Integrated Surgical Irrigation Device

Abstract

The device for dispensing a cleaning fluid comprises a connection part directly and reversibly connectable to a container configured to contain the cleaning fluid, a discharge part, a fluid path providing fluid communication between the container and the discharge part, and an actuator, wherein the connection part, the discharge part, the fluid path and the actuator form one single device.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Provisional Application No. 63 / 429035, filed November 30, 2022, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to a cleaning device and a system having the same. [Background technology]

[0003] Intraoperative wound irrigation is a common process for preventing surgical site infections (SSIs) in healthcare settings. Such processes generally require either a manual irrigation device (e.g., a valve or syringe) or a powered irrigation device (i.e., a device with an electric pump). Powered irrigation devices are generally designed to draw irrigation fluid from a container outside the sterile field, such as an IV bag or similar container, due to limited space within the sterile field. The fluid connection between the irrigation device and the container is typically provided via tubing.

[0004] However, such devices pose several problems. For example, the tubing required to connect these devices to the containers can pose safety concerns, such as tripping risks. Additionally, the containers' location outside the sterile field poses a risk of compromising the sterile field. In some cases, the tubing required by these devices can come into contact with non-sterile environments (e.g., the floor) and require replacement, resulting in increased waste and costs as well as process delays. Finally, the use of such tubing requires additional process steps, along with additional cleaning fluids, to prime the device.

[0005] Current powered irrigation devices also typically require spike ports to connect tubing to the irrigation fluid container. However, such connections pose additional problems because "spiking" the container is often difficult and / or improperly performed. Spike ports also often result in loss of irrigation fluid and can pose a safety hazard to medical professionals when handling them, especially if the medical professionals are not adequately trained in such procedures. Summary of the Invention

[0006] The present disclosure relates to a device for dispensing a cleaning fluid, the device having a connection portion directly and reversibly connectable to a container configured to contain the cleaning fluid, a discharge portion, a fluid path providing fluid communication between the container and the discharge portion, and an actuator. According to some aspects, the connection portion, the discharge portion, and the actuator form a single, integral device.

[0007] Also disclosed is a system for dispensing a cleaning fluid, the system including a device having a connection portion, an outlet portion, and an actuator, and further including a connection adapter having a first surface at least partially receivable in the connection portion and a second surface at least partially reversibly connectable to a container configured to contain the cleaning fluid. According to some embodiments, the system is configured to provide a fluid path from the container to the outlet portion, the connection adapter configured such that when the first surface is received in the connection portion and the second surface is connected to the container, the connection portion is directly adjacent to the container.

[0008] The present disclosure also relates to systems that include the devices of the present disclosure, one or more containers described herein, and optionally, the connecting adapters disclosed herein. Methods of making and using the devices and systems disclosed herein are also disclosed. [Brief explanation of the drawings]

[0009] [Figure 1] FIG. 1 illustrates an exemplary apparatus according to an embodiment of the present disclosure. [Figure 2]FIG. 2 illustrates an exemplary connection adapter according to an embodiment of the present disclosure. [Figure 3] FIG. 3 illustrates an exemplary apparatus according to an embodiment of the present disclosure. [Figure 4A] FIG. 4A illustrates an exemplary apparatus according to an embodiment of the present disclosure. [Figure 4B] FIG. 4B illustrates an exemplary apparatus according to an embodiment of the present disclosure. [Figure 4C] FIG. 4C illustrates an exemplary apparatus according to an embodiment of the present disclosure. [Figure 4D] FIG. 4D illustrates an exemplary apparatus according to an embodiment of the present disclosure. [Figure 4E] FIG. 4E illustrates an exemplary apparatus according to an embodiment of the present disclosure. [Figure 5A] FIG. 5A illustrates an exemplary fluid flow component according to an embodiment of the present disclosure. [Figure 5B] FIG. 5B illustrates an exemplary fluid flow component according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0010] The present disclosure relates to an apparatus for dispensing a cleaning fluid, the apparatus having a connector reversibly connectable to a container configured to hold the cleaning fluid, a discharge connector, a fluid path providing fluid communication between the container and the discharge connector, and an actuator, the connector configured to position the container at a first distance from the discharge connector, the first distance being sufficient to allow the container to be contained within a sterile field during operation of the apparatus.

[0011] As used herein, the term "fluid" refers to a substance that does not have a fixed shape, such as a liquid or gas. As used herein, the term "irrigation fluid" refers to a fluid that is suitable for irrigation processes. Non-limiting examples of irrigation processes include processes for irrigating body cavities, surgical cavities, and / or external wounds, and processes that involve irrigating medical devices prior to contact with a subject. Examples of medical devices include, but are not limited to, surgical instruments and medical implants.

