Patent Application
20220118169
The present disclosure is directed to devices and systems for applying a lavage fluid to a surface, the devices and systems comprising at least one venting component.
Currently, lavage (that is, the washing out of a body cavity, surgical cavity, or external wound with a medically acceptable fluid) is often employed to prevent contamination of an open surgical wound, which may occur for a variety of reasons such as accidental visceral entry or perforated viscus, operations complicated by gross spillage, departure from sterile technique, and/or existing, ongoing clinical infection. Lavage processes are thus often employed to provide intraoperative antiseptic wound irrigation.
The art of lavage currently embraces a wide variety of different approaches that vary based on the situation (for example, the size and shape of the cavity or wound) and on the medical practitioner performing the lavage process (for example, a practitioner's technique preference). Currently, no specific lavage technique is standard in the art, and as such, medical facilities often require numerous different lavage devices and systems to accommodate the variety of potential approaches. The presentation of such devices and systems is also sometimes a concern, as the inadvertently inappropriate use of such devices and systems (e.g., intravenously, if the device and/or system has a similar appearance to an intravenous device and/or system) could results in devastating effects.
Moreover, several drawbacks exist with current lavage practices, including insufficiencies in antiseptic fluid properties (e.g., the amount of time necessary for an antiseptic fluid to achieve an acceptable biological effect, which may be prohibitive), the risk of systemic absorption of the antiseptic fluid, adverse reactions such as anaphylaxis, peritoneal adhesions, neurotoxicity, and respiratory insufficiency, and improper dosage or contamination of the antiseptic fluid, which are sometimes prepared ad hoc by a medical practitioner performing the lavage.
In addition, current lavage devices often pose an increased risk of contamination. For example, some current lavage devices utilize a resilient hollow body that expel lavage fluid upon pressure applied thereto (e.g., a “squeeze bottle” or the like). In order to function, such devices require one or more re-equilibrium periods (i.e., a period of time wherein a reduced or no pressure is applied to the device) such that a gas such as air may be pulled into the device sufficient to re-equilibrate its internal pressure. However, by introducing non-sterile gas into the device, the sterility of a lavage fluid contained therein (and thus, surgical wounds contacted by the same) may be jeopardized. Furthermore, such devices intake gas during re-equilibrium periods along the same path that lavage fluid is dispensed from the device. However, these paths are generally not optimized for such a function, and as such, the re-equilibrium periods required by such devices often provide an unacceptable delay to the lavage process, which often results in an inefficient and/or ineffective lavage process.
There is thus a need in the art for versatile devices and systems for performing lavage processes, and in particular, devices and systems that enable medical practitioners to safely and effectively reduce contamination in surgical wounds that are susceptible to surgical site infections.
The present disclosure is directed to devices and systems for delivering a lavage fluid, such as an antiseptic solution, to a surface. The device comprises a body that is configured to house a lavage fluid, such as an antiseptic solution. The body is further configured to be in fluid communication with at least one application member, wherein the at least one application member is configured to apply the lavage fluid to a surface sufficient for a lavage process.
The devices and systems may be adaptable such that a user may select from two or more different fluid flow rates, fluid flow patterns, and/or fluid flow forces, thus providing selectable control of lavage fluid delivery to a surface. The present disclosure is also directed to methods of using the devices and systems described herein.
The present disclosure is also directed to a venting component useable with the devices and systems as described herein. The venting component comprises a fluid channel configured to provide fluid communication between the body and an external environment. The fluid channel may further comprise at least one filter provided relative to the fluid channel sufficient to remove contaminants from gas passing through the fluid channel. According to some aspects, at least a portion of the fluid channel is separate from a fluid path along which a lavage fluid is dispensed by the device or system.
The present disclosure is directed to devices and systems for delivering a lavage fluid, such as an antiseptic solution, to a surface. The device comprises a body that is configured to house a lavage fluid, such as an antiseptic solution. The body is further configured to be in fluid communication with at least one application member, wherein the at least one application member is configured to apply the lavage fluid to a surface sufficient for a lavage process. The devices and systems may be adaptable such that a user may select from two or more different fluid flow rates, fluid flow patterns, and/or fluid flow forces, thus providing selectable control of lavage fluid delivery. The present disclosure is also directed to methods of using the devices and systems described herein.
The present disclosure is also directed to a venting component useable with the devices and systems as described herein. The venting component comprises a fluid channel configured to provide fluid communication between the body and an external environment, and may further comprise at least one filter provided relative to the fluid channel sufficient to filter gas, such as air, passing through the fluid channel. According to some aspects, at least a portion of the fluid channel is separate from a fluid path along which a lavage fluid is dispensed by the device or system.
As used herein, the term “fluid” refers to a substance that has no fixed shape, such as a liquid or a gas. As used herein, the term “lavage fluid” refers to a fluid suitable for a lavage process as described herein. As used herein, “lavage” refers to the irrigation of a body cavity, a surgical cavity, and/or an external wound.
According to some aspects, the lavage fluid may comprise an antiseptic solution. As used herein, an “antiseptic solution” refers to a solution comprising at least a solvent and one or more antiseptic agents. According to some aspects, the antiseptic solution is an aqueous solution. As used herein, the term “aqueous solution” refers to a solution wherein 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 antiseptic solution is an alcoholic solution. As used herein, the term “alcoholic solution” refers to a solution wherein 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, isopropyl alcohol, n-propanol, and combinations thereof.
