Alternative fluid paths for serially connectable drug modules

Abstract

To provide modules useable in combinatorial drug delivery devices.SOLUTION: A module 10 may be provided with a vial spike 12 which is used to penetrate a vial septum 14 extending into an internal volume 16 of a drug vial 18 filled with liquid. A distal end 20 of the vial spike 12 may be sharp to facilitate penetration of the vial septum 14. The vial spike 12 must have sufficient length to fully penetrate the septum 14 when accessing the internal volume 16. The vial spike 12 includes two lumens that divide a module fluid device into a separate circuit, inflow path 22 and outflow path 24. When the vial spike 12 penetrates the septum, the inflow path 22 and outflow path 24 are connected to the internal volume 16 of the drug vial 18 through an opening formed at the distal end 20 of the vial spike 12.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The field of the invention is the compounding and preparation of liquid drugs, particularly for intravenous infusion and direct injection into a patient. More specifically, the invention relates to fluid circuit and connection solutions that will enable the use of a device for the preparation and compounding of combinations of two or more drugs. [Background technology]

[0002] It is common practice to administer medications via intravenous infusion, with medications compounded in a pharmacy environment. Such medications are typically supplied sterile in glass vials and may be provided in solid or aqueous solution form. If provided in solid form, the medication must be prepared in a sterile aqueous diluent before transfer to an infusion bag. Those skilled in the art will appreciate that such medication formulations typically include several excipients, such as buffers, pH adjusters, tonicity adjusters, stabilizers, etc. Liquid medications for intravenous infusion are typically compounded in infusion bags in a pharmacy environment before transfer for infusion to a patient. Because medication sterility must be maintained, the compounding procedure is typically performed in a sterile compounding room (hood) during compounding. Typically, a pharmacist or pharmacy technician (practitioner) prepares the medication according to an individual patient's prescription.

[0003] After ensuring the hood is clear, the practitioner retrieves vials of the required medication according to the prescription from the pharmacy's inventory and verifies their identity and content. The verification process is assisted by a barcode scanner or other identification technology. The practitioner also retrieves all other necessary equipment from inventory, including the infusion bag itself, syringes, needles, infusion sets, gloves, and sharps disposal containers, all of which are needed to safely prepare the medication for infusion. Once all necessary equipment is gathered, the practitioner follows the procedure for preparing the medication, which includes adding diluents to prepare the solid medication and sequentially drawing the liquid medication from individual vials through infusion ports into an intravenous (IV) bag. Typically, this procedure is performed manually and involves the use of multiple needles. The risk of needlestick injury to the practitioner increases with each needle required to compound the medication. For highly potent or toxic medications, such as cytotoxic chemotherapy drugs, there is a significant risk of exposure for the practitioner.

[0004] To eliminate some of the risks associated with manual preparation, including exposure to hazardous drugs and the risk of medication errors, drug compounding machines are known to those skilled in the art that automate many of the steps involved in drug preparation and compounding. Typically, such machines are complex electromechanical systems that implement sophisticated precision compounding mechanisms for accurately preparing liquid drugs. Aside from their cost, size, and complexity, many of the designs of such machines described in the art retrieve liquid drugs from inventory storage and use only a portion of the drug in the container. Due to the need to maintain sterility, unused liquid drugs typically must be discarded, resulting in waste. Due to the prohibitive cost of some drugs, particularly biological drugs, this disposal is a highly undesirable expense. When the wasted drugs are cytotoxic agents, their disposal creates significant environmental and safety hazards.

[0005] Recent advances in medicine, particularly in the treatment of cancer, have demonstrated that therapeutically beneficial effects can be achieved through the synergistic combination of two or more agents.

