Universal adapter for auxiliary and manual delivery

Abstract

An adapter, the adapter having: a connection portion connectable to a fluid container; a first fluid flow path having a first end and a second end, the first end configured to provide fluid communication with the fluid container, and the second end having a fluid outlet; at least one valve disposed along the first fluid flow path; and a second fluid flow path separate from the first fluid flow path, the at least one valve configured to provide a selection between auxiliary fluid delivery and manual fluid delivery. Systems, kits, and methods including the adapters are also described.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to an adapter usable with a fluid container to provide at least two selectable modes of fluid delivery. BACKGROUND

[0002] Intraoperative incision irrigation is a recognized method to help prevent surgical site infections (SSIs). For such procedures, irrigation is typically performed via one of two methods: manual (i.e., direct instillation, bulb syringe, etc.) or assisted (i.e., via a powered lavage device to deliver the solution).

[0003] In the assisted delivery method, the solution is typically present in a fluid container suspended on an intravenous (IV) pole in a non-sterile field, while the pulsatile lavage device operates in the sterile field. The fluid container is stored outside the sterile field, primarily because of limited space within the sterile field, but also to reduce clutter near the surgical cavity.

[0004] In the manual delivery method, the healthcare practitioner typically applies manual pressure to a compressible fluid container in order to deliver the irrigation fluid to the surgical cavity.

[0005] The choice of manual delivery or assisted delivery is often determined by surgeon preference and the specifics of the procedure. While some healthcare practitioners believe that assisted delivery can be detrimental to patient health (e.g., by pushing bacteria deeper into the wound or damaging tissue), other surgeons believe that assisted delivery offers advantages such as higher consistency and more thorough debridement of the surgical cavity. Depending on the specific surgical situation, a significant number of surgeons also prefer to use both manual and assisted delivery in their practices.

[0006] Manual delivery is typically accomplished using a device that interfaces with the irrigation fluid container by piercing the container. These devices typically have a relatively simple design, which is deficient in several respects. For example, after manually compressing the fluid container, the compression force is released and the container is allowed to relax toward its original shape geometry. During the relaxation phase, air is drawn back into the container, allowing the container to be compressed again to expel more fluid. However, typical devices usable with such containers allow the container shape to be restored with air traveling through the fluid passageway, which can introduce contaminants into the irrigation fluid itself or into the fluid passageway.

[0007] Assisted delivery is typically performed by piercing a fluid container with a device to create a fluid pathway. However, such devices cannot be used without a flush device, and thus, once the device pierces the fluid container, fluid cannot be manually delivered. As a result, healthcare providers need to stock both types of devices (i.e., devices designed for manual delivery and devices designed for assisted delivery). Current devices also limit delivery of fluid from each fluid container to a single delivery mode. SUMMARY

[0008] An adapter is disclosed herein having a connection portion connectable to a fluid container, a first fluid flow path having a first end configured to provide fluid communication with the fluid container and a second end including a fluid outlet, at least one valve disposed along the first fluid flow path, and a second fluid flow path separate from the first fluid flow path, wherein the at least one valve is configured to provide a selection between assisted fluid delivery and manual fluid delivery. Kits and systems having adapters as described herein are also described. BRIEF DESCRIPTION OF DRAWINGS

[0009] Figure 1A An example adapter is shown in accordance with aspects of the present disclosure.

[0010] Figure 1B An example adapter is shown in accordance with aspects of the present disclosure.

[0011] Figure 1C An example vent housing is shown in accordance with aspects of the present disclosure.

[0012] Figure 2 An example adapter having a valve is shown in accordance with aspects of the present disclosure.

[0013] Figure 3 An example cross-slit valve is shown in accordance with aspects of the present disclosure. DETAILED DESCRIPTION

[0014] The present disclosure relates to an adapter that can be used with a fluid container to provide at least two selectable fluid delivery modes. According to some aspects, the adapter can be configured to provide assisted fluid delivery and manual fluid delivery via a single fluid container. The adapter can include a connection portion, a first fluid flow path, a second fluid flow path, a fluid outlet, and at least one valve disposed along the first fluid flow path. The present disclosure also relates to kits and systems having adapters and fluid containers as described herein.

[0015] The adapters of the present disclosure can be used with a fluid container. As used herein, the term "fluid" refers to a substance that does not have a fixed shape, such as a liquid or a gas. In some non-limiting examples, the fluid is an irrigation fluid. As used herein, the term "irrigation fluid" refers to a fluid suitable for an irrigation procedure as described herein. As used herein, "irrigation" refers to the flushing of a body cavity, a surgical cavity, and / or an external wound.

