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WO2025014749A2 - Adaptateur universel pour distribution assistée et manuelle - Google Patents

Adaptateur universel pour distribution assistée et manuelle Download PDF

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Publication number
WO2025014749A2
WO2025014749A2 PCT/US2024/036732 US2024036732W WO2025014749A2 WO 2025014749 A2 WO2025014749 A2 WO 2025014749A2 US 2024036732 W US2024036732 W US 2024036732W WO 2025014749 A2 WO2025014749 A2 WO 2025014749A2
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
optionally
valve
adaptor
flow path
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/036732
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English (en)
Other versions
WO2025014749A3 (fr
Inventor
Christopher MCGINLEY
Karan KERWELL
John Krueger
James Patrick Mcdonald
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CareFusion 2200 Inc
Original Assignee
CareFusion 2200 Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by CareFusion 2200 Inc filed Critical CareFusion 2200 Inc
Publication of WO2025014749A2 publication Critical patent/WO2025014749A2/fr
Publication of WO2025014749A3 publication Critical patent/WO2025014749A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A61M3/0258—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped by means of electric pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
    • A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
    • A61M3/0262—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped manually, e.g. by squeezing a bulb
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1077—Adapters, e.g. couplings adapting a connector to one or several other connectors

Definitions

  • the present disclosure is directed to an adaptor useable with a fluid container to provide at least two selectable modes of fluid delivery.
  • Intraoperative incisional wound irrigation is an accepted method to aid in the prevention of surgical site infections (SSIs).
  • SSIs surgical site infections
  • irrigation is typically conducted via one of two modes: manually (i.e., direct pour, bulb syringes, etc.) or assisted (i.e., the delivery of solution via an electrically powered lavage device).
  • solution is ty pically present within a fluid container hung from an IV pole in the non-sterile field while a pulsed lavage device operates in the sterile field.
  • the fluid container is stored outside of the sterile field due primarily to the limited space within the sterile field and in order to reduce clutter in the immediate vicinity' of the surgical cavity.
  • a healthcare practitioner typically applies manual pressure to a compressible fluid container in order to deliver irrigation fluid to a surgical cavity.
  • Manual delivery is ty pically accomplished using a device that interfaces with an irrigation fluid container by puncturing the container.
  • These devices generally have a relatively straightforward design, which lack in several areas. For example, after manual compression of a 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 pulled back into the container, thereby allowing the container to be compressed again to expel more fluid.
  • typical devices useable with such containers allow restoration of the container shape with air travelling through the fluid channel, which could potentially introduce contamination into the irrigation fluid itself or into the fluid channel.
  • Assisted delivery is typically performed by puncturing a fluid container with a device to create a fluid pathway.
  • such devices cannot be used without the lavage device and thus, fluid cannot be delivered manually once the device has punctured the fluid container.
  • healthcare providers are required to stock both types of devices (i.e., devices designed for manual delivers- and those designed for assisted delivery).
  • Current devices also limit the delivery of fluid from each fluid container to a single deliver ⁇ ' mode.
  • an adaptor 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 comprising a fluid outlet, at least one valve provided along the first fluid flow path, and a second fluid flow path that is separate from the first fluid flow path, wherein the at least one valve is configured to provide selection between assisted fluid delivery and manual fluid delivery.
  • kits and systems having the adaptor as described herein.
  • FIG. 1A shows an example adaptor according to aspects of the present disclosure.
  • FIG. IB shows an example adaptor according to aspects of the present disclosure.
  • FIG. 1C shows an example vent housing according to aspects of the present disclosure.
  • FIG. 2 shows an example adaptor having a valve according to aspects of the present disclosure.
  • FIG. 3 shows an example cross-slit valve according to aspects of the present disclosure.
  • the present disclosure is directed to an adaptor that is useable with a fluid container to provide at least two selectable modes of fluid delivery.
  • the adaptor may be configured to provide both assisted fluid delivery and manual fluid delivery via a single fluid container.
  • the adaptor may include a connection portion, a first fluid flow path, a second fluid flow path, a fluid outlet, and at least one valve provided along the first fluid flow path.
  • the disclosure is also directed to kits and systems having an adaptor and a fluid container as described herein.
  • the adaptor of the present disclosure is usable with a fluid container.
  • a fluid refers to a substance that has no fixed shape, such as a liquid or a gas.