In one non-limiting example, the antiseptic agent may comprise 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 antiseptic agent may comprise a bis-(dihydropyridinyl)-decane derivative (i.e., a compound derived from bis-(dihydropyridinyl)-decane). According to some aspects, the antiseptic agent may comprise an octenidine salt and/or a chlorhexidine salt. According to some aspects, the antiseptic agent may comprise alexidine, octenidine dihydrochloride, chlorhexidine gluconate, or a combination thereof.
Additionally or alternatively, the antiseptic agent may comprise iodine. According to some aspects, the iodine may be provided as an iodine complex, such as povidone-iodine (PVPI), nonylphenoxy-(ethyleneoxy)-iodine, polyethylene oxy polyprop leneoxy-iodine, undecoylinium-chloride-iodine, iodine povacrylex, and combinations thereof.
Additionally or alternatively, the antiseptic agent may comprise an oxidant (i.e., an oxidizing agent). Non-limiting examples of oxidants according to the present disclosure include, but are not limited to, sodium hypochlorite, hydrogen peroxide, and combinations thereof.
The antiseptic agent may have an antimicrobial activity sufficient to provide an acceptable log reduction of microbes in a certain time period. It should be understood that as used herein, the term “microbes” may refer to any microorganism to be killed and/or removed as a result of lavage. Example microbes include bacteria, fungi, viruses, and combinations thereof.
Example bacteria include, but are not limited to, Streptococcus mutans, S. pyogenes (group A β-hemolytic streptococci), S. salivarius, S. sanguis, Staphylococcus aureus S. epidermidis, S. haemolyticus, S. hominis, S. simulans, S. saprophyticus, methicillin/oxacillin-resistant (MRSA/ORSA) and methicillin/oxacillin-susceptible Staphylococci (MSSA/OSSA), Enterococcus (e.g., E. faecalis E. faecium, and E. hirae), vancomycin-resistant Enterococcus (VRE) and vancomycin-susceptible Enterococcus (VSE), Bacteroides fragilis, Propionibacterium acnes, Clostridium difficile (spore and vegetative cells), Selenomonas, Pseudomonas aeruginosa, Escherichia coli, Burkholderia cepacia, Proteus mirabilis, Gardnerella vaginalis, Klebsiella aerogenes, K. pneumoniae, K. pneumoniae multidrug resistant (MDR), Acinetobacter baumannii, A. baumannii MDR, Achromobacter xylosoxidans. Micrococus luteus, Ralstonia pickettii, Haemophilus influenza, and Serratia marcescens
Example fungi include, but are not limited to, Aspergillus niger, Candida albicans, C. aurus, C. dubliniensis, C. glabrata (formerly Torulopsis glabrata), C. guillermondii, C. kefyr (formerly C. pseudotropicalis), C. krusei, C. lusitaniae, C. tropicalis, Epidermophyton floccosum, Microsporum gypseum, M. canis, and Trichophyton mentagrophytes
Example viruses include, but are not limited to, those having a lipid component in their outer coat or have an outer envelope such as cytomegalovirus (CMV), human immunodeficiency virus (HIV), herpes simplex virus types 1 (HSV-1) and 2 (HSV-2), influenza virus, parainfluenza virus, variola virus (smallpox virus), vaccinia, norovirus, and coronavirus
According to some aspects, the certain time period may be a 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.
According to some aspects, the certain time period may be no more than about 120 seconds, optionally no more than about 105 seconds, optionally no more than about 90 second, 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.
It should be understood that “an acceptable log reduction” may be microbe-dependent. For example, an acceptable log reduction as described herein may refer to an acceptable log reduction of one type of microbe present on a surface (e.g., present in a body cavity or at an external wound site), a combination of two more types of microbes present on a surface, or total microbes present on a surface.
According to some aspects, an acceptable log reduction may be at least about 1.0, optionally at least about 1.1, optionally at least about 1.2, optionally at least about 1.3, optionally at least about 1.4, optionally at least about 1.5, optionally at least about 1.6, optionally at least about 1.7, optionally at least about 1.8, optionally at least about 1.9, optionally at least about 2.0, optionally at least about 2.1, optionally at least about 2.2, optionally at least about 2.3, optionally at least about 2.4, optionally at least about 2.5, optionally at least about 2.6, optionally at least about 2.7, optionally at least about 2.8, optionally at least about 2.9, optionally at least about 3.0, 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.
According to some aspects, the antiseptic agent may be present in the antiseptic solution in a concentration sufficient to provide an acceptable log reduction of microbes in a certain time period as described herein. According to some aspects, the antiseptic agent may be present in the antiseptic solution at a concentration of 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% 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.
According to some aspects, the antiseptic agent may be present in the antiseptic solution at a concentration of 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.
According to some aspects, the antiseptic agent may be present in the antiseptic solution at a concentration of 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.
It should be understood that according to some aspects, the lavage fluid is not necessarily an antiseptic solution as described herein and may be any medically acceptable fluid configured to perform a lavage process as described herein. In one non-limiting example, the lavage fluid may comprise a saline solution. The saline solution may comprise water and sodium chloride in a medically acceptable concentration, such as between about 0.1 and 1%, w/v, optionally about 0.45% w/v, and optionally about 0.9% w/v.
