figure 2] An example of an adapter having a valve according to an aspect of this disclosure is shown. [Figure 3] An example of a cross-slit valve according to an aspect of this disclosure is shown. [Modes for carrying out the invention]

[0011] This disclosure relates to an adapter that can be used with a fluid container that provides at least two selectable fluid supply modes. According to some embodiments, the adapter can be configured to provide both auxiliary fluid supply and manual fluid supply through a single fluid container. The adapter may include a connector, a first fluid passage, a second fluid passage, a fluid outlet, and at least one valve provided along the first fluid passage. This disclosure also relates to kits and systems having adapters and fluid containers as described herein.

[0012] The adapters of this disclosure can be used with fluid containers. As used herein, the term “fluid” refers to a substance that does not have a fixed shape, such as a liquid or a gas. In some non-limiting examples, the fluid is a cleaning fluid. As used herein, the term “cleaning fluid” refers to a fluid suitable for cleaning processes such as those described herein. As used herein, “cleaning” refers to cleaning body cavities, surgical cavities, and / or wounds.

[0013] In some embodiments, the cleaning fluid may include a disinfectant. As used herein, “disinfectant” means a solution having at least a solvent and one or more disinfectants. In some embodiments, the disinfectant is an aqueous solution. As used herein, the term “aqueous solution” means a solution in which at least a large proportion of the solvent is water. In some examples, it should be understood that the solvent may consist of water. In some embodiments, the disinfectant is an alcohol solution. As used herein, the term “alcohol solution” means a solution in which at least a large proportion of the solvent is 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.

[0014] In a non-limiting example, the disinfectant may contain cationic molecules (i.e., positively charged molecules) such as cationic surfactants or cationic biguanide derivatives (i.e., compounds derived from biguanides). According to some embodiments, the disinfectant may contain bis(dihydropyridinyl)decane derivatives (i.e., compounds derived from bis(dihydropyridinyl)decane). According to some embodiments, the disinfectant may contain octenidine salts, quaternary ammonium salts, and / or chlorhexidine salts. According to some embodiments, the disinfectant may contain alexidine, octenidine dihydrochloride, chlorhexidine gluconate, sodium lauryl sulfate, citric acid, sodium citrate, benzalkonium chloride, polyaminopropyl biguanides, or combinations thereof.

[0015] In addition, or instead, disinfectants may contain iodine. According to some embodiments, iodine can be provided as iodine complexes such as povidone-iodine (PVPI), nonylphenoxy(ethyleneoxy)iodine, polyethyleneoxypolypropyleneoxyiodine, undecoylinium chloride iodine, iodine povacrilex, and combinations thereof.

[0016] In addition, or instead, disinfectants may contain oxidants (i.e., oxidizing agents). Non-limiting examples of oxidants as provided herein include, but are not limited to, sodium hypochlorite, hydrogen peroxide, hypochlorous acid, and combinations thereof.

[0017] Disinfectants can have sufficient antimicrobial activity to cause an acceptable logarithmic reduction of microorganisms within a given period. It should be understood that, as used herein, the term “microorganism” can refer to any microorganism that is killed and / or removed as a result of cleaning. Examples of microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0018] Exemplary bacteria include, but are not limited to, Streptococcus mutans, Streptococcus pyogenes (Group A β-hemolytic streptococcus), Streptococcus salivarius, S. sanguis, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, S. hominis, S. simulans, Staphylococcus saprophyticus, methicillin / oxacillin-resistant (MRSA / ORSA) and methicillin / oxacillin-susceptible Staphylococcus aureus (MSSA / OSSA), Enterococcus (e.g., E. faecalis, E. faecium, and E. hirae), vancomycin-resistant Enterococcus (VRE) and vancomycin-susceptible Enterococcus (VSE), Bacteroides fragilis, Propionibacterium acnes, Clostridium difficile (spores and vegetative cells), Selenomonas, Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Gardnerella vaginalis, Klebsiella aerogenes, K. pneumoniae, K. pneumoniae multi-drug resistant (MDR), Acinetobacter baumannii, A. baumannii MDR, Acinetobacter xylosoxidans, Micrococcus luteus, Ralstonia pickettii, Haemophilus influenza, and Serratia marcescens.

[0019] Exemplary fungi include, but are not limited to, Aspergillus niger, Candida albicans, C. auris, C. dubliensis, C. glabrata (formerly Torulopsis glabrata), C. guilliermondii, C. kefyr (formerly C. pseudotropicalis), C. krusei, C. lusitaniae, C. tropicalis, Epidermophyton floccosum, Microsporum gypseum, M. canis, and Trichophyton tonsurans.

[0020] Exemplary viruses include, but are not limited to, cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2), influenza virus, parainfluenza virus, variola virus (smallpox virus), vaccinia, norovirus, and those having a lipid component in the outer shell or having an outer envelope, such as coronavirus.

[0021] According to some embodiments, a certain 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.

[0022] According to some embodiments, a certain 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.

