A SEPTUM HOLDER WITH MOVEABLE SEPTUM

Abstract

Disclosed is a septum holder for use in a connector section of a fluid transfer apparatus for the transfer of a drug from one container to another. The septum holder comprises a body part and a septum support that are moveable in relation to each other. A septum is attached to the septum support. The body part and septum support are configured to be locked to each other at the end of a movement that brings them to their closest positions to each other.

Claims

1. A septum holder comprising at least two parts, wherein the at least two parts comprise a body part and a septum support that are moveable in relation to each other and a septum attached to the septum support, wherein the body part and septum support are configured to be locked to each other at the end of a movement that brings them to their closest positions to each other.

2. The septum holder of claim 1, wherein the septum holder is part of a connector section for a liquid transfer apparatus.

3. The septum holder of claim 1, wherein the body part and the septum support comprise components configured to releasably hold the septum support in an unblocked configuration and to allow it to be moved relative to the body part and to be locked in a blocked configuration.

4. The septum holder according to claim 1, wherein the septum support comprises a septum seat and the body part and septum support comprising openings to accommodate an insert comprising at least one bore that forms the seat of a needle valve.

5. The septum holder according to claim 1, wherein the septum support comprises at least one resilient elongated arm, terminating with a tooth shaped element that projects downward through the body part and the body part comprises projecting elements comprising at least one upper window through their interiors and at least one lower slot or window at their bottom section into which the tooth shaped elements at the bottom of at least one arm of the septum support can enter, wherein the at least one resilient elongated arm is configured to allow the tooth shaped element to click into the upper window to releasably hold the septum holder in the unblocked configuration and to allow the tooth shaped element to click into the lower slot or window to lock the septum holder in the blocked configuration.

6. The septum holder according to claim 4, wherein the septum is attached to the septum support.

7. The septum holder according to claim 6, wherein the septum comprises an upper part comprising a hollow interior in the form of a cylindrical recess having an inner diameter larger than that of the outer diameter of the disk shaped septum seat and a lower part of that extends downward beyond the lower edge of the septum support of the septum holder.

8. A connector section for a liquid transfer apparatus, the connector section comprising: an outer body having a proximal end adapted to be attached to syringe and an open distal end; at least one hollow needle fixedly attached to the proximal end of the body of the connector section, the needle having at least one port at its lower end adjacent to its pointed distal tip that allows fluid communication between the exterior and the hollow interior of the needle; and a septum holder located inside of the cylindrical body of the connector section, the septum holder comprising at least two parts, wherein the at least two parts of the septum holder comprise a body part and a septum support that are moveable in relation to each other and a septum attached to the septum support, wherein the body part and septum support are configured to be locked to each other at the end of a movement that brings them to their closest positions to each other.

9. The connector section of claim 8, wherein the body part and the septum support comprise components configured to releasably hold the septum support in an unblocked configuration and to allow it to be moved relative to the body part and to be locked in a blocked configuration.

10. The connector section according to claim 8, wherein the septum support comprises a septum seat and the body part and septum support comprising openings to accommodate an insert comprising at least one bore that forms the seat of a needle valve.

11. The connector section according to claim 8, wherein the septum seat comprises at least one resilient elongated arm, terminating with a tooth shaped element that projects downward through the body part and the body part comprises projecting elements comprising at least one upper window through their interiors and at least one lower slot or window at their bottom section into which the tooth shaped elements at the bottom of at least one arm of the septum support can enter, wherein the at least one resilient elongated arm is configured to allow the tooth shaped element to click into the upper window to releasably hold the septum holder in the unblocked configuration and to allow the tooth shaped element to click into the lower slot or window to lock the septum holder in the blocked configuration.

12. The connector section according to claim 10, wherein the septum is attached to the septum support.

13. The connector section according to claim 12, wherein the septum comprises an upper part comprising a hollow interior in the form of a cylindrical recess having an inner diameter larger than that of the outer diameter of the disk shaped septum seat and a lower part of that extends downward beyond the lower edge of the septum support of the septum holder.

