Abstract
The invention is a needle valve and connectors for use in liquid transfer apparatuses. The needle valve of the invention is not the conventional type of needle valve known in the art that comprises a threaded valve stem, which allows very accurate control of the flow through the valve, and that uses elastic materials, such as rubber, as a sealing component. The needle valve of the invention comprises two components: the first component is a hollow needle having a smooth exterior surface and a port at the side of the cylindrical shaft, the second component is a seat made of rigid material e.g. plastic with low friction properties.
Claims
1. A needle valve comprised of: a) at least one hollow needle comprised of a smooth surfaced hollow shaft and a port located in the side of said shaft at the distal end close to the tip of said hollow needle, said port adapted to allow fluid communication between the interior and the exterior of said hollow needle; and b) a seat made of rigid material, said seat comprising at least one bore adapted to accommodate one of said at least one hollow needles through said seat; wherein: i) said hollow needle can be pushed back and forth through said bore; and ii) the outer diameter of said hollow needle and the inner diameter of at least part of said bore are so closely matched that the presence of the shaft of said hollow needle in said bore blocks the passage of fluid through said part of said bore.
2. The needle valve of claim 1, wherein the seat is made of plastic with low friction properties.
3. The needle valve of claim 2, wherein the plastic with low friction properties is acetal plastic.
4. The needle valve of claim 1, comprising a lubricant for reducing the friction between the needle and the seat.
5. A connector for connecting two components of a fluid transfer apparatus to each other, said connector comprising: i) a cylindrical, hollow outer body; ii) a connection port adapted to connect to a first fluid transfer component, said connection port located on the outside of said outer body at its proximal end; iii) a needle holder located on the inside of said outer body at its proximal end; iv) a needle that functions as a fluid conduit, wherein said needle passes through and is rigidly attached to said needle holder, the distal end of said needle comprises at least one port that allows fluid communication between the outside and the inside of said needle; v) a single membrane seal actuator reciprocally displaceable within the hollow interior of said connector; said single membrane seal actuator comprising: a cylindrical actuator casing; a distal membrane that seals the distal end of said casing, wherein a part of said distal membrane protrudes distally from said casing; and at least one resilient arm which is connected at a proximal end thereof to an intermediate portion of the exterior of said casing and comprises enlarged locking elements at its distal end; said enlarged locking element having specifically shaped surface areas which interact with an inner wall of said cylindrical, hollow outer body of said connector to enable a four step procedure for connecting or separating said connector to a second fluid transfer component; said connector characterized in that said single membrane seal actuator comprises a rigid plastic needle valve seat located proximally of said membrane, said needle valve seat comprising a bore, wherein said bore is adapted to each allow said needle to be pushed back and forth through it and at least a portion of each of said bore is adapted such that fluid cannot pass through said portion when said needle is at least partially located in said bore; wherein, said connector is configured to allow a head portion of said second fluid transfer component to enter the interior of said connector and to allow said single membrane actuator to be pushed proximally when said membrane at its distal end is contacted by a membrane located in said head portion of said second fluid transfer component; whereupon further pushing of said membranes together causes said distal end of said needle to exit the distal end of said bore and to penetrate said membrane in said single membrane actuator and to penetrate said membrane in said head portion, thereby establishing a fluid channel via said needle between said connection port and the interior of said second fluid transfer component.
6. The connector of claim 5, wherein the port at the distal end of needle that allows exchange of fluid between the surroundings and the hollow interior of said needle is completely blocked by the interior of the bore in seat of the needle valve when said connector is not connected to a second fluid transfer component.
