Lavage system and device with flow regulation member

Abstract

A system for applying a lavage fluid to a surface has a sealing body for containing the lavage fluid and a flow regulation member configured to create a fracture in the sealing body where the lavage fluid is dispensed, where the sealing body and the lavage fluid contained in the sealing body are ultimately sterilized.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 358,401, filed on July 5, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to devices and systems for applying irrigation fluid to a surface that include at least one flow regulating member. Background Art

[0004] Currently, irrigation (i.e., flushing a body cavity, surgical cavity, or external wound with a medically acceptable fluid) is commonly used to prevent contamination of open surgical wounds, which may occur due to a variety of reasons, such as accidental visceral entry or perforation, procedures with significant spillage, violations of aseptic technique, and / or existing, ongoing clinical infection. Therefore, irrigation procedures are commonly used to provide intraoperative sterile wound irrigation.

[0005] Irrigation techniques currently include a variety of different methods that vary based on the situation (e.g., the size and shape of the cavity or wound) and the medical practitioner performing the irrigation procedure (e.g., the practitioner's technical preferences). Currently, no particular irrigation technique is standard in the art, and therefore, medical institutions typically require many different irrigation devices and systems to accommodate the various potential methods. The existence of such devices and systems is also sometimes problematic because the inadvertent inappropriate use of such devices and systems (e.g., in the case of intravenous injections, if the device and / or system has a similar appearance to an intravenous injection device and / or system) can result in devastating consequences.

[0006] In addition, current lavage practices suffer from several disadvantages, including inadequacies in the properties of the sterile fluid (e.g., the amount of time required for the sterile fluid to achieve an acceptable biologic effect, which may be prohibitive), the risk of systemic absorption of the sterile fluid, adverse reactions such as allergic reactions, peritoneal adhesions, neurotoxicity, and respiratory insufficiency, and inappropriate dosing or contamination of the sterile fluid, which is sometimes specially prepared by the medical practitioner performing the lavage.

[0007] In addition, current irrigating devices usually increase the risk of contamination. For example, some current irrigating devices utilize elastic hollow bodies, which discharge irrigating fluid when pressure is applied to them (e.g., "squeeze bottles", etc.). In order to play a role, such devices require one or more rebalancing stages (i.e., a period of time in which the pressure of reduction or no pressure is applied to the device), so that gas (such as air) can be drawn into the device, enough to rebalance the internal pressure of the device. However, by introducing non-sterile gas into the device, the sterility of the irrigating fluid contained in the device (and the surgical wound contacted by the irrigating fluid) may be compromised. In addition, such devices inhale gas along the same path of distributing irrigating fluid from the device during the rebalancing stage. However, these paths are usually not optimized for such functions, and therefore, the rebalancing stage required for such devices often provides unacceptable delays to the irrigating process, which often leads to inefficient and / or invalid irrigating processes. In addition, current irrigating devices only provide limited ability to control and aim at the flow of irrigating fluid to clinicians.

[0008] Therefore, there is a need in the art for general purpose devices and systems for performing irrigation procedures, particularly devices and systems that enable medical practitioners to safely and effectively reduce contamination in surgical wounds susceptible to surgical site infection. There is a need in the art for terminally sterilized irrigation devices, wherein the irrigation fluid contained therein is terminally sterilized along with the irrigation device without damaging the materials used in the production of the irrigation device. There is also a need in the art for irrigation devices that are capable of delivering large volumes of irrigation fluid in a short period of time, wherein the flow rate of the irrigation fluid can be optimally controlled and targeted by the clinician. Summary of the invention

[0009] The present disclosure relates to an apparatus and system for delivering an irrigation fluid (such as a flushing solution) to a surface. The apparatus includes a sealing body configured to contain an irrigation fluid, such as a flushing solution. Optionally, the sealing body and the irrigation fluid contained in the sealing body are ultimately sterilized. The system further includes at least one flow regulating member, wherein the at least one flow regulating member is configured to facilitate the process of applying the irrigation fluid to the surface to meet the requirements of the irrigation process.

[0010] The devices and systems can be adaptable so that a user can select from one or more different fluid flow rates, fluid flow designs, and / or fluid flow forces, thereby providing selectable control of the irrigation fluid delivered to the surface. The present disclosure also relates to methods of using the devices and systems described herein.

[0011] The present disclosure also relates to a flow regulating member that can be used with the devices and systems described herein. The flow regulating member is configured to form a rupture in a sealing body containing an irrigation fluid. The rupture formed in the sealing body facilitates the discharge of the irrigation fluid from the sealing body in a flow pattern. During the discharge of the irrigation fluid, the flow regulating member may be in communication with the main body fluid, or may not be in communication with the main body fluid. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 Examples of sealing bodies according to aspects of the present disclosure are shown.

[0013] Figure 2 Examples of flow regulating components according to aspects of the present disclosure are shown.

[0014] Figure 3 Examples of sealing bodies according to aspects of the present disclosure are shown.

[0015] Figure 4 Examples of sealing bodies and flow regulating members according to aspects of the present disclosure are shown.

[0016] Figure 5 Examples of flow regulating components according to aspects of the present disclosure are shown.

[0017] Figure 6 Examples of flow regulating components according to aspects of the present disclosure are shown.

[0018] Figure 7 Examples of flow regulating members and sealing bodies according to aspects of the present disclosure are shown.

[0019] Figure 8 Examples of flow regulating components according to aspects of the present disclosure are shown. DETAILED DESCRIPTION

[0020] The present disclosure relates to devices and systems for delivering irrigation fluids (such as flushing solutions) to surfaces. The system includes a device (such as a fluid receiver) comprising a sealed body configured to accommodate irrigation fluids (such as flushing solutions). The system further includes at least one flow regulating member, wherein the at least one flow regulating member is configured to facilitate the process of applying the irrigation fluid to the surface to meet the requirements of the irrigation process. The device and system can be adaptable so that a user can select from one or more different fluid flow rates, fluid flow designs and / or fluid flow forces, thereby providing selectable control of the irrigation fluid delivered to the surface. The present disclosure also relates to methods of using the devices and systems described herein.

