초록 ▼

The invention is a method that allows contamination-free transfer of a liquid from one container to another and devices including embodiments of a transfer apparatus and adaptors that are used to carry out the method. By contamination-free transfer of liquid it is meant that during the transfer proc

The invention is a method that allows contamination-free transfer of a liquid from one container to another and devices including embodiments of a transfer apparatus and adaptors that are used to carry out the method. By contamination-free transfer of liquid it is meant that during the transfer process there is no leakage of the liquid or air contaminated by the liquid or vapors of the liquid to the surroundings and also that no contaminants from the surroundings come into contact with the liquid. The main advantages of the method, in addition to its simplicity, is that at no stage of the transfer procedure is there leakage of the liquid or air contaminated by the liquid or vapors of the liquid to the surroundings and also that no contaminants from the surroundings come into contact with the liquid. The present invention is particularly directed towards providing an apparatus that is adapted to effect contamination-free transfer of a hazardous drug to and from any container equipped with a standard connector port.

대표청구항 ▼

1. A method for the contamination-free transfer of liquid from a first container containing a volume of said liquid and at least an equal volume of gas to a second container containing at least a volume of gas equal to the amount of liquid that is to be transferred into it, said method comprising th

1. A method for the contamination-free transfer of liquid from a first container containing a volume of said liquid and at least an equal volume of gas to a second container containing at least a volume of gas equal to the amount of liquid that is to be transferred into it, said method comprising the steps of: (a) providing a fluid transfer apparatus comprising: a closed container having a moveable internal partition that divides the interior of said container into two separate fluid tight chambers having variable volume, wherein one of said chambers is a gas chamber and the other of said chambers is a liquid chamber; and a first segment of a gas channel and a first segment of a liquid channel, wherein the proximal ends of said first segments are in fluid communication with the interiors of said gas chamber and said liquid chamber respectively and the distal ends of said first segments are enclosed by sealing means;(b) providing a second segment of a gas channel and a second segment of a liquid channel, wherein the distal ends of said second segments are in fluid communication with the interior of said first container and the proximal ends of said second segments are enclosed by sealing means;(c) pushing the distal end of said first segments in the direction of the proximal end of said second segments until the distal ends of said first segments penetrate said sealing means at the distal end of said first segments, penetrate said sealing means at the proximal end of said second segments, and enter the proximal ends of said second segments, thereby providing a continuous gas channel between the interior of said first container and the interior of said gas chamber and a separate continuous liquid channel between the interior of said first container and the interior of said liquid chamber;(d) allowing an equilibrium to be established between the pressure of the gas in said first container and the pressure of the gas in said gas chamber and between the pressure exerted on the liquid in said first container and the pressure exerted on the liquid in said liquid chamber;(e) moving said internal partition in a first direction in order to increase the volume of said liquid chamber and instantaneously decrease the pressure inside said liquid chamber and simultaneously decrease the volume of said gas chamber and instantaneously increase the pressure of said gas inside said gas chamber, wherein the differences of pressure caused by moving said internal partition cause liquid to flow from said first container through said continuous liquid channel into said liquid chamber and an equal volume of gas to flow simultaneously from said gas chamber through said continuous air channel into said first container, wherein said flow of liquid in one direction and simultaneous flow of gas in the other direction continues until said internal partition stops moving and said equilibrium is reestablished;(f) disconnecting said first container from said fluid transfer device by pulling the distal ends of said first segments back out of the proximal ends of said second segments, through said sealing means at the proximal end of said second segments, thereby enclosing the ends of said second segments, and through said sealing means at the distal end of said first segments, thereby enclosing the ends of said first segments;(g) providing a third segment of a gas channel and a third segment of a liquid channel, wherein the distal ends of said third segments are in fluid communication with the interior of said second container and the proximal ends of said third segments are enclosed by sealing means;(h) pushing the distal end of said first segments in the direction of the proximal end of said third segments until the distal ends of said first segments penetrate said sealing means at the distal end of said first segments, penetrate said sealing means at the proximal end of said third segments, and enter the proximal ends of said third segments, thereby providing a continuous gas channel between the interior of said second container and the interior of said gas chamber and a separate continuous liquid channel between the interior of said second container and the interior of said liquid chamber;(i) allowing an equilibrium to be established between the pressure of the gas in said second container and the pressure of the gas in said gas chamber and between the pressure exerted on the liquid in said second container and the pressure exerted on the liquid in said liquid chamber;(j) moving said internal partition in a second direction in order to decrease the volume of said liquid chamber and instantaneously increase the pressure inside said liquid chamber and simultaneously increase the volume of said gas chamber and instantaneously decrease the pressure of said gas inside said gas chamber, wherein the differences of pressure caused by moving said internal partition cause liquid to flow from said liquid chamber through said continuous liquid channel into said second container and an equal volume of gas to flow simultaneously from said second container through said continuous air