[0023] It should be understood that "acceptable log reduction" can depend on the microorganism. For example, an acceptable log reduction as described herein can refer to a single type of microorganism present on the surface (e.g., present in a body cavity or at a wound site), more combinations than two types of microorganisms present on the surface, or an acceptable log reduction of all microorganisms present on the surface.

[0024] According to some embodiments, the acceptable logarithmic decrease is at least about 1.0, at an arbitrary choice at least about 1.1, at an arbitrary choice at least about 1.2, at an arbitrary choice at least about 1.3, at an arbitrary choice at least about 1.4, at an arbitrary choice at least about 1.5, at an arbitrary choice at least about 1.6, at an arbitrary choice at least about 1.7, at an arbitrary choice at least about 1.8, at an arbitrary choice at least about 1.9, at an arbitrary choice at least about 2.0, at an arbitrary choice at least about 2.1, at an arbitrary choice at least about 2.2, at an arbitrary choice at least about 2.3, at an arbitrary choice at least about 2.4, at an arbitrary choice at least about 2.5, at an arbitrary choice at least about 2.6, at an arbitrary choice at least about 2.7, at an arbitrary choice at least about 2.8, at an arbitrary choice at least about 2.9, at an arbitrary choice It can be at least approximately 3.0, optionally at least approximately 3.1, optionally at least approximately 3.2, optionally at least approximately 3.3, optionally at least approximately 3.4, optionally at least approximately 3.5, optionally at least approximately 3.6, optionally at least approximately 3.7, optionally at least approximately 3.8, optionally at least approximately 3.9, optionally at least approximately 4.0, optionally at least approximately 4.1, optionally at least approximately 4.2, optionally at least approximately 4.3, optionally at least approximately 4.4, optionally at least approximately 4.5, optionally at least approximately 4.6, optionally at least approximately 4.7, optionally at least approximately 4.8, optionally at least approximately 4.9, and optionally at least approximately 5.0.

[0025] According to some embodiments, the disinfectant may be present in the disinfectant solution at a concentration sufficient to produce an acceptable logarithmic decrease in microorganisms within a certain period of time as described herein. According to some embodiments, the disinfectant may be present at concentrations between about 0.001 w / v% and 15 w / v%, optionally between about 0.001 w / v% and 10 w / v%, optionally between about 0.001 w / v% and 5 w / v%, optionally between about 0.001 w / v% and 2.5 w / v%, optionally between about 0.001 w / v% and 1 w / v%, optionally between about 0.001 w / v% and 0.1 w / v%, optionally between about 0 The disinfectant may be present in the disinfectant solution at concentrations between 0.001 w / v% and 0.01 w / v%, optionally between approximately 0.01 w / v% and 5 w / v%, optionally between approximately 0.01 w / v% and 2.5 w / v%, optionally between approximately 0.01 w / v% and 2 w / v%, optionally between approximately 0.01 w / v% and 1.5 w / v%, optionally between approximately 0.01 w / v% and 1 w / v%, and optionally at approximately 0.5 w / v%. According to some embodiments, the disinfectant may be present in the disinfectant solution at concentrations between approximately 0.001 w / v% and 20 w / v%, optionally between approximately 1.0 w / v% and 20 w / v%, optionally between approximately 10 w / v% and 20 w / v%, and optionally at approximately 15 w / v%.

[0026] According to some embodiments, the disinfectant may be present in the disinfectant solution at concentrations between approximately 0.1 w / v% and 0.9 w / v%, optionally between approximately 0.2 w / v% and 0.8 w / v%, optionally between approximately 0.3 w / v% and 0.7 w / v%, and optionally between approximately 0.4 w / v% and 0.6 w / v%.

[0027] According to some embodiments, the disinfectant may be present in the disinfectant solution at concentrations between about 0.1 w / v% and 1 w / v%, optionally between about 0.2 w / v% and 1 w / v%, optionally between about 0.3 w / v% and 1 w / v%, and optionally between about 0.4 w / v% and 1 w / v%.

[0028] In some non-limiting cases, disinfectants can function as preservatives by reducing or eliminating microbial contamination of the container holding the disinfectant after it has been opened.

[0029] It should be understood that, in some embodiments, the cleaning fluid may not necessarily be a disinfectant as described herein, but any medically acceptable fluid configured to perform the cleaning process as described herein. In a non-limiting example, the cleaning fluid may include saline solution. Saline solution may contain water and medically acceptable concentrations of sodium chloride, such as between about 0.1 w / v% and 1 w / v%, optionally about 0.45 w / v%, and optionally about 0.9 w / v%.

[0030] In some embodiments, cleaning fluids, such as disinfectants described herein, may include visualization aids. 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 disinfectant may function as a visualization agent. In addition, or instead, the cleaning fluid may include a visualization agent different from a disinfectant.

