MEDICAL VESSELS WITH DYNAMIC FLUID TRANSFER LOCK MECHANISM
20200315916 ยท 2020-10-08
Inventors
Cpc classification
A61J1/2051
HUMAN NECESSITIES
A61J1/2089
HUMAN NECESSITIES
A61J1/1443
HUMAN NECESSITIES
A61J1/2096
HUMAN NECESSITIES
A61M39/1011
HUMAN NECESSITIES
A61M5/145
HUMAN NECESSITIES
International classification
Abstract
The present invention relates, in some embodiments thereof, to devices, systems and methods for establishing a fluid passageway between vessels. In some embodiments, the invention provides a system that comprises a first vessel; a second vessel configured to be coupled to the first vessel; and a plunger locking mechanism disposed on the first vessel and configured to lock a plunger thereof and prevent the plunger from expelling content of the first vessel prior to an engagement with the second vessel, wherein the first and/or second vessel(s) comprise(s) an unlock mechanism configured to unlock the lock mechanism of the first vessel, and wherein at the time of or following the engagement between the first vessel and the second vessel, the unlock mechanism unlocks the lock mechanism of the plunger, allowing movement thereof and thereby a fluid transfer from the first vessel to the second vessel.
Claims
1. A method of unlocking a plunger of a vessel and establishing a fluid passageway between vessels, the method comprises the steps of: providing a first vessel and a second vessel; wherein the first vessel comprises a plunger and a plunger lock mechanism and the first and/or second vessel(s) include(s) a unlock mechanism; wherein the lock mechanism configured to lock the plunger thus preventing the plunger from expelling a content within the first vessel; and wherein the unlock mechanism configured to unlock the plunger lock mechanism; connecting the first vessel to the second vessel; unlocking the plunger lock mechanism; and pushing a plunger of the first vessel towards the second vessel to thereby allow the fluid passageway between the vessels.
2. The method of claim 1, wherein an airtight seal is formed between said vessels following the step of connecting/engaging the vessels, allowing a hermetically sealed connection between said first vessel and said second vessel.
3. The method of claim 1, wherein the step of connecting the vessels includes unlocking the lock mechanism.
4. The method of claim 3, wherein the step of unlocking the lock mechanism occurs via a push motion, a twist motion, a turn motion or a combination thereof.
5. The method of claim 1, wherein the connection/engagement the vessels occurs via a push motion, a twist motion, a turn motion or a combination thereof.
6. The method of claim 1, wherein the connection/engagement of said vessels is selected from a twisting of a thread onto a complementary thread, attaching ratchet teeth to a complementary retention member, and adhering a surface of a first vessel to the surface of said second vessel via an adhesive, and combinations thereof
7. The method of claim 1, further comprising actuating a piercing member/needle to pierce a vessel's surface.
8. The method of claim 1, further comprising opening a valve via a valve actuator to allow the fluid transfer between vessels.
9. The method of claim 1, further comprising providing a decontamination device having a wiping member, the wiping member configured to decontaminate a surface of the first and/or second vessel(s).
10. The method of claim 9, further comprising actuating the wiping member to move within the device, thereby decontaminating the surface of the first and/or second vessel.
11. The method of claim 9, further comprising moving at least a portion of the first vessel and/or second vessel within the device and via the wiping member, thereby decontaminating the surface of the first and/or second vessel.
12. The method of claim 1, wherein the vessel is selected from the group consisting of a bottle, a syringe, an infusion line, a connector, a filter, a manifold, a bag port, a bottle port, a vial port, a cartridge and a combination thereof
13. The method of claim 1, further comprising transferring a fluid substance between the vessels after engaging/connecting the vessels.
14. The method of claim 9, further comprising transferring a fluid substance within the at least one vessel through the device after the surface of the at least one vessel has been decontaminated.
15. Th method of claim 1, wherein the first vessel is a syringe.
16. The method of claim 1, wherein the first vessel is a syringe and the second vessel is a container.
17. The method of claim 1, wherein the first vessel is a cartridge and the second vessel is a bag.
18. The method of claim 1, wherein the first vessel is a container and the second vessel is a container.
19. The method of claim 1, wherein the first vessel is a bottle and the second vessel is a bottle.
20. The method of claim 1, wherein the first vessel has a plunger and the second vessel is a bag.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0059] 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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[0097] 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
[0098] 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 locking mechanisms and unlocking mechanisms 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.
