WO2024118742A2 - Dispositif de rinçage chirurgical intégré - Google Patents

Dispositif de rinçage chirurgical intégré Download PDF

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Publication number
WO2024118742A2
WO2024118742A2 PCT/US2023/081553 US2023081553W WO2024118742A2 WO 2024118742 A2 WO2024118742 A2 WO 2024118742A2 US 2023081553 W US2023081553 W US 2023081553W WO 2024118742 A2 WO2024118742 A2 WO 2024118742A2
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WO
WIPO (PCT)
Prior art keywords
container
fluid
connection
aspects
rinsing
Prior art date
Application number
PCT/US2023/081553
Other languages
English (en)
Inventor
Christopher MCGINLEY
John Krueger
Karan KERWELL
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 WO2024118742A2 publication Critical patent/WO2024118742A2/fr

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D47/00—Closures with filling and discharging, or with discharging, devices
    • B65D47/04—Closures with discharging devices other than pumps
    • B65D47/20—Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge

Definitions

  • the present disclosure is directed to rinsing devices and systems having the same.
  • Intraoperative incisional wound irrigation is a common process for preventing surgical site infections (SSIs) in medical settings.
  • Such processes generally require a manual irrigation device (e.g., a bulb or syringe) or a motorized irrigation device (i.e., a device having an electrical pump).
  • motorized irrigation devices are designed to pump irrigation fluid from a container outside of the sterile field, such as a container similar to an IV bag, due to limited space within the sterile field. Fluid connection between the irrigation device and container is normally provided via tubing.
  • tubing required to connect these devices to containers can introduce safety concerns, such as tripping risks.
  • location of the container outside of the sterile field introduces the risk of compromising the sterile field.
  • the tubing required by these devices may come into contact with a non-sterile environment (e.g., the floor) and therefore required replacement, prompting process delays in addition to increased waste and costs.
  • the use of such tubing requires additional process steps along with additional irrigation fluid in order to prime the device.
  • the present disclosure is directed to a device for dispensing a rinsing fluid, the device having a connection portion directly and reversibly connectable with a container, the container configured to house a rinsing fluid, a discharge portion, a fluid path providing fluid communication between the container and the discharge portion, and an actuator.
  • the connection portion, the discharge portion, and the actuator form a single unitary device.
  • Also disclosed are systems for dispensing a rinsing fluid the system including a device having a connection portion, a discharge portion, and an actuator, and further including a connection adaptor having a first face, at least a portion of which is receivable in the connection portion, and a second face, at least a portion of which is reversibly connectable with a container configured to house a rinsing fluid.
  • the system is configured to provide a fluid path from the container to the discharge portion, and the connection adaptor is configured such that when the first face is received in the connection portion and the second face is connected with the container, the connection portion is directly adjacent to the container.
  • the present disclosure is also directed to systems having the device of the present disclosure, one or more containers as described herein, and optionally a connection adaptor as disclosed herein. Also disclosed are methods of making and using the devices and systems as described herein.
  • FIG. 1 shows an example device according to aspects of the present disclosure.
  • FIG. 2 shows an example connection adaptor according to aspects of the present disclosure.
  • FIG. 3 shows an example device according to aspects of the present disclosure.
  • FIG. 4A shows an example device according to aspects of the present disclosure.
  • FIG. 4B shows an example device according to aspects of the present disclosure.
  • FIG. 4C shows an example device according to aspects of the present disclosure.
  • FIG. 4D shows an example device according to aspects of the present disclosure.
  • FIG. 4E shows an example device according to aspects of the present disclosure.
  • FIG. 5A shows an example fluid flow component according to aspects of the present disclosure.
  • FIG. 5B shows an example fluid flow component according to aspects of the present disclosure.
  • the present disclosure is directed to a device for dispensing a rinsing fluid, the device having a connection portion reversibly connectable with a container configured to house a rinsing fluid, a discharge portion, a fluid path providing fluid communication between the container and the discharge portion, and an actuator.
