DEVICES AND SYSTEMS WITH AN INTERNAL DISPLACEMENT MECHANISM FOR CONTAMINANT-FREE ENGAGEMENT OF MEDICAL VESSELS AND DEVICES
20190076328 ยท 2019-03-14
Inventors
Cpc classification
A61J1/2089
HUMAN NECESSITIES
A61J1/1443
HUMAN NECESSITIES
A61J1/2096
HUMAN NECESSITIES
International classification
Abstract
The present invention relates, in some embodiments thereof, to systems, device and methods for establishing a contaminant-free fluid passageway between vessels. In some embodiments of the invention, the systems and devices of the invention include a first connection interface configured to be coupled to a first vessel, and a second connection interface configured to be coupled to a second vessel, the first and second connection interfaces configured to engage with each other and entrap contaminants, the first connection interface and the second connection interface, following the engagement, are configured to internally displace within the first vessel or the second vessel, while allowing for a contaminant-free fluid passageway and hermetically sealed engagement of the vessels.
Claims
1. A decontamination connector for decontaminating a connection between a first vessel and a second vessel, the decontamination connector comprising: a first connection interface configured to be coupled to a first vessel, the first connection interface configured to engage with a second connection interface on a second vessel to entrap contaminants between the first connection interface and the second connection interface, wherein following said engagement of the first connection interface and said second interface, said decontamination connector and said first vessel form a hermetically coupled connection with said second vessel, while the first connection interface and said second interface are internally displaced within said first vessel or said second vessel while maintaining the hermetically coupled connection.
2. The decontamination connector of claim 1, further comprising an engagement mechanism, wherein said engagement mechanism is configured to provide coupling between the first connection interface of the decontamination connector and the second connection interface of said second vessel.
3. The decontamination connector of claim 2, wherein the engagement mechanism is selected from a group consisting of a thread, a luer, an adhesive, a ratchet teeth mechanism, and combination thereof.
4. The decontamination connector of claim 1, wherein the first connection interface is selected from a group consisting of a film, a bung, a plug and combinations thereof.
5. The decontamination connector of claim 1, wherein the first connection interface is made of plastic, rubber, elastomeric material, and combinations thereof.
6. The decontamination connector of claim 1, wherein the first connection interface is configured to displace internally within the decontamination connector and/or said first vessel.
7. The decontamination connector of claim 1, wherein an entire surface of the first connection interface and an entire surface of the second connection interface contact each other thus isolating contaminants between the surface of the first connection interface and the surface of the second connection interface.
8. The decontamination connector of claim 1, wherein a portion of a surface of the first connection interface and a portion of a surface of the second connection interface contact each other thus isolating contaminants between the surface of the first connection interface and the surface of the second connection interface.
9. The decontamination connector of claim 1, wherein 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 said first vessel and/or said second vessel when the first connection interface is engaged with the second connection interface.
10. The decontamination connector of claim 1, wherein 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 said first vessel and/or a second vessel when the first connection interface is engaged with the second connection interface.
11. The decontamination connector of claim 10, wherein the edges are circumferential edges.
12. The decontamination connector of claim 11, wherein the circumferential edges define the outer portion of the first connection interface and the second connection interface.
13. The decontamination connector of claim 10, wherein the edges are further configured so the sides of the edges are not exposed to contaminants.
14. The decontamination connector of claim 10, wherein the sides of the edges that are exposed to an internal compartment of said first vessel and/or said second vessel are not exposed to contaminants.
15. The decontamination connector of claim 10, wherein the outer portion of the edges of the first connection interface are not exposed to contaminants.
16. The decontamination connector of claim 10, wherein 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.
17. The decontamination connector of claim 10, wherein the edges of the first connection interface are flat.
18. The decontamination connector of claim 10, wherein the edges of the first connection interface are configured to snuggly fit the edges of the second connection interface.
19. The decontamination connector of claim 10, wherein the edge is an exterior portion of the that comes in contact with an interior compartment of the decontamination connector and/or vessel.
20. The decontamination connector of claim 1, wherein the contaminants are air particles.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0087] 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.
[0088] In the drawings:
[0089]
[0090]
[0091]
[0092]
[0093]
[0094]
[0095]
[0096]
[0097]
[0098]
[0099]
[0100]
[0101] 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.
DETAILED DESCRIPTION OF THE INVENTION
[0102] 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 bedding articles 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.