[0016] According to some aspects, the irrigation fluid can include a disinfecting solution. As used herein, "disinfecting solution" refers to a solution containing at least one solvent and one or more disinfectants. According to some aspects, the disinfecting solution is an aqueous solution. As used herein, the term "aqueous solution" refers to a solution in which the solvent contains at least a majority of water. It will be appreciated that in some examples, the solvent can consist of water. According to some aspects, the disinfecting solution is an alcoholic solution. As used herein, the term "alcoholic solution" refers to a solution in which the solvent contains at least a majority of alcohol. It will be appreciated that in some examples, the solvent can consist of one or more alcohols. Non-limiting examples of alcohols include, but are not limited to, ethanol, isopropyl alcohol, n-propanol, and combinations thereof.

[0017] In one non-limiting example, the disinfectant can include a cationic molecule (i.e., a molecule with a positive charge), such as a cationic surfactant or a cationic biguanide derivative (i.e., a compound derived from a biguanide). According to some aspects, the disinfectant can include a bis- (dihydropyridinyl) -decane derivative (i.e., a compound derived from a bis- (dihydropyridinyl) -decane). According to some aspects, the disinfectant can include an octenidine salt, a quaternary ammonium salt, and / or a chlorhexidine salt. According to some aspects, the disinfectant can include alexidine, octenidine dihydrochloride, chlorhexidine gluconate, sodium lauryl sulfate, citric acid, sodium citrate, benzalkonium chloride, polyaminopropyl biguanide, or combinations thereof.

[0018] Additionally or alternatively, the disinfectant can include iodine. According to some aspects, the iodine can be provided as an iodine complex, such as povidone-iodine (PVPI), nonoxynol- (ethyleneoxy) -iodine, polyethylenoxypolypropylenoxyl-iodine, undecyl chloro-iodine, iodophor, and combinations thereof.

[0019] Additionally or alternatively, the disinfectant can include an oxidizing agent (i.e., an oxidizing reagent). Non-limiting examples of oxidizing agents according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, hypochlorous acid, and combinations thereof.

[0020] The disinfectant can have sufficient antibacterial activity to provide an acceptable pathogenic microorganism log reduction in a specified time period. It will be appreciated that, as used herein, the term "pathogenic microorganism" can refer to any microorganism killed and / or removed as a result of the lavage. Example pathogenic microorganisms include bacteria, fungi, viruses, and combinations thereof.

[0021] Example bacteria include, but are not limited to, Streptococcus mutans, Streptococcus pyogenes (Group A beta-hemolytic Streptococcus), Streptococcus salivarius, Streptococcus sanguis, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus hemolyticus, Staphylococcus hominis, Staphylococcus simulans, Staphylococcus saprophyticus, Methicillin / oxacillin-resistant Staphylococcus aureus (MRSA / ORSA) and Methicillin / oxacillin-sensitive Staphylococcus aureus (MSSA / OSSA), Enterococcus (e.g., Enterococcus faecalis, Enterococcus faecium, and Enterococcus hirae), Vancomycin-resistant Enterococcus (VRE) and Vancomycin-sensitive Enterococcus (VSE), Bacteroides fragilis, Propionibacterium acnes, Clostridium difficile (spores and vegetative cells), Selenomonas, Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Gardnerella vaginalis, Klebsiella aerogenes, Klebsiella pneumoniae, multi-drug resistant (MDR) Klebsiella pneumoniae, Acinetobacter baumannii, MDR Acinetobacter baumannii, Acidovorax, Micrococcus luteus, Ralstonia pickettii, Haemophilus influenzae, and Serratia marcescens.

[0022] Example fungi include, but are not limited to, Aspergillus niger, Candida albicans, Candida auris, Candida dubliniensis, Candida glabrata (formerly Candida lipolytica), Candida guilliermondii, Candida kefyr (formerly Candida tropicalis), Candida krusei, Candida lusitaniae, Candida tropicalis, Epidermophyton floccosum, Microsporum gypseum, Microsporum canis, and Trichophyton mentagrophytes.

[0023] Example viruses include, but are not limited to, viruses having a lipid component in their outer coat or having an outer 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, smallpox virus, vaccinia virus, norovirus, and coronavirus.

[0024] According to some aspects, the specified time period can 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.

[0025] According to some aspects, the particular time period can 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.

[0026] It should be appreciated that the "acceptable log reduction" can depend on the microorganism. For example, the acceptable log reduction as described herein can 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.

[0027] According to some aspects, the acceptable log reduction can 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, 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.

[0028] According to some aspects, disinfectants can be present in disinfectant solutions at sufficient concentrations to provide an acceptable reduction in microbial logs over a specific time period as described herein. According to some aspects, the disinfectant may be present in the disinfectant solution at a concentration between about 0.001% and 15% w / v, optionally between about 0.001% and 10% 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 0.01%, optionally between about 0.01% and 5%, optionally between about 0.01% and 2.5%, 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. According to some sources, the disinfectant may be present in the disinfectant solution at a concentration between about 0.001% and 20% w / v, optionally between about 1.0% and 20% w / v, optionally between about 10% and 20% w / v, and optionally about 15% w / v.

[0029] According to some sources, disinfectants can be present in disinfectant solutions at concentrations 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.

[0030] According to some sources, disinfectants can be present in disinfectant solutions at concentrations 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.