[0012] According to some embodiments, the cleaning fluid may include a disinfectant solution. As used herein, "disinfectant solution" refers to a solution containing at least a solvent and one or more disinfectants. According to some embodiments, the disinfectant solution is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which the solvent contains at least a majority of water. It should be understood that in some instances, the solvent may consist of water. According to some embodiments, the disinfectant solution is an alcohol solution. As used herein, the term "alcohol solution" refers to a solution in which the solvent contains at least a majority of an alcohol component. It should be understood that in some instances, the solvent may consist of one or more alcohol components. Non-limiting examples of alcohol components include, but are not limited to, ethanol, isopropyl alcohol, n-propanol, and combinations thereof. According to some embodiments, the solvent may include both water and alcohol components. In some non-limiting examples, the solvent may comprise about 90% (v / v) alcoholic components and the remaining volume being water, optionally about 80% (v / v) alcoholic components and the remaining volume being water, optionally about 70% (v / v) alcoholic components and the remaining volume being water, optionally about 60% (v / v) alcoholic components and the remaining volume being water, optionally about 50% (v / v) alcoholic components and the remaining volume being water, optionally about 40% (v / v) alcoholic components and the remaining volume being water, optionally about 30% (v / v) alcoholic components and the remaining volume being water, optionally about 20% (v / v) alcoholic components and the remaining volume being water, and optionally about 10% (v / v) alcoholic components and the remaining volume being water.

[0013] In some non-limiting examples, the solvent may comprise about 90% (v / v) or less alcoholic component and the remaining volume being water, optionally about 80% (v / v) or less alcoholic component and the remaining volume being water, optionally about 70% (v / v) or less alcoholic component and the remaining volume being water, optionally about 60% (v / v) or less alcoholic component and the remaining volume being water, optionally about 50% (v / v) or less alcoholic component and the remaining volume being water, optionally about 40% (v / v) or less alcoholic component and the remaining volume being water, optionally about 30% (v / v) or less alcoholic component and the remaining volume being water, optionally about 20% (v / v) or less alcoholic component and the remaining volume being water, optionally about 10% (v / v) or less alcoholic component and the remaining volume being water.

[0014] In one non-limiting example, the preservative may include a cationic molecule (i.e., a molecule having a positive charge), such as a cationic surfactant or a cationic biguanide derivative (i.e., a compound derived from a biguanide). According to some embodiments, the preservative may include a bis-(dihydropyridinyl)-decane derivative (i.e., a compound derived from bis-(dihydropyridinyl)-decane). According to some embodiments, the preservative may include an octenidine salt and / or a chlorhexidine salt. According to some embodiments, the preservative may include alexidine, octenidine dihydrochloride, chlorhexidine gluconate, or a combination thereof.

[0015] Additionally or alternatively, the preservative may include iodine. According to some embodiments, the iodine may be provided as an iodine complex, such as povidone-iodine (PVPI), nonylphenoxy-(ethyleneoxy)-iodine, polyethyleneoxypolypropyleneoxy-iodine, undecoirinium-chloride-iodine, iodopovacrilex, and combinations thereof.

[0016] Additionally or alternatively, the preservative may include an oxidizing agent (i.e., an oxidizing agent). Non-limiting examples of oxidizing agents according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, and combinations thereof.

[0017] Additionally or alternatively, the preservative may comprise a quaternary ammonium salt, non-limiting examples of which include benzalkonium chloride, benzethonium chloride, methylbenzethonium chloride, cetalkonium chloride, cetylpyridinium chloride, cetrimonium, cetrimide, dophanium chloride, tetraethylammonium bromide, didecyldimethylammonium chloride, domiphen bromide, and combinations thereof.

[0018] Additionally or alternatively, the preservative may include one or more surfactants. The one or more surfactants may include ionic surfactants, nonionic surfactants, zwitterionic surfactants, or combinations thereof. In some non-limiting examples, the one or more surfactants may include sodium lauryl sulfate, sodium laureth sulfate, citric acid, sodium citrate, oleic acid, cetylpyridinium chloride, soybean lecithin, polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monostearate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (10) stearyl ether, polyoxyethylene (2) oleyl ether, polyoxyethylene-polyoxypropylene-ethylenediamine block copolymer, polyoxypropylene-polyoxyethylene block copolymer, castor oil ethoxylate, polyoxyethylene nonylphenol ether, cremophor, 2-(2-ethoxy-ethoxy)ethanol, salts thereof, and mixtures thereof.

[0019] Additionally or alternatively, the antiseptic may include one or more antibiotics, non-limiting examples of which include cefazolin, vancomycin, gentamicin, bacitracin, and combinations thereof.

[0020] According to some aspects, the cleaning solution may include any combination of disinfectants described herein.

[0021] The disinfectant and / or combination of disinfectants may have sufficient antimicrobial activity to provide an acceptable log reduction in microorganisms within a period of time. It should be understood that the term "microorganism" as used herein refers to any microorganism that is killed and / or removed as a result of cleaning. Examples of microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0022] Examples of bacteria include, but are not limited to, Streptococcus mutans, S. pyogenes (Group A beta-hemolytic streptococcus), S. salivarius, S. sanguis, Staphylococcus aureus, S. epidermidis, S. haemolyticus, S. hominis, S. simulans, S. saprophyticus, methicillin / oxacillin-resistant (MRSA / ORSA) and methicillin / oxacillin-susceptible Staphylococcus (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 multidrug resistance (MDR), Acinetobacter baumannii, A.baumannii MDR, Achromobacter xylosoxidan, Micrococcus luteus, Ralstonia pickettii, Haemophilus influenzae, and Serratia marcescens.

[0023] Examples of fungi include, but are not limited to, Aspergillus niger, Candida albicans, C. aurus, C. dubliniensis, and C. glabrata. (formerly C. pseudotropicalis), C. guillermondii, C. kefyr, C. krusei, C. lusitaniae, C. tropicalis, Epidermophyton floccosum, Microsporum gypseum, M. canis, and Trichophyton mentagrophytes.

