Septum holders for use in syringe connectors

Abstract

A septum holder having a disk shaped annular body. The body has a cylindrical bottom part that projects downward, a cavity created in the bottom part of the body, an insert comprising at least one bore that forms the seat of a needle valve fitted into the cavity, at least one resilient elongated arm attached to the side of the body, the at least one arm projecting downward and terminating with a distal enlarged element, and a septum. The septum is made of a single piece of cylindrically shaped resilient material. The upper part of the septum has a hollow interior forming a cylindrical recess having an inner diameter no larger than that of the outer diameter of the cylindrical section at the bottom of the body of the septum holder. The lowest part of the septum has a diameter that matches that of a septum in a fluid transfer component. The septum is adapted to be pushed over the bottom part of the body of the septum holder until the solid part of the septum below the recess butts against the bottom of the at least one bore in the insert.

Claims

1. A septum holder comprising: a disk shaped annular body having a cylindrical bottom part that projects downward, a cavity created in the bottom part of the body, an insert comprising at least one bore that forms a seat of a needle valve fitted into the cavity, at least one resilient elongated arm attached to a side of the body, the at least one arm projecting downward and terminating with a distal enlarged element, and a septum; wherein the septum is made of a single piece of cylindrically shaped resilient material, an upper part of the septum has a hollow interior forming a cylindrical recess having an inner diameter no larger than that of an outer diameter of the cylindrical bottom part of the body of the septum holder, a lowest part of the septum has a diameter that matches that of a septum in a fluid transfer component, and the septum is adapted to be pushed over the bottom part of the body of the septum holder until a solid part of the septum below the recess butts against a bottom of the at least one bore in the insert.

2. The septum holder of claim 1, wherein the septum is fixedly held on the body of the septum holder in one of the following ways: the resilient material of the septum may be strong enough to grip sides of the cylindrical bottom part of the septum holder body to hold the septum in place; the cylindrical bottom part of the septum holder body may have threads or teeth, or an interlocking structure created on its outer surface that can engage with a complementary interlocking structure on an inner surface of the septum hollow interior when the septum is pushed over the bottom part of the body; by gluing; by ultrasound forming; and by laser or ultrasound welding.

3. The septum holder of claim 1, wherein the insert is made of one of: a resilient material and a rigid material.

4. A syringe connector section for a liquid transfer apparatus, the syringe connector section comprising: a cylindrical body adapted to be attached to a syringe, the cylindrical body having a shoulder portion at its distal end; at least one hollow needle fixedly attached to an upper end of the cylindrical body, the needle having at least one port that allows fluid communication between an exterior and a hollow interior of the needle, the at least one port being located at a lower end of the needle adjacent to its pointed distal tip; and a septum holder according to claim 1 located inside of the cylindrical body; wherein, when 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 the cylindrical body and the distal end of the at least one needle is inserted into the at least one bore in the insert inside the body of the septum holder.

5. The syringe connector section of claim 4, wherein, when not connected to another element of the liquid transfer system, sides of the at least one bore in the insert inside the body of the septum holder push against a shaft of the at least one needle, thereby sealing the port at the lower end of the needle and preventing fluids from entering or exiting the hollow interior of the needle, and the distal tip of the at least one needle is isolated from the outside by the septum of the septum holder.

6. The syringe connector section of claim 4, wherein the liquid transfer apparatus is a closed system, the at least one hollow needle comprises two hollow needles, and the at least one bore in the insert in the body of the septum holder comprises two bores that functions as seats of needle valves.

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. 4 shows an embodiment of the apparatus of FIG. 1 in which a filter is introduced into the air channel by placing it in the vial adaptor;

(5) FIG. 5a and FIG. 6a are schematic cross-sectional views of an apparatus for transferring hazardous drugs identical to that shown in FIG. 4 disconnected from and connected to a vial adaptor respectively, with the exception that the prior art double membrane seal actuator is replaced with an actuator comprising a single membrane and an embodiment of the needle valve described in WO2014/181320 and IL234746;

(6) FIG. 5b and FIG. 6b are enlarged views of the actuator in the apparatus shown in FIG. 5a and FIG. 6a respectively;

(7) FIG. 7a, FIG. 7b and FIG. 7c are respectively front, cross-sectional, and exploded views of a first embodiment of a septum holder according to the invention;

(8) FIG. 7d schematically shows the holder of FIG. 7a in a connector section of a closed system drug transfer apparatus;

(9) FIG. 8a, FIG. 8b, and FIG. 8c are respectively front, cross-sectional, and exploded views of a first embodiment of a septum holder according to the invention;