[0021] The present invention also relates to a flow regulating member that can be used with the devices and systems described herein. The flow regulating member is configured to form a rupture, such as an incision, perforation, hole or slit, in a sealing body configured to accommodate an irrigation fluid. The rupture formed in the sealing body facilitates the discharge of the irrigation fluid from the sealing body in a certain flow pattern. During the discharge of the irrigation fluid, the flow regulating member may be in fluid communication with the sealing body, or may not be in fluid communication with the sealing body.

[0022] As used herein, the term "irrigation fluid" refers to a fluid suitable for use in an irrigation procedure as described herein. As used herein, "irrigation" refers to the flushing of a body cavity, surgical cavity, and / or external wound.

[0023] According to some aspects, the irrigation fluid may include a flushing solution. As used herein, a "flushing solution" refers to a solution comprising at least a solvent and one or more chemical agents. Non-limiting examples of chemical agents include, but are not limited to, disinfectants, antibiotics, antimicrobials, oxidants, and combinations thereof. According to some aspects, the flushing solution is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which the solvent comprises 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 flushing solution is an alcoholic solution. As used herein, the term "alcoholic solution" refers to a solution in which the solvent comprises at least a majority of alcohol. It should be understood that in some examples, the solvent may consist of one or more alcohols. Non-limiting examples of alcohols include, but are not limited to, ethanol, isopropanol, n-propanol, and combinations thereof.

[0024] In one non-limiting example, the chemical agent may include a disinfectant. According to some aspects, the disinfectant 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 biguanide). According to some aspects, the disinfectant may include a bis-(dihydropyridinyl)-decane derivative (i.e., a compound derived from bis-(dihydropyridinyl)-decane). According to some aspects, the disinfectant may include an octenidine salt and / or a chlorhexidine salt. According to some aspects, the disinfectant may include Alexidine, octenidine dihydrochloride, chlorhexidine gluconate, or a combination thereof.

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

[0026] Additionally or alternatively, the chemical agent may include an oxidizing substance (ie, an oxidant). Non-limiting examples of oxidizing substances according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, Dakin's solution, hypochlorous acid, and combinations thereof.

[0027] In one non-limiting example, the chemical agent may include an antibiotic. Non-limiting examples of antibiotics according to the present invention include, but are not limited to, bacillus, vancomycin, gentamicin, cefazolin, clindamycin, polymyxin, or a combination thereof.

[0028] The chemical agent may have a certain antimicrobial activity that is sufficient to provide an acceptable level of reduction in microorganisms within a specific period of time. It should be understood that, as used herein, the term "microorganism" may refer to any microorganism that is killed and / or removed as a result of lavage. Example microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0029] Exemplary bacteria include resistant and sensitive bacteria, but are not limited to: Streptococcus (e.g., Streptococcus mutans, Streptococcus pyogenes, Streptococcus salivarius, Streptococcus sanguis), Staphylococcus (e.g., Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus saprophyticus), Enterococcus (e.g., Enterococcus faecalis, Enterococcus faecium, and Enterococcus hilaris), Bacteroides fragilis, Propionibacterium acnes (formerly known as Propionibacterium acnes), Clostridium difficile (spores and vegetative cells), Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Klebsiella (e.g., Klebsiella aerogenes, Klebsiella pneumoniae), Acinetobacter baumannii, Micrococcus luteus, Haemophilus influenzae, and Serratia marcescens.

[0030] Exemplary fungi include, but are not limited to, resistant and sensitive fungi: Aspergillus brasiliensis, Candida species (Candida albicans, Candida aureus, Candida dubliniensis, Candida glabrata, Candida guillermonida, Candida kefir (formerly known as Candida pseudotropical), Candida krusei, Candida lusitaniae, Candida tropicalis), Epidermophyton floccosum, Microsporum species (e.g., Microsporum gypseum, Microsporum canis), and Trichophyton mentagrophytes.

[0031] Exemplary viruses include, but are not limited to, single-stranded or double-stranded DNA and RNA genomes with sense or antisense orientation, with or without a lipid envelope protein coat (capsid), 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, norovirus, and coronavirus.

[0032] According to some aspects, the particular time period may be a time period of no more than about five minutes, optionally no more than about four minutes, optionally no more than about three minutes, optionally no more than about two minutes, and optionally no more than about one minute.

[0033] In some aspects, the particular time period may be no more than about 120 seconds, optionally no more than about 105 seconds, optionally no more than about 90 seconds, optionally no more than about 75 seconds, optionally no more than about 60 seconds, optionally no more than about 45 seconds, optionally no more than about 30 seconds, and optionally no more than about 15 seconds.

[0034] It should be understood that an "acceptable log reduction" may depend on the microorganism. For example, an acceptable log reduction as described herein may refer to an acceptable log reduction of one type of microorganism present on a surface (e.g., present in a body cavity or at an external wound site), a combination of two or more types of microorganisms present on a surface, or all microorganisms present on a surface.

[0035] According to some aspects, an acceptable logarithmic order reduction may be at least about 1.0, optionally at least about 1.1, optionally at least about 1.2, optionally at least about 1.3, optionally at least about 1.4, optionally at least about 1.5, optionally at least about 1.6, optionally at least about 1.7, optionally at least about 1.8, optionally at least about 1.9, optionally at least about 2.0, optionally at least about 2.1, optionally at least about 2.2, optionally at least about 2.3, optionally at least about 2.4, optionally at least about 2.5, optionally at least about 2.6, optionally at least about 2.7, optionally at least about 2.8, optionally at least about 2.9, optionally at least about 3.0. 9, optionally at least about 3.0, optionally at least about 3.1, optionally at least about 3.2, optionally at least about 3.3, optionally at least about 3.4, optionally at least about 3.5, optionally at least about 3.6, optionally at least about 3.7, optionally at least about 3.8, optionally at least about 3.9, optionally at least about 4.0, optionally at least about 4.1, optionally at least about 4.2, optionally at least about 4.3, optionally at least about 4.4, optionally at least about 4.5, optionally at least about 4.6, optionally at least about 4.7, optionally at least about 4.8, optionally at least about 4.9, and optionally at least about 5.0.