[0006] For example, recent clinical studies have shown that the combination of anti-PD-1 and CTLA4 checkpoint inhibitors can produce beneficial synergistic effects in some tumor types, leading to better clinical outcomes than can be achieved with either agent administered individually. Typically, such checkpoint inhibitors are biotechnology-derived monoclonal antibodies or immunoglobulin-type fragments. In some circumstances, it may be beneficial to combine such biologic agents with conventional chemotherapeutic agents, such as cytotoxic drugs.

[0007] Applicant hereby expressly disclaims all allegations herein incorporated by reference in their entireties, which are incorporated herein by reference in their entireties, including but not limited to, U.S. Provisional Patent Application No. 62 / 670,266, filed May 11, 2018, PCT Application No. PCT / US2019 / 031727, filed May 10, 2019, PCT Application No. PCT / US2019 / 031762, filed May 10, 2019, and PCT Application No. PCT / US2019 / 031791, filed May 10, 2019, of the same assignee herein. The combinatorial principles incorporated herein can address several challenges encountered in the preparation and compounding of drugs for intravenous infusion and can provide several advantages, including, but not limited to, streamlining pharmacy procedures, reducing the risk of medication errors, containing and protecting practitioners from highly potent or toxic drugs, reducing the risk of needlestick injuries, reducing or eliminating drug waste, and avoiding the need for complex and expensive drug compounding machines. As a result of these advantages in embodiments, the present invention may further enable the preparation and compounding of drugs for intravenous (IV) infusion at locations away from a pharmacy and by non-professionals, for example, by appropriately trained technicians or nurses in the patient's home. This feasibility is enhanced by the inherent portability of the systems described herein. Summary of the Invention

[0008] The present invention provides a plurality of medication modules, each defining a chamber for receiving a medication-filled vial. In embodiments, spacer adapters may be provided or vial-retaining dimensions may be altered to accommodate different sizes of vials. The modules may further include a displaceable vial retainer that provides access to the vial septum for sterilization, a cannula positioned to rupture the vial septum upon displacement of the vial retainer, and sterile tubing defining a sterile fluid path from the cannula to inlet and outlet ports that connect to the sterile fluid pathways of adjacent modules. The modules may include male and female mating mechanisms to allow any number of modules of the same design to be connected to one another in a "stack." Furthermore, the mating mechanisms and ports may be arranged so that fluid connections between modules are automatic when the modules are connected to one another in series through their respective mating mechanisms. Each module may be provided with a vent port, including a vent port terminated by a sterile particulate filter, which allows pressure equalization within the vial during removal of liquid medication from the vial while preventing contaminants from entering the fluid pathway. The vents may be positioned so that when another module is mated adjacent to the vent side of the module, a seal is formed that closes the vent, thus allowing only the last module on the stack to vent to atmosphere.

[0009] In embodiments, the system can be equipped with a sterile air reservoir that would be used instead of atmospheric air. This feature allows the system to be used in less controlled environments, particularly in the patient's home environment.

[0010] The first module in the stack can be connected to a housing with a male port similar to the male port provided on the module. The housing can further include sterile tubing, and an eyelet tube can extend from the housing and terminate in a sterile hollow needle that can be used to puncture a sterile port on an infusion bag or other container and pump liquid medication into the bag or other container, or for administering medication directly to a patient. Additional pumping means can be provided so that when fully connected to the liquid medication in multiple vials, each vial is pumped into the needle as one.

[0011] In embodiments, such pumping means may be integral to the housing or may be external to the housing. The pumping means may be sterile and form a component of the fluid pathway, or may be of a non-contact type, such as a peristaltic pump. Those skilled in the art will be familiar with several pump technologies suitable for use in pumping liquid medicaments in the manner described.

[0012] This delivery system embodiment provides additional flexibility to the system by allowing modules to be configured not only to connect to each other but also to a common base tray, which provides a low-cost alternative to control module ordering and assembly without relying on more complex electronic error-proofing systems that would be required if the modules were configured in a purely stackable architecture.