[0031] In some non-limiting examples, once the container holding the disinfectant solution is opened, the disinfectant can act as a preservative by reducing or eliminating microbial contamination of the disinfectant solution.

[0032] It should be understood that, depending on some aspects, the irrigation fluid is not necessarily a disinfectant solution as described herein, but can be any medically acceptable fluid configured to perform the irrigation procedure as described herein. In a non-limiting example, the irrigation fluid may include a saline solution. The saline solution may include water and a medically acceptable concentration of sodium chloride, such that the acceptable concentration is, for example, between about 0.1% and 1% w / v, optionally about 0.45% w / v, and optionally about 0.9% w / v.

[0033] According to some aspects, the lavage fluid (such as the disinfecting solution described herein) can include a visualization aid. As used herein, the term "visualization aid" refers to an ingredient in the lavage fluid that is configured to aid in visualizing application of the lavage fluid. Example visualization agents include, but are not limited to, colorants, dyes, and radio-opaque agents. It should be appreciated that the visualization agent can be the same as or different from one of the other ingredients of the lavage fluid. For example, the disinfecting agent can function as the visualization agent. Additionally or alternatively, the lavage fluid can include a visualization agent that is different from the disinfecting agent.

[0034] According to some aspects, the lavage fluid can include a colorant. As used herein, the term "colorant" refers to an ingredient sufficient to provide an observable color to the fluid. The colorant can be sufficient to allow the lavage fluid to be visualized when applied to a surface. In some non-limiting examples, the colorant can include an anionic colorant, such as an anionic dye. The anionic dye can be any dye suitable for medical use, such as a dye approved by the Food and Drug Administration for use in food, drugs, and / or cosmetics (i.e., a "D&C" or "FD&C" dye). 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 (Allura Red), FD&C Yellow No. 5 (Tartrazine), 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 a particular color. For example, an orange tint can include FD&C Red No. 40 and D&C Yellow No. 8. Additionally or alternatively, the colorant can include a chemical compound that is observable when exposed to visible and / or non-visible light, including but not limited to vitamin B-12, medical honey, fluorescent polymer nanoparticles, water-soluble luminescent carbon nanodots, quinine, and combinations thereof.

[0035] According to some aspects, the lavage fluid (such as the disinfecting solution described herein) can include a dye. As used herein, the term "dye" refers to an ingredient sufficient to temporarily color or permanently color a surface that comes into contact therewith.

[0036] According to some aspects, the lavage fluid (such as the disinfecting solution described herein) can include a radio-opaque agent. As used herein, the term "radio-opaque agent" refers to an ingredient that is opaque to the x-ray portion and radio waves of the electromagnetic spectrum sufficient to be visualized. In some non-limiting examples, the radio-opaque agent can include barium, iodine, iron oxide nanoparticles, gadolinium complex nanospheres, silica nanospheres, and combinations thereof.

[0037] According to some aspects, the irrigation fluid (such as the disinfecting solution described herein) can be basic, neutral, or acidic. According to some aspects, the irrigation fluid can have a pH between about 1 and 8, optionally between about 1 and 7, optionally between about 1 and 6, and optionally between about 2 and 5.5.

[0038] According to some aspects, the irrigation fluid (such as the disinfecting 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 a significant change in pH caused by a strong acid or a strong base. The buffer system can include a single reagent or more than one reagent, such as a weak acid and its conjugate base. The buffer system can provide resistance to a significant change in pH by interacting with a strong acid or a strong base in the composition or solution, thereby at least partially preventing a significant change in the pH of the composition or solution.

[0039] Generally, a buffer system has one or more buffer ranges, where the buffer system has the ability to provide resistance to a significant change in pH. When the pH of a composition or solution having a buffer system is within the buffer range of the buffer system, the pH of the composition or solution does not significantly change upon the addition of an equimolar amount of a strong acid or a strong base.

[0040] The buffer range of a buffer system is related to the acid dissociation constant (Ka) of the weak acid(s) included in the buffer system. The term “acid dissociation constant” refers to the equilibrium constant for the dissociation reaction of an acid. The midpoint of the buffer range for a buffer system is generally about the logarithmic measure of the acid dissociation constant of the weak acid(s) included in the buffer system (i.e., pKa, equal to -log10Ka).

[0041] According to some aspects, the irrigation fluid (such as the disinfecting solution described herein) can include a stabilizer. As used herein, the term “stabilizer” refers to any ingredient that supports the stability of the irrigation fluid not otherwise explicitly described herein.

[0042] According to some aspects, the fluid container according to the present disclosure can include a body configured to contain a fluid as described herein. According to some aspects, the body can be compressible. As used herein, the term “compressible” refers to the ability to reversibly decrease volume without unacceptable changes, such as unacceptable permanent changes in size, shape, and / or one or more properties as described herein. According to some aspects, the body can be configured such that at least a portion of the fluid contained therein is dispensed upon compression. It should be understood that, as used herein, “dispensing” (or referred to as “discharging”) can refer to transferring the fluid to an adapter in fluid communication with the fluid container, and / or it can refer to transferring the fluid to a surface.