[0103] The present invention relates to devices, methods and systems allowing an engagement of vessels in a sterile manner. The present devices, methods and systems are particularly useful for medical purposes, wherein sterile preparations of medical substances are vastly needed. In one embodiment, the present invention provides connection interfaces, that may be coupled to, or integrally formed with, medical vessels or containers, such as vials, syringes, etc. The invention provides a solution to an unmet and long felt need in the medical settings and allows connecting, in a sterile manner, two or more vessels. The herein disclosed devices and systems are user friendly, cost effective and abolish the need for complicated and expensive known methods for transferring 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.
[0104] In an aspect of the invention, the devices and systems of the invention include a first connection interface configured to attach to a first vessel and a second connection interface configured to attach to a second vessel. The first and second connection interfaces are designed in a manner allowing them to engage with each other. An engagement between the interfaces entraps ambient air particles present at the vicinity of the vessels and interfaces. The air particles are entrapped within the engagement formed by the connection interfaces. The air particles are entrapped between the connection interfaces of the first and second vessels. The engagement between the connection interfaces further establishes an airtight seal between the vessels. The connection interfaces are further configured to internally displace within one of the vessels or within one of the vessel ports, thereby allowing fluid passageway and contaminant-free connection of the vessels.
[0105] In an aspect of the invention, the devices and systems of the invention includes a first connection interface with 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 the second vessel when the first connection interface is engaged with the second connection interface. In an aspect of the invention, the second connection interface is configured to engage with the first connection interface, the second connection interface having edges configured to isolate an entire surface of the second connection interface that is exposed to contaminants from contacting an internal compartment of the first vessel and/or second vessel when the second connection interface is engaged with the first connection interface.
[0106] In one or more embodiments, the entire surface of the edges of the first connection interface and the entire surface of the edges of the second connection interface contact each other thus isolating contaminants between the edges of the first connection interface and the edges of the second connection interface. In one or more embodiments, the edges of the first connection interface and the entire surface of the edges of the second connection are circumferential edges. In one or more embodiments, the circumferential edges define the outer portion of the connection interfaces. In one or more embodiments, the edges are further configured so the sides of the edges are not exposed to contaminants and/or are concealed from contaminants. In one or more embodiments, the sides of the edges of the first connection interface and/or the sides of the edges of the second connection interface are concealed within a wall or other portion of the first vessel and or within a wall or other portion of the second vessel.
[0107] In one or more embodiments, the sides of the edges that are exposed to an internal compartment or port of the first and/or second vessels are not exposed to contaminants.
[0108] In one or more embodiments, the herein disclosed invention allows transferring medical substances in a contaminant-free, or in a substantially contaminant-free manner.
[0109] In one or more embodiments, the herein disclosed invention affords an engagement of vessels in a sterile manner.
[0110] 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.
[0111] In one or more embodiments, the herein disclosed invention affords to isolate and/or entrap ambient air particles present between two or more, medical vessels. In one or more embodiments, the herein disclosed invention, allows to substantially decrease the chances to introduce contaminants within a medical substance, when preparing medical substances for administration to patients.
[0112] In yet a further aspect, the present invention provides a decontamination connector for providing a decontaminated connection and fluid passageway between a first vessel and a second vessel, the decontamination connector comprising:
[0113] a housing having a conduit disposed within the housing, wherein a first end of the conduit leads to a first opening in the housing and wherein a second end of the conduit leads to a second opening in the housing; and
[0114] a first internally displaceable connection interface covering the first opening of the conduit and a second internally displaceable interface covering the second opening of the conduit,
[0115] wherein upon internal displacement of the first and second connection interfaces of the decontamination connector, a fluidic passageway is established between two vessels.
[0116] In yet a further aspect, the present invention provides a system for providing a fluidic passageway between a first vessel and a second vessel, the system comprising:
[0117] a first vessel having a first connection interface, wherein the first connection interface is configured to couple with a third connection interface of a decontamination connector and internally displace within the first vessel or the decontamination connector;
[0118] a second vessel having a second connection interface, wherein the second connection interface is configured to couple with a fourth connection interface of a decontamination connector and internally displace within the second vessel or the decontamination connector; and
[0119] a decontamination connector having a third connection interface configured to couple with the first connection interface of the first vessel, wherein the first and third connection interfaces when coupled internally displace within the first vessel or the decontamination connector and the decontamination connector having a fourth connection interface configured to couple with the second connection interface of the second vessel, wherein the second and fourth connection interfaces when coupled internally displace within the second vessel or the decontamination connector,
[0120] wherein following engagement and internal displacement of the first and third connection interfaces and following engagement and internal displacement of the second and fourth connection interfaces a contaminant-free fluidic communication is established between the first vessel and the second vessel via the decontamination connector.