[0099] The present invention pertains to devices, methods and systems for fluid transfer between one or more vessels in a secure manner. The present invention pertains to systems, devices, and methods for preventing the premature spillage of beneficial substances/medicaments when transferred between containers/devices. The present invention pertains to systems, devices, and methods for preventing the premature spillage of beneficial substances/medicaments when transferred between containers/devices intended for use in a modular assembly format. The invention provides a solution to an unmet and long felt need in medical settings and allows for the locking of a plunger thus preventing expelling a medical substance, and unlocking of the plunger locking mechanism(s) at about the time, at the time, and/or after the engagement/coupling of at least two vessels/containers/devices. In one or more embodiments, the herein disclosed devices and systems pertain to a locking and unlocking mechanisms for securing and monitoring a fluid transfer between vessels. In one or more embodiments, the herein disclosed devices, systems, and/or methods pertain to plunger locking mechanism configured to secure/lock plungers of containers. In one or more embodiments, the herein disclosed devices, systems, and/or methods pertain to plunger unlocking mechanisms disposed on and/or in containers, the plunger unlocking mechanisms configured to unlock plungers of a second container. In one or more embodiments, the herein disclosed devices, systems, and/or methods pertain to systems comprising containers having plunger unlocking mechanisms and containers having plunger locking mechanisms, the plunger unlocking mechanisms configured to unlock plunger locking mechanism of a second container.
[0100] Thus, it is an object of the present invention, in some embodiments, to provide systems, devices, and methods for establishing fluidic communications between containers. It is an object of the present invention, in some embodiments, to provide vessels having a plunger locking mechanism(s). It is an object of the present invention, in some embodiments, to provide vessels having a plunger unlocking mechanism(s). It is an object of the present invention to provide vessels and/or decontamination devices having plunger unlocking mechanism(s) configured to unlock plunger locking mechanisms of other vessels. It is an object of the present invention to provide vessels having plunger locking mechanism(s) configured to be unlocked by plunger unlocking mechanisms of other vessel(s) and/or decontamination devices. It is an object of the present invention, in some embodiments, to provide systems, devices, and methods of preventing spillage of beneficial substances/medicaments prior to the engagement of at least two vessels.
[0101] Thus, in an aspect of the invention, there is provided a system for establishing a fluid passageway between vessels, the system comprises [0102] a first vessel; and [0103] a second vessel; [0104] wherein the first vessel comprises a plunger locking mechanism configured to lock a plunger thereof and prevent the plunger from expelling the content of the first vessel prior to an engagement with the second vessel, [0105] wherein the first and/or second vessel(s) comprise an unlocking mechanism configured to unlock the lock mechanism of the first vessel, [0106] wherein at the time of or following the engagement between the first vessel and the second vessel, the plunger unlocking mechanism unlocks the lock mechanism of the plunger allowing movement thereof and thereby a fluid transfer from the first vessel into the second vessel.
[0107] In one or more embodiments, the herein disclosed devices and systems include a vessel with a plunger and a plunger lock mechanism that can lock the plunger, preventing premature transfer of the content from the vessel. Various forms of the lock mechanism are herein contemplated. Non-limiting examples of the locking mechanism include a latch, a spring, a magnet, a hook, a tooth, a pin, a retractable pin, a ratchet tooth, a knob, a retractable knob, a ball, a retractable ball, a thread, a bangle, a locking key, a zip-tie, a moveable wall, a dent. The lock mechanism may be moveable between a locked position and an unlocked position. Optionally, the lock position includes extension of the lock mechanism into a hole/dent/socket/channel. Optionally, in the lock position, the lock mechanism is extended into the hole/dent/socket/channel and in the unlock position, the lock mechanism is retracted. The term lock mechanism is interchangeable with the term locking mechanism.