7. A fluid transfer apparatus comprising: a) a syringe-like proximal section comprising: i) a cylindrical body; ii) 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 attached to the distal end of said proximal section, wherein the distal end of said connector section is adapted to be connectable to a fluid transfer component, said connector section comprising: i) a cylindrical, hollow outer body; ii) a needle holder; iii) a first needle that functions as a liquid conduit, wherein said first needle passes through and is rigidly attached to said needle holder, the distal end of said first needle comprises at least one port that allows fluid communication between the outside and the inside of said first needle, the distal end of said first needle is located in said connector section, and the proximal end of said first needle is located in said liquid chamber; iv) a second needle that functions as a gas conduit, wherein said second needle passes through and is rigidly attached to said needle holder, the distal end of said second needle comprises at least one port that allows fluid communication between the outside and the inside of said second needle, the distal end of said second needle is located in said connector section, and the proximal end of said second needle is located in said gas chamber; v) a single membrane seal actuator reciprocally displaceable within the hollow interior of said connector section; said single membrane seal actuator comprising: a cylindrical actuator casing; a distal membrane that seals the distal end of said casing, wherein a part of said distal membrane protrudes distally from said casing; and at least one resilient arm which is connected at a proximal end thereof to an intermediate portion of the exterior of said casing and comprises enlarged locking elements at its distal end; said enlarged locking element having specifically shaped surface areas which interact with an inner wall of said cylindrical, hollow outer body of said connector section to enable a four step procedure for connecting or separating said connector section to a fluid transfer component; said fluid transfer apparatus characterized in that said single membrane seal actuator comprises a rigid plastic needle valve seat located proximally of said membrane, said needle valve seat comprising two bores, wherein each of said bores is adapted to each allow one of said first and second needles to be pushed back and forth through it and at least a portion of each of said bores is adapted such that fluid cannot pass through said portion when said first and second needles are at least partially located in the respective one of said bores; wherein, 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 single membrane actuator to be pushed proximally when said membrane at its distal end 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 first needle and said second needle to exit the distal end of their respective bores and to penetrate said membrane in said single membrane actuator and to penetrate said membrane in said head portion, thereby establishing a liquid channel via said first needle between the interior of said liquid chamber and the interior of said fluid transfer component and a separate gas channel via said second needle between the interior of said gas chamber and the interior of said fluid transfer component.
8. The fluid transfer apparatus of claim 7, wherein the ports at the distal ends of both the first needle and the second needle are located in the seat of needle valve and are fully sealed by the bores in which they are located thereby isolating the interiors of said first needle and said second needle from each other when the distal end of the connector section is not attached to any other fluid transfer component.
9. The fluid transfer apparatus of claim 7, wherein the ports at the distal ends of both the first needle and the second needle are located in the seat of needle valve and are open thereby allowing fluid communication between the interiors of said first needle and said second needle when the distal end of the connector section is not attached to any other fluid transfer component.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) FIG. 1 is a schematic cross-sectional view of a prior art apparatus for transferring hazardous drugs;
(2) FIG. 2a to FIG. 2d are cross-sectional views that schematically show the 4 steps connection sequence between the connector section and the vial adaptor of the apparatus of FIG. 1;
(3) FIG. 3a and FIG. 3b are cross-sectional views that schematically show the concept of using the apparatus of FIG. 1 for transferring hazardous drugs;
(4) FIG. 4a, FIG. 4b, and FIG. 4c schematically show the needle valve of the invention;
(5) FIG. 5a to FIG. 8b are cross-sectional views that schematically show different embodiments of the needle valve of the invention;
(6) FIG. 9a and FIG. 9b schematically show an embodiment of the needle valve of the invention that comprises two ports that allow fluid communication between the outside and interior of the needle shaft;
