DUAL DECONTAMINATION MECHANISM DEVICE
20210121592 ยท 2021-04-29
Inventors
Cpc classification
A61M39/12
HUMAN NECESSITIES
A61J1/2089
HUMAN NECESSITIES
A61J1/1443
HUMAN NECESSITIES
A61J1/2096
HUMAN NECESSITIES
A61M39/16
HUMAN NECESSITIES
A61M5/162
HUMAN NECESSITIES
A61L2202/16
HUMAN NECESSITIES
A61L2202/23
HUMAN NECESSITIES
International classification
Abstract
The present invention relates, in some embodiments thereof, to systems, devices, connection ports, and methods allowing for an engagement of two or more pharmaceutical vessels, containers, or pharmaceutical administration devices in a decontaminated and/or sterile manner. In some embodiments of the invention, the systems, devices, connection ports, and methods of the invention include a dual decontamination action device having a wiping member and a removable sealing member, a system comprising a device having a wiping member and a removable sealing member and a connection port having a removable sealing member. A first removable sealing member attached to a housing of a device is provided, the housing further comprising a wiping member configured to move across the housing; and a connection port having a removable sealing member, both removable sealing members configured to displace from the engagement between the device and the connection port while a hermetically sealed connection is maintained between the device and the connection port. In some embodiments of the invention, the systems, devices, connection ports and methods include a wiping member that is configured to wipe off the surface(s) of the engaged device and connection port, thus providing a decontaminated/sterile fluid communication between the device and the connection port.
Claims
1. A system for establishing a decontaminated fluid passageway between a device and a connection port, comprising: a device, comprising: a. a housing defining a fluid passageway, a distal end portion of the housing configured to couple a connection port, the distal end portion of the housing having a securing mechanism configured to engage the connection port; b. a wiping member located inside the housing, the wiping member configured to move across the housing; c. an actuator connected to the wiping member, the actuator configured for moving the wiping member across the housing, the actuator extending through an opening in the wall of the housing; d. a removable sealing member for sealing the distal end portion of the housing, the removable sealing member positioned to seal the distal end portion of the fluid passageway, the removable sealing member configured to be movable between a first sealed position and a second unsealed position, the removable sealing member being moveable by manual manipulation of the removable sealing member, wherein the removable sealing member is displaced from the fluid passageway when the removable sealing member is in the second unsealed position; a connection port, comprising: a. a proximal end portion defining a fluid passageway, the proximal end portion of the connection port configured to couple the distal end portion of the housing of the device, the proximal end portion of the connection port having a securing mechanism configured to engage the securing mechanism of the distal end portion of the housing of the device; and b. a removable sealing member for sealing the proximal end portion of the fluid passageway of the connection port, the removable sealing member of the connection port configured to be movable between a first sealed position and a second unsealed position, the removable sealing member of the connection port being movable by manual manipulation of the removable sealing member, wherein the removable sealing member is displaced from the fluid passageway of the connection port when the removable sealing member is in the second unsealed position.
2. The system of claim 1, wherein the removable sealing member of the device and the removable sealing member of the connection port are both configured to fluidly seal the fluid passageway between the device and the connection port when both the removable sealing member of the device and the removable sealing member of the connection port are in a first sealed position, and wherein the removable sealing member of the device and the removable sealing member of the connection port are configured to allow passage of fluid between the device and the connection port when the removable sealing member of the device and the removable sealing member of the connection port are both in the second unsealed position.
3. The system of claim 1, wherein at least one of the removable sealing member of the device and the removable sealing member of the connection port are in a folded configuration.
4. The system of claim 1, wherein the device further comprising a first sealing member, the first sealing member positioned so that a surface of the first sealing member can be wiped off by the wiping member when the wiping member moves across the housing.
5. The system of claim 1, wherein the actuator of the device is selected from a rod, a handle, and a tab.
6. The system of claim 1, wherein the housing of the device further comprising a locking member located on an interior wall of the housing, the locking member configured for locking the wiping member in an extended/second position to prevent the wiping member from returning to an original first position.
7. The system of claim 1, wherein the device further comprising a locking member in the form of a retractable pin configured to lock the wiping member in a final position after the wiping member has moved across the housing of the device.
8. The system of claim 1, wherein the connection port further comprising a second sealing member.
9. The system of claim 1, wherein the device further comprising a piercing member.
10. The system of claim 8, wherein the device further comprising a piercing member and a piercing member actuator, the piercing member actuator configured to move the piercing member through the second sealing member of the connection port.
11. The system of claim 8, wherein the second sealing member fluidly seals an opening of the connection port.
12. The system of claim 11, wherein a surface of the second sealing member of the connection port is characterized in that the surface of the second sealing member is positioned to be wiped off by the wiping member of the device when the wiping member moves across the housing of the device when the connection port is coupled/engaged to the device.
13. The system of claim 12, wherein the securing mechanism at the distal end portion of the housing is selected from a thread, a ratchet teeth mechanism, and a clamping member and the securing mechanism at the proximal end portion of the connection port is selected from a complimentary thread and a complimentary a retention member.
14. The system of claim 1, wherein the proximal end portion of the housing of the device is further configured to engage/couple a container and the distal end portion of the connection port is further configured to engage/couple a container.
15. The system of claim 1, wherein the removable sealing member of the device and the removable sealing member of the connection port are both configured to be displaced from the fluid passageway via a pulling motion.
16. The system of claim 1, wherein at least one of the device and the connection port further having at least one of a sealing member and an O-ring.
