Connector section

Abstract

A locking element for a connector configured to connect two components of a fluid transfer system and a connector that comprises the locking element are described. The connector comprising the locking element is configured to provide continuous fluid channels between a first component and a second component of a fluid transfer system, the fluid is a hazardous drug and the connector is designated for safe and contamination-free transfer of said hazardous drug from first to second container while isolating the needle tips and causing no dangerous and harmful leaks.

Claims

1. A locking element for a connector configured to connect a first component to a second component of a fluid transfer system, the locking element comprising: a. a body comprising an upper part having a hollow interior and a lower part having a channel passing through it; b. elongated flexible arms having distal enlarged elements attached to the sides of the upper part of the body and projecting downwards parallel to the sides of lower part of the body; and c. an insert configured to be inserted into the channel, wherein the insert is made of flexible material and comprises at least one bore passing through it which forms a sleeve through which at least one hollow needle is able to pass; characterized in that the locking element comprises a rigid flat plastic annular disc at the free end of the lower part of the body; the rigid flat plastic annular disc configured to be pressed tightly against a septum that seals against a proximal end of the second component of the fluid transfer system.

2. The locking element of claim 1, comprising two bores through the insert.

3. A connector configured to connect a first component to a second component of a fluid transfer system, the connector comprising: a. a hollow cylindrical body that has a closed upper end comprising an exterior side and an interior side, the upper end comprising a connection arrangement on the exterior side and a needle holder on the interior side, the connector configured to connect to the first component of the fluid transfer system; b. a locking element according to claim 1, wherein the body of the locking element is surrounded by the cylindrical body of the connector and is configured to slide up and down inside the hollow interior of the cylindrical body of the connector; c. an open lower end of the cylindrical body configured to allow an end of the second component of the fluid transfer system to be inserted into the interior of the cylindrical body; d. shoulder portions at the open lower end of the cylindrical body into which the enlarged elements of elongated flexible arms of the locking element fit when the connector is not connected to the second component of the fluid transfer system; and e. at least one hollow needle fixedly attached the needle holder, the at least one needle comprising an opening near its distal tip, the opening configured to allow passage of fluid between the interior and exterior of the needle, wherein the at least one needle extends through the hollow interior of the upper part of the body of the locking element into the insert in the at least one bore in the channel in the lower part of the body of the locking element.

4. The connector of claim 3 comprising two hollow needles and two bores through the insert.

5. The connector of claim 3 comprising one hollow needle and one bore through the insert.

6. The connector of claim 3 comprising one hollow needle and two bores through the insert.

7. The connector of claim 3 wherein, when the connector is not connected to the second component of the fluid transfer system, the locking element is at the distal end of the cylindrical body of the connector, distal enlarged elements of elongated flexible arms of the locking element are fit into shoulder portions at the open lower end of the cylindrical body of the connector, and the tips of the needles are located in the bores in the insert, whereupon the openings in the sides of the needles are blocked by the interior walls of the bores thereby completely isolating the needles from each other and the outside environment preventing passage of fluid between the interiors and exteriors of the needles and exchange of fluid with the surroundings.

8. A method of using the connector of claim 3 to provide continuous fluid channels between a first component and a second component of a fluid transfer system, the method comprising: a) connecting the first component to the connection arrangement on the cylindrical body of the connector; b) inserting the proximal end of the second component into the open lower end of the cylindrical body of the connector, wherein the second component comprises a septum that seals its proximal end; c) pushing the connector and the second component together axially until the septum at the proximal end of the second component is pressed tightly against the plastic annular disc at the distal end of the locking element; d) continue pushing the connector and second component together axially until the locking element and attached second component begin to slide upwards inside the hollow interior of the cylindrical body, thereby forcing the distal enlarged elements of the elongated flexible arms of the locking element to slide out of the shoulder portions at the distal end of the connector into recesses on the side of the exterior surface of the second component thereby attaching the locking element to the second component; e) continue pushing the connector and second component together axially causing the locking element and attached second component to continue sliding upwards inside the hollow interior of the cylindrical body of the connector until the tips of the needles are pushed out of the bores in the insert of the locking element and through the plastic annular disc at the distal end of the locking element and the septum that seals the proximal end of the second component, whereupon the openings in the sides of the needles are no longer blocked by the interior walls of the bores thereby providing continuous fluid channels between the first component and the second component via the interiors of the needles.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1 is a vertical cross sectional of an embodiment of the contamination-free drug transfer apparatus of the invention described in U.S. Pat. No. 8,196,614;

