The present invention relates, in some embodiments thereof, to connectors and systems comprising same for allowing an engagement and fluid passageway between medical vessels. In some embodiments, the connectors allow repeatable fluid transfer between vessels. In some embodiments, the connectors configured to connect between a plurality of medical vessels.
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.
Taken together, the above described systems and methods are either cumbersome and expensive or inefficient in addressing the problem of reducing/eliminating contaminants on connection interfaces.
Furthermore, typical connectors used to connect intravenous (IV) bags to vials, containers to containers, and/or containers to medical devices comprise a ratchet teeth mechanism or other retention mechanism which grasps a port of a bag, a port of a vial, a port of a container, and/or a port of a medical device. This results in a connection between the bag and the vial (via the connector), a container and a container (via a connector), and/or a container and medical device (via a connector) that is sufficient to hold the vial to the bag. However, there have been instances where the bag and the vial may disconnect either spontaneously, if the bag and vial fall to the floor, and disconnection may occur by a force of a user's hand. As a result, a connector that only grasps a vial “port”, a bag “port”, a container “port”, and/or a medical device “port” does not provide a connection that is very secure. This is of particular concern when toxic substances such as chemotherapeutic medicaments are housed in the vials because disconnection of a vial containing a toxic/chemotherapeutic substance from a bag/container/device may result in the leakage of the toxic/chemotherapeutic substance into the environment exposing the surroundings and a user to the toxic substance. Additionally, currently used connectors used for connecting two vessels, two medical devices, two containers, and/or a vessel to a medical device do not protect the vessel or the device. Therefore, if the vessel and/or container and/or device falls to the ground when connected to the connector the vessel/device/container/vial may break and release the toxic/chemotherapeutic substance from the vessel/device/container/vial thus contaminating the environment with a toxic dangerous substance and exposing a user to the toxic substance. Therefore, there is a dire need in the current state of the art to provide better connectors that will guarantee a connection between at least two vessels that will prevent disconnection of two vessels from each other spontaneously, upon accidental falling to the ground, and/or via manipulation/force of a user's hand. Additionally, there is a need in the art for connectors that will prevent breakage of a vessel and/or device upon falling to the ground.
There is furthermore a need for reliable, user friendly and cost-effective solutions allowing a secure fluid transfer and engagement between vessels. The herein described invention provides a solution to such long felt needs.
It is an object of the invention to provide connectors, systems and methods which allow vessels to fluidly communicate with each other.
It is an object of the invention to provide connectors, systems and methods which allow to transfer medical substances between vessels in a secure manner.
It is an object of the invention to provide connectors, systems and methods which allow to repeatedly transfer medical substances between vessels.
It is an object of the invention to provide connectors, systems and methods which allow to securely load/reload a vessel with a medical substance.
It is an object of one or more embodiments of the invention to overcome limitations in the prior art in relation to connectors typically used by healthcare personnel to connect pharmaceutical vessels, containers, and medical devices to each other.
It is an object, of one or more embodiments of the invention, to provide a connector having at least one cavity configured to accommodate at least a portion of a body of a container.
It is an object, of one or more embodiments of the invention, to provide a connector having at least one cavity that will protect a container and prevent breakage/cracking of the container during the preparation, delivery, and/or administration of a beneficial substance if the connector-container falls to the ground.
Objects of the invention are achieved by providing connectors, methods and systems comprising same which allow an engagement between vessels that are otherwise un-engageable. Objects of the invention are achieved by providing connectors and systems comprising same which allow vessels to connect and fluidly communicate.
The herein disclosed connectors demonstrate simplicity, reliability and provide a safe engagement between two to more vessels, and/or cartridges.
In a general aspect of the embodiments, the invention provides a connector having at least one cavity, the connector configured to connect two vessels to each other, the at least one cavity capable of accommodating at least a portion of a container's body.
In a general aspect of the embodiments, the invention provides connector(s) having at least one cavity, the cavity characterized in that it is capable of accommodating at least a portion of a container's body.
In one or more embodiments, the connector is configured to connect two containers to each other. In one or more embodiments, the connector is configured to couple two containers to each other. In one or more embodiments, the connector is configured to engage two containers to each other. In one or more embodiments, the connector is configured to engage a container to a medical device.
