Patent Application
20190117513
The present invention relates, in some embodiments thereof, to systems, devices, and methods allowing for an engagement of two or more pharmaceutical vessels or pharmaceutical administration devices in a decontaminated manner.
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 one or more embodiments, by providing systems, devices, vessels and methods for engaging medical devices, such as vessels, in a decontaminated manner.
Objects of the invention are achieved, in one or more 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 one or more embodiments, by providing sealing mechanisms configured to seal an aperture of a vessel.
Objects of the invention are achieved, in one or more embodiments, by providing sealing mechanisms adapted to apply pressure in an outward direction against an inner wall of a connection interface, thereby sealing an aperture.
Objects of the invention are achieved, in one or more embodiments, by providing containers and connectors having sealing mechanisms configured to seal an aperture at about the time and/or at the time of external displacement of at least one connection interface.
Objects of the invention are achieved, in one or more embodiments, by providing at least one spring mechanism configured to seal an aperture of a vessel, container, and/or connector.
Objects of the invention are achieved, in one or more embodiments, by providing a valve mechanism configured to seal an aperture of a vessel at the time, at about the time, and/or after external displacement of at least one connection interface of the vessel.
The present invention is based on two or more connection interfaces, each of which is attached to a vessel. The connection interfaces are configured to connect between two or more medical vessels and while doing so, isolate and entrap therebetween ambient air particles, after which the connection interfaces along with entrapped ambient air particles are configured to externally displace from the vessels. Such devices and systems allow for a hermetic and sterile connection between the vessels.
In an aspect of the invention, the present invention provides a decontamination system for the engagement of vessels, the system comprising: a first connection interface attached to a first vessel; and a second connection interface attached to a second vessel, wherein the first connection interface and the second connection interface are configured to allow for an engagement between the first vessel and the second vessel, and wherein the first connection interface and the second connection interface are further configured to externally displace from the engagement between the first vessel and the second vessel while a hermetically sealed connection is maintained between the first vessel and the second vessel.
In one or more embodiments, at least one of the first connection interface and the second connection interface is a film. In one or more embodiments, the film is a plastic or a metal alloy.
In one or more embodiments, upon the engagement between the first vessel and the second vessel, the first connection interface and the second connection interface are configured to slide with respect to the first vessel and the second vessel, thereby removing contaminants between the first vessel and the second vessel.
In one or more embodiments, the first connection interface is configured to seal and/or cover a port of the first vessel and/or a port of the second vessel.
In one or more embodiments, the first connection interface and the second connection interface are configured to seal and/or cover an aperture of the first vessel and an aperture of the second vessel, respectively.
In one or more embodiments, the decontamination system results in air particle-free engagement of the first vessel and the second vessel, wherein air particles that contact the first and second interfaces are entrapped by the first connection interface and the second connection interface.
In one or more embodiments, the system further comprises an engagement mechanism configured to provide a secure engagement between the first vessel and the second vessel. In one or more embodiments, the engagement mechanism is located on the first vessel and/or on the second vessel. In one or more embodiments, the engagement mechanism is selected from a thread, a luer, an adhesive, and a ratchet teeth mechanism. Optionally, a twisting, turning, and/or snapping motion is associated with the engagement. In an exemplary embodiment, a twisting motion is associated with a thread-luer mechanism. In an exemplary embodiment, a snapping motion is associated with a ratchet teeth mechanism. In one or more embodiments, when the first vessel and the second vessel engage via the engagement mechanism, an airtight seal is formed between the first vessel and the second vessel. In one or more embodiments, when the first vessel and the second vessel engage via the engagement mechanism a sealed aperture is formed between the first vessel and the second vessel.
In one or more embodiments, the sealed aperture formed between the first vessel and the second vessel allows for the displacement of at least one of the connection interfaces of the first vessel and the second vessel. In one or more embodiments, the sealed aperture is configured to displace at least one connection interface through the sealed aperture while maintaining the hermetic seal between the first vessel and the second vessel. In one or more embodiments, the system further comprises an engagement mechanism configured to provide a secure engagement between the first connection interface and the second connection interface. In one or more embodiments, the engagement mechanism is located on the first connection interface and/or on the second connection interface. In one or more embodiments, the engagement mechanism is selected from a thread, a luer, an adhesive, and a ratchet teeth mechanism. In one or more embodiments, the engagement mechanism includes a mechanical object that connects the first connection interface with the second connection interface providing for a simultaneous external displacement of the first and second connection interfaces. In one or more embodiments, the mechanical object is a protrusion, a dent, or a hook. In one or more embodiments, the engagement mechanism that secures the first connection interface to the second connection interface is an adhesive. In one or more embodiments, the engagement mechanism secures the first connection interface to the second connection interface forming an airtight seal between the first connection interface and the second connection interface. In one or more embodiments, the engagement mechanism is a thread on the first vessel configured to engage a complementary thread on the second vessel. In one or more embodiments, the engagement mechanism is a thread on the first connection interface configured to engage a complementary thread on the second connection interface. In one or more embodiments, the thread of at least one of the thread and complementary thread is a luer.
In one or more embodiments, the system further comprises a first rail mechanism on the first vessel configured to provide external displacement of the first connection interface. In one or more embodiments, the system further comprises a second rail mechanism on the second vessel configured to provide external displacement of the second connection interface.
In one or more embodiments, the system further comprises a first rail mechanism on the first vessel configured to provide external displacement of the first connection interface and configured to provide external displacement of the second connection interface.
In one or more embodiments, the system further comprises a first slit mechanism on the first vessel configured to allow external displacement of the first connection interface and configured to provide external displacement of the second connection interface. In one or more embodiments, the first slit mechanism is an aperture. In one or more embodiments, the first slit mechanism is a sealed aperture. In one or more embodiments, the seal of the sealed aperture is a frangible seal. In one ore more embodiments, the frangible seal is opened via a force of a user's hand.
In one or more embodiments, the system comprises a seal or a cover disposed between a vessel and a connection interface. In one or more embodiments, the seal or cover is frangible. In one or more embodiments, the seal or cover is pierceable.
In one or more embodiments, the system comprises a first seal or a first cover disposed between a first vessel and a first connection interface and a second seal or a second cover disposed between a second vessel and a second connection interface. In one or more embodiments, the first seal or first cover and a second seal or a second cover is frangible. In one or more embodiments, the first seal or first cover and a second seal or a second cover is frangible.
In one or more embodiments, the system further comprises a first hinge mechanism on a first vessel configured to provide external displacement of a first connection interface and comprising a second hinge mechanism on a second vessel configured to provide external displacement of a second connection interface.
In one or more embodiments, the system further comprises a piercing member on the first and/or second vessel configured to pierce a sealed opening of the first and/or second vessel, thereby allowing fluid to pass between the vessels. In one or more embodiments, the piercing member is a needle.
In one or more embodiments, the first and second connection interfaces are externally displaced via a sliding or a pulling motion.
In one or more embodiments, when the first connection interface and the second connection interface are displaced, the connection between the first vessel and the second vessel is decontaminated. In one or more embodiments, when the first and/or second connection interface slides off the first and/or second rail mechanism, the hermetic connection between the first vessel and the second vessel is maintained. In one or more embodiments, when the first and second connection interface slides off the first rail mechanism, the hermetic connection between the first vessel and the second vessel is maintained.
In one or more embodiments, the first connection interface and the second connection interface externally displace from the engagement between the first vessel and the second vessel through a slit or an aperture sealed by the force of the engagement between the first vessel and the second vessel.
In one or more embodiments, the first connection interface and the second connection interface externally displace from the engagement between the first vessel and the second vessel at or about the same time.
In one or more embodiments, the first vessel and/or the second vessel are selected from a vial, a bag, a bottle, a syringe, an infusion line, a connector, a filter, a manifold, a container port, a bag port, a bottle port, a vial port, and combinations thereof. In one or more embodiments, the interior of the container port may have a pressure less than the pressure of ambient air.
In one or more embodiments, circumferential ends of at least one of or both of the first and second connection interface ends are concealed within the hermetically sealed connection between the first vessel and the second vessel.