According to some aspects, the lavage fluid, such as an antiseptic solution as described herein, may comprise a visualizing aid. As used herein, the term “visualizing aid” refers to a component in a lavage fluid configured to aid in visualizing the application of the lavage fluid. Example visualizing agents include, but are not limited to, tinting agents, staining agents, and radiopaque agents. It should be understood that the visualizing agent may be the same as or different from one of the other components of the lavage fluid. For example, the antiseptic agent may function as a visualizing agent. Additionally or alternatively, the lavage fluid may comprise a visualizing agent that is disparate from the antiseptic agent.
According to some aspects, the lavage fluid may comprise a tinting agent. As used herein, the term “tinting agent” refers to a component sufficient to provide an observable color to a fluid. The tinting agent may be sufficient to allow visualization of the lavage fluid upon application to a surface. In some non-limiting examples, the tinting agent may comprise an anionic tinting agent, such as an anionic dye. The anionic dye may be any dye suitable for medical use, such as dyes approved by the Food and Drug Administration for use in food, drugs, and/or cosmetics (i.e., “D&C” or “FD&C” dyes). Example anionic dyes include, but are not limited to, FD&C Blue No. 1 (Brilliant Blue FCF), FD&C Blue No. 2 (Indigo Carmine), FD&C Green No. 3 (Fast Green FCF), FD&C Red No. 3 (Erythrosine), FD&C Red No. 40 (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 may be implemented to arrive at a particular color. For example, an orange tint may comprise both FD&C Red No. 40 and D&C Yellow No. 8. Additionally or alternatively, the tinting agent may comprise a chemical compound that is observable upon exposure to visible and/or non-visible light, including, but not limited to, vitamin B-12, medical honey, fluorescent polymeric nanoparticles, water soluble luminescent carbon nanodots, quinine, and combinations thereof.
According to some aspects, the lavage fluid, such as an antiseptic solution as described herein, may comprise a staining agent. As used herein, the term “staining agent” refers to a component sufficient to temporarily or permanently color a surface with which it comes in contact.
According to some aspects, the lavage fluid, such as an antiseptic solution as described herein, may comprise a radiopaque agent. As used herein, the term “radiopaque agent” refers to a component that is opaque to the radio wave and x-ray portion of the electromagnetic spectrum sufficient for visualization. In some non-limiting examples, the radiopaque agent may comprise barium, iodine, iron oxide nanoparticles, gadolinium complex nanospheres, silica nanospheres, and combinations thereof.
According to some aspects, the lavage fluid, such as an antiseptic solution as described herein, may be basic, neutral, or acidic. According to some aspects, the lavage fluid may have a pH of 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.
According to some aspects, the lavage fluid, such as an antiseptic solution as described herein, may comprise a buffer system. As used herein, the term “buffer system” refers to a component present in a composition or solution which may provide a resistance to significant change in pH caused by a strong acid or base. A buffer system may comprise a single agent or more than one agent, such as a weak acid and its conjugate base. A buffer system may provide a resistance to a significant pH change by interacting with a strong acid or strong base in a composition or solution, thereby at least partially preventing the pH of the composition or solution from changing significantly.
Generally, a buffer system has one or more buffer ranges wherein the buffer system has the ability to provide resistance to significant pH change. When a composition or solution comprising the buffer system has a pH inside the buffer system's buffer range, the pH of the composition or solution will not change significantly with the addition of equimolar amounts of a strong acid or strong base.
The buffer range of a buffer system is related to the acid dissociation constant (Ka) of one or more weak acids comprised by the buffer system. The term “acid dissociation constant” refers to the equilibrium constant of a dissociation reaction of an acid. The midpoint of a buffer range for a buffer system is generally about the logarithmic measure of the acid dissociation constant (i.e., the pKa, equal to −log10 Ka) of a weak acid comprised by the buffer system.
According to some aspects, the lavage fluid, such as an antiseptic solution as described herein, may comprise a stabilizing agent. As used herein, the term “stabilizing agent” refers to any component that supports the stability of a lavage fluid not otherwise explicitly described herein.
The device according to the present disclosure comprises a body configured to contain a lavage fluid as described herein. According to some aspects, the body may be compressible. As used herein, the term “compressible” refers to the ability to reversibly reduce in volume without unacceptable changes, such as an unacceptable permanent change to size, to shape, and/or to one or more of the properties as described herein. According to some aspects, the body may be configured such that upon compression, at least a portion of the lavage fluid contained therein is dispensed. It should be understood that as used herein, “dispense” (alternatively referred to as “discharge”) may refer to transferring the lavage fluid to an application member in fluid communication with the body and/or it may refer to transferring the lavage fluid from an application member to a surface.
According to some aspects, the body may be collapsible. As used herein, the term “collapsible” refers to the ability to permanently reduce in volume. For example, a collapsible body as described herein may have a first volume when a first volume of fluid is contained therein. When at least a portion of the fluid is dispensed, the collapsible body may collapse to have a second volume, the second volume being less than the first volume. It should be understood 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 may further provide for a more efficient fluid discharge.
According to some aspects, the body may be configured to allow at least a 10% reduction in volume when compressed and/or collapsed, optionally at least a 20% reduction in volume, optionally at least a 30% reduction in volume, optionally at least a 40% reduction in volume, optionally at least a 50% reduction in volume, optionally at least a 60% reduction in volume, optionally at least a 70% reduction in volume, optionally at least a 80% reduction in volume, optionally at least a 90% reduction in volume, and optionally at least a 99% reduction in volume.