(2) FIG. 2 is a cross sectional view of the connector section of the embodiment of the contamination-free drug transfer apparatus shown in FIG. 1;

(3) FIG. 3a, FIG. 3b and FIG. 3c are respectively front, cross-sectional, and exploded views of a first embodiment of a septum holder described in IL237788;

(4) FIG. 3d schematically shows the septum holder of FIG. 3a in a connector section similar to that shown in FIG. 2;

(5) FIG. 4a schematically shows an embodiment of a locking element for the connector section of the invention;

(6) FIG. 4b is a cross-sectional view of the locking element shown in FIG. 4a;

(7) FIG. 5 schematically shows a connector comprising a locking element according to the present invention;

(8) FIG. 6a schematically shows a connector of the invention and a vial adapter that will be attached to it;

(9) FIG. 6b and FIG. 6c respectively show views of the interior of the vial adapter and connector of FIG. 6a;

(10) FIG. 6d is an magnified view of a section of FIG. 6c;

(11) FIG. 7a schematically shows the connector of the invention and the vial adapter shown in FIG. 6a attached to each other;

(12) FIG. 7b shows a view of the interior of the vial adapter and connector of FIG. 7a;

(13) FIG. 7c is an magnified view of a section of FIG. 7b;

(14) FIG. 8a schematically shows an embodiment of a connector according to the invention and a luer lock adapter that are separated from each other;

(15) FIG. 8c schematically shows the connector and luer lock adapter of FIG. 8a connected together; and

(16) FIG. 8b and FIG. 8d are respectively cross-sectional views of FIG. 8a and FIG. 8c.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

(17) The invention is a locking element for a connector configured to connect two components of a fluid transfer system and a connector that comprises the locking element. The connector works on the same principle as that in connectors previously invented by the inventor examples of which are connector 25 shown in FIG. 2 and connector 750 shown in FIG. 3d. The locking element of the present invention replaces the double membrane seal actuator 130 in connector 25 and septum holder 700 in connector 750.

(18) The designations “upper” and “lower” used herein are of course relative and are used without reference to the orientation of components in the figures but with reference to how the components would normally be oriented during use.

(19) FIG. 4a schematically shows an embodiment of a locking element for the connector section of the invention. FIG. 4b is a cross-sectional view of the locking element shown in FIG. 4a. Locking element 200 has a body 202 made of either of a single piece of plastic material or of a few pieces of plastic material connected together, for example by welding or gluing, to form a single item. The upper part 202a of body 202 has a hollow interior and the lower part 202b has a channel 204 passing through it that, in this embodiment, has a cross section with the shape of the numeral eight that is formed by two overlapping bores. The free end of lower part 202b comprises a rigid flat annular disc 208. Elongated flexible arms 214 having distal enlarged elements 216 are attached to the sides of the upper part 202a of body 202 so that they project downwards parallel to the sides of lower part 202b of body 202.

(20) An insert 206 made of resilient material, such as, for instance, silicon or soft PVC, is inserted into channel 204. Insert 206 has two bores 210 and 212 passing through it, which form sleeves through which needles acting as liquid and air channels respectively pass. The insert 206 may, in one embodiment of the invention, be kept in place by friction created by the contact of its outer surface with the inner surface channel 204 or by plastic teeth (not shown) that extend from the channel 204. The friction can be obtained simply by providing an outer diameter of insert 206 that is greater than the diameter of the inner surface of channel 204. Thus, the resilient material of which insert 206 is made is compressed and pushes back toward the inner surface of channel 204. It is also possible to provide a roughening of the outer surface of insert 206, or to provide anchoring elements on either or both surfaces.