[0108] In one or more embodiments, the herein disclosed devices and systems include an unlock mechanism that can unlock the lock mechanism of the plunger. In one or more embodiments, the unlock mechanism unlocks the lock mechanism at about the time of, at the time of, or following an engagement and/or coupling between a first vessel and a second vessel. Various forms of the unlock mechanism are herein contemplated. Non-limiting examples of the unlocking mechanism include a latch, a spring, a magnet, a hook, a tooth, a pin, a retractable pin, a ratchet tooth, a knob, a retractable knob, a ball, a retractable ball, a thread, a bangle, a locking key, a zip-tie, a moveable wall, a hole, a dent, a socket, a channel, an elongated arm, a latch, a lock, and a slot. The term unlock mechanism is interchangeable with the term unlocking mechanism.
[0109] Various types, combinations and numbers of locking mechanisms may be provided in each of the herein disclosed systems, to ensure the locking action. For example, a combination of two locking mechanisms or more may be provided in each device/system/vessel.
[0110] Various types, combinations and numbers of unlocking mechanisms may be provided in each of the herein disclosed systems, to ensure the unlocking action. For example, a combination of two unlocking mechanisms or more may be provided in each device/system/vessel. In one or more embodiments, the locking mechanism is unlocked by the unlocking mechanism at the time and/or at about the time and/or after engagement of the first and second vessels. In one or more embodiments, the locking mechanism is unlocked by the unlocking mechanism after the engagement of the first and second vessels. In one or more embodiments, the locking and/or unlocking mechanism is disposed through a wall of the vessel. In one or more embodiments, the locking and/or unlocking mechanism is disposed on an interior wall of the vessel. In one or more embodiments, the locking and/or unlocking mechanism is disposed on an exterior wall of the vessel.
[0111] In one or more embodiments, the present invention provides a vessel having a moveable wall locking mechanism. In one or more embodiments, the present invention provides a vessel having a moveable wall and a moveable wall locking mechanism. In one or more embodiments, the present invention provides a vessel having a moveable wall unlocking mechanism. In one or more embodiments, the moveable wall may be a plunger. I one or more embodiments, the moveable wall may be made of a rubber material, a plastic material, a glass material, a metal alloy, and combinations thereof. In one or more embodiments, the moveable wall is configured to move within the vessel. In one or more embodiments, the moveable wall is configured to move within the vessel to expel the contents contained within the vessel out of the vessel.
[0112] Various forms of first and/or second vessels are contemplated. For example, the vessel may be a cartridge. In one or more embodiments, the cartridge includes protective side walls. In one or more embodiments, the moveable wall is a plunger. In one or more embodiments, the moveable wall is made of a rubber material. In one or more embodiments, the moveable wall is made of a plastic material. In one or more embodiments, the moveable wall is made of an elastomeric material. In one or more embodiments, the moveable wall is configured to move within the cartridge to expel the contents of the cartridge out of the cartridge. In one or more embodiments, at least one of the first and second vessels is a bag. In one or more embodiments, at least one of the first and second vessels is a bottle. In one or more embodiments, the first vessel is a bag and the second vessel is a syringe. In one or more embodiments, the first vessel is a syringe and the second vessel is a bag. In one or more embodiments, the first vessel is a bottle and the second vessel is a syringe. In one or more embodiments, the second vessel is a cartridge having a plunger. In one or more embodiments, the first vessel is a syringe and the second vessel is a bag. In one or more embodiments, the first vessel is a syringe and the second vessel is a bottle. In one or more embodiments, the first vessel is a cartridge and the second vessel is a bag. In one or more embodiments, the first vessel is a cartridge and the second vessel is a bottle. In one or more embodiments, the first vessel is a bottle and the second vessel is a bottle. In one or more embodiments, the first vessel is a vial and the second vessel is a bag.
[0113] In a further aspect, the present invention provides a method for establishing fluid communication between vessels, the method comprising: [0114] providing a first vessel having a plunger and a plunger locking mechanism; [0115] providing a second vessel having a plunger unlocking mechanism; [0116] connecting the first vessel to the second vessel; and [0117] pushing a plunger of the first vessels towards the second vessel to thereby establish a fluid passageway between the vessels, wherein the plunger locking mechanism configured to lock the plunger thus preventing the plunger from moving and expelling a substance from within the first vessel prior to the engagement between the first vessel and the second vessel, wherein the plunger unlocking mechanism configured to unlock the plunger locking mechanism of the first vessel; wherein upon the connection between the plunger unlocking mechanism and the plunger locking mechanism, the plunger locking mechanism is unlocked by the plunger unlocking mechanism thus allowing the plunger to move and expel the contents of the first vessel into the second vessel.