[0036] According to some aspects, as described herein, the chemical agent can be present in the rinse solution at a concentration sufficient to provide an acceptable log reduction of microorganisms over a specific period of time. According to some aspects, the chemical agent can be present in the rinse solution at a concentration between about 0.001 and 10% w / v, optionally between about 0.001 and 7.5% w / v, optionally between about 0.001 and 5% w / v, optionally between about 0.001 and 2.5% w / v, optionally between about 0.001 and 1% w / v, optionally between about 0.001 and 1% w / v, optionally between about 0.001 and 0.1% w / v, optionally between about 0.001 and 0.01 % w / v, optionally between about 0.01 and 10% w / v, optionally between about 0.01 and 7.5% w / v, optionally between about 0.01 and 5% w / v, optionally between about 0.01 and 2.5% w / v, optionally between about 0.01 and 2% w / v, optionally between about 0.01 and 1.5% w / v, optionally between about 0.01 and 1% w / v, and optionally at a concentration of about 0.5% w / v.

[0037] According to some aspects, the chemical agent can be present in the flushing solution at a concentration between about 0.1% and 0.9% w / v, optionally between about 0.2% and 0.8% w / v, optionally between about 0.3% and 0.7% w / v, and optionally between about 0.4% and 0.6% w / v.

[0038] According to some aspects, the chemical agent can be present in the flushing solution at a concentration between about 0.1% and 1% w / v, optionally between about 0.2% and 1% w / v, optionally between about 0.3% and 1% w / v, and optionally between about 0.4% and 1% w / v.

[0039] It should be understood that, according to some aspects, the irrigation fluid need not be a flushing solution as described herein, and can be any medically acceptable fluid configured to perform an irrigation process as described herein. In one non-limiting example, the irrigation fluid can include a saline solution. The saline solution can include water and a medically acceptable concentration of sodium chloride, such as between about 0.1% and 1% w / v, optionally about 0.45% w / v, and optionally about 0.9% w / v.

[0040] In a preferred embodiment, the irrigation fluid may include a preparation. The preparation may include sodium citrate, citric acid and sodium lauryl sulfate. The preparation may include sodium citrate at a medically acceptable concentration, such as between about 10g / l and 50g / l, optionally between about 20g / l and 40g / l, and optionally about 30g / l. The preparation may include citric acid at a medically acceptable concentration, such as between about 10g / l and 50g / l, optionally between about 20g / l and 40g / l, and optionally about 32g / l. The preparation may include sodium lauryl sulfate at a medically acceptable concentration, such as between about 0.1g / l and 5g / l, optionally between about 0.5g / l and 2g / l, and optionally about 1g / l.

[0041] In a preferred embodiment, the irrigation fluid may include a preparation. The preparation may include sodium acetate, acetic acid, benzalkonium chloride and ethanol. The preparation may include medically acceptable concentrations of sodium acetate, ranging from about 10 g / l to 50 g / l, optionally from about 20 g / l to 40 g / l, and optionally from about 30 g / l. The preparation may include medically acceptable concentrations of acetic acid, ranging from about 20 g / l to 100 g / l, optionally from about 40 g / l to 80 g / l, and optionally from about 50 g / l. The preparation may include medically acceptable concentrations of benzalkonium chloride, ranging from about 0.1 g / l to 5 g / l, optionally from about 0.5 g / l to 2 g / l, and optionally from about 1 g / l. The formulation may comprise ethanol in a medically acceptable concentration of between about 50 g / l and 150 g / l, alternatively between about 75 g / l and 125 g / l, and alternatively about 100 g / l.

[0042] According to some aspects, the irrigation fluid (such as the flushing solution described herein) can include a visualization aid. As used herein, the term "visualization aid" refers to a component in the irrigation fluid that is configured to assist in visualizing the application of the irrigation fluid. Example visualization agents include, but are not limited to, colorants, stains, and contrast agents. It should be understood that the visualization agent can be the same or different from one of the other components of the irrigation fluid. For example, the flushing agent can serve as a visualization agent. Additionally or alternatively, the irrigation fluid can include a visualization agent different from a chemical reagent.

[0043] According to some aspects, the irrigation fluid may include a colorant. As used herein, the term "colorant" refers to a component sufficient to provide an observable color to the fluid. The colorant may be sufficient to allow the irrigation fluid to be visualized when the irrigation fluid is applied to the surface. In some non-limiting examples, the colorant may include anionic colorants, such as anionic dyes. Anionic dyes can be any dye suitable for medical use, such as dyes approved by the Food and Drug Administration for use in food, drugs and / or cosmetics (i.e., "D&C" or "FD&C" dyes). Example anionic dyes include, but are not limited to, FD&C Blue No. 1 (Brilliant Blue FCF), FD&C Blue No. 2 (Indigo Carmine), FD&C Green No. 3 (Fast Green FCF), FD&C Red No. 3 (Erythrosine), FD&C Red No. 40 (Temptation Red), FD&C Yellow No. 5 (Lemon Yellow), FD&C Yellow No. 6 (Sunset Yellow FCF), D&C Yellow No. 8 (Fluorescein), D&C Orange No. 4 and combinations thereof. Combinations can be implemented to achieve specific colors. For example, orange hues may include FD&C Red No. 40 and D&C Yellow No. 8. Additionally or alternatively, colorants may include chemical compounds that are observable when exposed to visible and / or invisible light, including but not limited to vitamin B-12, medical honey, fluorescent polymer nanoparticles, water-soluble luminescent carbon nanodots, quinine, and combinations thereof.

[0044] According to some aspects, an irrigation fluid, such as the flushing solution described herein, can include a stain. As used herein, the term "stain" refers to a component sufficient to temporarily or permanently color a surface with which it comes into contact.