[0013] In the current embodiment of this system, which uses a base tray, drug modules are inserted and mechanically secured within a common base tray, fluidly connecting all inserted modules and delivering their contents. The base tray is comprised of several pre-positioned wells designed to accept the hinged caps of the modules. Within each well are two check valve-style fluid connection ports that mate with the input and output ports of the module vial spike plate. Fluid connections are made between the base tray valves via the vial spike plate by fully pressing the vial spike plate into the base tray valve. Internally, sterile tubing is used to fluidly connect the single check valves of adjacent wells to create a fluid circuit, which is completed when all wells in the base tray are filled with a particular module. The base tray includes an air filter and / or vent that terminates one end of the internal fluid circuit. The base tray fluid circuit drains drug product from the modules into a sterile main output line from the base tray. A one-way valve in the main output line prevents drug product from backflowing into the base tray.

[0014] Cooperating mechanical keying features present on both the interior walls of the base tray wells and the exterior surface of the module's hinged cap create a poka-yoke mechanism that ensures that modules are only inserted into the intended wells of the base tray.

[0015] The main output line from the base tray is terminated by a sterile hollow needle that can be used to puncture a sterile port on an infusion bag or other container and pump the liquid medication into the container, or for direct medication administration to a patient. Additionally, the pumps can be configured so that when fully connected, the liquid medication in the vials is pumped as one collective output from each vial to a bag, container, or patient.

[0016] The pump may be integrated into the base tray or may be external to the base tray. The pump may be sterilized and form a component of the fluid pathway, or may be a non-contact type such as a peristaltic pump. Those skilled in the art will be familiar with several pump technologies suitable for use in pumping liquid medications in the described manner.

[0017] Modifications can be made to the currently described systems to either the module or tray fluidic architecture, allowing modules to be configured in stackable arrangements or nested within a base tray. Configuration of these systems can be done on a case-by-case basis at the time of component assembly, within the supply chain, or by the user at the point of care. [Brief explanation of the drawings]

[0018] [Figure 1] Dual Circuit Module [Figure 2] Connected dual circuit modules [Figure 3] Dual circuit module connected to the pump [Figure 4] Dual circuit module with sterile air reservoir [Figure 5A] Configurable modular housing [Figure 5B] Configurable modular housing [Figure 6A] Removable Module Port [Figure 6B] Removable Module Port [Figure 7] Fluidic system of redundancy module [Figure 8] Horizontally loaded tray [Figure 9] Vial Float Valve [Figure 10] Collapsible tray [Figure 11] Module Tray Adapter DETAILED DESCRIPTION OF THE INVENTION

[0019] Various embodiments relating to modules usable in combination drug delivery devices are described herein, including devices formed by connecting multiple modules in series (e.g., to form a stack) and devices formed by attaching modules to a base tray or other support structure that fluidly connects the modules. Features of the embodiments can be combined in various combinations even if not explicitly disclosed. Descriptions of particular features, such as spike plates, interaction between the spike plate and attached vial, vents, etc., are provided for specific embodiments and are equally applicable to other embodiments, as will be understood by those skilled in the art.

[0020] In a first embodiment, as shown in FIGS. 1-4 , the module 10 may be provided with a vial spike 12 used to pierce a vial septum 14 that extends into the interior volume 16 of a liquid-filled drug vial 18. The distal end 20 of the vial spike 12 may be sharpened to facilitate piercing the vial septum 14. The vial spike 12 must be long enough to fully pierce the septum 14 to access the interior volume 16. The vial spike 12 includes two lumens that divide the modular fluidic system into separate circuits: an inlet path 22 and an outlet path 24. By piercing the septum, the inlet path 22 and the outlet path 24 connect with the interior volume 16 of the drug vial 18 through openings formed at the distal end 20 of the vial spike 12.