In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 35% the length of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 50% the length of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 75% the length of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 90% the length of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 100% the length of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate an entire length of a container.
In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 35% the width of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 50% the width of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 75% the width of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 90% the width of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 100% the width of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate an entire width of a container.
In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 35% the volume of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 50% the volume of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 75% the volume of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 90% the volume of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate at least 100% the volume of a container. In one or more embodiments, the connector is configured to have at least one cavity that will accommodate an entire volume of a container.
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 syringe.
In one or more embodiments, the container is a cartridge having at least one protective side wall. In one or more embodiments, the container has a circumferential protective side wall. In one or more embodiments, the container has a plunger. In one or more embodiments, the container has a plunger and at least one protective side wall. In one or more embodiments, the container has a moveable wall. In one or more embodiments, the container has an expulsion member. In one or more embodiments, the expulsion member is a plunger. In one or more embodiments, the container has a plunger.
In one or more embodiments, the connector further configured to enter a cavity of a bag. In one or more embodiments, the connector further configured to enter a cavity of a bottle. In one or more embodiments, the connector further configured to enter a cavity of a container.
In one or more embodiments, the connector further comprising a locking mechanism configured to lock a container to the connector. In one or more embodiments, the locking mechanism comprising a spring mechanism. In one or more embodiments, the locking mechanism comprising a spring mechanism and a retractable/extended retention member. In one or more embodiments, the locking member comprising a retractable/extendable retention member. In one or more embodiments, the locking mechanism disposed at about the opening of the connector's cavity. In one or more embodiments, the locking mechanism configured to secure the bottom of the container to the connector.
In one or more embodiments, the spring and retractable/extended retention member configured to hold the bottom of the container. In one or more embodiments, the locking mechanism of the connector being a ratchet teeth mechanism. In one or more embodiments, the ratchet teeth mechanism disposed on the interior side wall of the cavity of the connector. In one or more embodiments, the ratchet teeth mechanism disposed at about the opening of the cavity of the connector. In one or more embodiments, the ratchet teeth mechanism disposed at the opening of the cavity of the connector. In one or more embodiments, the ratchet teeth mechanism configured to grasp the bottom of the container when the container is engaged to the connector.
In one or more embodiments, the connector further comprising an engagement mechanism in the form of a dent, the dent configured to engage/couple/accommodate a wing of the container. In one or more embodiments, the wing is retractable/extendable allowing the container to enter the cavity of the connector. In one or more embodiments, the wing of the container is operable in at least two positions, a retractable position that allows the container to enter the connector and an extended position that locks the container inside the connector's cavity.
In one or more embodiments, the connector is further configured to enter a cavity of a bag/bottle while the connector houses/contains a container. In one or more embodiments, the connector is further configured to enter a cavity of a container. In one or more embodiments, the connector is further configured to enter a cavity of a bag. In one or more embodiments, the connector is further configured to enter a cavity of a bottle.
In one or more embodiments, the connectors allow an engagement between a cartridge and a vessel. In one or more embodiments, the connectors allow an engagement between a cartridge and another cartridge. In one or more embodiments, the connectors allow an engagement between a vessel and another vessel. In one or more embodiments, a plurality of cartridges can be connected to a vessel via the herein disclosed connectors. In one or more embodiments, a plurality of cartridges can be connected via the herein disclosed connectors. In one or more embodiments, a plurality of vessels can be connected via the herein disclosed connectors.
Thus, the present invention provides a system for the engagement and fluid passageway between vessels, the system comprising: a first vessel; a second vessel; and a connector having at least one cavity, the cavity configured to allow entry of at least one of the first vessel's body and the second vessel's body, the connector configured to allow a connection between the first vessel and the second vessel; wherein the first and second vessels connected to each other via the connector and wherein each of the first vessel, second vessel and connector includes an aperture and/or a seal for allowing the fluid passageway between the first vessel and the second vessel.
In one or more embodiments, the connector includes at least one cavity, the cavity configured to accommodate therein the first vessel, second vessel and/or a portion thereof.
In one or more embodiments, the connector includes a first cavity for accommodating therein the first vessel and a second cavity for accommodating therein the second vessel, thereby allowing the vessels' connection and fluid passageway via the connector.
