Collection device for single or multiple containers

Abstract

The invention relates to a pooling device for single or multiple containers. Specifically, a device (10) for pooling fluid from a container unit (12) having at least one container (14, 16) is provided, the device comprising: an inlet port (18) having at least one inlet channel (22, 24), the inlet port being configured for receiving fluid or ambient air; and an outlet port (26) having at least one outlet passage (32, 34), the outlet port configured for delivering fluid to the accessory. An inlet port and an outlet port are both provided on the device. A cavity (40) is provided for accommodating the insertion of the container unit (12) for collecting fluid from the at least one container. At least one pin is disposed in the cavity and is configured to pierce a stopper of the at least one container when the container unit is transferred from the upper position to the lower position.

Description

[0001] Divisional Application Instructions

[0002] This application is a divisional application of the Chinese invention patent application with application number 201680035766.0, application date June 17, 2016, and invention name “Collecting device for single or multiple containers”.

[0003] CROSS-REFERENCE TO RELATED APPLICATIONS

[0004] This application claims priority under 35 USC §119(e) to U.S. Provisional Patent Application Serial No. 62 / 182,099, filed on June 19, 2015, which is incorporated by reference. Technical Field

[0005] The present disclosure relates generally to pooling devices for medical purposes, and more particularly to devices configured for pooling the contents from medicinal containers for simultaneous use. Background Art

[0006] In many cases, pharmaceutical preparations or fluids are separated before use due to their chemical and physical stability. Therefore, fluids are packaged and stored individually until fluids are mixed together to be infused intravenously to the patient. Traditionally, by medical professionals, the mixing of fluids is realized by injecting a first fluid into a glass bottle or a container with a second fluid. After mixing the first fluid and the second fluid, the mixed solution is extracted into a syringe and injected intravenously into the patient. In some cases, before being delivered to the patient, in a larger container, two solutions are mixed, or the mixed solution is transferred to a larger container, such as an intravenous (IV) infusion bag or a kit.

[0007] Some medicinal fluids are infused sequentially without mixing. For example, the first fluid may be infused first to improve the conditions for delivering the second fluid to or being handled by the patient. An exemplary dual medical container unit for infusing the first and second fluids is described in co-assigned U.S. Patent No. 8,684,433, which is incorporated herein by reference. In some cases, several vials of medicinal fluid must be combined to provide the correct dose for the patient. Patients with certain immunodeficiency disorders are treated by injecting relatively large amounts of immunoglobulin (IG) fluids. The first fluid medicament is applied to enhance the body's reception of the relatively high viscosity IG fluid as the second medicament. Conventionally, the medical professional infusing the fluid verifies the properties and concentration of the fluid, wipes the corresponding stopper of each container with a disinfectant (such as alcohol), pierces the stopper of each container to deliver the fluid, collects the fluid from the corresponding container using a plurality of syringes and a collection bag, and then sequentially infuses the patient with the fluid. In some cases, the dual container unit is manually lifted or suspended on an IV stand so that one or more fluids are delivered to the collection bag by gravity flow.

[0008] Because of this multi-step process (which is performed alternately by the patient at home in some cases), conventional infusion methods are prone to mishandling and errors. For example, bottles, vials or other containers may be mishandled, and may even be damaged or broken. In addition, several manual steps are currently required to achieve the required infusion sequence in a sterile environment, which wastes a lot of time due to the large number of manual steps, and requires a large amount of space to store the inventory of equipment during use. If the sterile infusion of medicinal fluids may be affected, bacterial or environmental contamination may result. Any of these problems may have a negative impact on the infusion of fluids to patients and the health of patients.

[0009] Therefore, there is a need to develop an improved manifold device that provides an improved infusion method for single or multiple pharmaceutical containers in a simpler and more reliable manner. Summary of the invention

[0010] The present invention relates to a collection device for collecting medicinal fluids from at least one medical container, which integrates many of the above-mentioned manual steps. An important aspect of the collection device of the present invention is that a central cavity configured to receive the medical container is provided to collect the medicinal fluids from the medical container without repeatedly loading different medical containers. An internal cavity pin is provided in the cavity for piercing the stopper of each medical container, and a locking mechanism is provided to reliably retain the medical container in the cavity of the collection device of the present invention.

[0011] In some embodiments, two or more collection devices of the present invention can be linked or connected in a complementary relationship so that a separate medical container is automatically infused to a user or patient in sequence without having to replace the medical container during operation. As an example only, the outlet of the collection device of the present invention is linked or daisy-chained to the inlet of another collection device to promote the uninterrupted connection of the fluid path between all linked collection devices. In this configuration, two or more medicinal fluids can be infused to the user with a relatively high volume (in the range of 100 milliliters) without interruption or manipulation of the medical container. It is envisioned that the collection device of the link can be reversed from the above-mentioned orientation.