  • the connection portion may be configured such that the container is provided a first distance from the discharge portion, the first distance being sufficient for the container to be contained within a sterile field during operation of the device.
  • fluid refers to a substance that has no fixed shape, such as a liquid or a gas.
  • rinsing fluid refers to a fluid suitable for a rinsing process.
  • Non-limiting examples of rinsing processes include processes for flushing of a body cavity, a surgical cavity, and/or an external wound and processes involving the flushing of a medical device prior to contact with a subject.
  • Example medical devices include, but are not limited to, surgical equipment and medical implants.
  • the rinsing fluid may include an antiseptic solution.
  • an “antiseptic solution” refers to a solution including 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 includes at least a majority of water. It should be understood that in some examples, the solvent may consist of water.
  • the antiseptic solution is an alcoholic solution.
  • the term “alcoholic solution” refers to a solution wherein the solvent includes at least a majority of an alcoholic component.
  • the solvent may consist of one or more alcoholic components.
  • alcoholic components include, but are not limited to, ethanol, isopropyl alcohol, n-propanol, and combinations thereof.
  • the solvent may include both water and an alcoholic component.
  • the solvent may include about 90% (v/v) of an alcoholic component and the remaining volume water, optionally about 80% (v/v) of an alcoholic component and the remaining volume water, optionally about 70% (v/v) of an alcoholic component and the remaining volume water, optionally about 60% (v/v) of an alcoholic component and the remaining volume water, optionally about 50% (v/v) of an alcoholic component and the remaining volume water, optionally about 40% (v/v) of an alcoholic component and the remaining volume water, optionally about 30% (v/v) of an alcoholic component and the remaining volume water, optionally about 20% (v/v) of an alcoholic component and the remaining volume water, and optionally about 10% (v/v) of an alcoholic component and the remaining volume water.
  • the solvent may include about 90% (v/v) or less of an alcoholic component and the remaining volume water, optionally about 80% (v/v) or less of an alcoholic component and the remaining volume water, optionally about 70% (v/v) or less of an alcoholic component and the remaining volume water, optionally about 60% (v/v) or less of an alcoholic component and the remaining volume water, optionally about 50% (v/v) or less of an alcoholic component and the remaining volume water, optionally about 40% (v/v) or less of an alcoholic component and the remaining volume water, optionally about 30% (v/v) or less of an alcoholic component and the remaining volume water, optionally about 20% (v/v) or less of an alcoholic component and the remaining volume water, and optionally about 10% (v/v) or less of an alcoholic component and the remaining volume water.
  • 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 and/or a chlorhexidine salt.
  • the antiseptic agent may include alexidine, octenidine dihydrochloride, chlorhexidine gluconate, 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).
  • oxidants include, but are not limited to, sodium hypochlorite, hydrogen peroxide, and combinations thereof.
  • the antiseptic agent may include a quaternary ammonium salt.
  • Non-limiting examples of quaternary ammonium salts include benzalkonium chloride, benzethonium chloride, methylbenzethonium chloride, cetalkonium chloride, cetylpyridinium chloride, cetrimonium, cetrimide, dofanium chloride, tetraethylammonium bromide, didecyldimethylammonium chloride, domiphen bromide, and combinations thereof.
  • the antiseptic agent may include one or more surfactants.
  • the one or more surfactants may include an ionic surfactant, a non-ionic surfactant, a zwitterionic surfactant, or a combination thereof.
  • the one or more surfactants may include sodium lauryl sulfate, sodium laureth sulfate, citric acid, sodium citrate, oleic acid, cetylpyridinium chloride, soya lecithin, polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monostearate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (10) stearyl ether, polyoxyethylene (2) oleyl ether, polyoxyethylene-polyoxypropylene-ethylenediamine block copolymer, polyoxypropylenepolyoxyethylene block copolymers, castor oil ethoxylate, polyoxyethylene nonylphenol ether, Cremophor, 2-(2-ethoxy-ethoxy) ethanol, salts thereof, and mixtures thereof.
