SYSTEMS, DEVICES AND METHODS FOR DECONTAMINATING SURFACES OF PHARMACEUTICAL VESSELS AND PHARMACEUTICAL ADMINISTRATION DEVICES
20190076563 ยท 2019-03-14
Inventors
Cpc classification
A61L2/23
HUMAN NECESSITIES
A61J1/20
HUMAN NECESSITIES
A61J1/1443
HUMAN NECESSITIES
A61J1/2096
HUMAN NECESSITIES
A61L2202/21
HUMAN NECESSITIES
International classification
Abstract
The present invention relates, in some embodiments thereof, to systems, devices and methods for decontaminating a surface of one or more vessels. In some embodiments, the systems and devices of the invention include a housing, and a wiping member disposed within the housing being configured to wipe off the surface of one or more vessels and at least one safety mechanisms, thereby establishing a contaminant-free fluid passageway between vessels.
Claims
1. A device for the decontamination of a surface of a vessel, comprising: a housing having a top, a bottom, and a side; a wiping member disposed within the housing; and at least one safety mechanism.
2. The device of claim 1, further comprising a piercing member configured to pierce a surface of at least one vessel.
3. The device of claim 2, wherein the safety mechanism is a piercing member safety mechanism adapted to prevent premature piercing of a vessel's surface by the piercing member.
4. The device of claim 1, further comprising a rail mechanism configured to provide movement of a vessel surface between compartments of the device.
5. The device of claim 4, wherein the safety mechanism is a rail safety mechanism adapted to ensure sliding of a vessel along the rail, prevent premature sliding of the vessel on along the rail and/or secure the attachment of the vessel to the rail mechanism.
6. The device of claim 1, further comprising a resealing mechanism for resealing a vessel opening with a displaceable member, wherein the resealing occurs within a compartment of the device.
7. The device of claim 1, wherein the safety mechanism is a detachment safety mechanism configured to prevent premature detachment of a vessel from the device.
8. The device of claim 1, wherein the safety mechanism is a cap safety mechanism configured to prevent premature detachment of a displaceable member from the device.
9. The device of claim 1, wherein the safety mechanism is a retractable safety mechanism configured to provide for the one-directional movement of a vessel surface within the device.
10. The device of claim 1, wherein the safety mechanism is a locking member configured to prevent movement of a vessel surface from a secondary position to a previous position.
11. The device of claim 1, further comprising a hinge mechanism.
12. The device of claim 11, wherein the safety mechanism is a hinge safety mechanism configured to prevent premature rotation of a disc of the device.
13. The device of claim 1, further comprising a valve.
14. The device of claim 13, wherein the safety mechanism is a valve safety mechanism configured to prevent premature opening of the valve prior to correct positioning of a vessel surface within the device in a compartment where a fluidic passageway will be established.
15. A device for the decontamination of a surface of a vessel having at least one safety mechanisms.
16. The safety mechanisms of claim 15, wherein the safety mechanisms are selected from a piercing member safety mechanism, a detachment safety mechanism, a cap safety mechanism, a hinge safety mechanism, a rail safety mechanism, a valve safety mechanism and a retractable safety mechanism.
17. A connector for connecting two vessels, comprising: a first housing having a wiping member disposed within the housing and at least one safety mechanism; and a second housing having a wiping member disposed within the housing and at least one safety mechanism.
18. The connector of claim 17, wherein the at least one safety mechanism of the first housing is selected from a piercing member safety mechanism, a detachment safety mechanism, a cap safety mechanism, a hinge safety mechanism, a rail safety mechanism, a valve safety mechanism and a retractable safety mechanism.
19. The connector of claim 17, wherein the at least one safety mechanism of the first housing and at least one safety mechanism of the second housing is selected from a piercing member safety mechanism, a detachment safety mechanism, a cap safety mechanism, a hinge safety mechanism, a rail safety mechanism, a valve safety mechanism and a retractable safety mechanism.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0204] 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.
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[0245] 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
[0246] It is understood that the invention is not limited to the particular methodology, devices, items or products etc., described herein, as these may vary as the skilled artisan will recognize. It is also to be understood that the terminology used herein is used for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention. The following exemplary embodiments may be described in the context of exemplary medical devices for ease of description and understanding. However, the invention is not limited to the specifically described products and methods and may be adapted to various applications without departing from the overall scope of the invention. All ranges disclosed herein include the endpoints. The use of the term or shall be construed to mean and/or unless the specific context indicates otherwise.