14. A method for sterilizing a unit for closed transfer of liquids comprised of a syringe or any other airtight device for closed transfer of liquids connected to a connector section, the connector section comprising: an outer body having a proximal end adapted to be attached to syringe or airtight device for closed transfer of liquids and an open distal end; at least one hollow needle fixedly attached to the proximal end of the body of the connector section, the needle having at least one port at its lower end adjacent to its pointed distal tip that allows fluid communication between the exterior and the hollow interior of the needle; and a septum holder located inside of the cylindrical body of the connector section, the septum holder comprising at least two parts, wherein the at least two parts of the septum holder comprise a septum support comprising a septum seat and a body part that are moveable in relation to each other; the septum support and the body part comprising openings to accommodate an insert comprising at least one bore into which the least one port at the lower end adjacent to the pointed distal tip of the at least one hollow needle fits to forms a needle valve; wherein the body part and the septum support comprise components configured to releasably hold the septum holder in an unblocked configuration in which the at least one port is outside of the bore in the insert allowing fluid to flow through the hollow needle and to allow the septum support and the body part to be moved to their closest positions relative to each other and to be locked in a blocked configuration in which the at least one port is inside of the bore in the insert blocking the flow of fluid through the hollow needle; the method comprising: a) arranging the septum holder in its unblocked configuration; b) sealing the unit in a pack suitable for gas sterilization; c) placing the pack in a closed container or room; d) introducing sterilizing gas into the closed container or room; e) leaving the pack exposed to the sterilizing gas for a period long enough for the gas to enter the pack and enter the inside of the syringe and connector section through the ports adjacent to the pointed distal tip of the needles, thereby sterilizing the syringe and connector section; f) evacuating the sterilizing gas out of the container or room to draw the sterilizing gas out of the packs and the inside of the syringe and connector section; g) introducing air to replace the sterilizing gas into the container or room and the packs and the inside of the syringe and connector section wherein the air inside the pack is sterile; and h) repeating if necessary steps d through g until reaching a satisfactory level of sterility; wherein, connecting the unit to a second member of a closed system for transfer of liquids by inserting a proximal end of the second member into the open distal end of the body of the connector section causes the septum holder to move within the connector section moving the septum support and the body part to their closest positions relative to each other, thereby locking the septum holder in its blocked configuration.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0070] FIG. 1 is a schematic cross-sectional view of a prior art apparatus for transferring hazardous drugs;

[0071] FIG. 2a to FIG. 2d are cross-sectional views that schematically show the four-step connection sequence between the connector section and the vial adaptor of the apparatus of FIG. 1;

[0072] FIG. 3 is an enlarged view of the prior art double membrane seal actuator shown in FIG. 1;

[0073] FIG. 4 and FIG. 5 show an improvement in the double membrane seal actuator of FIG. 3 according to the present invention that prevents the possibility of liquid entering the air channel if the piston rod of the syringe is accidentally pushed or pulled;

[0074] FIG. 6 and FIG. 7 show an improvement in the double membrane seal actuator of FIG. 3 according to the present invention that simplifies manufacturing of the actuator;

[0075] FIG. 8 is a schematic cross-sectional view of a connector section;

[0076] FIG. 9a, FIG. 9b, and FIG. 9c are respectively front, cross-sectional, and exploded views of a first embodiment of a prior art septum holder;

[0077] FIG. 9d schematically shows the holder of FIG. 9a in a connector section of a closed system drug transfer apparatus;

[0078] FIG. 10a and FIG. 10b schematically show embodiments of a septum holder;

[0079] FIG. 11a and FIG. 11b schematically show the difference between the attachment of the arms to the septum holder of the prior art and the septum holder of FIG. 10a;

[0080] FIG. 12 schematically shows the exterior of a connector component configured to comprise a septum holder of FIG. 10a;

[0081] FIG. 13 schematically shows an exploded view of a septum holder according to an embodiment of the invention;

[0082] FIG. 14A to FIG. 14C schematically show assembled views pf the septum holder of FIG. 13; and

