Integrated surgical flushing device

Abstract

A device for dispensing an irrigation fluid, the device having a connection portion directly and reversibly connectable with a container containing the irrigation fluid, a discharge portion, a fluid path providing fluid communication between the container and the discharge portion, and an actuator, the connection portion, the discharge portion, the fluid path and the actuator forming a single one-piece device.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 429,035, filed on November 30, 2022, the entire content of which is incorporated herein by reference. Technical Field

[0003] The present disclosure relates to a flushing device and a system having the flushing device. Background Art

[0004] Intra - operative incision wound irrigation is a common procedure used to prevent surgical site infections (SSIs) in a medical setting. Such procedures typically require either a manual irrigation device (e.g., a balloon or syringe) or a motorized irrigation device (i.e., a device with an electric pump). Generally, due to limited space within the sterile field, motorized irrigation devices are designed to pump irrigation fluid from a container located outside the sterile field (such as a container similar to an intravenous (IV) bag). The fluid connection between the irrigation device and the container is typically provided via tubing.

[0005] However, such devices pose several problems. For example, the tubing required to connect these devices to the container can pose safety issues, such as a tripping hazard. Additionally, the location of the container outside the sterile field introduces a risk of breaching the sterile field. In some cases, the tubing required for these devices may come into contact with a non - sterile environment (e.g., the floor) and thus need to be replaced, which, in addition to increasing waste and cost, can cause process delays. Finally, using such tubing requires additional process steps as well as additional irrigation fluid in order to prime the device.

[0006] Current motorized irrigation devices typically also require a spike port in order to connect the tubing to the irrigation fluid container. However, such connections pose additional problems because "spiking" the container is often difficult and / or performed improperly. Spike ports also often result in loss of irrigation fluid and can pose a safety hazard to medical professionals during operation, especially if the medical professionals are not adequately trained in such procedures. Summary of the Invention

[0007] The present disclosure relates to a device for dispensing a flushing fluid, the device having a connection portion that can be directly and reversibly connected to a container configured to hold the flushing 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.

[0008] Also disclosed is a system for dispensing a flushing fluid, the system including a device having a connection portion, a discharge portion, and an actuator, and the system further including a connection adapter having a first face and a second face, at least a portion of the first face being receivable in the connection portion and at least a portion of the second face being reversibly connectable to a container configured to hold the flushing fluid. According to some aspects, the system is configured to provide a fluid path from the container to the discharge portion, and the connection adapter is configured such that when the first face is received in the connection portion and the second face is connected to the container, the connection portion is directly adjacent to the container.

[0009] The present disclosure also relates to a system having the device of the present disclosure, one or more containers as described herein, and optionally a connection adapter as described herein. Also disclosed are methods of making and using the devices and systems as described herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 Example devices in accordance with aspects of the present disclosure are shown.

[0011] Figure 2 Example connection adapters in accordance with aspects of the present disclosure are shown.

[0012] Figure 3 Example devices in accordance with aspects of the present disclosure are shown.

[0013] Figure 4A Example devices in accordance with aspects of the present disclosure are shown.

[0014] Figure 4B Example devices in accordance with aspects of the present disclosure are shown.

[0015] Figure 4C Example devices in accordance with aspects of the present disclosure are shown.

[0016] Figure 4D Example devices in accordance with aspects of the present disclosure are shown.

[0017] Figure 4E Example devices in accordance with aspects of the present disclosure are shown.

[0018] Figure 5A Example fluid flow components in accordance with aspects of the present disclosure are shown.

[0019] Figure 5B Example fluid flow components in accordance with aspects of the present disclosure are shown. DETAILED DESCRIPTION

[0020] The present disclosure relates to a device for dispensing a flushing fluid, the device having a connection portion reversibly connectable to a container configured to hold the flushing fluid, a discharge portion, a fluid path providing fluid communication between the container and the discharge portion, and an actuator. The connection portion may be configured such that the container is disposed at a first distance from the discharge portion, the first distance being sufficient to enable the container to be received within a sterile area during operation of the device.

[0021] As used herein, the term "fluid" refers to a substance that does not have a fixed shape, such as a liquid or a gas. As used herein, the term "flushing fluid" refers to a fluid suitable for use in a flushing process. Non-limiting examples of flushing processes include processes for flushing body cavities, surgical cavities, and / or external wounds and processes involving flushing a medical device prior to contact with a subject. Exemplary medical devices include, but are not limited to, surgical equipment and medical implants.

[0022] According to some aspects, the flushing fluid may include a disinfecting solution. As used herein, "disinfecting solution" refers to a solution including at least a solvent and one or more disinfectants. According to some aspects, the disinfecting solution is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which the solvent includes at least a majority of water. It should be understood that in some examples, the solvent may consist of water. According to some aspects, the disinfecting solution is an alcohol solution. As used herein, the term "alcohol solution" refers to a solution in which the solvent includes at least a majority of alcohol components. It should be understood that in some examples, 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 aspects, the solvent may include water and alcohol components. In some non-limiting examples, the solvent may include approximately 90% (v / v) alcohol components and the remaining volume of water, optionally approximately 80% (v / v) alcohol components and the remaining volume of water, optionally approximately 70% (v / v) alcohol components and the remaining volume of water, optionally approximately 60% (v / v) alcohol components and the remaining volume of water, optionally approximately 50% (v / v) alcohol components and the remaining volume of water, optionally approximately 40% (v / v) alcohol components and the remaining volume of water, optionally approximately 30% (v / v) alcohol components and the remaining volume of water, optionally approximately 20% (v / v) alcohol components and the remaining volume of water, and optionally approximately 10% (v / v) alcohol components and the remaining volume of water.