[0024] Examples of viruses include, but are not limited to, those that have lipid components in their envelope or have an envelope, such as cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2), influenza virus, parainfluenza virus, variola virus (smallpox virus), vaccinia, norovirus, and coronavirus.

[0025] However, it should be understood that the cleaning fluid need not necessarily be the disinfectant solution described herein, but may be any medically acceptable fluid sufficient to perform the cleaning process described herein. In one non-limiting example, the cleaning fluid may include saline. The saline may include water and sodium chloride at a medically acceptable concentration, such as about 0.1-1% w / v, optionally about 0.45% w / v, or optionally about 0.9% w / v.

[0026] According to some embodiments, the cleaning fluid may include a buffer system having one or more buffer components. As used herein, the term "buffer system" refers to a component of the cleaning fluid that provides resistance to significant changes in pH caused by strong acids or strong bases. The buffer system may include two or more buffer components, such as a weak acid and its conjugate base. The buffer system at least partially prevents significant changes in the pH of the cleaning fluid by interacting with the strong acid or strong base in the cleaning fluid to provide resistance to significant pH changes.

[0027] Generally, a buffer system has one or more buffer ranges within which the buffer system has the ability to provide resistance to significant pH changes. If a cleaning fluid having a buffer system has a pH within the buffer range of the buffer system, the pH of the cleaning fluid will not change significantly upon addition of an equimolar amount of a strong acid or strong base.

[0028] The buffering range of a buffer system is related to the acid dissociation constant (Ka) of one or more weak acids included 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 determined by the acid dissociation constant (i.e., -log 10 It is a logarithmic scale of the pH (pKa, which is equal to Ka).

[0029] According to some embodiments, the one or more buffer components may include one or more acid or salt forms of lactate, phosphate, borate, tartrate, glutamate, malate, citrate, gluconate, benzoate, succinate, acetate, glycine, and aspartate. According to some embodiments, the one or more buffer components may include lithium hydroxide, sodium hydroxide, potassium hydroxide, rubidium hydroxide, cesium hydroxide, calcium hydroxide, strontium hydroxide, sodium phosphate dibasic dihydrate, and / or barium hydroxide.

[0030] According to some embodiments, the cleaning fluid may include a pH adjuster. The term "pH adjuster" refers to a component of the cleaning fluid that alters the pH of the cleaning fluid.

[0031] According to some embodiments, the pH adjuster may include one or more of acetic acid, adipic acid, ascorbic acid, citric acid, hydrochloric acid, lactic acid, malic acid, potassium phosphate, sodium phosphate, phosphoric acid, pyrophosphoric acid, succinic acid, sulfuric acid, tartaric acid, and solutions thereof.

[0032] The cleaning fluids described herein may be contained in a container. The container of the present disclosure may include a body portion and an outlet configured to dispense the fluid therefrom.

[0033] According to some embodiments, the container may be formed from a container material that may be rigid or flexible. As used herein, the term "flexible" refers to the ability to bend, compress, or collapse under normal operating forces. According to some embodiments, a flexible container may be compressible. As used herein, the term "compressible" refers to the ability to reversibly reduce its volume without unacceptable changes, such as unacceptable permanent changes to size, shape, and / or one or more properties described herein. Additionally or alternatively, a flexible container may be collapsible. As used herein, the term "collapsible" refers to the ability to permanently reduce its capacity. For example, a collapsible container 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 container collapses to have a second volume, the second volume being smaller than the first volume.

[0034] As used herein, the term "rigid" refers to sufficient rigidity to resist deformation due to normal handling forces. It should be understood that a rigid container is not compressible or collapsible.

[0035] Examples of useful container materials according to the present disclosure 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, polyvinyl chloride (PVC), polyethylene terephthalate (PET), and any combination thereof. According to some embodiments, the container material may be a lined and / or coated material, such as lined and / or coated paper.

[0036] According to some embodiments, the container may include a venting element. The venting element may include a fluid channel configured to provide fluid communication between the container and an external environment. According to some embodiments, at least a portion of the fluid channel is separated from a fluid path through which the cleaning fluid is dispensed from the container (i.e., from an outlet of the container). The venting element may further include a filter, particularly a sterilizing filter.

[0037] Examples of useful ventilation components according to the present disclosure include those disclosed in U.S. Patent Publication No. 2022 / 0118169, the contents of which are expressly incorporated herein by reference in their entirety.

[0038] The device of the present disclosure includes a connector that is reversibly connectable to a container, as described herein. The connector may be connectable to a container such that an outlet of the container is provided in fluid communication with the device, thereby providing a fluid path for cleaning fluid to travel from the container to the device. As used herein, the term "reversibly connected" refers to a connection that can be selectively released. For example, a reversible connection may include a threaded connection that can be selectively unscrewed. In another example, the device may include an actuator (e.g., a button or lever) that can be activated to release the reversible connection. Non-limiting examples of robust, fluid-tight, reversible connections include threaded connections, bayonet connections, snap connections, friction connections, and combinations thereof.