[0247] The present invention relates to devices, methods and systems allowing an engagement of, and fluid passageway between vessels in a sterile or decontaminated manner. The present devices, methods and systems are particularly useful for medical purposes, wherein sterile preparations of medical substances are routinely required. In one embodiment, the present invention provides systems configured to allow a substantially decontaminated engagement between vessels. In one embodiment, the present invention provides systems configured to decontaminate one or more surfaces of at least one vessel. In one or more embodiments, the systems of the invention allow a substantially decontaminated fluid transfer between one or more vessels.
[0248] The invention provides a solution to an unmet and long felt need in medical settings and allows connecting in a sterile manner, two or more vessels. The herein disclosed devices and systems are user friendly, cost effective and abolish the need for complicated and expensive known methods for transferring and administering medical substances.
[0249] In an aspect of the invention there is provided a decontamination system for the engagement of medical vessels, the system comprising a first vessel, a second vessel, a sliding mechanism positioned on at least one of the first vessel and the second vessel and configured to allow traveling there along of at least one of the first vessel and the second vessel, such that at least one of the first vessel and the second vessel is configured to move from a first position to a second position; and [0250] a wiping member disposed on at least one of the first vessel and the second vessel, the wiping member is configured to remove contaminants from a surface of at least one of the first vessel and the second vessel at about the time of movement of the medical devices from the first position to the second position.
[0251] In one or more embodiments, the devices and systems of the invention include a housing having a side wall, a top wall and a bottom wall, and a wiping member disposed within the housing. In an embodiment of the invention, the top wall and/or bottom wall of the housing have at least one port with port openings for receiving the vessels. The ports and port openings may be formed by vertical walls extending from the top and/or bottom walls, forming an inner channel via which medical substances may be transferred following engagement between, and decontamination of the vessels. Optionally, the bottom wall of the housing includes a wall opening via which a medical vessel may engage with the housing.
[0252] In one or more embodiments, at least one of the first vessel and the second vessel is configured to engage with the housing and slide or move there along. A surface of the moveable vessel slides from a first position to a second position within the housing. The vessel may optionally move from a second position to a third position. In one or more embodiments, the movement of the vessel allows a hermetically sealed and essentially sterile engagement between a first vessel and a second vessel. The movement of the vessel is vertically, along a rail disposed within the housing and/or on top of the vessel. In one or more embodiments, the movement of at least one of the vessels from a first position to a second position allows a fluid communication between the first vessel and the second vessel. In one or more embodiments, the movement of the vessel is horizontally, along a rail disposed within or on the housing and/or on a surface of the vessel.
[0253] In one or more embodiments, the wiping member is manufactured from or comprises a material including, but not limited to an elastic material, a rigid material, a flexible material, an expandable material, an absorptive material or combinations thereof. In one or more embodiments, the wiping member is manufactured from or comprises an elastomeric material, such as, but not limited to a rubber material. In one or more embodiments, the wiping member is manufactured from or comprises a sponge or a sponge-like material.
[0254] In one or more embodiments, the medical vessel or medical vessel surface slides along the housing and passes through the wiping member under great friction, or under a friction sufficient to wipe off any contaminants from the surface of the vessel, such as dirt, bacteria or ambient air particles. In one or more embodiments, at least one locking member may be disposed in or on the housing to prevent the medical vessel from returning to its initial or to its previous position.
[0255] 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.
[0256] In one or more embodiments, one or more of the surfaces of the vessels is flat and/or smooth. The one or more surfaces may be substantially flat or partially flat or sufficiently flat, allowing efficient decontamination thereof by the wiping member.
[0257] In one or more embodiments, the wiping member is covered, at least partially by, or includes, a sterilizing substance. As used herein the term sterilizing substance encompasses any substance that can eliminate or reduce the presence of microorganisms, air particles, or any of the alike. In one embodiment, the term sterilizing substance is interchangeable with the term disinfecting substance. In one or more embodiments, the sterilizing substance is a liquid, a gas, or a semi-solid substance. In one or more embodiments, the sterilizing substance may be, but is not limited to, an antibacterial substance, an antiviral substance (e.g., an anti-HIV agent), an anti-tuberculin substance, an anti-fungal, and combinations thereof. In one or more embodiments, the sterilizing substance may be a bacteriostatic substance, a virustatic substance, a fungistatic substance, a bactericidal substance, a virucidal substance and/or a fungicidal substance. Exemplary sterilizing substances include, without limitation, alcohol, isopropyl alcohol, iodine, lugol's iodine solution and hydrogen peroxide. In one or more embodiments, the sterilizing substance is provided within the housing, optionally within separate compartments within the housing. In one or more embodiments, the sterilizing substance covers at least a portion of at least one wiping member.