17. The system of claim 1, wherein the securing mechanism of the device having teeth or holes/dents configured to provide the connection port to be moveable between an extended position and a contracted position when the connection port is engaged/coupled to the device.
18. The system of claim 17, wherein when the device is coupled to the connection port and when the securing mechanism of the device is in the extended position, an exterior surface of the second sealing member of the connection is not aligned with an interior surface of the housing, and wherein when the device is coupled to the connection port and the securing mechanism of the device is in the second contracted position, an exterior surface of the second sealing member of the connection port is aligned with an interior surface of the housing of the device.
19. The system of claim 18, wherein when the exterior surface of the second sealing member of the connection port is aligned with an interior surface of the housing, the wiping member is able to wipe off the exterior surface of the second sealing member of the connection port when the wiping member moves across the housing.
20. The system of claim 1, wherein the device further comprising a first sealing member and wherein the connection port further comprising a second sealing member, wherein both the first and second sealing members are positioned to be wiped off by the wiping member when the wiping member moves across the housing and when the connection port is coupled to the device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[2293] 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.
[2294] In the drawings:
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DETAILED DESCRIPTION OF THE INVENTION
[2310] 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 decontamination devices for ease of description and understanding. However, the invention is not limited to the specifically described products and methods and may be adapted to various applications without departing from the overall scope of the invention. All ranges disclosed herein include the endpoints. The use of the term or shall be construed to mean and/or unless the specific context indicates otherwise.
[2311] The system, device, and corresponding method disclosed herein allow a user (e.g., a pharmacist, nurse, doctor or other healthcare provider) to intermix at least two substances while maintaining sterility of vessel surfaces and sterility of a fluid passageway between the vessels while preventing unwanted release of the substance into the environment.
[2312] The type, size, shape, and material of the devices and connection ports are not critical features of the invention. Nor are the containers' contents. The invention is appropriate for all types of contents//medicaments/beneficial substances that require sterility of the contents/medicaments/beneficial substances be preserved. As described more fully below, the containers, devices, housings, and connection ports should have structures and/or features that allow for the sterile engagement between a device and a connection port to provide an airtight and decontaminated/sterile fluid communication/passageway between the device and the connection port.
[2313] The present invention relates to devices, methods and systems allowing an engagement of medical containers, devices, and connection ports in a sterile manner. In one embodiment, the present invention provides removable sealing members, that may be coupled to, or integrally formed with a container, a decontamination device, a device having a wiping member, and/or other vessels (such as vials, syringes, filters, infusion lines, etc.). The invention provides a solution to an unmet and long felt need in the medical setting and allows connecting in a sterile manner a device and connection port. The herein disclosed containers, devices, connection ports, systems, and methods are user friendly, cost effective and abolish the need for complicated and expensive known methods for transferring medical substances in a sterile manner. In an embodiment of the invention, the herein disclosed devices, connection ports, and systems are disposable. In an embodiment of the invention, the herein disclosed devices, connection ports, and systems are non-disposable. In an embodiment of the invention, the herein disclosed devices and connection ports are intended for one-time use. In an embodiment of the invention, the herein disclosed devices and connection ports are intended to be reused.
[2314] In an aspect of the invention, the devices and systems include a first removable sealing member attached to a first vessel and a second removable sealing member attached to a second vessel. A removable sealing member may be connected to a decontamination device having a housing with a wiping member. The first and second removable sealing members are configured to allow an engagement therebetween the removable sealing members. When the removable sealing members engage each other, ambient air particles present at the vicinity thereof are entrapped within/between the engagement formed by the removable sealing members. The engagement between the removable sealing members further establishes an airtight engagement of the vessels. The removable sealing members are further configured to externally displace from the vessels, thereby allowing fluid flow between the vessels and contaminants-free connection of the vessels. In one or more embodiments, either or both of the vessels are container(s). The containers may be a bag, a bottle, a vial and/or a syringe. In one or more embodiments the vessel may be a filter, an infusion line, or any other medicinal/medical device that stores, holds, or transfers beneficial substances/fluids.
[2315] The invention further provides a decontamination device having a housing with a wiping member operable to wipe off a surface of a vessel and decontaminate thereof. The decontamination devices may include a first removable sealing member and may be connected to a first vessel, allowing an engagement with a second vessel via a second removable sealing member. Once engaged, the removable sealing members may be pulled out by a user, maintaining a hermetically sealed connection between the vessels and via the housing of the decontamination device. The wiping member may be further actuated to wipe off a surface of the second vessel and of the housing, rendering a decontaminated fluid passageway between two vessels.
[2316] Accordingly, the herein disclosed invention allows transferring medical substances in a contaminants-free, or in a substantially contaminants-free manner. In one or more embodiments, the herein disclosed invention allows connecting vessels in a contaminants-free, or in a substantially contaminants-free manner.
[2317] In one or more embodiments, the herein disclosed invention provides a fluidic passageway or communication between medical containers in a contaminants-free, or in a substantially contaminants-free manner.
[2318] In one or more embodiments, the herein disclosed invention affords to isolate and/or entrap ambient air particles present between two, or more, vessels. In one or more embodiments, the herein disclosed invention, allows to substantially decrease the chances to introduce a contamination within a medical substance, when preparing or administering medical substances.
[2319] In one or more embodiments, the herein disclosed invention affords to isolate and/or entrap ambient air particles present between a device having a wiping member disposed inside the device and a connection port. In one or more embodiments, the device may be attached to a vessel such as a container, a bag, a bottle, a vial, a syringe, and the alike and the connection port may be attached to a vessel such as a container, a bag, a bottle, a vial, a syringe, and the a like. In one or more embodiments, the herein disclosed invention, allows to substantially decrease the chances to introduce contamination within a medical substance (such as a medicament, diluent), when preparing, or transferring, or administering medical/medicinal substances. In one or more embodiments, the herein disclosed invention allows the sterile fluid transfer of a beneficial substance between a device and a connection port.
