Self-supporting lavage systems, devices, and articles

Abstract

An article for applying a lavage fluid to a surface, the article having a sealing body for containing a lavage fluid, where the sealing body is configured to be self-supporting before and during discharge of the lavage fluid from the sealing body, wherein the sealing body and the lavage fluid contained therein are ultimately sterilized; and a system comprising the article according to claim 1 and an application member, where the application member is configured to break the wall of the sealing body to form a fluid delivery port and to create a fluid path for discharging lavage fluid.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 358,412, filed on July 5, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to self-supporting devices, systems, and articles for applying irrigation fluid to a surface. Background Art

[0004] Currently, irrigation (i.e., flushing a body cavity, surgical cavity, or external wound with a medically acceptable fluid) is often used to prevent contamination of open surgical wounds, which may occur for a variety of reasons, such as accidental visceral entry or organ perforation, complications of the procedure due to large spills, departures from aseptic technique, and / or existing, ongoing clinical infection. Irrigation procedures are therefore often used to provide sterile wound irrigation during surgery.

[0005] Irrigation techniques currently encompass a variety of different modalities that vary depending on the situation (e.g., the size and shape of the cavity or wound) and the medical staff performing the irrigation procedure (e.g., the medical staff's technical preferences). Currently, no particular irrigation technique is standardized in the art, and therefore, medical institutions typically require many different irrigation devices and systems to accommodate a variety of potential modalities. The existence of such devices and systems is also sometimes a problem because inadvertent improper use of such devices and systems (e.g., transvenously, if the device and / or system has a similar appearance to a transvenous device and / or system) can result in devastating consequences.

[0006] In addition, current lavage practices suffer from several disadvantages, including deficiencies 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 staff performing the lavage.

[0007] In addition, current irrigation devices usually increase the risk of contamination. For example, some current irrigation devices utilize a resilient hollow body that discharges irrigation fluid when pressure is applied thereto (e.g., a "squeeze bottle" etc.). In order to function, such devices require one or more rebalancing time periods (i.e., a period of time in which reduced pressure or no pressure is applied to the device) so that gases such as air can be sucked into the device, enough to rebalance its internal pressure. However, by introducing non-sterile gas into the device, the sterility of the irrigation fluid contained therein (and the surgical wound contacted by the irrigation fluid) may be compromised. In addition, such devices inhale gas along the same path of distributing irrigation fluid from the device during rebalancing. However, these paths are usually not optimized for this function, and therefore, the rebalancing time period required for such devices usually provides unacceptable delays to the irrigation process, which usually results in inefficient and / or ineffective irrigation processes.

[0008] Furthermore, current irrigation devices are not self-supporting and require some tool separate from the irrigation device itself to support them in order to perform their intended function. Current irrigation devices often require specific components to position the device in a certain orientation and to hold the device in a stable position for the irrigation fluid application process. Furthermore, current irrigation devices provide only limited ability for the clinician to control and aim the flow of irrigation fluid.

[0009] Therefore, there is a need in the art for self-supporting general purpose devices and systems for performing irrigation procedures, and in particular, there is a need for devices and systems that enable medical personnel to safely and effectively reduce contamination in surgical wounds that are susceptible to surgical site infections. There is a need in the art for a self-supporting irrigation device, wherein no separate tool is required to arrange and maintain a stable position of the irrigation device. There is a need in the art for a terminally sterilized irrigation device, wherein the irrigation fluid contained in the irrigation device 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 an irrigation device that can deliver a large amount of irrigation fluid in a short period of time, wherein the clinician can optimally control and aim the flow of the irrigation fluid. Summary of the invention

[0010] The present disclosure relates to devices, systems and articles for delivering irrigation fluids (such as flushing solutions) to surfaces. The articles include a sealing body configured to contain irrigation fluids (such as flushing solutions). The sealing body is further configured to be self-supporting before and during the drainage of irrigation fluids from the sealing body. Optionally, the sealing body and the irrigation fluid contained therein are terminally sterilized.

[0011] The devices, systems, and articles 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 over the delivery of irrigation fluid to a surface. The present disclosure also relates to methods of using the devices, systems, and articles described herein.

[0012] The present disclosure also relates to an application member that can be used with the devices, systems and articles described herein. The application member is configured to apply an irrigation fluid to a surface sufficient for an irrigation process. The application member includes a fluid channel that is configured to provide fluid communication between a sealing body and an external environment. The application member is configured to generate a disruption within a sealing body containing an irrigation fluid. The disruption generated in the sealing body helps the irrigation fluid to be discharged from the sealing body through the application member in a flow pattern. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Figure 1 Examples of articles of manufacture according to aspects of the present disclosure are shown.

[0014] Figure 2 Examples of articles of manufacture according to aspects of the present disclosure are shown.

[0015] Figure 3 An example of a sealing body according to the present disclosure is shown.

[0016] Figure 4 Examples of application members according to aspects of the present disclosure are shown.

[0017] Figure 5 An example of a sealing body according to the present disclosure is shown.