[0258] In one or more embodiments, the housing may be manufactured from various materials. Optionally, the housing is manufactured from an inert material, thus suitable for various types of pharmaceutical substances. The housing may be made from flexible or from rigid materials. Suitable materials include, without limitation a plastic, a glass, a rigid plastic, a flexible plastic, rubber or combinations thereof.
[0259] Various sizes and shapes of the housing are applicable. For example, the housing may have an external most width, length, or height of less than about 100 millimeters (mm). For example, less than about 50 mm, less than about 25 mm, or less than about 10 mm. The housing internal most width may be less than about 9 mm. For example, the housing internal width may be less than about 5 mm, less than about 2.5 mm, or less than about 1 mm. The housing may include one or more compartments which may optionally be separated or divided or isolated by the wiping member or by any other means. In one or more embodiments, the housing includes two compartments, wherein a first compartment is configured to receive a vessel and may be contaminated or non-sterile and a second compartment that is kept sterile allows fluid transfer between two vessels. In one or more embodiments, the sterile compartment can receive a vessel following decontamination of the vessel's surface. In one or more embodiments, the housing includes two compartments wherein a first compartment is configured to receive a vessel and a second compartment is configured to allow fluid transfer between two or more vessels. Optionally, the housing includes three or more compartments. In an exemplary embodiment, the second compartment includes a resealing mechanism and allows resealing or recapping of a vessel. In an exemplary embodiment, the third compartment includes a resealing mechanism and allows resealing or recapping of a vessel. In an exemplary embodiment, the fourth compartment includes a resealing mechanism and allows resealing or recapping of a vessel. In an exemplary embodiment, the fifth compartment includes a resealing mechanism and allows resealing or recapping of a vessel. In an exemplary embodiment, the resealing mechanism disposed in a sterile environment and/or compartment within the housing, ensuring sterilized resealing for the vessel with a displaceable member. In an exemplary embodiment, the second compartment includes a sterilizing/disinfecting substance. Optionally, the housing includes five compartments. In an exemplary embodiment, the second compartment and fourth compartment include a sterilizing/disinfecting substance. The housing may or may not include a bottom wall. The housing may include a bottom wall which is partially open. Optionally, the housing includes a first compartment which is open at the bottom or which does not include bottom wall. Alternatively, or additionally the first and third compartments may be open at the bottom or may not include a bottom wall. Further optionally, the second compartment may include a bottom wall which may include an opening. Further optionally, all compartments are open at the bottom or may not include a bottom wall. In one or more embodiments, the housing has a plurality of compartments. In one or more embodiments, the housing may abut a wall of a container, may be flush mounted to a wall of a container, and/or be surface mounted to a wall of a container. In one or more embodiments, the container may be a bag, a bottle or a vial. In one or more embodiments, the housing may be integrally attached to the container. In one or more embodiments, the housing may form a unitary structure with the container. In one or more embodiments, the housing may be attached and/or integrally attached to a syringe. In one or more embodiments, the housing may form a unitary structure with the syringe. In one or more embodiments, the housing may be attached and/or integrally attached to an infusion line. In one or more embodiments, the housing may form a unitary structure with the infusion line. In one or more embodiments, the infusion line may be an intravenous line. In one or more embodiments, the infusion line may be an arterial line.
[0260] The vessel may move from a first position in which a vessel surface is located within the first compartment to a second position in which the vessel surface is located in the second compartment. Optionally, the housing includes a third compartment and the vessel surface is moveable from the second position to a third position. Optionally, the housing includes a fourth compartment or a fifth compartment and the vessel surface is moveable from a third position to a fourth position and/or a fifth position.
[0261] In one or more embodiments, the housing is conveniently light presenting a weight of no more than about 100 grams (gr). For example, less than about 50 gr, less than about 25 gr, less than about 15 gr, less than about 10 gr, or less than about 5 gr.
[0262] The hosing may be transparent allowing visualization of its interior, or opaque.
[0263] The housing may be a closed chamber which forms a tight, optionally, airtight connection between the vessels. The housing may be a partially closed chamber. In one or more embodiments, when the ports or openings are connected to vessels or when the ports are covered by a cover or a seal, the housing may form an interior which is hermetically sealed/isolated from surrounding/environmental air.