  • the antiseptic agent may include one or more antibiotics.
  • antibiotics include cefazolin, vancomycin, gentamicin, bacitracin, and combinations thereof.
  • the rinsing solution may include any combinations of the antiseptic agents as described herein.
  • the antiseptic agent and/or combination of antiseptic agents may have an antimicrobial activity sufficient to provide an acceptable log reduction of microbes in a certain time period.
  • microbe may refer to any microorganism to be killed and/or removed as a result of rinsing.
  • Example microbes include bacteria, fungi, viruses, and combinations thereof.
  • Example bacteria include, but are not limited to, Streptococcus mutans, S. pyogenes (group A P-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.
  • Streptococcus mutans group A P-hemolytic streptococci
  • S. salivarius S. sanguis
  • Staphylococcus aureus S. epidermidis S. haemolyticus
  • S. hominis S. simulans
  • S. saprophyticus me
  • 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. 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 jloccosum, 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 rinsing fluid is not necessarily an antiseptic solution as described herein and may be any medically acceptable fluid sufficient for performing a rinsing process as described herein.
  • the rinsing 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 rinsing fluid may include a buffer system having one or more buffer components.
  • buffer system refers to a component of a rinsing fluid that provides a resistance to significant change in pH caused by a strong acid or base.
  • a buffer system may include two or more buffer components, 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 rinsing fluid, thereby at least partially preventing the pH of the rinsing fluid 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 rinsing fluid 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 (K a ) of one or more weak acids included 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 pK a , equal to -logioK a ) of a weak acid included by the buffer system.
  • the one or more buffer components may include the acid or salt forms of one or more of lactate, phosphate, borate, tartrate, glutamate, malate, citrate, gluconate, benzoate, succinate, acetate, glycine, and aspartate.
  • the one or more buffer components may include lithium hydroxide, sodium hydroxide, potassium hydroxide, rubidium hydroxide, cesium hydroxide, calcium hydroxide, strontium hydroxide, sodium phosphate dibasic dihydrate, and/or barium hydroxide.
  • the rinsing fluid may include a pH adjusting agent.
  • pH adjusting agent refers to a component of a rinsing fluid that modifies the rinsing fluid’s pH.
  • the pH adjusting agent may include one or more of acetic acid, adipic acid, ascorbic acid, citric acid, hydrochloric acid, lactic acid, malic acid, monopotassium phosphate, monosodium phosphate, phosphoric acid, pyrophosphoric acid, succinic acid, sulfuric acid, tartaric acid, and solutions thereof.
  • the rinsing fluid as described herein may be contained within a container.
  • the container of the present disclosure may include a body portion and an outlet configured to dispense fluid therefrom.
  • the container may be formed from a container material, which may be rigid or flexible.
  • the term “flexible” refers to the ability to bend, compress, or collapse under normal operating forces.
  • the flexible container may be compressible.
  • 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. Additionally or alternatively, the flexible container may be collapsible.
  • the term “collapsible” refers to the ability to permanently reduce in volume.
  • a collapsible container 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 container may collapse to have a second volume, the second volume being less than the first volume.
  • rigid refers to a stiffness sufficient to resist deformation upon normal operating forces. It should be understood that a rigid container may not be compressible or collapsible.
  • Examples of container materials useful according to the present disclosure 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, polyvinyl chloride (PVC), polyethylene terephthalate (PET), and any combination thereof.
  • the container material may be a lined and/or coated material, such as a lined and/or coated paper.
  • the container may include a venting component.
  • the venting component may include a fluid channel configured to provide fluid communication between the container and an external environment.
  • at least a portion of the fluid channel is separate from a fluid path along which the rinsing fluid is dispensed from the container (i.e., through the container’s outlet).
  • the venting component may further include a filter, particularly a sterile filter.