[0039] According to some embodiments, a connector of the device can include one or more connection components that mate with one or more corresponding connection components of a container to provide a robust, fluid-tight, reversible connection. FIG. 1 illustrates an exemplary device according to the present disclosure. In particular, FIG. 1 illustrates a device 100 having a connector 101 that is reversibly connectable with a container 102, as described herein. In this example, the container 102 can include an outlet (not shown) receivable within the connector 101. According to some embodiments, the container 102 can be any container known in the art for containing a cleaning fluid. In some non-limiting examples, the container 102 can include a pierceable material, and if a pierceable material is provided in association with the connector 101, a portion of the connector 101 and / or an adapter (described below) pierces the container 102 to provide fluid communication with the container 102.

[0040] According to some embodiments, the inner surface of connection portion 101 may include, for example, male or female threads configured to provide a threaded connection with corresponding male or female threads provided on the outer surface (i.e., the surface surrounding the outlet) of container 102. However, it should be understood that device 100 is not limited in this manner. For example, connection portion 101 may have one or more radial pins or one or more slots corresponding to one or more radial pins or one or more slots provided on the outer surface of container 102 sufficient to provide a bayonet connection.

[0041] In another example, the device 100 may include a separate connection adapter, as shown in FIG. 2. Among other things, FIG. 2 illustrates a connection adapter 200 that may mate with the connection portion 101 and the container 102 shown in FIG. 1 to provide a robust, fluid-tight, and reversible connection. In one example, the connection adapter 200 may have a first surface 203 that forms at least a portion of the exterior surface 201. The exterior surface 201 may have one or more connection components that mate with one or more corresponding connection components on the interior surface of the connection portion 101, as shown in FIG. 1. The connection adapter 200 may further include a second surface 204 that forms at least a portion of the interior surface (not shown). The interior surface may have one or more connection components that mate with one or more corresponding connection components on the exterior surface of the container 102, as shown in FIG. 1. Preferably, the second surface 204 is directly opposite the first surface 203. In this manner, the connection adapter 200 may be "sandwiched" between the connection portion 101 of the device 100 and the container 102 sufficiently to provide a robust, fluid-tight, reversible connection. According to some embodiments, the connection adapter 200 may be configured such that the connection portion 101 of the device 100 is directly adjacent to the container 102 when it is provided in this sandwiched position (i.e., when at least a portion of the first surface 203 is received in the connection portion 101 and at least a portion of the second surface 204 is connected to the container 102). The connection adapter 200 may further include an outlet 202 (e.g., an outlet of a nozzle portion) sufficient to provide a fluid path between the container 102 and the device 100.

[0042] It should be appreciated that the connection adapter 200 may enable a robust, fluid-tight, reversible connection between the device 100 and a variety of containers, including commercially available containers. For example, the connection adapter 200 may include an inner surface having male or female threads configured to provide a robust, fluid-tight, reversible connection with a variety of commercially available containers having male or female threads. In one non-limiting example, the commercially available container may include a 450 mL bottle of BD Surgiphor™ Antimicrobial Cleaning System.

[0043] Regardless of the type of connection, it should be understood that the container 102 is connected to the device 100 such that fluid contained within the container 102 can travel along a fluid path to the device 100. The fluid path can further communicate with the outlet 103 of the device 100, as shown in FIG.

[0044] According to some embodiments, the discharge portion 103 can be configured to apply irrigation fluid to a surface, such as a body cavity, a surgical cavity, and / or an external wound. Additionally or alternatively, the discharge portion 103 can be configured to apply irrigation fluid to a medical device prior to contact with a subject, as described herein. According to some embodiments, the discharge portion 103 can include a nozzle portion. Although not shown in FIG. 1 , the nozzle portion can include one, two, three, four, or more discharge openings. According to some embodiments, one or more discharge openings can include one or more restrictions configured to prevent the passage of unacceptable fluid. For example, one or more of the discharge openings can include a one-way valve having a first closed position that prevents the passage of fluid and a second open position that allows the passage of fluid. In this example, the one-way valve can be in a first position when subjected to pressure from one direction (e.g., hydraulic pressure from the irrigation fluid). The one-way valve can be easily moved to a second position when subjected to pressure from a different direction (i.e., air pressure from the ambient environment).

[0045] Each of the discharge openings may be the same size as or different from one or more of the other discharge openings. Additionally or alternatively, each of the discharge openings may be the same shape as or different from one or more of the other discharge openings. The shape and / or size of one or more discharge openings may be selected to provide a particular fluid flow force, fluid flow rate, and / or fluid flow pattern. According to some embodiments, the shape and / or size of one or more discharge openings may be adjustable such that the fluid flow force, fluid flow rate, and / or fluid flow pattern of the dispensed fluid is adjustable.

[0046] As used herein, the term "fluid flow force" refers to the force of a fluid acting on a surface, such as a human subject and / or medical device, during a cleaning process. It should be understood that fluid flow forces according to the present disclosure may be acceptable for use in the cleaning processes described herein.