[0018] Figure 6 An example of a sealing body according to the present disclosure is shown.

[0019] Figure 7 An example of a sealing body according to the present disclosure is shown.

[0020] Figure 8 Examples of application members according to aspects of the present disclosure are shown. DETAILED DESCRIPTION

[0021] The present disclosure relates to devices, systems and articles for delivering irrigation fluids (such as flushing solutions) to surfaces. The articles include a device (such as a fluid container) comprising a sealing body configured to contain an irrigation fluid (such as a flushing solution). The sealing body is further configured to be self-supporting before and during the discharge of the irrigation fluid from the sealing body. Optionally, the sealing body and the irrigation fluid contained therein are both terminally sterilized.

[0022] The present disclosure also relates to an application member that can be used with the devices, systems and products described herein. The application member is configured to apply an irrigation fluid to a surface sufficient for an irrigation process. The application member includes a fluid channel that is configured to provide fluid communication between a sealing body and an external environment. The application member is configured to produce damage, such as an incision, a puncture, a hole or a slit, in a sealing body containing an irrigation fluid. The damage produced in the sealing body helps the irrigation fluid to be discharged from the sealing body through the application member in a flow pattern. The devices, systems and products can be adaptive so that the user can choose from one or more different fluid flow rates, fluid flow designs and / or fluid flow forces, thereby providing selectable control over the delivery of irrigation fluid. The present disclosure also relates to methods for using the devices, systems and products described herein.

[0023] As used herein, the term "irrigation fluid" refers to a fluid suitable for use in the irrigating procedures described herein. As used herein, "irrigation" refers to the flushing of a body cavity, a surgical cavity, and / or an external wound.

[0024] 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 one 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.

[0025] 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.

[0026] Additionally or alternatively, the disinfectant may include iodine. According to some aspects, the 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.

[0027] Additionally or alternatively, the chemical reagent may include an oxidant component (ie, an oxidant). Non-limiting examples of oxidant components according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, Dakin's solution, hypochlorous acid, and combinations thereof.

[0028] In a 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, bacitracin, vancomycin, gentamicin, cefazolin, clindamycin, polymyxin, or a combination thereof.

[0029] The chemical agent may have an 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 "microorganism" may refer to any microorganism that is killed and / or removed as a result of lavage. Exemplary microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0030] Exemplary bacteria include drug-resistant bacteria and drug-sensitive bacteria, but are not limited to Streptococcus (e.g., Streptococcus mutans, Streptococcus pyogenes, Streptococcus salivarius, Streptococcus sanguinis), 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 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.

[0031] Exemplary fungi include drug-resistant fungi and drug-sensitive fungi, but are not limited to, Aspergillus brasiliensis, Candida species (Candida albicans, Candida aureus, Candida dubliniensis, Candida glabrata, Candida guillermonida, Candida kefir (formerly Candida pseudotropical), Candida krusei, Candida lusitaniae, Candida tropicalis), Epidermophyton floccosum, Microsporum species (e.g., Microsporum gypseum, Microsporum canis), and Trichophyton mentagrophytes.

[0032] Exemplary viruses include, but are not limited to, single-stranded or double-stranded DNA and RNA genomes, with sense or antisense orientation, with a protein coat (capsid) with or without a lipid 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, norovirus, and coronavirus.

[0033] According to some aspects, the certain period of time can be a period of time 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.

[0034] According to some aspects, the certain period of time 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.

[0035] It should be understood that an "acceptable log reduction value" may depend on the microorganism. For example, an acceptable log reduction value described herein may refer to an acceptable log reduction value for 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.

[0036] According to some aspects, an acceptable log reduction value 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. .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.

[0037] 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 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 0.1% w / v, optionally between about 0.001% and 0. 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 about 0.5% 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 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.

[0039] 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.

[0040] It should be understood that according to some aspects, the irrigation fluid is not necessarily 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.

[0041] In a preferred embodiment, the irrigation fluid may include a formulation. The formulation may include sodium citrate, citric acid, and sodium lauryl sulfate. The formulation may include sodium citrate at a medically acceptable concentration, such as between about 10 and 50 g / l, optionally between about 20 and 40 g / l, and optionally about 30 g / l. The formulation may include citric acid at a medically acceptable concentration, such as between about 10 and 50 g / l, optionally between about 20 and 40 g / l, and optionally about 32 g / l. The formulation may include sodium lauryl sulfate at a medically acceptable concentration, such as between about 0.1 and 5 g / l, optionally between about 0.5 and 2 g / l, and optionally about 1 g / l.

[0042] 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 sodium acetate at a medically acceptable concentration, such as between about 10 and 50 g / l, optionally between about 20 and 40 g / l, and optionally about 30 g / l. The preparation may include acetic acid at a medically acceptable concentration, such as between about 20 and 100 g / l, optionally between about 40 and 80 g / l, and optionally about 50 g / l. The preparation may include benzalkonium chloride at a medically acceptable concentration, such as between about 0.1 and 5 g / l, optionally between about 0.5 and 2 g / l, and optionally about 1 g / l. The preparation may include ethanol at a medically acceptable concentration, such as between about 50 and 150 g / l, optionally between about 75 and 125 g / l, and optionally about 100 g / l.