  • the fluid is a lavage fluid.
  • lavage fluid refers to a fluid suitable for a lavage process as described herein.
  • lavage refers to the irrigation of a body cavity, a surgical cavity', and/or an external wound.
  • the lavage fluid may include an antiseptic solution.
  • an “antiseptic solution” refers to a solution having at least a solvent and one or more antiseptic agents.
  • the antiseptic solution is an aqueous solution.
  • the term “aqueous solution” refers to a solution wherein the solvent has at least a majority' of water. It should be understood that in some examples, the solvent mayconsist of water.
  • the antiseptic solution is an alcoholic solution.
  • the term “alcoholic solution” refers to a solution wherein the solvent has 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.
  • the antiseptic agent may include a cationic molecule (i.e., a molecule having a positive charge), such as a cationic surfactant or a cationic biguanide derivative (i.e., a compound derived from biguanide).
  • the antiseptic agent may include a bis-(dihydropyridinyl)-decane derivative (i.e., a compound derived from bis-(dihydropyridinyl)-decane).
  • the antiseptic agent may include an octenidine salt, a quaternary ammonium salt, and/or a chlorhexidine salt.
  • the antiseptic agent may include alexidine, octenidine dihydrochloride, chlorhexidine gluconate, sodium lauryl sulfate, citric acid, sodium citrate, benzalkonium chloride, polyaminopropyl biguanide, or a combination thereof.
  • the antiseptic agent may include iodine.
  • 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.
  • PVPI povidone-iodine
  • nonylphenoxy-(ethyleneoxy)-iodine polyethylene oxy polyprop leneoxy-iodine
  • undecoylinium-chloride-iodine iodine povacrylex
  • the antiseptic agent may include an oxidant (i.e., an oxidizing agent).
  • an oxidant i.e., an oxidizing agent.
  • oxidants include, but are not limited to, sodium hypochlorite, hydrogen peroxide, hypochlorous acid, 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.
  • 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 (B-hemolytic streptococci), S. salivarius, S. sanguis, Staphylococcus aureus S. epidermidis, S. haemolyticus, S. hominis, S. simulans, S. saprophyticus, methicillin/ oxacillinresistant (MRSA ORSA) and methicillin/oxacillin-susceptible Staphylococci (MSSA/OSSA), Enterococcus (e.g., E. faecalis E. faecium. and E.
  • Streptococcus mutans group A (B-hemolytic streptococci)
  • S. salivarius S. sanguis
  • Staphylococcus aureus S. epidermidis S. haemolyticus
  • S. hominis S. simulans
  • VRE vancomycin-resistant Enterococcus
  • VSE vancomycin-susceptible Enterococcus
  • 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 .
  • 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
  • CMV cytomegalovirus
  • HAV-1 human immunodeficiency virus
  • HSV-2 herpes simplex virus types 1
  • HSV-2 herpes simplex virus types 1
  • influenza virus parainfluenza virus
  • variola virus smallpox virus
  • vaccinia norovirus
  • coronavirus coronavirus
  • 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.
  • 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.
  • an acceptable log reduction may be microbedependent.
  • 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.
  • 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.
  • 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 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.
  • the antiseptic agent may be present in the antiseptic solution at a concentration of 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.
  • 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.
  • 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.
  • the antiseptic agent may function as a preservative by reducing or eliminating microbial contamination of the antiseptic solution after a container containing the same has been opened.
  • 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.
  • the lavage fluid may include a saline solution.
  • the saline solution may include 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.
  • the lavage fluid such as an antiseptic solution as described herein, may include a visualizing aid.
  • 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.
  • the antiseptic agent may function as a visualizing agent.
  • the lavage fluid may include a visualizing agent that is disparate from the antiseptic agent.
  • the lavage fluid may include a tinting agent.
  • 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.
  • the tinting agent may include 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.
  • the tinting agent may include a chemical compound that is observable upon exposure to visible and/or non-visible light, including, butnot limited to, vitamin B-12, medical honey, fluorescent polymeric nanoparticles, water soluble luminescent carbon nanodots, quinine, and combinations thereof.
  • the lavage fluid such as an antiseptic solution as described herein, may include a staining agent.
  • staining agent refers to a component sufficient to temporarily or permanently color a surface with which it comes in contact.
  • the lavage fluid such as an antiseptic solution as described herein, may include a radiopaque agent.