In one or more embodiments, the system further comprises a tab on at least one of the first connection interface and the second connection interface, the tab configured to allow for external displacement of the first connection interface and the second connection interface with respect to the first vessel and the second vessel. In one or more embodiments, the tab is configured to be pulled axially by a user, the axial pulling of the tab configured to displace the first connection interface and the second connection interface from the first vessel and the second vessel, while maintaining a hermetic seal between the first vessel and the second vessel.
In one or more embodiments, the first vessel and the second vessel are in fluid communication with one another after external displacement of the first connection interface and the second connection interface from the first vessel and the second vessel.
In one or more embodiments, the first connection interface is coupled to the first vessel and wherein the second connection interface is coupled to the second vessel.
In one or more embodiments, the first connection interface has edges configured to isolate an entire surface of the first connection interface that is exposed to contaminants from contacting an internal compartment of the first vessel and/or said second vessel when the first connection interface is engaged with the second connection interface.
In one or more embodiments, the first connection interface has edges configured to isolate a portion of the surface of the first connection interface that is exposed to contaminants from contacting an internal compartment of the first vessel and/or the second vessel when the first connection interface is engaged with the second connection interface.
In one or more embodiments, the edges are circumferential edges. In one or more embodiments, the circumferential edges define the outer portion of the first connection interface and the second connection interface. In one or more embodiments, the edges are further configured so the sides of the edges are not exposed to contaminants. In one or more embodiments, the sides of the edges that are exposed to an internal compartment of the first vessel and/or the second vessel are not exposed to contaminants.
In one or more embodiments, the outer portion of the edges of the first connection interface are not exposed to contaminants. In one or more embodiments, the edges of the first connection interface are configured to fully entrap the contaminants between the first and second connection interfaces upon engagement of the first and second connection interfaces. In one or more embodiments, the edges of the first connection interface are flat.
In one or more embodiments, the edges of the first connection interface are configured to snuggly fit the edges of the second connection interface. In one or more embodiments, the edge is an exterior portion of the connection interface that comes in contact with an interior compartment of the decontamination device and/or vessel.
In one or more embodiments, the system further comprises a sealing mechanism on at least one of the first vessel and the second vessel, the sealing mechanism configured to seal an aperture of the vessel with the connection interface. In one or more embodiments, the system further comprises a sealing mechanism on at least one of the first vessel and second vessel, the sealing mechanism configured to seal an aperture of the vessel wherein the connection interface resides. In one or more embodiments, the sealing mechanism disposed within, or proximate the aperture, the sealing mechanism is adapted to apply pressure in an outward direction against an inner wall of the connection interface, thereby sealing the aperture. In one or more embodiments, the sealing mechanism comprises one or more springs and/or valves.
In one or more embodiments, the system further comprises a resealing mechanism on the first vessel and/or the second vessel, the resealing mechanism configured to allow for the hermetically sealed connection between the first vessel and the second vessel. In one or more embodiments, the resealing mechanism disposed within, or proximate the aperture, the resealing mechanism is adapted to extend into and close the aperture at the time of, or after the time of external displacement, thereby resealing the aperture. In one or more embodiments, the resealing mechanism is disposed within, or proximate the aperture, the resealing mechanism is adapted to extend and close the aperture at about the time of external displacement of at least one connection interfaces, thereby resealing the aperture. In one or more embodiments, the resealing mechanism comprises one or more springs and/or valves.
In a further aspect, the present invention provides a method of decontaminating a connection between two vessels, the method comprising the steps of: providing a first connection interface attached to a first vessel; providing a second connection interface attached to a second vessel, engaging the first vessel to the second vessel; and externally displacing the first and second connection interfaces from the engagement between the first vessel and the second vessel, while a hermetically sealed connection between the first and second vessels is maintained.
In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs via a sliding motion.
In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs via sliding the first connection interface and the second connection interface axially with respect to the first vessel and the second vessel, thereby removing contaminants located between the first connection interface and second connection interface.
In one or more embodiments, an airtight seal is formed between the first connection interface and the second connection interface prior to the external displacement of the first connection interface and the second connection interface.
In one or more embodiments, the displacement of the first connection interface and the second connection interface is via a rail mechanism, such that the airtight sealed compartment between the first connection interface and the second connection interface slides off the rail.
In one or more embodiments, when the airtight seal between the first connection interface and the second connection interface is displaced, the connection between the first vessel and the second vessel is decontaminated.
In one or more embodiments, the airtight seal between the first connection interface and the second connection interfaces slides off the rail while maintaining the hermetically sealed connection between the first and second vessels.
In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs via peeling.
In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs at about the same time.
In one or more embodiments, circumferential ends of at least one of or both of the first and second connection interfaces ends are concealed within the airtight seal, allowing for sterile external displacement.
In one or more embodiments, the method further comprises connecting the first connection interface to the second connection interface via an engagement mechanism.
In one or more embodiments, connecting of the first connection interface to the second connection interface occurs prior to externally displacing the first and second connection interfaces from the engagement between the first vessel and the second vessel.
In one or more embodiments, the connecting of the first connection interface to the second connection interface is selected from a twisting of a thread onto a complementary thread, attaching ratchet teeth to a complementary retention member, and adhering a first connection interface to the second connection interface via an adhesive.
In one or more embodiments, the sealed aperture is a valve. In one or more embodiments, the valve is a one-way valve.
In a further aspect, the present invention provides a container housing a substance intended for intracorporal administration to a patient, the container comprising: a rail mechanism, and an externally displaceable connection interface, wherein the rail mechanism is configured to provide for the external displacement of the connection interface.
In one or more embodiments, the container further comprises an engagement mechanism. In one or more embodiments, the engagement mechanism is selected from a group consisting of a thread, a ratchet teeth mechanism, a snap-on mechanism and combinations thereof. In one or more embodiments, the connection interface is disposed on the rail mechanism. In one or more embodiments, the connection interface is disposed between rails of the rail mechanism. In one or more embodiments, the connection interface is attached to the rail mechanism via a frangible seal, wherein the frangible seal is configured to break/rupture by a force of a user's hand upon displacement of the connection interface from the rail. In one or more embodiments, the connection interface is attached to the container via a frangible seal, wherein the frangible seal is configured to break/rupture by a force of the user's hand upon displacement of the connection interface from the rail. In one or more embodiments, the connection interface may displace externally between the teeth of a ratchet teeth engagement mechanism. In one or more embodiments, the connection interface may displace externally between the threads of a thread/luer engagement mechanism.
In one or more embodiments, the container has a flexible wall. In one or more embodiments, the container has a rigid wall.
In one or more embodiments, the container is a bag. In one or more embodiments, the container is a bottle. In one or more embodiments, the container is a vial. In one or more embodiments, the container is a syringe.
In one or more embodiments, the connection interface displaces between teeth of a ratchet teeth engagement mechanism. In one or more embodiments, the connection interface displaces between threads of a thread engagement mechanism. In one or more embodiments, the connection interface has an adhesive on a surface of the connection interface.
In one or more embodiments, the connection interface has at least one of a disinfecting agent and a sterilizing agent disposed on the surface of the connection interface.
In or more embodiments, the container further comprises a sealing mechanism, the sealing mechanism configured to allow sealing an aperture of the container with the connection interface. In or more embodiments, the sealing mechanism disposed within, or proximate the aperture, the sealing mechanism is adapted to apply pressure against an inner wall of the connection interface, thereby sealing the aperture. In or more embodiments, the sealing mechanism comprises one or more springs and/or valves.
In or more embodiments, the container further comprises a resealing mechanism, the resealing mechanism configured to allow resealing of an aperture of the container following the external displacement. In or more embodiments, the resealing mechanism disposed within, or proximate the aperture, the resealing mechanism is adapted to extend to and close the aperture at the time of, or after the time of external displacement, thereby resealing the aperture. In one or more embodiments, the resealing mechanism disposed within, or proximate the aperture, the resealing mechanism is adapted to extend and close the aperture at about the time of external displacement of at least one connection interfaces, thereby resealing the aperture. In or more embodiments, the resealing mechanism comprises one or more springs and/or valves.