[0264] The housing may optionally include one or more aperture(s), optionally covered by a filter, to thereby allow releasing air from the housing when a medical vessel passes through the wiping member. In one or more embodiments, the filter may be a sterilizing filter. In one or more embodiments, the filter may have a porosity of 0.22 microns or less. In one or more embodiments, a plurality of compartments of the housing have a filter in a wall of the compartments. Optionally, the one or more aperture(s) may be covered by a valve, to thereby allow releasing air from the housing when a medical vessel passes through the wiping member. In one or more embodiments, the valve may be a one-way valve.
[0265] In one or more embodiments, the system of the invention is provided when the housing is already connected to one or more medical vessels. In accordance with this embodiment, the one or more medical vessels may be integrally manufactured with the housing and provided or distributed to consumers as such. In accordance with this embodiment, the system may be configured to allow a connection to additional one or more vessels. Alternatively, the system of the invention is provided without any attachment to a vessel and is configured to connect a plurality of vessels and decontaminate the vessels.
[0266] In one or more embodiments, the at least one vessel ranges from one vessel to ten vessels, wherein a surface of at least one or each of the vessels is configured to be wiped off by the wiping member.
[0267] In one or more embodiments, the system includes one or more ports configured to attach a medical vessel.
[0268] In one or more embodiments, the systems and devices of the invention include a sliding mechanism positioned on at least one of a first medical vessel and a second medical vessel and is configured to allow traveling there along of at least one of the first medical vessel and the second medical vessel, such that at least one of the first medical vessel and the second medical vessel is configured to move from a first position to a second position. In one or more embodiments, the systems and devices of the invention include a sliding mechanism positioned on or within a housing thereby allowing traveling or sliding there along of at least one of the first medical vessel and the second medical vessel, such that at least one of the first medical vessel and the second medical vessel is configured to move from a first position to a second position. Optionally, in one or more embodiments, the system provides for the travelling of a vessel between a plurality of positions, such as from a second position to a third position, from a third position to a fourth position, and from a fourth position to a fifth position. In one or more embodiments, the sliding mechanism allows only unidirectional sliding. In one or more embodiments, the sliding mechanism allows for the vessel to retract/return to a previous position. Various types of sliding mechanisms are contemplated as long as they can be connected or engage a vessel and afford traveling there along and allow decontamination of a surface of the vessel. The sliding mechanism may include a rail. The rail may be optionally made from a plastic or polymetric material, but a metallic material or glass material is also applicable. In one embodiment, the rail is manufactured from a plastic material. In one or more embodiments, the plastic material is rigid. In one or more embodiments the vessel surface is positioned on a surface of the rail. In one or more embodiments, the vessel surface is positioned between the rails of the rail. In one or more embodiments, the vessel surface is positioned between a portion of the rails. In one or more embodiments, the rail may be a circumferential rail. In one or more embodiments, the sliding mechanism may be a hinge mechanism. In one or more embodiments, the sliding mechanism may include one or more rotatable discs capable of connecting to a medical vessel and being rotatable within the housing, such to allow a vessel's surface to pass through the wiping member. Optionally, the sliding mechanism includes a first disc and a second disc positioned one above the other and being rotatable with respect to each other. Optionally, one disc is rotatable, and another disc is stationary. Optionally, the wiping member is disposed between two discs.
[0269] In one or more embodiments, the housing and/or medical vessel has an engagement mechanism configured or adapted to connect the at least one vessel to the housing. In one or more embodiments, the herein disclosed systems include an engagement mechanism configured to provide an engagement between first and second medical vessels. Various types of engagement mechanisms may be applicable and are contemplated. For example, the engagement mechanism is selected from, without limitation, a thread, a luer, a luer-lock, a luer-slip, a smart-site, a ratchet teeth mechanism, a retention member, a fastener, a clamping element, a clamping rail, clamping members or arms, and an adhesive mechanism, and combinations thereof. The thread and the complementary thread may be a luer. an adhesive, a ratchet teeth mechanism, and combinations thereof. In an embodiment of the invention, the engagement mechanism positions the surface of the at least one vessel at about same level as an interior wall of the housing. In an embodiment of the invention, the engagement mechanism positions the surface of the pharmaceutical vessel at the same level as an interior wall of a housing of the system. In an embodiment of the invention, the engagement mechanism positions the surface of the at least one vessel in a manner that protrudes into the housing. In an embodiment of the invention, the protruding of the surface of the at least one vessel is a slight/minor protruding. In an embodiment of the invention, the protruding of the surface of the at least one vessel ranges from less than one twelfth of an inch to less than half an inch. In an embodiment of the invention, the engagement mechanism positions the surface of the at least one vessel in a manner that is below an inner surface of the housing. In an embodiment of the invention, the positioning of the surface of the at least one vessel ranges from less than one twelfth of an inch to less than a half an inch from the inner surface of the housing. In an embodiment of the invention, the engagement mechanism positions the surface of the at least one vessel slightly below an inner wall/surface of the housing while allowing the wiping member to wipe off the entire surface of the at least one vessel. In one or more embodiments, the surface of the at least one vessel is positioned at the same level as an inner surface of a housing wall.
