Patent Application
20190076563
The present invention relates, in some embodiments thereof, to systems, devices and methods for decontaminating a surface of one or more vessels. In some embodiments, the systems and devices of the invention include a housing, a wiping member disposed within the housing, at least one safety mechanisms and one or more vessels attached to, or configured to be coupled to the housing, the wiping member configured to decontaminate a surface of the one or more vessels when surfaces of the vessels move from an initial position to a second or final position within the housing.
The medicinal practice routinely involves administration of medical substances, such as, medicaments, fluids, nutritional substances and the alike, to patients or animals. The preparation and/or administration of such medicinal substances typically involves one or more transfers of those substances between pharmaceutical vessels or administration devices (such as, vials, syringes, infusion lines, connectors, etc.). Each such act of transferring substances between vessels or devices exposes the connection interfaces of the vessels and accordingly the medical substances themselves to contaminants present in ambient air or ambient air particles (e.g., bacteria, viruses, funguses, spores, pyrogens, dirt). In addition, connection interfaces are further prone to contaminations due to physical contact of the interfaces, for example, with nonsterile gloves, or devices.
Such contaminations are a major problem in the healthcare setting since contaminants, once invading within medicinal substances, may pose substantial danger if administered intracorporeally to patients.
Typical connection interfaces of pharmaceutical vessels or pharmaceutical administration devices include rubber bungs and/or stoppers covered by a cap and/or seal that can be flicked off and/or are removed prior to usage thereof. These rubber bungs/stoppers are used to allow penetration by a needle attached to a syringe or by other medical connectors. When the cap and/or seal is flicked off and/or removed, the rubber bung and/or stopper is exposed to ambient air and to contaminants present therein. Accordingly, exposure of connection interfaces to ambient air may involve contamination of the interfaces and consequently contamination of a beneficial substance to be provided to a patient.
Existing systems include USD720067; USD717947; USD703812; USD690418; USD639939; USD637713; U.S. Pat. Nos. 9,790,011; 9,775,777; 9,561,326; 9,493,281; 9,492,353; 9,309,020; 9,173,816; 9,168,203; 9,162,803; 9,039,672; 8,926,583; 8,827,978; 8,790,330; 8,662,985; 8,657,803; 8,622,985; 8,562,583; 8,545,475; 8,523,838; 8,491,563; 8,480,646; 8,449,521; 8,381,776; 8,336,587; 8,328,772; 8,287,513; 8,225,826; 8,075,550; 8,029,747; 7,998,134; 7,975,733; 7,942,860; 7,867,215; 7,744,581; 7,731,678; 7,387,216; 7,306,584; 6,875,203; 6,729,370; 6,715,520; 6,602,239; 6,409,708; 6,343,629; 6,162,199; 6,113,583; 6,063,068; 5,893,397; 5,876,380; 5,832,971; 5,807,374; 5,746,733; 5,569,235; 5,462,535; 5,405,326; 5,292,318; 5,279,582; 4,944,723; 4,932,947; 4,932,937; 4,919,657; 4,915,701; 4,826,489; 4,673,404; 4,564,054; 3,610,241; 3,605,743; 3,587,575; 3,583,399; 3,578,037; 3,556,099; 3,552,387; 3,406,686; 3,380,450; 3,375,825; 3,342,180; 3,330,282; 3,330,281; 3,306,290; 3,255,752; 3,253,592; 3,076,456; 2,972,991; 2,922,419; US20160262982; US20160038373; US20150209568; US20140183196; US20140016570; US20140007973; US20140000754; US20130184672; US20130006200; US20120209238; US20120209218; US20120203194; US20110284561; US20110186177; US20110125128; US20110108158; US20110098647; US20100249745; US20100198182; US20100152669; US20100147402; US20100036319; US20100004602; US20090057258; US20080312634; US20080223484; US20080171981; US20060276759; US20050215976; US20030199847; US20030187420; US20020130100; US20020115981; US20020099354; ES2577377T3; EP2852367B1; EP2666513; EP2155141B1.
In order to overcome this obstacle, the current medical practice involves swabbing the surface of a connection interface with a disinfecting agent, such as 70% isopropyl alcohol, prior to accessing the connection interface. Other methods include i.v. (intravenous) rooms which are used for the sterile preparation of i.v. medications. Such rooms, to keep medicinal preparations as sterile as possible, are equipped with special instruments including, hoods with air filtration systems (e.g., HEPA filters), ventilation systems and air pressure systems. Additionally, those rooms necessitate that the medical staff working in these rooms are properly garmented, are properly trained, and require aseptic techniques, and employ quality control and validation processes. These systems require regular upkeep by certified personnel and require regular cleaning. These systems are therefore expensive, labor intensive, and require regular maintenance and testing to assure that they are operating effectively. The above described systems and methods are either cumbersome and expensive or inefficient in addressing the problem of reducing/eliminating contaminants on connection interfaces.
Thus, there is a long felt and unmet need for pharmaceutical vessels, devices, systems and/or methods that afford transfer of medical substances in a sterile manner. There is a need for reliable, user friendly and cost-effective solutions allowing contaminant-free engagement of vessels and devices for drug preparation and administration processes.
Objects of the invention are achieved, in some embodiments, by providing systems, devices, vessels and methods for engaging and administering medical substances in a decontaminated manner.
Objects of the invention are achieved, in some embodiments, by providing systems, devices, vessels and methods which are directed to transferring medical substances in an efficient, user-friendly and sterile manner.
Objects of the invention are achieved, in some embodiments, by providing a safety mechanism directed to preventing premature piercing of a vessel surface by a piercing member.
Objects of the invention are achieved, in some embodiments, by providing a detachment safety mechanism directed to preventing premature detachment of vessel from a decontamination device prior to resealing of the vessel opening.
Objects of the invention are achieved, in some embodiments, by providing a cap/displaceable member safety mechanism direct to preventing premature detachment of a cap/displaceable member from a decontamination device.
Objects of the invention are achieved, in some embodiments, by providing a rail safety mechanism directed to preventing premature sliding of a vessel along a rail mechanism of a decontamination device.
Objects of the invention are achieved, in some embodiments, by providing a hinge safety mechanism directed to preventing premature rotation of a disc of a decontamination device.
Objects of the invention are achieved, in some embodiments, by providing a valve safety mechanism directed to preventing premature opening and/or closing of a valve of a decontamination device.
Objects of the invention are achieved, in some embodiments, by providing a retraction/locking safety mechanism directed to preventing retraction of a vessel from a secondary position back to a previous position within a decontamination device.
The present invention provides devices and systems that decontaminate connection surfaces of medical or pharmaceutical vessels and thereafter provide for a decontaminated fluid passageway between the vessels.
In a first aspect, the present invention provides a system for the engagement of medical devices, the system comprising: a first medical device; a second medical device; a sliding mechanism positioned on at least one of the first medical device and the second medical device and configured to allow traveling there along of at least one of the first medical device and the second medical device, such that at least one of the first medical device and the second medical device is configured to move from a first position to a second position; and a wiping member disposed on at least one of the first medical device and the second medical device, the wiping member configured to remove contaminants from a surface of at least one of the first medical device and the second medical device at about the time of the movement of the at least one of the first medical device and the second medical device from the first position to the second position.
In one or more embodiments, at least one of the first medical device and/or the second medical device includes a displaceable member, wherein the displaceable member is configured to externally displace from the medical device at about the time at least one of the first medical device and/or the second medical device moves from the first position to the second position. In one or more embodiments, the displaceable member is a surface of the first medical device and/or second medical device. In one or more embodiments, the displaceable member is a seal and/or a cover of an aperture of the first medical device and/or second medical device. In one or more embodiments, the displaceable member seals and/or covers a port and/or an opening of a first medical device and/or a second medical device. In one or more embodiments, the displaceable member is a plastic or a metal alloy. In one or more embodiments, the displaceable member is a polymer. In one or more embodiments, the first medical device and/or the second medical device includes a port. In one or more embodiments, the displaceable member is attached to the first and/or second medical device via an adhesive. In one or more embodiments, the displaceable member is attached to the first and/or second medical device via a rail mechanism disposed on the first medical device and/or second medical device. In one or more embodiments, the displaceable member is disposed on and/or in between the rails of the first and/or second medical devices.
In one or more embodiments, the first medical device is selected from a vial, a bag, a bottle, a syringe, an infusion line, a connector, a filter, a manifold, a spike, a manifold, a connector with multiple openings, a bag port, a bottle port, a vial port, a buretrol and combinations thereof.
In one or more embodiments, the second medical device is selected from a vial, a bag, a bottle, a syringe, an infusion line, a connector, a filter, a manifold, a spike, a manifold, a connector with multiple openings, a bag port, a bottle port, a vial port, a buretrol and combinations thereof.
In one or more embodiments, the sliding mechanism comprises a rail, the rail positioned along at least a portion of the first medical device and/or the second medical device. In one or more embodiments, the rail is a plastic material or a polymer. In one or more embodiments, the rail is a metal alloy. In one or more embodiments, the rail is integrally attached to the first and/or second medical device. In one or more embodiments, the rail forms a unitary structure with the first and/or second medical device.
In one or more embodiments, the system includes an engagement mechanism configured to provide an engagement between the first medical device and the second medical device.
In one or more embodiments, the engagement mechanism is located on the first medical device and/or on the second medical device. In one or more embodiments, the engagement mechanism is selected from a thread, a luer, an adhesive tape, a ratchet teeth mechanism, a clasping mechanism and combinations thereof.
In one or more embodiments, the engagement mechanism is attached and/or coupled to the sliding mechanism allowing the engagement mechanism to move from a first position adjacent to the first medical device to a second position, and optionally to a third position, a fourth position and/or a fifth position. In one or more embodiments, the engagement mechanism forms a unitary structure with the sliding mechanism. In one or more embodiments, the sliding mechanism is a rail mechanism.
In one or more embodiments, the engagement mechanism is further configured to move from the first position to the second position along with the second medical device. In one or more embodiments, the engagement mechanism is further configured to move between a plurality of positions along the medical device. In one or more embodiments, the engagement mechanism is configured to move between a plurality of compartments within the housing of the medical device. In one or more embodiments, the engagement mechanism is configured to move between a plurality of chambers within the housing of the medical device.
In one or more embodiments, the displaceable member is integrally connected to at least one of the first medical device and the second medical device. In one or more embodiments, the displaceable member is a seal, a cover or a cap.
In one or more embodiments, movement from the first position to the second position comprises removal of a sealing, cover or a cap of at least one of the medical device or medical device ports.
In one or more embodiments, after movement of the second medical device from the first position to the second position, a surface of the second medical device is sterile.
In one or more embodiments, the wiping member is disposed within a housing. In one or more embodiments, the wiping member is disposed within a housing, wherein the housing is attached to the first medical device or second medical device. In one or more embodiments, the housing is integrally attached to the first medical device or the second medical device. In one or more embodiments, the wiping member is located between the first medical device and the second medical device. In one or more embodiments, the wiping member is located on at least one of the first medical device and/or the second medical device. In one or more embodiments, the wiping member is located between compartments of the medical device. In one or more embodiments, a plurality of wiping members is located between the compartments of the housing of the medical device.