[0118] In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a pushing motion of the second vessel towards the first vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a pushing motion of the first vessel towards the second vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a pushing motion of the first and second vessels towards each other.
[0119] In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a twisting motion of the first vessel in relation to the second vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a twisting motion of the second vessel in relation to the first vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a twisting motion of the first and second vessels in relation to each other.
[0120] In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a turning motion of the first vessel in relation to the second vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a turning motion of the second vessel in relation to the first vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a turning motion of the first and second vessels in relation to each other.
[0121] In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a push and twist motion of the second vessel in relation to the first vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a push and twist motion of the first vessel in relation the second vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a push and twist motion of the first and second vessels in relation to each other.
[0122] In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a twist and push motion of the second vessel in relation to the first vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a twist and push motion of the first vessel in relation the second vessel. In one or more embodiments, the unlocking of the plunger locking mechanism is mediated via a twist and push motion of the first and second vessels in relation to each other.
[0123] In one or more embodiments, at least one of a push and twist motions moves the plunger locking mechanism from a locked position where the plunger is unable to move to an unlocked position where the plunger is can move forward.
[0124] In one embodiment, the present invention further provides devices, systems and methods configured to decontaminate one or more surfaces of a vessel(s). In one or more embodiments, the devices and systems of the invention allow a substantially decontaminated fluid transfer between the one or more vessel(s). The engagement and/or fluid transfer between the one or more vessels may accordingly be utilized via the decontamination devices which decontaminate the vessel(s) and also allow the fluid transfer. A locking mechanism and/or an unlocking mechanism may be disposed on the decontamination device, and one or both engaging vessels, thereby locking and unlocking a plunger.
[0125] In a further aspect, the present invention provides a system for decontaminating a surface of a vessel, the system comprising: [0126] a first vessel having a plunger lock mechanism, the plunger lock mechanism configured to lock a plunger within the vessel thus preventing premature movement thereof; [0127] a second vessel; and [0128] a decontamination device having a first and second ports for connection to the first and second vessels, the decontamination device comprising a wiper/wiping member disposed therein the device and configured to remove contaminants from a surface of at least one of the first and second vessels, the decontamination device further comprises a plunger unlock mechanism configured to unlock a plunger lock mechanism of the first vessel, [0129] wherein upon the engagement between the first vessel and the decontamination device, the lock mechanism is unlocked, allowing a fluid transfer between the first and second vessels via the decontamination device.
[0130] In one or more embodiments, the first vessel is a syringe. In one or more embodiments, the syringe has a plunger. In one or more embodiments, the first vessel is a cartridge. In one or more embodiments, the first vessel has a moveable wall. In one or more embodiments, the moveable wall is a plunger. In one or more embodiments, decontamination device has an actuator for effecting a wiping action of the wiping member. In one or more embodiments, the actuator is a handle. In one or more embodiments, the actuator is a tab.
[0131] In a further aspect, the present invention provides a method for establishing a fluid communication between vessels, the method comprises [0132] providing a first vessel having a plunger lock mechanism, the plunger lock mechanism configured to lock a plunger within the vessel thus preventing movement of the plunger; [0133] providing a second vessel; and [0134] providing a decontamination device having a first and second ports for connection to the first and second vessels, the decontamination device comprising a wiper/wiping member disposed therein the device and configured to remove contaminants from a surface of at least one of the first and second vessels, the decontamination device further comprises a plunger unlock mechanism configured to unlock a plunger lock mechanism of the first vessel, [0135] connecting the first vessel to the decontamination device; [0136] wherein upon the engagement between the first vessel and the decontamination device, the plunger unlock mechanism of the decontamination device unlocks the plunger lock mechanism of the first vessel, thus allowing for the movement of the plunger of the first vessel to expel the contents of the vessel into the decontamination device and thereby establish a fluid communication between the first vessel and the second vessel.
[0137] In one or more embodiments, the unlocking of the plunger lock mechanism of the first vessel occurs due to a pushing motion of the decontamination device towards the first vessel. In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a pushing motion of the vessel towards the decontamination device. In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a pushing motion of the vessel and the decontamination device towards each other.