[0031] In some embodiments, the cleaning fluid may contain a colorant. As used herein, the term “colorant” refers to a component sufficient to impart an observable color to the fluid. The colorant may be sufficient to allow the cleaning fluid to be visualized when applied to a surface. In some non-limiting examples, the colorant may include anionic colorants, such as anionic dyes. The anionic dye may be any dye suitable for medical use, such as dyes approved by the Food and Drug Administration for use in food, pharmaceuticals, and / or cosmetics (i.e., “D&C” or “FD&C” dyes). Examples of anionic dyes include, but are not limited to, FD&C Blue 1 (Brilliant Blue FCF), FD&C Blue 2 (Indigo Carmine), FD&C Green 3 (Fast Green FCF), FD&C Red 3 (Erythrosine), FD&C Red 40 (Alura Red), FD&C Yellow 5 (Tartrazine), FD&C Yellow 6 (Sunset Yellow FCF), D&C Yellow 8 (Fluorescein), D&C Orange 4, and combinations thereof. Combinations can be performed to obtain specific colors. For example, an orange shade can include both FD&C Red 40 and D&C Yellow 8. In addition, or instead, colorants may include, but are not limited to, vitamin B-12, medical honey, fluorescent polymer nanoparticles, water-soluble luminescent carbon nanodots, quinine, and combinations thereof, compounds observable upon exposure to visible and / or invisible light.

[0032] In some embodiments, cleaning fluids, such as disinfectants described herein, may contain dyes. As used herein, the term “dye” refers to components sufficient to temporarily or permanently color the surface being contacted.

[0033] In some embodiments, cleaning fluids, such as disinfectants described herein, may contain radiopaque agents. As used herein, the term “radiopaque agent” refers to a component that is impermeable to the radio and X-ray portions of the electromagnetic spectrum sufficient for visualization. In some non-limiting examples, radiopaque agents may include barium, iodine, iron oxide nanoparticles, gadolinium complex nanospheres, silica nanospheres, and combinations thereof.

[0034] In some embodiments, the cleaning fluid, such as a disinfectant solution as described herein, may be basic, neutral, or acidic. In some embodiments, the cleaning fluid may have a pH between about 1 and 8, optionally between about 1 and 7, optionally between about 1 and 6, and optionally between about 2 and 5.5.

[0035] In some embodiments, cleaning fluids, such as disinfectants 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 large pH changes caused by strong acids or bases. A buffer system may include a single agent or a group of agents, such as a weak acid and its conjugate base. A buffer system may provide resistance to large pH changes by interacting with strong acids or bases in a composition or solution, thereby at least partially preventing large changes in the pH of the composition or solution.

[0036] Generally, a buffer system has one or more buffer ranges and has the ability to provide resistance to large pH changes. When a composition or solution having a buffer system has a pH within the buffer range of the buffer system, the pH of that composition or solution will not change significantly with the addition of equimolar amounts of strong acid or strong base.

[0037] The buffering range of a buffer system is related to the acid dissociation constants (Ka) of one or more weak acids contained within it. The term "acid dissociation constant" refers to the equilibrium constant of the acid dissociation reaction. The midpoint of the buffering range for a buffer system is generally an approximate logarithmic scale of the acid dissociation constants of the weak acids contained within it (i.e., pKa, equal to -log10Ka).

[0038] In some embodiments, cleaning fluids, such as disinfectants described herein, may contain stabilizers. As used herein, the term “stabilizer” refers to any component that supports the stability of a cleaning fluid, not specifically described herein.

[0039] In some embodiments, the fluid vessels of this disclosure may include a body configured to contain a fluid as described herein. In some embodiments, the body may be compressible. As used herein, the term “compressible” means the ability to reversibly reduce its volume without any unacceptable change, such as an unacceptable permanent change to one or more of the properties as described herein. In some embodiments, the body may be configured such that, when compressed, at least a portion of the fluid contained therein is discharged. As used herein, “discharge” (or “eject”) should be understood to mean the transfer of the fluid to an adapter that is in fluid communication with the fluid vessel, and / or the transfer of the fluid to a surface.

[0040] In some embodiments, the body can be foldable. As used herein, the term “foldable” refers to the ability to permanently reduce its volume. For example, a foldable body as described herein may have a first volume when a first volume of fluid is contained within it. When at least a portion of the fluid is discharged, the foldable body may fold up to have a second volume, the second volume being less than the first volume. It should be understood that a foldable body will favorably reduce the volume of waste (for example, the volume of the body after the fluid within it has been discharged). A foldable body can also provide more efficient fluid discharge.

[0041] In some embodiments, the body can be configured to allow for a reduction in volume of at least 10%, optionally at least 20%, optionally at least 30%, optionally at least 40%, optionally at least 50%, optionally at least 60%, optionally at least 70%, optionally at least 80%, optionally at least 90%, and optionally at least 99% when compressed and / or folded.

[0042] In some embodiments, the body may include a body material compatible with the fluid contained therein, i.e., a material that does not react chemically or physically with the fluid, or otherwise render the fluid unsuitable for medical use.