In yet a further aspect, the present invention provides a decontamination connector for decontaminating a connection between vessels, comprising: a port; a connection interface configured to cover the port, wherein the connection interface is configured to displace externally from the port; an engagement mechanism, wherein the engagement mechanism is configured to provide coupling between the port and a vessel; and wherein following the coupling, the decontamination connector and the vessel form a hermetically coupled connection, while the connection interface is externally displaced from the port while maintaining the hermetically coupled connection between the decontamination connector and the vessel.
In yet a further aspect, the present invention provides a decontamination connector for decontaminating a connection between vessels, comprising:
a connector body, the connector body comprising:
wherein the connection interface is further configured to displace externally from
the aperture of the decontamination connector, and
an engagement mechanism, wherein the engagement mechanism is configured to provide a coupling between the body of the decontamination connector and a vessel; and
wherein following coupling, the decontamination connector and the vessel form a hermetically coupled connection, while the connection interface is externally displaced from the aperture of the decontamination connector while maintaining the hermetically coupled connection between the decontamination connector and the vessel.
In one or more embodiments, the connection interface is selected from the group consisting of a film, a plastic, a polymer, or a metal alloy.
In one or more embodiments, the connection interface is configured to seal the port of a first vessel.
In one or more embodiments, an engagement mechanism provides a secure engagement between the decontamination connector and the second vessel. In one or more embodiments, the engagement mechanism is selected from a thread, a luer, an adhesive, and a ratchet teeth mechanism. In one or more embodiments, the engagement mechanism is configured to form an airtight connection between the first vessel and the second vessel.
In one or more embodiments, the connection forms a sealed aperture. In one or more embodiments, the sealed aperture provides for the displacement of the connection interface through the sealed aperture while maintaining the hermetically coupled connection between the decontamination connector and the vessel.
In one or more embodiments, the connector further comprises an engagement mechanism configured to provide an engagement between the connection interface and a second connection interface on a second vessel.
In one or more embodiments, the engagement mechanism is selected from a thread, a luer, an adhesive, and a ratchet teeth mechanism. In one or more embodiments, the engagement mechanism includes a mechanical object that connects the first connection interface and a second connection interface on a second vessel providing for a simultaneous external displacement of the first and second connection interfaces. In one or more embodiments, the mechanical object is a protrusion, a dent or a hook.
In one or more embodiments, the connector further comprises a rail mechanism configured to provide for the external displacement of the connection interface. In one or more embodiments, the rail mechanism is configured to provide for the external displacement of the connection interface via a sliding motion.
In one or more embodiments, the connection interface displaces externally from the port via a hinge mechanism. In one or more embodiments, the connection interface displaces externally from the port via peeling.
In one or more embodiments, when the connection interface externally displaces from the port, the hermetic connection between the decontamination connector and the vessel is maintained.
In one or more embodiments, the decontamination connector is attached to or integrally attached to a vessel, to a container or to an administration device. In one or more embodiments, the container is selected from a vial, a bag, and a bottle. In one or more embodiments, the vessel is selected from a syringe, an infusion line, a connector, a filter, and a manifold.
In one or more embodiments, the port is selected from the group consisting of a container port, a syringe port, an infusion line port, a connector port, a manifold port, and a vessel port.
In one or more embodiments, the circumferential end of the connection interface end is concealed within the hermetically coupled connection between the decontamination connector and the vessel.
In one or more embodiments, the decontamination connector further comprises a tab, the tab configured to allow for the external displacement of the connection interface with respect to the port of the decontamination connector.
In one or more embodiments, the tab is configured to be pulled axially by a user, the axial pulling of the tab configured to displace the connection interface from the port of the decontamination connector while maintaining a hermetic seal between the decontamination connector and the vessel.
In one or more embodiments, the port is in fluid communication with the vessel after external displacement of the connection interface from the port.
In one or more embodiments, the connection interface is coupled to the port of the decontamination connector.
In one or more embodiments, the decontamination connector further comprises a piercing member configured to pierce a seal or cover of a vessel or a container.
In one or more embodiments, the decontamination connector further comprises a valve. In one or more embodiments, the valve is a one-way valve.
In yet a further aspect, the present invention provides a decontamination connector for the decontamination of a connection between vessels, comprising: a port; a connection interface configured to cover the port, wherein the connection interface is configured to displace externally from the port; a rail mechanism configured to provide for the external displacement of the connection interface; and an engagement mechanism, wherein the engagement mechanism is configured to provide coupling between the port and a vessel, wherein following the coupling, the decontamination connector and the vessel form a hermetically coupled connection, while the connection interface is externally displaced from the port via the rail mechanism while maintaining the hermetically coupled connection between the decontamination connector and the vessel.
In yet a further aspect, the present invention provides a decontamination connector for the decontamination of a connection between vessels, comprising: a port; a connection interface configured to cover the port, wherein the connection interface is configured to displace externally from the port; a sealed aperture configured to provide for the external displacement of the connection interface; and an engagement mechanism, wherein the engagement mechanism is configured to provide coupling between the port and a vessel, wherein following coupling, the decontamination connector and the vessel form a hermetically coupled connection, while the connection interface is externally displaced from the port through the sealed aperture while the hermetically coupled connection between the decontamination connector and the vessel is maintained.
In one or more embodiments, the sealed aperture reseals at about the time of external displacement of at least one of the connection interfaces of the decontamination connector and the vessel. In one or more embodiments, the sealed aperture reseals prior to detachment of at least one of the connection interfaces of the decontamination connector and the vessel from the decontamination connector and the vessel.
In or more embodiments, the connector further comprises a sealing mechanism on the connector body, the sealing mechanism configured to allow sealing an aperture wherein the interface resides. In one or more embodiments, the sealing mechanism disposed within, or proximate the aperture, the sealing mechanism is adapted to apply pressure in an outward direction against an inner wall of the connection interface, thereby sealing the aperture. In or more embodiments, the sealing mechanism comprises one or more springs and/or valves.
In or more embodiments, the connector further comprises a resealing mechanism on the connector body, the resealing mechanism configured to allow for the hermetically sealed connection between the connector and the vessel. In or more embodiments, the resealing mechanism disposed within, or proximate an aperture wherein the interface resides, the resealing mechanism is adapted to extend into and close the aperture at the time of, or after the time of external displacement, thereby resealing the aperture. In or more embodiments, the resealing mechanism comprises one or more springs and/or valves.
In yet a further aspect, the present invention provides a method of decontaminating a connection between two vessels, the method comprising the steps of: providing a first connection interface attached to a first vessel; providing a second vessel; engaging the first vessel to the second vessel; and externally displacing at least one of the first and second connection interfaces from the engagement between the first vessel and the second vessel, while a hermetically sealed connection between the first and second vessel is maintained.
In one or more embodiments, at least one of the first and second vessels further comprises a spring mechanism configured to reseal an aperture formed between the first and second vessels.
In one or more embodiments, at least one of the first and second vessels further comprises a spring mechanism configured to reseal an aperture formed between the first and second vessels.
In one or more embodiments, at least one of the first and second vessels further comprises a valve mechanism configured to reseal an aperture formed between the first and second vessels.
In one or more embodiments, at least one of the first and second vessels further comprises a valve mechanism configured to reseal an aperture formed between the first and second vessels.
In one or more embodiments, the step of externally displacing the connection interface occurs via a sliding motion. In one or more embodiments, the step of externally displacing the connection interface occurs via sliding axially with respect to the first vessel and the second vessel, thereby removing contaminants located on the first connection interface.
In one or more embodiments, displacement of the connection interface is via a rail mechanism. In one or more embodiments, when the connection interface is displaced, the connection between the first vessel and the second vessel is decontaminated. In one or more embodiments, the connection interface slides on the rail while maintaining the hermetically sealed connection between the first and second vessels.
In one or more embodiments, the step of externally displacing the connection interface occurs via peeling.