[0043] According to some aspects, the body can be collapsible. As used herein, the term "collapsible" refers to the ability to permanently decrease in volume. For example, a collapsible body as described herein can have a first volume when a first volume of fluid is contained therein. When at least a portion of the fluid is dispensed, the collapsible body can collapse to have a second volume, the second volume being less than the first volume. It will be appreciated that a collapsible body will advantageously reduce the volume of waste (e.g., the volume of the body after the fluid therein has been dispensed). A collapsible body can further provide for more efficient fluid discharge.

[0044] According to some aspects, the body can be configured to allow a volume reduction of at least 10%, optionally at least 20%, optionally at least 30%, optionally at least 40%, optionally at least 50%, optionally at least 60%, optionally at least 70%, optionally at least 80%, optionally at least 90%, and optionally at least 99% when compressed and / or collapsed.

[0045] According to some aspects, the body can comprise a body material that is compatible with the fluid contained therein, that is, a material that does not chemically or physically react with the fluid or otherwise render the fluid unsuitable for medical use.

[0046] According to some aspects, the body material can be sufficient to prevent unacceptable vapor or antiseptic loss of the fluid contained therein over a certain shelf life. It will be appreciated that "unacceptable vapor or antiseptic loss" can be a loss that results in the fluid becoming unsuitable for its intended use. Vapor or antiseptic loss can be caused by, for example, adsorption or absorption of the antiseptic by the material (e.g., the body material), evaporation of the solution, evaporation of a solution component (e.g., the antiseptic of an antiseptic solution), or a combination thereof. In one non-limiting example, where the 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.

[0047] As used herein, the term "shelf life" refers to the length of time a product (e.g., a disinfectant solution) can be stored while its form, suitability, and function remain within the required specifications. Shelf life can be determined by measuring certain characteristics of the product that may indicate it is unsuitable for medical use. For example, shelf life can be determined by measuring the concentration of impurities in the product, color changes in the product, the concentration of insoluble particles in the product, the potency of the active agents (e.g., disinfectants) contained in the product, the concentration of one or more components of the product, the pH 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 acceptedly stored for more than 72 hours. Depending on 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, shelf life can be determined by measuring the concentration of impurities in the product, color changes in the product, the concentration of insoluble particles in the product, the potency of the active agents in the product, the concentration of one or more components of the product, the pH of the product, and / or the sterility of the product after storage at 37°C and 65% relative humidity. Additionally or alternatively, shelf life can be determined by measuring the concentration of impurities in the product, color changes in the product, concentration of insoluble particles in the product, potency of the active agent in the product, concentration of one or more ingredients in the product, pH of the product, and / or sterility of the product after storage at approximately 15 to 30°C (with a temperature deviation not exceeding approximately 40°C).

[0048] Depending on some aspects, the retention period may be at least about 15 months, optionally at least about 16 months, optionally at least about 17 months, optionally at least about 18 months, optionally at least about 19 months, optionally at least about 20 months, optionally at least about 21 months, optionally at least about 22 months, optionally at least about 23 months, optionally at least about 24 months, optionally at least about 25 months, optionally at least about 26 months, optionally at least about 27 months, optionally at least about 28 months, optionally at least about 29 months, optionally at least about 30 months, optionally at least about 31 months, optionally at least about 32 months, optionally at least about 33 months, optionally at least about 34 months, optionally at least about 35 months, optionally at least about 36 months, optionally at least about 37 months, optionally at least about 38 months, optionally at least about 39 months, and optionally at least about 40 months.

[0049] According to some aspects, the body material can be adequately sterilized using any known sterilization technique useful according to this 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. According to some aspects, the body material can be determined to be adequately sterilized if the container containing the body material has a sterility assurance level (SAL) of at least 10⁻⁶ after sterilization and provides acceptable results when the container cap integrity test is performed after sterilization. According to some aspects, the body material can be determined to be adequately sterilized if the container containing the body material has a SAL of at least 10⁻³ after sterilization and provides acceptable results when the container cap integrity test is performed after sterilization.

[0050] According to some aspects, the body material may possess sufficient mechanical strength to provide an acceptable response to impact, vibration, shaking, or a combination thereof. According to some aspects, an acceptable response refers to a response conforming to 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 Compressive Strength of Marine Containers, Components, and Unit Loads), or any combination thereof. According to some aspects, the body material may be safe for biomedical applications. For example, the body material may conform to ISO 10993 and / or REACH requirements. According to some aspects, at temperatures between about 15°C and 30°C (with a temperature deviation not exceeding about 40°C), the body material may be sufficient to exhibit at least some of the characteristics described herein during a certain period of the fluid's shelf life. Additionally or alternatively, after storage at about 25°C and 60% relative humidity, the body material may be sufficient to exhibit at least some of the characteristics described herein during a certain period of the fluid's shelf life. Additionally or alternatively, after storage at approximately 37°C and 65% relative humidity, the host material may be sufficient to exhibit at least a portion of the characteristics described herein for a certain period of the fluid's shelf life.