[2320] As used herein, the term substances refers to various types of materials that should be kept sterile. The substances may be liquid, solid, semi-solid, or gas. In one or more embodiments, the substances are medical substances. As used herein the term medical substances refers to and encompasses any of the various medical drugs, fluids, nutritional products, solid powders, injectable medicaments, suspensions, liquids solutions and the like.
[2321] As used herein, the term contaminant-free is interchangeable with the term sterile, disinfected, and decontaminated. The term refers to substances that are free or substantially free of ambient air particles and/or pathogens, including but not limited to dirt, bacteria, viruses, funguses, spores, and/or pyrogens. Typically, when less or no air is introduced within medical substances, the chances of contamination by pathogens, such as, bacteria, viruses, funguses, spores, pyrogens or the alike is completely abolished or significantly reduced.
[2322] As used herein, substantially contaminants-free means significantly less ambient air present when transferring medical substances with the herein disclosed vessels and systems, as compared to comparable conditions for transferring medical substances without the herein disclosed vessels and systems.
[2323] As used herein, the term ambient air particles is interchangeable with the term environmental air particles and refers to air particles present in a non-filtered or filtered environment. For example, air can be purified by filters, such as a High Efficiency Particulate Air (HEPA) filter.
[2324] As used herein, the term fluidly seal and/or fluidly sealing is interchangeable with the term substantially fluidly seal and/or substantially fluidly sealing and refers to the sealing of an opening of a housing of a device and/or sealing an opening of a connection port in a manner that prevents a fluid from entering, exiting, and/or entering and exiting the interior of the housing of the device and/or the interior of the connection port. In one example, fluidly sealing and/or the term substantially fluidly sealing means covering an entire opening of a device thus preventing entry and/or exit of ambient air particles/contaminants into and/or out of the interior of the device. The device may have a wiping member disposed inside the device. In another example, fluidly sealing and/or the term substantially fluidly sealing means covering an entire opening of a connection port thus preventing entry and/or exit of ambient air particles/contaminants into and/or out of the connection port. In still another example, the term fluidly seal, fluidly sealing, substantially fluidly seal, and/or substantially fluidly sealing refers to hermetically/airtight sealing an opening of a device and/or hermetically/airtight sealing an opening of a connection port.
[2325] As used herein, the term removable sealing member is used interchangeably with the term connection interface and encompasses any surface, layer plane or the alike that can be attached to a vessel/device/connection port and removed from a vessel/device/connection port. The term may encompass a structure that can be coupled to a vessel/device/connection port and that can engage with a complementary connection interface/removable sealing member. As used herein, the term removable sealing member is meant to mean connection interface. As used herein, the term connection interface is meant to mean removable sealing member. In an embodiment of the invention, the connection interface/removable sealing member may seal or cover an aperture of a vessel. In an embodiment of the invention, the connection interface may seal or cover an opening for fluid passageway of a vessel or a device or a connection port. In an embodiment of the invention, the connection interface may be a surface of a container. In an embodiment of the invention, the connection interface may be a surface of a device. In an embodiment of the invention, the connection interface may be a surface of a vessel. In an embodiment of the invention, the connection interface/removable sealing member may cover another sealing member. In an embodiment of the invention, the connection interface abuts a container, a device, and/or a connection port. In an embodiment of the invention, the connection interface is surface mounted to a container, a device, and/or a connection port. In an embodiment of the invention, the connection interface is surface mounted to a wall of the container, a device, and/or a connection port. In an embodiment of the invention the connection interface is flush mounted to a container, a device, and/or a connection port.
[2326] In an embodiment of the invention, the connection interface abuts a device and/or a connection port. In an embodiment of the invention, the connection interface is surface mounted to a device and/or a connection port. In an embodiment of the invention, the connection interface is surface mounted to a wall of a device and/or a connection port. In an embodiment of the invention the connection interface is flush mounted to a device and/or a connection port.
[2327] In an embodiment of the invention, the connection interface abuts a vessel. In an embodiment of the invention, the connection interface is surface mounted to a vessel. In an embodiment of the invention, the connection interface is surface mounted to a wall of a vessel. In an embodiment of the invention the connection interface is flush mounted to a vessel. In an embodiment of the invention, the connection interface is flush mounted to a wall of a vessel.
[2328] In an embodiment of the invention, the present invention discloses a system comprising a removable sealing member attached to a device, the device having a wiping member disposed inside the device and the wiping member configured to move across the device, and a second removable sealing member attached to a connection port. The first removable sealing member and the second removable sealing member may be similar or may be different in size and/or shape. In one or more embodiments, the removable sealing member of the device and the removable sealing member of the connection port may be about the same size/surface area/dimensions. The exterior surface area of the removable sealing member faces ambient air particles/contaminants. In one or more embodiments, the exterior surface area facing ambient air, of the removable sealing members 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.
[2329] In an embodiment of the invention, the first removable sealing member of the device and the second removable sealing member of the connection port when engaged with each other (together) entrap ambient air particles therebetween. In an embodiment of the invention, the first removable sealing member of the device and the second removable sealing member of the connection port when engaged with each other externally displace from the device and the connection port. In one or more embodiments, the term externally displace means displacing from either or both the device and the connection port.