[0138] In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a twisting/turning motion of the decontamination device relative to the vessel. In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a twisting/turning motion of the vessel relative to the decontamination device. In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a twisting/turning motion of the vessel and the decontamination device relative to each other.
[0139] In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a push and twist motion of the decontamination device relative to the vessel. In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a push and twist motion of the vessel relative to the decontamination device. In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a push and twist motion of the vessel and the decontamination device towards each other.
[0140] In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a twist and push motion of the decontamination device relative to the vessel. In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a twist and push motion of the vessel relative to the decontamination device. In one or more embodiments, the unlocking of the plunger lock mechanism of the vessel occurs due to a twist and push motion of the vessel and the decontamination device towards each other.
[0141] Optionally, the decontamination device includes an actuator, disposed through a wall of the device, for manipulating the movement of the wiping member, and thereby decontaminating the surface of the first and/or second vessels.
[0142] Optionally, the locking mechanism may be disposed on the vessel and/or the unlocking mechanism on the decontamination device. Various positions of the locking/unlocking mechanism on the vessel and/or decontamination device are herein contemplated. The locking/unlocking mechanism may be disposed, without limitation, on a vessel's/device's body, port, aperture, wall, exterior, exterior wall, plunger and/or compartment. The locking mechanism may be disposed in an external and/or internal position of the vessel/device. Optionally, the decontamination device includes one or more compartments. Optionally, the decontamination device includes a first compartment thereof a connecting structure/port for receiving a vessel. The connecting structure/port may mediate a connection with a vessel, via an engagement mechanism. Various forms of connecting structures/ports are herein contemplated. In one or more embodiments, the connecting structure/port extends downwardly from a top inner wall of a first compartment. In one or more embodiments, the connecting structure/port includes extension bodies (e.g., an elongated arm), clamping members, a threaded structure, minimized built-in dent structures, elongated extensions, and a circular body.
[0143] The decontamination device of the invention includes a housing having side walls, a top wall and a bottom wall, and a wiping member disposed within the housing. The device configured to be coupled to at least two vessels and includes applicable connecting structures/ports or openings for receiving the vessels. The connecting structures/ports/ openings may optionally be formed by vertical walls extending from the top and/or bottom walls, forming an inner lumen via which medical substances may be transferred following engagement between, and decontamination of the vessel surfaces. Other port configurations include ports/openings without any walls, tilted walls, etc. The ports may be flush, or surface mounted to the housing. Optionally, a locking mechanism and/or unlocking mechanism may be disposed in a port of the device, for example, in an internal position within vertical walls of the port. Optionally, a locking mechanism and/or unlocking mechanism may be disposed on a surface, and exterior surface, or an interior surface of a decontamination device and/or a vessel.
[0144] The wiping member is configured to decontaminate a vessel's surface, optionally by a movement of the wiping member across the housing and a surface of the vessel, or by movement of the surface of the vessel within the housing. The wiping member may be moveable or may be static.
[0145] 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. 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 vessels via an actuator extending through an opening in the side wall of 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
[0146] 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 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.
[0147] Optionally, the wiping member is static within the housing and the decontamination of a vessel's surface is effective via movement of at least a portion of the vessel within the housing and via the wiping member. In accordance with this embodiment, the system optionally comprises a sliding mechanism positioned on at least one of the first vessel and the second vessel, and/or within/on the housing, the sliding mechanism 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. The sliding mechanism may in one or more embodiments be a rail mechanism. 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 vessels from the first position to the second position. In one or more embodiments, the medical vessel or medical vessel surface slides along the housing and passes through and/or under and/or over 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 and/or ambient air particles.
[0148] 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 include a hinge/pivot mechanism. In one or more embodiments, the sliding mechanism provides for the travelling 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. Alternatively, the sliding mechanism allows for the vessel to retract/return to a previous position.
[0149] 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. In one or more embodiments, the vessel's surface slides underneath the wiping member under great friction, or under a friction sufficient to wipe off any contaminants from the surface, such as dirt or bacteria.
[0150] 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
[0151] 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 and/or ports of the decontamination device are sealed and/or covered thus preventing the sterilizing substance from escaping from inside the housing of the decontamination device. The seals and/or covers maintain the sterility of the decontamination device until about the time of use of the decontamination device. 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.
[0152] 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.