[0270] In one or more embodiments, the system may include one or more safety mechanisms to secure one or more elements of the system and/or ensure proper use thereof. In one or more embodiments, the system includes at least one safety mechanism. In one or more embodiments, the safety mechanism is configured to prevent premature movement of a surface of a vessel within the housing. In one or more embodiments, the safety mechanism is configured to prevent premature decontamination of a surface of a vessel. In one or more embodiments, the safety mechanism is configured to prevent premature establishment of fluidic communication between vessels. In one or more embodiments, the safety mechanism is configured to prevent premature piercing of vessel's surface with the piercing member. In one or more embodiments, the safety mechanism is configured to prevent premature breaking of a frangible seal covering an opening of the housing. In one or more embodiments, the safety mechanism is configured to prevent retraction of the vessel between compartments. In one or more embodiments, the safety mechanism is configured to prevent premature detachment of the vessel from the housing. In one or more embodiments, the safety mechanism is configured to secure a valve within the housing. In one or more embodiments, the safety mechanism is configured to ensure and/or prevent premature sliding of a vessel on the rail within the housing. In one or more embodiments, the safety mechanism is configured to secure the attachment of a vessel to the rail. In one or more embodiments, the safety mechanism is configured to prevent premature rotation of the one or more discs within the housing.
[0271] In one or more embodiments, the system includes at least one safety mechanism selected from a valve safety mechanism, a piercing member safety mechanism, a rail safety mechanism, a detachment safety mechanism, a hinge safety mechanism and a retractable safety mechanism. In one or more embodiments, the system includes at least one safety mechanism to secure at least one element of the system selected from: a valve, a rail, a displaceable member, a piercing member, and a wiper.
[0272] Various configurations of the safety mechanism are contemplated. For example, the safety mechanism may have a stopper, or a locker structure. In an exemplary embodiment, the safety mechanism is selected from the group, but not limited to a plunger, a latch, a knob, a pin or a shaft. Optionally, the safety mechanism is movable from a retracted position wherein it is concealed within an inner wall of the housing to an extended position wherein it protrudes from an inner wall of the housing. In an exemplary embodiment, the safety mechanism is configured to press down against an inner wall of the housing when a surface of the vessel passes over the safety mechanism and extend to protrude from an inner wall of the housing after the vessel passed over the safety mechanism. Optionally, the movement between an extended to a retracted position of the safety mechanism is mediated by a spring which is optionally attached to the safety mechanism, optionally from below. The safety mechanism may be manufactured from various rigid materials, such as, a plastic or a metal (e.g., a metal alloy).
[0273] The safety mechanisms may be optionally unlocked by a movement of the vessel within the housing, for example, by an engagement of the vessel with the housing, by engagement of the vessel with an engagement mechanism of the decontamination device, by movement of the vessel between compartments, by movement of the vessel surface between compartments, by movement of an engagement mechanism of the device along the rail of the device, and/or by detachment of the vessel from the housing. Optionally, the vessel may comprise an unlocking member that engages the safety mechanism and unlocks the safety mechanism. Further optionally, or additionally the vessel may comprise a locking member that engages the safety mechanism and locks the safety mechanism with the vessel, or with a compartment or a component within the housing. Such locking or unlocking member may be disposed on the vessel's surface. In one or more embodiments, the safety mechanism is unlocked by and/or locked to the vessel via a motion selected from pushing, pulling (slight pulling), twisting, turning, sliding, push and twist, and/or twist and push, or a combination thereof.
[0274] In one or more embodiments, the safety mechanism makes an audible sound upon use thereof (e.g., when locked/unlocked/released). The audible sound may be a CLICK.