[0045] According to some aspects, the irrigation fluid (such as the flushing solution described herein) can include a contrast agent. As used herein, the term "contrast agent" refers to a composition that is opaque to the radio wave and x-ray portions of the electromagnetic spectrum sufficient for visualization. In some non-limiting examples, the contrast agent can include barium, iodine, iron oxide nanoparticles, gadolinium complex nanospheres, silica nanospheres, and combinations thereof.

[0046] According to some aspects, the irrigation fluid (such as the flushing solution described herein) can be alkaline, neutral or acidic. According to some aspects, the pH value of the irrigation fluid can be between about 1 and 10, optionally between about 1 and 7, optionally between about 1 and 6, and optionally between about 2 and 5.5.

[0047] According to some aspects, the irrigation fluid (such as the flushing solution described herein) can include a buffer system. As used herein, the term "buffer system" refers to a component present in a composition or solution that can provide resistance to significant changes in pH caused by a strong acid or a strong base. The buffer system can contain a single agent or more than one agent, such as a weak acid and its conjugate base. The buffer system can provide resistance to significant pH changes by interacting with a strong acid or a strong base in the composition or solution, thereby at least partially preventing significant changes in the pH of the composition or solution.

[0048] Typically, the buffer system has one or more buffer ranges, wherein the buffer system is able to provide resistance to significant pH changes. When the pH of a composition or solution comprising the buffer system is within the buffer range of the buffer system, the pH of the composition or solution will not change significantly when an equimolar amount of a strong acid or a strong base is added.

[0049] The buffer range of a buffer system is related to the acid dissociation constant (K a The term "acid dissociation constant" refers to the equilibrium constant of the dissociation reaction of an acid. The midpoint of the buffer range of a buffer system is usually approximately the acid dissociation constant (i.e., pK) of the weak acid contained in the buffer system. a , which is equal to -log 10 K a ) is the logarithmic measure of .

[0050] According to some aspects, an irrigation fluid, such as the flushing solution described herein, can include a stabilizer. As used herein, the term "stabilizer" refers to any ingredient that supports the stability of an irrigation fluid not expressly described herein.

[0051] According to some aspects, the irrigation fluid can be an irrigation fluid as described in US Application SN 17 / 152,565, which is incorporated herein by reference in its entirety.

[0052] According to the system of the present disclosure, a sealing body is configured to accommodate an irrigation fluid as described herein. According to some aspects, the sealing body can be compressible. As used herein, the term "compressible" is used in its ordinary and common manner, and refers to a reduction in volume to produce a pressure difference to support optimal fluid flow. In some aspects, this can include the ability to reversibly reduce the volume without unacceptable changes (such as unacceptable permanent changes in size, shape, and / or one or more characteristics described herein). According to some aspects, the sealing body can be configured so that at least a portion of the irrigation fluid contained in the sealing body is distributed when compressed. It should be understood that, as used herein, "distribution" (alternatively referred to as "discharge") can refer to transferring irrigation fluid to a surface.

[0053] According to some aspects, the sealing body can be collapsible. As used herein, the term "collapsed" is used in its ordinary and common manner and refers to the ability to permanently reduce volume. For example, when a first volume of fluid is contained in a collapsible body as described herein, a collapsible body as described herein can have a first volume. When at least a portion of the fluid is dispensed, the collapsible body can collapse to have a second volume that is less than the first volume. It should be understood that the collapsible body will advantageously reduce the volume of waste (e.g., the volume of the body after the fluid therein has been dispensed). The collapsible body can further provide more efficient fluid discharge.

[0054] In some aspects, the sealing body can be configured to allow a volume reduction of at least 10%, optionally a volume reduction of at least 20%, optionally a volume reduction of at least 30%, optionally a volume reduction of at least 40%, optionally a volume reduction of at least 50%, optionally a volume reduction of at least 60%, optionally a volume reduction of at least 70%, optionally a volume reduction of at least 80%, and optionally a volume reduction of at least 90% when compressed and / or deflated.

[0055] According to some aspects, the sealing body can include a body material that is compatible with the irrigation fluid contained therein, ie, a material that does not chemically or physically react with the irrigation fluid or otherwise render the irrigation fluid unsuitable for medical use.

[0056] According to some aspects, the body material may be sufficient to prevent unacceptable vapor or chemical losses of the irrigation fluid contained therein over a certain shelf life. It should be understood that "unacceptable vapor or chemical losses" can be losses that cause the irrigation fluid to become unsuitable for its intended use. The vapor or chemical losses can be caused by, for example, adsorption or absorption of chemicals by a material (e.g., the body material), evaporation of a solution, evaporation of a component of a solution (e.g., a disinfectant of a disinfecting solution), or a combination thereof. In a non-limiting example, where the irrigation fluid contains water and iodine as described herein, the body material may be sufficient to prevent water vapor loss and / or iodine loss over a certain shelf life.

[0057] As used in this application, the term "shelf life" refers to the length of time that a product (e.g., a disinfecting solution) can be stored while remaining within the specifications required for the form, fitness, and function of the product. The shelf life can be determined by measuring certain characteristics of the product, which may indicate that the product is not suitable for medical use. For example, the shelf life can be determined by measuring the concentration of impurities in the product, the color change of the product, the concentration of insoluble particles in the product, the effectiveness of the active agent (e.g., disinfectant) contained in the product, the concentration of one or more ingredients of the product, the pH value of the product, and / or the sterility of the product after storage under long-term storage conditions. As used herein, the term "long-term storage conditions" refers to environmental conditions sufficient to allow the product to be accepted for storage for more than 72 hours. According to some aspects, long-term storage conditions may refer to a temperature of about 25°C and a relative humidity of about 60%. Additionally or alternatively, the shelf life can be determined by measuring the concentration of impurities in the product, the color change of the product, the concentration of insoluble particles in the product, the effectiveness of the active agent of the product, the concentration of one or more ingredients of the product, the pH value of the product, and / or the sterility of the product after storage at 37°C and 65% relative humidity. Additionally or alternatively, the shelf life can be determined by measuring the concentration of impurities in the product, color change of the product, the concentration of insoluble particles in the product, the potency of the active agent of the product, the concentration of one or more ingredients of the product, the pH of the product and / or the sterility of the product after storage at about 15-30°C with a temperature fluctuation of no more than about 40°C.