[2330] In one or more embodiments, the removable sealing member(s) has a thin film layer. In an exemplary embodiment, the removable sealing member may present a thickness of about 1 mm or below/less. Alternatively, the removable sealing member may present a thickness of above 1 mm. The removable sealing member may be manufactured from various materials, including, an elastic polymer. The removable sealing member may be made from a plastic material. The removable sealing member may be a rubber or a polymer. The removable sealing member may be formed of a metal material (e.g., a metal alloy). In yet a further exemplary embodiment, the removable sealing member may preset the form of a thin film made of an aluminum foil, cling wrap, or the alike. The metal alloy may include, for example, aluminum. In yet a further exemplary embodiment, the removable sealing member may preset the form of a thin film made of an aluminum foil, or the alike. In one or more embodiments, the removable sealing member is attached to, or is integrally formed with a device, a connection port, a container, and/or a vessel. In one or more embodiments, the removable sealing member is peelable from the vessels. In one or more embodiments, the peelable removable sealing member is attached to a vessel via an adhesive. In one or more embodiments, the peelable removable sealing member may be detached from a vessel surface by the force of a user's hand. In one or more embodiments, the removable sealing member is movable or slidable along a rail located along a length of the aperture of a vessel. In one or more embodiments, the first and second removable sealing members may be attached to or engage each other via various mechanisms. For example, the removable sealing members may be engaged via an engagement mechanism, such as a thread, a luer, an adhesive, a mechanical object, a dent and a ratchet teeth mechanism. In one or more embodiments, the removable sealing member may be covered by a cover (not shown). In one or more embodiments, the cover may be a peelable cover. In one or more embodiments, a sterilizing or disinfecting substance may be located between the removable sealing member and the cover. In one or more embodiments, the sterilizing or disinfecting substance may be an alcohol. In one or more embodiments, the alcohol may be 70% isopropyl alcohol.
[2331] The removable sealing member may be coupled within any portion of the device and/or connection port. For example, the removable sealing member may be connected onto the device's body or aperture, the device's wall or port thereof. In another example, the removable sealing member may be connection onto the connection port's body or aperture, the connection port's wall or port thereof. The removable sealing member may be attached/coupled to an exterior surface of the device or connection port, to an interior surface of the device or connection port, and/or to both an exterior and interior surface of the device or connection port. In one or more embodiments, the removable sealing member of the device and/or connection port may be configured in a folded position that facilitates the peeling off of the removable sealing member from the device and/or the connection port.
[2332] In one or more embodiments, the first removable sealing member and the second removable sealing member are configured to prevent contaminants from entering the fluid passageway between a device and a connection port. In one or more embodiments, the first removable sealing member attached to the device and the second removable sealing member attached to the connection port are configured to prevent contaminants from entering the interior of the device, the interior of the housing of the device, and/or the interior of the connection port. In one or more embodiments, the first removable sealing member and the second removable sealing member are configured to prevent contaminants from entering a fluid housed inside a vessel's body, wherein the vessel is connected/attached to either or both the proximal end of the device and/or the distal end of the connection port.
[2333] In one or more embodiments, a first removable sealing member and is configured to prevent contaminants from contacting an internal compartment of the device, the inside/interior of the housing, and/or the interior of the first vessel attached to the proximal end portion of the device. In one or more embodiments, a second removable sealing member is configured to prevent contaminants from contacting an internal compartment of the connection port, the inside/interior of a second vessel attached to the distal end portion of the connection port.
[2334] As used herein the term external displacement refers to a displacement (i.e., dislocation) of the herein disclosed first and/or second, and/or any additional removable sealing member/connection interfaces. In an embodiment of the invention, the displacement is external, namely, outside the device and/or connection port and/or container(s) and/or vessels being connected by the herein disclosed system. In an embodiment of the invention, the displacement is external to the fluid communication established following engagement of the device with the connection port being connected by the herein disclosed system, methods, devices, and connection ports. In an embodiment of the invention, the displacement maintains a hermetic seal between the device and the connection port. In an embodiment of the invention, the external displacement maintains an airtight seal between the housing of the device and the connection port. The displacement may occur via a sliding motion, or by a pulling out motion, or by peeling the removable sealing members. In an embodiment of the invention, the displacement occurs for both the removable sealing member of the housing of the device and the removable sealing member of the connection port. The external displacement may optionally occur simultaneously for both removable sealing members or may at about the same time for both the removable sealing members. In an embodiment of the invention, the external displacement establishes a fluid passageway between two or more vessels. In one or more embodiments, the removable sealing member is configured to hermetically seal an aperture present in a housing of the device. In one or more embodiments, the removable sealing member is configured to hermetically seal an aperture present in a connection port. In one or more embodiments, the removable sealing member is configured to cover a second sealing member of the connection port. In one or more embodiments, the removable sealing member of the connection port is configured to hermetically seal the second sealing member of the connection port within the connection port. In one or more embodiments, at about the time of external displacement of the removable sealing members, the aperture through which the removable sealing members pass through reseals, allowing a hermetic airtight connection between the housing of the device and the connection port. In one or more embodiments, after external displacment of the removable sealing members, the aperture through which the removable sealing members pass through reseals, allowing a hermetic airtight connection between the device and the connection port. In one or more embodiments, the aperture through which the removable sealing members pass through reseals prior to detachment of the removable sealing members from the housing of the device and the connection port.