In one or more embodiments, the first and/or second vessels include a cavity for accommodating therein the connector or a portion thereof, thereby allowing the vessels connection and fluid passageway via the connector.
In one or more embodiments, the connector includes a cavity for accommodating therein the first vessel and wherein the second vessel includes a cavity for accommodating therein the connector, thereby allowing the vessels' connection and fluid passageway via the connector.
In one or more embodiments, the system comprises a plurality of first vessels and a plurality of connectors, such that each first vessel configured to connect a connector and the second vessel configured to connect the plurality of connectors and vessels. In one or more embodiments, the second vessel includes at least one cavity for accommodating therein at least one of the connectors. In one or more embodiments, at least one of the connectors includes a cavity for accommodating therein at least one of the first vessels.
In one or more embodiments, the vessel is selected from the group consisting of a bottle, a syringe, an infusion line, a connector, a filter, a manifold, a bag port, a bottle port, a vial port, a cartridge and a combination thereof. In one or more embodiments, the first vessel is a cartridge configured to fill the second vessel with a fluidic or semi fluidic substance.
In one or more embodiments, when connected, a wall of at least one of the first vessel and second vessel extends from the boundaries of a wall of the connector. In one or more embodiments, when connected, a wall of at least one of the first vessel and second vessel is aligned with the boundaries of a wall of the connector. In one or more embodiments, when connected, a wall of at least one of the first vessel and second vessel is concealed within the walls of the connector.
In one or more embodiments, when connected, a wall of the connector and/or the first vessel extends from the boundaries of a wall of the second vessel. In one or more embodiments, when connected, a wall the connector and/or the first vessel is aligned with the boundaries of a wall of the second vessel. In one or more embodiments, when connected, a wall the connector and/or the first vessel is concealed within the walls of the second vessel.
In one or more embodiments, the first vessel and/or second vessel includes a fluid transfer mechanism for transferring a fluidic or semi fluidic substance from the first vessel to the second vessel or vice versa. In one or more embodiments, the fluid transfer mechanism includes a moveable wall which when pushed towards an aperture of the vessel, forcibly pushes the fluidic or semi fluidic substance from the vessel. In one or more embodiments, the fluidic or semi fluidic substance is a liquid. In one or more embodiments, the fluidic or semi fluidic substance is a powdered solid. In one or more embodiments, the fluidic or semi fluidic substance is a lyophilized powder. In one or more embodiments, the fluidic or semi fluidic substance is a gas.
In one or more embodiments, the system further comprises a locking mechanism configured to secure the engagement between the vessel and connector. In one or more embodiments, the locking mechanism comprises a securing member selected from a hook, a tooth, a pin, a ratchet tooth, a thread, a ball, a bangle, a locking key, a knob, a luer, a retention member, an adhesive, a clamping member, a zip-tie and a combination thereof. In one or more embodiments, the securing member is locked into a locking member selected from a dent, a hole, a channel, and a slot. In one or more embodiments, the locking member is retractable and moveable between a retracted position wherein the locking member abuts or inserted within a wall of the vessel or connector and an extended position, wherein the locking member protrudes from a wall of the vessel or connector. In one or more embodiments, the locking member is spring loaded or attached to a spring, allowing planar movement of the locking member.
In another aspect, the present invention provides a connector for the engagement and establishment of a fluid passageway between vessels, the connector configured to connect a first vessel and a second vessel and includes at least one cavity for accommodating therein at least one of the first and second vessels, thereby allowing an engagement and a fluid passageway between the first and second vessels.
In another aspect, the present invention provides a connector having a cavity, the cavity characterized in that is allows entrance of at least a portion of a container into the cavity.
In one or more embodiments, the cavity accommodates at least 35% of at least one of a container's length and width.
In one or more embodiments, the cavity accommodates at least 50% of at least one of a container's length and width.
In one or more embodiments, the cavity accommodates at least 75% of at least one of a container's length and width.
In one or more embodiments, the cavity accommodates at least one of an entire container's length and width.
In one or more embodiments, the container is a vial.
In one or more embodiments, the container is a bottle.
In one or more embodiments, the container is a bottle with a plunger.