  • Example venting components useful according to the present disclosure include those disclosed in U.S. Patent Publication No. 2022/0118169, the contents of which are expressly incorporated herein by reference in their entirety.
  • the device of the present disclosure includes a connection portion that is reversibly connectable with a container as described herein.
  • the connection portion may be connectable with a container such that an outlet of the container is provided in fluid communication with the device, thus providing a fluid path for the rinsing fluid to travel from the container to the device.
  • the phrase “reversibly connected” refers to a connection that may be selectably disconnected.
  • a reversible connection may include a screw connection that may be selectably unscrewed.
  • the device may be provided with an activator (e.g., a button or a lever) that may be activated to disconnect the reversible connection.
  • an activator e.g., a button or a lever
  • Non-limiting examples of secure, fluid-tight, and reversible connections include screw connections, bayonet-style connections, snap connections, friction connections, and combinations thereof.
  • connection portion of the device may include one or more connection components that mate with one or more corresponding connection components of the container in order to provide a secure, fluid-tight, and reversible connection.
  • FIG. 1 shows an example device according to the present disclosure.
  • FIG. 1 shows a device 100 having a connection portion 101 that is reversibly connectable with a container 102 as described herein.
  • container 102 may include an outlet (not shown) receivable within connection portion 101.
  • container 102 may be any container for containing a rinsing fluid as known in the art.
  • container 102 may include a puncturable material such that when it is provided in connection with connection portion 101, a portion of connection portion 101 and/or an adaptor (as will be described) punctures container 102 to provide fluid communication therewith.
  • connection portion 101 may include, for example, male or female threading configured to provide a screw connection with a corresponding male or female threading provided on an outside surface of container 102 (i.e., the surface surrounding the outlet). It should be understood, however, that device 100 is not limited in this way.
  • connection portion 101 may have one or more one or more radial pins or one or more slots corresponding with one or more radial pins or one or more slots provided on an outside surface of container 102 sufficient to provide a bayonet-style connection.
  • connection adaptor 200 may mate with connection portion 101 and container 102 as shown in FIG. 1 to provide a secure, fluid- tight, and reversible connection.
  • connection adaptor 200 may have a first face 203 forming at least a portion of an outer surface 201.
  • Outer surface 201 may have one or more connection components that mate with one or more corresponding connection components on an inner surface of connection portion 101 as shown in FIG. 1.
  • Connection adaptor 200 may further include a second face 204 forming at least a portion of an inner surface (not shown).
  • connection adaptor 200 may be “sandwiched” between of connection portion 101 of device 100 and container 102 sufficient to provide a secure, fluid-tight, and reversible connection.
  • connection adaptor 200 may be configured such that when it is provided in this sandwiched position (that is, when at least a portion of the first face 203 is received in the connection portion 101 and at least a portion of the second face 204 is connected with the container 102), connection portion 101 of device 100 may be directly adjacent to container 102.
  • Connection adaptor 200 may further include an outlet 202 (e.g., an outlet of a nozzle portion) sufficient to provide a fluid path between container 102 and device 100.
  • connection adaptor 200 may allow for a secure, fluid-tight, and reversible connection between device 100 and various containers, including commercially available containers.
  • connection adaptor 200 may include an inner surface having a male or female threading configured to provide a secure, fluid-tight, and reversible connection with various commercial containers having a male or female threading.
  • the commercial container may include the BD SurgiphorTM Antimicrobial Irrigation System 450 mL bottle.
  • container 102 is connected to device 100 such that fluid housed inside container 102 may travel to device 100 along a fluid path.
  • the fluid path may further be in communication with a discharge portion 103 of device 100 as shown in FIG. 1.
  • discharge portion 103 may be configured to apply a rinsing fluid to a surface, such as a body cavity, a surgical cavity, and/or an external wound. Additionally or alternatively, discharge portion 103 may be configured to apply rinsing fluid to a medical device prior to contact with a subject, as described herein.