[2335] As used herein the term vessel refers to any device utilized for containing, housing or transferring substances as herein disclosed. In one or more embodiments, the vessel may be used for containing medical substances. In an embodiment of the invention, the vessel is a medical vessel. In an embodiment of the invention, the vessel is a medical device. In an embodiment of the invention, the vessels are used for, and adapted to allow connection to another vessel(s). In an embodiment of the invention, the vessel may be a medical container utilized for accommodating medical substances. Various types of medical containers are contemplated. The medical container may be selected, without limitation, from a vial, a bag, a chamber, a housing, a bottle, and the alike. In an embodiment of the invention, the term vessel further encompasses 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 port, a syringe, an infusion line, a tubing, a syringe, a filter, a spike, a port and a manifold. In an embodiment of the invention, one or more connection interfaces (for example, two or more, three or more, etc.) may be coupled to a first vessel and each of those connection interfaces may be coupled and engage with a one or more connection interfaces present on a one or more vessels. In one or more embodiments, the vessel may be a container, a bag, a bottle, a connector, an infusion line or a syringe having a plurality of externally displaceable connection interfaces. In one or more embodiments, the vessels to be engaged may have similar surface area or similar contact surface area (i.e., surface onto which the connection interface is coupled to). For example, a first vessel and a second vessel may have similar surface area or similar contact surface area. In one or more embodiments, the vessels to be engaged may have different surface area or different contact surface area. For example, a first removable sealing member attached to a first vessel may have a greater surface area or contact surface area than a second removable sealing member attached to a second vessel. As used herein the term fluid communication is used interchangeably with the term fluidic passageway and refers to a device and a connection port in which substances may pass therethrough either directly or indirectly. The fluid communication may occur via a fluid passageway through the device and the connection port that allows for the flow/transfer of a medical substance from the device to the connection port, flow/transfer of a medical substance from the connection port to the device, and/or flow/transfer of a medical substance between the connection port and the device.
[2336] As used herein, the term guiding member may be any type of mechanical object that guides either or both a connection port and a device to engage/couple each other (one another) in a manner in which a removable sealing member of the connection port aligns with the removable sealing member of the device so that the removable sealing member of the connection port lies against, optionally lies flat against, the removable sealing member of the device. The guiding member further aligns in the same direction at least one of the removable sealing member of the device and the removable sealing member of the connection port so that the tabs, optionally the portion of the removable sealing member(s) that a user pulls, will remove both removable sealing members (of the device and the connection port) at about the same time, optionally at the same time. The guiding member is characterized in that it directs an engagement between a device and a connection port in a manner that aligns the removable sealing member of the device with the removable sealing member of the connection port with the purpose of facilitating at about the same time, optionally at the same time, the external displacement of both the removable sealing member of the device and the removable sealing member of the connection port. The size, shape, and configuration of the guiding member and corresponding engagement member that engages/couples the guiding member is not important. The focus is the alignment of removable sealing members wherein the tabs are positioned in about the same direction, optionally in the same direction, that facilitates concurrent displacement of two removable sealing member from a first sealed position to a second unsealed position. The guiding member in one example may be a rod that engages/couples a complimentary hole/aperture in a on a device or connection port. Conversely, the guiding member may be a hole/aperture that engages/couples a complimentary rod. Either or both a device and a connection port may have the guiding member or complimentary engagement/coupling mechanism. The guiding member may be located on a device, on a device having a removable sealing member, on a device having a removable sealing member and a wiping member, on a connection port, on a vessel attached to any of said devices, on a container, on a container attached to any of said device, on a container attached to the connection port, and combinations thereof. The guiding member may have any type of geometric shape that will engage/couple a complimentary geometric shape of an engagement/coupling member configured to engage/couple the guiding member. The guiding member may be a thread, a luer-lock, a luer, a snap-on mechanism, a slide-on mechanism, etc. A complimentary engagement mechanism is provided to engage/couple the guiding member. In one example, the guiding member is located on an exterior of a device and the complimentary engagement mechanism is located on a connection port. In another example, the guiding member is located on an exterior of a connection port and the complimentary engagement mechanism is located on the device. In another example, both a device and a connection port may both have guiding members configured to couple a complimentary engagement/coupling member located on both the device and the connection port.
[2337] In an aspect of the invention, a container is provided having an external displacement mechanism and an internal displacement mechanism. The external displacement mechanism being a removable sealing member configured to be displaced form a first sealed position to a second unsealed position and a plug/stopper/bung configured to displace into the interior of the container or configured to displace to an exterior of the container.
[2338] In a further aspect of the invention, a system is provided comprising a first container and a second container. The first container is provided having an external displacement mechanism in the form of a removable sealing member configured to be displaced to a second unsealed position (displaced external to the fluid passageway that is formed between the first and second containers), the first container also having a displaceable plug/bung/stopper with an engagement mechanism, the engagement mechanism configured to engage/couple a second engagement mechanism of a displaceable plug/bung/stopper of a second container; and a second container configured to engage the first container, the second container having an external displacement mechanism in the form of a removable sealing member configured to be displaced to a second unsealed position (displaced external to the fluid passageway that is formed between the first and second container), the second container also having a displaceable plug/bung/stopper with an engagement mechanism configured to engage/couple with the displaceable plug/bung/stopper of the first container, wherein when the first container engages/couples with the second container, the removable sealing members of both the first and second containers are displaced from a first sealed position to a second unsealed position and the displaceable plugs of both the first and second containers engage/couple with each other and displace into the interior of the first container or into the interior of the second container. In accordance with this embodiment, the displacement of both removable sealing members to a second unsealed position decontaminates the connection between the first and second containers after which the displaceable plugs/bungs/stopper of the first and second container engage with each other and displace internally into either the first or second container thus establishing a decontaminated and sterile fluidic passageway between the first and second containers. The first container can be a bag, bottle, vial, etc. The second container can be a bag, bottle, vial, etc. The first container can be a bag and the second container can be a bottle/vial.