  • a radiopaque agent refers to a component that is opaque to the radio wave and x-ray portion of the electromagnetic spectrum sufficient for visualization.
  • the radiopaque agent may include barium, iodine, iron oxide nanoparticles, gadolinium complex nanospheres, silica nanospheres, and combinations thereof.
  • the lavage fluid such as an antiseptic solution as described herein, may be basic, neutral, or acidic.
  • 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.
  • the lavage fluid such as an antiseptic solution as described herein, may include a buffer system.
  • 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 include 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.
  • a buffer system has one or more buffer ranges wherein the buffer system has the ability to provide resistance to significant pH change.
  • 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.
  • Ka acid dissociation constant
  • 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 -loglOKa) of a weak acid comprised by the buffer system.
  • the lavage fluid such as an antiseptic solution as described herein, may include a stabilizing agent.
  • a stabilizing agent refers to any component that supports the stability of a lavage fluid not otherwise explicitly described herein.
  • the fluid container according to the present disclosure may include a body configured to contain a fluid as described herein.
  • the body may be compressible.
  • 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.
  • the body may be configured such that upon compression, at least a portion of the fluid contained therein is dispensed. It should be understood that as used herein, “dispense” (alternatively referred to as “discharge”) may refer to transferring the fluid to an adaptor in fluid communication with the fluid container and/or it may refer to transferring the fluid to a surface.
  • the body may be collapsible.
  • collapsible refers to the ability to permanently reduce in volume.
  • 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.
  • 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.
  • the body may include 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 unfit for medical use.
  • the body material may be sufficient to prevent unacceptable vapor or antiseptic loss from a fluid contained therein over a certain period of shelf life.
  • “unacceptable vapor or antiseptic loss'’ may be a loss that results in the 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.
  • the body material may be sufficient to prevent w ater vapor loss and/or iodine loss over a certain period of shelf life.
  • 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.
  • a product e.g., an antiseptic solution
  • 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.
  • shelflife 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.
  • the period of shelf life 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.
  • 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.
  • 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.
  • SAL Sterility Assurance Level
  • a body material may be determined to be sufficient for sterilization if a container comprising the body material has an SAL of at least 10‘ 3 after sterilization and provides an acceptable result upon integrity testing for the container closure after sterilization.
  • 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.
  • 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.
  • the body material may be safe for biomedical use.
  • the body material may comply with ISO 10993 and/or with REACH requirements.
  • the body material may be sufficient to exhibit at least a portion of the characteristics described herein over a certain period of the 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 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 fluid’s shelf life after storage at about 37° C and 65% relative humidity.
  • the body material may be rigid or flexible.
  • rigid refers to a stiffness sufficient to resist deformation upon normal operating forces.
  • 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.
  • the body material may be a lined and/or coated material, such as a lined and/or coated paper.
  • the present disclosure is directed to an adaptor that is useable with a fluid container as described herein.
  • the adaptor may include a connection portion configured to interact with a corresponding connection portion of a fluid container in order to provide a secure connection.
  • FIG. 1A shows an example adaptor 100 according to aspects of the present disclosure.
  • adaptor 100 may include a connection portion 101.
  • connection portion 101 may include one or more protrusions configured to interact with corresponding protrusions of a fluid container so as to form a screw connection, thereby allowing adaptor 100 to be screwed to a fluid container.
  • connection portion 101 may include any connection component sufficient to provide a secure connection between the adaptor and a fluid container.
  • connection portion 101 may be configured to provide a snap connection, a friction connection, or a combination thereof.
  • connection portion 101 may be configured to provide a secure connection with commercially available fluid containers as known in the art.
  • adaptor 100 may further include at least one spike element 104 at a first end of a first fluid flow path 102a.
  • spike element 104 may be configured to pierce a membrane of a fluid container sufficient to provide fluid communication between the fluid container and first fluid flow path 102a of adaptor 100.
  • spike element 104 may 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.
  • adaptor 100 is not necessarily limited in this way.
  • spike element 104 may be absent from adaptor 100 so long as a corresponding end of first fluid flow path 102a is terminated by at least one aperture sufficient to provide fluid communication between first fluid flow path 102a and a fluid container as described herein.
  • adaptor 100 may further include a second fluid flow path 102b configured to provide fluid communication between a fluid container as described herein and an atmosphere outside the fluid container when the fluid container is, for example, pierced by spike element 104 as described. In this way, pressure within the fluid container may be equalized as fluid is dispensed therefrom.