  • discharge portion 103 may include a nozzle portion. While not shown in FIG. 1, the nozzle portion may include one, two, three, four, or more discharge apertures. According to some aspects, one or more of the discharge apertures may include one or more restrictive features configured to prevent unacceptable fluid passage therethrough.
  • one or more of the discharge apertures may include a one-way valve having a first, closed position that prevents fluid passage therethough and a second, open position that allows fluid passage therethrough.
  • the one-way valve may be provided in the first position when subjected to pressure from one direction (e.g., liquid pressure from a rinsing fluid).
  • the oneway valve may readily move to the second position when subjected to pressure from a different direction (i.e., air pressure from a surrounding environment).
  • Each of the discharge apertures may be the same size as or a different size from one or more of the other discharge apertures. Additionally or alternatively, each of the discharge apertures may have the same shape as or a different shape from one or more of the other discharge apertures.
  • the shape and/or size of the one or more discharge apertures may be selected to provide a certain fluid flow force, fluid flow rate, and/or fluid flow pattern. According to some aspects, the shape and/or size of the one or more discharge apertures may be adjustable such that the fluid flow force, fluid flow rate, and/or fluid flow pattern of a dispensed fluid may be adjustable.
  • fluid flow force refers to the force of a fluid acting on a surface, such as on a human subject and/or medical device during a rinsing process. It should be understood that the fluid flow force according to the present disclosure may be acceptable for use in a rinsing 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 and/or a medical device during a rinsing 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 and/or a medical device during a rinsing process.
  • all or a portion of discharge portion 103 as shown in FIG. 1 may be removable and replaceable.
  • the nozzle portion may be removable and replaceable, thereby allowing the same discharge portion to interchangeably communicate with at least two different nozzle portions.
  • all or a portion of discharge portion 103 may be removable and replaceable before a rinsing process, during a rinsing process, after a rinsing process, or a combination thereof.
  • discharge portion 103 may include one or more extending features configured to provide increased accessibility to a surface, such as a body cavity, a surgical cavity, an external wound, and/or a medical device.
  • discharge portion 103 may include a bendable and/or telescopic feature that may be adjusted to perform a rinsing process on difficult to access surfaces.
  • device 100 may further include heating and/or cooling element configured to adjust the temperature of a rinsing fluid dispensed therefrom.
  • the heating and/or cooling element may be configured to maintain the temperature of the rising fluid within normothermia range during a rinsing process.
  • a “normothermia range” refers to the normal temperature range of the human body, such as between about 36 and 38° C.
  • device 100 may have a light source configured to increase visibility of a surface being rinsed.
  • device 100 may be configured to provide an adjustable fluid flow force, fluid flow rate, fluid flow pattern, or a combination thereof.
  • device 100 may be provided with a fluid flow component configured to adjust the shape and/or size of one or more discharge apertures as described herein.
  • the fluid flow component may include a rotatable component, such as a rotatable plate, provided at any point along the fluid path as described herein (e.g., over one or more apertures of the discharge portion).
  • the rotatable component may include one or more apertures that may be selectably aligned with the one or more apertures of the discharge portion to provide a selectable fluid flow force, fluid flow rate, and fluid flow pattern as described herein.
  • FIG. 5A shows one example of a fluid flow component 500 as described herein.
  • fluid flow component 500 may include one, two, three, or more apertures 501, each having the same size as or a different size from one or more other apertures 501. It should be understood that a user may select a fluid flow force, fluid flow rate, and/or fluid flow pattern by rotating fluid flow component 500 such that a desired aperture 501 is aligned with one or more apertures of the discharge portion as described herein.
  • fluid flow component 500 may have a different shape from the shape(s) shown in FIG. 5A.
  • fluid flow component 500 may include one or more apertures 501 that are configured to provide a variable fluid flow force, fluid flow rate, and/or fluid flow pattern.