[2339] In an aspect of the invention, the devices and systems of the invention include a housing having a side wall, a top wall and a bottom wall, and a wiping member disposed within the housing. In an embodiment of the invention, the top wall and/or bottom wall of the housing have at least one opening(s) for receiving the vessels. The opening(s) may be formed by vertical walls extending from the top and/or bottom walls, forming an inner channel via which medical substances may be transferred following engagement between, and decontamination of the vessel surfaces. In one or more embodiments, the openings have non-vertical walls. In one or more embodiments, the openings may be flush mounted to the housing. In one or more embodiments, the openings may be surface mounted to the housing. In one or more embodiments, the openings may be concealed within at least a portion of the housing. In one or more embodiments, the openings may be concealed within the housing.
[2340] In an embodiment of the invention, the wiping member is operable to move across and wipe off any contaminates present on the one or more surfaces of the vessels via an actuator extending through an opening of the housing. In an embodiments of the invention, the wiping member is operable to move across the housing of the device and wipe off contaminants present on one or more surfaces of the interior of the housing of the device and/or a surface of a connection port which is attached/coupled to the housing of the device. The actuator is configured to manipulate movement of the wiping member across the housing. In one or more embodiments, the wiping member is operable to move across and wipe off any contaminants present on the one or more surfaces of the housing and the connection port via an actuator extending through an opening in a wall of the housing. The actuator may extend through a side wall of the housing, through a top wall of the housing, and/or through a bottom wall of the housing. In one or more embodiments, the actuator may extend through a top or bottom wall of the housing. In one or more embodiments, the wiping member is operable to move within the housing to wipe off any contaminants present on the one or more surfaces of the vessels. In one or more embodiments, the wiping member quarantines any contaminants on one side/end of the housing of the device thus providing a decontaminated and/or sterile fluid passageway within the housing of the device.
[2341] Various types of actuators are contemplated for allowing manipulation of the wiping member to decontaminate a surface of a housing, connection port, and/or a vessel. In one or more embodiments, the actuator is connected to the wiping member and extends externally via an opening within the housing. Exemplary actuators include, without limitation, a handle, a tab, a button, a touch button, a lever, a gear, a spring, a mechanical actuator, an electric actuator, an air pressure actuator, and combinations thereof. In one or more embodiments, the wiping member is operable to move across and wipe off any contaminates present on the one or more surfaces of the housing, of the connection port, and/or of the vessels without any actuator for mediating the wiping action. In accordance with this embodiment, a user may, for example, apply force onto the housing to thereby forcibly manipulate the wiping member to slide across the housing. In accordance with this embodiment, the housing may be flexible, so the user can manipulate the wiping member from the outside and by applying for example press forces onto the housing. In one or more embodiments, the wiping member is moveable from an initial position which precedes the wiping action to an end position which follows the wiping action of the wiping member. In one or more embodiments, the movement of the wiping member between the positions is reversible. In one or more embodiments, the movement of the wiping member between the positions is non-reversible and the wiping member is prevented from returning to the initial position. In one or more embodiments, a locking member may be disposed in or on the housing to prevent the wiping member to return to its initial position. In one or more embodiments, the locking member locks the wiping member in a second position after the wiping member has wiped off a surface of the housing and a surface of the connection port.
[2342] In an embodiment of the invention, the herein disclosed devices and systems are disposable. In an embodiment of the invention, the herein disclosed devices and systems are non-disposable. In an embodiment of the invention, the herein disclosed devices and/or systems are intended for single use.
[2343] In one or more embodiments, the wiping member is manufactured from or comprises a material including, but not limited to an elastic material, a rigid material, a flexible material, an expandable material, a polymer, and combinations thereof. In one or more embodiments, the wiping member is manufactured from or comprises an elastomeric material, such as, but not limited to a rubber material. In one or more embodiments, the wiping member is manufactured from or comprises a sponge or a sponge-like material. In one or more embodiments, the wiping member slides across the surface of the one or more vessel(s) under great friction, or under a friction sufficient to wipe off any contaminants from the surface, such as dirt or bacteria.
[2344] In one or more embodiments, the wiping member is covered, at least partially, by a sterilizing substance. As used herein the term sterilizing substance encompasses any substance that can eliminate or reduce the presence of microorganisms, air particles, or any of the alike. In one embodiment, the term sterilizing substance is interchangeable with the term disinfecting substance. In one or more embodiments, the sterilizing substance may be, but is not limited to, an antibacterial substance, an antiviral substance (e.g., an anti-HIV agent), an anti-tuberculin substance, an anti-fungal, and combinations thereof. In one or more embodiments, the sterilizing substance may be a bactericidal substance, a virucidal substance, and/or a fungicidal substance. Exemplary sterilizing substances include, without limitation, alcohol, isopropyl alcohol, and hydrogen peroxide. In one or more embodiments, the sterilizing or disinfecting substance may be a fluid or a liquid. In one or more embodiments, the sterilizing or disinfecting substance may be a gas. In one or more embodiments, the gas may be a pressurized gas. In one or more embodiments, the sterilizing substance may be housed within the housing of the decontamination device. In one or more embodiments, at least one of the openings of the decontamination device are sealed and/or covered by a removable sealing member thus preventing the sterilizing substance from escaping from inside the housing of the decontamination device. The seals and/or covers and/or removable sealing members maintain the sterility of the decontamination device until about the time of use of the decontamination device.