In one or more embodiments, the housing has a plurality of compartments and/or chambers disposed within the housing. In one or more embodiments, at least one compartment and/or chamber of the housing has a pressure greater than an adjacent compartment and/or chamber of the housing. In one or more embodiments, at least one compartment and/or chamber of the housing has a pressure less than an adjacent compartment and/or chamber of the housing. In one or more embodiments, at least one compartment and/or chamber of the housing has a pressure greater than ambient air pressure and/or atmospheric pressure. In one or more embodiments, at least one compartment and/or chamber of the housing has a pressure less than ambient air pressure and/or atmospheric pressure.
In one or more embodiments, the wiping member is made of a plastic, an elastomeric material, an absorptive material or a rubber material. In one or more embodiments, the absorptive material is a sponge-like material. In one or more embodiments, the wiping member is covered by a disinfecting and/or sterilizing substance. In one or more embodiments, at least one wiping member rotates on an axle, hinge or the alike. In one or more embodiments, the at least one wiping member is at least partially disposed within the housing. In one or more embodiments, the at least one wiping member is disposed within the housing.
In one or more embodiments, the displaceable member is configured to externally displace from the port at about the time the second medical device moves from the first position to the second position. In one or more embodiments, the displaceable member is configured to externally displace from the port at the time the second medical device moves from the first position to the second position.
In one or more embodiments, the displaceable member on the first medical device is configured to engage a complementary displaceable member on the second medical device and vice versa. In one or more embodiments, the engagement between the displaceable member of the first medical device and the displaceable member of the second medical device is an airtight engagement.
In one or more embodiments, the movement of at least one of the medical devices from the first position to the second position allows a hermetically sealed and essentially sterile engagement between the first medical device and the second medical device.
In one or more embodiments, movement of at least one of the first medical device and/or the second medical device from the first position to the second position allows fluid communication between the first medical device and the second medical device.
In one or more embodiments, the system includes a piercing member configured to pierce a surface of at least one of the first medical device and/or the second medical device.
In one or more embodiments, the piercing member is a needle. In one or more embodiments, the piercing member comprises a hollow conduit which provides for fluidic communication between the first medical device and the second medical device.
In one or more embodiments, the wiping member is covered by a sterilizing substance and/or a disinfecting substance. In one or more embodiments, the sterilizing substance is an antibacterial, an antiviral, and anti-tuberculin, an anti-fungal and combinations thereof.
In another aspect the present invention provides a decontamination device for decontaminating a surface of a vessel, comprising; a medical device; a wiping member located on and/or attached to the medical device, wherein the wiping member is configured to wipe a surface of a vessel.
In yet another aspect the present invention provides a decontamination device for decontaminating a surface of a vessel, comprising: a medical device; a sliding mechanism located on and/or attached to the medical device, wherein the sliding mechanism is configured to allow for the traveling there along of a second medical device.
In yet another aspect the present invention provides a decontamination device for decontaminating a surface of a vessel, comprising: a medical device; a sliding mechanism located on and/or attached to the medical device, wherein the sliding mechanism is configured to allow for the traveling there along of an engagement mechanism; and an engagement mechanism configured to travel along the sliding mechanism, wherein the engagement mechanism is further configured to engage a medical device.
In yet another aspect the present invention provides a device for decontaminating a surface of a medical device, comprising: a medical device; a sliding mechanism located on and/or attached to the medical device, wherein the sliding mechanism is configured to allow for the traveling there along of an engagement mechanism; an engagement mechanism configured to travel along the sliding mechanism, wherein the engagement mechanism is further configured to engage a medical device; and a wiping member configured to wipe a surface of a vessel
In yet another aspect the present invention provides a system for the engagement of medical vessels, the system comprising: a first medical vessel; a second medical vessel; a housing configured to allow traveling there along of at least one of the first and second medical vessel, such that the vessel is configured to move from a first position to a second position within the housing; a wiping member at least partially disposed within the housing, wherein the wiping member is configured to remove contaminants from a surface of the at least one first vessel and the second vessel at about the time of movement of the first vessel and/or the second vessel from the first position to the second position.
In one or more embodiments, wherein the housing is further configured to allow traveling there along of at least one of the first and second medical devices, such that the vessel is configured to move between a plurality of position.
In one or more embodiments, the housing has at least two compartments, at least three compartments, at least four compartments, and at least five compartments.
In one or more embodiments, a rail mechanism is disposed on or in the housing configured to provide the traveling there along of the vessel from the first compartment of the housing, to a second compartment of the housing, to a third compartment of the housing. In one or more embodiments, the rail mechanism is further configured to allow traveling of the vessel to a fourth compartment of the housing and to a fifth compartment of the housing.
In one or more embodiments, the housing comprising a top and a bottom configure to rotate and/or move in relation to each other via a rail mechanism. In one or more embodiments, the rail mechanism is a circumferential rail mechanism.
In yet another aspect the present invention provides a system for the engagement of medical vessels, the system comprising: a first medical vessel attached to a plurality of housings, wherein each of the housings are attached to the first medical vessel via a port or an opening on the first medical vessel and are configured to allow traveling there along of a second medical vessel, such that a surface of the second medical vessel or a portion of the second medical vessel is configured to move from a first position to a second position within the housing, wherein the housing further comprises a wiping member, the wiping member disposed within the housing, the wiping member is configured to remove contaminants from a surface of the second medical vessel at about the time of movement of the first and/or second medical vessel from the first position to the second position.
In yet another aspect the present invention provides a connector for the engagement of medical vessels, the connector comprising: a first housing and a second housing, each configured to engage with and allow traveling there along of a medical vessel, such that the medical vessel may move from a first position to a second position within the housing, wherein the housing further comprises a wiping member disposed within the housing, wherein the wiping member is configured to remove contaminants from a surface of the medical vessel at about the time of movement of the medical vessel from the first position to the second position.
In one or more embodiments, the housing has a side wall, a top wall, and a bottom wall, wherein the top wall and the bottom wall each have an opening adapted for connection to the medical vessels.
In one or more embodiments, the housing has a side wall, and a top wall, wherein the top wall has an opening adapted for connection to the medical vessel and wherein the bottom of the housing is open allowing connection to the medical vessel.
In one or more embodiments, the opening is surrounded by vertical walls extending from the bottom or top wall.
In one or more embodiments, the opening includes internal threads, the internal threads being configured for cooperating with external threads on the first medical vessel and/or the second medical vessel to connect the first medical vessel and/or the second medical vessel to the housing. In one or more embodiments, the opening includes external threads, the external threads being configured for cooperating with internal threads on the first medical vessel and/or the second medical vessel to connect the first medical vessel and/or the second medical vessel to the housing.
In one or more embodiments, the housing has a first non-sterile compartment and a second substantially sterile compartment, and wherein the first position includes locating a surface or a portion of the medical vessel in the first compartment and wherein the second position includes locating the medical vessel in the second compartment.
In one or more embodiments, the wiping member is disposed between the compartments such to isolate hermetically the first and second compartments.
In one or more embodiments, the housing further comprises a third compartment comprising a resealing mechanism for resealing the at least one medical vessel with a cap, a seal or a cover. In one or more embodiments, the third compartment houses a resealing member configured to resealing the at least one medical vessel with a cap, a seal or a cover. In one or more embodiments, the third compartment at least partially houses a resealing member configured to resealing the at least one medical vessel with a cap, a seal or a cover. In one or more embodiments, the housing has a compartment with a resealing member disposed within the compartment. In one or more embodiments, the compartment housing the resealing member is sterile.
In one or more embodiments, the housing further comprises a wiping member disposed between the second compartment and the third compartment.
In one or more embodiments, the housing includes at least one double wiper comprising two or more wiping members disposed one after the other.
In one or more embodiments, the wiping members disposed when spaced apart or when in contact with each other.
In one or more embodiments, the bottom wall of the housing is open allowing traveling there along of the medical vessel. In one or more embodiments, the wiping member is configured to extend from the top wall to the bottom wall of the housing.
In one or more embodiments, the housing further comprises a filter disposed in an aperture in the housing for releasing air from the housing when the medical vessel moves along the housing. In one or more embodiments, the filter is a sterilizing filter. In one or more embodiments, the filter has a porosity of 0.22 microns or less. In one or more embodiments the filter may be replaced by a valve configured to release air or pressure from the housing when the medical vessel moves along the housing. In one or more embodiments, the valve is a one-way valve allowing for the release of air from the interior of the housing to the exterior of the housing while preventing ambient or environmental air from entering the housing.
In one or more embodiments, the housing further comprising a locking member disposed in the housing, the locking member being configured for locking the medical vessel in a first position or a second position, or a third position. In one or more embodiments, the locking member may be present in a plurality of compartments of the housing. In one or more embodiments, the locking member may be located in a first compartment, in a second compartment, in a third or more compartments of the housing. In one or more embodiments, the locking member may prevent retraction of a medical vessel surface or a portion of a medical vessel from the second position back to the first position. In one or more embodiments, the locking member prevents retraction of a medical vessel surface or a portion thereof from the third position back to the second position. In one or more embodiments, the locking member may prevent retraction of a medical vessel surface or a portion thereof from the fourth position back to third position. In one or more embodiments, the locking member may prevent retraction of a medical vessel surface or a portion thereof from the fifth position back to the fourth position.
In one or more embodiments, the housing is manufactured from a material selected from the group consisting of plastic, rigid plastic, flexible plastic, and combinations thereof. In one or more embodiments, the housing is manufactured from a glass material.
In one or more embodiments, the wiping member is comprised of an elastomeric material and/or a rubber material. In one or more embodiments, the wiping member is comprised of a rigid material, flexible material, expandable material, an absorptive material, a sponge-like material and combinations thereof. In one or more embodiments, the wiping member is covered by a sterilizing substance and/or disinfecting substance. In one or more embodiments, at least a portion of the wiping member is covered by a sterilizing substance and/or disinfecting substance. In one or more embodiments, the wiping member has a sterilizing and/or disinfecting substance absorbed by the wiping member.
In one or more embodiments, the sterilizing substance is selected from the group consisting of antibacterial, antiviral, anti-tuberculin, anti-fungal, bactericidal, virucidal, fungicidal, spirodical, bacteriostatic, virustatic, fungistatic and combinations thereof. In one or more embodiments, the sterilizing substance is sodium hypochlorite. In one or more embodiments, the concentration of sodium hypochlorite is 0.55% or higher. In one or more embodiments, the concentration of sodium hypochlorite is below 0.55% concentration. In certain embodiments, sterilizing substances may be on the wiper and/or on components in the housing.
In one or more embodiments, the system is disposable, intended for one-time use, or for repeat use.
In one or more embodiments, the medical vessel is configured to move across the housing via a sliding motion.
In one or more embodiments, the wiping member is configured to partially wipe off the surface of at least one vessel. In one or more embodiments, the wiping member is configured to wipe off the entire surface of at least one vessel.
In one or more embodiments, the system includes a plurality of vessels.
In one or more embodiments, the housing has an engagement mechanism to connect the at least one of the vessels to the housing.
In one or more embodiments, the engagement mechanism is selected from a thread, a luer, a ratchet teeth mechanism, a retention member, a smart-site mechanism, a rail mechanism, a snap-on mechanism, a slide-on mechanism and an adhesive mechanism. In one or more embodiments, the thread is configured for engaging a complementary thread on the at least one vessel to connect the at least one vessel to the housing.