[0275] In one or more embodiments, the valve safety mechanism is adapted to attach a valve or a locking mechanism thereof, ensuring opening of the valve after correct positioning of the vessel within a compartment (e.g., a second, a third, a fourth or a fifth compartment) of the housing or system. Valve safety mechanism may be a locker, or a stopper structure configured to lock a valve or an unlocking mechanism thereof after opening of the valve. The valve safety mechanism is thus configured, according to one or more embodiments, to maintain the valve in an opened configuration after correct positioning of the vessel within a compartment (e.g., a second, a third, a fourth or a fifth compartment) of the housing/system.
[0276] In one or more embodiments, the piercing member safety mechanism is adapted to prevent the premature piercing of a vessel's surface. For example, upon attachment of a vessel to a piercing member safety mechanism, the piercing member safety mechanism or an actuator of the piercing member is unlocked by the attachment, allowing activation of piercing member to pierce a vessel's surface. Alternatively, additionally, or optionally, piercing member safety mechanism is unlocked upon pressing piercing member actuator manually by a user. Optionally, piercing member safety mechanism is further adapted to lock a vessel in place and prevent retraction thereof. Optionally, the piercing member safety mechanism is connected directly or indirectly to a piercing member or to an actuator thereof (i.e., piercing member actuator). Optionally, the piercing member safety mechanism is connectable in a direct or an indirect manner to a vessel. Optionally, the piercing member safety mechanism connects between a vessel and the piercing member. Various configurations of piercing member safety mechanism are contemplated. In one embodiment, the piercing member safety mechanism comprises a longitudinal shaft that curves at a bottom end thereof allowing attachment thereof to a vessel via the curved end. Other configurations of piercing member safety mechanism are contemplated such as a plunger, a latch or a pin.
[0277] In one or more embodiments, the rail safety mechanism may be optionally further provided to ensure sliding of a vessel on the rail upon attachment thereof to the system. Optionally, the rail safety mechanism prevents premature sliding of the vessel on the rail. Optionally, alternatively or additionally, the rail safety mechanism secures the attachment of a vessel to the rail. Various configurations of rail member safety mechanism are contemplated. For example, the rail safety mechanism has a structure of a locker or a stopper. Optionally, the rail safety mechanism is configured to travel along the rail together with the vessel. According to this embodiment, the rail safety mechanism is configured to be able to attach the vessel either directly or indirectly via a connector element.
[0278] In one or more embodiments, the cap safety mechanism is configured to prevent premature detachment of a displaceable member. Optionally, cap safety mechanism is interchangeable with a detachment safety mechanism and is operable to prevent the premature detachment of a vessel from a compartment of the housing where resealing occurs. Optionally, the cap safety mechanism is unlocked at the time of movement of a vessel into a compartment within the housing. Optionally, additionally or alternatively, the cap safety mechanism is unlocked about the time of, or after resealing of a vessel. Cap safety mechanism may be attached to displaceable member or may hold the displaceable member in place. Various configurations of cap member safety mechanism are contemplated. For example, the cap safety mechanism has a structure of a locker or a stopper.
[0279] In one or more embodiments, the hinge safety mechanism may be further provided within a compartment of the housing, or other locations within or on the decontamination device, to prevent premature rotation of the one or more discs within the housing. Accordingly, the one or more discs within the housing may be released to allow rotation thereof with respect to each other upon attachment of vessel within the housing, e.g., within a first compartment of the housing. Optionally, hinge safety mechanism has a form of a plunger or a pin which can be retracted within a slot in a wall of the housing upon sliding of the vessel on top of the hinge safety mechanism.
[0280] In one or more embodiments, the system having a locking member to provide for the one directional movement of a vessel between compartments of the housing so that the vessel cannot retract. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a second position to a first position. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a third position to a second position. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a fourth position to a third position. In one or more embodiments, the locking member prevents a vessel when attached to the housing from retracting from a fifth position to a fourth position. In one or more embodiments, the locking member is applicable to any of the disclosed devices, systems, and methods of this invention. The locking member may be positioned in various locations within the housing. For example, the locking member may be disposed within the first, the second, the third or any of the other compartments. In an exemplary embodiment, the locking member is disposed within the second compartment, or between the first and second compartments. In an exemplary embodiment, the locking member is disposed within the third compartment, or between the third and second compartments. In an exemplary embodiment, the locking member is disposed within the fourth compartment, or between the third and fourth compartments. In an exemplary embodiment, the locking member is disposed within the fifth compartment, or between the fifth and fourth compartments. Various forms of retractable safety mechanisms are herein contemplated. Optionally, the locking member may be a stopper structure. The locking member may present various forms and/or mechanisms including, but not limited to a latch, a plunger, and/or a knob. Optionally, the locking member is movable from a retracted position such that the vessel may freely slide along or travel within the housing and an extended position to lock in place the vessel, upon positioning of the vessel in a second, a third, a fourth and/or a fifth position. In one or more embodiments, the term locking member is interchangeable with the term retractable safety mechanism.