In one or more embodiments, the method further comprises connecting the first vessel to the second vessel via an engagement mechanism. In one or more embodiments, connecting of the first vessel to the second vessel occurs prior to externally displacing the connection interface from the engagement between the first vessel and the second vessel.
In one or more embodiments, connecting of the first vessel to the second vessel is selected from a twisting of a thread onto a complementary thread, attaching ratchet teeth to a complementary retention member, and adhering the first vessel to the second vessel via an adhesive.
In yet a further aspect, the present invention provides a vessel with a rail mechanism.
In one or more embodiments, the vessel is a container. In one or more embodiments, the vessel has a flexible wall. In one or more embodiments, the vessel has a rigid wall. In one or more embodiments, the vessel is a bag or a bottle. In one or more embodiments, the vessel is a vial. In one or more embodiments, the vessel is a syringe. In one or more embodiments, the rail mechanism is attached to the vessel. In one or more embodiments, the rail mechanism is integrally attached to the vessel. In one or more embodiments, the rail mechanism forms a unitary structure with the vessel.
In yet a further aspect, the present invention provides a method of decontaminating a connection between two vessels, the method comprising: providing a first vessel having a first connection interface and a spring mechanism, the spring mechanism configured to apply an outward pressure to the first connection interface; providing a second vessel having a second connection interface; engaging the first vessel to the second vessel; and externally displacing the first and second connection interfaces from the engagement between the first vessel and the second vessel, while a hermetically sealed connection between the first and second vessel is maintained.
In one or more embodiments, the first vessel and the second vessel are containers.
In one or more embodiments, the first vessel is a bag and the second vessel is a vial.
In one or more embodiments, the first vessel is a vial and the second vessel is a bag.
In one or more embodiments, the first vessel is a bag and the second vessel is a bottle.
In one or more embodiments, the first vessel is a bag and the second vessel is a syringe.
In one or more embodiments, the first and second vessels are bottles.
In one or more embodiments, the spring mechanism reseals an aperture formed between the first and second vessels.
In one or more embodiments, the spring mechanism reseals an aperture formed between the first and second vessels at about the time of external displacement of the connection interfaces.
In one or more embodiments, the spring mechanism reseals an aperture formed between the first and second vessels at the time of external displacement of the connection interfaces.
In yet a further aspect, the present invention provides a method of decontaminating a connection between two vessels, the method comprising: providing a first vessel having a first connection interface and a first spring mechanism, the spring mechanism configured to apply an outward pressure to the first connection interface; providing a second vessel having a second connection interface and a second spring mechanism, the second spring mechanism configured to apply an outward pressure to the second connection interface; engaging the first vessel to the second vessel; and externally displacing the first and second connection interfaces from the engagement between the first vessel and the second vessel, while a hermetically sealed connection between the first and second vessel is maintained.
In one or more embodiments, the first and second spring mechanisms reseal an aperture formed between the first and second vessels.
In one or more embodiments, the first and second spring mechanisms reseal an aperture formed between the first and second vessels at about the time of external displacement of the connection interfaces.
or more embodiments, the first and second spring mechanisms reseal an aperture formed between the first and second vessels at the time of external displacement of the connection interfaces.
In yet a further aspect, the present invention provides a method of decontaminating a connection between a vessel and a connector, the method comprising: providing a connector having an externally displaceable connection interface; providing a vessel having an externally displaceable connection interface, engaging the connector to the vessel; and externally displacing the connection interface of the connector and externally displacing the connection interface of the vessel.
In one or more embodiments, the connector further comprising a spring mechanism configured to apply an outward pressure to the connection interface of the connector. In one or more embodiments, the spring mechanism reseals an aperture formed between the connector and the vessel.
In one or more embodiments, the vessel further comprising a spring mechanism configured to apply an outward pressure to the connection interface of the vessel. In one or more embodiments, the spring mechanism reseals an aperture formed between the connector and the vessel.
In one or more embodiments, the vessel and the connector both further comprising a spring mechanism configured to apply an outward pressure to the connection interface of the vessel and to the connection interface of the connector.
In one or more embodiments, the spring mechanisms of the vessel and the connector reseal an aperture formed between the vessel and the connector.
In yet a further aspect, the present invention provides a vessel having a rail mechanism and a vessel surface disposed on the rail mechanism. In one or more embodiments, the vessel surface is disposed between the rails of the rail mechanism. In one or more embodiments, the rail mechanism is configured to provide for the sliding of the vessel surface along the rail mechanism.
In yet a further aspect, the present invention provides a vessel having a spring resealing mechanism, the spring resealing mechanism adapted to close an aperture of the vessel.
In one or more embodiments, the vessel further comprises an externally displaceable connection interface.
In one or more embodiments, the vessel further comprises a rail mechanism configured to allow external displacement of the connection interface.
In yet a further aspect, the present invention provides a vessel having a spring resealing mechanism and a rail mechanism.
In one or more embodiments, the vessel further comprises a vessel surface configured to move along the rail mechanism.
In yet a further aspect, the present invention provides a vessel having a spring resealing mechanism, a rail mechanism, and a displaceable vessel surface.
In one or more embodiments, the rail mechanism is configured to allow the displaceable surface to move along the rail mechanism.
In one or more embodiments, the rail mechanism is configured to allow the displaceable surface to externally displace from the vessel.
In one or more embodiments, the spring mechanism is configured to apply an outward pressure onto the displaceable vessel surface.
In one or more embodiments, the spring mechanism is configured to apply an outward pressure onto the displaceable vessel surface at about the time of external displacement of the displaceable vessel surface.
In yet a further aspect, the invention provides a connector having a spring mechanism, the spring mechanism configured to reseal an aperture formed between the connector and a vessel.
In yet a further aspect, the invention provides a connector having a connection interface and a spring mechanism, the spring mechanism configured to apply an outward pressure on a connection interface of the connector.
In one or more embodiments, the connection interface is an externally displaceable connection interface.
In one or more embodiments, the connector further comprising a rail mechanism configured to allow the connection interface to travel along the rail mechanism.
In one or more embodiments, the connector further comprising a rail mechanism configured to allow the connection interface to move along the rail mechanism.
In yet a further aspect, the present invention provides a vessel having a valve resealing mechanism, a rail mechanism, and a displaceable vessel surface.
In one or more embodiments, the rail mechanism is configured to allow the displaceable surface to move along the rail mechanism.
In one or more embodiments, the rail mechanism is configured to allow the displaceable surface to externally displace from the vessel.
In one or more embodiments, the valve mechanism is configured to apply an outward pressure onto the displaceable vessel surface.
In one or more embodiments, the valve mechanism is configured to apply an outward pressure onto the displaceable vessel surface at about the time of external displacement of the displaceable vessel surface.
In one or more embodiments, the valve resealing mechanism is configured to allow a displaceable vessel surface to be disposed within the valve resealing mechanism.
In one or more embodiments, the valve resealing mechanism is configured to provide a displaceable connection interface to move through the valve resealing mechanism.
In one or more embodiments, the valve resealing mechanism is configured to reseal an aperture of the vessel at about the time of external displacement of the connection interface of the vessel.
In one or more embodiments, the valve resealing mechanism is configured to reseal an aperture of the vessel at the time of external displacement of the displaceable vessel surface.
In one or more embodiments, the vessel is a bag.
In one or more embodiments, the vessel is a vial.
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 bottle.
In yet a further aspect, the invention provides a connector having a valve mechanism, the valve mechanism configured to reseal an aperture formed between the connector and a vessel.
In yet a further aspect, the invention provides a connector having a connection interface and a valve mechanism, the valve mechanism configured to apply an outward pressure on a connection interface of the connector.
In one or more embodiments, the connection interface is an externally displaceable connection interface.
In one or more embodiments, the connection interface is a displaceable surface of the connector.
In one or more embodiments, the connector further comprising a rail mechanism configured to allow the connection interface to travel along the rail mechanism.
In one or more embodiments, the connector further comprising a rail mechanism configured to allow the connection interface to move along the rail mechanism.