[0153] Various sizes and shapes of the housing are applicable. For example, the housing may have an external most length, width, and/or height of less than about 3 inches. In one or more embodiments, the housing may have an external most length, width, and/or height of less than about 25 millimeters (mm). For example, less than about 20 mm, less than about 15 mm, or less than about 10 mm. The housing internal most length, width, and/or height may be less than about 10 mm. For example, less than about 4 mm, less than about 3 mm, or less than about 2 mm. The housing may include one or more compartments which may optionally be separated or divided by the wiping member or by any other means. In one or more embodiments, the housing includes two compartments, wherein a first compartment is kept sterile and a second compartment is configured to receive a vessel which may be contaminated. In one or more embodiments, the sterile compartment can receive a vessel following decontamination of the surface of the vessel. In one or more embodiments, the housing includes two compartments wherein a first includes a capping mechanism and the second is configured to receive a vessel. In one or more embodiments, the housing includes three, four, or five compartments. 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.
[0154] 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 75 gr, less than about 50 mm gr, less than about 25 gr, less than about 10 gr, or less than about 5 gr. In one or more embodiments, the housing may be transparent allowing visualization of its interior, or opaque.
[0155] 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 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. In one or more embodiments, the cover or the seal is frangible, breakable or rupturable. In one or more embodiments, the cover or the seal is pierceable by a piercing member such as a needle.
[0156] 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.
[0157] In one or more embodiments, the system or devices 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 or assembled with the housing of the decontamination device and provided or distributed to consumers as such. In accordance with this embodiment, the system may be configured to allow a connection/locking/engagement to additional one or more vessels.
[0158] In one or more embodiments, the system includes two or more ports which are disposed one above the other, or which are longitudinally aligned with respect to each other. In accordance with this embodiment, the vessels connected to such ports are positioned aligned allowing a direct and aligned fluid passageway between the vessels. In one or more embodiments, the system includes two or more ports which are shifted from each other. Yet, in accordance with this embodiment, a fluid passageway is formed between vessels which is twisted or curved. In yet one or more embodiments, the housing contains a plurality of ports configured for connecting a plurality of vessels to the housing. The system or device is configured so that actuating the wiping member allows wiping the surfaces of all vessels connected to the housing in one action.
[0159] In one or more embodiments, the housing has an engagement mechanism configured or adapted to connect the at least one vessel to the housing. In one or more embodiments, the engagement mechanism may be reversible, allowing to detach the engagement between a vessel and a decontamination device. Various types of engagement mechanisms may be applicable and are contemplated. For example, the engagement mechanism is selected from, without limitation, a thread, a luer, a luer-lock, a luer-slip, snap-on, twist-on, a ratchet teeth mechanism, a retention member, a clamping rail, and an adhesive mechanism. The thread and the complementary thread may be selected from, without limitation, a luer, a smart-site mechanism and combinations thereof. In an embodiment, the engagement mechanism may be selected from a ratchet teeth mechanism, a clamping rail mechanism and/or an adhesive. In one or more embodiments, the herein disclosed invention allows transferring medical substances in a contaminant-free, or in a substantially contaminant-free manner.
[0160] In one or more embodiments, the herein disclosed invention affords an engagement of vessels in a contaminant-free, or in a substantially contaminant-free manner. In one or more embodiments, the herein disclosed invention affords an engagement of vessels in an air-free, or in a substantially air-free manner.
[0161] In one or more embodiments, the herein disclosed invention provides a fluidic passageway or communication between vessels in a contaminant-free, or in a substantially contaminant-free manner. In one or more embodiments, the herein disclosed invention provides a fluidic passageway or communication between vessels in an air-free, or in a substantially air-free manner.
[0162] In one or more embodiments, the herein disclosed invention, allows to substantially decrease the chances to introduce contaminants within a medical substance, when preparing or administering medical substances for administration to patients.
[0163] As used herein the term substances refers to various types of materials that should be kept sterile. The substances may be liquid, semi-solid, or gas. In one or more embodiments, the substances are medical substances. As used herein the term medical substances refers to and encompasses any of the various pharmaceutical drugs, fluids, nutritional products and the like. In an embodiment of the invention the term medical substance is interchangeable with the terms a pharmaceutical substance, a beneficial substance and a medicament.