(7) FIG. 9c and FIG. 9d schematically show an embodiment of the needle valve of the invention in which the seat of the valve comprises a side channel that allows fluid communication between the interior of the needle shaft and a remote location via the port in the side of the needle;
(8) FIG. 10a and FIG. 11a are schematic cross-sectional views of an apparatus for transferring hazardous drugs identical to that shown in FIG. 1 and FIG. 2a respectively, with the exception that the prior art double membrane seal actuator is replaced with an actuator comprising an embodiment of the needle valve of the present invention;
(9) FIG. 10b and FIG. 11b are enlarged views of the actuator in the apparatus shown in FIG. 10a and FIG. 11a respectively;
(10) FIG. 12 shows another embodiment of an actuator comprising another embodiment of the needle valve of the invention that could be used in the apparatus of FIG. 10a and FIG. 10b;
(11) FIG. 13a schematically shows a connector comprising an actuator comprising a needle valve of the invention and an adapter configured to connect the connector to a component of a drug transfer apparatus;
(12) FIG. 13b shows the connector and adapter of FIG. 13a connected together;
(13) FIG. 14 and FIG. 15 show engineering drawings of the connectors described in FIG. 10a to FIG. 12.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
(14) The present invention is a new type of needle valve and connectors for use in liquid transfer apparatuses that comprise the needle valve. The needle valve of the invention is not the conventional type of needle valve known in the art that comprises a threaded valve stem, which allows very accurate control of the flow through the valve, and that uses elastic materials, such as rubber, as a sealing component. The needle valve of the invention comprises two components: the first component is a hollow needle having a smooth exterior surface and a port at the side of the cylindrical shaft, the second component is a seat made of rigid material e.g. plastic with low friction properties. A lubricant for further reducing the friction between the needle and the seat is desired and preferred, but the needle valve works also without a lubricant.
(15) FIG. 4a shows three embodiments of hollow needle 200 such as needles 38 and 40 in FIG. 1. Needle 200 comprises a smooth surfaced hollow shaft 202 and a port 204 located in the side of the shaft at the distal end close to tip 206. Port 204 allows fluid communication between the interior of shaft 202 and the exterior of the shaft. Tip 206 is generally pointed as shown in FIG. 4a, but in embodiments of the valve the tip can have other shapes, e.g. round or flat.
(16) FIG. 4b shows the simplest embodiment of the seat 208 of the valve. In this embodiment, seat 208 is a cylindrical block of a rigid material such as acetal plastic, with a bore 210 through it.
(17) FIG. 4c shows the shaft of the needle inserted into the bore in the seat. The seat 208 is made of a rigid material such as acetal plastic, which has good dimensional stability and a very low coefficient of friction. This allows the valve to be manufactured with the outer diameter of needle 200 and the inner diameter of bore 210 so closely matching that, on the one hand, needle 200 can be pushed back and forth through bore 210 and, on the other hand, the presence of the shaft 202 of needle 200 in the bore 210 blocks the passage of fluid (gas or liquid) through bore 210.
(18) FIG. 5a to FIG. 8b are cross-sectional views that schematically show different embodiments of the needle valve of the invention. Each of these figures shows two views of the valve. In the left view (labeled a) the port 204 is located within the bore 210 in the seat 208 and in the right view (labeled b) the needle has been pushed distally so that the port 204 has exited the bore 210.
(19) In the embodiment of the valve shown in FIG. 5a and FIG. 5b fluid communication between the outside and the interior of the shaft 202 through port 204 is blocked by the walls of the bore in FIG. 5a and is allowed between the space below the valve and the interior of the needle in the FIG. 5b. In this embodiment, no matter what the position of the port 204 relative to seat 208 there is no fluid communication between the interior of the needle and the space above the valve.
(20) In the embodiment of the valve shown in FIG. 6a and FIG. 6b the diameter of bore 210 in seat 208 is increased after bore 210 penetrates a short distance into seat 208 creating a chamber 210 having a much larger diameter then that of the shaft 202 of needle 200. In this embodiment bore 210 seals the shaft 202 above the port 204, thereby preventing fluid communication between the space above the valve and the interior of the needle but always allowing fluid communication between the space below the valve and the interior of the shaft 202 through port 204 is always allowed.