In one or more embodiments, the engagement mechanism positions the surface of the at least one vessel at about same level as an interior wall of the housing. In one or more embodiments, the engagement mechanism positions the surface of the pharmaceutical vessel at the same level as an interior wall of a housing of the system. In one or more embodiments, the engagement mechanism positions the surface of the at least one vessel in a manner that protrudes into the housing. In one or more embodiments, the protruding of the surface of the at least one vessel is a slight/minor protruding.
In one or more embodiments, the protruding of the surface of the at least one vessel is ranges from less than one twelfth of an inch to less than half an inch. In one or more embodiments, the engagement mechanism positions the surface of the at least one vessel in a manner that is below an inner surface of the housing. In one or more embodiments, positioning of the surface of the at least one vessel ranges from less than one twentieth of an inch to less than a half an inch from the inner surface of the housing. In one or more embodiments, the engagement mechanism positions the surface of the at least one vessel slightly below an inner wall/surface of the housing while allowing the wiping member to wipe off the entire surface of the at least one vessel.
In one or more embodiments, the at least one vessel ranges from one vessel to ten vessels, wherein a surface of each of the vessels is configured to be wiped off by the wiping member, wherein each of the vessels are configured to couple with the housing.
In one or more embodiments, the port of the housing has an adhesive configured for engaging the at least one vessel to connect the at least one vessel to the housing. In one or more embodiments, the vessel has an adhesive configured for engaging the housing.
In one or more embodiments, each of the ports is connected to a vessel such that the housing forms an interior which is sealed/isolated from surrounding/environmental air. In one or more embodiments, each of the ports is connected to a vessel such that the housing forms an interior which is hermetically sealed/isolated from surrounding/environmental air. In one or more embodiments, each of the plurality of ports provides airtight engagement between the housing and a vessel.
In one or more embodiments, the housing further comprising at least one port configured for coupling to the first and/or the second vessel, wherein the port provides a connection between the housing and the first vessel and/or the second vessel.
In one or more embodiments, the port is covered by a cover. In one or more embodiments, the port is sealed. In one or more embodiments, the seal is a frangible seal. In one or more embodiments, the seal is a rupturable/breakable seal. In one or more embodiments, the seal is a pierceable seal.
In one or more embodiments, the housing has at least two ports, wherein one of the at least two ports are attached to or integrally attached to one of the first vessel and/or the second vessel.
In one or more embodiments, the housing has at least two ports, wherein one of the at least two ports are permanently/fixedly attached to the first or second vessel. In one or more embodiments, the one of the at least two ports form a unitary structure with a vessel. In one or more embodiments, the housing has at least two ports, wherein one of the at least two ports are attached to or coupled to the at least one vessel at about the time of manufacture and/or distribution of the system.
In one or more embodiments, the port is a container port, bag port, bottle port, vial port, syringe port, infusion line port, connector port, manifold port, a vessel port, a spike port and combinations thereof.
In one or more embodiments, the vessel is selected from a bag, a bottle, a vial, a syringe, an infusion line, a connector, a filter, a manifold, a bag port, a bottle port, and a vial port.
In one or more embodiments, the surface of the first and/or second vessel is flat and smooth. In one or more embodiments, the surface of the first and/or second vessel is rigid. In one or more embodiments, the surface of the first and/or second vessel is not smooth.
In one or more embodiments, the contact between the wiping member and the surface provides enough friction between the surface and the wiping member to wipe off contaminants from the surface of the at least one vessel.
In yet another aspect the present invention provides a housing having a plurality of compartments, wherein at least one of the compartments houses a sterilizing or disinfecting substance. In one or more embodiments, the housing having at least two compartments, at least three compartments, at least four compartments or at least five compartments. In one or more embodiments, the sterilizing substance is present inside at least two compartments, at least three compartments, at least four compartments or at least five compartments.
In one or more embodiments, the housing has at least one compartment having an interior pressure greater than an adjacent compartment of the housing.
In one or more embodiments, the housing has at least one compartment having an interior pressure greater than ambient air pressure. In one or more embodiments, the housing has at least one compartment having an interior pressure greater than atmospheric pressure. In one or more embodiments, the housing has at least one compartment having an interior pressure less than an adjacent compartment of the housing. In one or more embodiments, the housing has at least one compartment having an interior pressure less than ambient air pressure. In one or more embodiments, the housing has at least one compartment having an interior pressure less than atmospheric pressure.
In yet another aspect the present invention provides a device for decontaminating a surface of a vessel, comprising: a housing having a top and a bottom; a rail mechanism configured to provide for the top of the housing to rotate in relation to the bottom of the housing; at least one wiping member disposed within the housing; and at least one opening configured to engage a vessel, wherein when the vessel engages the at least one opening and when a surface of the vessel is moved from an initial position to a second position, the surface of the vessel is decontaminated.
In one or more embodiments, the housing has at least one compartment that remains sterile. In one or more embodiments, the housing has at least two compartments. In one or more embodiments, the housing has at least three compartments. In one or more embodiments, the housing has at least four compartments. In one or more embodiments, the housing has five compartments. In one or more embodiments, the housing has a plurality of compartments.
In one or more embodiments, the housing has at least one compartment which are sterile. In one or more embodiments, the housing has at least two compartment which are sterile. In one or more embodiments, the housing has at least three compartments which are sterile. In one or more embodiments, the housing has at least four compartment which are sterile. In one or more embodiments, the housing has five compartments which are sterile.
In one or more embodiments, the housing has at least one double wiper. In one or more embodiments, the housing has at least two double wipers. In one or more embodiments, the housing has a plurality of double wipers. In one or more embodiments, the housing has a compartment that serves as a fluidic passageway between two vessels.
In one or more embodiments, the housing has a compartment housing a resealing member. In one or more embodiments, the resealing member is a cap or a seal. In one or more embodiments, the compartment housing the resealing member is sterile. In one or more embodiments, the resealing member remains sterile.
In one or more embodiments, the housing is attached to a vessel. In one or more embodiments, the housing is integrally attached to a vessel. In one or more embodiments, the housing forms a unitary structure with a vessel. In one or more embodiments, the top of the housing and the bottom of the housing form an interior compartment that is isolated from ambient/environmental air.
In one or more embodiments, the top of the housing and the bottom of the housing form an interior chamber that is isolated from ambient/environmental air. In one or more embodiments, the opening is sealed/covered.
In one or more embodiments, the device is configured to move the vessel between a plurality of compartments. In one or more embodiments, the device is configured to move the vessel from an initial position, to a secondary position, then to a third position. In one or more embodiments, the device is configured to move the vessel from a third position to a fourth position. In one or more embodiments, the device is configured to move the vessel from a fourth position to a fifth position.
In one or more embodiments, at least one of the compartments of the housing contains a sterilizing or disinfecting substance.
In one or more embodiments, at least one of the compartments of the housing has a pressure greater than an adjacent compartment of the housing. In one or more embodiments, at least one of the compartments of the housing has a pressure less than an adjacent compartment of the housing. In one or more embodiments, at least one of the compartments of the housing has a pressure greater than ambient air or atmospheric pressure. In one or more embodiments, at least one of the compartments of the housing has a pressure less than ambient air or atmospheric pressure.
In one or more embodiments, the rail mechanism is a circumferential rail mechanism. In one or more embodiments, the housing is surface mounted to a wall of a vessel. In one or more embodiments, the housing is flush mounted to a wall of a vessel. In one or more embodiments, the housing abuts a wall of a vessel.
In yet another aspect the present invention provides a device for decontaminating a surface of a vessel, comprising: a housing having a top and a bottom; a hinge mechanism configured to provide for the top of the housing to rotate in relation to the bottom of the housing; at least one wiping member disposed within the housing; and at least one opening configured to engage a vessel, wherein when the vessel engages the at least one opening and when a surface of the vessel is moved from an initial position to a second position, the surface of the vessel is decontaminated.
In one or more embodiments, the housing has at least one compartment that remains sterile. In one or more embodiments, the housing has at least two compartments. In one or more embodiments, the housing has at least three compartments. In one or more embodiments, the housing has at least four compartments. In one or more embodiments, the housing has five compartments. In one or more embodiments, the housing has a plurality of compartments. In one or more embodiments, the housing has at least one compartment which are sterile. In one or more embodiments, the housing has at least two compartment which are sterile. In one or more embodiments, the housing has at least three compartments which are sterile. In one or more embodiments, the housing has at least four compartment which are sterile. In one or more embodiments, the housing has five compartments which are sterile.
In one or more embodiments, the housing has at least one double wiper. In one or more embodiments, the housing has at least two double wipers.
In one or more embodiments, the housing has a compartment that serves as a fluidic passageway between two vessels. In one or more embodiments, the housing has a compartment housing a resealing member. In one or more embodiments, the resealing member is a cap or a seal. In one or more embodiments, the compartment housing the resealing member is sterile. In one or more embodiments, the resealing member remains sterile.
In one or more embodiments, the housing is attached to a vessel. In one or more embodiments, the housing is integrally attached to a vessel. In one or more embodiments, the housing forms a unitary structure with a vessel.
In one or more embodiments, the top of the housing and the bottom of the housing form an interior compartment that is isolated from ambient/environmental air. In one or more embodiments, the top of the housing and the bottom of the housing form an interior chamber that is isolated from ambient/environmental air. In one or more embodiments, the opening is sealed/covered.
In one or more embodiments, the device is configured to move the vessel between a plurality of compartments. In one or more embodiments, the device is configured to move the vessel from an initial position, to a secondary position, then to a third position. In one or more embodiments, the device is configured to move the vessel from a third position to a fourth position. In one or more embodiments, the device is configured to move the vessel from a fourth position to a fifth position.
In one or more embodiments, at least one of the compartments of the housing contains a sterilizing or disinfecting substance.
In one or more embodiments, at least one of the compartments of the housing has a pressure greater than an adjacent compartment of the housing. In one or more embodiments, at least one of the compartments of the housing has a pressure less than an adjacent compartment of the housing. In one or more embodiments, at least one of the compartments of the housing has a pressure greater than ambient air or atmospheric pressure. In one or more embodiments, at least one of the compartments of the housing has a pressure less than ambient air or atmospheric pressure.
In one or more embodiments, the housing is surface mounted to a vessel. In one or more embodiments, the housing is flush mounted to a vessel. In one or more embodiments, the housing abuts a wall of a vessel.
In yet another aspect the present invention provides a method of decontaminating a surface of at least one medical device, the method comprising the steps of: providing a first medical device; providing a second medical device, wherein at least one of the first medical device and the second medical device has a sliding mechanism configured to allow traveling there along of at least one of the first medical device and the second medical device, such that at least one of the first medical device and the second medical device is configured to move from a first position to a second position; providing a wiping member disposed on at least one of the first medical device and the second medical device, the wiping member configured to remove contaminants from a surface of at least one of the first medical device and the second medical device at about the time of the movement of at least one the medical device from the first position to the second position; engaging at least one of the first medical device and the second medical device to the sliding mechanism of complementary medical device; and sliding at least one of the first medical device and the second medical device along the sliding mechanism such that at least one of the first medical device and the second medical device is configured to move from a first position to a second position, wherein the wiping member removes contaminants from a surface of at least one of the first medical device and the second medical device upon the movement of at least one of the first medical device and the second medical device from the first position to the second position.