[0058] According to some aspects, the shelf life can be at least about 20 months, optionally at least about 21 months, optionally at least about 22 months, optionally at least about 23 months, optionally at least about 24 months, optionally at least about 25 months, optionally at least about 26 months, optionally at least about 27 months, optionally at least about 28 months, optionally at least about 29 months, optionally at least about 30 months, optionally at least about 31 months, optionally at least about 32 months, optionally at least about 33 months, optionally at least about 34 months, optionally at least about 35 months, optionally at least about 36 months, optionally at least about 37 months, optionally at least about 38 months, optionally at least about 39 months, and optionally at least about 40 months.

[0059] According to some aspects, the subject material may be sufficiently sterilizable by any known sterilization technique useful in accordance with the present disclosure, including moist heat sterilization (i.e., autoclaving), gas sterilization, gamma radiation, electron beam (e-beam) sterilization, aseptic manufacturing processes (e.g., aseptic filtration and / or blow-fill-seal operations), and combinations thereof. Preferably, the subject material may be sufficiently sterilizable by gamma radiation, wherein the subject material is compatible with the gamma radiation process. According to some aspects, the subject material does not chemically or physically react with the irrigation fluid as a result of the gamma radiation process, nor does it otherwise render the irrigation fluid unsuitable for medical use. According to some aspects, if the container containing the subject material has at least 10 -6 If a subject material meets a sterility assurance level (SAL) of 100% and provides acceptable results when the container closure is integrity tested after sterilization, the subject material can be determined to be sufficient for sterilization.

[0060] According to some aspects, the subject material can have sufficient mechanical strength so that the subject provides an acceptable response to shock, vibration, shaking, or a combination thereof. According to some aspects, an acceptable response refers to a response that complies with ASTM D4169-16 (Standard Practice for Performance Testing of Marine Containers and Systems), ASTM D4728-06 (Standard Test Method for Random Vibration Testing of Marine Containers), ASTM D642-15 (Standard Test Method for Determining the Compressive Capacity of Marine Containers, Components, and Unit Loads), or any combination thereof. According to some aspects, the subject material can be safe for biomedical use. For example, the subject material can comply with ISO 10993 and / or REACH requirements. According to some aspects, the subject material may be sufficient to exhibit at least a portion of the features described herein at a temperature between about 15°C and 30°C (with a temperature fluctuation of no more than 40°C) during a period of the shelf life of the irrigation fluid. Additionally or alternatively, the subject material may be sufficient to exhibit at least a portion of the features described herein after storage at about 25°C and 60% relative humidity during a period of the shelf life of the irrigation fluid. Additionally or alternatively, the subject material may be sufficient to exhibit at least a portion of the characteristics described herein after storage at about 37°C and 65% relative humidity for a period of time during the shelf life of the irrigation fluid.

[0061] The body material may be rigid or flexible. As used herein, the term "rigid" refers to a stiffness sufficient to resist deformation under normal operating forces. As used herein, the term "flexible" refers to the ability to bend or compress under normal operating forces.

[0062] Example host materials include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Example plastics useful according to the present disclosure include, but are not limited to, high density polyethylene (HDPE), low density polyethylene (LDPE), polypropylene, polystyrene, nylon, and any combination thereof. According to some aspects, the host material can be a lined and / or coated material, such as a lined and / or coated paper.

[0063] According to some aspects, the body material can be polypropylene. Preferably, the body material can be radiation grade polypropylene. In this article, if the body material is radiation grade polypropylene, then the body material may be able to withstand terminal sterilization. The body material according to the present disclosure can be configured to withstand gamma radiation as part of terminal sterilization. Radiation grade polypropylene plastic as the body material allows the sealed body containing irrigation fluid to be subjected to gamma radiation, wherein the sterilization is performed with the irrigation fluid already present inside the sealed body.

[0064] The sealing body according to the present disclosure can remain flexible when subjected to gamma radiation, wherein the irrigation fluid contained in the sealing body is not significantly affected by the gamma radiation, that is, the stability and integrity of the irrigation fluid can be maintained. In this article, the sealing body maintains its ability to bend or compress under normal operating forces. The sealing body according to the present disclosure is not significantly affected by the gamma radiation when subjected to gamma radiation, wherein the stability and integrity of the sealing body can be maintained.

[0065] As will be described herein, according to some aspects, the sealing body can undergo certain changes in material characteristics when subjected to gamma radiation, which can help reduce stretching of the sealing body when the flow regulating member forms a rupture in the sealing body. As will be described herein, the reduction in stretching of the sealing body allows the flow regulating member to easily form a rupture in the sealing body.

[0066] According to some aspects, the system includes a flow regulating member configured to form a rupture in a sealing body to facilitate discharge of an irrigation fluid contained in the sealing body. In some embodiments, the flow regulating member forms a cutout in the sealing body to facilitate discharge of the irrigation fluid. In some embodiments, the flow regulating member forms a cutout in a wall of the sealing body.

[0067] According to some aspects, the sealing body containing the irrigation fluid can change in the wall thickness of the sealing body. In particular, compared with the thickness of other parts or walls of the sealing body, one or more wall parts of the sealing body can have different thicknesses. Preferably, compared with other parts or walls of the sealing body, the thickness of a certain wall part can be smaller. The thickness of such a specific wall part can be at most 95% of the thickness of other parts or walls, optionally at most 90%, optionally at most 85%, optionally at most 80%, optionally at most 75%, optionally at most 70%, optionally at most 65%, optionally at most 60%, optionally at most 55%, optionally at most 50%, optionally at most 45%, optionally at most 40%, optionally at most 35%, optionally at most 30%, and optionally at most 25%. As described above, the wall part with less thickness can be located on the top wall, bottom wall or side wall of the sealing body. Preferably, as described above, the wall part with less thickness can be the bottom wall of the sealing body relative to the ground. As in Figure 4 As seen in , the reduction in thickness of the wall portion 43 allows the flow regulating member 42 outside the sealing body 41 to easily form a rupture (such as a cut) in the sealing body. In a related embodiment, by allowing the flow regulating member to form a rupture in the sealing body, the change in wall thickness and the trapped gas within the sealing body cooperate when venting the sealing body. Preferably, the trapped gas is at a pressure above atmospheric pressure. The trapped gas may include air and / or an inert gas, such as nitrogen.