In one or more embodiments, the container is a cartridge with a protective side wall.
In another aspect, the present invention provides a connector having a cavity, the cavity configured to engulf at least a portion of a container's length.
In one or more embodiments, the cavity engulfs at least 25% of a container's length.
In one or more embodiments, the cavity engulfs at least 50% of a container's length.
In one or more embodiments, the cavity engulfs at least 75% of a container's length.
In one or more embodiments, the cavity engulfs the entire length of a container.
In one or more embodiments, the connector further comprising a piercing member.
In one or more embodiments, the piercing member is a needle.
In one or more embodiments, the piercing member is a hollowed needle.
In one or more embodiments, the connector further comprising a frangible seal.
In one or more embodiments, the present invention provides a method of connecting and establishing a fluid passageway between vessels, the method comprising the steps of: connecting a first vessel to a connector, the connector having a cavity, the cavity characterized in that is allows at least a portion of the first vessel's body to enter the cavity; connecting a second vessel to the connector; and allowing a fluid passageway between the first vessel and the second vessel via the connector.
In one or more embodiments, an airtight seal is formed between the vessels and the connector following the step of connection, allowing a hermetically sealed connection between said first vessel and said second vessel.
In one or more embodiments, the method further comprising locking and/or engaging the first and/or second vessel to the connector via a locking mechanism. In one or more embodiments, the step of locking the vessel to a connector includes coupling a locking member to a securing member. In one or more embodiments, locking of said first vessel to said second vessel is via a push, a twist, a slide activation, or combinations thereof.
In one or more embodiments, the method further comprising transferring a fluid substance between the vessels after connecting the vessels.
In one or more embodiments, the step of connecting a vessel includes inserting the vessel into a cavity within the connector. In one or more embodiments, the method comprises connecting a first vessel into a first cavity within the connector and further connecting a second vessel into a second cavity within the connector.
In one or more embodiments, the step of connecting a vessel includes inserting the connector into a cavity within the vessel. In one or more embodiments, the step of connecting the vessel includes inserting the connector into the cavity within the second vessel. In one or more embodiments, the step of connecting a vessel includes inserting a connector into a cavity within a second vessel.
In one or more embodiments, the method comprises connecting a first vessel into a cavity within the connector and further connecting the connector into a cavity within the second vessel. In one or more embodiments, the method comprises connecting a plurality of connectors to a plurality of first and/or second vessels. In one or more embodiments, the method comprises a second vessel having a plurality of cavities disposed within the second vessel, the plurality of the cavities configured to allow entry of a plurality of connectors into the cavities.
Unless otherwise defined, all technical or/and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods or/and materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
In the drawings:
It should be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements are exaggerated relative to each other for clarity. Further, where considered appropriate, reference numerals have been repeated among the figures to indicate corresponding elements.
It is understood that the invention is not limited to the particular methodology, devices, items or products etc., described herein, as these may vary as the skilled artisan will recognize. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention. The following exemplary embodiments may be described in the context of exemplary connector 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.
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.
It is understood that the invention is not limited to the particular methodology, devices, items or products etc., described herein, as these may vary as the skilled artisan will recognize. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention. The following exemplary embodiments may be described in the context of exemplary medical devices/containers/systems 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 embodiments are described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the inventive concept are shown. In the drawings, the size and relative sizes of layers and regions can be exaggerated for clarity. Like numbers refer to like elements throughout. The embodiments can, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the inventive concept to those skilled in the art. The following embodiments are discussed, for simplicity, with regard to the terminology and structure of a medical services environments, such as a hospital, nursing home, doctor's office, walk-in clinic, or home infusion setting.
Reference throughout the specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment of the embodiments. Thus, the appearance of the phrases “in one embodiment” or “in an embodiment” in various places throughout the specification is not necessarily referring to the same embodiment. Further, the particular feature, structures, or characteristics can be combined in any suitable manner in one or more embodiments.
The present invention pertains to connectors, methods and systems for allowing connection between one or more vessels. In one or more embodiments, the connectors allow a fluid passageway between the connected vessels. In one or more embodiments, the connectors allow a connection and fluid passageway between vessels which are otherwise un-engageable.