[0043] In some embodiments, the body material may be sufficient to prevent unacceptable vapor or disinfectant loss from the fluid contained therein over a certain shelf life. “Unacceptable vapor or disinfectant loss” should be understood as a loss that would consequently render the fluid unsuitable for its intended use. Vapor or disinfectant loss may occur, for example, as a result of adsorption or absorption of disinfectant by the material (e.g., by the body material), evaporation of the solution, evaporation of components of the solution (e.g., disinfectant in a disinfectant solution), or a combination thereof. In a non-limiting example where the fluid 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.

[0044] As used throughout this application, the term “storage life” refers to the length of time a product (e.g., disinfectant) can be stored while remaining within the specifications required for its form, suitability, and function. Storage life can be determined by measuring several characteristics of the product that may indicate that the product is unsuitable for medical use. For example, storage life can be determined by measuring the concentration of impurities in the product after storage under long-term storage conditions, changes in the product's color, the concentration of insoluble particles in the product, the potency of activators (e.g., disinfectants) contained in the product, the concentration of one or more components in the product, the product's pH, and / or the product's sterility. As used herein, the term “long-term storage conditions” refers to environmental conditions sufficient to allow the product to be stored acceptable for more than 72 hours. In some embodiments, long-term storage conditions may refer to a temperature of about 25°C and a relative humidity of about 60%. In addition, or alternatively, shelf life can be determined by measuring the concentration of impurities in the product, the change in the product's color, the concentration of insoluble particles in the product, the potency of the activator in the product, the concentration of one or more components in the product, the pH of the product, and / or the sterility of the product after storage at 37°C and 65% relative humidity. In addition, or alternatively, shelf life can be determined by measuring the concentration of impurities in the product, the change in the product's color, the concentration of insoluble particles in the product, the potency of the activator in the product, the concentration of one or more components in the product, the pH of the product, and / or the sterility of the product after storage between approximately 15°C and 30°C with deviations to approximately 40°C or less.

[0045] In some embodiments, the shelf life can be at least about 15 months, optionally at least about 16 months, optionally at least about 17 months, optionally at least about 18 months, optionally at least about 19 months, optionally at least about 20 months, optionally at least about 21 months, optionally at least about 22 months, optionally at least about 23 months, optionally at least about 24 months, optionally at least about 25 months, optionally at least about 26 months, optionally at least about 27 months, optionally at least about 28 months, optionally at least about 29 months, optionally at least about 30 months, optionally at least about 31 months, optionally at least about 32 months, optionally at least about 33 months, optionally at least about 34 months, optionally at least about 35 months, optionally at least about 36 months, optionally at least about 37 months, optionally at least about 38 months, optionally at least about 39 months, and optionally at least about 40 months.

[0046] According to several embodiments, the main material may be sterilizable by any known sterilization technique useful in accordance with this disclosure, including moist heat sterilization (i.e., autoclave), 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. According to several embodiments, the main material may be sterilizable by any known sterilization technique useful in accordance with this disclosure, such that the container containing the main material can withstand sterilization for at least 10 days. -6 If it has a sterility assurance level (SAL) and provides acceptable results in integrity testing of the container closure after sterilization, it can be determined that it is sufficiently sterilized. According to some embodiments, the main material is such that the container containing the main material is sterilized to at least 10 -3 If a container has a sufficient SAL (Sterilization Acquisition Rate) and provides acceptable results in an integrity test of container closure after sterilization, it can be determined that it is sufficiently sterilized.

[0047] In some embodiments, the body material may have sufficient mechanical strength to provide the body with an acceptable response to shock, vibration, shaking, or a combination thereof. In some embodiments, an acceptable response refers to a response conforming to ASTM D4169-16 (Standard Procedure for Performance Testing of Transport Containers and Systems), ASTM D4728-06 (Standard Test Method for Random Vibration Testing of Transport Containers), ASTM D642-15 (Standard Test Method for Determining Compression Resistance of Transport Containers, Components, and Unit Loads), or any combination thereof. In some embodiments, the body material may be safe for biomedical applications. For example, the body material may conform to ISO 10993 and / or REACH requirements. In some embodiments, the body material may be sufficient to exhibit at least some of the properties described herein over the shelf life of a certain fluid with temperatures between about 15°C and 30°C, with deviations to temperatures below about 40°C. In addition, or alternatively, the main material may be sufficient to exhibit at least some of the properties described herein for a certain period of time after storage at approximately 25°C and 60% relative humidity. In addition, or alternatively, the main material may be sufficient to exhibit at least some of the properties described herein for a certain period of time after storage at approximately 37°C and 65% relative humidity.

[0048] The main material may be rigid or flexible. As used herein, “rigidity” means sufficient rigidity to resist deformation under normal operating forces. As used herein, “flexibility” means the ability to bend or compress under normal operating forces.