[0043] According to some aspects, the irrigation fluid, such as the flushing solution described herein, can contain 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 administration of the irrigation fluid. Exemplary imaging agents include, but are not limited to, colorants, stains, and radiopaque agents. It should be understood that the imaging agent can be the same as or different from one of the other components of the irrigation fluid. For example, a chemical agent can function as an imaging agent. Additionally or alternatively, the irrigation fluid can include an imaging agent that is different from the chemical agent.

[0044] According to some aspects, the lavage fluid may include a colorant. As used herein, the term "colorant" refers to a composition that is sufficient to provide an observable color for the fluid. The colorant may be sufficient to visualize the lavage fluid when applied to the surface. In some non-limiting examples, the colorant may include anionic colorants, such as anionic dyes. Anionic dyes may be any dye suitable for medical use, such as dyes (i.e., "D&C" or "FD&C" dyes) approved by the Food and Drug Administration for food, medicine and / or cosmetics. Exemplary 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 may be implemented to achieve specific colors. For example, an orange hue may include FD&C Red No. 40 and D&C Yellow No. 8. Additionally or alternatively, the colorant 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.

[0045] 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 stain a surface with which it comes into contact.

[0046] According to some aspects, the irrigation fluid, such as the flushing solution described herein, can contain a radiopaque agent. As used herein, the term "radiopaque agent" refers to a component that is opaque to the radio wave and x-ray portions of the electromagnetic spectrum, sufficient for visualization. In some non-limiting examples, the radiopaque agent can include barium, iodine, iron oxide nanoparticles, gadolinium complex nanospheres, silica nanospheres, and combinations thereof.

[0047] 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.

[0048] 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 an ingredient 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 include 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 changes in pH 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.

[0049] 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 be significantly changed by adding an equimolar amount of a strong acid or a strong base.

[0050] The buffer range of a buffer system is related to the acid dissociation constant (K) of one or more weak acids contained in the buffer system. a The term "acid dissociation constant" refers to the equilibrium constant for the dissociation reaction of an acid. The midpoint of the buffer range of a buffer system is usually about 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 .

[0051] 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.

[0052] 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.

[0053] The article according to the present disclosure includes a sealing body that 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 is to reduce the 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 when compressed, at least a portion of the irrigation fluid contained therein is distributed. It should be understood that, as used herein, "distribution" (or "discharge") can refer to transferring the irrigation fluid to an application member that is fluidly connected to the sealing body, and / or can refer to transferring the irrigation fluid from the application member to the surface.

[0054] According to some aspects, the sealing body can be shrinkable. As used herein, the term "shrinkable" is used in its common and common manner, and refers to the ability of permanent volume reduction. For example, when a first volume of fluid is contained therein, a shrinkable sealing body as described herein can have a first volume. When at least a portion of the fluid is dispensed, the shrinkable sealing body can shrink to have a second volume that is less than the first volume. It should be understood that the shrinkable sealing body will advantageously reduce unused volume (e.g., the volume of the body after the fluid therein has been dispensed). The shrinkable sealing body can further provide more effective fluid discharge.

[0055] In some aspects, the sealing body can be configured to allow at least a 10% volume reduction when compressed and / or contracted, optionally at least a 20% volume reduction, optionally at least a 30% volume reduction, optionally at least a 40% volume reduction, optionally at least a 50% volume reduction, optionally at least a 60% volume reduction, optionally at least a 70% volume reduction, optionally at least an 80% volume reduction, and optionally at least a 90% volume reduction.

[0056] 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.

[0057] According to some aspects, the body material can be sufficient to prevent unacceptable vapor loss or chemical loss in the irrigation fluid contained therein over a certain shelf life. It should be understood that "unacceptable vapor loss or chemical loss" can be a loss that causes the irrigation fluid to become unsuitable for its intended use. For example, the vapor loss or chemical loss can be caused by adsorption or absorption of the chemical by the material (e.g., by the body material), evaporation of the solution, evaporation of the solution component (e.g., the disinfectant of the disinfection solution), or a combination thereof. In a non-limiting example, where the irrigation fluid comprises water and iodine as described herein, the body material can be sufficient to prevent water vapor loss and / or iodine loss over a certain shelf life.

[0058] 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 keeping the product 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 after storage under long-term storage conditions, 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 in the product, the pH value of the product, and / or the sterility of the product. 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 after storage at 37°C and 65% relative humidity, the color change of the product, the concentration of insoluble particles in the product, the effectiveness of the product active agent, the concentration of one or more ingredients in the product, the pH value of the product, and / or the sterility of the product. Additionally or alternatively, shelf life can be determined by measuring the concentration of impurities in the product after storage at a temperature between about 15°C and 30°C (with fluctuations at a temperature not exceeding about 40°C), color change of the product, concentration of insoluble particles in the product, potency of the product active agent, concentration of one or more ingredients in the product, pH of the product and / or sterility of the product.