[0023] In some non-limiting examples, the solvent can include about 90% (v / v) or less of an alcohol component and the remaining volume of water, optionally about 80% (v / v) or less of the alcohol component and the remaining volume of water, optionally about 70% (v / v) or less of the alcohol component and the remaining volume of water, optionally about 60% (v / v) or less of the alcohol component and the remaining volume of water, optionally about 50% (v / v) or less of the alcohol component and the remaining volume of water, optionally about 40% (v / v) or less of the alcohol component and the remaining volume of water, optionally about 30% (v / v) or less of the alcohol component and the remaining volume of water, optionally about 20% (v / v) or less of the alcohol component and the remaining volume of water, and optionally about 10% (v / v) or less of the alcohol component and the remaining volume of water.

[0024] In one non-limiting example, the disinfectant can include cationic molecules (i.e., molecules having a positive charge), such as cationic surfactants or cationic biguanide derivatives (i.e., compounds derived from biguanide). According to some aspects, the disinfectant can include bis-(dihydropyridyl)-decane derivatives (i.e., compounds derived from bis-(dihydropyridyl)-decane). According to some aspects, the disinfectant can include octenidine salts and / or chlorhexidine salts. According to some aspects, the disinfectant can include alexidine, octenidine dihydrochloride, chlorhexidine gluconate, or combinations thereof.

[0025] Additionally or alternatively, the disinfectant can include iodine. According to some aspects, the iodine can be provided as an iodine complex, such as povidone iodine (PVPI), nonylphenoxy-(ethyleneoxy)-iodine, polyethoxy polypropoxy-iodine, undecylamine chloride iodine, iodine povacrylex, and combinations thereof.

[0026] Additionally or alternatively, the disinfectant can include an oxidizing agent (i.e., an oxidation reagent). Non-limiting examples of the oxidizing agent according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, and combinations thereof.

[0027] Additionally or alternatively, the disinfectant can include quaternary ammonium salts. Non-limiting examples of the quaternary ammonium salts include benzalkonium chloride, benzethonium chloride, methylbenzethonium chloride, cetalkonium chloride, cetylpyridinium chloride, cetrimonium, cetrimide, dofanium chloride, tetraethylammonium bromide, dicetyldimethylammonium chloride, domiphen bromide, and combinations thereof.

[0028] Additionally or alternatively, the disinfectant can include one or more surfactants. The one or more surfactants can include ionic surfactants, non-ionic surfactants, zwitterionic surfactants, or combinations thereof. In some non-limiting examples, the one or more surfactants can include sodium dodecyl sulfate, sodium laureth sulfate, citric acid, sodium citrate, oleic acid, cetylpyridinium chloride, soy 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, polypropylene-polyoxyethylene block copolymer, castor oil ethoxylate, polyoxyethylene nonylphenol ether, hydrogenated castor oil (Cremophor), 2-(2-ethoxy-ethoxy)ethanol, its salts, and mixtures thereof.

[0029] Additionally or alternatively, the disinfectant can include one or more antibiotics. Non-limiting examples of antibiotics include cefazolin, vancomycin, gentamicin, bacitracin, and combinations thereof.

[0030] According to some aspects, the rinse solution can include any combination of disinfectants as described herein.

[0031] The disinfectant and / or combination of disinfectants can have antimicrobial activity sufficient to provide an acceptable log reduction of microorganisms over a period of time. It should be understood that, as used herein, the term "microorganisms" can refer to any microbial community that is killed and / or removed by rinsing. Example microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0032] Example bacteria include, but are not limited to, Streptococcus mutans, Streptococcus pyogenes (Group A β-hemolytic streptococcus), Streptococcus salivarius, Streptococcus sanguinis, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus hemolyticus, Streptococcus hominis, Streptococcus mitis, Streptococcus saprophyticus, methicillin / oxacillin-resistant Staphylococcus aureus (MRSA / ORSA) and methicillin / oxacillin-sensitive Staphylococcus aureus (MSSA / OSSA), Enterococcus (e.g., Enterococcus faecalis, Enterococcus faecium, and Helcococcus kunzii), vancomycin-resistant Enterococcus (VRE) and vancomycin-sensitive 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, Klebsiella pneumoniae, multi-drug resistant (MDR), Acinetobacter baumannii, Acinetobacter baumannii MDR, Achromobacter xylosoxidans, Micrococcus luteus, Ralstonia pickettii, Haemophilus influenzae, and Serratia marcescens.