[0083] FIG. 15A and FIG. 15B schematically show the septum holder of FIG. 13 respectively in unblocked and blocked configurations in a connector section of a closed system liquid transfer apparatus.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0084] One of the products manufactured by the applicant of this patent application is a unit for closed transfer of liquids comprised of a syringe connected to a connector section. These units, after manufacture and assembly, are packed in blister packs and sent to be sterilized before shipment to customers. Sterilization is carried out by placing the blister packs in a closed container or room that is then filled with ethylene oxide. The blister pack is comprised of a thermoplastic front, which is impervious to gas and bacteria, sealed to a paper back, which is impervious to bacteria but allows gas molecules to pass through it. The ethylene oxide gas enters the blister pack through the paper back and enters the inside of the syringe and connector section through the needle openings and sterilizes the syringe and connector section. After a period of time a vacuum is created in the container to draw the sterilizing gas out of the blister packs and then air is introduced into the blister packs, which are then a sterile product ready for use.

[0085] If the connector section comprises a septum holder such as shown in FIG. 9d, the ports 56 at the tips of the air and liquid channels are blocked by the sides of the bores in the insert 68 when the connector section is not connected at its distal end to another element such as a vial adapter. This is the situation when the product described above is placed in the blister pack. Because ports 56 are blocked the sterilizing gas cannot enter the body of the syringe which can't be sterilized, which of course is unacceptable. The current solution to this problem is to seal the syringe and attached connector in the blister pack with the septum holder 58 pulled downwards from the location shown in FIG. 9d until the distal enlarged elements 63 of arms 62 are outside of the outer housing 78 of the connector section. In this configuration the ports 56 have been removed from the bores in the insert 68 allowing the sterilizing gas to enter the interior of the syringe and to be replaced with sterile air. After the sterilization process is completed the septum holder is pushed back without opening the blister pack to its correct location with the distal enlarged elements 63 engaged in the shoulder portion 90 at the distal end of outer housing 78, the tips of the needles in the bores 70 in insert 68, and the top of septum 72 sealing the bottom of the bores 70 as shown in FIG. 9b and FIG. 9d.

[0086] After sterilization the boxed product is delivered from the sterilization site to the manufacturing site and the blister packs need to be taken out from the boxes in order to move the septum holder to its correct position and then pack the blisters back into the boxes. Moving the septum holder to its correct position inside the connector section while both are sealed inside the blister pack is a difficult and very time-consuming task that can only be done manually. All of this extra handling adds a great deal of expense to the manufacturing process.

[0087] The same problem exists for all embodiments of the prior art connectors shown in the background section of this application.

[0088] The present invention is a septum holder that was invented to overcome this problem. It can be used, for example in connector section 92 shown in FIG. 9b or connector section 104 shown in FIG. 12. The septum holder of this invention comprises a septum and insert that can be moved up and down in the septum holder to alternately block or unblock the ports at the tips of the needles.

[0089] FIG. 13 schematically shows an exploded view of septum holder 300 according to an embodiment of the invention. Septum holder 300 is comprised of a body part 360 and a septum support 361.

[0090] Body part 360 comprises a disk shaped upper surface and side elements 392 that project downward from the upper surface. The elements 392 can have other shapes and sizes than those shown in the figures. Two equal length resilient elongated arms 362 that terminate with distal enlarged elements 363 are attached at its sides projecting vertically upwards parallel to each other as shown in FIG. 13. Two pairs of projecting elements 377 project vertically upwards from the upper surface of body part 360. Each pair of projecting elements 377 defines a slot 378 between the elements of the pair. Slots 377 pass vertically downward through the disk shaped upper surface of body part 360. Also seen in FIG. 13 are one of two windows 380 and one of two slots 389 in the elements 392 of body part 360 and holes 379 that pass through the upper surface of body part 360. The functions of windows 380, slots 389 and holes 379 will be described herein below. In embodiments of the invention slots 389 can be replaced with windows near the bottom edge of elements 392.