According to some aspects, the body may comprise a body material that is compatible with the lavage fluid contained therein, that is, a material that does not chemically or physically react with the lavage fluid or otherwise render the lavage fluid unfit for medical use.
According to some aspects, the body material may be sufficient to prevent unacceptable vapor or antiseptic loss from a lavage fluid contained therein over a certain period of shelf life. It should be understood that “unacceptable vapor or antiseptic loss” may be a loss that results in the lavage fluid becoming unsuitable for its intended use. Vapor or antiseptic loss may result from, for example, adsorption or absorption of the antiseptic by a material (e.g., by the body material), evaporation of solution, evaporation of a component of a solution (e.g., an antiseptic agent of an antiseptic solution), or a combination thereof. In one non-limiting example wherein the lavage fluid comprises water and iodine as described herein, the body material may be sufficient to prevent water vapor loss and/or iodine loss over a certain period of shelf life.
As used throughout this application, the term “shelf life” refers to the length of time that a product (e.g., an antiseptic solution) may be stored while remaining within the specifications required for the form, fit, and function of the product. Shelf life may be determined by measuring certain characteristics of the product that may indicate that the product is unfit for medical use. For example, shelf life may be determined by measuring the concentration of impurities in the product, the color change of the product, the concentration of insoluble particles in the product, the potency of an active agent contained by the product (e.g., an antiseptic agent), the concentration of one or more components of the product, the pH of the product, and/or the sterility of the product after storage in long-term storage conditions. As used herein, the term “long-term storage conditions” refers to environmental conditions sufficient for a product to be acceptably stored 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, shelf life may be determined by measuring the concentration of impurities in the product, the color change of the product, the concentration of insoluble particles in the product, the potency of an active agent of 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 may be determined by measuring the concentration of impurities in the product, the color change of the product, the concentration of insoluble particles in the product, the potency of an active agent of 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 between about 15 and 30° C., with excursions at a temperature of no more than about 40° C.
According to some aspects, the period of shelf life may 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.
According to some aspects, the body material may be sufficient for sterilization by any known sterilization techniques useful according to the present disclosure, including moist heat sterilization (i.e., autoclaving), gas sterilization, gamma irradiation, 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, a body material may be determined to be sufficient for sterilization if a container comprising the body material has a Sterility Assurance Level (SAL) of at least 10−6 after sterilization and provides an acceptable result upon integrity testing for the container closure after sterilization.
According to some aspects, the body material may have a sufficient mechanical strength such that the body provides an acceptable response to impact, vibration, shaking, or a combination thereof. According to some aspects, an acceptable response refers to a response compliant 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 Compressive Resistance of Shipping Containers, Components, and Unit Loads), or any combination thereof. According to some aspects, the body material may be safe for biomedical use. For example, the body material may comply with ISO 10993 and/or with REACH requirements. According to some aspects, the body material may be sufficient to exhibit at least a portion of the characteristics described herein over a certain period of the lavage fluid's shelf life at a temperature of between about 15 and 30° C., with excursions at a temperature of no more than about 40° C. Additionally or alternatively, the body material may be sufficient to exhibit at least a portion of the characteristics described herein over a certain period of the lavage fluid's shelf life after storage at about 25° C. and 60% relative humidity. Additionally or alternatively, the body material may be sufficient to exhibit at least a portion of the characteristics described herein over a certain period of the lavage fluid's shelf life after storage at about 37° C. and 65% relative humidity.
The body material may be rigid or flexible. As used herein, the term “rigid” refers to a stiffness sufficient to resist deformation upon normal operating forces. As used herein, the term “flexible” refers to the ability to bend or compress under normal operating forces.
Example body materials include, but are not limited to, glass, plastic, paper, foil, and any combination thereof. Example plastics useful according to the present disclosure include, but are not limited to, high-density polyethylene (HDPE), low-density polyethylene (LDPE), polypropylene, polystyrene, nylon, and any combination thereof. According to some aspects, the body material may be a lined and/or coated material, such as a lined and/or coated paper.
According to some aspects, the body material may be polypropylene. Preferably, the body material may be a radiation grade polypropylene. Herein, if the body material is a radiation grade polypropylene, the body material may be able to undergo terminal sterilization. The body material according to the present disclosure may be configured to undergo gamma irradiation as part of terminal sterilization. A radiation grade polypropylene plastic as the body material allows the body containing the lavage fluid to undergo gamma irradiation wherein the sterilization takes place with the lavage fluid already present inside the sealed body.
The body according to the present disclosure, upon undergoing gamma irradiation may maintain flexibility, wherein the lavage fluid contained therein is not significantly affected by the gamma irradiation, that is, the stability and integrity of the lavage fluid may be maintained. Herein, the body maintains its ability to bend or compress under normal operating forces. The body according to the present disclosure, upon undergoing gamma radiation undergoes certain material characteristic changes that may help in reducing the stretching of the body when it is pierced with a venting adaptor comprising a protrusion configured for insertion into a wall of the body, as will be described herein. The reduction of stretching of the body allows a venting adaptor to easily pierce a wall of the body, as will be described herein.