In one or more embodiments, the wiping member is disposed within the first and/or second medical device. In one or more embodiments, the wiping member is disposed within a port of the first and/or second medical device. In one or more embodiments, the first and/or second medical device having a housing, wherein the wiping member is disposed within the housing.
In yet another aspect the present invention provides a method of decontaminating a surface of at least one vessel, the method comprising: providing a decontamination device having a housing and a wiping member at least partially disposed within the housing and configured to wipe a surface of a vessel; providing at least one vessel having a surface; connecting the decontamination device to the at least one vessel; and moving the vessel surface within the housing, thus, decontaminating the surface of the at least one vessel.
In one or more embodiments, movement from the first position to the second position allows hermetically sealed and essentially sterile engagement between the first medical device and second medical device. In one or more embodiments, movement from the first position to the second position allows for fluid communication between the first medical device and second medical device.
In one or more embodiments, the step of sliding occurs via a sliding mechanism comprising a rail, the rail positioned along at least a portion of at least one of the first medical device and the second medical device.
In one or more embodiments, the step of engaging occurs via an engagement mechanism configured to provide a secure engagement between the first medical device and the second medical device.
In one or more embodiments, the method further comprising providing a displaceable member disposed on at least one of the first medical device and the second medical device, the displaceable member being configured to externally displace from at least one of the first medical device and the second medical device at about the time of movement from a first position to a second position.
In one or more embodiments, movement from the first position to the second position comprises removal of a sealing or a cap member of at least one of the first medical device and the second medical device.
In one or more embodiments, the method further comprising providing a piercing member located on and/or attached to at least one of the first medical device and the second medical device.
In one or more embodiments, the method further comprising piercing a surface of at least one of the first medical device and the second medical device.
In one or more embodiments, the piercing establishes a fluid communication between the first medical device and the second medical device.
In one or more embodiments, the method further comprising applying pressure to at least one surface of the first medical device and the second medical device, wherein application of pressure breaks the frangible surface of at least one of the first medical device and the second medical device, thus establishing a fluidic communication between the first and second medical devices.
In one or more embodiments, the method further comprises movement of a vessel surface between/amongst a plurality of positions. In one or more embodiments, the method further comprises movement of a vessel surface between/amongst a plurality of compartments of the housing.
In one or more embodiments, the method further comprises sliding at least one of said first medical device and said second medical device along said sliding mechanism from a second position to a third position.
In one or more embodiments, the method further comprises resealing the at least one of said first medical device and said second medical device in the third position.
In one or more embodiments, the method further comprises disconnecting the at least one of said first medical device and said second medical device.
In yet another aspect, a syringe tip/opening/aperture is sealed with a puncturable and/or frangible seal. The seal is configured to be wiped off by the wiping member. In one or more embodiments, the syringe tip/opening/aperture may be covered by a seal that is punctured by piercing member of decontamination device or ruptured inside decontamination device. The syringe seal may also be displaceable inside the decontamination device.
In yet another aspect the present invention provides a device for the decontamination of a surface of a vessel, comprising: a housing having a top and a bottom; at least one wiping member disposed within the housing; at least one opening within the housing configured to engage at least one vessel; and a sliding mechanism configured to provide for the sliding of the vessel surface from a first compartment of the housing to at least a second compartment of the housing, wherein when the at least one vessel engages the at least one opening of the vessel, the at least one vessel slide along the sliding mechanism of the device from a first position to at least a second position.
In one or more embodiments, the system includes a third compartment.
In one or more embodiments, the third compartment includes a resealing mechanism for resealing the at least one vessel with a cap, a seal or a cover.
In one or more embodiments, when the at least one vessel slides from the second position to the third position, the at least one vessel interacts with the resealing mechanism to reseal the at least one vessel. In one or more embodiments, resealing occurs within a compartment/chamber of the housing. In one or more embodiments, the compartment/chamber is a sterile.
In one or more embodiments, at least one wiping mechanism is located between the first compartment and the second compartment. In one or more embodiments, a second wiping member is located between the second compartment and the third compartment. In one or more embodiments, the second compartment includes a sterilizing/disinfecting substance. In one or more embodiments, the third compartment includes a sterilizing/disinfecting substance. In one or more embodiments, the system includes a fourth compartment and a fifth compartment.
In one or more embodiments, a third wiping member is located between the third compartment and the fourth compartment and a fourth wiping member is located between the fourth compartment and the fifth compartment.
In one or more embodiments, the fifth compartment includes a resealing mechanism for resealing the at least one vessel with a cap, a seal or a cover. In one or more embodiments, the resealing member is disposed within the housing.
In one or more embodiments, the housing has a plurality of compartments. In one or more embodiments, the housing has detachment safety mechanism configured to prevent the premature detachment of a vessel from a compartment of the housing where resealing occurs. In one or more embodiments, the detachment safety mechanism is unlocked by the movement of a vessel into the compartment where resealing occurs. In one or more embodiments, the detachment safety mechanism is unlocked at about the time of resealing of a vessel surface within the resealing compartment of the housing. In one or more embodiments, the detachment safety mechanism is unlocked at the time of resealing of a vessel surface within the resealing compartment of the housing. In one or more embodiments, the detachment safety mechanism is unlocked after resealing of a vessel surface within the resealing compartment of the housing. In one or more embodiments, the detachment safety mechanism unlocks a wall or sealed aperture of the resealing compartment of the housing at about the time, at the time, and/or after the time of resealing of the vessel surface. In one or more embodiments, the detachment safety mechanism is applicable to any of the disclosed systems, devices, and methods of this invention.
In one or more embodiments, the resealing seal/cover attachment to the vessel is permanent and/or irreversible. In one or more embodiments, the resealing seal/cover attachment to the vessel is temporary, allowing the resealing seal/cover to detach from the vessel surface. In one or more embodiments, the resealing seal/cover is frangible and/or pierceable.
In yet another aspect the present invention provides a device for the decontamination of a surface of a vessel, comprising: a housing having a top and a bottom; at least one wiping member disposed within the housing; at least one opening within the housing configured to engage at least one vessel; and a hinge mechanism configured to provide for the sliding of the vessel surface from a first compartment of the housing to at least a second compartment of the housing, wherein when the at least one vessel engages the at least one opening of the vessel, the at least one vessel may move from a first position to at least a second position.
In one or more embodiments, the system includes a third compartment.
In one or more embodiments, the third compartment includes a resealing mechanism for resealing the at least one vessel with a cap, a seal or a cover.
In one or more embodiments, when the at least one vessel slides or moves from the second position to the third position, the at least one vessel interacts with the resealing mechanism to reseal the at least one vessel.
In one or more embodiments, the at least one wiping mechanism is located between the first compartment and the second compartment. In one or more embodiments, a second wiping member is located between the second compartment and the third compartment. In one or more embodiments, the housing further comprises a fourth compartment. In one or more embodiments, the housing further comprises at least a fifth compartment.
In one or more embodiments, the hinge mechanism is configured to allow for the movement of a vessel surface between a plurality of compartments.
In one or more embodiments, the device further comprises a hinge safety mechanism configured to prevent premature sliding of a vessel surface between compartment. In one or more embodiments, premature sliding may mean sliding before secure attachment of the device to a vessel.
In one or more embodiments, the second compartment includes a sterilizing/disinfecting substance.
In one or more embodiments, the third compartment includes a sterilizing/disinfecting substance.
In yet another aspect the present invention provides a vessel having a plurality of decontamination devices. In one or more embodiments, at least one decontamination device is an exit port of the vessel and at least one decontamination device is an entry port of the vessel. In one or more embodiments, at least two decontamination devices are entry ports of the vessel. In one or more embodiments, at least three decontamination devices are entry ports of the vessel.
In one or more embodiments, the vessel is a container. In one or more embodiments, the vessel is a syringe. In one or more embodiments, the vessel is a bag. In one or more embodiments, the vessel has a flexible wall. In one or more embodiments, the vessel is a bottle. In one or more embodiments, the vessel has a rigid wall.
In one or more embodiments, the vessel has a plurality of housings, wherein each of the housings has a wiping member disposed within the housings.
In one or more embodiments, the vessel has a plurality of housings, wherein a plurality of wiping member is disposed within the plurality of housings and a plurality of rail or hinge mechanisms are disposed within the housings.
In one or more embodiments, the housing includes at least one disc positioned horizontally within the housing and adapted to connect a vessel, the at least one disc configured to rotate within the housing while passing or traveling through the wiping member, thereby wiping off the surface of the vessel. In one or more embodiments, the housing includes a plurality of discs. In one or more embodiments, the housing includes a first disc and a second disc disposed one above the other, wherein at least one of the discs being rotatable within the housing. In one or more embodiments, the housing includes a first disc and a second disc disposed one above the other and being rotatable with respect to each other. In one or more embodiments, the first disc and/or second disc being rotatable via a hinge mechanism. In one or more embodiments, the first and second discs configured to accommodate one or more wiping members therebetween the discs such that upon engagement of a vessel's surface to the first or second disc and rotation thereof within the housing, the surface of the vessel is wiped off by the one or more wiping members.
In one or more embodiments, the housing includes one or more safety mechanisms to secure one or more components of the system and/or ensure proper use thereof. In one or more embodiments, the housing includes at least one safety mechanism selected from a valve safety mechanism, a piercing member safety mechanism, a rail safety mechanism, a detachment safety mechanism, a hinge safety mechanism and a retractable safety mechanism. In one or more embodiments, the housing includes at least one safety mechanism, to secure at least one component of the housing, selected from: a valve, a rail, a displaceable member, a piercing member, a wiper and a vessel.
In one or more embodiments, the device includes a valve safety mechanism adapted to ensure opening of the valve after correct positioning of the vessel within the housing.
In one or more embodiments, the device includes a piercing member safety mechanism adapted to prevent premature piercing of a vessel's surface by the piercing member.
In one or more embodiments, the housing includes a rail safety mechanism adapted to ensure sliding of a vessel on the rail, prevent premature sliding of the vessel on the rail, and/or secure the attachment of the vessel to the rail.
In one or more embodiments, the housing includes a detachment safety mechanism configured to prevent the premature detachment of a vessel from a compartment of the housing where resealing occurs.
In one or more embodiments, the housing includes a cap safety mechanism configured to prevent premature detachment of a displaceable member from the housing.
In one or more embodiments, the housing includes a hinge safety mechanism configured to prevent premature rotation of the one or more discs.
In one or more embodiments, at least one locking member may be disposed in or on the housing to prevent the medical vessel from returning to its initial or to its previous position.
In one or more embodiments, the device having a locking member to provide for the one directional movement of a vessel between compartments of the housing so that the vessel cannot retract. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a second position to a first position. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a third position to a second position. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a fourth position to a third position. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a fifth position to a fourth position. In one or more embodiments, the locking member is applicable to any of the disclosed systems, devices, and methods of this invention. The locking member may be positioned in various locations within the housing. For example, the locking member may be disposed within the first, the second, the third or any of the other compartments. In an exemplary embodiment, the locking member is disposed within the second compartment, or between the first and second compartments. In an exemplary embodiment, the locking member is disposed within the third compartment, or between the third and second compartments. In an exemplary embodiment, the locking member is disposed within the fourth compartment, or between the third and fourth compartments. In an exemplary embodiment, the locking member is disposed within the fifth compartment, or between the fifth and fourth compartments.