[0049] The example body materials include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Example plastics useful in accordance with this disclosure include, but are not limited to, high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene, polystyrene, nylon, and any combination thereof. According to some embodiments, the body material may be a backing and / or coated material, such as backing and / or coated paper.

[0050] This disclosure relates to an adapter that can be used with fluid vessels such as those described herein. According to some embodiments, the adapter may include a connector configured to interact with a corresponding connector of the fluid vessel in order to provide a secure connection.

[0051] Figure 1A shows an example adapter 100 according to an aspect of the present disclosure. As shown in Figure 1A, the adapter 100 may include a connector 101. In some non-limiting examples, the connector 101 may include one or more projections configured to interact with corresponding projections of a fluid container to form a threaded connection, thereby allowing the adapter 100 to be screwed onto the fluid container.

[0052] However, it should be understood that this disclosure is not necessarily limited to the example shown in Figure 1A. For example, in addition to or instead of the projection, the connector 101 may include any connecting components sufficient to provide a secure connection between the adapter and the fluid container. In some non-limiting examples, the connector 101 may be configured to provide a snap connection, a friction connection, or a combination thereof. According to some embodiments, the connector 101 may be configured to provide a secure connection with commercially available fluid containers as known in the art.

[0053] As shown in Figure 1A, the adapter 100 may further include at least one spike element 104 at the first end of the first fluid channel 102a. According to some embodiments, the spike element 104 may be configured to perforate enough the membrane of the fluid vessel to provide fluid communication between the fluid vessel and the first fluid channel 102a of the adapter 100. In some non-limiting examples, the spike element 104 may include one or more features of a spike interface as described in Patent Document 1, the disclosure thereof, is incorporated in whole herein.

[0054] However, it should be understood that the adapter 100 is not necessarily limited in this way. For example, the spike element 104 can be omitted from the adapter 100 as long as the corresponding end of the first fluid channel 102a terminates with at least one opening sufficient to provide fluid communication between the first fluid channel 102a and a fluid container as described herein.

[0055] As shown in Figure 1A, the adapter 100 may further include a second fluid channel 102b configured to provide fluid communication between the fluid container and the atmosphere outside the fluid container, as described herein, when the fluid container is perforated, for example, by the spike element 104 as described herein. In this way, the pressure inside the fluid container can be equalized when fluid is discharged from the fluid container.

[0056] In some embodiments, as shown in Figure 1A, the second fluid passage 102b may include at least one vent 106 which may have one or more features as described in Patent Document 1. For example, the vent 106 may be configured to prevent contaminants from entering the fluid container when air or gas flows into the second fluid passage 102b and, consequently, into the fluid container. In one non-limiting example, the vent 106 may include a one-way valve or membrane, such as a membrane, which allows air to move freely in and out of the container while preventing a solution from passing through. In some embodiments, the vent 106 may include at least one material having a polarity opposite to the polarity of the fluid contained in the fluid container as described herein. For example, if the fluid container mainly contains an aqueous fluid, the vent 106 may include at least one hydrophobic material to reduce the possibility of aqueous fluid passing through. In some examples, the vent 106 may include a sterile filter, a sterile porous foam, or a sterile membrane to reduce or prevent contaminants from entering the second fluid passage 102b.

[0057] Figure 1B shows an exploded view of an example adapter 100 having at least one vent (provided in vent halves 106a and 106b). As shown, the vent halves 106a and 106b are provided in the vent housing 107 of the adapter 100. The vent halves 106a and 106b can be irreversibly fixed to the vent housing 107 in a manner sufficient to withstand the pressure associated with discharging fluid from a fluid vessel as described herein, for example, via manual and / or auxiliary fluid supply (e.g., the pressure associated with equilibrating the fluid vessel). For example, the vent halves 106a and 106b can be welded and / or bonded to the vent housing 107.

[0058] Figure 1C shows an example vent housing 107 without a filter, porous foam, or membrane.

[0059] As shown in Figure 1A, the adapter 100 further includes an outlet 103 provided at one end of the first fluid channel 102a opposite the spike element 104. The outlet 103 is configured to discharge fluid onto a surface, such as a surgical site, during the cleaning process. Figure 1A shows an example of adapter 100 having an outlet 103 with a single outlet, but it should be understood that the outlet 103 is not necessarily limited to this. For example, the outlet 103 may include multiple outlets, such as two, three, four, or more outlets. Each outlet may be the same size as or different from one or more of the other outlets. In addition, or instead, each outlet may have the same shape as or different from one or more of the other outlets.

[0060] The adapter 100 may further include at least one valve 105 provided along the first fluid path 102a, particularly between the spike element 104 and the outlet 103. According to some embodiments, the valve 105 is configured so that the adapter 100 can provide at least two selectable fluid supply modes. In some non-limiting examples, the at least two selectable fluid supply modes include auxiliary fluid supply and manual fluid supply.