According to some aspects, the body containing the lavage fluid may have variations in the thickness of walls of the body. In particular, certain walls of the body may be of a different thickness as compared to the thickness of other walls of the body. Preferably, the thickness of a certain wall may be lesser as compared to other walls of the body. The thickness of such certain wall may be at most 95% of the thickness of other walls, optionally at most 90%, optionally at most 85%, optionally at most 80%, optionally at most 75%, optionally at most 70%, and optionally at most 65% of the thickness of other walls. The wall having lesser thickness as described above may be the top, bottom or side walls of the body. Preferably, the wall having lesser thickness as described above may be the bottom wall of the body in relation to the ground. Preferably, the wall having lesser thickness as described above may the wall opposite to the wall of the body configured to be in fluid communication with an application member, as will be described herein. The reduction of thickness in the wall allows a venting adaptor external to the body to easily pierce a wall of the body, as will be described herein. In a related embodiment, the variation of wall thicknesses as well as the trapped gas within the body cooperate in venting the body by allowing a venting adaptor to easily pierce the wall of the body. Preferably, the trapped gas is under pressure that is higher than atmospheric pressure. The trapped gas may comprise air and/or an inert gas such as nitrogen.
According to some aspects, the body may be provided with an outer casing. For example,
The body according to the present disclosure is configured to dispense a lavage fluid, such as an antiseptic solution, contained therein via one or more mechanisms. According to some aspects, the body may be configured to dispense the lavage fluid upon compression as described herein. For example, as shown in
Additionally or alternatively, the body may be configured to dispense at least a portion of the lavage fluid contained therein upon orienting the body in a certain orientation. For example, as shown in
In the example shown in
According to some aspects, the body may be configured to communicate with a dispensing aid, wherein the dispensing aid is configured to provide a force sufficient to at least partially dispense the lavage fluid contained in the body. For example, the dispensing aid may comprise a pump configured to move the lavage fluid from the body. The pump may be a mechanical pump, a motorized pump, a vacuum pump, or any combination thereof.
It should be understood that the body may be configured to dispense the lavage fluid via one or a combination of the mechanisms as described herein. For example, the body may be configured to dispense the lavage fluid upon compression in conjunction with the force of gravity. Additionally or alternatively, the body may be configured to dispense the lavage fluid upon compression and/or by the force of gravity in conjunction with the force created by the pump (including, but not limited to, a vacuum force created by a vacuum pump). According to some aspects, the body may be configured to selectably dispense the lavage fluid via one or more of the mechanisms as described herein. In one non-limiting example, the body may be configured to dispense the lavage fluid upon compression both with and without the force of a pump. In this way, the user may select a desired delivery mechanism based on physical limitations (e.g., the physical capabilities of the user), a desired fluid flow force, a desired fluid flow rate, a desired fluid flow pattern (e.g., pulsed or constant), or a combination thereof.
According to some aspects, the body may be configured to dispense at least about 75% of the lavage 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 body may be configured to continually dispense the lavage fluid and/or to intermittently dispense the lavage fluid. In one non-limiting example, the body may be configured to intermittently dispense the lavage fluid such that the lavage fluid is only dispensed upon compression of the body and/or upon actuation of a dispensing aid such as a pump.
The body may be configured to contain a volume of lavage fluid sufficient to perform at least a portion of a lavage process. According to some aspects, the body may be configured to contain between about 250 and 2000 mL of fluid, and optionally between about 500 and 1000 mL. According to some aspects, the body may be configured to contain about 500 mL of fluid. According to some aspects, the body may be configured to contain about 1 L of fluid.
The body according to the present disclosure may comprise a body connection portion configured to selectively place the body in fluid communication with an applicator member and/or a venting adaptor as will be described herein. As used herein, the term “body connection portion” refers to a portion of the body configured to provide a secure connection between the body and an application member and/or between the body and a venting adaptor such that fluid (e.g., a lavage fluid) may be controllably dispensed from the body to the application member.
In one example, the body connection portion is configured to fix the body relative to the application member such that a first aperture comprised by the body is aligned with a second aperture comprised by the application member sufficient to provide fluid communication between the body and application member. In another example, the body connection portion is configured to fix the body relative to a venting adaptor such that a first aperture comprised by the body is aligned with a second aperture comprised by the venting adaptor. The venting adaptor may be further configured to interact with an application member having a third aperture such that the first aperture comprised by the body and the second aperture comprised by the venting adaptor are aligned with the third aperture comprised by the application member sufficient to provide fluid communication between the body and application member via the venting adaptor. The body connection portion may comprise any connection type(s) known in the art useful according to the present disclosure.
According to some aspects, the body may be provided with a removable lid, for example, a cap configured to interact with the body connection portion of the body in place of the application member and/or venting adaptor. It should be understood that the lid may prevent fluid discharge from the body, for example, during storage or transportation of the body.
According to some aspects, the body connection portion may be provided with a fluid metering device, for example, a valve. The fluid metering device may be provided in communication with the body aperture (e.g., provided in the body aperture) sufficient to affect fluid flow from the body.
The present disclosure is also directed to a system comprising a body as described herein and one or more application members. The one or more application members may each be configured to apply a lavage fluid to a surface sufficient for a lavage process.