  • FIG. 5B shows a fluid flow component 500 having an aperture 501 with a varying diameter. It should be understood that a user may select a fluid flow force, fluid flow rate, and/or fluid flow pattern by rotating fluid flow component 500 such that a selected portion of aperture 501 is aligned with one or more apertures of the discharge portion as described herein.
  • device 100 may be configured such that fluid is intermittently dispensed, also referred to herein as a “pulsed” flow.
  • device 100 may include a pulsing component that intermittently interrupts the fluid path as described herein.
  • the pulsing component may include a rotating component provided at any point along the fluid path as described herein (e.g., within an aperture of the discharge portion or over an aperture of the discharge portion).
  • the pulsing component may have one or more apertures therein such that, as the pulsing component rotates, the one or more apertures may intermittently allow for fluid to pass therethrough and along the fluid path, thus providing a pulsed flow of fluid as described herein.
  • the rotating component includes a rotating plate.
  • the rotating component has a pinwheel shape.
  • the rotating component may be driven by a power source (e.g., a motor). Additionally or alternatively, fluid moving along the fluid path may drive the rotating component, for example, when the rotating component has a pinwheel shape.
  • the pulsing component may be a permanent component of the device (i.e., not removable by normal operating procedures) or may be removable.
  • connection portion 101 of device 100 may be configured such that container 102 is provided a first distance from discharge portion 103, the first distance being sufficient for container 102 to be contained within a sterile filed during operation of device 100 (e.g., during a rinsing process).
  • the first distance may be less than about 3 feet, optionally less than about 2.5 feet, optionally less than about 2 feet, optionally less than about 1.5 feet, optionally less than about 1 foot, optionally less than about 11 inches, optionally less than about 10 inches, optionally less than about 9 inches, optionally less than about 8 inches, optionally less than about 7 inches, optionally less than about 6 inches, optionally less than about 5 inches, optionally less than about 4 inches, optionally less than about 3 inches, optionally less than about 2 inches, and optionally less than about 1 inch.
  • Device 100 may further include an actuator such that when the actuator is actuated, fluid is discharged via discharge portion 103.
  • actuator 104 may include a button.
  • actuator 104 may additionally or alternatively include a switch, lever, knob, trigger, or combination thereof. It should also be understood that while FIG. 1 shows actuator 104 provided on a proximal end of handle 105, actuator 104 may be provided on any portion of device 100 sufficient for a user to actuate device 100 during use of device 100, particularly during use of device 100 in a rinsing process.
  • actuator 104 may be in communication with a motor (not shown), the motor being configured to drive fluid from container 102 along a fluid path to a discharge portion 103 sufficient to dispense fluid to a surface as described herein.
  • the motor may be powered by a power source that is completely contained within the device (e.g., a battery).
  • device 100 may be configured such that fluid is continuously dispensed upon actuation of actuator 104.
  • device 100 may be configured such that when actuator 104 is actuated, fluid is dispensed from device 100 in an uninterrupted stream until actuator 104 is no longer actuated.
  • device 100 may be configured so as to provide a pulsed flow of fluid.
  • device 100 may be configured such that when actuator 104 is actuated, fluid is dispensed from device 100 in discrete pulses until actuator 104 is no longer actuated.
  • the motor may be configured to fluctuate between an active and inactive state upon actuation of the actuator such that the motor fluctuates between driving fluid and not driving fluid as described herein.
  • device 100 may be configured such that a user may select a continuous flow or a pulsed flow. Additionally or alternatively, device 100 may be configured such that a user may select a fluid flow force and/or a fluid flow rate as described herein. In one non-limiting example, the motor may be configured to provide a selected level of power corresponding with a selected fluid flow force and/or a fluid flow rate. According to some aspects, device 100 may be configured such that a user may select from a continuous spectrum of a fluid flow forces and/or a fluid flow rates. Additionally or alternatively, device 100 may be configured such that a user may select from one, two, three, four, or more discrete fluid flow forces and/or a fluid flow rates.
  • device 100 may be configured such that, when provided as part of a system herein along with one or more containers 102, every component of the system may be contained within a sterile field during use.