[0121] In one or more embodiments, the decontamination connector further comprises an engagement mechanism, wherein the engagement mechanism is configured to provide a coupling between the first connection interface of the first vessel and the third connection interface of the decontamination connector. In one or more embodiments, the engagement mechanism is selected from a group consisting of a thread, a luer, an adhesive, a clamping rail, a rail, a ratchet teeth mechanism, and combinations thereof. In one or more embodiments, the engagement mechanism is made of a plastic, a metal, an elastomeric substance, a rubber and combinations thereof. In one or more embodiments, the decontamination connector comprises two of said engagement mechanisms. In one or more embodiments, the decontamination may comprise a plurality of said engagement mechanism. In one or more embodiments, the decontamination connector may comprise three or more internally displaceable connection interfaces. In one or more embodiments, the decontamination connector may comprise at least three internally displaceable connection interfaces and at least three engagement mechanisms.
[0122] In one or more embodiments, the first connection interface is selected from a group consisting of a film, a bung, a plug and combinations thereof. In one or more embodiments, the first connection interface is made of plastic, rubber, elastomeric material, and combinations thereof. In one or more embodiments, the first connection interface is configured to displace internally within the decontamination connector and/or the first vessel.
[0123] or more embodiments, the second connection interface is selected from a group consisting of a film, a bung, a plug and combinations thereof. In one or more embodiments, the second connection interface is made of plastic, rubber, elastomeric material, and combinations thereof. In one or more embodiments, the second connection interface is configured to displace internally within the decontamination connector and/or the first vessel.
[0124] or more embodiments, the third connection interface is selected from a group consisting of a film, a bung, a plug and combinations thereof. In one or more embodiments, the third connection interface is made of plastic, rubber, elastomeric material, and combinations thereof. In one or more embodiments, the third connection interface is configured to displace internally within the decontamination connector and/or the first vessel.
[0125] or more embodiments, the fourth connection interface is selected from a group consisting of a film, a bung, a plug and combinations thereof. In one or more embodiments, the fourth connection interface is made of plastic, rubber, elastomeric material, and combinations thereof. In one or more embodiments, the fourth connection interface is configured to displace internally within the decontamination connector and/or the first vessel.
[0126] In one or more embodiments, an entire surface of the first connection interface and an entire surface of the third connection interface contact each other thus isolating contaminants between the surface of the first connection interface and the surface of the third connection interface.
[0127] In one or more embodiments, an entire surface of the second connection interface and an entire surface of the fourth connection interface contact each other thus isolating contaminants between the surface of the second connection interface and the surface of the fourth connection interface.
[0128] In one or more embodiments, a portion of a surface of the first connection interface and a portion of a surface of the third connection interface contact each other thus isolating contaminants between the surface of the first connection interface and the surface of the third connection interface.
[0129] In one or more embodiments, a portion of a surface of the second connection interface and a portion of a surface of the fourth connection interface contact each other thus isolating contaminants between the surface of the second connection interface and the surface of the fourth connection interface.
[0130] 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 the decontamination connector when the first connection interface is engaged with the third connection interface.
[0131] In one or more embodiments, the second connection interface has edges configured to isolate an entire surface of the second connection interface that is exposed to contaminants from contacting an internal compartment of the second vessel and/or the decontamination connector when the second connection interface is engaged with the fourth connection interface.
[0132] 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 decontamination connector when the first connection interface is engaged with the third 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 third 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 decontamination connector 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 third connection interfaces upon engagement of the first and third 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 third connection interface of the decontamination connector. In one or more embodiments, the edges of the first connection interface are an exterior portion of the connection interface that comes in contact with an interior compartment of the decontamination connector and/or vessel.
[0133] In one or more embodiments, the second connection interface has edges configured to isolate a portion of the surface of the second connection interface that is exposed to contaminants from contacting an internal compartment of the second vessel and/or the decontamination connector when the second connection interface is engaged with the fourth 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 second connection interface and the fourth 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 second vessel and/or the decontamination connector are not exposed to contaminants. In one or more embodiments, the outer portion of the edges of the second connection interface are not exposed to contaminants. In one or more embodiments, the edges of the second connection interface are configured to fully entrap the contaminants between the second and fourth connection interfaces upon engagement of the second and fourth connection interfaces. In one or more embodiments, the edges of the second connection interface are flat. In one or more embodiments, the edges of the second connection interface are configured to snuggly fit the edges of the fourth connection interface of the decontamination connector. In one or more embodiments, the edges of the second connection interface are an exterior portion of the connection interface that comes in contact with an interior compartment of the decontamination connector and/or vessel.