[0033] Exemplary fungi include, but are not limited to, Aspergillus niger, Candida albicans, Candida auris, Candida dubliniensis, Candida glabrata (formerly Torulopsis glabrata), Candida guilliermondii, Candida kefyr (formerly Candida pseudotropicalis), Candida krusei, Candida lusitaniae, Candida tropicalis, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis, and Trichophyton mentagrophytes.

[0034] Exemplary viruses include, but are not limited to, viruses that have a lipid component in their capsid or an envelope, such as cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2), influenza virus, parainfluenza virus, variola virus (smallpox virus), vaccinia virus, norovirus, and coronavirus.

[0035] However, it should be understood that the flushing fluid is not necessarily a disinfection solution as described herein, and can be any medically acceptable fluid sufficient to perform the flushing process as described herein. In one non-limiting example, the flushing fluid can include a saline solution. The saline solution can include water and sodium chloride, where the sodium chloride has a medically acceptable concentration, 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.

[0036] According to some aspects, the flushing fluid can include a buffer system having one or more buffering components. As used herein, the term "buffer system" refers to the component of the flushing fluid that provides resistance to significant changes in pH caused by strong acids or strong bases. The buffer system can include two or more buffering components, such as a weak acid and its conjugate base. The buffer system can provide resistance to significant pH changes by interacting with strong acids or strong bases in the flushing fluid, thereby at least partially preventing a significant change in the pH of the flushing fluid.

[0037] Generally, a buffer system has one or more buffering ranges in which the buffer system has the ability to provide resistance to significant pH changes. When a flushing fluid having a buffer system has a pH within the buffering range of the buffer system, the pH of the flushing fluid will not change significantly upon addition of an equimolar amount of a strong acid or a strong base.

[0038] The buffering range of a buffer system is related to the acid dissociation constant (K a ) 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 typically approximately the logarithmic measure of the acid dissociation constant of the weak acid included in the buffer system (i.e., pK a , equal to log 10 K a ).

[0039] According to some aspects, one or more buffering components may include an acid or salt form of one or more of lactate, phosphate, borate, tartrate, glutamate, malate, citrate, gluconate, benzoate, succinate, acetate, glycine, and aspartate. According to some aspects, one or more buffering components may include lithium hydroxide, sodium hydroxide, potassium hydroxide, rubidium hydroxide, cesium hydroxide, calcium hydroxide, strontium hydroxide, disodium hydrogen phosphate dihydrate, and / or barium hydroxide.

[0040] According to some aspects, the flushing fluid may include a pH adjuster. The term "pH adjuster" refers to a component that changes the pH of the flushing fluid.

[0041] According to some aspects, the pH adjuster may include one or more of acetic acid, adipic acid, ascorbic acid, citric acid, hydrochloric acid, lactic acid, malic acid, monopotassium phosphate, monosodium phosphate, phosphoric acid, pyrophosphoric acid, succinic acid, sulfuric acid, tartaric acid, and solutions thereof.

[0042] The flushing fluid as described herein may be contained within a container. The container of the present disclosure may include a body portion and an outlet configured to dispense fluid therefrom.

[0043] According to some aspects, 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 aspects, the flexible container may be compressible. As used herein, the term "compressible" refers to the ability to reversibly reduce volume without unacceptable changes (such as unacceptable permanent changes to one or more of the dimensions, shape, and / or properties as described herein). Additionally or alternatively, the flexible container may be collapsible. As used herein, the term "collapsible" refers to the ability to permanently reduce volume. For example, when a first volume of fluid is contained within a collapsible container as described herein, the collapsible container may have a first volume. When at least a portion of the fluid is dispensed, the collapsible container may collapse to have a second volume, where the second volume is less than the first volume.

[0044] As used herein, the term "rigid" refers to a stiffness sufficient to resist deformation under normal operating forces. It should be understood that a rigid container may be incompressible or non-collapsible.

[0045] Examples of useful container materials according to the present disclosure include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Useful example 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 aspects, the container material can be a lined and / or coated material, such as lined and / or coated paper.

[0046] According to some aspects, the container can include a venting component. The venting component can include a fluid passage configured to provide fluid communication between the container and the external environment. According to some aspects, at least a portion of the fluid passage is separated from the fluid path along which flushing fluid is dispensed from the container (i.e., through an outlet of the container). The venting component can further include a filter, particularly a sterile filter.

[0047] Useful example venting components according to the present disclosure include the venting components disclosed in U.S. Patent Publication No. 2022 / 0118169, the content of which is hereby expressly incorporated by reference in its entirety.

[0048] The device of the present disclosure includes a connection portion that can be reversibly connected to a container as described herein. The connection portion can be connected to the container such that the outlet of the container is set in fluid communication with the device, thus providing a fluid path for flushing fluid to travel from the container to the device. As used herein, the phrase "reversibly connected" means a connection that can be selectively disconnected. For example, a reversible connection can include a threaded connection that can be selectively unscrewed. In another example, the device can be provided with an activator (e.g., a button or lever) that can be activated to disconnect the reversible connection. Non-limiting examples of secure, fluid-tight, and reversible connections include threaded connections, bayonet connections, snap connections, friction connections, and combinations thereof.