In one or more embodiments, the device further comprising a piercing member safety mechanism configured to prevent the premature piercing of a vessel's surface. In one or more embodiments, the piercing member safety mechanism is unlocked by the movement of a vessel from a first compartment to a second compartment of the housing. In one or more embodiments, the piercing member safety mechanism is unlocked by the movement of a vessel from a second compartment to a third compartment of the housing. In one or more embodiments, the piercing member safety mechanism is unlocked by the movement of a vessel from a third compartment to a fourth compartment of the housing. In one or more embodiments, the piercing member safety mechanism is unlocked by the movement of a vessel from a fourth compartment to a fifth compartment of the housing. In one or more embodiments, the piercing member safety mechanism is applicable to any of the disclosed systems, devices, and methods of this invention.
In yet another aspect the present invention provides a method for unlocking/releasing a piercing member safety mechanism of a decontamination device, the method comprising: providing a decontamination device having a wiping member disposed within the device, the device further characterized in that it has a piercing member safety mechanism configured to prevent the premature piercing of a vessel surface by a piercing member; providing a surface of a vessel; moving the surface of the vessel from an initial position to a compartment of the device where a surface of the vessel will be pierced; and unlocking/releasing the piercing member safety mechanism.
In one or more embodiments, the unlocking/releasing of the piercing member safety mechanism is due to the motion of the vessel. In one or more embodiments, the motion of the vessel is along a rail mechanism or a hinge mechanism of the decontamination device.
In yet a further aspect the present invention provides a method for unlocking/releasing a detachment safety mechanism of a decontamination device, the method comprising: providing a decontamination device having a wiping member disposed within the device, the device further characterized in that it has a detachment safety mechanism configured to prevent the premature detachment of a vessel from the device; providing a vessel; moving a portion of the vessel into a compartment of the device where a displaceable member and/or cap is located/disposed, resealing an opening of the vessel with the displaceable member and/or cap; and unlocking/releasing the detachment safety mechanism.
In one or more embodiments, the unlocking/releasing of the detachment safety mechanism releases/detaches the displaceable member/cap from an inner surface of a compartment of the decontamination device.
In one or more embodiments, the unlocking/releasing of the detachment safety mechanism allows for the detachment of the vessel from the decontamination device.
In or more embodiments, the unlocking/releasing of the detachment safety mechanism allows for the detachment of the vessel from the decontamination device after an opening of the vessel has been sealed/capped.
In one or more embodiments, the unlocking/releasing of the detachment safety mechanism allows for the detachment of the displaceable member
In one or more embodiments, the unlocking/releasing of the detachment safety mechanism allows for the opening of a wall and/or surface of the decontamination device thus allowing the vessel to detach from the decontamination device.
In yet a further aspect the present invention provides a method for unlocking/releasing a cap safety mechanism of a decontamination device, the method comprising: providing a decontamination device having a wiping member disposed within the device, the device further characterized in that it has a cap safety mechanism configured to prevent the premature detachment of a displaceable member and/or cap from the decontamination device; providing a vessel; moving a portion of the vessel into a compartment of the decontamination device where a displaceable member and/or cap is located/disposed; and unlocking/releasing the cap safety mechanism allowing the displaceable member and/or cap to detach from an inner surface of the decontamination device and also allowing the displaceable member and/or cap to reseal/recap an opening of the vessel.
In yet a further aspect the present invention provides a method for unlocking/releasing a hinge safety mechanism of a decontamination device, the method comprising: providing a decontamination device having a wiping member disposed within the device, the device further characterized in that it has a hinge mechanism safety mechanism configured to prevent rotation of at least one disc of the decontamination device until about the time and/or after the attachment of a vessel to the decontamination device, providing a vessel; attaching the vessel to the decontamination device; and unlocking the hinge safety mechanism.
In one or more embodiments, at about the time and/or after unlocking of the hinge safety mechanism at least one portion of the decontamination device is allowed to move in relation to another portion of the decontamination device.
In one or more embodiments, at about the time and/or after unlocking of the hinge safety mechanism at least one disc of the decontamination device is allowed to move in relation to another disc of the decontamination device.
In one or more embodiments, at about the time and/or after unlocking of the hinge safety mechanism, the vessel is allowed to move from a first compartment of the decontamination device to a second and/or third compartment of the decontamination device.
In yet a further aspect the present invention provides a method for unlocking/releasing a rail safety mechanism of a decontamination device, the method comprising: providing a decontamination device having a wiping member disposed within the device, the device further characterized in that it has a rail safety mechanism configured to prevent movement of a vessel along a rail safety mechanism until about the time and/or after the vessel is attached to the decontamination device, providing a vessel; attaching the vessel to the decontamination device; and unlocking the rail safety mechanism.
In one or more embodiments, the rail safety mechanism is unlocked by the vessel when the vessel attaches to the decontamination device.
In one or more embodiments, the rail safety mechanism engages a surface of the vessel at about the time and/or after the vessel attaches to the decontamination device, wherein upon said engagement the rail safety mechanism is unlocked by the vessel.
In one or more embodiments, upon unlocking of the rail safety mechanism the vessel is allowed to slide along the rail of the decontamination device between compartment.
In yet a further aspect the present invention provides a method for unlocking/releasing a valve safety mechanism of a decontamination device, the method comprising: providing a decontamination device having a wiping member disposed within the device, the device further characterized in that it has a valve safety mechanism configured to prevent the premature opening of the valve prior to the positioning of a vessel surface within a compartment where a fluidic communication will be established; providing a vessel, connecting/engaging the vessel to the decontamination device, moving the vessel from an initial position to a secondary position where a fluidic communication will be established; and unlocking/releasing the valve safety mechanism.
In one or more embodiments, the valve safety mechanism is unlocked by the vessel when a surface of the vessel moves into the compartment where a fluidic communication will be established. In one or more embodiments, the valve safety mechanism is unlocked by the movement of the vessel between compartments.
In one or more embodiments, a surface of the vessels engages/moves/interacts with the valve safety mechanism thus unlocking/releasing the valve safety mechanism allowing the valve to open. In one or more embodiments, a twisting, turning, pushing, slight pulling, twist and push, or a push and twist movement of the vessel unlocks/releases the valve safety mechanism. In one or more embodiments, the valve safety mechanism is configured to maintain the valve in an opened position.
In yet a further aspect the present invention provides a method for unlocking/releasing a retractable safety mechanism, the method comprising: providing a decontamination device having at least one retractable safety mechanism, the retractable safety mechanism configured to allow a vessel to move in one direction between compartments of the decontamination device while preventing the vessel from moving back to a previous compartment of the decontamination device; providing a vessel; moving the vessel from an initial position to at least a secondary position; and having the retractable safety mechanism lock the vessel in the at least secondary position thus preventing the vessel from moving from a secondary position back to a previous position.
In one or more embodiments, the retractable safety mechanism is a locking member.
In one or more embodiments, the retractable safety mechanism is configured to allow the vessel to move in a unidirectional path along the decontamination device while preventing backward movement of the vessel to a previous position.
In yet a further aspect the present invention provides a device for the decontamination of a surface of a vessel, comprising: a housing having a top, a bottom, and a side; a wiping member disposed within the housing; and at least one safety mechanism.
In one or more embodiments, the device includes a piercing member configured to pierce a surface of at least one vessel.
In one or more embodiments, the safety mechanism is a piercing member safety mechanism adapted to prevent premature piercing of a vessel's surface by the piercing member.
In one or more embodiments, the device includes a rail mechanism configured to provide movement of a vessel surface between compartments of the device.
In one or more embodiments, the safety mechanism is a rail safety mechanism adapted to ensure sliding of a vessel along the rail, prevent premature sliding of the vessel on along the rail and/or secure the attachment of the vessel to the rail mechanism.
In one or more embodiments, the device includes a resealing mechanism for resealing a vessel opening with a displaceable member, wherein the resealing occurs within a compartment of the device.
In one or more embodiments, the safety mechanism is a detachment safety mechanism configured to prevent premature detachment of a vessel from the device.
In one or more embodiments, the safety mechanism is a cap safety mechanism configured to prevent premature detachment of a displaceable member from the device.
In one or more embodiments, the safety mechanism is a retractable safety mechanism configured to provide for the one-directional movement of a vessel surface within the device.
In one or more embodiments, the safety mechanism is a locking member configured to prevent movement of a vessel surface from a secondary position to a previous position.
In one or more embodiments, the device includes a hinge mechanism.
In one or more embodiments, the safety mechanism is a hinge safety mechanism configured to prevent premature rotation of a disc of the device.
In one or more embodiments, the device includes a valve.
In one or more embodiments, the safety mechanism is a valve safety mechanism configured to prevent premature opening of the valve prior to correct positioning of a vessel surface within the device in a compartment where a fluidic passageway will be established.
In yet a further aspect the present invention provides a device for the decontamination of a surface of a vessel having at least one safety mechanisms.
In one or more embodiments, the safety mechanisms are selected from a piercing member safety mechanism, a detachment safety mechanism, a cap safety mechanism, a hinge safety mechanism, a rail safety mechanism, a valve safety mechanism and a retractable safety mechanism.
In yet a further aspect the present invention provides a connector for connecting two vessels, comprising: a first housing having a wiping member disposed within the housing and at least one safety mechanism; and a second housing having a wiping member disposed within the housing and at least one safety mechanism.
In one or more embodiments, the at least one safety mechanism of the first housing is selected from a piercing member safety mechanism, a detachment safety mechanism, a cap safety mechanism, a hinge safety mechanism, a rail safety mechanism, a valve safety mechanism and a retractable safety mechanism.
In one or more embodiments, the at least one safety mechanism of the first housing and at least one safety mechanism of the second housing is selected from a piercing member safety mechanism, a detachment safety mechanism, a cap safety mechanism, a hinge safety mechanism, a rail safety mechanism, a valve safety mechanism and a retractable safety mechanism.
Unless otherwise defined, all technical or/and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods or/and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
In the drawings:
It should be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements are exaggerated relative to each other for clarity. Further, where considered appropriate, reference numerals have been repeated among the figures to indicate corresponding elements.
It is understood that the invention is not limited to the particular methodology, devices, items or products etc., described herein, as these may vary as the skilled artisan will recognize. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention. The following exemplary embodiments may be described in the context of exemplary medical devices for ease of description and understanding. However, the invention is not limited to the specifically described products and methods and may be adapted to various applications without departing from the overall scope of the invention. All ranges disclosed herein include the endpoints. The use of the term “or” shall be construed to mean “and/or” unless the specific context indicates otherwise.
The present invention relates to devices, methods and systems allowing an engagement of, and fluid passageway between vessels in a sterile or decontaminated manner. The present devices, methods and systems are particularly useful for medical purposes, wherein sterile preparations of medical substances are routinely required. In one embodiment, the present invention provides systems configured to allow a substantially decontaminated engagement between vessels. In one embodiment, the present invention provides systems configured to decontaminate one or more surfaces of at least one vessel. In one or more embodiments, the systems of the invention allow a substantially decontaminated fluid transfer between one or more vessels.