[0134] In one or more embodiments, the contaminants are air particles. In one or more embodiments, the contaminants are water particles.
[0135] In one or more embodiments, the first connection interface and the third connection interface are configured to prevent contaminants from contacting the fluid passageway established between the decontamination connector and the first vessel.
[0136] In one or more embodiments, the second connection interface and the fourth connection interface are configured to prevent contaminants from contacting the fluid passageway established between the decontamination connector and the second vessel.
[0137] In one or more embodiments, the first connection interface and the third connection interface are configured to prevent a surface of the first and third connection interfaces that are exposed to contaminants from contacting a fluid passageway and/or interior compartment of the first vessel and/or decontamination connector.
[0138] In one or more embodiments, the second connection interface and the fourth connection interface are configured to prevent a surface of the second and fourth connection interfaces that are exposed to contaminants from contacting a fluid passageway and/or interior compartment of the second vessel and/or decontamination connector.
[0139] In one or more embodiments, the first connection interface is configured to hermetically seal an aperture of the first vessel. In one or more embodiments, the second connection interface is configured to hermetically seal an aperture of the second vessel. In one or more embodiments, the third connection interface is configured to hermetically seal an aperture of the decontamination connector. In one or more embodiments, the fourth connection interface is configured to hermetically seal an aperture of the decontamination connector.
[0140] In one or more embodiments, the first and/or second connection interfaces is configured to be internally coupled within the aperture and/or conduit of the decontamination connector.
[0141] In one or more embodiments, the aperture is a port. In one or more embodiments, the first and/or second vessels are selected from a vial, a bag, a bottle, a syringe, an infusion line, a connector, a filter, a manifold, a spike, a manifold port, a bag port, a bottle port, a vial port, and combinations thereof.
[0142] In one or more embodiments, the decontamination connector further comprises an engagement mechanism configured to securely engage the decontamination connector with the first vessel.
[0143] In one or more embodiments, the decontamination connector further comprises a second engagement mechanism configured to securely engage the decontamination connector with the second vessel.
[0144] In one or more embodiments, the engagement mechanism(s) provides an airtight engagement between the decontamination connector and the vessel.
[0145] In one or more embodiments, at least one of the engagement mechanisms is selected from a thread, a luer, ratchet teeth mechanism, adhesive, a rail and combinations thereof. In one or more embodiments, the engagement mechanism is located on the first connection interface.
[0146] In one or more embodiments, the engagement mechanism engages a complimentary engagement mechanism on a first and/or second connection interface.
[0147] In one or more embodiments, the engagement mechanism forms an airtight seal between the first connection interface and the third connection interface.
[0148] In one or more embodiments, the third and/or fourth connection interfaces are integrally connected to the decontamination connector.
[0149] In one or more embodiments, the decontamination connector and the vessel are hermetically sealed upon engagement of the first and third connection interfaces and/or the second and the fourth connection interfaces.
[0150] In one or more embodiments, the internal fluid passageway between the decontamination connector and the first and/or second vessel is devoid of air particles.
[0151] In one or more embodiments, the internal fluid passageway between the decontamination connector and the first and/or second vessel is devoid of air particles at about the time or after internal displacement of the first and third connection interfaces and/or the second and fourth connection interfaces.
[0152] In one or more embodiments, the internal fluid passageway between the decontamination connector and at least one vessel is sterile.
[0153] In one or more embodiments, the internal fluid passageway between the decontamination connector and a first and/or third vessel is sterile at about the time or after internal displacement of the first and second connection interfaces and/or the second and fourth connection interfaces.
[0154] 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, liquids, solids, suspensions and the like.
[0155] 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. 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.
[0156] 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.
[0157] 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. For example, air can be purified by filters, such as a High Efficiency Particulate Air (HEPA) filter.