  • a “sterile field” refers to an area in which a medical procedure is performed (e.g., an area around a patient’s body) and in which all items are sterile.
  • device 100 of FIG. 1 may be configured such that when used in a rinsing process, all components of device 100 and container 102 may be contained within the sterile field.
  • two or more of the components as described herein may be configured to provide a single unitary device.
  • unitary device refers to a device that is configured to form a single unit wherein no portions thereof are detachable under normal operating conditions.
  • at least the connection portion, the discharge portion, and the actuator of the present disclosure form a single unitary device.
  • device 100 may be configured such that when it is connected to container 102, container 102 is provided in a certain position relative to device 100.
  • the certain position may be a position acceptable for a medical procedure, such as a rinsing process.
  • an acceptable position is a position that does not obstruct a practitioner’s line of vision during a medical procedure.
  • an acceptable position is a position that does not disrupt a medical procedure, for example, by providing inadvertent contact between the system and a patient’s body.
  • an acceptable position is a position that provides acceptable device balance during use.
  • an acceptable position may be such that when a practitioner is using the device for a medical procedure, the weight of a first end of the device is approximately equal to the weight of a second end of a device to enable ease of use.
  • FIG. 1 shows one example of an acceptable position. Specifically, FIG. 1 shows that when container 102 is connected to device 100, a central axis 106 of container 102 is approximately parallel with a central axis 107 of at least a portion of a fluid path along which a fluid travels through device 100, as described herein.
  • FIG. 3 shows another example of a device 300 connected to a container 302, similar to device 100 and container 102 as shown in FIG. 1.
  • a central axis 306 of container 302 may be at an angle relative to a central axis 307 of at least a portion of a fluid path along which a fluid travels through device 300, as described herein.
  • the angle may be any angle that provides an acceptable position as described herein.
  • the angle is between 0 0 and 180 °, optionally between about 0 0 and 90°, including every value in this range.
  • a central axis of the container may be approximately perpendicular to a central axis of at least a portion of a fluid path along which a fluid travels through the device.
  • FIGS. 1 and 3 show a container 102, 302 that is provided on a side 108, 308 of the device 100, 300 that is approximately opposite the handle 105, 305 (alternatively referred to herein as the “top” of the device), the disclosure is not limited in this way.
  • a container 102, 302 may be provided on the same side 109, 309 of the device as the handle 105, 305 (alternatively referred to as the “bottom” or the device) or any location of the device 100, 300 therebetween.
  • FIG. 4A shows a top view of another example device 400 according to aspects of the present disclosure.
  • device 400 may function as described in relation to devices 100, 300 of FIGS. 1 and 3.
  • device 400 may include a connection portion 401 that is reversibly connectable with a container (not shown) as described herein.
  • connection portion 401 may be connectable with a connection adaptor (not shown), such as connection adaptor 200 of FIG. 2.
  • FIG. 4 A further shows an actuator 404, similar to actuator 104 as shown in FIG. 1.
  • FIG. 4B shows a perspective view of device 400.
  • device 400 may further include an outlet 410 that is connectable with a discharge portion (not shown), such as a discharge portion 103 as shown in FIG. 1.
  • a discharge portion such as a discharge portion 103 as shown in FIG. 1.
  • outlet 410 is in fluid communication with a fluid flow path (not shown in FIG. 4B) that connects outlet 410 with connection portion 401.
  • fluid from a container may travel along the fluid flow path to a discharge portion, which may be configured to apply a rinsing fluid to a surface as described herein.
  • FIG. 4E shows an exploded view of device 400 as described herein.
  • FIG. 4E shows connection portion 401, actuator 404, and outlet 410.
  • FIG. 4E further shows tubing components 41 la, 41 lb that together form a fluid flow path between connection portion 401 and outlet 410.
  • FIG. 4E further shows a motor 412 as described herein, motor 412 being powered by a power source 414 (e.g., batteries).