The invention provides a solution to an unmet and long felt need in medical settings and allows connecting in a sterile manner, two or more vessels. The herein disclosed devices and systems are user friendly, cost effective and abolish the need for complicated and expensive known methods for transferring and administering medical substances.
In an aspect of the invention there is provided a decontamination system for the engagement of medical vessels, the system comprising a first vessel, a second vessel, a sliding mechanism positioned on at least one of the first vessel and the second vessel and configured to allow traveling there along of at least one of the first vessel and the second vessel, such that at least one of the first vessel and the second vessel is configured to move from a first position to a second position; and
In one or more embodiments, the devices and systems of the invention include a housing having a side wall, a top wall and a bottom wall, and a wiping member disposed within the housing. In an embodiment of the invention, the top wall and/or bottom wall of the housing have at least one port with port openings for receiving the vessels. The ports and port openings may be formed by vertical walls extending from the top and/or bottom walls, forming an inner channel via which medical substances may be transferred following engagement between, and decontamination of the vessels. Optionally, the bottom wall of the housing includes a wall opening via which a medical vessel may engage with the housing.
In one or more embodiments, at least one of the first vessel and the second vessel is configured to engage with the housing and slide or move there along. A surface of the moveable vessel slides from a first position to a second position within the housing. The vessel may optionally move from a second position to a third position. In one or more embodiments, the movement of the vessel allows a hermetically sealed and essentially sterile engagement between a first vessel and a second vessel. The movement of the vessel is vertically, along a rail disposed within the housing and/or on top of the vessel. In one or more embodiments, the movement of at least one of the vessels from a first position to a second position allows a fluid communication between the first vessel and the second vessel. In one or more embodiments, the movement of the vessel is horizontally, along a rail disposed within or on the housing and/or on a surface of the vessel.
In one or more embodiments, the wiping member is manufactured from or comprises a material including, but not limited to an elastic material, a rigid material, a flexible material, an expandable material, an absorptive material or combinations thereof. In one or more embodiments, the wiping member is manufactured from or comprises an elastomeric material, such as, but not limited to a rubber material. In one or more embodiments, the wiping member is manufactured from or comprises a sponge or a sponge-like material.
In one or more embodiments, the medical vessel or medical vessel surface slides along the housing and passes through the wiping member under great friction, or under a friction sufficient to wipe off any contaminants from the surface of the vessel, such as dirt, bacteria or ambient air particles. In one or more embodiments, at least one locking member may be disposed in or on the housing to prevent the medical vessel from returning to its initial or to its previous position.
In an embodiment of the invention, the herein disclosed devices and systems are disposable. In an embodiment of the invention, the herein disclosed devices and systems are non-disposable.
In one or more embodiments, one or more of the surfaces of the vessels is flat and/or smooth. The one or more surfaces may be substantially flat or partially flat or sufficiently flat, allowing efficient decontamination thereof by the wiping member.
In one or more embodiments, the wiping member is covered, at least partially by, or includes, a sterilizing substance. As used herein the term “sterilizing substance” encompasses any substance that can eliminate or reduce the presence of microorganisms, air particles, or any of the alike. In one embodiment, the term “sterilizing substance” is interchangeable with the term “disinfecting substance”. In one or more embodiments, the sterilizing substance is a liquid, a gas, or a semi-solid substance. In one or more embodiments, the sterilizing substance may be, but is not limited to, an antibacterial substance, an antiviral substance (e.g., an anti-HIV agent), an anti-tuberculin substance, an anti-fungal, and combinations thereof. In one or more embodiments, the sterilizing substance may be a bacteriostatic substance, a virustatic substance, a fungistatic substance, a bactericidal substance, a virucidal substance and/or a fungicidal substance. Exemplary sterilizing substances include, without limitation, alcohol, isopropyl alcohol, iodine, lugol's iodine solution and hydrogen peroxide. In one or more embodiments, the sterilizing substance is provided within the housing, optionally within separate compartments within the housing. In one or more embodiments, the sterilizing substance covers at least a portion of at least one wiping member.
In one or more embodiments, the housing may be manufactured from various materials. Optionally, the housing is manufactured from an inert material, thus suitable for various types of pharmaceutical substances. The housing may be made from flexible or from rigid materials. Suitable materials include, without limitation a plastic, a glass, a rigid plastic, a flexible plastic, rubber or combinations thereof.
Various sizes and shapes of the housing are applicable. For example, the housing may have an external most width, length, or height of less than about 100 millimeters (mm). For example, less than about 50 mm, less than about 25 mm, or less than about 10 mm. The housing internal most width may be less than about 9 mm. For example, the housing internal width may be less than about 5 mm, less than about 2.5 mm, or less than about 1 mm. The housing may include one or more compartments which may optionally be separated or divided or isolated by the wiping member or by any other means. In one or more embodiments, the housing includes two compartments, wherein a first compartment is configured to receive a vessel and may be contaminated or non-sterile and a second compartment that is kept sterile allows fluid transfer between two vessels. In one or more embodiments, the sterile compartment can receive a vessel following decontamination of the vessel's surface. In one or more embodiments, the housing includes two compartments wherein a first compartment is configured to receive a vessel and a second compartment is configured to allow fluid transfer between two or more vessels. Optionally, the housing includes three or more compartments. In an exemplary embodiment, the second compartment includes a resealing mechanism and allows resealing or recapping of a vessel. In an exemplary embodiment, the third compartment includes a resealing mechanism and allows resealing or recapping of a vessel. In an exemplary embodiment, the fourth compartment includes a resealing mechanism and allows resealing or recapping of a vessel. In an exemplary embodiment, the fifth compartment includes a resealing mechanism and allows resealing or recapping of a vessel. In an exemplary embodiment, the resealing mechanism disposed in a sterile environment and/or compartment within the housing, ensuring sterilized resealing for the vessel with a displaceable member. In an exemplary embodiment, the second compartment includes a sterilizing/disinfecting substance. Optionally, the housing includes five compartments. In an exemplary embodiment, the second compartment and fourth compartment include a sterilizing/disinfecting substance. The housing may or may not include a bottom wall. The housing may include a bottom wall which is partially open. Optionally, the housing includes a first compartment which is open at the bottom or which does not include bottom wall. Alternatively, or additionally the first and third compartments may be open at the bottom or may not include a bottom wall. Further optionally, the second compartment may include a bottom wall which may include an opening. Further optionally, all compartments are open at the bottom or may not include a bottom wall. In one or more embodiments, the housing has a plurality of compartments. In one or more embodiments, the housing may abut a wall of a container, may be flush mounted to a wall of a container, and/or be surface mounted to a wall of a container. In one or more embodiments, the container may be a bag, a bottle or a vial. In one or more embodiments, the housing may be integrally attached to the container. In one or more embodiments, the housing may form a unitary structure with the container. In one or more embodiments, the housing may be attached and/or integrally attached to a syringe. In one or more embodiments, the housing may form a unitary structure with the syringe. In one or more embodiments, the housing may be attached and/or integrally attached to an infusion line. In one or more embodiments, the housing may form a unitary structure with the infusion line. In one or more embodiments, the infusion line may be an intravenous line. In one or more embodiments, the infusion line may be an arterial line.
The vessel may move from a first position in which a vessel surface is located within the first compartment to a second position in which the vessel surface is located in the second compartment. Optionally, the housing includes a third compartment and the vessel surface is moveable from the second position to a third position. Optionally, the housing includes a fourth compartment or a fifth compartment and the vessel surface is moveable from a third position to a fourth position and/or a fifth position.
In one or more embodiments, the housing is conveniently light presenting a weight of no more than about 100 grams (gr). For example, less than about 50 gr, less than about 25 gr, less than about 15 gr, less than about 10 gr, or less than about 5 gr.
The hosing may be transparent allowing visualization of its interior, or opaque.
The housing may be a closed chamber which forms a tight, optionally, airtight connection between the vessels. The housing may be a partially closed chamber. In one or more embodiments, when the ports or openings are connected to vessels or when the ports are covered by a cover or a seal, the housing may form an interior which is hermetically sealed/isolated from surrounding/environmental air.
The housing may optionally include one or more aperture(s), optionally covered by a filter, to thereby allow releasing air from the housing when a medical vessel passes through the wiping member. In one or more embodiments, the filter may be a sterilizing filter. In one or more embodiments, the filter may have a porosity of 0.22 microns or less. In one or more embodiments, a plurality of compartments of the housing have a filter in a wall of the compartments. Optionally, the one or more aperture(s) may be covered by a valve, to thereby allow releasing air from the housing when a medical vessel passes through the wiping member. In one or more embodiments, the valve may be a one-way valve.
In one or more embodiments, the system of the invention is provided when the housing is already connected to one or more medical vessels. In accordance with this embodiment, the one or more medical vessels may be integrally manufactured with the housing and provided or distributed to consumers as such. In accordance with this embodiment, the system may be configured to allow a connection to additional one or more vessels. Alternatively, the system of the invention is provided without any attachment to a vessel and is configured to connect a plurality of vessels and decontaminate the vessels.
In one or more embodiments, the at least one vessel ranges from one vessel to ten vessels, wherein a surface of at least one or each of the vessels is configured to be wiped off by the wiping member.
In one or more embodiments, the system includes one or more ports configured to attach a medical vessel.
In one or more embodiments, the systems and devices of the invention include a sliding mechanism positioned on at least one of a first medical vessel and a second medical vessel and is configured to allow traveling there along of at least one of the first medical vessel and the second medical vessel, such that at least one of the first medical vessel and the second medical vessel is configured to move from a first position to a second position. In one or more embodiments, the systems and devices of the invention include a sliding mechanism positioned on or within a housing thereby allowing traveling or sliding there along of at least one of the first medical vessel and the second medical vessel, such that at least one of the first medical vessel and the second medical vessel is configured to move from a first position to a second position. Optionally, in one or more embodiments, the system provides for the travelling of a vessel between a plurality of positions, such as from a second position to a third position, from a third position to a fourth position, and from a fourth position to a fifth position. In one or more embodiments, the sliding mechanism allows only unidirectional sliding. In one or more embodiments, the sliding mechanism allows for the vessel to retract/return to a previous position. Various types of sliding mechanisms are contemplated as long as they can be connected or engage a vessel and afford traveling there along and allow decontamination of a surface of the vessel. The sliding mechanism may include a rail. The rail may be optionally made from a plastic or polymetric material, but a metallic material or glass material is also applicable. In one embodiment, the rail is manufactured from a plastic material. In one or more embodiments, the plastic material is rigid. In one or more embodiments the vessel surface is positioned on a surface of the rail. In one or more embodiments, the vessel surface is positioned between the rails of the rail. In one or more embodiments, the vessel surface is positioned between a portion of the rails. In one or more embodiments, the rail may be a circumferential rail. In one or more embodiments, the sliding mechanism may be a hinge mechanism. In one or more embodiments, the sliding mechanism may include one or more rotatable discs capable of connecting to a medical vessel and being rotatable within the housing, such to allow a vessel's surface to pass through the wiping member. Optionally, the sliding mechanism includes a first disc and a second disc positioned one above the other and being rotatable with respect to each other. Optionally, one disc is rotatable, and another disc is stationary. Optionally, the wiping member is disposed between two discs.