[0059] 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.

[0060] According to some aspects, the subject material can be sufficiently sterilized 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., sterile filtration and / or blow-fill-seal operations), and combinations thereof. Preferably, the subject material can be sufficiently sterilized 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 or otherwise render the irrigation fluid unsuitable for medical use as a result of the gamma radiation process. According to some aspects, if the container containing the subject material has at least 10 -6 The body material can be determined to be adequately sterilizable if the body meets a sterilization assurance level (SAL) and provides acceptable results when the integrity of the container closure is tested after sterilization.

[0061] According to some aspects, the body material can have sufficient mechanical strength so that the body 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 Shipping Containers and Systems), ASTM D4728-06 (Standard Test Method for Random Vibration Testing of Shipping Containers), ASTM D642-15 (Standard Test Method for Determining the Compressive Capacity of Shipping Containers, Components, and Unit Loads), or any combination thereof. According to some aspects, the body material can be safe for biomedical use. For example, the body material can comply with ISO 10993 and / or REACH requirements. According to some aspects, the body material can be sufficient to exhibit at least some of the properties described herein at a temperature between about 15°C and 30°C for a period of time over the shelf life of the irrigation fluid, and with fluctuations at a temperature not exceeding about 40°C. Additionally or alternatively, the body material can be sufficient to exhibit at least some of the properties described herein for a period of time over the shelf life of the irrigation fluid after storage at about 25°C and 60% relative humidity. Additionally or alternatively, the subject material may be sufficient to exhibit at least some of the properties described herein over a period of the shelf life of the irrigation fluid following storage at approximately 37°C and 65% relative humidity.

[0062] The body material may be rigid or flexible. As used herein, the term "rigid" refers to a degree of 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.

[0063] Exemplary host materials include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Exemplary 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.

[0064] According to some aspects, the body material can be polypropylene. Preferably, the body material can be radiation grade polypropylene. Herein, 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 undergo 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 using the irrigation fluid already present inside the sealed body.

[0065] 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. Herein, the sealing body maintains its ability to bend or compress under normal operating forces. The sealing body according to the present invention 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.

[0066] According to some aspects, the sealing body may undergo certain material property changes when subjected to gamma radiation, which can help reduce the stretching of the sealing body when the application member creates a breach in the sealing body, as will be described herein. The reduction in the stretching of the sealing body allows the application member to easily create a breach in the sealing body, as will be described herein.

[0067] According to some aspects, such as Figure 1 As shown, the sealing body 11 includes a wall that is configured to be destroyed to facilitate the discharge of the irrigation fluid contained therein. In some embodiments, the wall is configured to form a fluid delivery port when destroyed. According to some aspects, the application member 14 creates a destruction 18 in the wall of the sealing body to facilitate the discharge of the irrigation fluid contained in the sealing body. In some embodiments, the application member creates a destruction in the wall of the sealing body, such as an incision, puncture, hole or slit.

[0068] According to some aspects, the sealing body containing the irrigation fluid can have a variation in the thickness of the wall of the sealing body. In particular, one or more wall portions of the sealing body can have a different thickness compared to the thickness of other wall portions of the sealing body or other walls of the sealing body. Preferably, the wall configured to form a fluid delivery port when broken has a wall portion of a different thickness compared to the thickness of other wall portions of the sealing body or other walls of the sealing body. Preferably, the thickness of the wall portion configured to form a fluid delivery port when broken can be smaller than other wall portions of the body or other walls of the body. The thickness of described wall section can be 95% at most of the thickness of other wall section or other wall, optionally 90% at most, optionally 85% at most, optionally 80% at most, optionally 75% at most, optionally 70% at most, optionally 65% ​​at most, optionally 60% at most, optionally 55% at most, optionally 50% at most, optionally 45% at most, optionally 40% at most, optionally 35% at most, optionally 30% at most, and optionally 25% at most of the thickness of other wall section or other wall.As mentioned above, the wall section with less thickness can be the top wall section, bottom wall section or the sidewall section of sealing body.Preferably, as mentioned above, the wall section with less thickness can be the bottom wall section of sealing body relative to ground.The reduction of wall section thickness allows the application member of sealing body outside to easily produce destruction in sealing body.Preferably, the trapped gas is under the pressure higher than atmospheric pressure.The trapped gas can include air and / or inert gas, such as nitrogen.

[0069] According to some aspects, a wall configured to form a fluid delivery port when broken includes a first portion and a second portion, wherein the first portion has a reduced thickness compared to the second portion. According to some aspects, such as Figure 1 As shown, the fluid delivery port is formed in the first portion 19 of the wall of the sealing body. Figure 3 As shown, the fluid delivery port 31 is formed upon the destruction of a first portion 32 of the wall of the sealing body, wherein the destruction is caused by the application member to facilitate the discharge of the irrigation fluid, and the second portion of the wall is indicated as 33. In some embodiments, the destruction of the first portion of the wall of the sealing body creates the fluid delivery port, thereby causing the formation of a fluid path for discharging the irrigation fluid.