[0068] According to some aspects, the sealing body can be self-supporting. According to some aspects, one wall of the sealing body is configured to be placed on a surface in a stable manner. Herein, one wall of the sealing body supports the rest of the sealing body when placed on a surface to provide a stable position for an individual to use a flow regulating member to form a rupture in the sealing body to facilitate the discharge of irrigation fluid. For example, an individual can easily place the sealing body on a table and stably form the incision with the flow regulating member.

[0069] According to some aspects, such as Figure 1 As seen in FIG. 1 , the sealing body 11 may be marked as 12 to indicate a location on the sealing body where the sealing body is configured to be breached by the flow regulating member, e.g., an individual uses the flow regulating member to form a rupture in the sealing body. According to some aspects, the sealing body is marked using a process selected from the group consisting of embossing, engraving, marking, etc.

[0070] The sealing body according to the present disclosure is configured to distribute the irrigation fluid (such as flushing solution) contained in the sealing body via one or more mechanisms. According to some aspects, the body can be configured to distribute the irrigation fluid when compressed as described herein. For example, the sealing body can be configured to distribute at least a portion of the irrigation fluid contained in the sealing body in response to compression (such as squeezing). Additionally or alternatively, the sealing body can be configured to distribute at least a portion of the irrigation fluid contained in the sealing body in response to longitudinal compression.

[0071] Additionally or alternatively, the sealing body can be configured to dispense at least a portion of the irrigation fluid contained in the sealing body when the body is oriented in a particular orientation. Preferably, the flow regulating member forms a break (such as a cut, perforation, hole or slit) in the sealing body through which the irrigation fluid can be dispensed. The sealing body can be configured such that when provided in a particular orientation (e.g., wherein the break formed by the flow regulating member is provided at or near the bottom of the sealing body relative to the ground), at least a portion of the irrigation fluid is dispensed by gravity.

[0072] The sealing body may further include a positioning component that allows the sealing body to be arranged in a specific orientation. The positioning component can be any component configured to position and / or fix the sealing body in a selected orientation, such as a hook, a belt, a snap, a button, a strip, or a combination thereof. The positioning component can be integral with the sealing body, and / or can be a separate component configured to interact with the body, such as a belt that can be attached to the body. The positioning component can be configured to interact with a second positioning component (such as an extension arm), which is configured to interact with a hook included by the sealing body and / or attached to the sealing body.

[0073] It should be understood that the sealing body can be configured to distribute irrigation fluid via a mechanism or a combination of mechanisms as described herein. For example, the sealing body can be configured to distribute irrigation fluid in combination with gravity when compressed. According to some aspects, the sealing body can be configured to selectively distribute irrigation fluid via one or more of the mechanisms as described herein. In a non-limiting example, the sealing body can be configured to distribute irrigation fluid when compressed with and without external forces. In this way, the user can select a desired delivery mechanism based on physical limitations (e.g., the user's physical ability), desired fluid flow force, desired fluid flow rate, desired fluid flow design (e.g., pulsed or constant) or a combination thereof.

[0074] According to some aspects, the flow regulating member forms a rupture in the sealing body to facilitate the discharge of the irrigation fluid through the rupture. In this context, the irrigation fluid is discharged in a specific flow pattern. According to some aspects, such as in Figure 3As seen in FIG. 1 , the shape and size of the rupture 33 formed by the flow regulating member determines the flow pattern 32 of the irrigation fluid from the sealing body 31 .

[0075] According to some aspects, the flow pattern of the irrigation fluid is described as the irrigation fluid being discharged at a specific pressure. According to some aspects, the irrigation fluid is discharged from the sealing body at a pressure below 15 psi, below 12 psi, below 10 psi, below 8 psi, or below 5 psi.

[0076] According to some aspects, the flow pattern of the irrigation fluid is described as the irrigation fluid being discharged in a spray wave over a specific area. According to some aspects, the irrigation fluid is discharged from the sealing body in a spray wave of 10 square inches, 9 square inches, 8 square inches, 7 square inches, 6 square inches, 5 square inches, 4 square inches, 3 square inches, 2 square inches, or 1 square inch. In particular, the spray wave can be any shape.

[0077] According to some aspects, the flow pattern of the irrigation fluid is described as substantially all of the irrigation fluid being discharged from the sealing body within 20 seconds, less than 20 seconds, within 15 seconds, less than 15 seconds, within 10 seconds, less than 10 seconds, or within 5 seconds.

[0078] According to some aspects, the sealing body can be configured to dispense at least about 75%, optionally at least about 80%, optionally at least about 85%, optionally at least about 90%, optionally at least about 95%, and optionally about 100% of the irrigation fluid contained in the sealing body. The sealing body can be configured to continuously dispense irrigation fluid and / or to intermittently dispense irrigation fluid. In a non-limiting example, the sealing body can be configured to intermittently dispense irrigation fluid such that irrigation fluid is dispensed only when the sealing body is compressed.

[0079] The sealing body can be configured to contain a volume of irrigation fluid sufficient to perform at least a portion of the irrigation process. According to some aspects, the sealing body can be configured to contain between about 250mL and 2000mL of fluid, optionally between about 500mL and 1000mL. According to some aspects, the sealing body can be configured to contain about 500mL of fluid. According to some aspects, the sealing body can be configured to contain about 1L of fluid.