[0047] In some non-limiting examples, acceptable fluid flow forces can be between 1 and 100 psi, optionally between 1 and 90 psi, optionally between 1 and 80 psi, optionally between about 1 and 70 psi, optionally between 1 and 60 psi, optionally between 1 and 50 psi, optionally between 1 and 40 psi, optionally between 1 and 30 psi, optionally between 1 and 20 psi, and optionally between 1 and 10 psi. In some non-limiting examples, acceptable fluid flow forces can be between 1 and 20 psi, optionally between 1 and 15 psi, and optionally between about 4 and 15 psi. In some non-limiting examples, acceptable fluid flow forces can be about 70 psi, optionally about 65 psi, optionally about 60 psi, optionally about 55 psi, optionally about 50 psi, optionally about 45 psi, optionally about 40 psi, optionally about 35 psi, optionally about 30 psi, optionally about 25 psi, optionally about 20 psi, optionally about 15 psi, optionally about 10 psi, and optionally about 5 psi.

[0048] As used herein, the term "fluid flow rate" refers to the rate at which a fluid is applied to a surface, such as a human subject and / or medical device, during a cleaning process. As used herein, the term "fluid flow pattern" refers to the pattern in which a fluid is dispensed from a device and / or applied to a surface, such as a human subject and / or medical device, during a cleaning process.

[0049] According to some embodiments, all or a portion of the discharge portion 103 shown in Figure 1 may be removable and replaceable. For example, the nozzle portion may be removable and replaceable so that the same discharge portion can be in interchangeable communication with at least two different nozzle portions. According to some embodiments, all or a portion of the discharge portion 103 may be removable and replaceable before, during, or after a cleaning process, or a combination thereof.

[0050] Although not shown, the discharge portion 103 may include one or more extension features configured to enhance access to surfaces, such as a body cavity, a surgical cavity, an external wound, and / or a medical device. For example, the discharge portion 103 may include a bendable and / or stretchable member that can be adjusted to perform the cleaning process on difficult-to-access surfaces. Although not shown, the device 100 may further include a heating and / or cooling element configured to adjust the temperature of the cleaning fluid dispensed therefrom. For example, the heating and / or cooling element may be configured to maintain the temperature of the fluid, which increases during the cleaning process, within a normal temperature range. As used herein, "normal temperature range" refers to the normal temperature range of the human body, such as approximately 36°C to 38°C. Additionally or alternatively, the device 100 may include a light source configured to enhance the visibility of the surface being cleaned.

[0051] According to some embodiments, device 100 can be configured to provide adjustable fluid forces, fluid flow rates, fluid flow patterns, or combinations thereof. For example, device 100 can include a fluid flow component configured to adjust the shape and / or size of one or more discharge openings, as described herein. In some non-limiting examples, the fluid flow component can include a rotatable component, such as a rotatable plate, disposed at any point along the fluid path (e.g., over one or more openings in the discharge), as described herein. The rotatable component can include one or more openings that can be selectably aligned with one or more openings in the discharge to provide selectable fluid forces, fluid flow rates, and fluid flow patterns, as described herein.

[0052] 5A illustrates an example of a fluid flow component 500 as described herein. As shown in FIG. 5A, the fluid flow component 500 may include one, two, three, or more openings 501, each of which may be the same size or different from one or more of the other openings 501. It should be understood that a user may select the fluid flow force, fluid flow rate, and / or fluid flow pattern by rotating the fluid flow component 500 so that a desired opening 501 aligns with one or more openings in the discharge, as described herein.

[0053] It should be understood that the present disclosure is not limited to the example shown in FIG. 5A . For example, one or more openings 501 of the fluid flow component 500 can have a different shape than that shown in FIG. 5A . In another example, the fluid flow component 500 can include one or more openings 501 configured to provide variable fluid flow forces, fluid flow rates, and / or fluid flow patterns. For example, FIG. 5B illustrates a fluid flow component 500 having openings 501 with variable diameters. It should be understood that a user can select the fluid flow forces, fluid flow rates, and / or fluid flow patterns by rotating the fluid flow component 500 so that selected portions of the openings 501 are aligned with one or more openings in the discharge portion as described herein.

[0054] According to some embodiments, device 100 can be configured to dispense fluid intermittently, also referred to herein as a "pulsed" flow. For example, device 100 can include a pulsing component that intermittently interrupts the fluid path, as described herein. In one non-limiting example, the pulsing component can include a rotating component disposed at any point along the fluid path (e.g., in or on an outlet opening), as described herein. The pulsing component can have one or more openings therein, and as the pulsing component rotates, the one or more openings allow fluid to pass therethrough intermittently along the fluid path, providing a pulsating flow of fluid, as described herein.

[0055] In one non-limiting example, the rotating component includes a rotating plate. In another non-limiting example, the rotating component has a pinwheel shape. The rotating component can be driven by a power source (e.g., a motor). Additionally or alternatively, fluid moving along the fluid path can drive the rotating component, for example, if the rotating component has a pinwheel shape.

[0056] According to some embodiments, the pulse component may be a permanent component of the device (ie, not removable through normal operating procedures) or may be removable.

[0057] According to some embodiments, connection 101 of device 100 may be configured to provide container 102 a first distance from discharge 103, the first distance being sufficient to contain container 102 within the sterile field during operation of device 100 (e.g., during a cleaning process). The first distance may be less than about 3 feet, optionally less than about 2.5 feet, optionally less than about 2 feet, optionally less than about 1.5 feet, optionally less than about 1 foot, optionally less than about 11 inches, optionally less than about 10 inches, optionally less than about 9 inches, optionally less than about 8 inches, optionally less than about 7 inches, optionally less than about 5 inches, optionally less than about 4 inches, optionally less than about 3 inches, optionally less than about 2 inches, and optionally less than about 1 inch.