[0049] According to some aspects, the connection portion of the device can include one or more connection components that mate with one or more corresponding connection components of the container to provide a secure, fluid-tight, and reversible connection. Figure 1 An example device according to the present disclosure is shown. Specifically, Figure 1Device 100 is shown having a connection portion 101 that can be reversibly connected to a container 102 as described herein. In this example, container 102 may include an outlet (not shown) that can be received within connection portion 101. According to some aspects, container 102 can be any container known in the art for containing a flushing fluid. In some non-limiting examples, container 102 can include a pierceable material such that when the container is set to be connected to connection portion 101, an adapter (as will be described) and / or a portion of connection portion 101 will pierce container 102 to provide fluid communication with the container.

[0050] According to some aspects, the inner surface of connection portion 101 can include, for example, male or female threads configured to provide a threaded connection with corresponding male or female threads disposed on the outer surface of container 102 (i.e., the surface surrounding the outlet). However, it should be understood that device 100 is not limited to this manner. For example, connection portion 101 can have one or more radial pins or one or more slots corresponding to one or more radial pins or one or more slots disposed on the outer surface of container 102 sufficient to provide a bayonet connection.

[0051] In another example, device 100 can be provided with a discrete connection adapter as Figure 2 shown. In particular, Figure 2 connection adapter 200 is shown that can mate with connection portion 101 and container 102 as Figure 1 shown to provide a secure, fluid-tight, and reversible connection. In one example, connection adapter 200 can have a first face 203 that forms at least a portion of outer surface 201. Outer surface 201 can have one or more connection components that mate with one or more corresponding connection components on the inner surface of connection portion 101 as Figure 1 shown. Connection adapter 200 can further include a second face 204 that forms at least a portion of an inner surface (not shown). The inner surface can have one or more connection components that mate with one or more corresponding connection components on container 102 as Figure 1One or more connecting components that mate with one or more corresponding connecting components on the outer surface of the illustrated container 102. Preferably, the second face 204 is directly opposite the first face 203. In this way, the connection adapter 200 can be "sandwiched" between the connection portion 101 of the device 100 and the container 102, sufficient to provide a secure, fluid-tight and reversible connection. According to some aspects, the connection adapter 200 can be configured such that when the connection adapter is set in the sandwiched position (i.e., when at least a portion of the first face 203 is received in the connection portion 101 and at least a portion of the second face 204 is connected to the container 102), the connection portion 101 of the device 100 can be directly adjacent to the container 102. The connection adapter 200 can further include an outlet 202 (e.g., the outlet of a nozzle portion) sufficient to provide a fluid path between the container 102 and the device 100.

[0052] It should be understood that the connection adapter 200 can allow a secure, fluid-tight and reversible connection between the device 100 and various containers (including commercially available containers). For example, the connection adapter 200 can include an inner surface having male or female threads, which is configured to provide a secure, fluid-tight and reversible connection with various commercially available containers having male or female threads. In one non-limiting example, the commercially available container can include BD Surgiphor TM Antibacterial irrigation system 450 mL bottle.

[0053] Regardless of the type of connection, it should be understood that the container 102 is connected to the device 100 such that the fluid contained inside the container 102 can travel along the fluid path to the device 100. As Figure 1 shown, the fluid path can further communicate with the discharge portion 103 of the device 100.

[0054] According to some aspects, the discharge portion 103 can be configured to apply the 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 the irrigation fluid to a medical device before contact with the subject, as described herein. According to some aspects, the discharge portion 103 can include a nozzle portion. Although Figure 1Although not shown in the figure, the nozzle portion may include one, two, three, four or more discharge holes. According to some aspects, one or more of the discharge holes may include one or more restricting features configured to prevent unacceptable fluid from passing therethrough. For example, one or more of the discharge holes may include a one-way valve having a first closed position that prevents fluid from passing therethrough and a second open position that allows fluid to pass therethrough. In this example, the one-way valve may be set in the first position when subjected to pressure from one direction (e.g., liquid pressure from the flushing fluid). The one-way valve may be easily moved to the second position when subjected to pressure from a different direction (i.e., air pressure from the surrounding environment).

[0055] Each of the discharge holes may have the same size or a different size from one or more of the other discharge holes. Additionally or alternatively, each of the discharge holes may have the same shape or a different shape from one or more of the other discharge holes. The shape and / or size of one or more of the discharge holes may be selected to provide a certain fluid flow force, fluid flow velocity, and / or fluid flow pattern. According to some aspects, the shape and / or size of one or more of the discharge holes may be adjustable such that the fluid flow force, fluid flow velocity, and / or fluid flow pattern of the dispensed fluid may be adjustable.

[0056] As used herein, the term "fluid flow force" refers to the force exerted by the fluid on a surface (such as on a human subject and / or a medical device) during the flushing process. It should be understood that the fluid flow force according to the present disclosure may be acceptable for use in the flushing process as described herein.

[0057] In some non-limiting examples, acceptable fluid flow forces 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, acceptable fluid flow forces 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, acceptable fluid flow forces can be approximately 70 psi, optionally approximately 65 psi, optionally approximately 60 psi, optionally approximately 55 psi, optionally approximately 50 psi, optionally approximately 45 psi, optionally approximately 40 psi, optionally approximately 35 psi, optionally approximately 30 psi, optionally approximately 25 psi, optionally approximately 20 psi, optionally approximately 15 psi, optionally approximately 10 psi, and optionally approximately 5 psi.