Optionally, the connectors allow a repeated use thereof. Optionally, the connectors allow to refill vessels with cartridges. Optionally, the connectors are connected to the vessels via cavities within the connectors. In accordance with this embodiment, the cavities are sized and shaped to accommodate the body of the vessel. In one or more embodiments, the cavities are sized and shaped to accommodate at least a portion of the body of the vessel. Additionally, or alternatively, the vessel includes a cavity for accommodating therein the connector. In one or more embodiments, the vessel includes a cavity for accommodating at least a portion of the connector. In one or more embodiments, the vessel includes a cavity for accommodating an entire length and/or width of the connector.
As used herein the term “vessel” refers to any device utilized for containing, transferring and/or administering substances. In one or more embodiments, the vessels may be used for containing medical substances. In an embodiment of the invention, the vessel is a medical vessel. In one or more embodiments, the term “medical vessel” is interchangeable with the term “pharmaceutical 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 or to a connector. In an embodiment of the invention, the vessel is utilized for containing or housing a medical substance. In one or more embodiments, the medical substance may be a medicament. In one or more embodiments, the medicament may be an injectable medicament. In one or more embodiments, the medicament may be a sterile medicament, nutritional substance, a diagnostic substance, a diluent, a sterile fluid, and combinations thereof. Various types of vessels are contemplated. The vessel may be selected, without limitation, from a vial, a bag, a chamber, a bottle, a cartridge and the alike. In an embodiment of the invention, the term vessel further encompasses elements that can be used to connect between vessels. In accordance with this embodiment, the vessel may be selected, without limitation, from a connector, a connector having a plurality of openings, a connector having a cavity, a syringe, an infusion line, a tubing, an infusion line, a spike, a syringe, a filter, a port and a manifold.
In one or more embodiments, the connector is applicable for connecting two or more vessels. In one or more embodiments, the connector is applicable for allowing connection between two or more vessels which are otherwise un-engageable. In one or more embodiments, the connector is applicable for refilling one or more vessels with a fluid or semi-fluid substance. In one or more embodiments, the vessel is a cartridge.
As used herein the term “fluid communication” refers to two or more vessels (e.g., a cartridge) in which substances may pass therethrough either directly or indirectly. The fluid communication may occur via a fluid passageway that allows for the flow/transfer of substances. In an embodiment of the invention, fluid passageway between vessels is established when any seals or covers of the apertures of the herein disclosed systems and/or of the vessels and/or of a connector are open. Optionally, the vessels and/or connectors of the systems are provided with seals/covers and those seals/cover become open upon piercing by a piercing member or breaking/rupturing thereof. Optionally, the vessels and/or apertures of the systems are provided with seals/covers and those seals/covers are opened upon uncovering or removing thereof by a user. Optionally, one or more of the seals/covers disclosed herein are fragile, allowing piercing thereof with a sharp instrument (i.e., a piercing member) or by the application of a sufficient force to break or rupture the seals/covers. The piercing member may optionally be a needle, for example, a hollowed needle, but other sharp elements are contemplated. In one or more embodiments, the seals/covers may be peelable. In one or more embodiments, the seals/covers may be frangible.
In an embodiment of the invention, the herein disclosed connectors, systems and methods allow fluid communication between two or more, three or more, four or more, five or more, six or more, or seven or more vessels. In an embodiment of the invention, the herein disclosed connectors, systems and methods allow fluid communication in a contaminant-free, or in a substantially contaminant-free manner. For example, between two, three or more, four or more, five or more or six or more vessels. For example, the connectors, systems, and methods of the invention allow fluid communication between two cartridges, two bags, between two containers, between two bottles, between a syringe and a bag, between a syringe and a container, between a syringe and a vial, between a connector and a bag, between a container and a bag, between a vial and a bag, between a container and an infusion line or between a syringe and a connector. In an embodiment of the invention, the herein disclosed connectors and systems are disposable. In an embodiment of the invention, the herein disclosed connectors and systems are non-disposable.
In one or more embodiments, the herein disclosed connectors include a locking mechanism that can lock together the connector to the vessel. In one or more embodiments, the locking mechanism includes a locking member and a securing member. In one or more embodiments, the herein disclosed connectors and/or vessels comprise at least 2 locking mechanism and/or at least 2 engagement mechanisms.