In yet a further aspect, the invention provides a vessel having a connection interface and a valve mechanism.
In one or more embodiments, the connection interface is an externally displaceable connection interface.
In one or more embodiments, the valve mechanism is configured to allow the externally displaceable connection interface to move through the valve mechanism.
In one or more embodiments, the valve mechanism is configured to reseal an aperture of the vessel at about the time the displaceable connection interface moves through the aperture.
In one or more embodiments, the valve mechanism is configured to reseal an aperture of the vessel at the time the displaceable connection interface moves through the aperture.
In one or more embodiments, the valve mechanism is configured to reseal an aperture of the vessel at about the time the displaceable connection interface moves through the valve mechanism.
In one or more embodiments, the valve mechanism is configured to reseal an aperture of the vessel at the time the displaceable connection interface moves through the valve 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, members shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the members are exaggerated relative to each other for clarity. Further, where considered appropriate, reference numerals have been repeated among the figures to indicate corresponding members.
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 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 medical containers or devices in a sterile manner. In one embodiment, the present invention provides connection interfaces, that may be coupled to, or integrally formed with, vessels or containers, such as vials, syringes, etc. The invention provides a solution to an unmet and long felt need in the medical setting 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 medical substances. 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 an embodiment of the invention, the herein disclosed vessels and devices are intended for one-time use. In an embodiment of the invention, the herein disclosed vessels and devices are intended to be reused.
In an aspect of the invention, the devices and systems include a first connection interface attached to a first vessel and a second connection interface attached to a second vessel. The first and second connection interfaces are configured to allow an engagement therebetween the connection interfaces. When the connection interfaces engage each other, ambient air particles present at the vicinity thereof are entrapped within/between the engagement formed by the connection interfaces. The engagement between the connection interfaces further establishes an airtight engagement of the vessels. The connection interfaces are further configured to externally displace from the vessels, thereby allowing fluid flow between the vessels and contaminants-free connection of the vessels.
Accordingly, the herein disclosed invention allows transferring medical substances in a contaminants-free, or in a substantially contaminants-free manner. In one or more embodiments, the herein disclosed invention allows connecting vessels in a contaminants-free, or in a substantially contaminants-free manner.
In one or more embodiments, the herein disclosed invention provides a fluidic passageway or communication between medical containers in a contaminants-free, or in a substantially contaminants-free manner.
In one or more embodiments, the herein disclosed invention affords to isolate and/or entrap ambient air particles present between two, or more, vessels. In one or more embodiments, the herein disclosed invention, allows to substantially decrease the chances to introduce a contamination within a medical substance, when preparing or administering medical substances.
As used herein, the term “substances” refers to various types of materials that should be kept sterile. The substances may be liquid, solid, 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 medical drugs, fluids, nutritional products, solid powders, suspensions, liquids solutions and the like.
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 dirt, bacteria, viruses, funguses, spores, 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, “substantially contaminants-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 or filtered environment. For example, air can be purified by filters, such as a High Efficiency Particulate Air (HEPA) filter.
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 is disposed in an aperture of a vessel. In an embodiment of the invention, the connection interface is disposed within an aperture of a vessel's port. 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. In an embodiment of the invention, the connection interface may be a surface of a container. In an embodiment of the invention, the connection interface may be a surface of a device. In an embodiment of the invention, the connection interface may be a surface of a vessel. In an embodiment of the invention, the connection interface abuts a container. In an embodiment of the invention, the connection interface is surface mounted to a container. In an embodiment of the invention, the connection interface is surface mounted to a wall of the container. In an embodiment of the invention the connection interface is flush mounted to a container.
In an embodiment of the invention, the connection interface abuts a device. In an embodiment of the invention, the connection interface is surface mounted to a device. In an embodiment of the invention, the connection interface is surface mounted to a wall of a device. In an embodiment of the invention the connection interface is flush mounted to a device.
In an embodiment of the invention, the connection interface abuts a vessel. In an embodiment of the invention, the connection interface is surface mounted to a vessel. In an embodiment of the invention, the connection interface is surface mounted to a wall of a vessel. In an embodiment of the invention the connection interface is flush mounted to a vessel. In an embodiment of the invention, the connection interface is flush mounted to a wall of a vessel. In one or more embodiments, a plurality of connection interfaces abuts a vessel and/or device. In an embodiment of the invention, a plurality of connection interfaces is surface mounted to a vessel. In an embodiment of the invention, a plurality of connection interfaces is surface mounted to a at least one wall of a vessel. In an embodiment of the invention, a plurality of connection interfaces is surface mounted to a vessel. In an embodiment of the invention, a plurality of connection interfaces is flush mounted to a vessel. In an embodiment of the invention, a plurality of connection interface is flush mounted to at least one wall of a vessel. In one or more embodiments, a plurality of connection interfaces is attached to a vessel, a container, and/or a device.
In an embodiment of the invention, the present invention discloses a first connection interface and a second connection interface. The first connection interface and the second connection interface may be similar or may be different in size and/or shape. In one or more embodiments, the exterior surface area facing ambient air, of the connection interfaces may be equal. In one or more embodiments, the exterior surface area facing ambient air, of the connection interfaces may be non-equal. In one or more embodiments, the difference in surface area between the exterior surface area of a plurality of connection interfaces is less than 0.3 inches squared. For example, less than 0.2 inches squared, or less than 0.1 inches squared.
In an embodiment of the invention, the first connection interface and the second connection interface when engaged with each other entrap ambient air particles therebetween. In an embodiment of the invention, the first connection interface and the second connection interface when engaged with each other externally displace from a vessel(s), and/or from the connection interface(s).
In one or more embodiments, the connection interface has a thin film layer. In an exemplary embodiment, the connection interface may present a thickness of about 1 mm or below. Alternatively, the connection interface may present a thickness of above 1 mm. For example, the connection interface may be between about 1 millimeter and 5 millimeters in thickness. The connection interface may be manufactured from various materials, including, an elastic polymer. The connection interface may be made from a plastic material. The connection interface may be a rubber or a polymer. The connection interface may be formed of a metal material (e.g., a metal alloy). In yet a further exemplary embodiment, the connection interface may preset the form of a thin film made of an aluminum foil, cling wrap, or the alike. The metal alloy may include, for example, aluminum. In yet a further exemplary embodiment, the connection interface may preset the form of a thin film made of an aluminum foil, or the alike. In one or more embodiments, the connection interface is attached to, or is integrally formed with a vessel, or port thereof. In one or more embodiments, the connection interface is peelable from the vessels. In one or more embodiments, the peelable connection interface is attached to a vessel via an adhesive. In one or more embodiments, the peelable connection interface may be detached from a vessel surface by the force of a user's hand. In one or more embodiments, the connection interface is movable or slidable along a rail located along a length of the aperture of a vessel. In one or more embodiments, the first and second connection interfaces may be attached to or engage each other via various mechanisms. For example, the connection interfaces may be engaged via an engagement mechanism, such as a thread, a luer, an adhesive, a mechanical object, a dent and a ratchet teeth mechanism. In one or more embodiments, the connection interface may be covered by a cover (not shown). In one or more embodiments, the cover may be a peelable cover. In one or more embodiments, a sterilizing or disinfecting substance may be located between the connection interface and the cover. In one or more embodiments, the sterilizing or disinfecting substance may be an alcohol. In one or more embodiments, the alcohol may be 70% isopropyl alcohol.
The connection interfaces may be coupled within any portion of the vessel. For example, the connection interfaces may be connected onto the vessels' body or aperture, the vessels' wall or port thereof.
In one or more embodiments, the first connection interface and the second connection interface are configured to prevent contaminants from entering the fluid passageway between a first vessel and a second vessel. In one or more embodiments, the first connection interface and the second connection interface are configured to prevent contaminants from entering the interior of the vessel's body. In one or more embodiments, the first connection interface and the second connection interface are configured to prevent contaminants from entering a fluid housed inside the vessel's body.
In one or more embodiments, a first connection interface and a second connection interface are configured to prevent contaminants from contacting an internal compartment of the first vessel and/or the second vessel.