[0281] In one or more embodiments, the herein disclosed invention allows transferring medical substances in a contaminant-free, or in a substantially contaminant-free manner.
[0282] In one or more embodiments, the herein disclosed invention affords an engagement of vessels in a contaminant-free, or in a substantially contaminant-free manner.
[0283] 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.
[0284] 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.
[0285] In one or more embodiments, the herein disclosed invention, allows for the air-free engagement between at least two vessels.
[0286] As used herein the term substances refers to various types of materials that should be kept sterile. The substances may be liquid, solid, gelatinous, semi-solid, or gas. In one or more embodiments, the substances are medical substances. As used herein the term medical substances refers to and encompasses any of the various pharmaceutical drugs, medical drugs, fluids, nutritional products, solid powders, suspensions, liquids and the like. In an embodiment of the invention the term medical substance is interchangeable with the term pharmaceutical substance. In one or more embodiments medical substances refers to and encompasses sterile injectable substances intended for intracorporal administration to persons in need or animals.
[0287] As used herein, the term contaminant-free is interchangeable with the term sterile, disinfected, and decontaminated. The term refers to substances that are free or substantially free of ambient air particles and/or pathogens, including but not limited to bacteria, viruses, funguses, spores, dirt and/or pyrogens. Typically, when less or no air is introduced within medical substances, the chances of contamination by pathogens, such as, bacteria, viruses, funguses, spores, pyrogens or the alike is completely abolished or significantly reduced.
[0288] 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.
[0289] As used herein the term ambient air particles is interchangeable with the term environmental air particles and refers to air particles present in a non-filtered environment. The air particles may contain dirt, such as dust. Alternatively, or additionally, the air particles may contain pathogens or other microorganisms, or any of the alike. For example, air can be purified by filters, such as a High Efficiency Particulate Air (HEPA) filter.
[0290] As used herein the term vessel refers to any device utilized for containing, transferring or administering substances as herein disclosed. In one or more embodiments, the vessels may be used for containing medical substances. In an embodiment of the invention, the vessel is a medical vessel. In one or more embodiments, the term medical vessel is interchangeable with the terms pharmaceutical vessel and medical device. In an embodiment of the invention, the vessel is a medical device. In an embodiment of the invention, the vessels are used for, and adapted to allow connection to another vessel. The vessel may have a vessel's port via which medical substances may pass towards another vessel. In an embodiment of the invention, the vessel is utilized for containing a medical substance. Various types of vessels are contemplated. The vessel may be selected, without limitation, from a vial, a bag, a chamber, a bottle, a syringe, an infusion line, an administration line, a connector, a filter, a spike, a manifold, a bag port, a bottle port, a vial port and the alike. In an embodiment of the invention, the term vessel further encompasses elements that can be used to connect between vessels. In accordance with this embodiment, the vessel may be selected, without limitation, from a connector, a connector with multiple openings, a connector with multiple ports, a syringe, an infusion line, a tubing, a syringe, a filter, a port and a manifold.
[0291] As used herein, the term connection interface encompasses any surface, layer plane or the alike that can be attached to a vessel. The term may encompass a structure that can be coupled to a vessel and that can engage with a complementary connection interface. In an embodiment of the invention, the connection interface may seal or cover an aperture of a vessel. In an embodiment of the invention, the connection interface may seal or cover an opening for fluid passageway of a vessel.