[2345] In one or more embodiments, the sterilizing substance is sodium hypochlorite. In one or more embodiments, the concentration of sodium hypochlorite is 0.55% or higher. In one or more embodiments, the concentration of sodium hypochlorite is below 0.55% concentration.
[2346] In one or more embodiments, the housing may be manufactured from various materials. Optionally, the housing is manufactured from an inert material, thus suitable for various types of pharmaceutical substances. The housing may be made from flexible or from rigid materials. Suitable materials include, without limitation a plastic, a glass, a rigid plastic, a flexible plastic, and combinations thereof. In one or more embodiments, the housing may be transparent. In one or more embodiments, the housing may be opaque.
[2347] In one or more embodiments, the housing may be a closed chamber which forms a tight, optionally, airtight connection between the vessels. In one or more embodiments, when the openings of the housing are connected to vessels or connection ports, or when the openings are covered by a cover or a seal or a removable sealing member, the housing may form an interior which is hermetically sealed/isolated from surrounding/environmental air. In one or more embodiments, the cover or the seal or the removable 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.
[2348] In one or more embodiments, the housing may optionally include one or more apertures, optionally covered by a filter, to thereby allow releasing air from the housing when actuating the wiping member. Optionally, the one or more apertures may be covered by a valve, to thereby allow releasing of air or pressure from within the housing when actuating the wiping member. In one or more embodiments, the valve may be a one-way valve, thereby allowing the release of air or pressure from within the housing when actuating the wiping member while preventing ambient or environmental air from entering the housing. In one or more embodiments, the filter or valve may be located in or on a wall of the housing's first, second or third compartment.
[2349] In one or more embodiments, the system or devices of the invention is provided when the housing of the device is already connected via the proximal end of the device to one or more medical vessels. In accordance with this embodiment, the one or more medical vessels may be integrally manufactured or assembled with the proximal end portion of housing and provided or distributed to consumers as such. In accordance with this embodiment, the system may be configured to allow a connection to additional one or more vessels. In one or more embodiments, the proximal end portion of the housing of the decontamination device with a wiper disposed inside the housing abuts a wall of a container. In one or more embodiments, the proximal end portion of the housing of the decontamination device with a wiper disposed inside the housing is flush mounted to a wall of a container. In one or more embodiments, the proximal end portion of the housing of the decontamination device with a wiper disposed inside the housing is surface mounted to a wall 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 vial. In one or more embodiments, the vessel is a syringe. Alternatively, the device and/or system of the invention is provided without any attachment to a vessel. Alternatively, the device and/or system of the invention is provided without any attachment to a vessel and is configured to connect a plurality of vessels and decontaminate thereof.
[2350] In one or more embodiments, the housing of the device has an engagement mechanism configured or adapted to connect the at least one vessel and/or connection port to the housing. 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 an embodiment of the invention, the engagement mechanism positions the surface of the second sealing member of the connection port at about same level as an interior wall of the housing of the device. In an embodiment of the invention, the engagement mechanism positions an exterior surface of the second sealing member of the connection port at the same level as an interior wall of a housing of the device. In an embodiment of the invention, the engagement mechanism positions the surface of the second sealing member of the connection port in a manner that protrudes into the housing of the device. In an embodiment of the invention, the protruding of the surface of the second sealing member connection port is a slight/minor protruding. In an embodiment of the invention, the protruding of the surface of the second sealing member of the connection port is less than one-eighth of an inch. In an embodiment of the invention, the engagement mechanism positions the surface of the second sealing member of the connection port in a manner that is below an inner surface of the housing. In an embodiment of the invention, the positioning of the surface of the second sealing member of the connection port ranges from less than one tenth of an inch to less than a half an inch from the inner surface of the housing. In an embodiment of the invention, the engagement mechanism positions the surface of the second sealing member of the connection port slightly below an inner wall/surface of the housing while allowing the wiping member of the device to wipe off the entire surface of the second sealing member of the connection port. Optionally, or alternately, the engagement mechanism may be configured or adapted to connect at least one opening of the housing of the housing of the device to a connection port In one or more embodiments, the connection port may be configured to couple/engage with an opening of the housing of the decontamination device. In one or more embodiments, the herein disclosed invention allows transferring medical substances in a contaminant-free, or in a substantially contaminant-free manner.