[0058] Device 100 may further include an actuator that, when activated, ejects fluid through ejection portion 103. As shown in FIG. 1 , actuator 104 may include a button. However, the disclosure is not so limited. For example, actuator 104 may additionally or alternatively include a switch, a lever, a knob, a trigger, or a combination thereof. While FIG. 1 shows actuator 104 located at the proximal end of handle 105, it should also be understood that actuator 104 may be located in any portion of device 100 sufficient to allow a user to operate device 100 during use of device 100, particularly during use of device 100 in a cleaning process.

[0059] According to some embodiments, the actuator 104 is in communication with a motor (not shown), which is configured to drive fluid from the reservoir 102 to the outlet 103 along a fluid path sufficient to dispense the fluid onto a surface, as described herein. In some non-limiting examples, the motor may be powered by a power source (e.g., a battery) that is entirely contained within the device.

[0060] According to some embodiments, device 100 may be configured such that fluid is dispensed continuously upon actuation of actuator 104. For example, device 100 may be configured such that once actuator 104 is actuated, fluid is dispensed from device 100 in an uninterrupted stream until actuator 104 is no longer actuated.

[0061] According to some embodiments, device 100 may be configured to provide a pulsed flow of fluid. For example, device 100 may be configured such that when actuator 104 is actuated, fluid is dispensed from device 100 in discrete pulses until actuator 104 is no longer actuated. In one non-limiting example, the motor may be configured to vary between an active state and an inactive state upon actuation of the actuator, such that the motor varies between driving fluid and not driving fluid, as described herein.

[0062] According to some embodiments, device 100 may be configured to allow a user to select continuous or pulsed flow. Additionally or alternatively, device 100 may be configured to allow a user to select a fluid flow force and / or fluid flow rate, as described herein. In one non-limiting example, the motor may be configured to provide a selected level of power corresponding to the selected fluid flow force and / or fluid flow rate. According to some embodiments, device 100 may be configured to allow a user to select from a continuous spectrum of fluid flow forces and / or fluid flow rates. Additionally or alternatively, device 100 may be configured to allow a user to select from one, two, three, four, or more discrete fluid flow forces and / or fluid flow rates.

[0063] According to some embodiments, when provided as part of a system herein along with one or more containers 102, the device 100 can be configured such that all components of the system can be contained within a sterile field during use. As used herein, "sterile field" refers to an area where a medical procedure is performed (e.g., an area around a patient's body) and all items are sterile. For example, the device 100 of FIG. 1 can be configured such that all components of the device 100 and the containers 102 can be contained within a sterile field when used in a cleaning process.

[0064] According to some embodiments, two or more of the components described herein may be configured to provide a single device. As used herein, the term "single device" refers to a device configured to form a single unit, no part of which is removable under normal operating conditions. According to some embodiments, at least the connection portion, discharge portion, and actuator of the present disclosure form a single device.

[0065] As shown in FIG. 1 , the device 100 can be configured such that when the device 100 is connected to the container 102, the container 102 is positioned relative to the device 100. According to some embodiments, the position can be an acceptable position for a medical procedure, such as a cleaning process. In some non-limiting examples, an acceptable position is one that does not obstruct a medical practitioner's line of sight during a medical procedure. Additionally or alternatively, an acceptable position is one that does not disrupt the medical procedure, for example, by providing inadvertent contact between the system and the patient's body. In some non-limiting examples, an acceptable position is one that provides acceptable device balance during use. For example, an acceptable position can be one in which the weight of a first end of the device is approximately equal to the weight of a second end of the device for ease of use when a medical practitioner is using the device for a medical procedure.

[0066] An example of an acceptable position is shown in Figure 1. Specifically, Figure 1 shows that when container 102 is connected to device 100, central axis 106 of container 102 is generally parallel to central axis 107 of at least a portion of a fluid path along which fluid travels through device 100, as described herein.

[0067] However, it should be understood that the present disclosure is not limited to the example shown in FIG. 1 . For example, FIG. 3 illustrates another example of an apparatus 300 connected to a container 302, similar to the apparatus 100 and container 102 shown in FIG. 1 . As shown in FIG. 3 , when the container 302 is connected to the apparatus 300, the central axis 306 of the container 302 can be at an angle relative to the central axis 307 of at least a portion of a fluid path along which the fluid travels through the apparatus 300, as described herein. This angle can be any angle that provides an acceptable position, as described herein. According to some embodiments, this angle is between 0° and 180°, including all values ​​therein, and optionally between about 0° and 90°. According to some embodiments, the central axis of the container can be approximately perpendicular to the central axis of at least a portion of a fluid path along which the fluid travels through the apparatus.

[0068] 1 and 3 show the container 102, 302 located on the side 108, 308 of the device 100, 300 generally opposite the handle 105, 305 (alternatively referred to herein as the "top" of the device), the disclosure is not limited to this. For example, the container 102, 302 could be located on the same side 109, 309 of the device 100, 300 as the handle 105, 305 (alternatively referred to herein as the "bottom" of the device) or anywhere therebetween.