In one or more embodiments, the housing and/or medical vessel has an engagement mechanism configured or adapted to connect the at least one vessel to the housing. In one or more embodiments, the herein disclosed systems include an engagement mechanism configured to provide an engagement between first and second medical vessels. Various types of engagement mechanisms may be applicable and are contemplated. For example, the engagement mechanism is selected from, without limitation, a thread, a luer, a luer-lock, a luer-slip, a smart-site, a ratchet teeth mechanism, a retention member, a fastener, a clamping element, a clamping rail, clamping members or arms, and an adhesive mechanism, and combinations thereof. The thread and the complementary thread may be a luer. an adhesive, a ratchet teeth mechanism, and combinations thereof. In an embodiment of the invention, the engagement mechanism positions the surface of the at least one vessel at about same level as an interior wall of the housing. In an embodiment of the invention, the engagement mechanism positions the surface of the pharmaceutical vessel at the same level as an interior wall of a housing of the system. In an embodiment of the invention, the engagement mechanism positions the surface of the at least one vessel in a manner that protrudes into the housing. In an embodiment of the invention, the protruding of the surface of the at least one vessel is a slight/minor protruding. In an embodiment of the invention, the protruding of the surface of the at least one vessel ranges from less than one twelfth of an inch to less than half an inch. In an embodiment of the invention, the engagement mechanism positions the surface of the at least one vessel in a manner that is below an inner surface of the housing. In an embodiment of the invention, the positioning of the surface of the at least one vessel ranges from less than one twelfth of an inch to less than a half an inch from the inner surface of the housing. In an embodiment of the invention, the engagement mechanism positions the surface of the at least one vessel slightly below an inner wall/surface of the housing while allowing the wiping member to wipe off the entire surface of the at least one vessel. In one or more embodiments, the surface of the at least one vessel is positioned at the same level as an inner surface of a housing wall.
In one or more embodiments, the system may include one or more safety mechanisms to secure one or more elements of the system and/or ensure proper use thereof. In one or more embodiments, the system includes at least one safety mechanism. In one or more embodiments, the safety mechanism is configured to prevent premature movement of a surface of a vessel within the housing. In one or more embodiments, the safety mechanism is configured to prevent premature decontamination of a surface of a vessel. In one or more embodiments, the safety mechanism is configured to prevent premature establishment of fluidic communication between vessels. In one or more embodiments, the safety mechanism is configured to prevent premature piercing of vessel's surface with the piercing member. In one or more embodiments, the safety mechanism is configured to prevent premature breaking of a frangible seal covering an opening of the housing. In one or more embodiments, the safety mechanism is configured to prevent retraction of the vessel between compartments. In one or more embodiments, the safety mechanism is configured to prevent premature detachment of the vessel from the housing. In one or more embodiments, the safety mechanism is configured to secure a valve within the housing. In one or more embodiments, the safety mechanism is configured to ensure and/or prevent premature sliding of a vessel on the rail within the housing. In one or more embodiments, the safety mechanism is configured to secure the attachment of a vessel to the rail. In one or more embodiments, the safety mechanism is configured to prevent premature rotation of the one or more discs within the housing.
In one or more embodiments, the system includes at least one safety mechanism selected from a valve safety mechanism, a piercing member safety mechanism, a rail safety mechanism, a detachment safety mechanism, a hinge safety mechanism and a retractable safety mechanism. In one or more embodiments, the system includes at least one safety mechanism to secure at least one element of the system selected from: a valve, a rail, a displaceable member, a piercing member, and a wiper.
Various configurations of the safety mechanism are contemplated. For example, the safety mechanism may have a stopper, or a locker structure. In an exemplary embodiment, the safety mechanism is selected from the group, but not limited to a plunger, a latch, a knob, a pin or a shaft. Optionally, the safety mechanism is movable from a retracted position wherein it is concealed within an inner wall of the housing to an extended position wherein it protrudes from an inner wall of the housing. In an exemplary embodiment, the safety mechanism is configured to press down against an inner wall of the housing when a surface of the vessel passes over the safety mechanism and extend to protrude from an inner wall of the housing after the vessel passed over the safety mechanism. Optionally, the movement between an extended to a retracted position of the safety mechanism is mediated by a spring which is optionally attached to the safety mechanism, optionally from below. The safety mechanism may be manufactured from various rigid materials, such as, a plastic or a metal (e.g., a metal alloy).
The safety mechanisms may be optionally unlocked by a movement of the vessel within the housing, for example, by an engagement of the vessel with the housing, by engagement of the vessel with an engagement mechanism of the decontamination device, by movement of the vessel between compartments, by movement of the vessel surface between compartments, by movement of an engagement mechanism of the device along the rail of the device, and/or by detachment of the vessel from the housing. Optionally, the vessel may comprise an unlocking member that engages the safety mechanism and unlocks the safety mechanism. Further optionally, or additionally the vessel may comprise a locking member that engages the safety mechanism and locks the safety mechanism with the vessel, or with a compartment or a component within the housing. Such locking or unlocking member may be disposed on the vessel's surface. In one or more embodiments, the safety mechanism is unlocked by and/or locked to the vessel via a motion selected from pushing, pulling (slight pulling), twisting, turning, sliding, push and twist, and/or twist and push, or a combination thereof.
In one or more embodiments, the safety mechanism makes an audible sound upon use thereof (e.g., when locked/unlocked/released). The audible sound may be a “CLICK”.
In one or more embodiments, the valve safety mechanism is adapted to attach a valve or a locking mechanism thereof, ensuring opening of the valve after correct positioning of the vessel within a compartment (e.g., a second, a third, a fourth or a fifth compartment) of the housing or system. Valve safety mechanism may be a locker, or a stopper structure configured to lock a valve or an unlocking mechanism thereof after opening of the valve. The valve safety mechanism is thus configured, according to one or more embodiments, to maintain the valve in an opened configuration after correct positioning of the vessel within a compartment (e.g., a second, a third, a fourth or a fifth compartment) of the housing/system.
In one or more embodiments, the piercing member safety mechanism is adapted to prevent the premature piercing of a vessel's surface. For example, upon attachment of a vessel to a piercing member safety mechanism, the piercing member safety mechanism or an actuator of the piercing member is unlocked by the attachment, allowing activation of piercing member to pierce a vessel's surface. Alternatively, additionally, or optionally, piercing member safety mechanism is unlocked upon pressing piercing member actuator manually by a user. Optionally, piercing member safety mechanism is further adapted to lock a vessel in place and prevent retraction thereof. Optionally, the piercing member safety mechanism is connected directly or indirectly to a piercing member or to an actuator thereof (i.e., piercing member actuator). Optionally, the piercing member safety mechanism is connectable in a direct or an indirect manner to a vessel. Optionally, the piercing member safety mechanism connects between a vessel and the piercing member. Various configurations of piercing member safety mechanism are contemplated. In one embodiment, the piercing member safety mechanism comprises a longitudinal shaft that curves at a bottom end thereof allowing attachment thereof to a vessel via the curved end. Other configurations of piercing member safety mechanism are contemplated such as a plunger, a latch or a pin.
In one or more embodiments, the rail safety mechanism may be optionally further provided to ensure sliding of a vessel on the rail upon attachment thereof to the system. Optionally, the rail safety mechanism prevents premature sliding of the vessel on the rail. Optionally, alternatively or additionally, the rail safety mechanism secures the attachment of a vessel to the rail. Various configurations of rail member safety mechanism are contemplated. For example, the rail safety mechanism has a structure of a locker or a stopper. Optionally, the rail safety mechanism is configured to travel along the rail together with the vessel. According to this embodiment, the rail safety mechanism is configured to be able to attach the vessel either directly or indirectly via a connector element.
In one or more embodiments, the cap safety mechanism is configured to prevent premature detachment of a displaceable member. Optionally, cap safety mechanism is interchangeable with a detachment safety mechanism and is operable to prevent the premature detachment of a vessel from a compartment of the housing where resealing occurs. Optionally, the cap safety mechanism is unlocked at the time of movement of a vessel into a compartment within the housing. Optionally, additionally or alternatively, the cap safety mechanism is unlocked about the time of, or after resealing of a vessel. Cap safety mechanism may be attached to displaceable member or may hold the displaceable member in place. Various configurations of cap member safety mechanism are contemplated. For example, the cap safety mechanism has a structure of a locker or a stopper.
In one or more embodiments, the hinge safety mechanism may be further provided within a compartment of the housing, or other locations within or on the decontamination device, to prevent premature rotation of the one or more discs within the housing. Accordingly, the one or more discs within the housing may be released to allow rotation thereof with respect to each other upon attachment of vessel within the housing, e.g., within a first compartment of the housing. Optionally, hinge safety mechanism has a form of a plunger or a pin which can be retracted within a slot in a wall of the housing upon sliding of the vessel on top of the hinge safety mechanism.
In one or more embodiments, the system having a locking member to provide for the one directional movement of a vessel between compartments of the housing so that the vessel cannot retract. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a second position to a first position. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a third position to a second position. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a fourth position to a third position. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a fifth position to a fourth position. In one or more embodiments, the locking member is applicable to any of the disclosed devices, systems, and methods of this invention. The locking member may be positioned in various locations within the housing. For example, the locking member may be disposed within the first, the second, the third or any of the other compartments. In an exemplary embodiment, the locking member is disposed within the second compartment, or between the first and second compartments. In an exemplary embodiment, the locking member is disposed within the third compartment, or between the third and second compartments. In an exemplary embodiment, the locking member is disposed within the fourth compartment, or between the third and fourth compartments. In an exemplary embodiment, the locking member is disposed within the fifth compartment, or between the fifth and fourth compartments. Various forms of retractable safety mechanisms are herein contemplated. Optionally, the locking member may be a stopper structure. The locking member may present various forms and/or mechanisms including, but not limited to a latch, a plunger, and/or a knob. Optionally, the locking member is movable from a retracted position such that the vessel may freely slide along or travel within the housing and an extended position to lock in place the vessel, upon positioning of the vessel in a second, a third, a fourth and/or a fifth position. In one or more embodiments, the term locking member is interchangeable with the term retractable safety mechanism.
In one or more embodiments, the herein disclosed invention allows transferring medical substances in a contaminant-free, or in a substantially contaminant-free manner.
In one or more embodiments, the herein disclosed invention affords an engagement of vessels in a contaminant-free, or in a substantially contaminant-free manner.
In one or more embodiments, the herein disclosed invention provides a fluidic passageway or communication between vessels in a contaminant-free, or in a substantially contaminant-free manner.
In one or more embodiments, the herein disclosed invention, allows to substantially decrease the chances to introduce contaminants within a medical substance, when preparing medical substances for administration to patients.
In one or more embodiments, the herein disclosed invention, allows for the air-free engagement between at least two vessels.
As used herein the term “substances” refers to various types of materials that should be kept sterile. The substances may be liquid, solid, gelatinous, semi-solid, or gas. In one or more embodiments, the substances are “medical substances”. As used herein the term “medical substances” refers to and encompasses any of the various pharmaceutical drugs, medical drugs, fluids, nutritional products, solid powders, suspensions, liquids and the like. In an embodiment of the invention the term “medical substance” is interchangeable with the term “pharmaceutical substance”. In one or more embodiments medical substances refers to and encompasses sterile injectable substances intended for intracorporal administration to persons in need or animals.