  • second fluid flow 7 path 102b may include at least one vent 106 which may have one or more features as describe in U.S. Provisional Patent Application No. 63/366,588.
  • vent 106 may be configured such that when air or gas flows into second fluid flow path 102b and thus into a fluid container, vent 106 prevents contaminants from entering the fluid container.
  • vent 106 may include a one-w ay valve or membrane, such as a membrane which prevents liquid solution from passing therethrough while allowing air to freely move into and/or out of a container.
  • vent 106 may include at least one material having a polarity that is opposite of the polarity of a fluid contained in a fluid container as described herein.
  • vent 106 may include at least one hydrophobic material in order to reduce the likelihood of aqueous fluid passing therethrough.
  • vent 106 may include a sterile filter, sterile porous foam, or sterile membrane in order to reduce or prevent contaminants from entering second fluid flow path 102b.
  • FIG. IB shows an example adaptor 100 having at least one vent (provided in vent halves 106a, 106b) in an exploded view.
  • vent halves 106a, 106b may be provided in a vent housing 107 of adaptor 100.
  • Vent halves 106a, 106b may be irreversibly secured in vent housing 107 in a manner sufficient to withstand pressure associated with dispensing a fluid from a fluid container as described herein, such as via manual and/or assisted fluid delivery (e.g., pressure associated with equilibrating the fluid container).
  • vent halves 106a, 106b may be welded and/or glued into vent housing 107.
  • FIG. 1C shows an example vent housing 107 without a filter, porous foam, or membrane.
  • adaptor 100 further includes an outlet 103 provided at an end of first fluid flow path 102a that is opposite spike element 104.
  • Outlet 103 is configured to dispense a fluid onto a surface, such as a surgical site during a lavage process.
  • FIG. 1A shows an example adaptor 100 having outlet 103 with a single discharge aperture
  • outlet 103 is not necessarily limited in this way.
  • outlet 103 may comprise a plurality of discharge apertures, such as two, three, four, or more discharge apertures.
  • Each of the discharge apertures may be the same size as or a different size from one or more of the other discharge apertures.
  • each of the discharge apertures may have the same shape as or a different shape from one or more of the other discharge apertures.
  • Adaptor 100 may further include at least one valve 105 provided along first fluid path 102a, and in particular, between spike element 104 and outlet 103.
  • valve 105 is configured such that adaptor 100 may provide at least two selectable modes of fluid delivery.
  • the at least two selectable modes of fluid delivery include assisted fluid delivery and manual fluid delivery.
  • “assisted fluid delivery” refers to delivery 7 of fluid using at least one pumping device.
  • pumping devices include electric pumps, electromechanical devices, pneumatic devices, and syringes.
  • pumping devices may be configured to provide a continuous flow of fluid from a fluid device. Additionally or alternatively, pumping devices may be configured to provide an intermittent flow of fluid, also referred to herein as a “pulsed” flow.
  • manual fluid delivery refers to delivery of fluid without a pumping device.
  • manual fluid delivery may include compressing the body such that at least a portion of the fluid contained therein is dispensed.
  • FIG. 2 shows an example of an adaptor 200 having a valve 201 as described herein.
  • FIG. 2 also shows three different positions of valve 201.
  • valve 201 in a first position 2001, valve 201 is closed so as to prevent the passage of fluid therethrough.
  • Second position 2002 shows an example of manual fluid delivery’.
  • pressure from a fluid stream 202 created by, for example, compressing a fluid container as described herein forces valve 201 into an open position. In this way, fluid from fluid stream 202 may pass therethrough.
  • valve 201 may return to the closed position, i.e., first position 2001.
  • valve 201 In this way, air from an outside environment may be prevented from entering a fluid container through valve 201.
  • in the closed position inadvertent passage of fluid from fluid container through valve 201 may be prevented. Rather, air from an outside environment would enter the fluid container via a second fluid flow path (e.g., second fluid flow path 102b, as shown and described in relation to FIG. 1A), thereby passing through at least one vent and preventing contaminants from entering the fluid container.
  • second fluid flow path e.g., second fluid flow path 102b, as shown and described in relation to FIG. 1A
  • Third position 2003 shows an example of assisted fluid delivery.
  • a portion of a pumping device such as a spike 203
  • Valve 201 therefore remains in the open position to allow fluid 205 to flow therethrough.