[0069] FIG. 4A illustrates a top view of another exemplary device 400 according to an embodiment of the present disclosure. It should be understood that device 400 may function as described with respect to devices 100, 300 of FIGS. 1 and 3. Notably, similar to devices 100, 300, device 400 may include a connector 401 reversibly connectable to a container (not shown) as described herein. Additionally or alternatively, connector 401 may be connectable to a connection adapter (not shown), such as connector adapter 200 of FIG. 2. FIG. 4A also illustrates an actuator 404 similar to actuator 104 shown in FIG. 1.

[0070] 4B shows a perspective view of device 400. As shown in this figure, device 400 may further include an outlet 410 connectable to an outlet (not shown), such as outlet 103 shown in FIG. 1. It should be understood that outlet 410 is in fluid communication with a fluid flow path (not shown in FIG. 4B) that connects outlet 410 to connection 401. In this manner, fluid from a reservoir (not shown) may travel along the fluid flow path to an outlet, which may be configured to apply a cleaning fluid to a surface, as described herein.

[0071] FIG. 4E shows an exploded view of a device 400 as described herein. Among other things, FIG. 4E shows a connection 401, an actuator 404, and an outlet 410. FIG. 4E also shows tubing components 411 a, 411 b, which together form a fluid flow path between the connection 401 and the outlet 410. FIG. 4E also shows a motor 412 as described herein, which is powered by a power source 414 (e.g., a battery). As shown in FIG. 4E, the tubing components 411 a, 411 b, the motor 412, and the power source 414 are all housed entirely within a device 400 as described herein, which in this example includes an upper housing 415 a and a lower housing 415 b as shown.

[0072] 4C and 4D show end and side views, respectively, of device 400. As described herein, device 400 can be sized so that all of its components can be contained within a sterile field during use. For example, as shown in FIG. 4D, device 400 can have a length 416 (i.e., its longest dimension) of about 12 inches or less, optionally about 10 inches or less, optionally about 8 inches or less, optionally about 7 inches or less, optionally about 6 inches or less, and optionally about 5 inches or less.

[0073] 1, 3, and 4 depict devices 100, 300, 400 connectable to a single container at a time, it should be understood that the disclosure is not so limited. For example, devices of the present disclosure can be connectable to two, three, four, or more containers, each container as described herein. Each of the containers may be independently connected to the same fluid pathway as another container or to a different fluid pathway. Additionally, each container may contain the same or a different fluid as another container. In this manner, devices of the present disclosure can be configured to simultaneously and / or sequentially dispense two or more fluids as described herein without the need to remove the containers from the device and / or remove the device from the sterile field.

[0074] According to some aspects, all or a portion of the device of the present disclosure may be sterilized. In some non-limiting examples, the device or portions thereof may be sterilized by any acceptable sterilization process known in the art, such as gamma sterilization, electron beam sterilization, ethylene oxide sterilization, or a combination thereof. Additionally or alternatively, the device may be provided in sterile packaging known in the art.

[0075] According to some embodiments, the devices of the present disclosure may be reusable, i.e., they may be used to dispense cleaning fluids from more than one container. For example, a device may be connected to a first container sufficient to dispense a first cleaning fluid, as described herein, and the same device may be connected to a second container sufficient to dispense a second cleaning fluid contained therein. In some non-limiting examples, all or portions of the device may be replaceable. For example, after a first cleaning fluid is dispensed by the device, all or portions of the fluid flow path (such as tubing components 411a, 411b described in connection with FIG. 4E) may be removed and replaced before dispensing a second cleaning fluid. In this manner, a second cleaning fluid may be dispensed using the device without risk of contamination by the first cleaning fluid. Additionally or alternatively, after a first cleaning fluid is dispensed by the device, the device may be washed with a flushing fluid before dispensing a second cleaning fluid. Non-limiting examples of flushing fluids according to the present disclosure include water, saline solutions as described herein, aqueous solutions as described herein, aqueous solutions with buffer systems as described herein, alcohol solutions as described herein, povidone-iodine solutions, and combinations thereof.

[0076] According to some aspects, devices of the present disclosure may be rechargeable. For example, if the power source includes a battery, the battery may be replaceable. Additionally or alternatively, the power source may itself be rechargeable, such as a rechargeable battery.

[0077] The present disclosure also relates to a system having the device described herein and at least one container. According to some embodiments, the system of the present disclosure can be sterilized. In some non-limiting examples, the system can be provided in sterile packaging known in the art. Each component of the system can be provided independently in the same packaging as other components of the system or in different packaging, as known in the art.

[0078] The present disclosure also relates to methods of manufacturing and using the devices and systems described herein. According to some aspects, the methods may include connecting a container described herein to a connection portion of the device and actuating an actuator of the device sufficient to dispense irrigation fluid onto a surface via a dispensing portion of the device. The methods may further include an irrigation process, i.e., flushing a body cavity, surgical cavity, and / or external wound with irrigation fluid from the device.

[0079] While the embodiments described herein have been described in conjunction with the example embodiments set forth above, various alternatives, modifications, variations, improvements, and / or substantial equivalents, whether known or presently unforeseen, may become apparent to at least those skilled in the art. Accordingly, the example embodiments set forth above are intended to be illustrative and not limiting. Various changes may be made without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to embrace all known or later-developed alternatives, modifications, variations, improvements, and / or substantial equivalents.