According to some aspects, the body may comprise a body connection portion configured to interact with two or more different application members such that the system is adapted for interchanging application members. For illustrative purposes, taking the example shown in
In the example shown in
As shown in
It should be understood that application member 60 having dispensing aid 65 as described herein may dispense a lavage fluid (e.g., an antiseptic solution) from body 600 upon actuation of dispensing aid 65 (e.g., actuation of a pump as described herein). Additionally or alternatively, dispensing aid 65 may function to dispense fluid from body 600 in conjunction with the force of gravity. For example,
While the examples shown in
According to some aspects, the one or more discharge apertures may be provided in a nozzle portion of the discharge portion of an application member. For example,
In the example shown in
The example system shown in
According to some aspects, one or more components of the device and/or system as described herein may comprise one or more restrictive features that prevent unacceptable fluid passage. For example, at least one restrictive feature may be provided at a position along the flow path of a dispensed fluid, such as proximate or adjacent a discharge portion of an application member as described herein. In one non-limiting example, the restrictive feature may comprise a one-way valve having a first, closed position that prevents fluid passage therethough and a second, open position that allows fluid passage therethrough. In this example, the one-way valve may be provided in the first position when subjected to pressure from one direction (i.e., gas pressure from a surrounding environment, such as during a re-equilibrium period as will be described herein). The one-way valve may readily move to the second position when subjected to pressure from a different direction (i.e., gas pressure from inside a body upon compression of the body and/or liquid pressure from a lavage fluid contained in the body). In this way, the discharge portion may dispense lavage fluid as described herein while preventing gas from an external environment from entering into the body via the flow path of a dispensed fluid.
The present disclosure is also directed to a venting component configured for use with the device and/or system as described herein. The venting component according to the present disclosure comprises a fluid channel, at least a portion of the fluid channel being separate from a fluid path along which a lavage fluid is dispensed, also referred to herein as the flow path of a dispensed fluid. According to some aspects, the fluid channel is configured to provide fluid communication between the body and an external environment.
In one example, the device or system according to the present disclosure may comprise a compressible body as described herein, the compressible body configured such that, upon compression, at least a portion of the lavage fluid contained therein is dispensed. In this example, completely dispensing the lavage fluid contained in the compressible body may require one or more re-equilibrium periods wherein gas from an external environment is pulled into the body sufficient to re-equilibrate the body's internal pressure prior to the next compression. According to some aspects, the fluid channel comprised by the venting component may provide a path for gas from an external environment to rapidly enter the compressible body during the one or more re-equilibrium periods.
In another example, the body may be configured to dispense lavage fluid upon compression and/or by the force of gravity in conjunction with a force created by a pump, as described herein. In this example, the pump may require a fluid (e.g., gas from an external environment) to flow into the body between pumps. In this example, the fluid channel comprised by the venting component may provide a path for gas from an external environment to rapidly enter the body sufficient for the pump's function.
According to some aspects, the venting component may comprise at least one filter provided relative to the fluid channel sufficient to filter a gas, such as air, passing through the fluid channel. As used herein, the action of filtering refers to removing contaminants, such as biological and/or chemical contaminants, from a gas. Preferably, the filter removes an acceptable level of contaminants in order to render the gas sufficient for contact with a lavage fluid as described herein. According to some aspects, a gas may be sufficient for contact with a lavage fluid if and when it has an appropriate purity (e.g., free from oil) and its microbiological and particle quality after filtration is equal to or better than that of the air in the environment into which the gas is introduced, for example, as described in “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice” published September 2004 by the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Office of Regulatory Affairs (ORA), the contents of which are expressly incorporated herein by reference in their entirety.
Example biological contaminants that may be removed by the at least one filter include, but are not limited to, bacteria, fungi, and viruses. Example chemical contaminants that may be removed by the at least one filter include, but are not limited to, environmental pollutants, chemical irritants, particulate matter, environmental allergens, and/or debris.
Example materials useful for the at least one filter include, but are not limited to, nylon, polyvinylidene difluoride (PVDF), polyethersulfone (PES), polycarbonate, polypropylene, polytetrafluoroethylene, cellulose, and combinations thereof.
Example filters useful according to the present disclosure include filters having an average pore size of between about 0.01 and 20 μm, optionally between about 0.1 and 10 μm, optionally about 0.1 μm, optionally about 0.2 μm, optionally about 0.22 μm, and optionally about 10 μm. Additional example filters useful according to the present disclosure include filters having an average pore size of up to about 10 μm, optionally up to about 9 μm, optionally up to about 8 μm, optionally up to about 7 μm, optionally up to about 6 μm, optionally up to about 5 μm, optionally up to about 4 μm, optionally up to about 3 μm, optionally up to about 2 μm, up to about 1.0 μm, optionally up to about 0.5 μm, optionally up to about 0.4 μm, optionally up to about 0.3 μm, optionally up to about 0.2 μm, and optionally up to about 0.1 μm.
According to some aspects, the fluid channel may comprise one or more restrictive features as described herein, wherein the one or more restrictive features are configured to prevent unacceptable fluid passage through the fluid channel, for example, the passage of lavage fluid therethrough. For example, the fluid channel may comprise a one-way valve having a first, closed position that prevents fluid passage therethough and a second, open position that allows fluid passage therethrough. In this example, the one-way valve may be provided in the first position when subjected to pressure from one direction (e.g., air pressure from inside the body upon compression of the body and/or liquid pressure from a lavage fluid contained in the body). The one-way valve may readily move to the second position when subjected to pressure from a different direction (i.e., air pressure from a surrounding environment, for example, during a re-equilibrium period as described herein).