[0070] In some embodiments, the wall configured to form a fluid delivery port when destroyed further includes a lancet port, wherein the lancet port is located in the first portion of the wall. In some embodiments, the application member destroys the lancet port by creating an incision, puncture, hole or slit in the lancet port to produce a fluid delivery port, thereby facilitating the discharge of the irrigation fluid. In some embodiments, the destruction of the lancet port produces a fluid delivery port, thereby causing the formation of a fluid path for discharging the irrigation fluid. In some embodiments, the lancet port further includes a flexible membrane. Preferably, the flexible membrane includes an elastic disc. In particular, the elastic disc is made of materials including but not limited to silicone, thermoplastic polyurethane (TPU), nylon and polyvinylidene fluoride (PVDF).

[0071] According to some aspects, such as Figure 6 As shown, the sealing body 61 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, when placed on a surface, one of the walls of the sealing body supports the rest of the sealing body to provide a stable position for an individual to use an application member to create a breach in the sealing body to facilitate the discharge of irrigation fluid. For example, an individual can easily place the self-supporting sealing body on a table and stably create a breach with the application member. In some embodiments, the sealing body is self-supporting before and during the discharge of irrigation fluid from the sealing body.

[0072] According to some aspects, the sealing body can be marked to indicate a location on the sealing body where the sealing body is configured to be broken by the application member, for example, a break in the sealing body produced by an individual using the application member. According to some aspects, the sealing body is marked using a process selected from the group consisting of embossing, engraving, marking, etc.

[0073] The sealing body according to the present disclosure is configured to distribute an irrigation fluid, such as a flushing solution, contained therein via one or more mechanisms. According to some aspects, the sealing body can be configured to distribute the irrigation fluid upon compression as described herein. For example, the sealing body can be configured to distribute at least a portion of the irrigation fluid contained therein 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 therein in response to longitudinal compression.

[0074] Additionally or alternatively, the sealing body can be configured to dispense at least a portion of the irrigation fluid contained therein when the sealing body is oriented in a certain orientation. Preferably, the application member creates a disruption in the sealing body, such as an incision, puncture, hole or slit, through which the irrigation fluid can be dispensed. The sealing body can be configured such that when disposed in a certain orientation (e.g., wherein the disruption created by the application member is disposed 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.

[0075] It should be understood that the sealing body can be configured to distribute irrigation fluid via a combination of one or more mechanisms 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 mechanisms described herein. In a non-limiting example, the sealing body can be configured to distribute irrigation fluid when compressed with and without external force. 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 speed, desired fluid flow design (e.g., pulsed or constant) or a combination thereof.

[0076] According to some aspects, the sealing body can be configured to dispense at least about 75% of the irrigation fluid contained therein, optionally at least about 80%, optionally at least about 85%, optionally at least about 90%, optionally at least about 95%, and optionally about 100%. The sealing body can be configured to continuously dispense irrigation fluid and / or 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.

[0077] The sealing body can be configured to hold 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 hold between about 250mL and 2000mL of fluid, and optionally between about 500mL and 1000mL. According to some aspects, the sealing body can be configured to hold about 500mL of fluid. According to some aspects, the sealing body can be configured to hold about 1L of fluid.

[0078] According to some aspects, the application member creates a disruption in the sealing body to facilitate the discharge of irrigation fluid through the fluid path. Herein, the irrigation fluid is discharged through the fluid path in a specific flow pattern. According to some aspects, the shape and size of the disruption created by the application member determines the flow pattern of the irrigation fluid from the sealing body.

[0079] 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.

[0080] According to some aspects, the flow pattern of the irrigation fluid is described as the irrigation fluid being discharged in a jet wave of a certain area. According to some aspects, the irrigation fluid is discharged from the sealing body in a jet 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 jet wave can be any shape.

[0081] 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.

[0082] like Figure 1 As shown, the article according to the present disclosure further includes an application member 14, which is configured to generate a rupture 18 in the sealing body 11 to facilitate the discharge of the irrigation fluid through the fluid path. According to some aspects, the application member includes a tubular structure 15, which includes a first end and a second end. According to some aspects, the first end of the application member includes a needle 16 to generate the rupture 18 in the sealing body. According to some aspects, the second end of the application member includes an injection gun 17 to facilitate the discharge of the irrigation fluid.

[0083] In some embodiments, Figure 2 As shown, the application member 24 further includes a connector 21 to facilitate connecting a single application member 24 to more than one sealing body 22 and 23. In some embodiments, the first end of the application member 24 includes more than one spike 25 and 26 to facilitate connecting a single application member 24 to more than one sealing body 22 and 23. For example, the application member 24 includes two spikes 25 and 26 on the first end of the application member, wherein the spike A25 creates a break in the sealing body A22, and the spike B26 creates a break in the sealing body B23, and wherein the connector 21 facilitates connecting a single application member 24 to two sealing bodies 22 and 23 containing irrigation fluid.

