A SEPTUM HOLDER WITH MOVEABLE SEPTUM

Abstract

Disclosed is a septum holder that comprises a body having an upper body part and a lower body part that has a bored out interior. An insert comprising at least one bore that forms the seat of a needle valve fits loosely into the bored out interior of the lower body part. A septum comprising an upper part is attached to an exterior surface of the lower body part of the septum holder. A lower part of the septum extends downward beyond the lower edge of the lower body part of the septum holder. The septum holder is characterized in that the insert can freely move up and down in the interior of the lower body part and the septum can freely move up and down on the exterior surface of the lower body part. Also disclosed is a connector section for a liquid transfer apparatus that comprises the septum holder.

Claims

1. A septum holder comprising: a body having an upper body part and a lower body part, the lower body part comprising a bored out interior; an insert comprising at least one bore that forms the seat of a needle valve, the insert fitted loosely into the bored out interior of the lower body part; and, a septum comprising an upper part attached to an exterior surface of the lower body part of the septum holder and a lower part of the septum that extends downward beyond the lower edge of the lower body part of the septum holder; wherein the insert can freely move up and down in the interior of the lower body part and the septum can freely move up and down on the exterior surface of the lower body part.

2. A septum holder according to claim 1, wherein the body comprises a disk shaped annular upper body part with at least one resilient elongated arm terminating with a distal enlarged element attached to the side of the upper body part.

3. A septum holder according to claim 2, wherein the body comprises a lower body part comprised of a cylindrically shaped annular section that projects downward from the upper part parallel to the at least one arm.

4. A septum holder according to claim 3, wherein the lower body part comprises an outwardly projecting edge at its lower end.

5. A septum holder according to claim 3, wherein the septum comprises an upper part having a hollow interior in the form of a cylindrical recess having an inner diameter larger than that of the outer diameter of the cylindrically shaped annular section.

6. A septum holder according to claim 5, wherein the upper rim of the septum is structured as an inwardly projecting edge configured such that, when pushed over the outwardly projecting edge at the lower end of the cylindrically shaped annular section of the lower body part, the upper rim of the septum interacts with the outwardly projecting edge to hold the septum on exterior surface of the septum holder.

7. A connector section for a liquid transfer apparatus, the connector section comprising: a cylindrical outer body having a proximal end adapted to be attached to syringe and an open distal end comprising a shoulder portion; 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: a body having an upper body part and a lower body part, the lower body part comprising a bored out interior; an insert comprising at least one bore that forms the seat of a needle valve, the insert fitted loosely into the interior of the lower body part; and, a septum comprising an upper part attached to an exterior surface of the lower body part of the septum holder and a lower part of the septum that extends downward beyond the lower edge of the lower body part of the septum holder; wherein the insert can freely move up and down in the interior of the lower body part and the septum can freely move up and down on the exterior surface of the lower body part.

8. The connector section of claim 7, wherein the body of the septum holder comprises a disk shaped annular upper body part with at least one resilient elongated arm terminating with a distal enlarged element attached to the side of the upper body part.

9. The connector section of claim 8, wherein the body of the septum holder comprises a lower body part comprised of a cylindrically shaped annular section that projects downward from the upper part parallel to the at least one arm.

10. The connector section of claim 9, wherein the lower body part of the septum holder comprises an outwardly projecting edge at its lower end.

11. The connector section of claim 9, wherein the septum of the septum holder comprises an upper part having a hollow interior in the form of a cylindrical recess having an inner diameter larger than that of the outer diameter of the cylindrically shaped annular section.

12. The connector section of claim 11, wherein the upper rim of the septum of the septum holder is structured as an inwardly projecting edge configured such that, when pushed over the outwardly projecting edge at the lower end of the cylindrically shaped annular section of the lower body part, the upper rim of the septum interacts with the outwardly projecting edge to hold the septum on exterior surface of the septum holder.