Additionally or alternatively, the fluid channel may comprise a selective membrane that allows only select fluids to pass therethrough. For example, the selective membrane may allow the passage of gas (e.g., air) therethrough but may substantially prevent the passage of liquid (e.g., a lavage fluid) therethrough. Example membranes according to the present disclosure include, but are not limited to, hydrophobic membranes. Non-limiting examples of hydrophobic membranes include those comprising expanded PTFE (ePTFE), electrospun (i.e., nanospun) polymers (e.g., electrospun polyurethane), or a combination thereof. Additionally or alternatively, the membrane may comprise a material that has been surface modified to be hydrophobic, such as a nanoporous alumina membrane. According to some aspects, the selective membrane may comprise a membrane that has been treated with electrical charge(s) in order to provide selective porosity (e.g., so as to allow air flow therethrough and to prevent liquid flow therethrough).
According to some aspects, the venting component according to the present disclosure may be provided as part of a venting adaptor.
The example venting adaptor shown in
Second connection portion 131 may further comprise an application member securing portion 133 having one or more features configured to interact with corresponding features on an application member in order to provide a secure connection between the venting adaptor and the application member. For example, as shown in
It should be understood, however, that the first connection portion 136 and the second connection portion 131 of the venting adaptor 130 shown in
As shown in
According to some aspects, fluid channel 138 and/or aperture 1311 may have a size sufficient to provide an acceptable rate of fluid advancement along the fluid channel 138. For example, fluid channel 138 and/or aperture 1311 may have an average diameter and/or a length such that gas flowing from an external environment into a body through fluid channel 138 travels rapidly, thus providing a minimal re-equilibrium period as described herein.
In the example shown in
According to some aspects, protrusion 146 of venting adaptor 140 has a thickness that is at least one and half times the thickness of any wall of the body 144, optionally at least twice the thickness, optionally at least two and half times the thickness, optionally at least thrice the thickness, optionally at least three and half times the thickness, optionally at least four times the thickness, optionally four and half times the thickness, and optionally at least five times the thickness of any wall of the body 144. A wall having lesser thickness as compared to protrusion 146 may be a top, bottom or side wall of body 144. Preferably, a wall having lesser thickness as described above may be bottom wall 148 of body 144 in relation to the ground. Preferably, a wall having lesser thickness as described above may a wall opposite to a wall of body 144 configured to be in fluid communication with an application member, as described herein.
It should be understood that while the examples shown in
Additionally or alternatively, as shown in
Venting adaptor 170 may be inserted at any position relative to body 174 so long as the function as described herein is achieved. Venting adaptor 170 may further comprise one or more filters as described herein, for example, at or near second end 173 of fluid channel 171. In the example shown in
According to some aspects, protrusion 176 of venting adaptor 170 has a thickness that is at least one and half times the thickness of any wall of the body 174, optionally at least twice the thickness, optionally at least two and half times the thickness, optionally at least thrice the thickness, optionally at least three and half times the thickness, optionally at least four times the thickness, optionally four and half times the thickness, and optionally at least five times the thickness of any wall of the body 174. A wall having lesser thickness as compared to protrusion 176 may be a top, bottom or side wall of body 174. Preferably, a wall having lesser thickness as described above may be bottom wall 178 of body 174 in relation to the ground. Preferably, a wall having lesser thickness as described above may a wall opposite to a wall of body 174 configured to be in fluid communication with an application member, as described herein.
While not shown, one or more nozzles as described herein may comprise a venting component as an integral portion thereof.
It should be understood that the systems described herein may comprise at least a body configured to be in fluid communication with one or more different application members, each of the one or more different applications members having at least one discharge aperture, wherein the at least one discharge aperture is optionally comprised by a removable and replaceable nozzle, as described herein. It should be understood that the systems as described herein may thus be configured to deliver a lavage fluid to a surface via one or more different, selectable fluid flow rates, fluid flow patterns, and/or fluid flow forces, as described herein. The systems of the present disclosure further include at least one venting component as described herein, the at least one venting component provided as an integral part of a body, an application member, and/or a nozzle of the system, or as part of a venting adaptor as described herein.
For example, the system may comprise at least two different application members and/or at least two different nozzles as described herein, wherein each of the at least two different application members and/or at least two different nozzles are configured to provide a unique fluid flow rate, fluid flow pattern, and/or fluid flow force. According to some aspects, a single application member and/or a single nozzle may be configured to provide at least two unique fluid flow rates, fluid flow patterns, and/or fluid flow forces, such as by providing one or more discharge apertures with adjustable shapes and/or sizes, as described herein.
According to some aspects, the system may be configured to provide an acceptable fluid flow rate for a lavage 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 subject during a lavage process. The fluid flow rate may depend at least partially on the delivery mechanism (e.g., compressing the body, orientating the body, utilizing a dispensing aid, or a combination thereof, as described herein) and/or the properties of the application member and/or nozzle as described herein. According to some aspects, a fluid flow rate may be related to a fluid flow force. For example, an increased fluid flow rate may correspond with an increased fluid flow force, and vice versa. The system according to the present disclosure may be configured to provide at least two different, selectable fluid flow rates, optionally at least three, optionally at least four, and optionally at least five.
According to some aspects, the system may be configured to provide an acceptable fluid flow force for a lavage process. As used herein, the term “fluid flow force” refers to the force of a fluid acting on a surface, such as on a human subject during a lavage process. An acceptable fluid flow force may be determined based on the lavage process requirements. Example fluid flow forces useful according to the present disclosure include, but are not limited to, between about 10 and 50 g, and optionally between about 15 and 45 g. According to some aspects, the fluid flow force may be about 15 g. According to some aspects, the fluid flow force may be between about 30 and 45 g. Other example fluid flow forces useful according to the present disclosure include, but are not limited to, between about 1 and 15 psi (referred to herein as “low pressure”) and between about 35 and 70 psi (referred to herein as “high pressure”).