[0084] According to some aspects, such as Figure 4As shown, the application member includes a lancet cap 41. The lancet cap is configured to damage the wall of the sealing body to facilitate the discharge of the irrigation fluid contained in the sealing body. Herein, when the lancet cap is attached to the sealing body, the lancet of the lancet cap creates a damage on the wall of the sealing body to ensure that the irrigation fluid is discharged through the fluid path 43 created thereby. According to some aspects, the lancet cap includes a lancet geometry 42. The lancet geometry determines the shape of the lancet, which will create a damage in the wall of the sealing body. According to some aspects, as Figure 8 As shown, the lancet geometry includes a beveled tip 82 or an aligned tip 81. In this context, the lancet geometry determines the flow pattern of the irrigation fluid discharged from the seal body through the fluid path, as described herein. The lancet geometry also determines the force required for an individual to pierce the wall of the seal body to pierce the seal body by attaching the lancet cap to the wall of the seal body to facilitate the discharge of the irrigation fluid.

[0085] According to some aspects, such as Figure 7 As shown, the sealing body may further include a sawtooth thread 71 on the wall, which is configured to form a fluid delivery port when broken. According to some aspects, the lancet cap may further include a sawtooth thread on the first end of the lancet cap. Herein, the sawtooth thread comprising the wall of the sealing body and the sawtooth thread comprising the end of the lancet cap are attached to each other, or screwed together or threaded together to ensure that the lancet cap creates a break in the wall of the sealing body for discharging irrigation fluid.

[0086] According to some aspects, when the lancet cap is attached to the wall of the sealing body, the lancet cap with a beveled tip facilitates the process of creating a break in the wall of the sealing body, wherein the beveled tip penetrates a selected location on the wall of the sealing body to create a fluid delivery port. According to some aspects, when the lancet cap is attached to the wall of the sealing body, the lancet cap with an aligned tip coordinates the breaking process with the threading process.

[0087] According to some aspects, more than one lancet cap may be provided. According to some aspects, lancet caps having different lancet geometries are provided as needed to achieve different flow patterns of the irrigation fluid.

[0088] According to some aspects, the needles of the application member include a specific material, wherein the material has the ability to utilize its own sharp edges, thereby eliminating metal sharps that pose a risk in the care environment. According to some aspects, the needles of the application member are made of a plastic material. In particular, the flow regulating member can be made of plastic, 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).

[0089] 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 an 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.

[0090] According to some aspects, the lancet of the application member may further include a vent hole to ventilate the lancet. In some embodiments, the application member includes a venting lancet that compresses a sealing body, wherein the sealing body is configured such that irrigation fluid is expelled when the sealing body is compressed.

[0091] According to some aspects, the application member includes a non-vented lancet that allows the seal body to collapse, wherein the seal body is configured such that when irrigation fluid is expelled from the seal body, the seal body collapses upon itself.

[0092] According to some aspects, the applicator member is integral with an article comprising a sealing body. According to some aspects, the applicator member is in fluid communication with the sealing body during drainage of irrigation fluid from the sealing body, wherein the applicator member creates a fluid delivery port and a fluid path for drainage of irrigation fluid.

[0093] According to some aspects, the application member comprises a specific material. According to some aspects, the application member is made of a plastic material. In particular, the flow conditioning member can be made of plastic, 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).

[0094] 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 an 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.

[0095] According to some aspects, such as Figure 1 As shown, the sealing body may further include a notch 13 on the first end 12 of the sealing body 11. According to some aspects, Figure 5 Further shown is an indentation 51 that covers the entire length of the sealing body. The indentation on the sealing body can assist in the contraction of the sealing body. For example, the presence of the indentation on the sealing body assists in the contraction of the sealing body itself when the irrigation fluid is discharged, wherein the indentation assists the sealing body itself to contract evenly. According to some aspects, the indentation on the sealing body can assist in providing a grip for an individual holding the sealing body to perform the actions required for the irrigation process. For example, the presence of the indentation on the sealing body provides a grip for an individual holding the sealing body and placing it on a surface; provides a grip for an individual holding the sealing body and destroying the sealing body with an application member; and provides a grip for an individual holding the sealing body together with an application member when applying irrigation fluid to a selected surface.

[0096] 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.

[0097] According to some aspects, the article may further include a frame separate from the article of the present invention. When the sealing body is filled with irrigation fluid, the frame can help maintain the shape of the sealing body during the period when the sealing body contains the irrigation fluid, and when the irrigation fluid is dispensed from the sealing body. According to one aspect of the present invention, the frame can be retractable, wherein the frame can shrink itself when the irrigation fluid is discharged from the sealing body. Therefore, when the irrigation fluid is discharged from the sealing body, the frame can contribute to the gradual and complete contraction of the sealing body. According to one aspect of the present invention, the frame can help maintain the integrity of the sealing body, especially supporting the bottom section or edge / corner of the sealing body. According to another aspect of the present invention, the frame is separated from the article of the present invention and the sealing body, wherein the frame can be present on the outside of the sealing body or on the inside of the sealing body.