[0080] Systems according to the present disclosure include a flow regulating member configured to form a rupture in the sealing body to facilitate discharge of irrigation fluid. Figure 2As seen in , the flow regulating member 21 comprises a tool that is provided as a system with a sealing body to form a rupture in the sealing body. The tool 21 preferably includes a tapered end 22 that forms a rupture in the sealing body. Non-limiting examples of the tool are tools having a tapered end that can be used to form a rupture (such as a cut, perforation, hole, or slit), or a tool that can pierce or puncture the sealing body at a selected location. The tool can be selected from a group including a generally cylindrical tool with a tapered end, a knife, a screw, a pin, a blade, a tapered rod, a point, or any tool having a tapered first end 22 and a handle 23 toward a second end to form a rupture in the sealing body. As shown in Figure 5 As seen in FIG. 5 , various flow regulating members 53 may be used to form the rupture 52 in the sealing body 51 .

[0081] According to some aspects, such as Figure 6 As seen in , the flow regulating member includes a spike cap 61. The spike cap is configured to be attached to an end of a sealing body to facilitate the discharge of irrigation fluid contained in the sealing body. Herein, when the spike cap is attached to the sealing body, the spike of the spike cap forms a rupture in the sealing body to ensure that the irrigation fluid is discharged through the rupture. According to some aspects, the spike cap includes a spike geometry 62. The spike geometry determines the shape of the spike that forms the rupture in the sealing body. According to some aspects, as shown in Figure 8 As seen in the , the spike geometry includes a beveled tip 82 or an aligned tip 81. In the present context, the spike geometry determines the flow pattern of the irrigation fluid discharged from the sealing body, as described herein. The spike geometry also determines the force required for an individual to puncture the sealing body by attaching the spike cap to the sealing body to facilitate the discharge of the irrigation fluid.

[0082] According to some aspects, the sealing body can further include a sawtooth thread located on the first end of the sealing body. According to some aspects, the spike cap can further include a sawtooth thread located on the first end of the spike cap. In this article, the sawtooth threads included in the end of the spike cap and the end of the sealing body are attached to each other, or screwed together, or threaded together to ensure that the spike cap forms a cutout in the sealing body for discharging irrigation fluid.

[0083] According to some aspects, such as Figure 7 As seen in FIG. 7 , a spike cap 71 having a beveled tip 72 facilitates the process of forming a rupture in a seal body 73 when the spike cap is attached to the seal body, wherein the beveled tip pierces a selected location on the seal body. According to some aspects, a spike cap having an aligned tip allows the piercing process to coincide with the threading process when the spike cap is attached to the seal body.

[0084] According to some aspects, more than one spike cap is provided with the sealing body. According to some aspects, spike caps having different spike geometries are provided with the sealing body to achieve different flow patterns of irrigation fluid as desired.

[0085] According to some aspects, the flow regulating member is integral to a system including a seal body. According to some aspects, the flow regulating member may or may not be in fluid communication with the seal body during discharge of irrigation fluid from the seal body.

[0086] According to some aspects, the flow regulating member comprises a specific material, wherein the material has the ability to utilize its own sharp edges, thereby eliminating metal sharp objects that pose a risk in a healthcare environment. According to some aspects, the flow regulating member is made of a plastic material. In particular, the flow regulating member can be made of plastics including but not limited to high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene, polystyrene, acrylic, nylon, polycarbonate, polymethyl methacrylate (PMMA), polyacrylonitrile (PAN), polyester, acrylonitrile butadiene styrene (ABS), polyvinyl chloride (PVC) and polyvinylidene fluoride (PVDF).

[0087] According to some aspects, the flow regulating member can be made of a metal material or an alloy material. In particular, the flow regulating member can be made of a metal or alloy including but not limited to stainless steel, cobalt-chromium alloy, titanium, nickel-titanium alloy, gold, platinum, silver, iridium, tantalum, tungsten, aluminum, copper and magnesium.

[0088] According to some aspects, the sealing body can be provided with a removable cover to prevent fluid from being discharged from the sealing body, for example during storage or transportation of the sealing body.

[0089] According to some aspects, the system can be configured to provide an acceptable fluid flow rate for an irrigation process. 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, during an irrigation process. The fluid flow rate can depend at least in part on the characteristics of a flow regulating member and / or a delivery mechanism as described herein. According to some aspects, the fluid flow rate can be related to the fluid flow force. For example, an increased fluid flow rate can correspond to an increased fluid flow force, and vice versa. According to the present disclosure, the system can be configured to provide different, selectable fluid flow rates.

[0090] According to some aspects, the system can be configured to provide acceptable fluid flow forces for the irrigation process. As used herein, the term "fluid flow force" refers to the force exerted by a fluid on a surface, such as a human subject, during an irrigation process. The acceptable fluid flow force can be determined based on the requirements of the irrigation process.

[0091] It should be understood that the fluid flow forces provided by the system as described herein may depend at least in part on the characteristics of the flow regulating member and / or the delivery mechanism as described herein. The system according to the present disclosure may be configured to provide different, selectable fluid flow forces. It should be understood that each of the selectable fluid flow forces may correspond to, for example, a specific delivery mechanism, a specific flow regulating member, or a combination thereof, as described herein.

[0092] According to some aspects, the system is configured to provide an acceptable fluid flow design for the irrigation process. As used herein, the term "fluid flow design" refers to a design for dispensing and / or applying fluid from a device to a surface, such as a human subject, during an irrigation process. In some non-limiting examples, the fluid flow design can include a fluid mist (i.e., a suspension of a finely divided fluid in a gas), a fluid stream (i.e., a steady, continuous fluid), a fluid spray (i.e., a finely divided fluid), or a combination thereof. The fluid flow design can be constant (e.g., the fluid is continuously dispensed and / or applied to the surface from the device) or pulsed (e.g., the fluid is intermittently dispensed and / or applied to the surface from the device).