[0091] Septum holder 300 will be described herein as being configured for use in a connector section that comprises two needles that serve as separate air and liquid conduits. Embodiments of septum holder 300 can also be provided mutatis mutandis for use in connector sections that comprise only one needle.

[0092] In the embodiment shown in the figures septum support 361 is comprised of a disk shaped septum seat 382 from which two resilient elongated arms 386 projects downward parallel to the arms 362. At the upper end of each arm 386 is an outwardly projecting shoulder 390 and at the lower end of each arm 386 is an outwardly projecting tooth-shaped element 388 having an upper horizontal surface and a lower sloped surface. An insert 368, which in this embodiment comprises two bores 370, forms the seats of two needle valves. Insert 368 passes through opening 384 in septum seat 382 and is attached to septum seat 382 by small spikes 381 and 383 that extend from septum seat 382 into the opening 384 and spike/bite into insert 368 holding it in place. The insert 368 moves up and down in septum holder 300 together with septum seat 382, as will be described herein below. In other embodiments insert 368 can be fastened to septum seat 382 by other means known in the art such as gluing or laser welding or other mechanical fixation.

[0093] The septum can be attached to the septum support in many ways. In the specific embodiment shown in the figures septum 372 is made of a single piece of cylindrically shaped resilient material. The lower part of septum 372 has a hollow interior forming a cylindrical recess 374 having an inner diameter larger than that of the outer diameter of septum seat 382. The lower rim of the septum 372 is structured as an inwardly projecting edge 376 (see FIG. 15A) that, when pushed over septum seat 382 to hold septum 372 on septum seat 382. In other embodiments septum 372 can be fastened to septum seat 382 by other means known in the art such as gluing, welding or another type of mechanical fixation.

[0094] FIG. 14A to FIG. 14C schematically show assembled views of septum holder 300. Because of the length of the arms 386 of septum support 361, septum seat 382 and attached insert 368 and septum 372 can be moved up or down in the septum holder between the two limiting positions defined by shoulders 390 at the top of arms 386 and tooth-shaped elements 388 at the bottom of arms 386. FIG. 14A and FIG. 14B show septum holder 300, respectively without and with septum 372 attached to septum seat 382, in a blocked configuration. FIG. 14C shows septum holder 300 in an unblocked configuration.

[0095] In the unblocked configuration septum support 361 has been pushed upwards away from body part 360 until further upward motion of arms 386 in slots 378 was prevented by the tooth-shaped elements 388 at the bottom of arms 386 that click into windows 380. The septum support is releasably held in the unblocked configuration such that a small downward force is enough release the septum support from its unblocked configuration. To move from the unblocked to the blocked configuration shown in FIG. 14A and FIG. 14B septum support 361 is pushed downwards towards body part 360. The sloped bottom surfaces of tooth-shaped elements 388 at the bottom of arms 386 slide out of windows 380 and septum support 361 continues downward until further downward motion of arms 386 through slots 378 is prevented by shoulders 390 contacting the projecting elements 377. When this occurs the tooth shaped elements 388 at the bottom of arms 386 click into slots 389, which then prevents septum holder from being returned to the unblocked configuration.

[0096] FIG. 15A and FIG. 15B schematically show the septum holder 300 of the invention in a connector section 92/104 of a closed system liquid transfer apparatus. In both figures connector section 92/104 is shown not connected to another component of the liquid transfer apparatus. In FIG. 15A and FIG. 15B connector section 300 is shown respectively in the unblocked and blocked configurations. In the unblocked and blocked configurations shown in FIGS. 15A and 15B the tips and ports 56 of needles 38 and 40 are respectively out of and inside bores 370 in the insert 368 of septum holder 300.The connector section is, with the exception of the septum holder, the same as that in the prior art connector section 92 shown in FIG. 9b or connector section 104 shown in FIG. 12 described herein above. Outer housing 78 or 104 of the connector section is configured at its upper end to be connected to another component of the liquid transfer system such as a syringe or an IV line. Two hollow needles, which function as an air conduit 38 and as a liquid conduit 40 respectively, are fixedly attached by needle holder 36 to the upper end of outer housing 78 or 104 of the connector section. At the lower end of the needles, adjacent to the pointed distal tips, are ports 56 that allow fluid communication between the exterior and the hollow interiors of the needles.