[0061] As used herein, “auxiliary fluid supply” refers to the supply of fluid using at least one pumping device. Non-limiting examples of pumping devices include electric pumps, electromechanical devices, pneumatic devices, and syringes. As known in the art, a pumping device may be configured to provide a continuous flow of fluid from a fluid device. In addition, or instead, a pumping device may be configured to provide an intermittent flow of fluid, also referred herein as a “pulsed” flow.

[0062] As used herein, “manual fluid supply” refers to the supply of fluid without a pumping device. For example, if a fluid container includes a compressible body, manual fluid supply includes compressing the body so that at least a portion of the fluid contained therein is discharged.

[0063] Figure 2 shows an example of an adapter 200 having a valve 201 as described herein. Figure 2 also shows three different positions of the valve 201. In particular, in the first position 2001, the valve 201 is closed to prevent the passage of fluid. The second position 2002 shows an example of manual fluid supply. In this position, the valve 201 is opened by the pressure from the fluid flow 202, which is generated, for example, by compressing a fluid container as described herein. In this way, the fluid from the fluid flow 202 can pass through the valve 201. In this example, when the pressure from the fluid flow 202 is removed (for example, when the fluid container is no longer compressed), the valve 201 can return to the closed position, i.e., the first position 2001. In this way, it is possible to prevent air from the external environment from entering the fluid container through the valve 201. In addition, in the closed position, it is possible to prevent fluid from accidentally passing from the fluid container through the valve 201. Rather, air from the external environment enters the fluid container through a second fluid channel (for example, a second fluid channel 102b as illustrated and described in relation to Figure 1A), thereby passing through at least one vent and preventing contaminants from entering the fluid container.

[0064] A third position 2003 shows an example of auxiliary fluid supply. In this example, a portion of a pumping device, such as a spike 203, can be inserted through a valve 201. The valve 201 then remains in an open position, allowing fluid 205 to flow through the valve 201. According to some embodiments, the valve 201 is configured to prevent the pumping device (e.g., spike 203) passing through the valve 201 from accidentally falling out. For example, the valve 201 can be configured to generate sufficient friction between the valve 201 and the spike 203 to reduce or prevent the spike 203 from slipping against the valve 201. This friction can be provided by selecting a particular valve material and / or by providing a valve having one or more texture-adding features configured to interact with a portion of the pumping device (e.g., spike 203). Texture-adding features may include, but are not limited to, ridges, bumps, and combinations thereof.

[0065] As shown in Figure 2, the valve 201 may have a structure that allows for both manual and auxiliary fluid supply as described. For example, the valve 201 may include a cross-slit valve 300 as shown in Figure 3. As shown in Figure 3, the cross-slit valve 300 may include two slits that form a substantially "X shape". It should be understood that the cross-slit valve 300 may open in two directions. For example, as shown in Figure 2, the valve 201 may open in a first direction (for example, toward the outlet 204 of the adapter 200) in position 2002 and in a second direction (i.e., in the opposite direction to the first direction) in position 2003. However, it should be understood that this disclosure is not necessarily limited to this example. In particular, the valve may have any structure that can provide at least two selectable fluid supply modes as described herein. For example, the valve may have a single slit or three, four, five, or more slits. In some non-limiting examples, the valve may be a duckbill valve. In some non-exclusive examples, a valve is a check valve, such as a mechanical or pneumatic check valve.

[0066] In some non-limiting examples, a valve may be configured to provide a specific fluid force, fluid flow rate, and / or fluid flow pattern. As used herein, the term “fluid force” refers to the fluid force acting on a surface, for example, on a person, during a cleaning process. It should be understood that the fluid forces provided herein may be acceptable for use in cleaning processes such as those described herein.

[0067] In some non-limiting examples, the acceptable fluid force can be between 1 psi and 100 psi, optionally between 1 psi and 90 psi, optionally between 1 psi and 80 psi, optionally between approximately 1 psi and 70 psi, optionally between 1 psi and 60 psi, optionally between 1 psi and 50 psi, optionally between 1 psi and 40 psi, optionally between 1 psi and 30 psi, optionally between 1 psi and 20 psi, and optionally between 1 psi and 10 psi. In some non-limiting examples, the acceptable fluid force can be between 1 psi and 20 psi, optionally between 1 psi and 15 psi, and optionally between approximately 4 psi and 15 psi. In some non-limiting examples, the acceptable fluid force can be approximately 70 psi, optionally 65 psi, optionally 60 psi, optionally 55 psi, optionally 50 psi, optionally 45 psi, optionally 40 psi, optionally 35 psi, optionally 30 psi, optionally 25 psi, optionally 20 psi, optionally 15 psi, optionally 10 psi, and optionally 5 psi.

[0068] As used herein, the term “fluid flow rate” refers to the rate at which the fluid is applied to a surface, for example, to a person, during a cleaning process. As used herein, the term “fluid flow pattern” refers to the pattern in which the fluid is discharged from the apparatus and / or applied to a surface, for example, to a person, during a cleaning process.