[0093] Fluid flow design can additionally or alternatively refer to the angle at which the fluid flow path is distributed and / or applied to the surface from the device. For example, as described herein, the fluid flow path can have a fluid flow design that is approximately perpendicular to the longitudinal axis of the sealing body.

[0094] Additionally or alternatively, fluid flow design may refer to the geometry of the fluid path. It should be understood that the geometry of the fluid path refers to the shape defined by a cross-sectional view of the fluid flow path in any of the x-, y-, and z-directions.

[0095] It should be appreciated that fluid flow design may depend at least in part on the flow regulating member and / or delivery mechanism as described herein.

[0096] According to some aspects, one or more components of the system described herein can be provided in sterile packaging. As used herein, the term "sterile packaging" refers to a packaging that provides a sterile environment in order to maintain the sterility of the sterile product contained. Example sterile packaging includes, but is not limited to, sterile blister packaging, sterile safety edge trays, sterile surgical trays, sterile custom thermoformed products, sterile bags, sterile plastic forming trays with top covers, and combinations thereof. It should be understood that one or more components of the system can be provided in the same sterile packaging and / or a sterile packaging separated from at least one other component of the system. For example, the first component of the system can be included in a first sterile packaging, and the second component of the system can be included in a second sterile packaging. In a non-limiting example, the system can include a sealing body included in the first sterile packaging and a flow regulating member included in the second sterile packaging. It should be understood that providing one or more components of the system in different sterile packaging allows each component of the system to be removed immediately before use, thereby preventing one or more components from being exposed to a non-sterile environment for a long time. In this way, a fully assembled sterile display of the system can be achieved.

[0097] Although the aspects described herein have been described in conjunction with the example aspects summarized above, various alternatives, modifications, variations, improvements, and / or substantial equivalents (whether known or currently unforeseen or currently possibly unforeseen) may become apparent to those of ordinary skill in the art. Therefore, the example aspects as described above are intended to be illustrative rather than restrictive. Various changes may be made without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to cover all known or later developed alternatives, modifications, variations, improvements, and / or substantial equivalents.

[0098] Therefore, the claims are not intended to be limited to the aspects shown herein, but to be consistent with the full scope consistent with the language of the claims, wherein, unless explicitly stated, reference to an element in the singular is not intended to mean "one and only one", but "one or more". All structural and functional equivalents of the elements of the various aspects described throughout the present disclosure are known or later become known to those of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be covered by the claims. In addition, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is explicitly recited in the claims. Unless a claim element is expressly stated using the phrase "device for...", the element shall not be interpreted as a device plus function.

[0099] In addition, the word "example" is used herein to mean "used as an example, instance or illustration". Any aspect described as an "example" in this article is not necessarily to be construed as being advantageous or preferred over other aspects. Unless otherwise specifically stated, the term "some" refers to one or more. For example, the combination of "at least one of A, B or C", "at least one of A, B and C" and "A, B, C or any combination thereof" includes any combination of A, B and / or C, and may include multiples of A, multiples of B or multiples of C. Specifically, the combination of "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 be only A, only B, only C, A and B, A and C, B and C, or A and B and C, wherein any such combination may include one or more members of A, B or C.

[0100] The word "about" is used herein to mean within ±5%, optionally within ±4%, optionally within ±3%, optionally within ±2%, optionally within ±1%, optionally within ±0.5%, optionally within ±0.1%, and optionally within ±0.01% of the stated value.

Claims

1. A system for applying an irrigation fluid to a surface, the system comprising: a sealing body containing an irrigation fluid, wherein the sealing body and the irrigation fluid contained therein are terminally sterilized; and A flow regulating member, wherein the flow regulating member is configured to form a rupture in the sealing body to facilitate discharge of the irrigation fluid in a certain flow pattern.

2. The system according to claim 1, wherein: The flow regulating member includes a tool having a tapered end.

3. The system according to claim 1, wherein: The flow regulating member includes a spike cap configured to be attached to the first end of the sealing body, wherein the spike cap includes a spike geometry.

4. The system according to claim 3, wherein: The body includes buttress threads on a first end of the sealing body.

5. The system according to claim 4, wherein: The spike cap further includes buttress threads attached to the buttress threads on the first end of the seal body.

6. The system according to claim 3, wherein: The tip geometry includes a beveled tip.

7. The system according to claim 3, wherein: The tip geometry includes aligned tips.

8. The system according to claim 1, wherein: The flow regulating member is separated from the sealing body during discharge of the irrigation fluid.

9. The system according to claim 1, wherein: The flow regulating member is in fluid communication with the sealing body during discharge of the irrigation fluid.

10. The system according to claim 1, wherein: The flow regulating member forms a cutout in the sealing body, wherein a shape and size of the cutout determines a flow pattern of the irrigation fluid.

11. The system according to claim 1, wherein: The seal body is compressible, and the seal body is configured such that at least a portion of the irrigation fluid is discharged through the rupture when the seal body is compressed.

12. The system of claim 1, wherein: The seal body is configured such that at least a portion of the irrigation fluid is discharged through the rupture when the seal body is compressed or when the seal body is uncompressed.

13. The system of claim 1, wherein: The sealing body is collapsible.

14. The system of claim 1, wherein: The flow regulating member is integral with the sealing body.

15. The system of claim 1, wherein: The irrigation fluid comprises a chemical reagent and water, the chemical reagent comprising iodine.

16. The system of claim 1, wherein: The flow pattern includes substantially all of the irrigation fluid being discharged from the sealing body within 20 seconds.

17. The system of claim 1, wherein: The flow pattern includes the irrigation fluid being discharged at a pressure of less than 15 psi.

18. The system of claim 1, wherein: The flow pattern includes the irrigation fluid being discharged in a 6 inch square spray wave.

19. The system of claim 1, wherein: The flow regulating member comprises a material selected from the group consisting of plastic, metal and alloy.

20. The system of claim 1, wherein: The sealing body comprises a plastic that is compatible with gamma radiation.

21. The system of claim 1, wherein: The sealing body and irrigation fluid contained therein are terminally sterilized via gamma radiation.

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