(21) FIG. 5 schematically shows a connector comprising a locking element according to the present invention. Except for locking element 200 that replaces septum holder 700, connector 250 is identical to prior art connector 750 shown in FIG. 3d. Connector 250 comprises a hollow cylindrical body 252 that has a closed upper end having a connection arrangement 254, e.g. a luer lock or luer slip connector, on its exterior side to connect to a first component, e.g. a syringe of a fluid transfer system, and a needle holder 264 in the interior side. The body 202 of the locking element 200 is surrounded by the cylindrical body 252 of the connector 250 and is able to slide up and down inside the hollow interior of the cylindrical body 252 of the connector 250. The lower end 256 of cylindrical body 252 is open to allow an end of a second component, e.g. a vial adapter connected to a drug vial, to be inserted into the interior of cylindrical body 252. This end of body 252 comprises shoulder portions 258 into which the enlarged elements 216 of the elongated flexible arms 214 of locking element 200 fit when connector 250 is not connected to a second component of a fluid transfer system, as shown in FIG. 5.

(22) Also see in FIG. 5 are two hollow needles 260 and 262 that respectively function as liquid and air channels through connector 252. Needles 260 and 262 have openings 266 near their pointed distal tips. Openings 266 allow passage of fluid between the interiors and exteriors of the needles. The needles pass through the closed end of connector body 252 and the hollow interior of the upper part 202a of the body 202 of the locking element 200 and are fixedly attached to body 252 by needle holder 264.

(23) When connector 250 is not connected to a second component of a fluid transfer apparatus, as shown in FIG. 5, the locking element 200 is at the distal end of connector 250, the distal enlarged elements of the elongated flexible arms of the locking element are fit into shoulder portions at the open lower end of the cylindrical body of the connector, and the tips of needles 260 and 262 are located in the bores 210 and 212 in the insert 206. The insert is made of a resilient material and the diameters of bores 210 and 212 are slightly smaller than the outer diameters of needles 260 and 262. As will be apparent to a skilled person, depending on its intended use, each specific connector may require using a different tolerance in the differences of the diameters in order to balance between the force needed to move the needle so as to maintain user's convenience, and the pressure resistance desired of the valve to prevent leaks, so as to maintain safety. In the configuration shown in FIG. 5, the openings 266 in the sides of the needles are blocked by the interior walls of the bores completely isolating the needles from each other and the outside environment, thereby preventing air from entering the liquid chamber of the syringe or liquid from entering the air chamber even at very high pressures and also preventing exchange of air or liquid with the surroundings.

(24) FIG. 6a schematically shows a connector 250 of the invention and a vial adapter 300 that will be attached to it. The vial adapter 300 is described in co-pending patent application WO 2014/12264. FIG. 6b and FIG. 6c respectively show views of the interior of the vial adapter and connector of FIG. 6a and FIG. 6d is a magnified view of section A in FIG. 6c.

(25) Referring to FIG. 6a to FIG. 6d, the part of the vial adapter that is relevant to describing the present invention is the longitudinal extension 302 that is designed to enter connector 250 through its open end 256 and engage the locking element 200. The top of longitudinal extension 302 is sealed with a septum 304 and on the side of its exterior surface are recesses 306 into which the enlarged elements 216 at the ends of arms 214 of locking element 200 fit when the connector and vial adapter are attached to each other. The interior of longitudinal extension 302 is hollow and acts as an air channel 310. A closed tube that passes through the interior of longitudinal extension 302 functions as a liquid channel 308.

(26) FIG. 7a schematically shows the connector of the invention and the vial adapter shown in FIG. 6a attached to each other. FIG. 7b shows a view of the interior of the vial adapter and connector of FIG. 7a and FIG. 7c is a magnified view of section B in FIG. 7b. Referring to these figures and to FIG. 5, when longitudinal extension 302 of vial adapter 300 begins to be pushed into the interior of connector 250, septum 304 at the top of longitudinal extension 302 presses against annular disc 208 at the bottom of locking element 200 forcing the latter to move upwards. At the same time enlarged elements 216 are forced out of shoulder portions 258 at the end of connector 250 and enter the recesses 306 in the longitudinal extension 302. As the locking element is pushed upwards, the enlarged elements 216 are held in the recesses 306 by the interior wall of body 252 of the connector, thereby locking the connector and vial adapter together with septum 304 of the vial adapter pressed tightly against annular disc 208 creating, with no septum in the connector section, the equivalent of the double septum seal of the prior art.