[0069] In some non-limiting examples, a valve may have a certain number of slits to provide a specific fluid force, fluid flow rate, and / or fluid flow pattern as described herein. For example, a valve may have one slit, two slits, three slits, four slits, five slits, or more, as is known in the art. It should be understood that the number of slits may also affect the level of force required to open the valve (for example, as the number of slits increases, the force required for the fluid flow to open the valve may decrease). In addition, the number of slits may instead correspond to the size of the opening created by the opened valve, which may affect the fluid force, fluid flow rate, and / or fluid flow pattern.

[0070] In some non-limiting examples, a valve may have one or more slits of a particular length and / or shape. The length of one or more slits may affect the level of force required to open the valve (for example, increasing the slit length may decrease the force required of the fluid flow to open the valve). In addition, or instead, one or more slits may have a particular geometric pattern configured to provide a particular fluid force, fluid flow rate, and / or fluid flow pattern.

[0071] In addition, or instead, one or more other properties of the valve can be selected to provide a specific fluid flow force, fluid flow rate, and / or fluid flow pattern. Example valve properties include valve size (e.g., valve diameter), valve shape, valve material, valve thickness, valve orientation in the adapter, valve position along the first fluid flow path, and combinations thereof.

[0072] In some embodiments, a valve may include a valve material selected to provide a specific fluid flow force, fluid flow rate, and / or fluid flow pattern. Example valve materials include, but are not limited to, silicone, rubber, laminate, and elastomer materials. In some non-limiting examples, the valve material may include polyisoprene, polybutadiene, polyether, polysulfide, polyethylene, polyvinyl chloride, polyetheretherketone, polypropylene, nitrile, neoprene, ethylene propylene diene monomer rubber, rigid plastics, metallic steel, glass, or combinations thereof. The valve may include one or more check balls and / or springs. In some non-limiting examples, a more flexible valve material (e.g., silicone) may require less force to open than a more rigid material (e.g., vulcanized rubber). In some non-limiting examples, molecular weight, degree of crosslinking, and / or certain additives contained in the valve material may affect the level of force required to open the valve.

[0073] In some embodiments, the thickness of a valve can affect the level of force required to open the valve (for example, increasing the thickness may increase the force required for the fluid flow to open the valve).

[0074] In some embodiments, the shape of the valve can affect the level of force required to open it. For example, a valve may include a duckbill valve, which may require a different level of opening force than a cross-slit valve.

[0075] In some embodiments, the orientation of the valve in the adapter and / or the position of the valve along the first fluid passage can affect the level of force required to open the valve. In some non-limiting examples, the orientation of the valve can affect the force required for a portion of the pumping device to pass through the adapter.

[0076] In some non-limiting examples, the adapter 100 may include a burst disc instead of, or in addition to, the valve 105 as described herein. For example, the burst disc may be configured to rupture when a certain compressive force is applied to the fluid vessel. Once the burst disc has ruptured, the fluid can be supplied manually as described herein. Alternatively, the burst disc may be ruptured by a spike 203 of a pumping device as described herein.

[0077] In some embodiments, one or more components of the adapter 100 may include a transparent material. As used herein, “transparent material” means a material that allows sufficient light to pass through so that an object on the opposite side of the observer can be seen. In this way, the adapter 100 can reduce the risks associated with the incorrect insertion of the spike 203 of the pumping device as described herein, and consequently, the risk of the spike 203 being accidentally dislodged.

[0078] This disclosure also relates to a kit having an adapter as described herein. In some examples, the kit may include an adapter and instructions for use, such as instructions for securing the adapter to a fluid container as described herein. In some non-limiting examples, the kit may include an adapter, a fluid container, and instructions as described herein, optionally.

[0079] This disclosure also relates to a system having a fluid container having at least a first connection that connects to a second connection of an adapter as described herein.

[0080] Furthermore, a method using an adapter as described herein is also disclosed. This method may include the steps of providing a fluid container, securely connecting an adapter to the fluid container, and discharging fluid from the fluid container through the adapter, either manually or by auxiliary supply. This method may further include the step of performing a cleaning process, i.e., rinsing body cavities, surgical cavities, and / or wounds with fluid from the apparatus.

[0081] While the embodiments described herein have been presented in conjunction with the embodiments of examples outlined above, various alternatives, modifications, variations, improvements, and / or substantially equivalents, whether known, currently unforeseeable, or potentially available, may be obvious to those skilled in the art. Therefore, the embodiments of examples provided above are intended to be illustrative, not restrictive. Various modifications can be made without departing from the spirit and scope of this disclosure. Accordingly, this disclosure is intended to encompass all known or subsequently developed alternatives, modifications, variations, improvements, and / or substantially equivalents.

[0082] Accordingly, the claims are not intended to be limited to the embodiments shown herein, but should be given the full scope consistent with the language of the claims, and references to singular elements are intended to mean "one or more" rather than "only one" unless specifically stated so. All structural and functional equivalents to elements of various embodiments described throughout this disclosure, known to those skilled in the art or to be known thereafter, are intended to be expressly incorporated by reference herein and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, whether such disclosure is expressly provided for in the claims. Elements of the claims should not be construed as means plus function unless the element is expressly defined using the phrase "means for".