[0051] The base material can be rigid or flexible. As used herein, the term "rigid" refers to 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.

[0052] Example host materials include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Example plastics useful in accordance with 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 lined and / or coated paper.

[0053] The present disclosure is directed to an adapter that can be used with a fluid container as described herein. According to some aspects, the adapter can include a connection portion configured to interact with a corresponding connection portion of a fluid container in order to provide a secure connection.

[0054] Figure 1A An example adapter 100 in accordance with aspects of the present disclosure is shown. As Figure 1A shown, the adapter 100 can include a connection portion 101. In some non-limiting examples, the connection portion 101 can include one or more protrusions configured to interact with corresponding protrusions of a fluid container in order to form a screw connection, allowing the adapter 100 to be tightened to the fluid container.

[0055] It should be appreciated, however, that the present disclosure is not necessarily limited to Figure 1A the examples shown. For example, in addition to or in place of protrusions, the connection portion 101 can include any connection means sufficient to provide a secure connection between the adapter and a fluid container. In some non-limiting examples, the connection portion 101 can be configured to provide a snap connection, a friction connection, or a combination thereof. According to some aspects, the connection portion 101 can be configured to provide a secure connection with commercially available fluid containers known in the art.

[0056] As Figure 1A shown, the adapter 100 can further include at least one spike element 104 at a first end of the first fluid flow path 102a. According to some aspects, the spike element 104 can be configured to pierce a membrane of a fluid container sufficient to provide fluid communication between the fluid container and the first fluid flow path 102a of the adapter 100. In some non-limiting examples, the spike element 104 can include one or more features of a spike interface as described in U.S. Provisional Patent Application No. 63 / 366,588, the disclosure of which is incorporated herein in its entirety.

[0057] It should be appreciated, however, that the adapter 100 is not necessarily limited in this manner. For example, the adapter 100 can be absent a spike element 104 so long as a corresponding end of the first fluid flow path 102a terminates in at least one aperture sufficient to provide fluid communication between the first fluid flow path 102a and a fluid container as described herein.

[0058] As Figure 1A shown, the adapter 100 can further include a second fluid flow path 102b configured to provide fluid communication between a fluid container and the atmosphere outside the fluid container when the fluid container is pierced, for example, by the lancet element 104 as described herein. In this way, the pressure within the fluid container can be equalized as fluid is dispensed from the fluid container.

[0059] According to some aspects, and as Figure 1A shown, the second fluid flow path 102b can include at least one vent 106, which can have one or more features described in U.S. Provisional Patent Application No. 63 / 366,588. For example, the vent 106 can be configured such that the vent 106 prevents contaminants from entering the fluid container when air or gas flows into the second fluid flow path 102b and thus into the fluid container. In one non-limiting example, the vent 106 can include a one-way valve or a membrane, such as a membrane that prevents liquid solutions from passing through the vent, while allowing air to move freely into and / or out of the container. According to some aspects, the vent 106 can include at least one material having a polarity opposite to that of the fluid contained in the fluid container as described herein. For example, where the fluid container contains a primarily aqueous fluid, the vent 106 can include at least one hydrophobic material in order to reduce the likelihood of the aqueous fluid passing therethrough. In some examples, the vent 106 can include a sterile filter, a sterile porous foam, or a sterile membrane in order to reduce or prevent contaminants from entering the second fluid flow path 102b.

[0060] Figure 1B An example adapter 100 having at least one vent (disposed in vent halves 106a, 106b) is shown in exploded view. As shown, the vent halves 106a, 106b can be disposed in a vent housing 107 of the adapter 100. The vent halves 106a, 106b can be irreversibly affixed in the vent housing 107 in a manner sufficient to withstand pressures associated with dispensing fluid from a fluid container as described herein, such as via manual and / or assisted fluid delivery (e.g., pressures associated with equalizing a fluid container). For example, the vent halves 106a, 106b can be welded and / or glued into the vent housing 107.

[0061] Figure 1C An example vent housing 107 without a filter, porous foam, or membrane is shown.

[0062] As Figure 1AAs shown, the adapter 100 further includes an outlet 103 disposed at an end of the first fluid flow path 102a opposite the needle element 104. The outlet 103 is configured to dispense fluid onto a surface (such as a surgical site) during an irrigation procedure. It should be appreciated that while the example adapter 100 is shown with an outlet 103 having a single discharge aperture, the outlet 103 is not necessarily limited in this manner. For example, the outlet 103 can include multiple discharge apertures, such as two, three, four, or more discharge apertures. Each of the discharge apertures can have the same size or a different size than one or more of the other discharge apertures. Additionally or alternatively, each of the discharge apertures can have the same shape or a different shape than one or more of the other discharge apertures. Figure 1A The example adapter 100 is shown with an outlet 103 having a single discharge aperture, but the outlet 103 is not necessarily limited in this manner. For example, the outlet 103 can include multiple discharge apertures, such as two, three, four, or more discharge apertures. Each of the discharge apertures can have the same size or a different size than one or more of the other discharge apertures. Additionally or alternatively, each of the discharge apertures can have the same shape or a different shape than one or more of the other discharge apertures.