[0292] As used herein the term fluid communication refers to two or more vessels in which substances may pass therethrough either directly or indirectly. The fluid communication may occur via a fluid passageway that allows for the flow/transfer of substances. In an embodiment of the invention, fluid passageway between vessels is established when any seals or covers of the ports of the herein disclosed systems and/or of the vessels are open. Optionally, the vessels and/or ports of the systems are provided with seals/covers and those seals/cover become open upon piercing thereof, for example, by a piercing member. Optionally, the vessels and/or ports of the systems are provided with seals/covers and those seals/cover are opened upon uncovering or removing thereof by a user. Optionally, one or more of the seals/covers disclosed herein take the form of a film, e.g., a thin film. Optionally, one or more of the seals/covers disclosed herein are fragile, allowing piercing thereof with a sharp instrument (i.e., a piercing member). The piercing member may optionally be a needle, for example, a hollowed needle, but other sharp elements are contemplated. Optionally, one or more of the seals/covers disclosed herein are frangible, allowing for the rupturing/breaking of the seals/covers with the application of sufficient force by a user. Optionally, one or more of the vessels includes a displaceable member in the form of a seal or a cap. The displaceable member may be made from various materials, such as, but no limited to a plastic material or a metal material, such as a metal alloy. The displaceable material may be in the form of a foil, or a membrane or a layer. The foil, membrane or layer may be frangible. The displaceable member may be integrally connected to a medical vessel or to a port thereof and may be configured to externally displace from the medical vessel or port at the time the medical vessel moves from the first position to the second position. In one or more embodiments, the displaceable member is configured to engage a complementary displaceable member on a complementary medical vessel. In one or more embodiment, such an engagement is an airtight engagement.
[0293] In an embodiment of the invention, the herein disclosed devices, systems and methods allow fluid communication in a contaminant-free, or in a substantially contaminant-free manner. For example, between three or more, four or more, five or more or six or more vessels. In an embodiment of the invention, the herein disclosed devices, systems and methods allow fluid communication between three, four, five six, or seven vessels. For example, the devices, systems, and methods of the invention allow fluid communication between two bags, between a syringe and a bag, between a connector and a bag, between a container and a bag, between a vial and a bag, between a syringe and a vial, between a syringe and a container, between a connector and a container, between a connector and a vial, between a connector and a bag, between an infusion line and a bag, between an infusion line and a syringe or between a syringe and a connector.
[0294] In an embodiment of the invention, the herein disclosed device has a plurality of compartments/chambers, wherein there is a pressure differential between at least two of the compartments/chambers. In one or more embodiments, at least one compartment/chamber of the housing has a higher pressure than an adjacent compartment/chamber of the housing. In one or more embodiments, at least one compartment/chamber of the housing has a lower pressure than an adjacent compartment/chamber of the housing. In one or more embodiments, at least one compartment/chamber of the housing has about the same pressure as an adjacent compartment/chamber of the housing. In one or more embodiments, at least one compartment/chamber of the housing has the same pressure as an adjacent compartment/chamber of the housing. In one or more embodiments, at least one compartment chamber of the housing has a pressure greater than or less than ambient air pressure or atmospheric pressure. In one or more embodiments, the pressure of at least one compartment/chamber of the housing is the same as ambient air or atmospheric pressure. In one or more embodiments, the pressure differential between compartments may be at least 0.02 i.w.c. (inches water column). In one or more embodiments, the pressure differential between compartments is at least 0.1 i.w.c. In one or more embodiments, the pressure differential between compartments is between 0.01 i.w.c. and 1 i.w.c. In one or more embodiments, the pressure differential between compartments may be at least negative 0.05 i.w.c. In one or more embodiments, the pressure differential between compartments is between negative 0.04 i.w.c. and negative 0.01 i.w.c. As used herein, the term i.w.c. encompasses the definition as provided or accepted by the United States Pharmacopeia, The American Society of Health-Systems Pharmacists, The American Pharmacists Association or other nationally or internationally recognized organizations.
[0295] Referring now to the drawings,
[0296] Referring now to
[0297] Referring now to
[0298] System 10 is demonstrated when a syringe 40 is to be engaged with vessel 24. Syringe 40 includes a vessel's rail 37 disposed on top or around syringe port 42, and a displaceable member 44 disposed on top of vessel's rail 37. The displaceable member 44 is configured to externally displace from the syringe port 42 following engagement of syringe 40 at first compartment 20. Optionally, displaceable member 44 externally displaces from the port 42 at about the time syringe 40 moves from the first position (
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[0302] Other engagement mechanisms are herein contemplated. For example,
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[0310] In
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[0334] 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.
[0335] Each of the phrases consisting of and consists of, as used herein, means including and limited to.
[0336] 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.
[0337] 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.
[0338] 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.
[0339] 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.
[0340] 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.
[0341] 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.
[0342] 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.