[0083] In this specification, the definition of numerical ranges by endpoints (for example, between about 50:1 and 1:1, between about 100°C and 500°C, between about 1 minute and 60 minutes) includes all numbers that fall within that range. For example, between about 1 minute and 60 minutes includes 21 minutes, 22 minutes, 23 minutes, and 24 minutes as endpoints within the specified range. Therefore, ranges such as 22-36, 25-32, and 23-29 are also ranges where the endpoints fall within the range of 1-60, depending on the starting materials used, temperature, specific application, specific embodiment, or, if necessary, the limitation of the claims. The examples and methods disclosed herein demonstrate that the described ranges include all points within the range, as changing one or more reaction parameters results in different synthetic products. Furthermore, the methods and examples disclosed herein illustrate various aspects of the disclosed ranges and the effects when these ranges are modified individually or in combination with other defined ranges.

[0084] Furthermore, the term “example” is used herein to mean “serving as an example, illustration, or illustration.” Any aspect described herein as “example” should not necessarily be construed as being preferable or more favorable than any other aspect. Unless otherwise stated, the term “several” 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, multiple B, or multiple C. Specifically, combinations such as “at least one of A, B, or C,” “at least one of A, B, and C,” and “A, B, C, or any combination thereof” can be A only, B only, C only, A and B, A and C, B and C, or A and B and C, and any such combination may include one or more elements of A, B, or C. Nothing disclosed herein is intended to be made available to the public, whether or not such disclosure is expressly provided for in the claims.

[0085] As used herein, the terms “about” and “approximately” are defined as being close enough to be understood by those skilled in the art. In a non-limiting embodiment, the terms “about” and “approximately” are defined as being within 10%, preferably within 5%, more preferably within 1%, and most preferably within 0.5%. [Explanation of symbols]

[0086] 100 adapter 101 Connection part 102a First fluid channel 102b Second fluid channel 103 Exit 104 Spike elements 105 Valve 106 Bent 106a, 106b Bent Half 107 Vent Housing 200 adapter 201 Valve 202 Fluid flow 203 Spikes 204 Exit 205 Fluid 2001 Position 1 2002 Position 2 2003 Third position 300 Cross-slit valve

Claims

1. A connector that can be connected to a fluid container, A first fluid passage having a first end and a second end, wherein the first end is configured to provide fluid communication with the fluid container, and the second end includes a fluid outlet, At least one valve provided along the first fluid passage, A second fluid channel, which is separate from the first fluid channel, Includes, The adapter wherein at least one valve is configured to provide a choice between auxiliary fluid supply and manual fluid supply.

2. The adapter according to claim 1, wherein the first end of the first fluid channel includes a spike element.

3. The adapter according to claim 1, wherein the at least one valve includes a cross-slit valve.

4. The adapter according to claim 1, wherein the at least one valve is configured to open in two directions.

5. The adapter according to claim 1, further comprising a vent provided along the second fluid passage.

6. The adapter according to claim 5, wherein the vent is irreversibly fixed to the vent housing.

7. A fluid container and It is an adapter, A connection part connected to the fluid container, A first fluid passage having a first end and a second end, wherein the first end is configured to provide fluid communication with the fluid container, and the second end includes a fluid outlet, A valve provided along the first fluid passage, configured to provide a choice between auxiliary fluid supply and manual fluid supply, A second fluid channel, which is separate from the first fluid channel, Includes an adapter, A system that includes this.

8. The system according to claim 7, wherein the first end of the first fluid channel includes a spike element.

9. The system according to claim 7, wherein the at least one valve includes a cross-slit valve.

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

11. The system according to claim 7, wherein the adapter further includes a vent provided along the second fluid passage.

12. The system according to claim 7, wherein the fluid container contains a cleaning fluid.

13. It is an adapter, A connector that can be connected to a fluid container, A first fluid passage having a first end and a second end, wherein the first end is configured to provide fluid communication with the fluid container, and the second end includes a fluid outlet, At least one valve provided along the first fluid passage, configured to provide a choice between auxiliary fluid supply and manual fluid supply, A second fluid channel, which is separate from the first fluid channel, Includes an adapter, Instructions for connecting the adapter to the fluid container, A kit that includes this.

14. The kit according to claim 13, wherein the first end of the first fluid channel includes a spike element.

15. The kit according to claim 13, wherein the at least one valve includes a cross-slit valve.

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

17. The kit according to claim 13, wherein the adapter further includes a vent provided along the second fluid passage.

18. The kit according to claim 17, wherein the vent is irreversibly fixed to the vent housing.

19. The kit according to claim 13, further comprising the fluid container.

20. The kit according to claim 19, wherein the fluid container contains a cleaning fluid.

Images