(10) FIG. 8d schematically shows the holder of FIG. 8a in a connector section of a closed system drug transfer apparatus;

(11) FIG. 9a, FIG. 9b, and FIG. 9c are respectively front, cross-sectional, and exploded views of a first embodiment of a septum holder according to the invention;

(12) FIG. 9d schematically shows the holder of FIG. 9a in a connector section of a closed system drug transfer apparatus;

(13) FIG. 10a, FIG. 10b, and FIG. 10c are respectively front, cross-sectional, and exploded views of a first embodiment of a septum holder according to the invention; and

(14) FIG. 10d schematically shows the holder of FIG. 10a in a connector section of a closed system drug transfer apparatus.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

(15) The present invention is embodiments of septum holders for use in syringe connectors that are used to connect syringes to other elements of liquid transfer apparatuses. All of the embodiments of the septum holders described herein comprise a septum holder body, at least one resilient elongated arm that terminates with a distal enlarged element attached to the sides of the body, and a septum. The septum holders of the invention are characterized in that they comprise at least one bore that functions as the seat of a needle valve. The bore is created in the septum or in an insert fixed in either the body of the septum holder or in the septum. The septum holders of the invention are also characterized in that the septum is attached to the bottom of the body of the septum holder projecting downwards parallel to the at least one elongated arm.

(16) The embodiments of the septum holder that are described herein below all have two bores for use in syringe connectors that comprise two hollow needles, they also have two resilient arms attached to the body part. However it is to be understood that these same embodiments can be manufactured mutatis mutandis with only one bore to be used with syringe connectors that comprise one hollow needle and one, three, or more arms. Also it is apparent that in embodiments where the two arms are shown attached to the sides of the body at a certain location, it would require only a simple modification to attach them at other locations.

(17) FIG. 7a, FIG. 7b, and FIG. 7c are respectively front, cross-sectional, and exploded views of a first embodiment of a septum holder 700 according to the invention. Septum holder 700 is comprised of a body 702 having a disk shaped annular upper body part 702a and a lower body part 702b. Two equal length resilient elongated arms 704 are attached to the sides of body 700. The arms terminate with distal enlarged elements 706.

(18) As can be seen in exploded view of FIG. 7c, a septum 708 is fitted into the lower body part 702b so that it extends downward between arms 704. Septum 708 is made of a single piece of cylindrically shaped resilient material. The upper part of septum 708 has a diameter larger than the middle part in order to form a flange that rests on an annular ledge 702c created around the inside of the bottom section 702b of body 702 when the middle part of septum 708 slides through the open center at the bottom of bottom section 702b. Upper section 702a is then pushed onto the lower section in order to connect septum 708 to body 702. The upper and lower sections of body 702 can be held permanently together with the septum 702 held between them by any method known in the art, e.g. press fitting, gluing, snap fitting, ultrasonic forming, and laser or ultrasonic welding.

(19) In an alternative embodiment the septum, shaped as described above can be forced into the circular opening at the bottom of the bottom section 702b from below and, when the flange snaps onto annular ledge 702c the upper section 702a of the body is pushed into the lower section 702b to hold the septum in place. In another embodiment, the upper and middle sections of the septum can have the same diameter that is at least as large as the diameter of annular ledge 702c. In this embodiment the septum is forced into the lower section 702b from the bottom. Because of the flexibility of the material of which the septum is made the upper part of the septum is at first compressed to enter the lower section of the holder and then expands to fill the space on top of ledge 702c.

(20) Two bores 710 that function as the seat of a needle valve are created part of the way through the height of the middle part of septum 708. The lowest part of septum 708 has a diameter that matches that of the septum in the fluid transfer component, e.g. vial adaptor, to which it will be connected. Note that in FIGS. 7a to 10d the lower part of the septum is shown as having a diameter less than that of the rest of the septum; however, this is not always necessary and in some cases the lower part of the septum can have the same diameter as the middle part of the septum or the entire septum can have the same diameter. The only condition being that the septum in the septum holder has to be able to contact a septum in a fluid transfer component and form a seal that prevents leakage of air or liquid.

(21) FIG. 7d schematically shows the holder of FIG. 7a, FIG. 7b, and FIG. 7c in a syringe connector section of a closed system liquid transfer apparatus. The connector section is essentially the same as that in the prior art apparatus described herein above. Cylindrical body 718 of the connector section is attached to syringe 712. Two hollow needles 714, which function as an air conduit, and 716, which functions as a liquid conduit, are fixedly attached to the upper end of body 718 of the connector section. At the lower end of the needles, adjacent to the pointed distal tips, are ports 724 that allow fluid communication between the exterior and the hollow interiors of the needles. External ridges 722 near the bottom of cylindrical body 718 serve as finger grips for use when attaching the connector section and syringe to other elements of the drug transfer system. Ridges 722 are not essential and can be eliminated or replaced with other means, for example a roughened surface area, to accomplish the same purpose.