[0058] As used herein, the term "fluid flow velocity" refers to the velocity at which fluid is applied to a surface (such as applied to a human subject and / or a medical device) during a rinsing process. As used herein, the term "fluid flow pattern" refers to the pattern at which fluid is dispensed and / or applied from a device to a surface (such as applied to a human subject and / or a medical device) during a rinsing process.

[0059] According to some aspects, as Figure 1 shown, all or a portion of the discharge portion 103 can be removable and replaceable. For example, the nozzle portion can be removable and replaceable, thereby allowing the same discharge portion to communicate interchangeably with at least two different nozzle portions. According to some aspects, all or a portion of the discharge portion 103 can be removable and replaceable before, during, after, or a combination of a rinsing process.

[0060] Although not shown, the discharge portion 103 may include one or more extension features configured to provide increased accessibility to a surface, such as a body cavity, surgical cavity, external wound, and / or medical device. For example, the discharge portion 103 may include bendable and / or extensible features that may be adjusted to perform a flushing process on a difficult-to-reach surface. Although also not shown, the device 100 may further include heating and / or cooling elements configured to regulate the temperature of the flushing fluid dispensed therefrom. For example, the heating and / or cooling elements may be configured to maintain the temperature of the flushing fluid within the normal body temperature range during the flushing process. As used herein, "normal body temperature range" refers to the normal temperature range of the human body, such as between approximately 36°C and 38°C. Additionally or alternatively, the device 100 may have a light source configured to increase the visibility of the surface being flushed.

[0061] According to some aspects, the device 100 may be configured to provide adjustable fluid flow force, fluid flow rate, fluid flow pattern, or a combination thereof. For example, the device 100 may be provided with fluid flow components configured to adjust the shape and / or size of one or more discharge holes as described herein. In some non-limiting examples, the fluid flow components may include rotatable components, such as rotatable plates, disposed at any point along the fluid path as described herein (e.g., above one or more holes of the discharge portion). The rotatable component may include one or more holes that may be selectively aligned with one or more holes of the discharge portion to provide selectable fluid flow force, fluid flow rate, and fluid flow pattern as described herein.

[0062] Figure 5A An example of a fluid flow component 500 as described herein is shown. As Figure 5A shown, the fluid flow component 500 may include one, two, three, or more holes 501, each having the same size or a different size from one or more other holes 501. It should be understood that the user may select the fluid flow force, fluid flow rate, and / or fluid flow pattern by rotating the fluid flow component 500 such that the desired hole 501 is aligned with one or more holes of the discharge portion as described herein.

[0063] It should be understood that the present disclosure is not limited to Figure 5A the example shown. For example, one or more of the holes 501 of the fluid flow component 500 may have a shape different from Figure 5A the shape shown. In another example, the fluid flow component 500 may include one or more holes 501 configured to provide variable fluid flow force, fluid flow rate, and / or fluid flow pattern. For example,Figure 5B A fluid flow component 500 having holes 501 with different diameters is shown. It should be understood that a user can select a fluid flow force, a fluid flow velocity, and / or a fluid flow pattern by rotating the fluid flow component 500 such that a selected portion of the holes 501 is aligned with one or more holes of the discharge portion as described herein.

[0064] According to some aspects, the device 100 can be configured such that the fluid is dispensed intermittently, also referred to herein as “pulsed” flow. For example, the device 100 can include a pulse component that intermittently interrupts the fluid path as described herein. In one non-limiting example, the pulse component can include a rotating component disposed at any point along the fluid path as described herein (e.g., within or above the holes of the discharge portion). The pulse component can have one or more holes therein such that when the pulse component rotates, the one or more holes can intermittently allow fluid to pass therethrough and along the fluid path, thus providing a pulsed flow of the fluid as described herein.

[0065] In one non-limiting example, the rotating component includes a rotating plate. In another non-limiting example, the rotating component has a windmill shape. The rotating component can be driven by a power source (e.g., a motor). Additionally or alternatively, for example, when the rotating component has a windmill shape, the fluid moving along the fluid path can drive the rotating component.

[0066] According to some aspects, the pulse component can be a permanent component of the device (i.e., not removable by normal operating procedures) or can be removable.

[0067] According to some aspects, the connection portion 101 of the device 100 can be configured such that the container 102 is disposed at a first distance from the discharge portion 103, the first distance being sufficient to keep the container 102 within a sterile area during operation of the device 100 (e.g., during a flushing process). The first distance can 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 6 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.

[0068] The device 100 can further include an actuator such that when the actuator is actuated, fluid is discharged via the discharge portion 103. As Figure 1As shown, the actuator 104 may include a button. However, the present disclosure is not limited to this manner. For example, the actuator 104 may additionally or alternatively include a switch, a lever, a knob, a trigger, or a combination thereof. It should also be understood that although Figure 1 the actuator 104 is shown disposed on the proximal end of the handle 105, the actuator 104 may be disposed on any part of the device 100 sufficient for a user to actuate the device 100 during use of the device 100, particularly during use of the device 100 during a rinsing process.