(27) As the locking element 200 and longitudinal extension 302 are pushed up into the interior of the body 252 the tips of needles 260 and 262 are forced out of the bores 210 and 212 in insert 206 and eventually through septum 304. When this happens the openings 266 near the tips of needles 260 and 262 are unblocked and the needles enter liquid channel 308 and air channel 310 in the vial adapter, thereby opening continuous separate liquid and air channels between a drug vial connected to vial adapter 300 to a syringe connected to connector 250.

(28) After the fluid transfer process has taken place connector 250 and drug vial 300 can be separated by pulling them apart in an axial direction. As this is done locking element 200 moves downwards inside the body of connector 250 until the enlarged elements 216 are able to spring back into the shoulder portions 258 at the end of connector 250 and exit the recesses 306 in the longitudinal extension 302 thereby unlocking the vial adapter from the connector. As locking element 200 moves downwards inside the body of connector 250, needles 260 and 262 are pulled upwards through the septum 304 at the top of the vial adapter and into the bores 210 and 212 in insert 206; thereby sealing openings 266 near the tips of the needles. As the needles are pulled through self-sealing septum 304 in the vial adapter, the tips of the needles are wiped clean leaving the external surfaces of both connector and vial adapter clean of drug residue.

(29) Many different embodiments of the connector of the invention can be produced. For example FIG. 8a schematically shows an embodiment of a connector according to the invention and a luer lock adapter that are separated from each other. FIG. 8c schematically shows the connector and luer lock adapter of FIG. 8a connected together; and FIG. 8b and FIG. 8d are respectively cross-sectional views of FIG. 8a and FIG. 8c.

(30) Luer lock adapter 450 is a product produced by the applicant of the present application to connect to infusion tubing. The features of luer lock adapter 450 that are relevant to the present invention are self-sealing septum 452, liquid channel 454, recesses 456 located near the septum and a trigger-like locking mechanism 458.

(31) In this embodiment connector 400 is very similar in structure to connector 250 but has only one hollow needle 402 that functions as a liquid conduit. Connector 400 comprises a locking element 420 that is very similar in structure to that of locking element 200, including having an annular disc 404 at its end facing the open end of the connector. When not connected to another component, as shown in FIGS. 8a and 8b, the tip of needle 402 is located inside a bore 408 in insert 406 in locking element 420. The opening 410 near the tip of needle 402 is sealed shut by the resilient material of bore 408 pressing against the exterior of the needle and enlarged elements 412 at the end of the arms of the locking element 420 are located in the shoulder portions 414 at the open end of connector 400. In the embodiment of the locking element shown in FIG. 8b the insert has two bores, only one of which is used; however embodiments can easily be made in which the insert has only one bore.

(32) Referring now to FIG. 8d, when the end of the luer lock adapter 450 is pushed into the open end of connector 400, the septum 452 in luer lock adapter 450 pushes against the annular disc 404 of the locking mechanism. As locking element 420 moves further inside the body of connector 400, enlarged elements 412 at the end of the arms of the locking element 420 are released from the shoulder portions 414 and eventually settle into recess 456 on the luer lock adapter 450 and the locking mechanism 458 on the luer lock adapter 450 snaps into the shoulder portion 414 of the connector locking adapter and connector together with septum 452 pressed tightly against annular disc 404 creating the equivalent of the double septum seal of the prior art without a septum in the connector. As in the previously described embodiment, as the locking element 420 and attached luer lock adapter are pushed further into the interior of the body of connector 400 the tip of needle 402 i2 forced out of the bore 408 in insert 406 and eventually through septum 452. When this happens the opening 410 near the tip of needle 402 is unblocked and the needle enters liquid channel 454 in the luer lock adapter, thereby opening a continuous liquid channel through luer lock adapter 450 and connector 400.

(33) The fact that the locking element of the present connector does not have a septum at its distal end as is present in all prior art septum holders and connectors that contain them provides the locking element with the following important advantages over the prior art: 1. From the manufacturer's (and ultimately the customer's) point of view the locking element is more cost effective because the number of components and assembly steps are reduced; and 2. From the user's point of view less force is needed to connect the locking element to another component because there is only one septum to pierce as opposed to two with prior art connectors.

(34) The applicant has performed tests to compare connectors comprising the locking element of the invention with prior art connectors that form a double septum seal. The results of these comparison tests show no difference in safety and leak prevention performance.

(35) 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.