(22) A septum holder 700 is located inside of cylindrical body 718 of the connector section. As shown, the distal ends of needles 716,718 are inserted into bores 710 in septum 708. The diameters of bores 710 are smaller than the outer diameter of the shafts of the needles and therefore the resilient material of which the septum is manufactured pushes radially against the shaft of the needle sealing the ports 724. When not connected to another element of the liquid transfer system the distal enlarged elements 706 of arms 704 are engaged in the shoulder portion 720 at the distal end of body 718. As shown in FIG. 7d, in this position the tips of the needles are isolated from the outside by septum 708 and the walls of the bores 710 pressing radially inwards on the shafts of the needles prevent fluids from entering or exiting the interior of the needles.

(23) Connection of the syringe connector 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, 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 septum 708, septum holder 700 begins to move upwards inside body 718 and the tips of the needles begin to exit bores 710 penetrate the solid material of septum 708. The tips of the needles pass through septum 708 and the septum of the fluid transfer component as holder 700 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.

(24) FIG. 8a, FIG. 8b, and FIG. 8c are respectively front, cross-sectional, and exploded views of a second embodiment of a septum holder 800 according to the invention. Septum holder 800 is comprised of a body 702 having a disk shaped annular upper body part 702a and a lower body part 702b. Two equal length resilient elongated arms 704 are attached to the sides of lower body part 702b. The arms terminate with distal enlarged elements 706.

(25) As can be seen in exploded view of FIG. 8c, a septum 808 is fitted into the lower body part 702b so that it extends downward between arms 704. Septum 808 is made of a single piece of cylindrically shaped resilient material. The upper part of septum 808 has a diameter larger than the middle part in order to form a flange that rests on an annular ledge 702c created around the inside of the bottom section 702b of body 702 when the middle part of septum 808 slides through the open center at the bottom of bottom section 702b. Upper section 702a is then pushed onto the lower section in order to connect septum 808 to body 702. The upper and lower sections of body 702 can be held permanently together with the septum 808 held between them by any method known in the art, e.g. press fitting, gluing, snap fitting, ultrasonic forming, and laser or ultrasonic welding.

(26) In an alternative embodiment the septum 808, shaped as described above can be forced into the circular opening at the bottom of the bottom section 702b from below and, when the flange snaps onto annular ledge 702c the upper section 702a of the body is pushed into the lower section 702b to hold the septum in place. In another embodiment, the upper and middle sections of the septum can have the same diameter that is at least as large as the diameter of annular ledge 702c. In this embodiment the septum is forced into the lower section 702b from the bottom. Because of the flexibility of the material of which the septum is made the upper part of the septum is at first compressed to enter the lower section of the holder and then expands to fill the space on top of ledge 702c.

(27) A cavity 804 is created in the middle part of septum 808 is created into which an insert 802 is fitted. Insert 802 can be a single piece of material comprising two bores 710 that function as the seat of a needle valve as shown in FIG. 8b. In alternative embodiments insert 802 can have different shapes than that shown and in one embodiment can be comprised of two separate pieces of tubing that are inserted into parallel bores of appropriate diameters created into the middle part of septum 808. The lowest part of septum 808 has a diameter that matches that of the septum in the fluid transfer component, e.g. vial adaptor, to which it will be connected. This embodiment of the septum is very useful because the required elasticity properties of the septum and of the insert 802 are different. The septum itself should be very elastic with good re-sealing properties while the material of the insert must be less flexible to resist pressures on the needle ports. For example, septum 808 can be made from Polyisoprene and insert 802 from silicon.

(28) FIG. 8d schematically shows the holder of FIG. 8a, FIG. 8b, and FIG. 8c in a syringe connector section of a closed system liquid transfer apparatus. The connector section is essentially the same as that in the prior art apparatus described herein above. Cylindrical body 718 of the connector section is attached to syringe 712. Two hollow needles 714, which function as an air conduit, and 716, which functions as a liquid conduit, are fixedly attached to the upper end of body 718 of the connector section. At the lower end of the needles, adjacent to the pointed distal tips, are ports 724 that allow fluid communication between the exterior and the hollow interiors of the needles. External ridges 722 near the bottom of cylindrical body 718 serve as finger grips for use when attaching the connector section and syringe to other elements of the liquid transfer system. Ridges 722 are not essential and can be eliminated or replaced with other means, for example a roughened surface area, to accomplish the same purpose.