[0069] According to some aspects, the actuator 104 may communicate with a motor (not shown) configured to drive fluid from the container 102 along a fluid path to the discharge portion 103, 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 fully contained within the device.

[0070] According to some aspects, the device 100 may be configured such that fluid is continuously dispensed when the actuator 104 is actuated. For example, the device 100 may be configured such that when the actuator 104 is actuated, fluid is dispensed from the device 100 in an uninterrupted stream until the actuator 104 is no longer actuated.

[0071] According to some aspects, the device 100 may be configured to provide a pulsed flow of fluid. For example, the device 100 may be configured such that when the actuator 104 is actuated, fluid is dispensed from the device 100 in discrete pulses until the actuator 104 is no longer actuated. In one non-limiting example, the motor may be configured to fluctuate between an active state and an inactive state when the actuator is actuated, such that the motor fluctuates between driving the fluid and not driving the fluid, as described herein.

[0072] According to some aspects, the device 100 may be configured such that a user may select continuous flow or pulsed flow. Additionally or alternatively, the device 100 may be configured such that a user may select a fluid flow force and / or a fluid flow velocity as described herein. In one non-limiting example, the motor may be configured to provide a selected power level corresponding to the selected fluid flow force and / or fluid flow velocity. According to some aspects, the device 100 may be configured such that a user may select from a continuous spectrum of fluid flow forces and / or fluid flow velocities. Additionally or alternatively, the device 100 may be configured such that a user may select from one, two, three, four, or more discrete fluid flow forces and / or fluid flow velocities.

[0073] According to some aspects, the device 100 can be configured such that when provided as part of the systems herein with one or more containers 102, each component of the system can be housed within a sterile area during use. As used herein, a "sterile area" refers to an area where a medical procedure is being performed (e.g., the area around a patient's body), and all items within that area are sterile. For example, Figure 1 the device 100 can be configured such that when used during a flushing procedure, all components of the device 100 and the container 102 can be housed within a sterile area.

[0074] According to some aspects, two or more of the components described herein can be configured to provide a single integral device. As used herein, the term "integral device" refers to a device that is configured to form a single unit, where, under normal operating conditions, no part of the device is removable. According to some aspects, at least the connection portion, the discharge portion, and the actuator of the present disclosure form a single integral device.

[0075] As Figure 1 shown, the device 100 can be configured such that when the device is connected to the container 102, the container 102 is disposed in a specific position relative to the device 100. According to some aspects, the specific position can be a position acceptable for a medical procedure (such as a flushing procedure). In some non-limiting examples, an acceptable position is a position that does not block the physician's line of sight during the medical procedure. Additionally or alternatively, an acceptable position is a position that does not disrupt the medical procedure, for example, by providing an unintentional contact between the system and the patient's body. In some non-limiting examples, an acceptable position is a position that provides an acceptable balance of the device during use. For example, the acceptable position can be such that when a physician uses the device to perform a medical procedure, the weight of the first end of the device is approximately equal to the weight of the second end of the device, for ease of use.

[0076] Figure 1 An example of an acceptable position is shown. Specifically, Figure 1 it is shown that when the container 102 is connected to the device 100, the central axis 106 of the container 102 is substantially parallel to the central axis 107 of at least a portion of the fluid path along which fluid travels through the device 100 as described herein.

[0077] However, it should be understood that the present disclosure is not limited to Figure 1 the example shown. For example, Figure 3 it is shown another example of a device 300 connected to a container 302, similar to Figure 1 the device 100 and the container 102 shown. As Figure 3As shown, when the container 302 is connected to the device 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 the fluid path along which the fluid travels through the device 300 as described herein. This angle can be any angle that provides an acceptable position as described herein. According to some aspects, this angle is between 0° and 180°, optionally between approximately 0° and 90°, including each value within this range. According to some aspects, the central axis of the container can be substantially perpendicular to the central axis of at least a portion of the fluid path along which the fluid travels through the device.

[0078] Additionally, although Figure 1 and Figure 3 show the containers 102, 302 disposed on the sides 108, 308 of the devices 100, 300 that are generally opposite the handles 105, 305 (alternatively, referred to herein as the "tops" of the devices), the present disclosure is not limited to this manner. For example, the containers 102, 302 can be disposed on the same sides 109, 309 of the devices as the handles 105, 305 (alternatively, referred to as the "bottoms" of the devices) or at any position therebetween on the devices 100, 300.

[0079] Figure 4A Shows a top view of another exemplary device 400 according to aspects of the present disclosure. It should be understood that the device 400 can operate as described for the devices 100, 300 with respect to Figure 1 and Figure 3 . In particular, like the devices 100, 300, the device 400 can include a connection portion 401 that can be reversibly connected to a container (not shown) as described herein. Additionally or alternatively, the connection portion 401 can be connected to a connection adapter (not shown) (such as the connection adapter 200 of Figure 2 ). Figure 4A Further shown is an actuator 404 similar to the actuator 104 shown in Figure 1 .