  • valve 201 is configured to prevent inadvertent dislodgement of a pumping device (e.g., spike 203) therethrough.
  • valve 201 may be configured such that a sufficient friction is generated between valve 201 and spike 203 so as to reduce or prevent slippage of spike 203 relative to valve 201.
  • This friction may be provided by selecting a certain valve material and/or by providing a valve having one or more texturizing features configured to interact with a portion of a pumping device (e.g., spike 203).
  • Texturizing features may include, but are not limited to, ridges, ribs, bumps, and combinations thereof.
  • valve 201 may have a structure that allow s both manual fluid delivery’ and assisted fluid delivery’ as described.
  • valve 201 may include a cross-slit valve 300 as shown in FIG. 3.
  • cross-slit valves 300 may include two slits forming a generally ‘'x-shape.”
  • cross-slight valves 300 may open in two directions.
  • valve 201 opens in a first direction in position 2002 (e.g., toward an outlet 204 of adaptor 200) and in a second direction in position 2003 (i.e., in a direction opposite the first direction).
  • first direction in position 2002 e.g., toward an outlet 204 of adaptor 200
  • second direction in position 2003 i.e., in a direction opposite the first direction.
  • the present disclosure is not necessarily limited to this example.
  • the valve may have any structure capable of providing at least two selectable modes of fluid delivery as described herein.
  • the valve may have a single slit or three, four, five, or more slits.
  • the valve is a duckbill valve.
  • the valve is a check valve, such as a mechanical or pneumatic check valve.
  • the valve may be configured to provide a certain fluid flow force, fluid flow rate, and/or fluid flow pattern.
  • fluid flow force 7 refers to the force of a fluid acting on a surface, such as on a human subject during a lavage process. It should be understood that the fluid flow force according to the present disclosure may be acceptable for use in a lavage process as described herein.
  • an acceptable fluid flow force may 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.
  • an acceptable fluid flow force may be between 1 and 20 psi, optionally between 1 and 15 psi, and optionally between about 4 and 15 psi.
  • an acceptable fluid flow force may 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.
  • 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.
  • 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.
  • the valve may have a certain number of slits in order to provide a certain fluid flow force, fluid flow rate, and/or fluid flow pattern as described herein.
  • the valve may have one slit, two slits, three slits, four slits, five slits, or more slits as known in the art.
  • the number of slits may also affect the level of force required to open the valve (e.g.. an increase in slit number may decrease the force required by a fluid stream to open the valve).
  • the number of slits may also correspond with the size of an aperture created by the open valve, which may affect the fluid flow force, fluid flow rate, and/or fluid flow pattern.
  • the valve may have one or more slits with a certain length and/or geometry. It should be understood that the length of the one or more slits may affect the level of force required to open the valve (e.g., an increase in slit length may decrease the force required by a fluid stream to open the valve). Additionally or alternatively, the one or more slits may have a certain geometric pattern configured to provide a certain fluid flow force, fluid flow rate, and/or fluid flow pattern.
  • one or more other characteristics of the valve may be selected to provide a certain fluid flow force, fluid flow rate, and/or fluid flow pattern.
  • Example valve characteristics including valve size (e.g.. valve diameter), valve shape, valve material, valve thickness, orientation of the valve in the adaptor, position of the valve along the first fluid flow path, and combinations thereof.
  • the valve may include a valve material selected to provide a certain fluid flow force, fluid flow rate, and/or fluid flow pattern.
  • Example valve materials include, for are not limited to, silicone, rubber, laminates, elastomeric materials.
  • the valve material may include polyisoprene, polybutadiene, polyether, polysulfide, polyethylene, polyvinyl chloride, polyetheretherketone, polypropylene, nitrile, neoprene, ethylene propylene diene monomer rubber, rigid plastic, metal steel, glass, or a combination thereof.
  • the valve may include one or more check balls and/or springs.
  • a more flexible valve material e g., silicone
  • a more rigid material e.g., vulcanized rubber
  • the molecular weight, degree of cross-linkage, and/or specific additives contained by the valve material may affect the level of force required to open the valve.
  • the thickness of the valve may affect the level of force required to open the valve (e.g., an increase in thickness may increase the force required by a fluid stream to open the valve).
  • the shape of the valve may affect the level of force required to open the valve.