[0021] A first fluid line 26 extends from the inlet pathway 22 to a first sealing port 28 located on the rear surface 30 of the module 10, connecting the interior volume 16 of the drug vial 18 to the first sealing port 28. A first branch line 32 extends from the first fluid line 26 and connects with the first fluid line 26. The first branch line 32 includes an exposed tubing portion 34 that is exposed through the rear surface 30 of the module 10. The exposed tubing portion 34 is preferably formed of flexible tubing. A second sealing port 36 is located on the rear surface 30 of the module 10 and is connected by a second fluid line 42 to a third sealing port 38 located on the front surface 40 of the module 10. The first branch line 32 extends to and connects with the second fluid line 42. A fourth sealing port 44 is located on the front surface 40 and is connected to the outlet pathway 24 by a third fluid line 46. Male pins 48 protrude from the front surface 40 and are configured to positively engage the exposed tubing portions 34 of similarly formed modules connected to the module 10, as described below. Ports or openings 50 may be formed in the back surface 30 exposing the exposed tubing portions 34 and configured to receive the male pins 48.

[0022] 2-4 show two modules 10 connected in series. As will be appreciated by those skilled in the art, any number of modules 10 may be utilized in a series connection. This allows the drug vials 18 of the modules 10 to contain different drug types and concentrations that can be drawn sequentially and administered in combination. For illustrative purposes, the second module of the modules 10 is designated by the same reference numeral used for the drug module 10, but with the addition of the letter "a." As shown in FIG. 2, when the modules 10, 10a are connected, the first and second seal ports 28, 36 on the back surface 30 of the module 10 mate with the third and fourth seal ports 38a, 44a of the second module 10a, forming a fluid connection between the primary and secondary circuits of the modules 10, 10a. The male pin 48a of the second module 10a is received in the port 50 and couples with the exposed tubing section 34, specifically, pinching and compressing the exposed tubing section 34 to close the flexible tubing, thereby connecting the primary and secondary inlet circuits of the series modules 10, 10a up to the last module 10a. Specifically, a fluid chain is created between the modules 10, 10a, with the primary and secondary inlet circuits connected by being bridged by the first branch line 32a with the exposed tubing section 34a open to flow therethrough. This arrangement allows the first branch line 32 of the modules 10 to be sealed, except for the final module 10a, where flow is permitted to close the fluid circuit. Thus, a fluid path can begin at the third sealing port 38 of the first module 10, extend through the second fluid line 42 of each module 10, 10a, through the first branch line 32a of the last module 10a in the chain, and then through the drug vials 18, 18a of each module 10, 10a and return to the fourth sealing port 44 on the front face 40 of the first module 10.

[0023] As will be appreciated by those skilled in the art, the fluid paths through the modules 10, 10a may be vented in any known manner. For example, one or both of the first sealing port 28 and the second sealing port 36 may be provided with an antibacterial filter that allows airflow but limits the passage of microorganisms. Additionally or alternatively, as shown in FIG. 4, one or more collapsible gas chambers 52 may be provided in connection with any of the fluid lines, including the first fluid line 26, the second fluid line 42, and the third fluid line 46, to accommodate, for example, a sterilizing gas (e.g., sterile air) or a stable gas (e.g., argon). Furthermore, the fluid lines (first fluid line 26, first branch line 32, second fluid line 42, and third fluid line 46) may be formed in whole or in part by tubing, including flexible tubing. Additionally or alternatively, the fluid lines (first fluid line 26, first branch line 32, second fluid line 42, and third fluid line 46) may be formed in whole or in part by passages formed in the module 10. As noted above, the exposed tube portion 34 is preferably formed from flexible tubing so that it is pinchable in response to compressive engagement by the male pins 48 of adjacent connected modules 10 .

[0024] Additionally, modules 10 may be connected in any known manner, including, for example, cooperating fastening elements on opposing faces. Interengagement of ports 50 and male pins 48 between adjacent modules 10 may be utilized to form connections therebetween.