[0080] Figure 4B Shows a perspective view of the device 400. As shown in this view, the device 400 can further include an outlet 410 that can be connected to a discharge portion (not shown) (such as the discharge portion 103 shown in Figure 1 ). It should be understood that the outlet 410 is in fluid communication with a fluid flow path (not shown in Figure 4B ) that connects the outlet 410 and the connection portion 401. In this way, fluid from a container (not shown) can travel along the fluid flow path to the discharge portion, which can be configured to apply a flushing fluid to a surface as described herein.

[0081] Figure 4EA exploded view of the device 400 as described herein is shown. In particular, Figure 4E the connecting portion 401, the actuator 404, and the outlet 410 are shown. Figure 4E The pipe fitting components 411a, 411b are further shown, and the pipe fitting components together form a fluid flow path located between the connecting portion 401 and the outlet 410. Figure 4E The motor 412 as described herein is further shown, and the motor 412 is powered by a power source 414 (e.g., a battery). As Figure 4E shown, the pipe fitting components 411a, 411b, the motor 412, and the power source 414 are all completely accommodated within the device 400 as described herein, and the device includes a top housing 415a and a bottom housing 415b in this example, as shown.

[0082] Figure 4C and Figure 4D show an end view and a side view of the device 400, respectively. As described herein, the device 400 can be sized such that each of its components can be accommodated within a sterile area during use. For example, as Figure 4D shown, the length 416 of the device 400 (i.e., its longest dimension) does not exceed approximately 12 inches, optionally does not exceed approximately 10 inches, optionally does not exceed approximately 8 inches, optionally does not exceed approximately 7 inches, optionally does not exceed approximately 6 inches, and optionally does not exceed approximately 5 inches.

[0083] It should be understood that although Figure 1 、 Figure 3 and FIG. 4 show the devices 100, 300, 400 that can be connected to a single container at a time, the present disclosure is not limited to this manner. For example, the devices of the present disclosure can be connected to two, three, four, or more containers, and each container is as described herein. Each of the containers can communicate with the same fluid path or a different fluid path as another container independently. Additionally, each container can contain the same fluid as another container or a different fluid from another container. In this way, the devices of the present disclosure can be configured to simultaneously and / or sequentially dispense more than one type of fluid as described herein without the need to remove the container from the device and / or remove the device from the sterile area.

[0084] According to some aspects, all or part of the devices of the present disclosure can be sterile. In some non-limiting examples, the device or a portion thereof can 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 can be provided in a sterile package known in the art.

[0085] According to some aspects, the devices of the present disclosure can be reusable, that is, they can be used to dispense a flushing fluid from two or more containers. For example, the device can be connected to a first container sufficient to dispense a first flushing fluid as described herein, and the same device can then be connected to a second container sufficient to dispense a second flushing fluid contained therein. In some non-limiting examples, all or a portion of the device can be replaceable. For example, after the first flushing fluid has been dispensed by the device, and before the second flushing fluid is dispensed, all or a portion of the fluid flow path (such as the fitting components 411a, 411b as described with respect to Figure 4E those described) can be removed and replaced. In this way, the device can be used to dispense the second flushing fluid without the risk of being contaminated by the first flushing fluid. Additionally or alternatively, after the first flushing fluid has been dispensed by the device, the device can be flushed with a flushing fluid before the second flushing fluid is dispensed. Non-limiting examples of the flushing fluid according to the present disclosure include water, a salt solution as described herein, an aqueous solution as described herein, an aqueous solution having a buffer system as described herein, an alcohol solution as described herein, a povidone iodine solution, and combinations thereof.

[0086] According to some aspects, the devices of the present disclosure can be rechargeable. For example, in the case where the power supply includes a battery, the battery can be replaceable. Additionally or alternatively, the power supply itself can be rechargeable, such as a rechargeable battery.

[0087] The present disclosure also relates to a system having a device as described herein and at least one container. According to some aspects, the system of the present disclosure can be sterile. In some non-limiting examples, the system can be provided in a sterile package known in the art. Each component of the system can be provided independently in the same package as another component of the system, or in a different package known in the art.

[0088] The present disclosure also relates to methods of manufacturing the devices and systems as described herein and methods of using the same. According to some aspects, the method can include connecting a container to a connection portion of the device as described herein and actuating an actuator of the device sufficient to dispense a flushing fluid to a surface via a dispensing portion of the device. The method can further include performing a flushing process, that is, flushing a body cavity, a surgical cavity, and / or an external wound with the flushing fluid from the device.

[0089] While the aspects described herein have been described in connection with the example aspects outlined above, various alternatives, modifications, variations, improvements, and / or substantial equivalents, whether known, currently unforeseen or may not be foreseeable, may be apparent to those of ordinary skill in the art at least. Thus, as set forth above, the example aspects are intended to be illustrative and not restrictive. Various changes may be made without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to cover all alternatives, modifications, variations, improvements, and / or substantial equivalents that are known or later developed.

[0090] Accordingly, the claims are not intended to be limited to the aspects shown herein, but rather to the full scope consistent with the language of the claims, where, unless otherwise specified, a reference to an element in the singular is not intended to mean "one and only one" but rather "one or more." All structural and functional equivalents of the elements of the aspects described throughout this disclosure (which are known or will be known to those of ordinary skill in the art) are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public, whether or not such disclosure is expressly recited in the claims. No claim element should be construed as a means-plus-function unless the claim element expressly recites the phrase "means for."