channel into said gas chamber, wherein said flow of liquid in one direction and simultaneous flow of gas in the other direction continues until said internal partition stops moving and said equilibrium is reestablished; and(k) disconnecting said second container from said fluid transfer device by pulling the distal ends of said first segments back out of the proximal ends of said third segments, through said sealing means at the proximal end of said third segments, thereby enclosing the ends of said third segments, and through said sealing means at the distal end of said first segments, thereby enclosing the ends of said first segments;said method characterized in that all of the liquid and the gas that flows between said fluid transfer device and said first container was present in either said fluid transfer device or said first container before said continuous liquid and gas channels between them were provided and all of the liquid and the gas that flows between said fluid transfer device and said second container was present in either said fluid transfer device or said second container before said continuous liquid and gas channels between them were provided. 2. A method according to claim 1, wherein if the second container does not contain a volume of gas that is at least equal to the volume of liquid to be transferred, then the gas chamber is not in fluid communication with the interior of said second container and the distal end of the third segment of gas channel is connected to a one-way valve, thereby allowing filtered air from the surroundings to flow into said gas chamber as said liquid flows from the liquid chamber into said second container. 3. A method according to claim 1, wherein the liquid is a hazardous drug. 4. A fluid transfer apparatus comprising: (a) a syringe-like proximal section comprising: (i) a cylindrical body;(ii) a tubular throat;(iii) a separating element that prevents the passage of fluids between said connector section and said throat; and(iv) a piston that is displaceable within said cylindrical body, said piston defining a distal liquid chamber and a proximal gas chamber, both of variable volume;(b) a connector section fixedly attached to the distal end of said throat of said proximal section, wherein the distal end of said connector section is adapted to be connectable to a fluid transfer component;(c) a liquid conduit that passes through and is rigidly attached to said separating element, wherein the distal end of said liquid conduit begins in said connector section and the proximal end of said liquid conduit terminates in said liquid chamber;(d) a gas conduit that passes through and is rigidly attached to said separating element, wherein the distal end of said gas conduit begins in said connector section and the proximal end of said gas conduit terminates in said gas chamber; and(e) a membrane located at the distal end of said connector section, wherein said membrane encloses the distal ends of said liquid conduit and said gas conduit isolating them from the surroundings;characterized in that, said connector section is configured to allow a head portion of said fluid transfer component to enter the interior of said connector section and to allow said membrane in said connector section to be pushed proximally when it is contacted by a membrane located in said head portion of said fluid transfer component; whereupon further pushing of said membranes together causes said distal ends of said liquid conduit and said air conduit to penetrate said membrane in said connector section and a central seal in said head portion, thereby establishing an open liquid channel via said liquid conduit between the interior of said liquid chamber and the interior of said fluid transfer component and a separate open air channel via said air conduit between the interior of said air chamber and the interior of said fluid transfer component. 5. An apparatus according to claim 4, wherein the connector section comprises a distal collar formed integrally with, or connected to the throat and suitably sized to surround the head portion of the fluid transfer component, and locking elements connected to said collar and adapted to releasably engage the distal edge of the head portion of the fluid transfer component. 6. An apparatus according to claim 5, wherein the membrane located at the distal end of the connector section is a deformable membrane having the shape of a truncated cone, which is firmly attached at its base to the separating element and distally extends to the distal end of the distal collar. 7. An apparatus according to claim 6, comprising safety means for preventing deformation of the membrane. 8. A method for coupling the apparatus of claim 5 to a fluid transfer component in order to affect a secured double membrane engagement, said method comprising the steps of: (a) positioning the head portion of the fluid transfer component close to the distal collar;(b) moving said head portion and said distal collar axially closer together until the membrane located in said head portion contacts the deformable membrane in the connector section;(c) continuing to move said head portion and said distal collar axially closer together compressing said deformable membrane in said connector section until the distal ends of the liquid and air conduits penetrate through both of said membranes;(d) continuing to move said head portion and said distal collar axially closer until the locking elements connected to said collar releasably engage the distal edge of said head portion. 9. A method according to claim 8, wherein the connector section of the liquid transfer device is coupled to the liquid transfer component by carrying out one axial motion. 10. An apparatus according to claim 4, wherein the connector section comprises a hollow cylindrical outer body having: (a) a distal shoulder portion radially protruding from said outer body and terminating with an opening through which the proximal end of a fluid transfer component can be inserted for coupling;(b) a closed proximal cap having a central portion comprising connection means protruding proximally from it to connect to the distal end of the syringe-like proximal portion of said apparatus;(c) a needle holder protruding into the interior of said outer body from a central portion of said closed proximal cap for retaining therein two conduits comprising sharp pointed ends and further provided with apertures through which liquid and gas respectively are transferred during a fluid transfer operation; and(d) a double membrane seal actuator reciprocably displaceable within the hollow interior of said outer body;wherein said double membrane seal actuator comprises: (i) a cylindrical actuator casing;(ii) a proximal