[0063] The adapter 100 can further include at least one valve 105 disposed along the first fluid path 102a, and in particular, between the needle element 104 and the outlet 103. According to some aspects, the valve 105 is configured such that the adapter 100 can provide at least two alternative fluid delivery modes. In some non-limiting examples, the at least two alternative fluid delivery modes include assisted fluid delivery and manual fluid delivery.

[0064] As used herein, “assisted fluid delivery” refers to the delivery of fluid using at least one pumping device. Non-limiting examples of pumping devices include electrically powered pumps, electromechanical devices, pneumatic devices, and syringes. As is known in the art, the pumping device can be configured to provide a continuous flow of fluid from the fluid device. Additionally or alternatively, the pumping device can be configured to provide an intermittent flow of fluid (also referred to herein as a “pulsed” flow).

[0065] As used herein, “manual fluid delivery” refers to the delivery of fluid without the use of a pumping device. For example, where the fluid container includes a compressible body, manual fluid delivery can include compressing the body such that at least a portion of the fluid contained therein is dispensed.

[0066] Figure 2 An example of an adapter 200 having a valve 201 as described herein is shown. Figure 2Three different positions of valve 201 are also shown. Specifically, in the first position 2001, valve 201 is closed to prevent fluid from passing through it. The second position 2002 shows an example of manual fluid delivery. In this position, pressure from the fluid flow 202, generated, for example, by compressing a fluid container as described herein, forces valve 201 into the open position. In this way, fluid from the fluid flow 202 can pass through the valve. In this example, when the pressure from the fluid flow 202 stops (e.g., when the fluid container is no longer compressed), valve 201 can return to the closed position, i.e., the first position 2001. In this way, air from the external environment can be prevented from entering the fluid container through valve 201. Additionally, in the closed position, fluid can be prevented from accidentally passing through valve 201 from the fluid container. Instead, air from the external environment will pass through a second fluid flow path (e.g., second fluid flow path 102b, as per [reference]). Figure 1A (As shown and described) enters the fluid container, thereby passing through at least one vent and preventing contaminants from entering the fluid container.

[0067] The third position 2003 illustrates an example of assisted fluid delivery. In this example, a portion of a pumping device (e.g., needle 203) can be inserted through a valve 201. Therefore, the valve 201 is held in the open position to allow fluid 205 to flow through it. According to some aspects, the valve 201 is configured to prevent accidental displacement of the pumping device (e.g., needle 203). For example, the valve 201 can be configured to generate sufficient friction between the valve 201 and the needle 203 to reduce or prevent slippage of the needle 203 relative to the valve 201. This friction can be provided by selecting a specific valve material and / or by providing a valve with one or more textured features configured to interact with a portion of the pumping device (e.g., needle 203). Textured features can include, but are not limited to, ridges, ribs, protrusions, and combinations thereof.

[0068] like Figure 2 As shown, valve 201 may have a structure that allows for both manual and assisted fluid delivery. For example, valve 201 may include, for instance, […]. Figure 3 The cross-shaped slit valve 300 is shown. (As shown...) Figure 3 As shown, the cross-shaped slit valve 300 may include two slits forming a generally "X" shape. It should be understood that the cross-shaped slit valve 300 can open in both directions. For example, as... Figure 2As shown, the valve 201 opens in a first direction (e.g., toward the outlet 204 of the adapter 200) in position 2002 and in a second direction (i.e., in a direction opposite the first direction) in position 2003. However, it should be appreciated that the present disclosure is not necessarily limited to this example. In particular, the valve can have any structure capable of providing at least two alternative fluid delivery modes as described herein. For example, the valve can have a single slit or three, four, five, or more slits. In some non-limiting examples, the valve is a duckbill valve. In some non-limiting examples, the valve is a check valve, such as a mechanical or pneumatic check valve.

[0069] In some non-limiting examples, the valve can be configured to provide a particular fluid flow force, fluid flow rate, and / or fluid flow pattern. As used herein, the term “fluid flow force” refers to the force that fluid acts on a surface, such as a human subject, during an irrigation procedure. It should be appreciated that the fluid flow force according to the present disclosure is acceptable for use in the irrigation procedures described herein.