In one or more embodiments, the locking member is configured to attach a securing member and the securing member configured to hold the locking member. Various forms of the locking members are herein contemplated. Non-limiting examples of the locking members include a hook, a tooth, a pin, a ratchet tooth, a knob, a ball, a thread, a bangle, a locking key, a stopper, and a zip-tie. The locking member is optionally selected from a structure that protrudes from a surface and grips a matching dent.
The locking member may be optionally moveable between a retracted position and an extended position. Such design allows to conveniently engage the vessels to each other, optionally or additionally allows to conveniently engage a connector to at least one vessel to each other, and while doing so, retracting the locking mechanism until positioning thereof to lock into the securing member. Optionally, the locking member extends from the securing member. For example, in cases where the securing member is a hole or the alike, the locking member may be positioned to extend from the hole. Various forms of the securing member are herein contemplated. Non-limiting examples of the securing member include a dent, a hole, a channel and a slot.
In one or more embodiments, the locking mechanism allows a secure (i.e., the connection is stable and does not spontaneously detach) and reversible locking (i.e., by a purposely initiated action of user). In accordance with this embodiment, the herein disclosed devices and systems may be reused, and the connection may be unlocked. In one or more embodiment, the locking mechanism may allow a permanent connection (i.e., the connection cannot be detached by a simple action and requires special instrumentation to detach). In one or more embodiments, the locking mechanism may optionally allow an irreversible connection (i.e., the resulting connection cannot be detached, unless the locking mechanism is destructed). In accordance with those embodiments, the herein disclosed devices and systems are intended for a single use.
Various types, combinations and numbers of locking members and securing members may be provided in each of the herein disclosed systems, to ensure the locking action. For example, a combination of two locking mechanisms or more may be provided in each connector/system/vessel.
The locking mechanism may be provided to lock or connect a connector to a vessel. In accordance with this embodiment, the locking member may be disposed on the connector and the securing member on the vessel, or vice versa. Various positions of the securing/locking member on the vessels or connectors are herein contemplated. The locking/securing member may be disposed on a body, port, and/or aperture, and/cavity of the connector and/or vessel. The locking mechanism may be disposed in an external or an internal position of the vessel and/or connector.
Optionally, the locking mechanism may be provided to lock or connect between a vessel to a connector or a connector to a cartridge. In accordance with this embodiment, the locking member may be disposed on the vessel/cartridge and the securing member on the connector, or vice versa. Various positions of the securing/locking member on the vessel/cartridge/connector are herein contemplated. The locking/securing member may be disposed on a vessel's/cartridge's/connector's body, port, aperture, and/or cavity. The locking mechanism may be disposed in an external or in an internal position of the vessel/cartridge/connector.
Optionally, the vessel-connector and/or connector-cartridge connection may include in addition to the locking mechanism an engagement mechanism configured or adapted to allow an engagement between the vessels and connectors. The engagement mechanism may be reversible, allowing disconnection of the vessel-connector. Various types of engagement mechanisms may be applicable and are contemplated. For example, the engagement mechanism is selected from, without limitation, a thread, a luer, a luer-lock, a luer-slip, snap-on, twist-on, a ratchet teeth mechanism, a retention member, a clamping rail, and an adhesive mechanism. The thread and the complementary thread may be selected from, without limitation, a luer, a smart-site mechanism and combinations thereof. In an embodiment, the engagement mechanism may be selected from a ratchet teeth mechanism, a clamping rail mechanism and/or an adhesive.
In one embodiment, the invention provides devices and systems configured to allow a substantially decontaminated locking of/engagement between vessels. In one or more embodiments, the devices and systems of the invention allow a substantially decontaminated fluid transfer between the one or more vessel(s) and or vessels and connectors. The engagement and/or locking and fluid transfer between the one or more vessels may accordingly be utilized via the connector which is substantially sterile and also allows the fluid transfer.