(21) In the embodiment of the valve shown in FIG. 7a and FIG. 7b the bore through the seat 208 is created with chambers 210 at the top and bottom and a section of the bore 210 having diameter essentially equal to that of the outer diameter of the shaft 202 of needle 200. This embodiment allows fluid communication between the space above the valve and the interior of the shaft 202 through port 204 as shown in FIG. 7a and between the space below the valve and the interior of the needle as shown in FIG. 7b.
(22) In the embodiment of the valve shown in FIG. 8a and FIG. 8b, the valve is identical with the valve shown in FIG. 5a and FIG. 5b and in addition the bottom of the seat comprises a recess 212 into which a resilient elastic membrane 34b is inserted. The membrane serves as a barrier between the port 204 and the environment, preventing contaminants such as microorganisms from contaminating the bore and the needle tip retained in it, thereby maintaining sterility. On the other hand the membrane also protects the environment from hazardous substances present as residuals on the needle tip, which might be present after transfer of fluids through the needle.
(23) FIG. 9a and FIG. 9b schematically show an embodiment of the needle valve of the invention that comprises two ports that allow fluid communication between the outside and interior of the needle shaft. In FIG. 9a port 204 is blocked by the walls of bore 210 and fluid communication between the space above the valve and the interior of the needle is allowed through port 204. In FIG. 9b fluid communication between the space below the valve and the interior of the needle is allowed through port 204 while the port 204 is blocked. This embodiment of needle valve is usable in applications with more than one fluid chamber that needs to be accessed by the needle ports, such as reconstitution devices. Typically such devices have chambers for lyophilized powder and chambers for diluents. A membrane pierced by the shaft and located between port 204 and the top of seat 208 can be used to separate the multiple chambers. It is noted that embodiments of the needle valve of the invention similar to the embodiment shown in FIG. 9a and FIG. 9b with three or more ports in the side of the needle can be produced.
(24) FIG. 9c and FIG. 9d schematically show an embodiment of the needle valve of the invention in which the seat 208 of the valve comprises a side channel 216 that allows fluid communication between the interior of the needle shaft and a remote location (not shown) via the port 204 in the side of the needle 200.
(25) The needle valve embodiments described in FIG. 4a to FIG. 9d allow a variety of uses for special needs. They allow improved designs in comparison to existing valves and connectors, improved resistance to high pressures and thereby improved general performance.
(26) FIG. 10a and FIG. 11a are schematic cross-sectional views of an apparatus for transferring hazardous drugs. The apparatus and all of the components shown in these figures are identical to those shown in FIG. 1 and FIG. 2a respectively, with two exceptions. The vial adaptor 15 comprises a filter 50, as described in IL224630 and the prior art double membrane seal actuator 34 in the connector section 14 comprising two membranes 34a and 34b and arms 35 is replaced with an actuator 218 comprising an embodiment of the needle valve of the present invention, only one membrane 34b, and arms 35. It is important to note that in all embodiments of the present invention, including those shown in FIG. 10a through 13b, it is not necessary to seal the proximal end of actuator 218 in any fashion because the task of enclosing the bores 204 at the distal ends of the air and liquid conduits when the connector is not connected to another fluid transfer component, which in the prior art was accomplished by membranes 34a and 34b, is accomplished in the present invention by the needle valve arrangement and membrane 34b alone and in some embodiments by the needle valve itself.
(27) FIG. 10a shows syringe 12 attached to connector section 14 and vial adaptor 15 connected to drug vial 16. FIG. 11a shows all components of the apparatus connected together. FIG. 10b and FIG. 11b are enlarged views of the actuator in the apparatus shown in FIG. 10a and FIG. 11a respectively.