As used herein the term “external displacement” refers to a displacement (i.e., dislocation) of the herein disclosed first and/or second, and/or any additional connection interfaces. In an embodiment of the invention, the displacement is external, namely, outside the vessels being connected by the herein disclosed system. In an embodiment of the invention, the displacement is external to the fluid communication established following engagement of the vessels being connected by the herein disclosed system, methods and devices. In an embodiment of the invention, the displacement maintains a hermetic seal of the connection interfaces and/or the vessels. The displacement may occur via a sliding motion, or by a pulling out motion, or by a pushing motion, or by peeling the connection interfaces. In an embodiment of the invention, the displacement occurs for both the first connection interface and the second connection interface. The external displacement may optionally occur simultaneously for both connection interfaces or may occur consecutively. In an embodiment of the invention, the external displacement establishes a fluid passageway between two or more vessels. In one or more embodiments, the connection interface is configured to hermetically seal an aperture present in and/or on a vessel. In one or more embodiments, at about the time of external displacement of the connection interfaces, the aperture through which the connection interfaces pass through reseals, allowing a hermetic airtight connection between two or more vessels. In one or more embodiments, after external displacment of the connection interfaces, the aperture through which the connection interfaces pass through reseals, allowing a hermetic airtight connection between two or more vessels. In one or more embodiments, the aperture through which the connection interfaces pass through reseals prior to detachment of the connection interfaces from the vessels.
In one or more embodiments, the herein disclosed vessel/container/connector includes a sealing mechanism configured to allow sealing an aperture of the vessel/container/connector. In one embodiment, the sealing mechanism allows sealing an aperture with the connection interface. Optionally, the sealing mechanism includes a sealing member which presses the connection interface from the interior of the vessel/container/connector to the outside, to thereby hermetically seal the aperture. The sealing member may encompass various mechanisms and structures. In an exemplary embodiment, the sealing member is selected from a valve, and/or a spring. The sealing member may be disposed within the aperture, proximate the aperture, on the sides of the aperture, below the aperture, or above the aperture.
In one or more embodiments, the herein disclosed vessel/container/connector includes a resealing mechanism configured to allow resealing an aperture of the vessel/container/connector. In one embodiment, the resealing mechanism allows resealing an aperture after the external displacement. Optionally, the resealing mechanism includes a resealing member which closes the aperture after the external displacement, to thereby reseal the aperture. The resealing member may encompass various mechanisms and structures. In an exemplary embodiment, the resealing member is selected from a valve, and/or a spring. The resealing member may be disposed within the aperture, proximate the aperture, on the sides of the aperture or above the aperture. The resealing member may move from a retracted position to an extended position at which it extends or resides within the aperture. In one or more embodiments, the resealing member may be a coiled spring when in the retracted position and/or in an uncoiled configuration when in the extended position.
In one or more embodiments, the sealing mechanism acts also as a resealing mechanism. In accordance with this embodiment, the sealing member also acts as a resealing member and vice versa. In an exemplary embodiment, the sealing member is a spring which initially presses against an inner wall of the connection interface to thereby close or shut the aperture and which following an external displacement, acts as a resealing member and extends within the aperture to thereby close or shut it. In an exemplary embodiment, the sealing/resealing member is a valve, whereby, in its sealing position presses against an inner wall of the connection interface to thereby close or shut the aperture and in its resealing position, that follows the external displacement, moves and extends into the aperture to thereby close or shut it.
As used herein the term “vessel” refers to any device utilized for containing, housing or transferring substances as herein disclosed. In one or more embodiments, the vessel may be used for containing medical substances. In an embodiment of the invention, the vessel is a medical vessel. 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(s). In an embodiment of the invention, the vessel may be a medical container utilized for accommodating medical substances. Various types of medical containers are contemplated. The medical container may be selected, without limitation, from a vial, a bag, a chamber, a housing, a bottle, and the alike. In an embodiment of the invention, the term vessel further encompasses members that can be used to connect between vessels. In accordance with this embodiment, the vessel may be selected, without limitation, from a connector, a port, a syringe, an infusion line, a tubing, a syringe, a filter, a spike, a port and a manifold. In an embodiment of the invention, one or more connection interfaces (for example, two or more, three or more, etc.) may be coupled to a first vessel and each of those connection interfaces may be coupled and engage with a one or more connection interfaces present on a one or more vessels. In one or more embodiments, the vessel may be a container, a bag, a bottle, a connector, an infusion line or a syringe having a plurality of externally displaceable connection interfaces. In one or more embodiments, the vessels to be engaged may have similar surface area or similar contact surface area (i.e., surface onto which the connection interface is coupled to). For example, a first vessel and a second vessel may have similar surface area or similar contact surface area. In one or more embodiments, the vessels to be engaged may have different surface area or different contact surface area. For example, a first connection interface may have a greater surface area or contact surface area than a second vessel. As used herein the term “fluid communication” refers to two 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 a medical substance.
The herein systems and connectors may include one or more valves that restrict fluid flow or passageway. For example, one or more valves may be located at the opening of one or more vessels. In a further exemplary embodiment one or more valves may be disposed at the aperture(s) of the vessels or at a location within a port or vessel body of the vessels. The valves are generally provided to seal and prevent fluid flow prior to any engagement of vessels and/or external displacement of connection interfaces. In an exemplary embodiment, when valves are provided to seal an aperture that provides for the external displacement of connection interfaces, the valves may establish resealing of the apertures at about the time, at the time, or following the external displacement of the connection interfaces, preventing any leakage of fluids from the engagement between the vessels. The valve(s) may be configured to allow the movement of one connection interface through the valve, optionally and/or alternately the valve(s) may be configured to allow the movement of at least two connection interfaces through the valve(s). In certain embodiments, the resealing occurs at about the time, at the time, or prior to the external displacement. In certain embodiments, the valves that provide for the passage and external displacement of the connection interfaces may be made of a rubber material, an elastomeric material, a plastic material, and combinations thereof. In an embodiment of the invention, the valve or aperture providing for the passage and external displacement of at least one or two connection interfaces maintains a hermetic seal between at least two vessels or between at least two devices or between a vessel and a device by a force of the engagement between at least two vessels or devices (or between a vessel and a device). In some embodiments the force of engagement that maintains the hermetic seal between two vessels or devices during the external displacement of the connection interfaces is provided by an engagement mechanism selected from a thread, a luer, a ratchet teeth mechanism, a snap-on mechanism, and combinations thereof. In certain embodiments, the aperture, sealed aperture, or valve providing for the passage and external displacement of at least one or at least two connection interfaces reseals prior to the connection interfaces fully displacing from the first and/or second vessel or device. In some embodiments, the displacement of the connection interfaces occurs in the space between two ratchet teeth (or in the space between two clamping elements). In certain embodiments, the displacement of the connection interfaces occurs between threads of a thread/luer engagement mechanism. In certain embodiments, the valves may prevent backflow of fluids. In some embodiments, the valves may be one-way valves.
In an embodiment of the invention, the herein disclosed devices, systems and methods allow fluid communication in contaminant-free, or 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 containers, between two bags, between a syringe and a bag, between a connector and a bag, between a vial and a bag, between a vial and a bottle, between a syringe and a vial or between a syringe and a connector.
A further purpose of this invention is to provide a connection interface that reduces the presence of non-purified air and/or air particles. This invention focuses on connection interfaces that are substantially reduced of contaminants and ambient air particles and/or entirely contaminant free and entirely free of ambient air particles.
Referring now to the drawings,
First connection interface 102 and second connection interface 106 are configured to allow for an engagement between first vessel 104 and second vessel 108.
Decontamination system 100 may further comprise a tab 103 positioned on a longitudinal end of first connection interface 102, and a tab 113 positioned on a longitudinal end of second connection interface 106. Tabs 103 and 113 are configured to allow for an external displacement of first connection interface 102 and second connection interface 106 with respect to first vessel 104 and second vessel 108, respectively. The tabs 103 and 113 are configured to be pulled out axially by a user, the axial pulling of the tabs 103 and 113 is configured to allow for a displacement of first connection interface 102 and second connection interface 106 from the first vessel 104 and second vessel 108, respectively.