[0158] As used herein the term connection interface encompasses any surface, layer, plane or the alike that can be attached to a vessel. The term may encompass a structure that can be coupled to a vessel and that can engage with a complementary connection interface. In an embodiment of the invention, the connection interface may seal or cover an aperture of a vessel. In an embodiment of the invention, the connection interface may seal or cover an aperture for fluid passageway of a vessel. In an embodiment of the invention, the connection interface may plug an aperture or fluid passageway of a vessel. 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 and second connection interfaces when engaged with each other entrap ambient air particles therebetween. In an embodiment of the invention, the first and second connection interfaces when engaged with each other internally displace within a vessel. In one or more embodiments, the connection interface comprises or presents the form of a thin film layer. 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. The connection interface may be formed of a metal material (e.g., a metal alloy). The metal alloy may include, for example, aluminum. In one or more embodiments, the connection interface may be made of glass. In one or more embodiments, the connection interface is attached to, or is integrally formed with a medical vessel, or a port thereof. In one or more embodiments, the connection interface is detachable from the vessel. In one or more embodiments, the connection interface is displaceable from the 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 ratchet teeth mechanism, a retention member-keeper member mechanism and combinations thereof.
[0159] 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, or port thereof. In one or more embodiments, the connection interfaces may be surface mounted to a wall of a vessel. In one or more embodiments, the connection interfaces may be flush mounted to a wall of a vessel. In one or more embodiments, the connection interfaces may abut a wall of a vessel. In one or more embodiments, a plurality of internally displaceable connection interfaces may be attached and/or coupled to a vessel. In one or more embodiments, a plurality of connection interfaces may be flush mounted, surface mounted, and/or abut a wall of a vessel. In one or more embodiments the vessel is a container. In one or more embodiments, the container is a bag, bottle, or vial.
[0160] 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.
[0161] 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. In one or more embodiments, the internal compartment of the first and/or second vessel houses a beneficial substance. In one or more embodiments, the beneficial substance is a sterile fluid.
[0162] In one or more embodiments, a first connection interface and a second connection interface are configured to prevent contaminants from contacting an internal portion of a port of the first and/or second vessel.
[0163] As used herein the term internal displacement refers to a displacement (i.e., dislocation) of the herein disclosed first and/or second connection interfaces. In an embodiment of the invention, the displacement is internal, namely, dislocation into one of the vessels or vessel ports associated with a connection interface. In an embodiment of the invention, the displacement is within the fluid passageway established following engagement of the herein disclosed vessels. In an embodiment of the invention, the internal displacement occurs for one or both the first and second connection interfaces. The internal displacement may optionally occur simultaneously for both connection interfaces or may occur consecutively. The displacement may occur via a pressure exerted on the exterior of the connection interfaces, a twisting of the connection interfaces with respect to one another, or an engagement of the interfaces with one another and actuation by a user. Optionally, the displacement may occur via a pressure exerted through the exterior of a wall of a container, such as a bag, by a user's hand. Optionally, the displacement may occur via the manual manipulation of the first and/or second connection interfaces through the exterior wall of a container, such as a bag, by a force of the user's hand. In one or more embodiments, the term internal displacement refers to a displacement (i.e., dislocation) of herein disclosed third and/or fourth connection interfaces. In an embodiment of the invention, the displacement is internal, namely, dislocation into a decontamination connector and/or into a conduit of the decontamination connector.
[0164] In one or more embodiments, the connection interface is configured to hermetically seal an aperture present in or on a vessel. In accordance with this embodiment, following the internal displacement, a fluid passageway provides for the fluid communication between vessels.
[0165] As used herein the term vessel refers to any device utilized for containing and/or transferring substances as herein disclosed. In one or more embodiments, the vessels may be used for containing medical substances. In an embodiment of the invention, the vessel is a medical vessel. In 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. In an embodiment of the invention, the vessel is utilized for containing a medical substance. Various types of vessels are contemplated. The vessel may be selected, without limitation, from a vial, a bag, a chamber, a bottle, 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 syringe, an infusion line, a tubing, a spike, a filter, a port and a manifold.
[0166] As used herein the term fluid communication refers to two or more vessels in which substances may pass therethrough either directly or indirectly. The fluid communication may occur via a fluid passageway that allows for the flow/transfer of substances. In one or more embodiments, the fluid passageway may allow the passage of fluids, liquids, powders, or solids. In one or more embodiments, the term fluid communication refers to a decontamination connector through which substance may pass therethrough between two or at least two vessels.
[0167] In an embodiment of the invention, the herein disclosed devices, systems and methods allow fluid communication in a 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 bags, between a syringe and a bag, between a connector and a bag, between a connector and a vial, between a bag and a vial or between a syringe and a connector.