(29) A septum holder 800 is located inside of cylindrical body 718 of the connector section. As shown, the distal ends of needles 716,718 are inserted into bores 710 in insert 802 in septum 808. If insert 802 is made of resilient material, the diameters of bores 710 are smaller than the outer diameter of the shafts of the needles and therefore the resilient material of which the insert is manufactured pushes radially against the shaft of the needle sealing the ports 724. In embodiments of septum holder 800 the insert 802 can be made of a rigid material, e.g. acetal plastic. In these embodiments the diameters of the bores 710 are very close to the outer diameters of the needles and sealing of ports 724 is the result of the close manufacturing tolerances. When not connected to another element of the liquid transfer system the distal enlarged elements 706 of arms 704 are engaged in the shoulder portion 720 at the distal end of body 718. As shown in FIG. 8c, in this position the tips of the needles are isolated from the outside by septum 808 and the walls of the bores 710 pressing radially on the shafts of the needles prevent fluids from entering or exiting the interior of the needles.

(30) Connection of the syringe connector 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, 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 septum 808, septum holder 800 begins to move upwards inside body 718 and the tips of the needles begin to exit bores 710 penetrate the solid material of septum 808. The tips of the needles pass through septum 808 and the septum of the fluid transfer component as holder 800 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.

(31) FIG. 9a, FIG. 9b, and FIG. 9c are respectively front, cross-sectional, and exploded views of a third embodiment of a septum holder 900 according to the invention. Septum holder 900 is comprised of a disk shaped annular body 902. Two equal length resilient elongated arms 704 are attached to the sides of body 902. The arms terminate with distal enlarged elements 706. The bottom part of body 902 is comprised of a cylindrical section that projects downward between arms 704. A cavity 904 is created in the bottom part of body 902 into which is fitted an insert 906 comprising two bores 710 that form the seat of a needle valve. In alternative embodiments insert 906 can have different shapes than that shown and in one embodiment can be comprised of two separate pieces of tubing that are inserted into parallel bores of appropriate diameters created in the bottom part of body 902. Septum 908 is made of a single piece of cylindrically shaped resilient material. The upper part of septum 908 has a hollow interior forming a cylindrical recess 910 having an inner diameter no larger than that of the outer diameter of the cylindrical section at the bottom of body 902. After insert 906 is fitted into cavity 904, septum 908 is pushed over the bottom part of body 902 until the solid part of septum 908 below recess 910 butts against the bottom of bores 710 in insert 906 thereby isolating bottoms of the interior of the bores from the external environment. Septum 908 is fixedly held on the body 902 of holder 900 by any means known in the art. For example, the resilient material of the septum may be strong enough to grip the sides of the cylindrical section at the bottom of body 902 to hold the septum in place; or, as shown in FIG. 9c, the cylindrical section at the bottom of body 902 may have threads or teeth, or an equivalent structure created on its outer surface and septum 908 may have similar structure on the inner diameter of its hollow interior (not shown in FIG. 9c) so that the two structures interlock when septum 908 is pushed over the bottom part of body 902. In other embodiments other methods, such as gluing, ultrasonic forming, or laser or ultrasound welding may be used. The lowest part of septum 908 has a diameter that matches that of the septum in the fluid transfer component, e.g. vial adaptor, to which it will be connected.

(32) FIG. 9d schematically shows the holder of FIG. 9a, FIG. 9b, and FIG. 9c in a syringe connector section of a closed system liquid transfer apparatus. The connector section is essentially the same as that in the prior art apparatus described herein above. Cylindrical body 718 of the connector section is attached to syringe 712. Two hollow needles 714, which function as an air conduit, and 716, which functions as a liquid conduit, are fixedly attached to the upper end of body 718 of the connector section. At the lower end of the needles, adjacent to the pointed distal tips, are ports 724 that allow fluid communication between the exterior and the hollow interiors of the needles. External ridges 722 near the bottom of cylindrical body 718 serve as finger grips for use when attaching the connector section and syringe to other elements of the drug transfer system. Ridges 722 are not essential and can be eliminated or replaced with other means, for example a roughened surface area, to accomplish the same purpose.