Reference is now made to
Reference is now made to
It is to be noted that lock-unlock mechanism 32 and 35 may be disposed onto one or both vessels, vessel's ports, or connection interfaces. Lock-unlock mechanism 32 and 35 may additionally, allow locking the connection interfaces 22 and 26 to their respective vessel and unlock thereof at about the time or following engagement of the vessels 34 and 24 and/or connection interfaces 22 and 26 to allow the external displacement.
Reference is now made to
The connection interfaces 42 and 46 further comprise an engagement mechanism in the form of ratchet teeth 43 and 45 positioned on interfaces 42 and 46, respectively. Engagement mechanism 43/45 is configured to provide a secure engagement between the interfaces and to form an airtight seal between the first connection interface and the second connection interface. Other engagement mechanisms that may secure the first connection interface 42 to a second connection interface 46 are contemplated and may include an adhesive that secures the first connection interface 42 to the second connection interface 46 or an indentation that may secure the connection interfaces. The engagement mechanism 43/45 includes a mechanical object in the form of a hook 53. Hook 53 allows for a simultaneous external displacement of first and second connection interfaces 42 and 45. Optionally, the hook 53 may be a handle or a tab.
Reference is now made to
Reference is now made to
Reference is now made to
Reference is now made to
A sealed aperture having a spring 211 or a valve (not shown) may be disposed between port 206 and connection interface 208 and is configured to allow for the accommodation and external displacement of connection interface 208. Optionally, a frangible seal (not shown) may be disposed between port 206 and connection interface 208. The frangible seal may be breakable or rupturable by applying a force by hand. Optionally, a pierceable seal (not shown) may be disposed between port 206 and connection interface 208. The pierceable seal may be pierced by a piercing member (not shown) of the connector or by a piercing member (not shown) of vessel 204. The decontamination connector 200 may further include a rail mechanism 215 positioned between port 206 and interface 208. Optionally, rail mechanism 215 may be positioned on the decontamination connector 200. The rail mechanism 215 is configured to provide for the external displacement, optionally via a sliding motion, of the connection interface 208. Alternatively, interface 208 may be peeled off when external displacement occurs. Interface 208 may be externally displaced via a pulling motion. Optionally, interface 208 may be peeled off via a pulling motion. The sealing mechanism with spring 211 is configured to press against an inner wall 221 of connection interface 208 prior to any external displacement, thereby effecting a sealed port 206. Alternatively, or additionally, the resealing mechanism with spring 211 is configured to reseal an aperture 220 (shown in
The connection interfaces 510 and 512 may remain attached to hinges 514 and 516, respectively. The connection interfaces 510 and 512 remain attached to ports 506 and 508 of vessels 502 and 504, respectively, during the external displacement. The connection interfaces 510 and 512 may firstly move sideways, optionally via a sliding motion conducted through a rail mechanism and thereafter rotates upwards (as shown in
Reference is now made to
Reference is now made to
One or more of valves 607 and 620 may be disposed onto and/or inside port 606 such that the valves 607 and 620 are closed prior to and/or during the external displacement of the connection interfaces 610 and 612. It is to be noted that similar or other valves, such as valves 607 and 620 may be disposed onto vessel 604, or port 608 and restrict fluid passageway to the stage that follows the external displacement. The valve 607 and or 620 may be a one-way valve. Valves 607 and 620 may be actuated by valve unlocking mechanism 624 which may be operated externally by a user. Valve unlocking mechanism 624 may be actuated by any of a twisting, a turning, a pushing motion and combinations thereof. In one or more embodiments, valve unlocking mechanism 624 may be also operable to actuate the piercing member 614. In one or more embodiments, the valve unlocking mechanism 624 may be actuated by the external displacement of connection interface 610 or by the external displacement of both connection interfaces 610 and 612. In one or more embodiments, the valve 607 and 620 may prevent backflow of fluid from the first vessel 602 to second vessel 604. It is to be noted that the piercing member and/or the valve unlocking mechanism 624 may be relevant to any of the herein disclosed connectors and/or connection interfaces and/or decontamination systems.
Following the external displacement of the connection interfaces 610 and 612, piercing member 614 is actuated to pierce vessel surface seal 616 and thereby establish a fluid communication between the vessels 602 and 604. Piercing member 614 is thus movable from a first position wherein the piercing member 614 is concealed from ambient air particles and disposed within one or both vessels 602 and 604, to a second position wherein the piercing member 614 is actuated to establish the fluid passageway. Piercing member 614 pierces vessel surface seal 616 at about the time and/or following a hermetic engagement between vessels 602 and 604 or at about the time and/or following a hermetic engagement between connection interfaces 610 and 610. In an embodiment of the invention, the external displacement releases the piercing member 614 and allows it to move from the first to the second position. . Optionally, piercing member 614 pierces at least one vessel surface seal 616 of vessel 604 and/or a vessel surface seal (not shown) of vessel 602 following external displacement of connection interfaces 610 and 612. Piercing member 614 may be locked into an initial position by a safety mechanism (not shown) disposed on or within port 606 or on or within vessel 602. The safety mechanism (not shown) prevents premature movement/activation and/or piercing of the piercing member prior to a hermetic engagement between vessels 602 and 604. Optionally, the safety mechanism (not shown) may be released or unlocked at or at about the time of engagement of vessels 602 and 604, at or at about the time of engagement of connection interfaces 610 and 612, and/or at or at about the time of external displacement of connection interfaces 610 and 612. It is to be noted that the herein disclosed piercing member, mechanism of action of the piercing member and safety mechanism may be relevant to any of the herein disclosed connectors and/or connection interfaces and/or decontamination systems. In one or more embodiments, the vessel surface seal 616 on vessel 602 and/or vessel 604 may be a frangible seal configured to be ruptured or broken by applying a force by hand to vessel 602 and/or vessel 604 and/or port 606 thus pushing fluid from vessel 602 or vessel 604 through the vessel surface seal 616.
Reference is now made to
Reference is now made to
Reference is now made to
In an aspect of the invention, the present invention provides a method of decontaminating a connection between two vessels, the method comprising the steps of: providing a first connection interface attached to a first vessel; providing a second connection interface attached to a second vessel, engaging the first vessel to the second vessel; and externally displacing the first and second connection interfaces from the engagement between the first vessel and the second vessel, while a hermetically sealed connection between the first and second vessels is maintained.
In yet a further aspect, the present invention provides a method of decontaminating a connection between two vessels, the method comprising the steps of: providing a first connection interface attached to a first vessel; providing a second vessel; engaging the first vessel to the second vessel; and externally displacing the first connection interface from the engagement between the first vessel and the second vessel, while a hermetically sealed connection between the first and second vessel is maintained.
In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs via a sliding motion.
In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs via sliding axially with respect to the first vessel and the second vessel, thereby removing contaminants located between the first and second interfaces.
In one or more embodiments, an airtight seal is formed between the first connection interface and the second connection interface prior to the external displacement of the first and second connection interfaces.
In one or more embodiments, the displacement of the first connection interface and the second connection interface is via a rail mechanism, such that the airtight sealed compartment between the first connection interface and the second connection interface slides off the rail.
In one or more embodiments, when the airtight seal between the first connection interface and the second connection interface is displaced, the connection between the first vessel and the second vessel is decontaminated.
In one or more embodiments, the airtight seal between the first connection interface and the second connection interfaces slides off the rail while maintaining the hermetically sealed connection between the first and second vessels.
In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs via peeling.
In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs via a hinge mechanism.
In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs at about the same time. In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs at the same time. In one or more embodiments, the step of externally displacing the first connection interface and the second connection interface occurs sequentially.
In one or more embodiments, the method further comprises connecting the first connection interface to the second connection interface via an engagement mechanism.
In one or more embodiments, connecting of the first connection interface to the second connection interface occurs prior to externally displacing the first and second connection interfaces from the engagement between the first vessel and the second vessel. In one or more embodiments, connecting of the first connection interface to the second connection interface occurs at about the time of external displacement of the first and second connection interfaces from the first and second vessels.