(28) Referring to FIG. 10b and FIG. 11b, actuator 218 comprises a valve seat 208 comprising two bores through which the needles of air conduit 38 and liquid conduit 40 pass. All parts of the actuator (with the exception of membrane 34b and needles 38 and 40) are made from rigid low friction plastic, e.g. acetal, so that needles 38 and 40 slidingly fit into the bores in the seat while preventing passage of liquid or air through the bores. The diameters of the shaft and the bores require fine tuning during the product development phase, since tighter bore causes higher friction and higher pressure resistance, while less tighter bores cause less friction and moderate pressure resistance. The surface quality of the needle influences the friction, as well as the lubricant applied during the manufacture process. Materials such as acetal have excellent low friction properties and allow the valve to function even after the lubricant has been removed due to repeated connections and exposure to aggressive substances in the drugs.
(29) When the syringe and attached connector are not connected to any other component of the apparatus, as shown in FIG. 10b, the actuator 218 is at the distal end of connector section 14 and the tips of needles 38 and 40 are located in the bores in the seat 208 of the needle valve. In this configuration the ports 204 in the sides of the needles are blocked by the interior walls of the bores completely isolating the needles from each other, thereby preventing air from entering the liquid chamber of the syringe or liquid from entering the air chamber even at very high pressures.
(30) When the syringe and attached connector are connected to another component of the apparatus, such as a vial adaptor as shown in FIG. 11b, the actuator 218 is pushed towards the proximal end of connector section 14. Since needles 38 and 40 are fixed to the needle holder 36, as actuator 218 moves proximally, the tips of needles 38 and 40 and ports 204 are pushed out through the distal end of the bores in the seat 208 of the needle valve, through membrane 34b, and through membrane 15a of the vial adaptor, thereby establishing open fluid paths in the respective channels.
(31) The first goal for the connector is to completely eliminate the possibility of migration of liquid to the air chamber. This can happen, for example, if pressure differentials between the air and liquid chambers exist after disconnection from a vial adaptor and if the pressure in the air chamber is lower than that in the liquid chamber, resulting in undesired migration of liquid to the air chamber. The second goal is to prevent leaks or damage to the connector during accidental pushing of the syringe plunger. One of the frequently performed drug transfer operations in hospital settings is known as IV push or bolus injection. Typically the required amount of drug is prepared in a syringe in the hospital pharmacy and delivered to the ward where a qualified nurse administers to the patient the drug through a previously established IV line. A common problem associated with the procedure is that during the trip from pharmacy to ward or at bedside the piston of the syringe is sometimes unintentionally pushed expelling some of the drug from the barrel of the syringe or unintentionally pulled, High pressures of up to 20 atmospheres can be easily generated by manually pushing the plunger of small volume syringes (1-5 ml). Such pressure may cause the connector to disintegrate or the membranes to be detached. The connector shown in FIG. 10a through FIG. 11b solves the problems associated with such unintended transfer of fluids between the air and liquid chambers and resists high pressures created during accidental pushing the of plunger. As can be seen in these figures, when the connector 14 is not connected to the adapter 15, the ports 204 at the distal end of needles 38 and 40 that allow exchange of fluid between the surroundings and the hollow interiors of the needles are blocked by the interior of the bore in seat 208 of the needle valve. If the syringe is filled or partially filled with liquid, then no matter how much force is exerted to try to push the plunger forward and to force liquid to flow through the needle, no liquid can exit the needle through port 204. Conversely, no matter how much force is exerted to pull the plunger backwards no air can enter through port 204 and flow through the interior of the needle into the barrel of the syringe.
(32) FIG. 12 shows another embodiment of an actuator 218 comprising another embodiment of the needle valve of the invention that could be used in the apparatus of FIG. 10a and FIG. 10b. In this embodiment the seat 208 of the needle valve is constructed such that, when the syringe and attached connector are not connected to any other component of the apparatus, the actuator 218 is at the distal end of connector section 14 as shown in the figure. In this configuration the tips and the ports 204 in the sides of needles 38 and 40 are located in the enclosed space 220 between seat 208 of the needle valve and membrane 34b. In this configuration exchange of liquid and air can take place via the two needles.
(33) This connector is similar to the needle valve described in embodiment shown in FIG. 6a and FIG. 6b. In this embodiment the seat 208 seals the shaft of the needles 38 and 40 above the ports 204, thereby preventing fluid communication between the environment above the actuator 218 and the interior of the space 220.