[0070] In some non-limiting examples, the acceptable fluid flow force can be between 1 and 100 psi, optionally between 1 and 90 psi, optionally between 1 and 80 psi, optionally between about 1 and 70 psi, optionally between 1 and 60 psi, optionally between 1 and 50 psi, optionally between 1 and 40 psi, optionally between 1 and 30 psi, optionally between 1 and 20 psi, and optionally between 1 and 10 psi. In some non-limiting examples, the acceptable fluid flow force can be between 1 and 20 psi, optionally between 1 and 15 psi, and optionally between about 4 and 15 psi. In some non-limiting examples, the acceptable fluid flow force can be about 70 psi, optionally about 65 psi, optionally about 60 psi, optionally about 55 psi, optionally about 50 psi, optionally about 45 psi, optionally about 40 psi, optionally about 35 psi, optionally about 30 psi, optionally about 25 psi, optionally about 20 psi, optionally about 15 psi, optionally about 10 psi, and optionally about 5 psi.

[0071] As used herein, the term “fluid flow rate” refers to the rate at which fluid is applied to a surface, such as a human subject, during an irrigation procedure. As used herein, the term “fluid flow pattern” refers to the pattern in which fluid is dispensed from a device and / or applied to a surface, such as a human subject, during an irrigation procedure.

[0072] In some non-limiting examples, the valve can have a number of slits in order to provide a particular fluid flow force, fluid flow rate, and / or fluid flow pattern as described herein. For example, the valve can have one slit, two slits, three slits, four slits, five slits, or more slits as known in the art. It should be appreciated that the number of slits can also affect the level of force required to open the valve (e.g., an increase in the number of slits can decrease the force required by the fluid flow to open the valve). Additionally or alternatively, the number of slits can also correspond to the size of the aperture created by the open valve, which can affect the fluid flow force, fluid flow rate, and / or fluid flow pattern.

[0073] In some non-limiting examples, the valve can have one or more slits having a particular length and / or geometry. It should be appreciated that the length of the one or more slits can affect the level of force required to open the valve (e.g., an increase in the length of the slit can decrease the force required by the fluid flow to open the valve). Additionally or alternatively, the one or more slits can have a particular geometric pattern configured to provide a particular fluid flow force, fluid flow rate, and / or fluid flow pattern.

[0074] Additionally or alternatively, one or more other features of the valve can be selected to provide a particular fluid flow force, fluid flow rate, and / or fluid flow pattern. Example valve features include valve size (e.g., valve diameter), valve shape, valve material, valve thickness, valve orientation in the adapter, valve position along the first fluid flow path, and combinations thereof.

[0075] According to some aspects, the valve can include a valve material selected to provide a particular fluid flow force, fluid flow rate, and / or fluid flow pattern. Example valve materials include, but are not limited to, silicone, rubber, laminate, elastomeric material. In some non-limiting examples, the valve material can include polyisoprene, polybutadiene, polyether, polysulfide, polyethylene, polyvinyl chloride, polyether ether ketone, polypropylene, nitrile, neoprene, ethylene propylene diene rubber, rigid plastic, metal steel, glass, or combinations thereof. The valve can include one or more check balls and / or springs. In some non-limiting examples, a more flexible valve material (e.g., silicone) can require less force to open as compared to a more rigid material (e.g., vulcanized rubber). In some non-limiting examples, the molecular weight, degree of cross-linking, and / or particular additives included by the valve material can affect the level of force required to open the valve.

[0076] According to some aspects, the thickness of the valve can affect the level of force required to open the valve (e.g., an increase in the thickness can increase the force required by the fluid flow to open the valve).

[0077] According to some aspects, the shape of the valve can affect the level of force required to open the valve. For example, the valve can comprise a duckbill valve, which can require a different level of force to open than a cross-slit valve.

[0078] According to some aspects, the orientation of the valve in the adapter and / or the position of the valve along the first fluid flow path can affect the level of force required to open the valve. In some non-limiting examples, the orientation of the valve can affect the force required for a portion of the pumping device to pass therethrough.

[0079] In some non-limiting examples, the adapter 100 can comprise a burst disc instead of or in addition to the valve 105 as described herein. For example, the burst disc can be configured to rupture when a certain compressive force is applied to the fluid container. Once the burst disc ruptures, the fluid can be manually delivered as described herein. Alternatively, the burst disc can be ruptured by the spike 203 of the pumping device as described herein.

[0080] According to some aspects, one or more components of the adapter 100 can comprise a transparent material. As used herein, a "transparent material" refers to a material that allows light to pass through it, sufficient for objects on the opposite side of the observer to be seen. In this way, the adapter 100 can reduce the risk associated with improper insertion of the spike 203 of the pumping device as described herein, and thus the risk of accidental displacement of the spike 203.

[0081] The present disclosure also relates to a kit having an adapter as described herein. In some examples, the kit can comprise the adapter and instructions for use, such as instructions for securing the adapter to a fluid container as described herein. In some non-limiting examples, the kit can comprise the adapter, a fluid container, and optionally instructions as described herein.

[0082] The present disclosure also relates to a system having a fluid container with at least a first connection portion that connects with a second connection portion of an adapter as described herein.