[0098] According to some aspects, the article 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 to a human body) during an irrigation process. As described herein, the fluid flow rate can depend at least in part on the characteristics of the delivery mechanism and / or the application member. 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. Articles according to the present invention can be configured to provide different, selectable fluid flow rates.

[0099] According to some aspects, the article 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 of a fluid acting on a surface (such as a human body) during an irrigation process. The acceptable fluid flow force can be determined based on the irrigation process requirements.

[0100] It should be understood that the fluid flow forces provided by the articles described herein may depend at least in part on the characteristics of the delivery mechanisms and / or application members described herein. Articles according to the present invention can be configured to provide different, selectable fluid flow forces. It should be understood that each selectable fluid flow force can correspond to, for example, a specific delivery mechanism, a specific application member, or a combination thereof described herein.

[0101] According to some aspects, the article is configured to provide an acceptable fluid flow design for an irrigation process. As used herein, the term "fluid flow design" refers to a design by which a fluid is dispensed from a device and / or applied to a surface (such as to a human body) during an irrigation process. In some non-limiting examples, the fluid flow design may 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 jet (i.e., a finely divided fluid), or a combination thereof. The fluid flow design may be constant (e.g., the fluid is continuously dispensed from the device and / or applied to the surface) or pulsed (e.g., the fluid is intermittently dispensed from the device and / or applied to the surface).

[0102] Fluid flow design may additionally or alternatively refer to the angle at which the fluid flow path is dispensed from the device and / or applied to the surface. For example, the fluid flow path may have a fluid flow design that is substantially perpendicular to the longitudinal axis of the sealing body as described herein.

[0103] Additionally or alternatively, fluid flow design can refer to the geometric configuration of the fluid path. It should be understood that the geometric configuration of the fluid path refers to the shape defined by the cross-sectional view of the fluid flow path in any direction of the x-direction, y-direction, and z-direction. It should be understood that the fluid flow design can depend at least in part on the delivery mechanism and / or flow regulation member described herein.

[0104] According to some aspects, one or more components of the article described herein can be provided in a sterile package. As used herein, the term "sterile package" refers to a package that provides a sterile environment to maintain the sterility of the sterile product contained. Examples of sterile packages include, but are not limited to, sterile blister packages, 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 article can be provided in the same sterile package and / or in a sterile package separated from at least one other component of the article. For example, the first component of the article can be contained in a first sterile package, and the second component of the article can be contained in a second sterile package. In a non-limiting example, the article can include a sealed body contained in a first sterile package and an application member contained in a second sterile package. It should be understood that providing one or more components of the article in different sterile packages allows each component of the article to be removed immediately before use, thereby preventing one or more components from being exposed to an unsterilized environment for a long time. In this way, the fully assembled sterile presentation of the article can be achieved.

[0105] According to some aspects, the present invention includes a method of applying an irrigation fluid to a surface, wherein the method includes providing a sealing body containing an irrigation fluid, and providing an application member including a spike, and further wherein the sealing body and the irrigation fluid contained therein are terminally sterilized. The method further includes disrupting a wall of the sealing body with the spike of the application member, wherein a certain force promotes the expulsion of the irrigation fluid from the sealing body. The expelled irrigation fluid is then applied to a selected surface using the application member.

[0106] According to some aspects, the certain force that promotes the discharge of irrigation fluid from the sealing body includes pressure, gravity, internal force, external force, vacuum, etc.

[0107] According to some aspects, the application member includes a venting spike, wherein the presence of a vent in the spike of the application member renders the sealing body compressible. Herein, the compressible sealing body is configured such that irrigation fluid is expelled from the sealing body upon compression of the sealing body. In some embodiments, the presence of the vent in the spike of the application member renders the sealing body self-supporting before, during, and after expelling the irrigation fluid.

[0108] According to some aspects, the application member includes a non-vented needle, wherein the absence of a vent hole in the needle of the application member allows the sealing body to be collapsible. Herein, the collapsible sealing body is configured such that when the irrigation fluid is discharged from the sealing body, the sealing body itself collapses. In some embodiments, the absence of a vent hole in the needle of the application member allows the sealing body to be self-supporting before and after the irrigation fluid is discharged.

[0109] Although the aspects described herein have been described in conjunction with the example aspects outlined above, various substitutions, modifications, variations, improvements, and / or substantial equivalents, whether known or currently unforeseen or possibly unforeseen, may be apparent to a person having at least ordinary skill in the art. Therefore, as described above, the example aspects are intended to be illustrative, not 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 substitutions, modifications, variations, improvements, and / or substantial equivalents.

[0110] Therefore, the claims are not intended to be limited to the aspects shown herein, but are to be consistent with the full scope consistent with the language of the claims, wherein, unless otherwise stated, an element in the singular form is not intended to mean "one and only one", but rather "one or more". All structural and functional equivalents of the elements of the various aspects described in 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 included in the claims. In addition, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is explicitly listed in the claims. No claim element is to be interpreted as a tool plus function unless the element is explicitly stated using the phrase "tool for".