[2351] The herein systems and connectors may include one or more valves that restrict fluid flow or passageway. For example, one or more valves may be located at the opening of one or more vessels, at one or more openings of the housing of the device, and/or at one or more openings of the connection port. In a further exemplary embodiment one or more valves may be disposed at the aperture(s) of the vessels or at a location within a connection port or within a housing of the device. In one or more embodiments, the valve may be located at a proximal end portion of a device having a wiping member disposed inside the device and removable sealing member attached to a distal end portion of the device. In one or more embodiments, the valve may be located at a distal end portion of a device having a wiping member disposed inside the device and a removable sealing member attached to a distal end portion of the device. In one or more embodiments, the valve may be a one-way valve. In one or more embodiments, the one-way valve may be configured to allow a fluid to flow through the valve in one direction. In one or more embodiments, the one-way valve may allow fluid to flow from a proximal end portion of the device to a distal end portion of the device. In one or more embodiments, the one-way valve may allow fluid to flow from the distal end portion of the device to the proximal end portion of the device. In one or more embodiments, the connection port may have a one-way valve disposed inside the connection port, on the connection port, and/or over an opening/aperture of a/the connection port. In one or more embodiments, the valves are generally provided to seal and prevent fluid flow prior to any engagement of the housing of the device to the connection port and/or external displacement of connection interfaces. In an exemplary embodiment, when valves are provided to seal an aperture that provides for the external displacement of removable sealing members, the valves may establish resealing of the apertures at about the time, at the time, or following the external displacement of the removable sealing members, preventing any leakage of fluids from the engagement between the vessels. In certain embodiments, the resealing occurs at about the time or prior to the external displacement. In certain embodiments, the valves that provide for the passage and external displacement of the removable sealing members may be made of a rubber material, an elastomeric material, a plastic material, and combinations thereof. In an embodiment of the invention, the valve or aperture providing for the passage and external displacement of at least one or two removable sealing members maintains a hermetic seal between the device and the connection port by a force of the engagement between the distal end portion of the housing of the device and the proximal end portion of the connection port. In some embodiments the force of engagement that maintains the hermetic seal between the housing of the device and the connection port during the external displacement of the removable sealing members is provided by an engagement mechanism selected from a thread, a luer, a ratchet teeth mechanism, a snap-on mechanism, and combinations thereof. In certain embodiments, the aperture, sealed aperture, or valve providing for the passage and external displacement of at least one or at least two removable sealing members reseals prior to the removable sealing members fully displacing from the device and connection port. In some embodiments, the displacement of the removable sealing members occurs in the space between two ratchet teeth. In certain embodiments, the displacement of the removable sealing members occurs between threads of a thread/luer engagement mechanism. In certain embodiments, the valves may prevent backflow of fluids. In some embodiments, the valves may be one-way valves.
[2352] In an embodiment of the invention, the herein disclosed devices, systems and methods allow fluid communication in contaminant-free, or substantially contaminant-free manner. For example, between three or more, four or more, five or more or six or more vessels. In an embodiment of the invention, the herein disclosed devices, systems and methods allow fluid communication between three, four, five, six, or seven vessels. For example, the devices, systems, and methods of the invention allow fluid communication between two containers, between two bags, between a syringe and a bag, between a connector and a bag, between a vial and a bag, between a vial and a bottle, between a syringe and a vial or between a syringe and a connector.
[2353] A further purpose of this invention is to provide a device having a removable sealing member and a wiping member. Still a further purpose of this invention is to provide a system comprising a device having a wiping member and a removable sealing member, and a connection port having a removable sealing member, the device configured to engage/couple the connection port and the connection port configured to engage/couple the device thus providing a system that reduces the presence of non-purified air and/or air particles. This invention focuses on removable sealing members and wiping members that serve a decontamination/sterility function which substantially reduces of contaminants and ambient air particles and/or provides entirely contaminant-free and sterile engagement and/or fluid passageway between said device and said connection port. This invention focuses on a device, system, and method having a dual mechanism of action the first mechanism of action being external displacement of a removable sealing member from the device and the second mechanism of action being wiping off by the wiping member one or more surfaces of the device and optionally a connection port.
[2354] Referring now to the drawings,
[2355]
[2356] Decontamination system 100 may further comprise a tab 109 positioned on a longitudinal end of first removable sealing member 101 of device 120, and a tab 110 positioned on a longitudinal end of second removable sealing member 102 of connection port 141. Tabs 109 and 110 are configured to be pulled out axially by a user, the axial pulling of the tabs 109 and 110 is configured to allow for a displacement of the removable sealing members 101 and 102 external to device 120 and external to connection port 141.
[2357] It is important to note that the interior 121 of housing 140 is the location of a fluid passageway of housing 140 and the interior 117 of connection port 141 is the location of a fluid passageway of connection port 141. Therefore, the fluidic passageway between housing 140 and connection port 141 is represented by either or both elements 121 and 117.
[2358] Reference is now made to
[2359]
[2360]
[2361]
[2362]
[2363]
[2364]
[2365]
[2366]
[2367]
[2368]
[2369]
[2370]
[2371]
[2372]
[2373]
[2374]
[2375]
[2376] In accordance with said embodiments wherein first sealing member 1111 and/or second sealing member 1198 are (internally) displaceable plugs, housing 1199 will engage/couple with connection port 1197, then removable sealing members 1101 and 1102 will displace external to housing 1199 and connection port 1197, and then either or both first sealing member 1111 and second sealing member 1198 will displace internally into the interior 1150 of housing 1199 or into the interior 1130 of connection port 1197.
[2377] In another embodiment wherein first sealing member 1111 and/or second sealing member 1198 are (internally) displaceable plugs, housing 1199 will engage/couple with connection port 1197, then removable sealing members 1101 and 1102 will displace external to housing 1199 and connection port 1197, then wiping member 1105 will move across housing 1199 via actuation of actuator handle/rod 1106 thus wiping off any residual contaminants from a surface of first sealing member 1111 and second sealing member 1198, and then either or both first sealing member 1111 and second sealing member 1198 will displace internally into the interior 1150 of housing 1199 or into the interior 1130 of connection port 1197.
[2378]
[2379]
[2380]
[2381]
[2382] In one or more embodiments, at least one of the first and second vessels 1504 and 1503 is a container. In one or more embodiments, the containers 1503 and 1502 may be a bag or a bottle. In one or more embodiments, at least one of the first and second vessels 1504 and 1503 may be a syringe. In one or more embodiments, the container 1504 and/or 1503 has a flexible wall.
[2383] 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.
[2384] Each of the phrases consisting of and consists of, as used herein, means including and limited to.
[2385] 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.
[2386] 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.
[2387] 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.
[2388] 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.
[2389] 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.
[2390] 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.
[2391] 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.