PISTON VALVING FOR SERIALLY CONNECTABLE DRUG MODULES OF A COMBINATORIAL DRUG DELIVERY DEVICE

Abstract

A valving arrangement is provided herein for regulating fluidics of modules usable in a combinatorial drug delivery device. The valving includes a slidable piston valve, adjustable to selectively seal an outlet path from a drug vial and a sealing port, in parallel to a vent, for selectively sealing an inlet path to the drug vial. Advantageously, the subject invention allows for applied negative pressure to adjust the valving to allow flow between serially-connected modules forming a drug delivery device.

Claims

1. A module for use in a combinatorial drug delivery device, the module formed to accommodate a drug vial with a septum, the module comprising: a vial spike formed to pierce the septum of the drug vial with a free end of the vial spike being located interiorly of the septum, the vial spike including an inlet path open at the free end and extending along the vial spike to an inlet opening, and an outlet path open at the free end and extending along the vial spike to an outlet chamber, the outlet path being separate from the inlet path; a sealing port selectively sealing the inlet opening; a vent in communication with the inlet path between the inlet opening and the free end; a slidable piston valve located in the outlet chamber, the piston valve forming a seal in the outlet chamber to define first and second chamber portions, the outlet path being in communication with the first chamber portion; an outlet fitting in communication with the second chamber portion; and, a bypass passageway extending between the outlet fitting and an opening in the outlet chamber, wherein, in an initial state, the piston valve is located in a first position where the first chamber portion is sealed from the bypass passageway, and, wherein, with negative pressure introduced through the outlet fitting, the piston valve is caused to move to a second position where the first chamber portion is in communication with the bypass passageway.

2. A module as in claim 1, wherein the vent is a one-way vent which is normally closed and allows for gas flow into the inlet path.

3. A module as in claim 1, wherein the piston valve includes a radial seal in sealing contact with a wall of the outlet chamber.

4. A combination comprising: a first module including: a first vial spike with a first free end, the first vial spike including a first inlet path open at the first free end and extending along the first vial spike to a first inlet opening, and a first outlet path open at the first free end and extending along the first vial spike to a first outlet chamber, the first outlet path being separate from the first inlet path; a first sealing port selectively sealing the first inlet opening; a first vent in communication with the first inlet path between the first inlet opening and the first free end; a slidable first piston valve located in the first outlet chamber, the first piston valve forming a seal in the first outlet chamber to define first and second primary chamber portions, the first outlet path being in communication with the first primary chamber portion; a first outlet fitting in communication with the second primary chamber portion; and, a first bypass passageway extending between the first outlet fitting and a first opening in the first outlet chamber, a second module including: a second vial spike with a second free end, the second vial spike including a second inlet path open at the second free end and extending along the second vial spike to a second inlet opening, and a second outlet path open at the second free end and extending along the second vial spike to a second outlet chamber, the second outlet path being separate from the second inlet path; a second sealing port selectively sealing the second inlet opening; a second vent in communication with the second inlet path between the second inlet opening and the second free end; a slidable second piston valve located in the second outlet chamber, the second piston valve forming a seal in the second outlet chamber to define first and second secondary chamber portions, the second outlet path being in communication with the first secondary chamber portion; a second outlet fitting in communication with the second secondary chamber portion; and, a second bypass passageway extending between the second outlet fitting and a second opening in the second outlet chamber, wherein, the second module is coupled to the first module with the second outlet fitting extending through the first seal port to be in communication with the first inlet opening, wherein, in an initial state, the first piston valve is located in a first position where the first primary chamber portion is sealed from the first bypass passageway, wherein, with negative pressure introduced through the first outlet fitting, the first piston valve is caused to move to a second position where the first primary chamber portion is in communication with the first bypass passageway, and, wherein, with the first piston valve in the second position, the negative pressure is introduced to the second outlet fitting via the first outlet path and the first inlet path.

5. A combination as in claim 4, wherein the first vent is covered by the second module with the second module coupled to the first module.

6. A combination as in claim 4, wherein the second vent is exposed with the second sealing port sealing the second inlet opening with the second module coupled to the first module.

7. A combination as in claim 4, wherein, with the negative pressure introduced through the second outlet fitting, the second piston valve is caused to move within the second outlet chamber to cause the first secondary chamber portion to come into communication with the second bypass passageway.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. 1 shows a piston valve in a closed position in accordance with the subject invention;

[0014] FIG. 2 shows a piston valve relieving vial positive pressure in accordance with the subject invention;

[0015] FIG. 3 shows a piston valve in an open position in accordance with the subject invention;

[0016] FIG. 4 shows a drug vial coupled to valving in accordance with the subject invention;

[0017] FIG. 5 shows piston valves connected in series in accordance with the subject invention; and,

[0018] FIG. 6 shows a fluid pathway for piston valves connected in series in accordance with the subject invention.

DETAILED DESCRIPTION

[0019] The subject invention is particularly well-suited for use with serially-connected drug modules, particularly in forming fluid paths therebetween. The subject invention is shown in a context of a single module 9, but it is understood that the subject invention operates with a plurality of similarly formed modules 9, serially connected. As depicted in FIGS. 1 and 4, each of the modules 9 includes valving having a vial spike 1 used to pierce a vial septum S extending into the interior volume V of a liquid filled drug vial DV. A free, distal end 11 of the vial spike 1 may be sharpened to facilitate piercing of the vial septum S. The vial spike 1 must be provided with sufficient length to fully pierce the septum S in accessing the interior volume V.