The connectors of the invention include a structure allowing connection to two vessels. The connectors include one or more walls, e.g., a side wall, a top wall and/or a bottom wall. The connectors configured to be coupled to two or more vessels and include applicable cavities for receiving the vessels. The cavities optionally formed by the side walls forming an inner lumen for accommodating therein the vessels. In one or more embodiments, the cavities of the connector may engulf the entire vessel's body. In one or more embodiments, the cavity engulfs a portion of a vessel. In one or more embodiments, the cavity of the connector engulfs at least a portion of a vessel's body. In one or more embodiments, the cavity of the connector engulfs at least a portion of a vessel's body and the port of the vessel. In one or more embodiments, the cavity of the connector engulfs a substantial portion of the vessel's body. In one or more embodiments, the cavity of the connector engulfs at least a substantial portion of the vessel's body and the port of the vessel. In one or more embodiments, the cavity of the connector engulfs the entire body of the vessel and the port of the vessel. In one or more embodiments, the cavity of the connector engulfs the entire length of the vessel. In one or more embodiments, the cavity of the connector engulfs the entire width of the vessel. In one or more embodiments, the cavity of the connector engulfs the entire length and width of the vessel. In one or more embodiments, the cavities engulf a port of a vessel or a portion thereof. The cavities optionally act further as a conduit via which medical substances may be transferred following engagement between, the vessels. Various sized and shapes of the connectors are applicable. For example, the connector may have a U-like structure. Alternatively, or additionally, the connector may have a shape of the vessel that should connect the connector. In one or more embodiments, the connector's cavity may have a shape that corresponds to the vessel's shape to allow the vessel to engage/couple with the connector's cavity. In one or more embodiments, at least a portion of the connector's cavity may have a shape that corresponds to at least a portion of the vessel's shape to allow the vessel to engage/couple with the connector's cavity. 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 cartridge. In one or more embodiments, the vessel is a bottle. In one or more embodiments, the vessel is a container with a protective side wall and a plunger. In one or more embodiments, the vessel having a plunger and/or a moveable wall.
In one or more embodiments, the connectors may be manufactured from various materials. Optionally, the connector is manufactured from an inert material, thus suitable for various types of pharmaceutical substances. The connector may be made from flexible or from rigid materials. Suitable materials include, without limitation a plastic, a glass, a rigid plastic, a flexible plastic, and combinations thereof. In one or more embodiments, the connector may be transparent. In one or more embodiments, the connector may be opaque. In one or more embodiments, at least a portion of the cavity of the connector may be made of a rubber material to provide an airtight/hermetic engagement between the connector and a vessel.
Various sizes and shapes of the connector are applicable. For example, the connector may have an external most length, width, and/or height of about 6 inches or less, 5 inches or less, 4 inches or less, 3 inches or less, 2 inches or less, or 1 inch or less.
The connector may include two or more cavities for accommodating two or more vessels. For example, the connector may include two, three, four, five, six, or more cavities.
In one or more embodiments, the connector is conveniently light presenting a weight of no more than about 100 grams, no more than about 50 grams, no more than about 25 grams, no more than about 15 grams, no more than about 10 grams, or no more than about 5 grams.
In one or more embodiments, the connector may be a closed structure which forms a tight, optionally, airtight connection with vessels. In one or more embodiments, the cavities of the connector are sealed by a cover/seal prior to an engagement or connection with a vessel. The seal or cover may be opened at the time of engagement, optionally by the engagement itself. Alternatively, or additionally, the seal or cover may be opened prior to any engagement or connection to a vessel. In one or more embodiments, when the cavities of the connector are connected to vessels or when covered by a cover or a seal, the interior of the connector is hermetically sealed/isolated from surrounding/environmental air. In one or more embodiments, the cover or the seal is frangible, breakable or rupturable. In one or more embodiments, the cover or the seal is pierceable by a piercing member such as a needle. In one or more embodiments, the cover or the seal is peelable.
In one or more embodiments, the system or connectors of the invention is provided when the connector is already connected to one or more vessels. In accordance with this embodiment, the one or more vessels may be integrally manufactured or assembled with the connector and provided or distributed to consumers as such. In one or more embodiments, at least one connector may form a unitary structure with a vessel. In accordance with these embodiments, the system/connector may be configured to allow a connection/locking/engagement to additional one or more vessels.