  • the valve may comprise a duckbill valve, which may require a different level of force to open than the force required to open a cross-slit valve.
  • the orientation of the valve in the adaptor and/or the position of the valve along the first fluid flow path may affect the level of force required to open the valve.
  • the orientation of the valve may affect the force required for a portion of a pumping device to pass therethrough.
  • adaptor 100 may include a burst disc instead of or in addition to valve 105 as described herein.
  • the burst disc may be configured rupture when a certain compression force is applied to the fluid container. Once the burst disc has ruptured, fluid may be manually delivered as described herein. Alternatively, burst disc may be ruptured by a spike 203 of a pumping device as described herein.
  • one or more components of adaptor 100 may include a transparent material.
  • a “transparent material” refers to a material that allows light to pass therethrough sufficient for objects on an opposite side from a viewer to be seen. In this way. adaptor 100 may reduce the risk associated with incorrect insertion of a spike 203 of a pumping device as described herein, and thus, the risk of inadvertent dislodgement of spike 203.
  • kits having an adaptor as described herein may include the adaptor and instructions for use, such as instructions for securing the adaptor to a fluid container as described herein.
  • the kit may include an adaptor, a fluid container, and optionally instructions as described herein.
  • the present disclosure is also directed to systems having a fluid container with at least a first connection portion that is connected with a second connection portion of an adaptor as described herein.
  • the method may include providing a fluid container, securely connecting an adaptor to the fluid container, and dispensing fluid from the fluid container via the adaptor by manual or assisted delivery.
  • the method may further include performing a lavage process, that is, flushing of a body cavity, a surgical cavity, and/or an external wound with the fluid from the device.
  • ranges by endpoints include all numbers subsumed within that range, for example, between about 1 minute and 60 minutes includes 21, 22, 23, and 24 minutes as endpoints within the specified range.
  • ranges 22-36, 25-32, 23-29, etc. are also ranges with endpoints subsumed within the range 1- 60 depending on the starting materials used, temperature, specific applications, specific embodiments, or limitations of the claims if needed.
  • the Examples and methods disclosed herein demonstrate the recited ranges subsume every point within the ranges because different synthetic products result from changing one or more reaction parameters. Further, the methods and Examples disclosed herein describe various aspects of the disclosed ranges and the effects if the ranges are changed individually or in combination with other recited ranges.
  • 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.
  • 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 term “about” and “approximately” are defined to being close to as understood by one of ordinary skill in the art. In one non-limiting embodiment, the term “about” and “approximately” are defined to be within 10%, preferably within 5%, more preferably within 1%, and most preferably within 0.5%.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Pulmonology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Quick-Acting Or Multi-Walled Pipe Joints (AREA)
  • Mechanically-Actuated Valves (AREA)
  • Valve Housings (AREA)

Abstract

L'invention concerne un adaptateur ayant une partie de connexion pouvant être connectée à un récipient de fluide, un premier trajet d'écoulement de fluide ayant une première extrémité et une seconde extrémité, la première extrémité étant configurée pour fournir une communication fluidique avec le récipient de fluide et la seconde extrémité ayant une sortie de fluide, au moins une soupape disposée le long du premier trajet d'écoulement de fluide, et un second trajet d'écoulement de fluide qui est séparé du premier trajet d'écoulement de fluide, la ou les soupapes étant configurées pour fournir une sélection entre une distribution de fluide assistée et une distribution manuelle de fluide. L'invention concerne également des systèmes, des kits et des procédés comprenant un adaptateur.
PCT/US2024/036732 2023-07-07 2024-07-03 Adaptateur universel pour distribution assistée et manuelle Pending WO2025014749A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363525501P 2023-07-07 2023-07-07
US63/525,501 2023-07-07

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WO2025014749A2 true WO2025014749A2 (fr) 2025-01-16
WO2025014749A3 WO2025014749A3 (fr) 2025-04-17

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WO (1) WO2025014749A2 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2957501A (en) * 1958-08-25 1960-10-25 Burroughs Wellcome Co Device for dispensing muscle relaxant drugs
US4532969A (en) * 1983-09-21 1985-08-06 Kwaan Hau C Fluid withdrawal and instillation device
IN2014MN00187A (fr) * 2003-10-30 2015-08-21 Teva Medical Ltd
US9585812B2 (en) * 2012-02-07 2017-03-07 Yukon Medical, Llc Transfer device with fluid filter

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