[0080] Therefore, the claims are not intended to be limited to the embodiments set forth herein, but are to be accorded the full scope consistent with the language of the claims. Reference to an element in the singular is not intended to mean "one and only one," unless specifically stated otherwise, but rather "one or more." All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or later become known to those skilled in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed in this application is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element should be construed as a means-plus-function unless the element is expressly recited using the term "means."

[0081] In this application, recitation of numerical ranges by endpoint (e.g., between about 50:1 and 1:1, between about 100°C and 500°C, between about 1 minute and 60 minutes) includes all values ​​subsumed 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. Thus, for example, ranges such as 22-36, 25-32, and 23-29 may also have endpoints within the range of 1-60, depending on the starting materials used, the temperature, the particular application, the particular embodiment, or, as needed, the limitations of the claims. The examples and methods disclosed herein demonstrate that the recited ranges encompass all points within the range, since different synthesis products may result from varying one or more reaction parameters. The methods and examples disclosed herein also describe various aspects and effects of the disclosed ranges when the ranges are varied individually or in combination with other recited ranges.

[0082] Also, the term "exemplary" is used herein to mean "serving as an example, illustration, or illustration." Any aspect described herein as "exemplary" should not necessarily be construed as preferred or advantageous over other aspects. Unless expressly stated otherwise, the term "some" means one or more. Combinations such as "at least one of A, B, or C," "at least one of A, B, and C," and "A, B, C, or any combination thereof" include any combination of A, B, and / or C, and may include multiples of A, multiples of B, or multiples of C. Specifically, combinations such as "at least one of A, B, or C," "at least one of A, B, and C," and "A, B, C, or any combination thereof" may include A only, B only, C only, A and B, A and C, B and C, or A and B and C, and any combination thereof may include one or more members of A, B, or C. Nothing disclosed in this application is intended to be offered to the public, regardless of whether such disclosure is expressly recited in the claims.

[0083] As used herein, the terms "about" and "approximately" are defined as close as understood by one of ordinary skill in the art. In one non-limiting embodiment, the terms "about" and "approximately" are defined as within 10%, preferably within 5%, more preferably within 1%, and most preferably within 0.5%.

Claims

1. 1. An apparatus for dispensing a cleaning fluid, comprising: a connection part directly and reversibly connectable to a container, the container being configured to contain a cleaning fluid; A discharge portion; a fluid pathway providing fluid communication between the container and the outlet; An actuator; Including, The connection portion, the outlet portion, the fluid path and the actuator form one single device.

2. The device of claim 1 , wherein the connection portion includes a first connection component configured to mate with a second connection component included in the container.

3. The device of claim 2 , wherein the first connecting component and the second connecting component each include a screw.

4. 2. The device of claim 1, wherein the connection portion is configured to position the container a first distance from the discharge portion, the first distance being sufficient to contain the container within a sterile field during operation of the device.

5. The device of claim 1 , wherein the irrigation fluid comprises povidone-iodine, chlorhexidine gluconate, or a combination thereof.

6. The device of claim 1 , further comprising a pulse component configured to intermittently interrupt the fluid path.

7. The apparatus of claim 1 , further comprising a motor configured to vary between an active state and an inactive state upon actuation of the actuator.

8. 1. A system for dispensing a cleaning fluid, comprising: a device including a connection portion, a discharge portion, and an actuator; a connection adapter having a first surface at least a portion of which is receivable in the connection portion and a second surface at least a portion of which is reversibly connectable to a container, the container being configured to contain a cleaning fluid; Including, the system being configured to provide a fluid path from the container to the outlet; The connection adapter is configured such that when at least a portion of the first surface is received in the connection portion and at least a portion of the second surface is connected to the container, the connection portion is directly adjacent to the container.

9. 9. The system of claim 8, wherein the connecting adapter is configured to position the container at a first distance from the discharge portion, the first distance being sufficient to accommodate the container within a sterile field during operation of the device.

10. The system of claim 8 , wherein the irrigation fluid comprises povidone-iodine, chlorhexidine gluconate, or a combination thereof.

11. The system of claim 8 , further comprising a pulse component configured to intermittently interrupt the fluid path.

12. The system of claim 8 , further comprising a motor configured to vary between an active state and an inactive state upon actuation of the actuator.

13. The system of claim 8 , wherein the second surface includes first threads configured to mate with second threads of the container.

14. 1. A system for dispensing a cleaning fluid, comprising: a container configured to contain a cleaning fluid; 1. An apparatus comprising: a connection part that can be directly and reversibly connected to the container; A discharge portion; a fluid pathway providing fluid communication between the container and the discharge portion; An actuator; an apparatus comprising: Including, A system wherein the connection portion, the outlet portion, the fluid path and the actuator form one single device.

15. 15. The system of claim 14, wherein the connection portion includes a first connection component configured to mate with a second connection component included in the container.

16. The system of claim 15 , wherein the first connection component and the second connection component each include a screw.

17. 15. The system of claim 14, wherein the connection is configured to position the container a first distance from the discharge, the first distance being sufficient to contain the container within a sterile field during operation of the device.

18. 15. The system of claim 14, wherein the irrigation fluid comprises povidone-iodine, chlorhexidine gluconate, or a combination thereof.

19. The system of claim 14 , further comprising a pulse component configured to intermittently interrupt the fluid path.

20. The system of claim 14 , further comprising a motor configured to vary between an active state and an inactive state upon actuation of the actuator.

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