[0020] The vial spike 1 includes two lumens dividing the module fluidics into separate circuits, an inlet path 2, and an outlet path 3. With the vial spike 1 piercing the septum S, both the inlet path 2 and the outlet path 3 are open at the free end 11 of the vial spike 1 and in communication with the interior volume V of the drug vial DV. The inlet path 2 extends from the interior volume V of the drug vial DV to an inlet opening 12 which is selectively sealed by spring-biased sealing port 4. A vent 10 exists on the inlet path 2, preferably between the free end 11 and the inlet opening 12, to allow air into the drug vial DV, as needed, to displace fluid during transfer. Preferably, the vent 10 is a one-way vent which is normally closed and allows for gas flow into the inlet path 2. The outlet path 3 extends from the interior volume V of the drug vial DV down to outlet chamber 6. A piston valve 5 is slidably seated inside the outlet chamber 6 creating a seal against the chamber inner wall 13. The piston valve 5 may include a radial seal 14 in sealing contact with the wall 13 to define the seal whilst allowing the piston valve 5 to slide within the outlet chamber 6.

[0021] The piston valve 5 forms a seal in the outlet chamber 6 to define first and second chamber portions 6a, 6b, which are adjustable in size with movement of the piston valve 5 within the outlet chamber 6, with the seal therebetween being maintained. The outlet path 3 is in communication with the first chamber portion 6a. An outlet fitting 7 is provided which is in communication with the outlet chamber 6, particularly, the second outlet chamber 6b.

[0022] In an initial state, as shown in FIG. 1, the piston valve 5 is placed in a first position at the medial end of the outlet chamber 6 preventing fluid entering from the outlet lumen 3 from accessing the outlet fitting 7. A bypass passageway 8 connects the outlet chamber 6 to the outlet fitting 7. In particular, the bypass passageway 8 terminates at an opening 15 in the wall 13 of the outlet chamber 6. With the piston valve 5 in the first position, the first chamber portion 6a is sealed from the bypass passageway 8.

[0023] With this arrangement (the piston valve 5 being in the first position), and, as shown in FIG. 2, pressurized fluid forced from the drug vial DV, as a result of vial spike 1 spiking the septum S, will be contained in the inlet pathway 2 by the spring-biased sealing port 4, while any entering the outlet pathway 3 will be contained within the first chamber portion 6a behind the piston valve 5. As shown in FIG. 2, pressure in the fluid may move the piston valve 5 slightly; this movement in position will equilibrate the pressure within the drug vial DV and fluid path to a negligible amount.

[0024] As shown in FIG. 3, at the time of fluid transfer, a source of negative pressure, e.g., a vacuum, will be provided to the outlet fitting 7, thereby evacuating air from the bypass passageway 8 and the outlet chamber 6, particularly, the second chamber portion 6b. This will generate a pressure differential across the piston valve 5 which will cause the piston valve 5 to slide along the outlet chamber 6 towards the outlet fitting 7. This results in an increase in volume of the first chamber portion 6a. Eventually, as the piston valve 5 continues moving it will pass over the bypass passageway 8, thereby allowing the first chamber portion 6a, along with the outlet path 3, to come into communication with the bypass passageway 8. As shown in FIG. 3, with the bypass passageway 8 carrying vacuum, fluid will then be able to move from the vial, through the outlet pathway 3, through the bypass passageway 8 circumventing the piston valve 5, and out through the outlet fitting 7.

[0025] As shown in FIGS. 5 and 6, a plurality of the modules 9 may be coupled in series with the outlet fitting 7a of a secondary module 9a breaching the sealing port 4 of an adjacent module 9 such that the outlet fitting 7a is in communication with the inlet opening 12 thereof. The secondary module 9a is formed similar to the module 9 with like parts being similarly numbered, but additionally designated with the letter “a” (except for the outlet chamber of the secondary module which is designated as 6′). The coupled arrangement allows for a fluid path to be defined from a drug vial DV coupled to vial spike 1a of the secondary module 9a to the outlet fitting 7 of the module 9, through a drug vial DV coupled to vial spike 1, as shown schematically in FIG. 6. This fluid pathway is achieved with sliding movement of piston valve 5a, resulting from negative pressure being applied to the outlet fitting 7a, via the outlet path 3 and the inlet path 2 of the module 9. In similar manner to that described above, flow bypasses the piston valve 5a with the bypass passageway 8a, upon sufficient sliding displacement of the piston valve 5a. This arrangement allows for a series of modules 9 to be coupled, with the respective drug vials DV being in-line to define a single flow path, acted upon by a single source of negative pressure.

[0026] It is also noted that the vent 10 may be located to terminate at a vent opening 16 located to be exposed to open atmosphere. Preferably, the vent opening 16 is located on a common wall as the sealing port 4, such that an adjacent coupled module 9a covers the vent opening 16. This obstruction restricts venting in the module 9 thereby maximizing negative pressure applied to the adjacent coupled module 9a. Obstructed venting may continue through a series of coupled modules, with the ultimate module 9 (e.g., module 9a) having the vent opening 16 be exposed, thereby, providing venting for the whole series.