Method and apparatus for contamination-free transfer of a hazardous drug
A method for contamination-free transfer of liquid from one container to another, and devices to carry out the method are disclosed. Contamination-free transfer means that during the transfer process there is no (1) leakage of (a) the liquid, (b) air contaminated by the liquid, and (c) vapor from the liquid to the surroundings, and (2) surrounding contaminants from outside the containers that contact the liquid. The method's advantages include its simplicity, and the contamination-free transfer as defined above. The devices are adapted to effect contamination-free transfer of a hazardous drug to and from any container equipped with a standard connector port.
1. A connector section for use in a fluid transfer operation, said connector section comprising a hollow cylindrical outer body having:
(a) a distal shoulder portion radially protruding from said outer body and terminating with an opening through which a 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 a distal end of a fluid transfer apparatus;
(c) a needle holder protruding into the interior of said outer body from the central portion of said closed proximal cap for retaining therein at least one conduit comprising a sharp pointed end and further provided with an aperture through which fluid is transferred during said 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.
2. A connector section according to claim 1 , 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 the 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.
3. A connector section according to claim 2 , 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.
4. A connector section according to claim 1 , wherein when the double membrane seal actuator is at the distal end of the cylindrical body of said conductor section, the sharp pointed end of the at least one conduit are located between the proximal membrane and the distal membrane of said double membrane seal actuator.
5. A connector section according to claim 3 , 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 at least one conduit are such that, when said actuator and said attached fluid transfer component are displaced proximally, the sharp pointed end of said at least one conduit penetrates the distal membrane of said actuator and the membrane in the membrane enclosure, thereby establishing a fluid path 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 end of said at least one conduit is pulled back through said distal membrane of said actuator and said membrane in said membrane enclosure, thereby breaking the fluid path between said connector section and said fluid transfer component.
6. A method for coupling the connector section of claim 1 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 a 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 a 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 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 end of the at least one conduit penetrates the distal membrane of said actuator and the membrane in said membrane enclosure, thereby establishing a fluid path 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 end of said at least one conduit is pulled back through said distal membrane of said actuator and said membrane in said membrane enclosure, thereby breaking said fluid path between said connector section and said fluid transfer component.
7. A method according to claim 6 wherein the structure of the connector section enables the connector section and the fluid transfer component 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.