In one or more embodiments, the connecting of the first connection interface to the second connection interface is selected from a twisting of a thread onto a complementary thread, attaching ratchet teeth to a complementary retention member, and adhering a first connection interface to the second connection interface via an adhesive.
In one or more embodiments, the sealed aperture is a valve. In one or more embodiments, the valve is a one-way valve.
In one or more embodiments, the sealed aperture reseals at about the time of external displacement of the first and second connection interfaces.
In one or more embodiments, the sealed aperture reseals prior to detachment of the first and second connection interfaces from the first and second vessels.
In one or more embodiments, at least one of the first and second vessels is a container. In one or more embodiments, the container is a bag or a bottle. In one or more embodiments, at least one of the first and second vessels is a syringe. In one or more embodiments, the container has a flexible wall.
In yet a further aspect, the present invention provides a method of displacing two connection interfaces, the method comprising: providing a first vessel having a first displaceable connection interface and a spring mechanism; providing a second vessel having a second displaceable connection interface; and externally displacing the first and second displaceable connection interfaces.
In one or more embodiments, the method further comprising the spring mechanism applying a pressure on at least one of the first and second connection interfaces.
In one or more embodiments, the method further comprising the spring mechanism applying a pressure on the first connection interface.
In one or more embodiments, the method further comprising the spring mechanism applying an outward pressure onto an interior surface of the first connection interface.
In one or more embodiments, the method further comprising the spring mechanism applying an outward pressure onto the first connection interface.
In one or more embodiments, the method further comprising the spring mechanism resealing an aperture formed between the first and second vessels.
In yet a further aspect, the present invention provides a method of displacing two vessel surfaces, the method comprising: providing a first vessel having an externally displaceable vessel surface and a spring mechanism; providing a second vessel having a second externally displaceable vessel surface; and externally displacing the first and second displaceable vessel surfaces.
In one or more embodiments, the method further comprising the spring mechanism applying an outward pressure onto the first externally displaceable vessel surface.
In one or more embodiments, the method further comprising the spring mechanism applying an outward pressure onto an internal surface of the first externally displaceable vessel surface.
In yet a further aspect, the present invention provides a method of displacing two connection interfaces, the method comprising: providing a first vessel having a first displaceable connection interface and a valve mechanism: providing a second vessel having a second displaceable connection interface; and externally displacing the first and second displaceable connection interfaces.
In or more embodiments, the method further comprising the valve mechanism applying a pressure on at least one of the first and second connection interfaces.
In one or more embodiments, the method further comprising the valve mechanism applying a pressure on the first connection interface.
In one or more embodiments, the method further comprising the valve mechanism applying an outward pressure onto an interior surface of the first connection interface.
In one or more embodiments, the method further comprising the valve mechanism applying an outward pressure onto the first connection interface.
In one or more embodiments, the method further comprising the valve mechanism resealing an aperture formed between the first and second vessels.
In yet a further aspect, the present invention provides a method of displacing two vessel surfaces, the method comprising: providing a first vessel having an externally displaceable vessel surface and a valve mechanism; providing a second vessel having a second externally displaceable vessel surface; and externally displacing the first and second displaceable vessel surfaces.
In one or more embodiments, the method further comprising the valve mechanism applying an outward pressure onto the first externally displaceable vessel surface.
In one or more embodiments, the method further comprising the valve mechanism applying an outward pressure onto an internal surface of the first externally displaceable vessel surface.
In yet a further aspect, the present invention provides a method of displacing two connection interfaces, the method comprising: providing a connector having a first externally displaceable connection interface and a spring mechanism; providing a vessel having a second externally displaceable connection interface; and sliding the first and second displaceable connection interfaces.
In one or more embodiments, the first and second connection interfaces are slide externally to a fluidic passageway that will be formed between the connector and the vessel.
In one or more embodiments, the first and second connection interfaces are pulled.
In one or more embodiments, the first and second connection interfaces are pulled out from between the connector and the vessel.
In one or more embodiments, the spring mechanism is configured to apply a pressure to the first externally displaceable connection interface.
In one or more embodiments, the spring mechanism is configured to apply an outward pressure onto a surface of the first connection interface.
In one or more embodiments, the spring mechanism is configured to apply an outward pressure onto an interior surface of the first connection interface.
In one ore more embodiments, the spring mechanism is configured to reseal an aperture formed between the connector and the vessel.
In one or more embodiments, the resealing occurs at about the time of external displacement of the first and second connection interfaces.
In one or more embodiments, the resealing occurs during external displacement of the first and second connection interfaces.
In one or more embodiments, the resealing occurs after external displacement of the first and second connection interfaces.
In yet a further aspect, the present invention provides a method of displacing two connection interfaces, the method comprising: providing a connector having a first externally displaceable connection interface and a valve mechanism; providing a vessel having a second externally displaceable connection interface; and sliding the first and second displaceable connection interfaces.
In one or more embodiments, the first and second connection interfaces are slide externally to a fluidic passageway that will be formed between the connector and the vessel.
In one or more embodiments, the first and second connection interfaces are pulled.
In one or more embodiments, the first and second connection interfaces are pulled out from between the connector and the vessel.
In one or more embodiments, the valve mechanism is configured to apply a pressure to the first externally displaceable connection interface.
In one or more embodiments, the valve mechanism is configured to apply an outward pressure onto a surface of the first connection interface.
In one or more embodiments, the valve mechanism is configured to apply an outward pressure onto an interior surface of the first connection interface.
In one or more embodiments, the valve mechanism is configured to reseal an aperture formed between the connector and the vessel.
In one or more embodiments, the resealing occurs at about the time of external displacement of the first and second connection interfaces.
In one or more embodiments, the resealing occurs during external displacement of the first and second connection interfaces.
In one or more embodiments, the resealing occurs after external displacement of the first and second connection interfaces.
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. 16/100,594 entitled DEVICES AND SYSTEMS WITH AN EXTERNAL DISPLACEMENT MECHANISM FOR CONTAMINANT-FREE ENGAGEMENT 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 Sep. 25, 2017; 62/563,072 filed Sep. 26, 2017; 62/564,933 filed Sep. 28, 2017; 62/566,414 filed on Sep. 30, 2017; 62/582,922 filed on Nov. 7, 2017; 62/612,267 filed on Dec. 29, 2017; 62/619,795 filed on Jan. 20, 2018; 62/619,920 filed on Jan. 22, 2018; 62/625,334 filed on Feb. 1, 2018; 62/644,185 filed on Mar. 16, 2018; 62/651,000 filed on Mar. 30, 2018; 62/653,356 filed on Apr. 5, 2018; 62/657,809 filed on Apr. 15, 2018; 62/662,743 filed on Apr. 25, 2018; 62/669,948 filed on May 10, 2018; and 62/675,058 filed on May 22, 2018. This application claims the benefit of priority of U.S. Provisional Patent Application No. 52/738,801 filed on Sep. 28, 2018. The contents of the above applications are all incorporated by reference as if fully set forth herein in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62619795 | Jan 2018 | US | |
| 62619920 | Jan 2018 | US | |
| 62562490 | Sep 2017 | US | |
| 62564933 | Sep 2017 | US | |
| 62612267 | Dec 2017 | US | |
| 62566414 | Sep 2017 | US | |
| 62582922 | Nov 2017 | US | |
| 62560195 | Sep 2017 | US | |
| 62563072 | Sep 2017 | US | |
| 62558502 | Sep 2017 | US | |
| 62625334 | Feb 2018 | US | |
| 62644185 | Mar 2018 | US | |
| 62651000 | Mar 2018 | US | |
| 62653356 | Apr 2018 | US | |
| 62657809 | Apr 2018 | US | |
| 62662743 | Apr 2018 | US | |
| 62669948 | May 2018 | US | |
| 62675058 | May 2018 | US | |
| 62738801 | Sep 2018 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16100594 | Aug 2018 | US |
| Child | 16196814 | US |