[0025] To form a drug delivery device 54 with all modules 10 fluidly connected in series, a pump module 56 can be positioned at the front 40 of the first module 10 in the chain and coupled with the third sealing port 38 and the fourth sealing port 44 as the inlet and outlet ports of the module chain. The pump module 56 includes a first inlet sealing port 58 configured to interengage with the fourth sealing port 44 of the first module 10, a second inlet sealing port 60 configured to interengage with the third sealing port 38 of the first module 10, a first outlet port 62, and a pump 64. An outlet passage 66 is defined between the first inlet sealing port 58 and the first outlet port 62, and the pump 64 is configured to draw liquid drug into the outlet passage 66 via the fourth sealing port 44 / first inlet sealing port 58 interface and to push the drawn liquid drug out the first outlet port 62. The outlet passage 66 may be a closed passage in which the pump 64 acts peristaltically on the outlet passage 66 to maintain the sterility of the liquid medication passing therethrough.

[0026] A vent passageway 68 may be provided in connection with the second inlet sealing port 60 to provide vent to the fluid circuit of the module 10, 10a via the third sealing port 38. The vent passageway 68 may terminate in a one-way air vent 70. As shown in FIG. 4, the one-way air vent 70 may be replaced with one or more collapsible gas chambers 52 containing, for example, a sterilizing gas (e.g., sterile air) or a stable gas (e.g., argon). This allows the device 54 to be utilized in home care environments where access to a controlled environment with air filtration may not be available.

[0027] The medication delivery device 54 can be utilized in a variety of applications. The medication delivery device 54 is particularly suited for home use and is self-contained for providing combination medication therapy. The first exit port 62 is connected to flexible tubing 72, which can be connected to a medication delivery needle (not shown) for direct medication administration to a patient, or to a container, such as an IV bag 74, in which medication can be collected for subsequent administration. During use, as shown in FIGS. 3 and 4 , the pump 64 can be actuated to draw liquid medication from the medication vial 18, 18a and deliver it through the first exit port 62, with venting provided by one or more of the collapsible gas chamber 52 and / or vent passageway 68.

[0028] Alternative embodiments of modular fluidic devices may be desirable using configurable modules that can be serially connected together or configured for mounting to other support structures, such as base trays or "poka-yoke" trays. As shown in FIGS. 5A and 5B, a cross section of a modular body housing 100 is shown with cutouts 102 for securing different components of a fluid path subassembly. The top surface 104 of the housing 100 has a cutout 102a for a spike plate 106 formed for accessing a drug from a drug vial in a manner similar to that described above, while the front surface 108 and back surface 110 have cutouts 102b, 102c, respectively, for securing a sealing port 112, and the bottom surface 114 has cutouts 102d, 102e for two sealing ports 112. The spike plate 106 is a two-lumen spike plate, with each lumen continuing to a section of flexible tubing 116 that terminates at a sealing port 112. At the time of module assembly, spike plates 106 are assembled into the top cutouts 102a, and sealing ports 112 can be positioned as inlet and outlet fluid paths by being located on either the opposing front 108 and back 110 of the module housing 100 for in-line stacking (FIG. 5A), or on the bottom 114 (FIG. 5B) to allow interaction of the module 100 with a base tray or other support structure.

[0029] Further embodiments of this concept may include configuring modules for stackable or tray configuration at the point of care. Using configurable subassemblies with flexible tubing, the fluid pathways may be permanently contained within the solid module body 200 during assembly, with the input and output seal ports 202, 204 held within a port housing 206 attached to the module body 200 by a hinge. The hinge of the port housing 206 to the module body 200 allows the input and output seal ports 202, 204 of the fluid pathways to be oriented for either base tray mounting, as shown in FIG. 6A, or for serial connection, as shown in FIG. 6B.