[0083] A method of using an adapter as described herein is also disclosed herein. The method can comprise providing a fluid container, securely connecting the adapter to the fluid container, and dispensing fluid from the fluid container via the adapter by manual or assisted delivery. The method can further comprise performing an irrigation procedure, that is, irrigating a body cavity, a surgical cavity, and / or an external wound with fluid from the device.

[0084] While aspects described herein have been described in conjunction with example aspects outlined above, various alternatives, modifications, variations, improvements, and / or substantial equivalents that are or can become apparent to those of ordinary skill in the art, in light of the foregoing, can be employed in accordance with the broadest possible spirit and scope of the disclosure. Accordingly, embodiments, as set forth above, are intended to be illustrative only and not limiting of the scope of the disclosure. Various changes can be made without departing from the spirit and scope of the disclosure. Therefore, the disclosure is intended to embrace all known or later-developed alternatives, modifications, variations, improvements, and / or substantial equivalents. The disclosure can be, and herewith is, directed to each individual aspect and every combination of aspects described herein.

[0085] Accordingly, the claims are not intended to be limited to the aspects shown herein, but are to be accorded the full scope consistent with the language of the claims, wherein reference to a singular aspect is also to be accorded the same meaning as a plural aspect, unless otherwise clear from the context. All structural and functional equivalents to the aspects described herein that are or can be known or later devised are expressly incorporated by reference and are intended to be encompassed by the claims. Furthermore, no aspect recited herein is intended to be dedicated to the public, regardless of whether these aspects are explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase "means for." The requirements of Article 1 6 of the Patent Code in no way preclude the claim of as many claims as there are aspects, as a large number of aspects might clearly result from the specification as originally filed without the claim element being a means plus function.

[0086] In this document, numeric ranges are expressed in terms of "about" a number that contains the endpoints, for example, between about 50:1 and 1 :1, between about 100°C and 500°C, between about 1 minute and 60 minutes, includes all numbers contained within the range, e.g., 21 minutes, 22 minutes, 23 minutes, and 24 minutes are included as endpoints within the specific range of between about 1 minute and 60 minutes. Thus, for example, ranges of 22-36, 25-32, 23-29, etc. are also ranges formed by endpoints included in the range of 1-60, depending upon the starting material used, temperature, specific application, limitations of the particular example or claim, if needed. The examples and methods disclosed herein demonstrate that the ranges include every point within the range, as different synthetic products result from varying one or more reaction parameters. Furthermore, the methods and examples disclosed herein describe the effect of each aspect of the disclosed ranges, both individually and when varied or combined with other recited ranges.

[0087] Further, the word "example" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as "example" is not necessarily to be construed as preferred or advantageous over other aspects. Unless specifically stated otherwise, 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, or C, and can 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" can be A only, B only, C only, A and B, A and C, B and C, or A and B and C, where any such combination can contain one or more member of A, B, or C. Nothing in the following claims, unless explicitly recited, is intended to be a disclaimer of claim scope.

[0088] As used herein, the terms "about" and "approximately" are defined as being near to, but not necessarily exactly, as understood by one of ordinary skill in the art. In one non-limiting embodiment, the terms "about" and "approximately" are defined as within 10%, preferably within 5%, more preferably within 1%, and most preferably within 0.5%.

Claims

1. An adapter, comprising: The connection part is capable of connecting to a fluid container. A first fluid flow path has a first end and a second end, the first end being configured to provide fluid communication with the fluid container, and the second end including a fluid outlet. At least one valve is disposed along the first fluid flow path, and The second fluid flow path is separate from the first fluid flow path. The at least one valve is configured to provide a choice between assisted fluid delivery and manual fluid delivery.

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

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

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

5. The adapter according to claim 1, wherein, The adapter further includes a vent disposed along the second fluid flow path.

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

7. A system comprising: fluid container ； An adapter, wherein the adapter includes: The connection part is connected to the fluid container. A first fluid flow path has a first end and a second end, the first end being configured to provide fluid communication with the fluid container, and the second end including a fluid outlet. At least one valve is disposed along the first fluid flow path, wherein the valve is configured to provide selection between assisted fluid delivery and manual fluid delivery, and The second fluid flow path is separate from the first fluid flow path.

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

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

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

11. The system according to claim 7, wherein, The adapter further includes a vent disposed along the second fluid flow path.

12. The system according to claim 7, wherein, The fluid container holds the flushing fluid.

13. A kit comprising: An adapter, wherein the adapter includes: The connection part is capable of connecting to a fluid container. A first fluid flow path has a first end and a second end, the first end being configured to provide fluid communication with the fluid container, and the second end including a fluid outlet. At least one valve is disposed along the first fluid flow path, wherein the at least one valve is configured to provide selection between assisted fluid delivery and manual fluid delivery, and A second fluid flow path, separate from the first fluid flow path; and Instructions for connecting the adapter to the fluid container.

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

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

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

17. The kit according to claim 13, wherein, The adapter further includes a vent disposed along the second fluid flow path.

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

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

20. The kit of claim 19, wherein, The fluid container holds the flushing fluid.

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