[0168] 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.
[0169] Referring now to the drawings,
[0170] The first and second vessels 14 and 18, respectively, may be any vessel capable for containing substances, such as medical substances. The vessels may be used as intermediate tools that connect between vessels. The vessels may be selected from a vial, a bag, a bottle, a syringe, an infusion line, a connector, a filter, a manifold, a bag port, a bottle port, a vial port, a spike and combinations thereof. The vessels may be similar in size and/or shape. Alternatively, the vessels may be different in size and/or shape.
[0171] In an embodiment of the invention, first connection interface 12 includes an exterior surface 13 which is exposed to AA particles and second connection interface 16 includes an exterior surface 15 which is exposed to AA particles. Exterior surfaces 13 and 15 may be substantially equal in surface area. In one or more embodiments, the first and/or second connection interfaces are attached to, optionally integrally manufactured with the corresponding first and/or second vessels.
[0172]
[0173]
[0174]
[0175] The first connection interface 12 prior to the internal displacement is configured to hermetically seal an aperture 19 in the first vessel 14. The second connection interface 16 prior to the internal displacement is configured to hermetically seal an aperture 11 in the second vessel 18.
[0176] In one or more embodiments, the engagement between the first vessel 14 and the second vessel 18 provides for an airtight engagement between the vessels.
[0177] In one or more embodiments, the vessels 14 and 18 and/or connection interfaces 12 and 16 are hermetically sealed upon engagement thereof and upon engagement of the connection interfaces 12 and 16.
[0178] In one or more embodiments, at least one of the first connection interface 12 and the second connection interface 16 is a selected from a group consisting of a film, a bung, a plug and combinations thereof. In one or more embodiments, the film is a plastic or a metal alloy. In one or more embodiments, the bung is made of a rubber or an elastomeric material.
[0179]
[0180]
[0181]
[0182]
[0183] Referring now to
[0184]
[0185]
[0186]
[0187]
[0188]
[0189]
[0190]
[0191]
[0192]
[0193]
[0194]
[0195]
[0196]
[0197]
[0198]
[0199]
[0200]
[0201]
[0202]
[0203] The present invention further 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 internally displacing the first and second connection interfaces within one of the first vessel or the second vessel, while a hermetically sealed connection between the first and second vessel is maintained.
[0204] 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 the second vessel when the first connection interface is engaged with the second connection interface, and wherein the second connection interface is configured to engage with the first connection interface, the second connection interface having edges configured to isolate an entire surface of the second connection interface that is exposed to contaminants from contacting an internal compartment of the first vessel and/or second vessel when the second connection interface is engaged with the first connection interface.
[0205] In one or more embodiments, the first connection interface has edges configured to isolate at least 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 a second vessel when the first connection interface is engaged with the second connection interface, and wherein the second connection interface has edges configured to isolate at least a portion of the surface of the second connection interface that is exposed to contaminants from contacting an internal compartment of the first vessel and/or second vessel when the second connection interface is engaged with the first connection interface.
[0206] In one or more embodiments, an airtight seal is formed between the first connection interface and the second connection interface prior to the internal displacement of the first and second connection interfaces. 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.
[0207] In one or more embodiments, circumferential edges of at least one of or both of the first and second connection interfaces ends are concealed within the airtight seal, allowing for sterile internal displacement.
[0208] In one or more embodiments, the external portion of the circumferential edges of at least one of or both of the first and second connection interfaces are concealed within the airtight seal between the first and second connection interface, allowing for sterile internal displacement and contaminant-free engagement of vessels.
[0209] In one or more embodiments, when the circumferential edges of both the first and second connection interfaces ends are aligned, an airtight seal is formed between first and second connection interfaces, allowing for internal displacement of first and second connection interfaces and a contaminant free fluid passageway between the first and second vessels. In one or more embodiments, the method further comprises connecting the first connection interface to the second connection interface via an engagement mechanism.
[0210] In one or more embodiments, 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.
[0211] In one or more embodiments, the engagement of first connection interface to the second connection interface occurs prior to internal displacement of the connection interfaces. In one or more embodiments, the engagement of first connection interface to the second connection interface occurs concomitantly or at about the time of internal displacement of the connection interfaces.
[0212] 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.
[0213] Each of the phrases consisting of and consists of, as used herein, means including and limited to.
[0214] 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.
[0215] 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.
[0216] 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.
[0217] 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.
[0218] 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.
[0219] 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.
[0220] 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.