[0030] An alternative modular fluidic system solution utilizes redundant fluidic systems for use in either configuration, closing unused circuits during use to allow for alternative base tray mounting and serial connection of modules. As shown in FIG. 7 , each module 300 includes a vial spike 302 that is used to penetrate the vial septum to extend into the interior volume of a liquid-filled drug vial and access the drug therein. The vial spike 302 must be long enough to fully penetrate the septum to access the interior volume. The vial spike 302 includes two lumens that divide the modular fluidic system into separate circuits, inlet path 304 and outlet path 306. By penetrating the septum, the inlet path 304 and outlet path 306 connect with the interior volume of the drug vial through openings formed at the distal end 308 of the vial spike 302 in a manner similar to that described above in connection with vial spike 12.

[0031] A first fluid line 310 extends from the inlet pathway 304 to a first sealing port 312 located on a back surface 314 of the module 300, connecting the interior volume of the drug vial with the first sealing port 312. The first fluid line 310 includes a first exposed tubing portion 316 that is exposed through a bottom surface 318 of the module 300. A first branch line 320 extends from the first fluid line 310 and connects with the first fluid line 310. The first branch line 320 includes a second exposed tubing portion 322 that is exposed through the back surface 314 and extends to a second sealing port 324. A third sealing port 326 is located on a front surface 328 of the module 300. A second fluid line 330 connects the outlet pathway 306 to the third sealing port 326. A fourth sealing port 332 is disposed in the bottom surface 318, with a second branch line 334 extending therefrom to the second fluid line 330, connecting the fourth sealing port 332 and the second branch line 334. A first male pin 336 protrudes from the front surface 328 and is configured to negatively engage a second exposed tubing portion 322 of a similarly formed module connected to the module 300, as described below. A first port or opening 338 may be formed in the back surface 314, exposing the second exposed tubing portion 322 and configured to receive the first male pin 336. As shown, with two of the modules 300, 300a connected in series, the first male pin 336a of the second module 300a is received in the first port 338 of the adjacent module 300, negatively blocking the second exposed tubing portion 322. In this manner, a continuous flow path spanning all of the drug vials in the module 300 can be formed outside the second sealing port 324 and the fourth sealing port 332 .

[0032] The module 300 can be utilized with a base tray 340, and when the module 300 is directly connected to the base tray 340, a second male pin 342 configured to positively engage the first exposed tube portion 316 protrudes from the base tray 340. A second port or opening 344 can be formed in the bottom surface 318 of the module 300, exposing the first exposed tube portion 316 and configured to receive the second male pin 342. The base tray 340 can include a nest 346 configured to insertably receive the module 300. When the module 300 is received in the nest 346, a first exhaust seal port 348 and a second exhaust seal port 350 in a base 352 of the nest 346 interconnect with the second seal port 324 and the fourth seal port 332 of the module 300, respectively, and the second male pin 342 is received in the second port 344 to negatively block the first exposed tube portion 316. In this manner, a flow path to and from the base tray 340 can be created that bypasses the first sealing port 312 and the third sealing port 326 .

[0033] To facilitate the formation of desired fluid circuits, one or more one-way check valves 354 may be provided to restrict flow in one direction, thereby blocking unused fluid lines. For example, one check valve 354 may be positioned along the second branch line 334 to allow flow only from the fourth sealing port 332, thereby restricting unwanted flow to the fourth sealing port 332 when the modules 300 are connected in series. Additionally or alternatively, one check valve 354 may be positioned along the second fluid line 330 to allow flow only from the third sealing port 326, thereby restricting unwanted flow to the third sealing port 326 when the modules 300 are attached to the base tray 340.

[0034] As will be appreciated by those skilled in the art, the fluid pathways through module 300 may be vented in any known manner. For example, one or both of first sealing port 312 and second sealing port 324 may include an antibacterial filter that allows airflow therethrough but limits the passage of microorganisms therethrough. Additionally or alternatively, the fluid lines (first fluid line 310, first branch line 320, second fluid line 330, second branch line 334) may be formed in whole or in part by passages formed in module 300. First exposed tube portion 316 and second exposed tube portion 322 are preferably formed from flexible tubing such that they are pinchable in response to push-fit engagement by first male pin 336 and second male pin 342, respectively.