membrane that seals the proximal end of said casing(iii) a distal membrane that seals the distal end of said casing, wherein a part of said distal membrane protrudes distally from said casing; and(iv) at least two resilient arms which are connected at a proximal end thereof to an intermediate portion of the exterior of said casing and comprise enlarged elements at their distal ends. 11. An apparatus according to claim 10, wherein when the double membrane seal actuator is at the distal end of the cylindrical body of said connector section the enlarged elements of the resilient arms are pressed into the distal shoulder portion of the cylindrical body of said connector section, thereby allowing the membrane enclosure at the proximal end of a fluid transfer component to be inserted into the opening at the distal end of said connector section and advanced until said membrane in said membrane enclosure contacts the part of the distal membrane that protrudes distally from the casing of said double membrane seal actuator. 12. An apparatus according to claim 11, wherein the diameter of the distal shoulder portion and the size of the enlarged elements at the distal end of the arms are such that, when an axial force is applied to push the double membrane seal actuator and fluid transfer component towards each other, the sides of the membrane enclosure prevent said enlarged elements at the distal end of the arms from moving radially inwards thereby causing the distal actuator membrane to be compressed against the membrane in said membrane enclosure until the sides of said membrane enclosure are displaced proximally in relation to said enlarged elements; at which point said enlarged elements have room to move radially inwards, are released from the distal shoulder portion of said double membrane seal actuator, and abut the distal underside of said membrane enclosure; thereby locking said distal actuator membrane against said membrane in said membrane enclosure in secured and compressed engagement, preventing disengagement of said actuator from said fluid transfer component, and allowing said actuator and said coupled fluid transfer component to be reciprocably displaced within the hollow interior of the outer body of said connector section. 13. An apparatus according to claim 12, wherein the distance that the actuator and attached fluid transfer component can be displaced proximally within the hollow interior of the outer body of said connector section and the length of the two conduits are such that, when said actuator and said attached fluid transfer component are displaced proximally, the sharp pointed ends of said two conduits penetrate the distal membrane of said actuator and the membrane in the membrane enclosure, thereby establishing a liquid path and a gas path respectively between said connector section and said fluid transfer component; and, when said actuator and attached fluid transfer component are displaced distally within said hollow interior of said outer body of said connector section, said sharp pointed ends of said two conduits are pulled back through said distal membrane of said actuator and said membrane in said membrane enclosure, thereby breaking the liquid path and the gas path respectively between said connector section and said fluid transfer component. 14. An apparatus according to claim 10, wherein when the double membrane seal actuator is at the distal end of the cylindrical body of said conductor section, the sharp pointed ends of the two conduits are located between the proximal membrane and the distal membrane of said double membrane seal actuator. 15. A method for coupling the apparatus of claim 10 to a fluid transfer component in order to affect a secured double membrane engagement, said method comprising the steps of: (a) positioning the opening in the distal shoulder portion of the outer body of said connector section in the vicinity of the proximal end of said fluid transfer component;(b) initiating a double membrane engagement operation by distally displacing the outer body of said connector section until the membrane enclosure at the proximal end of said fluid transfer component is received in the interior of said connector section;(c) additionally displacing distally said outer body relative to said fluid transfer component until the distal membrane of said actuator contacts and is pressed against the membrane in said membrane enclosure at the proximal end of said fluid transfer component, wherein during this step the enlarged elements at the distal end of the arms attached to the double membrane seal actuator are held in the distal shoulder portion of said outer body of said connector section by the sides of said membrane enclosure, thereby preventing said actuator from moving proximally within said outer body of said connector section; and(d) additionally displacing distally said outer body relative to said fluid transfer component until said distal membrane of said actuator and said membrane in said membrane enclosure at the proximal end of said second fluid transfer component are compressed together sufficiently to allow said sides of said membrane enclosure to pass said enlarged elements, allowing said arms to move radially inwards, thereby locking said distal actuator membrane against said membrane in said membrane enclosure in secured and compressed engagement, preventing disengagement of said actuator from said fluid transfer component, and allowing said actuator and said attached fluid transfer component to be reciprocably displaced within the hollow interior of the outer body of said connector section, whereupon when said actuator and attached fluid transfer component are displaced proximally within the hollow interior of said outer body of said connector section, the sharp pointed ends of the two conduits penetrate the distal membrane of said actuator and the membrane in said membrane enclosure, thereby establishing separate liquid and gas paths between said connector section and said fluid transfer component; and, when said actuator and attached fluid transfer component are displaced distally within said hollow interior of said outer body of said connector section, said sharp pointed ends of said two conduits are pulled back through said distal membrane of said actuator and said membrane in said membrane enclosure, thereby breaking said liquid and gas paths between said connector section and said fluid transfer component. 16. A method according to claim 15 wherein the structure of the connector section enables the connector section and the fluid transfer components to be connected by a single axial motion and disconnected by a single axial motion without having to set a locking securing device or a release mechanism.