13. The connector section of claim 7 wherein, when the connector section is not connected to another element of the liquid transfer system, the distal enlarged element of the at least one arm of the septum holder is engaged in the shoulder portion at the distal end of body of the syringe connector and the distal end of the at least one needle is inserted into the at least one bore in the insert of the septum holder.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0060] FIG. 1 is a schematic cross-sectional view of a prior art apparatus for transferring hazardous drugs;

[0061] 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;

[0062] FIG. 3 is an enlarged view of the prior art double membrane seal actuator shown in FIG. 1;

[0063] 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 accidently pushed or pulled;

[0064] 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;

[0065] FIG. 8 is a schematic cross-sectional view of a connector section;

[0066] 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;

[0067] FIG. 9d schematically shows the holder of FIG. 9a in a connector section of a closed system drug transfer apparatus;

[0068] FIG. 10a and FIG. 10b schematically show embodiments of a septum holder;

[0069] 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;

[0070] FIG. 12 schematically shows the exterior of a connector component configured to comprise a septum holder of FIG. 10a; and

[0071] FIG. 13 and FIG. 14 are cross-sectional views that show the moveable septum at two different locations on the septum holder.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0072] 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 chloride. 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.

[0073] 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 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.

[0074] 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.

[0075] The same problem exists for all embodiments of the prior art connectors shown in the background section of this application.

[0076] 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 that can be moved up and down on the septum holder to alternately block or unblock the ports at the tips of the needles.

[0077] FIG. 13 and FIG. 14 are cross-sectional views that show the moveable septum at two different locations on the septum holder.

[0078] FIG. 13 schematically shows the septum holder 158 of the invention in a connector section of a closed system liquid transfer apparatus. 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 140 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 to the upper end of outer housing 78 or 140 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. External ridges 88 near the bottom of outer housing 78/140 serve as finger grips for use when attaching the connector section and syringe to other elements of the drug transfer system. Ridges 88 are not essential and can be eliminated or replaced with other means, for example a roughened surface area, to accomplish the same purpose.

[0079] Septum holder 158 is comprised of a body 160 comprising a disk shaped annular upper part. Two equal length resilient elongated arms 162 are attached at the sides of the upper part of body 160. The arms terminate with distal enlarged elements 163. The bottom part of body 160 is comprised of a cylindrically shaped annular section 202 that projects downward from the upper part between arms 162. At the lower end of annular section 202 is an outwardly projecting edge 204. An insert 168 comprising two bores 170 that form the seat of a needle valve is fitted loosely into the center of annular section 202 so that the insert is free to move up and down in annular section 202.

[0080] Septum 172 is made of a single piece of cylindrically shaped resilient material. The upper part of septum 172 has a hollow interior forming a cylindrical recess 206 having an inner diameter larger than that of the outer diameter of annular section 202 at the bottom of body 160. The upper rim of the septum 172 is structured as an inwardly projecting edge 208 that, when pushed over outwardly projecting edge 204 at the bottom of annular section 202, interacts with edge 204 to hold septum 172 on septum holder 158. Because of the length of the wall of annular section 202, septum 172 can move up or down on the septum holder between the two limiting positions shown in FIG. 13 and FIG. 14.

[0081] After the prior art connector sections described herein as well as those shown in FIGS. 13 and 14 is 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 172 in the septum holder until the simulated adapter and the septum holder become attached to each other. Continue pushing the simulated adapter and the attached septum holder 158 upwards in the connector section until the tips of the needles 38,40 exit bores 170 and pass through septum 172. The simulated adapter and attached septum holder are then pulled downwards until the tips of the needles are pulled back through septum 172 and reenter bores 170 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.

[0082] 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.

[0083] The syringe-connector section unit is sealed in the blister pack with septum 172 pulled down as shown in FIG. 13. With the septum in this configuration the insert 168 is also lowered removing ports 56 at the distal end of the needles from bores 170 in insert 168 and the sterilization procedure can be carried out as required.

[0084] 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 re-seal the ports 56. Re-sealing of the ports 56 is accomplished automatically when septum 172 and insert 168 are pushed upward from the location shown in FIG. 13 to the location shown in FIG. 14 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 in sealed position in all following connection procedures.

[0085] 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 172, septum 172 and insert 168 will move upwards until insert 168 is fully inserted into the annular section 202. As the connector section and fluid transfer component continue to be pushed together, septum holder 158 begins to move upwards inside outer housing 78/140 and the tips of the needles begin to exit the bottoms of bores 170 and penetrate the solid material of septum 172. The tips of the needles pass through septum 172 and the septum at the top of the fluid transfer component as septum holder 158 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.

[0086] 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.