[0035] Additionally, modules 300 may be connected in any known manner, including, for example, cooperating fastening elements on opposing faces. Interengagement of first male pins 336 and first ports 338 between adjacent modules 300 may be utilized to form a connection therebetween.

[0036] In alternative fluidic device embodiments, modules can be coupled to a fluidic device in a base tray through modifications to the base tray to form a medication delivery device. As shown in FIG. 8 , the wells 402 in the base tray 400 can be configured horizontally, allowing modules 404 to be loaded laterally onto the tray 400. Because the modules 404 are not connected in series, only one fluid coupling is required to connect each of the outlet ports 406 of the modules 404 to the corresponding inlet ports 408 of the tray 400. The inlet ports 408 of the tray 400 can be connected to a common outlet 410, for example, by being manifolded within the tray 400. The common outlet 410 can discharge to flexible tubing 412 for delivery to a needle 413 or a container such as an IV bag. Negative pressure can be applied to the common outlet 410, for example, via the flexible tubing 412. For example, a peristaltic pump can be applied to the flexible tubing 412 to deliver the output to an IV bag.

[0037] The modules 404 may be vented to the atmosphere, so that as fluid is drawn from the modules 404, air may be automatically drawn into each vial, replacing the fluid during transfer. As the modules 404 begin to empty, their fluid paths may be closed to prevent drawing straight from the atmosphere. As a non-limiting example, the drug vials 418 of the modules 404 may each be modified to include a float valve 414, as shown in FIG. 9. The float valve 414 may be a piece of pierceable, low-density material held inside each drug vial 418 that floats on top of the liquid drug product 420. As medication 420 is pulled from the bottom of vial 418 through vial spike 422, the level of medication 420 drops, and eventually, when vial 418 is empty and float 414 is all that remains in the valve, the vacuum from spike 422 pulls float 414 onto spike 422, sealing off spike 424, and specifically the inlet and outlet lumens, from the vial and any vent paths.

[0038] Additionally, the wells 402 may each be formed with a cross-section that matches the cross-section of a corresponding fixed portion 424 protruding from the bottom 426 of one of the modules 404. This provides a sliding guide for the outlet port 406 to mate with the inlet port 408. Additionally, the wells 402 may have a non-rectangular cross-section, e.g., a trapezoidal cross-section, with the fixed portions 424 having a matching cross-section, such that interengagement therebetween limits removal of the module 404 from the well 402. Furthermore, the quantity of wells 402 may be varied with the corresponding number of fixed portions 424. This allows for controlled sequential placement of the modules 404 in a desired order. The cross-sections of the wells 402 / fixed portions 424 may also and / or alternatively be varied to specify a desired order of the modules 404.

[0039] A further embodiment in which the placement of current modules can be managed via controls on the tray 500 is shown in FIG. 10 . The tray 500 consists of individual POKAYOKE platforms 502 joined together by telescoping rails 504. The platforms 502 have keying features on their top surfaces that correspond to features on the undersides of the modules 506. During assembly, the modules 506 are attached to the correct matching platforms 502 on the tray 500. When the user presses the ends of the tray 500 together, the tray 500 can collapse along the telescoping rails 504, allowing the modules 506 to connect to each other and creating a stack of fluidly connected modules 506. A tubing set 508 can then be placed in the front module 506 to transfer the contents of the module 506 to a needle or container, such as an IV bag.