  • a power source 414 e.g., batteries
  • FIGS. 4C and 4D show an end view and a side view, respectively, of device 400.
  • device 400 may be sized such that every component thereof may be contained within a sterile field during use.
  • device 400 may have a length 416 (i.e., a longest dimension thereof) that is no more than about 12 inches, optionally no more than about 10 inches, optionally no more than about 8 inches, optionally no more than about 7 inches, optionally no more than about 6 inches, and optionally no more than about 5 inches.
  • FIGS. 1, 3, and 4 show a device 100, 300, 400 connectable with a single container at a time
  • the disclosure is not limited in this way.
  • the device of the present disclosure may be connectable with two, three, four, or more containers, each container being as described herein.
  • Each of the containers may independently be in communication with the same fluid path as another container or a different fluid path.
  • each container may house the same fluid as another container or a different fluid therefrom.
  • the device of the of the present disclosure may be configured to dispense more than one type of fluid as described herein simultaneously and/or sequentially without requiring removal of a container from the device and/or removal of the device from a sterile field.
  • all or a portion of the device of the present disclosure may be sterile.
  • the device or portions thereof may be sterilized by any acceptable sterilization process known in this art, such as gamma sterilization, e-beam sterilization, ethylene oxide sterilization, or a combination thereof.
  • the device may be provided in sterile packaging as known in the art.
  • the device of the present disclosure may be reusable, that is, may be used to dispense a rinsing fluid from two or more containers.
  • the device may be connected with a first container sufficient to dispense a first rinsing fluid as described herein, and the same device may then be connected with a second container sufficient to dispense a second rinsing fluid contained therein.
  • all or a portion of the device may be replaceable.
  • all or a portion of the fluid flow path such as tubing components 411a, 411b as described in relation to FIG.
  • flushing fluids include water, saline solutions as described herein, aqueous solutions as described herein, aqueous solutions having a buffer system as described herein, alcoholic solutions as described herein, povidone-iodine solutions, and combinations thereof.
  • the device of the present disclosure may be rechargeable.
  • the batteries may be replaceable.
  • the power supply may itself be rechargeable, such as rechargeable batteries.
  • the present disclosure is also directed to a system having a device and at least one container as described herein.
  • the system of the present disclosure may be sterile.
  • the system may be provided in sterile packaging as known in the art.
  • Each component of the system may independently be provided in the same packaging as another component of the system or in different packaging as known in the art.
  • the present disclosure is also directed to methods of making the devices and systems as described herein and methods of using the same.
  • the method may include connecting a container to a connection portion of a device as described herein and actuating an actuator of the device sufficient to dispense a rinsing fluid to a surface via a dispensing portion of the device.
  • the method may further include performing a rinsing process, that is, flushing of a body cavity, a surgical cavity, and/or an external wound with the rinsing fluid from the device.
  • the recitation of numerical 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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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Apparatus For Disinfection Or Sterilisation (AREA)

Abstract

L'invention concerne un dispositif de distribution d'un fluide de rinçage ayant une partie de raccordement pouvant être reliée directement et de manière réversible à un récipient, le récipient logeant un fluide de rinçage, une partie d'évacuation, un trajet de fluide assurant une communication fluidique entre le récipient et la partie d'évacuation, et un actionneur, la partie de raccordement, la partie d'évacuation, le trajet de fluide et l'actionneur formant un seul dispositif unitaire
PCT/US2023/081553 2022-11-30 2023-11-29 Dispositif de rinçage chirurgical intégré WO2024118742A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263429035P 2022-11-30 2022-11-30
US63/429,035 2022-11-30

Publications (1)

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WO2024118742A2 true WO2024118742A2 (fr) 2024-06-06

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PCT/US2023/081553 WO2024118742A2 (fr) 2022-11-30 2023-11-29 Dispositif de rinçage chirurgical intégré

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WO (1) WO2024118742A2 (fr)

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