[0097] After the prior art connector sections described herein as well as those shown in FIGS. 13 to 15C are manufactured a quality control check is carried out by inserting the proximal end of a simulated adapter, such as that used to connect the connector section to a drug vial, intravenous bag, or an intravenous line, into the opening at the distal end of the cylindrical, hollow outer body of the connector section. As in the procedure for assembling the drug transfer apparatus described herein above the simulated adapter is pushed against the septum 372 in the septum holder. This forces the arms 386 of septum support 361, septum seat 382 and attached insert 368 and septum 372 to move up in the septum holder until reaching the blocked configuration shown in FIG. 14A, FIG. 14B and FIG. 15B where the tooth shaped elements 388 at the bottom of arms 386 have clicked into slots 389. As described above, once the blocked configuration is reached the septum holder 300 will forever remain in this configuration. Continue pushing the simulated adapter causes the simulated adapter and the septum holder to become attached to each other by means of distal enlarged elements 363 and the attached septum holder 300 is moved upwards in the connector section until the tips of the needles 38 and 40 exit bores 370 pass through holes 379 in body part 360 and through septum 372. The simulated adapter and attached septum holder are then pulled downwards until the tips of the needles are pulled back through septum 372, through holes 379 in body part 360, and reenter bores 370 blocking ports 56. The elastomeric material of which the septum is made seals the hole as the needle is pulled back through it. Further pulling of the simulated adapter downwards separates it from the septum holder. This process is repeated at least one more time before the quality of the connector section is verified.

[0098] The quality control check described above provides an additional benefit. The act of puncturing the septum greatly reduces the amount of force that the end user is required to exert to assemble the drug transfer apparatus in the pharmacy, clinic, or hospital ward. It has been found that a considerable amount of force is needed to puncture the septum the first time. The second time that the needle passes through the septum requires significantly less force than the first time and the third and subsequent times that the needle passes through the septum requires significantly less force than the second time.

[0099] After the quality control check described above, a specially designed manufacturing tool unlocks the blocked configuration and units comprised of a syringe connected to a connector section comprising a septum holder 300 are sealed in the blister pack with septum holder 300 in the unblocked configuration as shown in FIG. 14C and FIG. 15A. With the septum in this configuration the tips and ports 56 of the needles are outside of bores 370 in insert 368 and the sterilization procedure can be carried out as required.

[0100] After the sterilization procedure is completed the product can be delivered to a customer as is and without the need to be sent to the manufacturing site for moving the septum holder to reseal the ports 56. Resealing of the ports 56 is accomplished automatically at first use when septum support 361 and attached insert 368 are pushed upward from the location shown in FIG. 15A to the location shown in FIG. 15B during first connection of the connector section to a fluid transfer component, e.g. a vial adaptor, a spike adaptor for connection to an IV bag, or a connector for connection to an IV line. After the first connection the ports 56 remain sealed in the blocked configuration in all following connection procedures.

[0101] The connection is accomplished in the same manner as in the prior art described herein above. When the septum of the fluid transfer component is pushed against the bottom of septum 372, septum seat 382 and attached insert 368 an septum 372 will move upwards until the distal tips of the needles are fully inserted into the bores 370 in inserts 168. As the connector section and fluid transfer component continue to be pushed together, septum holder 300 begins to move upwards inside outer housing 78/140 and the tips of the needles begin to exit the bottoms of bores 370, pass through holes 379 in body part 360, and penetrate the solid material of septum 372. The tips of the needles pass through septum 372 and the septum at the top of the fluid transfer component as septum holder 300 continues to be pushed upwards, thereby establishing air and liquid channels between the element of the liquid transfer system attached to the fluid transfer component and the proximal air chamber and distal liquid chamber in the syringe.

[0102] 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.