[0040] A further solution, allowing modules to be both mated with a base tray and connected in series without changing either design, can be achieved by using an adapter component 600 that assembles around a module 602 and changes the location of the fluid inlet and outlet ports, as shown in FIG. 11 . The module 602 includes a spike plate 604 with an inlet path 606 and an outlet path 608 formed in a manner similar to the spike plate 12 described above. The module 602 further includes a first sealing port 610 connected to the inlet path 606 by a first fluid line 612 and a second sealing port 614 connected to the outlet path 608 by a second fluid line 616. The first sealing port 610 is located along a rear surface 618 of the module 602, while the second sealing port 614 is located along a front surface 620 of the module 602. In this configuration, the first sealing port 610 and the second sealing port 614 are located in opposite directions on opposite faces of the module 602. This configuration allows the module 604 to be connected in series with similarly formed modules 604 in forming a combination drug delivery device.

[0041] The adapter 600 is made from multiple parts 600a, 600b, possibly including two halves representing an input side and an output side. The adapter 600 can be attached to the module 602 by mating the parts 600a, 600b. For example, the halves 600a, 600b of the adapter 600 can be placed around the module 602 and pressed together to permanently mate with a plastic snap mechanism around the module 602.

[0042] The adapter 600 includes a first interior port 622 and a second interior port 624. When the adapter 600 is attached to the module 602, the first interior port 622 is positioned to align with the first sealing port 610, and the second interior port 624 is positioned to align with the second sealing port 614. A first secondary fluid line 626 connects the first interior port 622 to a first exhaust port 628. A second secondary fluid line 630 connects the second interior port 632 to a second exhaust port 634. The first exhaust port 628 and the second exhaust port 634 are positioned on a common face 636 of the adapter 600 and face in a common direction transverse to the orientation of the first sealing port 610 and the second sealing port 614. This arrangement allows the adapter 600 to fluidly connect the module 602 to a base tray. Thus, the modules 602 can be connected in series without the adapter 600, and can be used with the base tray with the adapter 600.

[0043] The components of the adapter 600 may be divided, including evenly, between the parts 600a and 600b. For example, the first internal port 622, the first secondary fluid line 626, and the first exhaust port 628 may be located in one of the parts 600a, while the second internal port 624, the second secondary fluid line 630, and the second exhaust port 634 may be located in the second part 600b. This allows the fluid paths to be fully contained in each of the parts 600a and 600b without interruption. Additionally, one or more mating parts may be formed on the adapter 600 and the module 602 to strengthen the connection therebetween. For example, one or more protrusions 638 may be formed on the adapter 600 and / or the module 602 and configured to nest within corresponding recesses 640 formed in the adapter 600 and / or the module 602.

Claims

1. 1. A module for use in a combination drug delivery device, said module configured to receive a drug vial sealed by a septum, said module comprising: a vial spike configured to pierce the septum of the drug vial housed by the module, the vial spike including an inlet path and a separate outlet path; a first sealing port; a first fluid line connecting the inlet path to the first sealing port; a second sealing port; a second fluid line connecting the discharge path with the second sealing port; the first and second sealing ports are located on opposite sides of the module and face in opposite directions; Modules and an adapter attachable to the module, the adapter comprising: a first internal port; a second internal port; a first exhaust port; a first secondary fluid line connecting the first internal port with the first exhaust port; a second exhaust port; a second secondary fluid line connecting the second internal port with the second exhaust port; an adapter including: Equipped with the first exhaust port and the second exhaust port are disposed on a common side of the adapter and face the same common direction; When the adapter is attached to the module, the first internal port is aligned with the first sealing port, the second internal port is aligned with the second sealing port, and the common direction of the first exhaust port and the second exhaust port is transverse to the direction of the first sealing port and the second sealing port. combination.

2. The combination of claim 1 , wherein the adapter is formed from multiple pieces.

3. The combination of claim 2 , wherein the adapter is attached to the module by joining the plurality of parts together.

4. 3. The combination of claim 2, wherein a first part of the plurality of parts includes the first internal port, the first secondary fluid line, and the first exhaust port, and a second part of the plurality of parts includes the second internal port, the second secondary fluid line, and the second exhaust port.

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