(33) A septum holder 900 is located inside of cylindrical body 718 of the connector section. As shown, the distal ends of needles 716,718 are inserted into bores 710 in insert 906. If the insert 906 is made of a flexible material, e.g. silicon, the diameters of bores 710 are smaller than the outer diameter of the shafts of the needles and therefore the resilient material of which the insert is manufactured pushes radially against the shaft of the needle sealing the ports 724. When not connected to another element of a liquid transfer system the distal enlarged elements 706 of arms 704 are engaged in the shoulder portion 720 at the distal end of body 718. As shown in FIG. 9d, in this position the tips of the needles are isolated from the outside by septum 908 at the bottom and the walls of the bores 710 pressing radially on the shafts of the needles prevent fluids from entering or exiting the interior of the needles.

(34) Connection of the syringe connector 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, 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 septum 908, septum holder 900 begins to move upwards inside body 718 and the tips of the needles begin to exit bores 710 penetrate the solid material of septum 908. The tips of the needles pass through septum 908 and the septum of the fluid transfer component as holder 900 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.

(35) FIG. 10a, FIG. 10b, and FIG. 10c are respectively front, cross-sectional, and exploded views of a fourth embodiment of a septum holder 1000 according to the invention. Septum holder 1000 comprises body 1002 having a disk shaped annular lower body portion 1002b and an H-shaped upper body portion 1002a. Two equal length resilient elongated arms 704 are attached to the sides of the vertical posts of the upper body portion 1002a. The arms terminate with distal enlarged elements 706. A septum 1006 is attached to the bottom of body 1002 extending downward from body 1002 between arms 704.

(36) The horizontal bar in the upper body section 1002a and the bottom section 1002b of holder body 1002 are configured to fixedly support an insert 1004 comprising two bores 710 that form the seat of a needle valve. In alternative embodiments insert 1004 can have different shapes than that shown and in one embodiment can be comprised of two separate parallel pieces of tubing.

(37) In alternative embodiments, instead of an H-shaped upper body portion 1002a, the upper body portion of the septum holder can comprise more than two vertical posts and more than one horizontal bar. The requirement being that the arrangement of vertical posts and horizontal bars is configured to fixedly support the upper end of insert 1004 and that, in this embodiment the insert 1004 stands exposed to the environment and is not enclosed in the septum or septum holder body like in the previous embodiments.

(38) Septum 1006 is made of a single piece of cylindrically shaped resilient material. The upper part of septum 1006 fits into a seat 1008 created around the inside of the bottom portion 1002b of body 1002. Septum 1006 is held fixedly in seat 1008 by any method known in the art, e.g. press fitting, gluing, snap fitting, ultrasonic forming, and laser or ultrasonic welding. The lower part of septum 1006 has a diameter that matches that of the septum in the fluid transfer component, e.g. vial adaptor, to which it will be connected.

(39) FIG. 10d schematically shows the holder of FIG. 10a, FIG. 10b, and FIG. 10c in a syringe connector section of a closed system liquid transfer apparatus. The connector section is essentially the same as that in the prior art apparatus described herein above. Cylindrical body 718 of the connector section is attached to syringe 712. Two hollow needles 714, which function as an air conduit, and 716, which functions as a liquid conduit, are fixedly attached to the upper end of body 718 of the connector section. At the lower end of the needles, adjacent to the pointed distal tips, are ports 724 that allow fluid communication between the exterior and the hollow interiors of the needles. External ridges 722 near the bottom of cylindrical body 718 serve as finger grips for use when attaching the connector section and syringe to other elements of the drug transfer system. Ridges 722 are not essential and can be eliminated or replaced with other means, for example a roughened surface area, to accomplish the same purpose.

(40) A septum holder 1000 is located inside of cylindrical body 718 of the connector section. As shown, the distal ends of needles 716,718 are inserted into bores 710 in insert 1004. If the insert 1004 is made of a flexible material, e.g. silicon, the diameters of bores 710 are smaller than the outer diameter of the shafts of the needles and therefore the resilient material of which the insert is manufactured pushes radially against the shaft of the needle sealing the ports 724. When not connected to another element of a liquid transfer system the distal enlarged elements 706 of arms 704 are engaged in the shoulder portion 720 at the distal end of body 718. As shown in FIG. 10d, in this position the tips of the needles are isolated from the outside by septum 1006 at the bottom and the walls of the bores 710 pressing radially on the shafts of the needles prevent fluids from entering or exiting the interior of the needles.

(41) Connection of the syringe connector 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, 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 septum 1006, septum holder 1000 begins to move upwards inside body 718 and the tips of the needles begin to exit bores 710 penetrate the solid material of septum 1006. The tips of the needles pass through septum 1006 and the septum of the fluid transfer component as holder 1000 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.

(42) 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.