As used herein, the term “contaminant-free” is interchangeable with the term “sterile”, “disinfected”, and “decontaminated”. The term refers to substances that are free or substantially free of ambient air particles and/or pathogens, including but not limited to bacteria, viruses, funguses, spores, dirt and/or pyrogens. Typically, when less or no air is introduced within medical substances, the chances of contamination by pathogens, such as, bacteria, viruses, funguses, spores, pyrogens or the alike is completely abolished or significantly reduced.
As used herein, the term “substantially contaminant-free” means significantly less ambient air present when transferring medical substances with the herein disclosed vessels and systems, as compared to comparable conditions for transferring medical substances without the herein disclosed vessels and systems.
As used herein the term “ambient air particles” is interchangeable with the term “environmental air particles” and refers to air particles present in a non-filtered environment. The air particles may contain dirt, such as dust. Alternatively, or additionally, the air particles may contain pathogens or other microorganisms, or any of the alike. For example, air can be purified by filters, such as a High Efficiency Particulate Air (HEPA) filter.
As used herein the term “vessel” refers to any device utilized for containing, transferring or administering substances as herein disclosed. In one or more embodiments, the vessels may be used for containing medical substances. In an embodiment of the invention, the vessel is a medical vessel. In one or more embodiments, the term “medical vessel” is interchangeable with the terms “pharmaceutical vessel” and “medical device”. In an embodiment of the invention, the vessel is a medical device. In an embodiment of the invention, the vessels are used for, and adapted to allow connection to another vessel. The vessel may have a vessel's port via which medical substances may pass towards another vessel. In an embodiment of the invention, the vessel is utilized for containing a medical substance. Various types of vessels are contemplated. The vessel may be selected, without limitation, from a vial, a bag, a chamber, a bottle, a syringe, an infusion line, an administration line, a connector, a filter, a spike, a manifold, a bag port, a bottle port, a vial port and the alike. In an embodiment of the invention, the term vessel further encompasses elements that can be used to connect between vessels. In accordance with this embodiment, the vessel may be selected, without limitation, from a connector, a connector with multiple openings, a connector with multiple ports, a syringe, an infusion line, a tubing, a syringe, a filter, a port and a manifold.
As used herein, the term “connection interface” encompasses any surface, layer plane or the alike that can be attached to a vessel. The term may encompass a structure that can be coupled to a vessel and that can engage with a complementary connection interface. In an embodiment of the invention, the connection interface may seal or cover an aperture of a vessel. In an embodiment of the invention, the connection interface may seal or cover an opening for fluid passageway of a vessel.
As used herein the term “fluid communication” refers to two or more vessels in which substances may pass therethrough either directly or indirectly. The fluid communication may occur via a fluid passageway that allows for the flow/transfer of substances. In an embodiment of the invention, fluid passageway between vessels is established when any seals or covers of the ports of the herein disclosed systems and/or of the vessels are open. Optionally, the vessels and/or ports of the systems are provided with seals/covers and those seals/cover become open upon piercing thereof, for example, by a piercing member. Optionally, the vessels and/or ports of the systems are provided with seals/covers and those seals/cover are opened upon uncovering or removing thereof by a user. Optionally, one or more of the seals/covers disclosed herein take the form of a film, e.g., a thin film. Optionally, one or more of the seals/covers disclosed herein are fragile, allowing piercing thereof with a sharp instrument (i.e., a piercing member). The piercing member may optionally be a needle, for example, a hollowed needle, but other sharp elements are contemplated. Optionally, one or more of the seals/covers disclosed herein are frangible, allowing for the rupturing/breaking of the seals/covers with the application of sufficient force by a user. Optionally, one or more of the vessels includes a displaceable member in the form of a seal or a cap. The displaceable member may be made from various materials, such as, but no limited to a plastic material or a metal material, such as a metal alloy. The displaceable material may be in the form of a foil, or a membrane or a layer. The foil, membrane or layer may be frangible. The displaceable member may be integrally connected to a medical vessel or to a port thereof and may be configured to externally displace from the medical vessel or port at the time the medical vessel moves from the first position to the second position. In one or more embodiments, the displaceable member is configured to engage a complementary displaceable member on a complementary medical vessel. In one or more embodiment, such an engagement is an airtight engagement.
In an embodiment of the invention, the herein disclosed devices, systems and methods allow fluid communication in a contaminant-free, or in a substantially contaminant-free manner. For example, between three or more, four or more, five or more or six or more vessels. In an embodiment of the invention, the herein disclosed devices, systems and methods allow fluid communication between three, four, five six, or seven vessels. For example, the devices, systems, and methods of the invention allow fluid communication between two bags, between a syringe and a bag, between a connector and a bag, between a container and a bag, between a vial and a bag, between a syringe and a vial, between a syringe and a container, between a connector and a container, between a connector and a vial, between a connector and a bag, between an infusion line and a bag, between an infusion line and a syringe or between a syringe and a connector.
In an embodiment of the invention, the herein disclosed device has a plurality of compartments/chambers, wherein there is a pressure differential between at least two of the compartments/chambers. In one or more embodiments, at least one compartment/chamber of the housing has a higher pressure than an adjacent compartment/chamber of the housing. In one or more embodiments, at least one compartment/chamber of the housing has a lower pressure than an adjacent compartment/chamber of the housing. In one or more embodiments, at least one compartment/chamber of the housing has about the same pressure as an adjacent compartment/chamber of the housing. In one or more embodiments, at least one compartment/chamber of the housing has the same pressure as an adjacent compartment/chamber of the housing. In one or more embodiments, at least one compartment chamber of the housing has a pressure greater than or less than ambient air pressure or atmospheric pressure. In one or more embodiments, the pressure of at least one compartment/chamber of the housing is the same as ambient air or atmospheric pressure. In one or more embodiments, the pressure differential between compartments may be at least 0.02 i.w.c. (inches water column). In one or more embodiments, the pressure differential between compartments is at least 0.1 i.w.c. In one or more embodiments, the pressure differential between compartments is between 0.01 i.w.c. and 1 i.w.c. In one or more embodiments, the pressure differential between compartments may be at least negative 0.05 i.w.c. In one or more embodiments, the pressure differential between compartments is between negative 0.04 i.w.c. and negative 0.01 i.w.c. As used herein, the term “i.w.c.” encompasses the definition as provided or accepted by the United States Pharmacopeia, The American Society of Health-Systems Pharmacists, The American Pharmacists Association or other nationally or internationally recognized organizations.
Referring now to the drawings,
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System 10 is demonstrated when a syringe 40 is to be engaged with vessel 24. Syringe 40 includes a vessel's rail 37 disposed on top or around syringe port 42, and a displaceable member 44 disposed on top of vessel's rail 37. The displaceable member 44 is configured to externally displace from the syringe port 42 following engagement of syringe 40 at first compartment 20. Optionally, displaceable member 44 externally displaces from the port 42 at about the time syringe 40 moves from the first position (
Other engagement mechanisms are herein contemplated. For example,
In
Each of the following terms: ‘includes’, ‘including’, ‘has’, ‘having’, ‘comprises’, and ‘comprising’, and, their linguistic, as used herein, means ‘including, but not limited to’, and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof. Each of these terms is considered equivalent in meaning to the phrase ‘consisting essentially of’.
Each of the phrases ‘consisting of’ and ‘consists of’, as used herein, means ‘including and limited to’.
The term ‘method’, as used herein, refers to steps, procedures, manners, means, or/and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or/and techniques, either known to, or readily developed from known steps, procedures, manners, means, or/and techniques, by practitioners in the relevant field(s) of the disclosed invention.
Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments of the invention, and does not inflexibly limit the scope of the exemplary embodiments of the invention. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range ‘from 1 to 6’ also refers to, and encompasses, all possible sub-ranges, such as ‘from 1 to 3’, ‘from 1 to 4’, ‘from 1 to 5’, ‘from 2 to 4’, ‘from 2 to 6’, ‘from 3 to 6’, etc., and individual numerical values, such as ‘1’, ‘1.3’, ‘2’, ‘2.8’, ‘3’, ‘3.5’, ‘4’, ‘4.6’, ‘5’, ‘5.2’, and ‘6’, within the stated or described numerical range of ‘from 1 to 6’. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.
Moreover, for stating or describing a numerical range, the phrase ‘in a range of between about a first numerical value and about a second numerical value’, is considered equivalent to, and meaning the same as, the phrase ‘in a range of from about a first numerical value to about a second numerical value’, and, thus, the two equivalently meaning phrases may be used interchangeably.
The term ‘about’, is some embodiments, refers to ±30% of the stated numerical value. In further embodiments, the term refers to ±20% of the stated numerical value. In yet further embodiments, the term refers to ±10% of the stated numerical value.
It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are illustratively described and presented in combination or sub combination in the context or format of a single embodiment, may also be illustratively described and presented in the context or format of a plurality of separate embodiments.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.
All publications, patents, and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.
This application is a continuation-in part of U.S. application Ser. No. 16/100,840 entitled SYSTEMS, DEVICES AND METHODS FOR DECONTAMINATING SURFACES OF PHARMACEUTICAL VESSELS AND PHARMACEUTICAL ADMINISTRATION DEVICES filed Aug. 10, 2018, which claims the benefit of U.S. Provisional Patent Application No. 62/558,502 filed on Sep. 14, 2017; 62/560,195 filed on Sep. 19, 2017; 62/562,490 filed on Sep. 25, 2017; 62/563,072 filed on Sep. 26, 2017; 62/564,933 filed on Sep. 28, 2017; 62/582,922 filed on Nov. 7, 2017; 62/612,267 filed on Dec. 29, 2017; 62/619,795 filed Jan. 20, 2018; 62/619,920 filed Jan. 22, 2018; 62/625,334 filed on Feb. 1, 2018; 62/644,185 filed on Mar. 16, 2018; 62/662,721 filed on Apr. 25, 2018; 62/676,822 filed on May 25, 2018; 62/679,817 filed on Jun. 3, 2018; 62/686,602 filed on Jun. 18, 2018; 62/686,612 filed on Jun. 18, 2018; and 62/690,260 filed on Jun. 26, 2018. This application claims the benefit of priority of U.S. Provisional Patent Application No. 62/741,131 filed on Oct. 4, 2018. The contents of the above applications are all incorporated by reference as if fully set forth herein in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62690260 | Jun 2018 | US | |
| 62686612 | Jun 2018 | US | |
| 62686602 | Jun 2018 | US | |
| 62679817 | Jun 2018 | US | |
| 62676822 | May 2018 | US | |
| 62664933 | Apr 2018 | US | |
| 62662721 | Apr 2018 | US | |
| 62644185 | Mar 2018 | US | |
| 62625334 | Feb 2018 | US | |
| 62619920 | Jan 2018 | US | |
| 62619795 | Jan 2018 | US | |
| 62612267 | Dec 2017 | US | |
| 62582922 | Nov 2017 | US | |
| 62564933 | Sep 2017 | US | |
| 62563072 | Sep 2017 | US | |
| 62562490 | Sep 2017 | US | |
| 62560195 | Sep 2017 | US | |
| 62558502 | Sep 2017 | US | |
| 62741131 | Oct 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16100840 | Aug 2018 | US |
| Child | 16169695 | US |