It should be understood that the fluid flow force provided by the systems as described herein may depend at least partially on the delivery mechanism and/or the properties of the application member and/or nozzle as described herein. The system according to the present disclosure may be configured to provide at least two different, selectable fluid flow forces, optionally at least three, optionally at least four, and optionally at least five. It should be understood that each of the selectable fluid flow forces may correspond with, for example, a specific delivery mechanism, a specific application member, a specific nozzle, or a combination thereof, as described herein. For example, one or more selectable flow forces may correspond with an application member having an actuator as described herein, such as a trigger, wherein each of the one or more selectable flow forces may correspond with a degree of trigger compression. In another example, one or more selectable flow forces may correspond with a nozzle having one or more discharge apertures, wherein each of the one or more selectable flow forces may correspond with the shape and/or size of the one or more discharge apertures.
According to some aspects, the system is configured to provide an acceptable fluid flow pattern for a lavage process. As used herein, the term “fluid flow pattern” refers to the pattern with which a fluid is dispensed from a device and/or applied to a surface, such as to a human subject during a lavage process. In some non-limiting examples, the fluid flow pattern may comprise a fluid mist (i.e., a suspension of finely divided fluid in a gas), a fluid stream (i.e., a steady succession of fluid), a fluid spray (i.e., finely divided fluid), or a combination thereof. The fluid flow pattern may be constant (e.g., fluid continually dispensed from a device and/or applied to a surface) or pulsed (e.g., the fluid intermittently dispensed from a device and/or applied to a surface).
A fluid flow pattern may additionally or alternatively refer to the angle at which a fluid flow path is dispensed from a device and/or applied to a surface. For example, a fluid flow path may have a fluid flow pattern that is about perpendicular to a longitudinal axis of a body as described herein.
Additionally or alternatively, a fluid flow pattern may refer to the geometric shape of a fluid path. It should be understood that the geometric shape of a fluid path refers to a shape defined by the cross-sectional view of a fluid flow path in any of the x-direction, y-direction, and z-direction.
It should be understood that the fluid flow pattern may depend at least in part on the delivery mechanism and/or the application member and/or nozzle as described herein. The system according to the present disclosure may be configured to provide at least two different, selectable fluid flow patterns, optionally at least three, optionally at least four, and optionally at least five. For example, one or more selectable flow patterns may correspond with a dispensing aid such as a pump, wherein the pump may be configured to provide a constant flow of fluid from the body and/or to provide a pulsed flow of fluid from the body. In another example, one or more selectable flow patterns may correspond with the application member's discharge portion, such as a discharge portion comprising a semi-flexible conduit as described herein. In this example, the one or more selectable flow patterns may comprise one or more fluid delivery angles corresponding with the shape and/or orientation of the semi-flexible conduit as described herein.
Additionally or alternatively, the systems as described herein may be configured to provide rapid re-equilibrium periods. The systems as described herein may additionally or alternatively ensure that only filtered and/or sterile gas contacts a lavage fluid contained in the body.
According to some aspects, one or more components of the system described herein may be provided in sterile packaging. As used herein, the term “sterile packaging” refers to packaging that provides a sterile environment so as to maintain sterility of a contained sterile product. Example sterile packaging includes, but is not limited to, sterile blister packaging, sterile safe-edge trays, sterile surgical trays, sterile customized thermoforms, and combinations thereof. It should be understood that one or more components of the system may be provided in the same sterile packaging and/or separate sterile packaging from at least one other component of the system. For example, a first component of the system may be contained in a first sterile packaging and a second component of the system may be contained in a second sterile packaging. In one non-limiting example, the system may comprise a body contained in a first sterile packaging and an application member contained in a second sterile packaging. It should be understood that providing one or more components of the system in different sterile packaging allows for the removal of each component of the system immediately prior to its use, thus preventing one or more components from prolonged exposure to an unsterile environment. in this way, a fully assembled sterile presentation of the system may be achieved.
The present disclosure is also directed to a venting component useable with the devices and systems as described herein. The venting component comprises a fluid channel configured to provide fluid communication between the body and an external environment, and may further comprise at least one filter provided relative to the fluid channel sufficient to filter gas passing through the fluid channel. According to some aspects, at least a portion of the fluid channel is separate from a fluid path along which a lavage fluid is dispensed by the device or system.
The present disclosure is also directed to methods of using the devices and systems described herein. For example, the method may comprise providing a body containing a lavage fluid, wherein the body comprises a body connection portion. The method may comprise placing the body in fluid communication with an application member and dispensing the lavage fluid as described herein sufficient to perform a lavage process.
While the aspects described herein have been described in conjunction with the example aspects outlined above, various alternatives, modifications, variations, improvements, and/or substantial equivalents, whether known or that are or may be presently unforeseen, may become apparent to those having at least ordinary skill in the art. Accordingly, the example aspects, as set forth above, are intended to be illustrative, not limiting. Various changes may 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.
Thus, 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 an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is 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.”
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, 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 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 combinations may contain one or more member or members of A, B, or C. Nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims.
The word “about” is used herein to mean within ±5% of the stated value, 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%.
This application claims priority to U.S. Provisional Application No. 63/092,235, filed Oct. 15, 2020, the disclosures of which are expressly incorporated herein by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63092235 | Oct 2020 | US |