[0164] As used herein the term contaminant-free is interchangeable with the term sterile, disinfected, and decontaminated. The term refers to substances that are free or substantially free of ambient air particles and/or pathogens and/or micro-organisms, and/or any of the alike. Typically, when less or no air is introduced within medical substances, the chances of contamination by pathogens, such as, bacteria, viruses, funguses, spores, pyrogens or the alike is completely abolished or significantly reduced.
[0165] 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.
[0166] 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.
[0167] 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 term pharmaceutical vessel. In an embodiment of the invention, the vessel is a medical device. In an embodiment of the invention, the vessels are used for, and adapted to allow connection to another vessel. In an embodiment of the invention, the vessel is utilized for containing or housing a medical substance. Various types of vessels are contemplated. The vessel may be selected, without limitation, from a vial, a syringe, a bag, a chamber, a bottle, a container, a cartridge and the alike. In an embodiment of the invention, the term vessel further encompasses elements that can be used to connect between vessels. In accordance with this embodiment, the vessel may be selected, without limitation, from a connector, a connector having a plurality of openings, a syringe, an infusion line, a tubing, an infusion line, a spike, a syringe, a filter, a port and a manifold. In one or more embodiments, the first container is a bag. In one or more embodiments, the herein system include a first vessel and a second vessel. In one or more embodiments, the first vessel is a cartridge configured to fill the second vessel. In accordance with this embodiment, the cartridge includes a mechanism for allowing the fluid transfer. Suitable fluid transfer mechanisms may include, without limitation a plunger, and a moveable wall. Optionally, the cartridge may have various forms, such as a syringe, a vial, a bottle, a bag, etc. In one or more embodiments, the first vessel is a bottle. In one or more embodiments, the first vessel is a syringe and the second vessel is a bag, or vice versa. In one or more embodiments, the first vessel is a syringe and the second vessel is a bottle, or vice versa. In one or more embodiments, the first vessel is a cartridge with a moveable wall and the second vessel is a bag. In one or more embodiments, the first vessel is a cartridge with a plunger and the second vessel is a bag. In one or more embodiments, the first vessel is a cartridge with a moveable wall and the second vessel is a bottle. In one or more embodiments, the first vessel is a cartridge with a plunger and the second vessel is a bottle. In one or more embodiments, at least one of the first and second containers is a bag. In one or more embodiments, at least one of the first and second vessels is a bottle. In one or more embodiments, the vessel is a cartridge having a plunger and protective side walls.
[0168] 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 by a piercing member or breaking/rupturing thereof. Optionally, the vessels and/or ports of the systems are provided with seals/covers and those seals/covers are opened upon uncovering or removing thereof by a user. Optionally, one or more of the seals/covers disclosed herein are fragile, allowing piercing thereof with a sharp instrument (i.e., a piercing member) or by the application of a sufficient force to break or rupture the seals/covers. The piercing member may optionally be a needle, for example, a hollowed needle, but other sharp elements are contemplated. In one or more embodiments, the seals/covers may be peelable.
[0169] 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 two containers, between two bottles, between a syringe and a bag, between a syringe and a container, between a syringe and a vial, between a connector and a bag, between a container and a bag, between a vial and a bag, between a container and an infusion line or between a syringe and a connector. In an embodiment of the invention, the herein disclosed devices and systems are disposable. In an embodiment of the invention, the herein disclosed devices and systems are non-disposable.
[0170] Referring now to the drawings,
[0171] It is to be noted that similar lock -unlock mechanisms may be incorporated to various forms of vessels, such as cartridges, vials, bottles, etc. As shown in
[0172] As depicted herein above and in the following examples, various forms of the lock/unlock mechanisms are applicable and contemplated, for example, the lock/unlock mechanisms may include a pin (e.g., a retractable/rotatable pin), a ball (e.g., a retractable/rotatable ball), a clamp, a latch, an elongated arm, and combinations thereof.
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[0185] Systems with a decontamination device having a moveable wiping member that can be used as connectors are shown in
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[0187] A system 3100 is shown in
[0188]
[0189] 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.
[0190] Each of the phrases consisting of and consists of, as used herein, means including and limited to.
[0191] 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.
[0192] 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.
[0193] 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.
[0194] 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.
[0195] 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.
[0196] 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.
[0197] 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.