(34) The embodiments of drug transfer apparatus shown in FIG. 1 and FIG. 2a do not comprise a hydrophobic filter barrier to separate the air channel from the liquid channel; therefore the method for discarding air bubbles which are naturally created during withdrawal of liquid from a vial is as follows: the bubbles are ejected from the syringe by disconnecting the vial and holding the syringe with the needles facing up, the air bubbles float naturally above the liquid in the syringe, then the plunger is depressed and the bubbles are pushed to the air chamber. For this procedure a communication between both needle ports is necessary, as exists in the embodiment of the connector 14 shown in FIG. 12.
(35) FIG. 13a schematically shows a connector 222 comprising an actuator 218 comprising a needle valve of the invention and an adapter 228 configured to connect the connector 222 to a component of a drug transfer apparatus. FIG. 13b shows the connector 222 and adapter 228 of FIG. 13a connected together.
(36) Connector 222 comprises at its proximal end a connection port 224 e.g. a female Luer lock, adapted to be connected to a component of a drug transfer apparatus, e.g. a needless syringe or an IV tubing; a single needle 200 comprising a smooth surfaced hollow shaft and a port 204 located in the side of the shaft at the distal end close to the tip; an actuator 218 comprising the seat of a needle valve of the invention 208. A membrane 15a located below the seat 208, and arms 35; and an open distal end 226. The proximal end of needle 200 is fixedly attached to the housing of connector 222 by needle holder 36. The interior of the needle is in fluid communication with the interior of connection port 224. As described herein above, the needle 200 fit slidingly in the bore in seat 208 and prevents fluid from passing through the bore.
(37) Adapter 228 comprises a membrane 234 at its proximal end, an elongated body adapted to fit into the open distal end 226 of connector 222, and at its distal end a connection port 230 e.g. a threaded male Luer lock, adapted to be connected to a component of a drug transfer apparatus, e.g. an IV tubing set. A channel 232 passes through the length of adapter 228 from below membrane 234 through connection port 230.
(38) To connect connector 222 and adapter 228 the proximal end of the adapter is inserted into open distal end 226 of the connector and advanced until membrane 234 contacts membrane 15a. Further pushing of connector and adaptor together causes the tip of needle 200 out of seat of the valve 208 and through membranes 15a and 234 into channel 232, thereby locking connector 222 and adapter 228 together by means of arms 35, as shown in FIG. 13b, and establishing an open fluid path from connection port 224 on connector 222 to connection port 230 on adapter 228.
(39) The connector shown in FIG. 13a like the connector shown in FIG. 10a through FIG. 11b prevents all problems associated with high pressures in general and those specifically created during accidental pushing the of plunger. As can be seen in this figure, when the connector 222 is not connected to the adapter 234, the port 204 at the distal end of needle 200 that allows exchange of fluid between the surroundings and the hollow interior of the needle is blocked by the interior of the bore in seat 208 of the needle valve. If a syringe filled or partially filled with liquid is attached to connection port 224, then no matter how much force is exerted to try to push the plunger forward and to force liquid to flow through the needle, no liquid can exit the needle through port 204. Conversely, no matter how much force is exerted to pull the plunger backwards no air can enter through port 204 and flow through the interior of the needle into the barrel of the syringe.
(40) FIG. 14 and FIG. 15 are engineering drawings of two embodiments of a connector comprising needle valves according to the present invention. In the embodiment shown in FIG. 14 the ports near the tips of both the air and the liquid conduit are fully sealed and isolated from each other. In the embodiment shown in FIG. 15 the ports near the tips of the air and the liquid conduit are open to allow fluid communication between them.
(41) Although embodiments of the invention have been described by way of illustration, it will be understood that the invention may be carried out with many variations, modifications, and adaptations, without exceeding the scope of the claims.