[0111] In addition, the word "example" is used herein to mean "used as an example, instance, or illustration". Any aspect described herein as an "example" is not necessarily to be construed as being preferred or advantageous over other aspects. Unless otherwise specified, the term "some" refers to one or more. Combinations such as "at least one of A, B, or C", "at least one of A, B, and C", and "A, B, C, or any combination thereof" include any combination of A, B, and / or C, and may include multiples of A, multiples of B, or multiples of C. Specifically, combinations such as "at least one of A, B, or C", "at least one of A, B, and C", and "A, B, C, or any combination thereof" may include 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 components or one or more components of A, B, or C. Nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is explicitly stated in the claims.

[0112] As used herein, the word “approximately” means 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. An article comprising a sealing body for containing an irrigation fluid, in, The sealing body and the irrigation fluid contained therein are terminally sterilized; wherein the sealing body includes a wall configured to form a fluid delivery port when breached to facilitate drainage of the irrigation fluid in a flow pattern; wherein the sealing body is self-supporting before and during expulsion of the irrigation fluid; and Wherein, when the irrigation fluid is discharged from the sealing body, the sealing body itself contracts.

2. The article according to claim 1, wherein The wall includes a first portion and a second portion, the first portion having a reduced thickness compared to the second portion, and wherein the fluid delivery port is formed in the first portion.

3. A system comprising the article of claim 1 and an application member, in, The application member is configured to disrupt a wall of the sealing body to form the fluid delivery port and create a fluid path for draining the irrigation fluid.

4. The article according to claim 2, wherein: a lancet port located in said first portion; Wherein, the lancet port is configured to be destroyed to form the fluid delivery port.

5. The article according to claim 4, wherein The lancet port includes a flexible membrane.

6. The article according to claim 5, wherein The flexible membrane comprises a resilient disc.

7. The system according to claim 3, wherein: The application member comprises a tubular structure including a first end and a second end, wherein the first end of the tubular object comprises a lancet; and The second end of the tubular object comprises an injection gun.

8. The system according to claim 7, wherein: The application member further comprises a connector connected to one or more sealing bodies, wherein the first end of the tubular comprises at least two spikes.

9. The system according to claim 3, wherein: The application member comprises a lancet cap, Wherein, the puncture needle cap comprises a puncture needle geometric structure.

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

11. The system according to claim 10, wherein: The lancet cap includes buttress threads attached to buttress threads on a wall of the sealing body.

12. The system according to claim 9, wherein: The lancet geometry includes a beveled tip.

13. The system according to claim 9, wherein: The lancet geometry includes an alignment tip.

14. The system according to claim 3, wherein: The applicator member is in fluid communication with the sealing body during expulsion of the irrigation fluid.

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

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

17. The article of claim 1, wherein: The flow mode includes discharging the irrigation fluid at a pressure of less than 15 psi.

18. The article of claim 1, wherein: The flow pattern includes expelling irrigation fluid in a 6 inch square jet wave.

19. The system of claim 3, wherein: The application member is made of a material selected from the group consisting of plastics, metals and alloys.

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

21. The article of claim 1, wherein: The sealed body and the irrigation fluid contained therein are terminally sterilized by gamma radiation.

22. The system of claim 3, wherein: The applicator member punctures the wall, wherein the shape and size of the puncture determines the flow pattern of the irrigation fluid.

23. The article of claim 1, wherein: The sealing body further includes an indentation on the first end of the sealing body.

24. A method of applying an irrigation fluid to a surface, the method comprising: providing a sealed body containing an irrigation fluid, and an application member including a non-vented lancet; disrupting a wall of the sealed body with a non-vented lancet of an application member; wherein a force assists in expelling the irrigation fluid from the sealing body, wherein the force comprises a vacuum degree; and applying the discharged irrigation fluid to a selected surface with an applicator member; wherein the sealing body is collapsible and is configured such that when the irrigation fluid is discharged from the sealing body, the sealing body itself collapses; wherein the sealing body is self-supporting before and during expulsion of the irrigation fluid; and Wherein, the sealing body and the irrigation fluid contained therein are terminally sterilized.

25. A method of applying an irrigation fluid to a surface, the method comprising: providing a sealing body containing an irrigation fluid, and an application member including a ventilation lancet; destroying a wall of the sealing body with a venting spike of the application member; wherein a force assists in expelling the irrigation fluid from the sealing body, wherein the force comprises internal pressure; and applying the discharged irrigation fluid to a selected surface with an applicator member; wherein the sealing body is compressible and configured such that upon compression of the sealing body, at least a portion of the irrigation fluid is expelled through the application member; wherein the sealing body is self-supporting before, during and after expelling the irrigation fluid; and Wherein, the sealing body and the irrigation fluid contained therein are terminally sterilized.

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