[0091] In this document, numerical ranges expressed by endpoints (e.g., between about 50:1 and 1:1, between about 100 °C and 500 °C, between about 1 minute and 60 minutes) include all numbers contained within the range. For example, between about 1 minute and 60 minutes includes 21 minutes, 22 minutes, 23 minutes, and 24 minutes as endpoints within the specific range. Thus, for example, ranges such as 22 - 36, 25 - 32, 23 - 29, etc. are also ranges whose endpoints are contained within the 1 - 60 range, depending on the starting materials used, temperature, specific application, specific embodiment, or claim limitations (if required). The examples and methods disclosed herein demonstrate that the recited ranges encompass every point within the range because different synthetic products are produced by varying one or more reaction parameters. In addition, the methods and examples disclosed herein describe various aspects of the disclosed ranges and the effects when the range is varied alone or in combination with other recited ranges.

[0092] In addition, the term "example" is used herein to mean "serving as an example, instance, or illustration". Any aspect described herein as an "example" is not necessarily to be construed as more preferred or advantageous than other aspects. Unless otherwise specifically stated, 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 "any combination of 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 "any combination of A, B, C, or any combination thereof" can be only A, only B, only C, A and B, A and C, B and C, or A, B, and C, where any such combination can include one or more components or one or more components of A, B, or C. Nothing disclosed herein is intended to be dedicated to the public, whether or not such disclosure is expressly recited in the claims.

[0093] As used herein, the terms "about" and "substantially" are defined as being close to what is understood by one of ordinary skill in the art. In a non-limiting embodiment, the terms "about" and "substantially" are defined as being within 10%, preferably within 5%, more preferably within 1%, and most preferably within 0.5%.

Claims

1. An apparatus for dispensing a flushing fluid, the apparatus comprising: a connection portion capable of being directly and reversibly connected to a container configured to hold the flushing fluid; a discharge portion; a fluid path providing fluid communication between the container and the discharge portion; and an actuator, wherein the connection portion, the discharge portion, the fluid path, and the actuator form a single integral device.

2. The device according to claim 1, wherein The connection portion includes a first connection member configured to cooperate with a second connection member included by the container.

3. The device according to claim 2, wherein The first connection member and the second connection member each include a thread.

4. The apparatus according to claim 1, wherein The connection portion is configured such that the container is disposed at a first distance from the discharge portion, the first distance being sufficient to allow the container to be received within a sterile area during operation of the apparatus.

5. The apparatus according to claim 1, wherein, The flushing fluid includes povidone iodine, chlorhexidine gluconate, or a combination thereof.

6. The apparatus according to claim 1, further comprising a pulsating member configured to intermittently interrupt the fluid path.

7. The apparatus according to claim 1, further comprising a motor configured to fluctuate between an active state and an inactive state when the actuator is actuated.

8. A system for dispensing a flushing fluid, the system comprising: an apparatus including: a connection portion, a discharge portion, and an actuator; and a connection adapter having a first face and a second face, at least a portion of the first face being receivable within the connection portion and at least a portion of the second face being reversibly connectable to a container configured to hold the flushing fluid, wherein the system is configured to provide a fluid path from the container to the discharge portion, and wherein the connection adapter is configured such that when at least a portion of the first face is received within the connection portion and at least a portion of the second face is connected to the container, the connection portion is directly adjacent to the container.

9. The system according to claim 8, wherein, The connection adapter is configured such that the container is disposed at a first distance from the discharge portion, the first distance being sufficient to allow the container to be received within a sterile area during operation of the apparatus.

10. The system according to claim 8, wherein, The flushing fluid includes povidone iodine, chlorhexidine gluconate, or a combination thereof.

11. The system according to claim 8, further comprising a pulsating member configured to intermittently interrupt the fluid path.

12. The system according to claim 8, further comprising a motor configured to fluctuate between an active state and an inactive state when the actuator is actuated.

13. The system according to claim 8, wherein The second face includes a first thread configured to cooperate with a second thread of the container.

14. A system for dispensing a flushing fluid, the system comprising: a container configured to hold the flushing fluid; an apparatus including: a connection portion capable of being directly and reversibly connected to the container, a discharge portion, a fluid path providing fluid communication between the container and the discharge portion, and an actuator, Wherein, the connection portion, the discharge portion, the fluid path, and the actuator constitute a single integrated device.

15. The system according to claim 14, wherein The connection portion includes a first connection member configured to cooperate with a second connection member included by the container.

16. The system according to claim 15, wherein, The first connection member and the second connection member each include a thread.

17. The system according to claim 14, wherein The connection portion is configured such that the container is disposed at a first distance from the discharge portion, the first distance being sufficient to accommodate the container within a sterile area during operation of the device.

18. The system according to claim 14, wherein, The flushing fluid includes povidone iodine, chlorhexidine gluconate, or a combination thereof.

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

20. The system according to claim 14, further comprising a motor configured to fluctuate between an active state and an inactive state when the actuator is actuated.

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