In one or more embodiments, the connector includes one cavity. In one or more embodiments, the connector includes two or more cavities disposed one above the other (i.e., parallel to each other) or which are longitudinally aligned with respect to each other (i.e., at opposing sides of the connector). In accordance with these embodiments, the vessels connected to such cavities are positioned aligned allowing a direct and aligned fluid passageway between the vessels. In one or more embodiments, the connector includes two or more ports which are shifted from each other. Yet, in accordance with this embodiment, a fluid passageway is formed between vessels which is twisted or curved. In yet one or more embodiments, the connector contains a plurality of cavities configured for connecting a plurality of vessels and/or providing a fluidic passageway between the plurality of the vessels.
In one or more embodiments, the herein disclosed invention allows transferring medical substances in a contaminant-free, or in a substantially contaminant-free manner.
In one or more embodiments, the herein disclosed invention affords an engagement of vessels in a contaminant-free, or in a substantially contaminant-free manner. In one or more embodiments, the herein disclosed invention affords an engagement of vessels in an air-free, or in a substantially air-free manner. In one or more embodiments, the herein disclosed invention affords locking of vessels in a contaminant-free, or in a substantially contaminant-free manner. In one or more embodiments, the herein disclosed invention affords locking of vessels in an air-free, or in a substantially air-free manner. In one or more embodiments, the herein disclosed invention provides a fluidic passageway or communication between vessels in a contaminant-free, or in a substantially contaminant-free manner. In one or more embodiments, the herein disclosed invention provides a fluidic passageway or communication between vessels in an air-free, or in a substantially air-free manner. In one or more embodiments, the herein disclosed invention, allows to substantially decrease the chances to introduce contaminants within a medical substance, when preparing or administering medical substances for administration to patients. 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 and/or micro-organisms, and/or any of the alike. Typically, when less or no air is introduced within medical substances, the chances of contamination by pathogens, such as, bacteria, viruses, funguses, spores, pyrogens or the alike is completely abolished or significantly reduced.
As used herein, the term “substantially contaminant-free” means significantly less ambient air present when transferring medical substances with the herein disclosed vessels and systems, as compared to comparable conditions for transferring medical substances without the herein disclosed vessels and systems.
As used herein the term “ambient air particles” is interchangeable with the term “environmental air particles” and refers to air particles present in a non-filtered environment. The air particles may contain dirt, such as dust. Alternatively, or additionally, the air particles may contain pathogens or other microorganisms, or any of the alike.
As used herein the term “substances” refers to various types of materials. The substances may be liquid, semi-solid, or gas. In one or more embodiments, the substances are “medical substances”. As used herein the term “medical substances” refers to and encompasses any of the various pharmaceutical drugs, fluids, nutritional products and the like. In an embodiment of the invention the term “medical substance” is interchangeable with the term “pharmaceutical substance”.
The connector 101 hence includes a first cavity 108 for accommodating or receiving a first cartridge 102 and a second cavity 107, for accommodating or receiving a second cartridge 103. The connector 101 is thus configured such to accommodate therein or engulf the bodies of at least two cartridges and/or vessels.
An aperture 106 is disposed between the cavities 107 and 108 for allowing passage of fluids (or solids/powdered solids) therethrough and between the cartridges. Cartridge 103 includes a cartridge aperture 105 and cartridge 102 includes a cartridge aperture 104. The connector aperture 106, first cartridge aperture 104 and/or second cartridge aperture 105 may include a seal and/or a cover which can be opened to allow fluid transfer between the cartridges 102 and 103. The seal and/or cover of any of aperture(s) 106, 104, and 105 may optionally be a frangible seal, a rupturable seal, a peelable seal, a pierceable seal, and combinations thereof. As illustrated in
An audible sound such as a “click” sound or any other sound may be emitted at about the time, or at the time of connection of cartridge 102 and/or 103 with connector 101.
In
The fluid transfer mechanism of the system 1300 includes moveable wall (plunger) 1325 which when pushed by a user allows the fluid transfer between the cartridges 1303 and the vessel 1302. Optionally, wall 1325 is moveable via a sliding mechanism including rails disposed on/in cartridge 1303.
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.
The present application claims priority to U.S. Provisional Application No. 62/797,361 filed on Jan. 28, 2019. The entire contents of this application is expressly incorporated herein by reference.
Number | Date | Country | |
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62797361 | Jan 2019 | US |