[0012] In one embodiment, a collecting device for collecting fluid from a container unit having at least one container is provided, and the collecting device includes an inlet port having at least one inlet channel and an outlet port having at least one outlet channel, the inlet port being configured to receive fluid or ambient air, and the outlet port being configured to deliver the fluid to an accessory. Both the inlet port and the outlet port are disposed on the device. A cavity is provided for accommodating an insertion of the container unit to collect fluid from the at least one container. At least one pin is disposed in the cavity, and the at least one pin is configured to pierce a stopper of the at least one container when the container unit is transferred from an upper position to a lower position.

[0013] In another embodiment, a collection device for collecting medicinal fluids is provided, and the collection device includes a container unit having at least one container configured to store fluids, wherein the container unit is pre-attached to the collection device. An inlet port having at least one inlet channel is also included in the collection device, and the inlet port is configured to receive fluids or ambient air. An outlet port having at least one outlet channel is configured to deliver fluids to an attachment. Both the inlet port and the outlet port are arranged on the collection device. A cavity is provided for accommodating the insertion of the container unit from a pre-attached position to collect fluids from the at least one container. At least one pin is arranged in the cavity, and the at least one pin is configured to pierce the stopper of the at least one container when the container unit is transferred from an upper position to a lower position.

[0014] In yet another embodiment, a device for collecting medicinal fluids is provided, and the device includes a container unit having at least one container configured to store fluids, wherein the container unit is pre-attached to the collection device. An inlet port having at least one inlet channel is configured to receive fluids or ambient air. An outlet port having at least one outlet channel is configured to deliver fluids to an attachment. The inlet port and the outlet port are both arranged on the collection device. A cavity for accommodating the insertion of the container unit from a pre-attached position is provided to collect fluids from the at least one container. At least one pin is provided in the cavity, and the at least one pin is configured to pierce the stopper of the at least one container when the container unit is transferred from an upper position to a lower position. The collection device can be linked to another collection device in a series arrangement with respect to the longitudinal axis of each collection device, so as to establish an uninterrupted supply of fluids from the linked collection devices.

[0015] In yet another embodiment, a collection device for collecting fluid from a container unit having at least one container is provided, and the collection device includes an inlet port having at least one inlet channel, the inlet port being configured to receive fluid or ambient air. An outlet port having at least one outlet channel is also included in the collection device, the outlet port being configured to deliver the fluid to an accessory, and the inlet port and the outlet port are disposed on the collection device. A cavity is configured to accommodate the insertion of the container unit for collecting fluid from the at least one container. At least one pin is disposed in the cavity, and the at least one pin is configured to pierce a stopper of the at least one container when the container unit is transferred from an upper position to a lower position.

[0016] More specifically, the inlet port is connected to the outlet port in fluid communication with the at least one pin via a corresponding tube, and the at least one pin has a first pin channel connected to the at least one inlet channel. In addition, the at least one pin has a second pin channel connected to the at least one outlet channel. At least one of the inlet port and the outlet port has a protective cover to protect the corresponding inlet channel and outlet channel from contamination, and the at least one pin protrudes vertically from the inner surface of the base of the collection device.

[0017] A locking mechanism is provided for the collection device, and the locking mechanism is configured to securely hold the container unit in the cavity during use, and the locking mechanism is preferably provided on the inner wall of the cavity. The cavity is configured to accommodate the insertion of the container unit for collecting fluids from a single container. At least one container is configured to store fluid, and the container unit is attached to the collection device. A locking mechanism is provided for the collection device, and the locking mechanism is configured to prevent the container unit from being transferred from an upper position to a lower position.

[0018] For the container unit, a locking pin is included and can be inserted into a slot provided on the body of the container unit. A pressure strip is provided on the top of the container unit, and the container unit is transferred from an upper position to a lower position by pushing the pressure strip downward. Advantageously, the collection device can be linked in series with another collection device in a complementary relationship to establish an uninterrupted supply of fluid from the linked collection devices. Preferably, the inlet port of the first collection device is configured to be able to be inserted into the outlet port of the second collection device in a complementary relationship. The first collection device and the second collection device are linked together in series in a complementary relationship relative to the longitudinal axis of each collection device.

[0019] A cap remover is provided for the collection device, and the cap remover is attached to the at least one container and is configured to remove a top cap of the at least one container. The anti-leak mechanism has: a fluid connection assembly configured to control a fluid path in the collection device; and an air connection assembly configured to control a ventilation path in the collection device. The air connection assembly includes an air path connector, which is connected to an inlet port of the collection device via a hydrophobic filter.

[0020] A first fluid check valve and a second fluid check valve are included in the fluid connection assembly, the first fluid check valve being connected to the outlet port of the manifold device to selectively regulate the directional fluid flow of the fluid, and the second fluid check valve being connected to the inlet port of the manifold device to selectively regulate the directional fluid flow of the fluid. The first fluid check valve has a first fluid path connector configured to be releasably connected to the second check valve of another manifold device in a complementary manner, and the second fluid check valve has a second fluid path connector configured to be releasably connected to the first fluid check valve of another manifold device in a complementary manner. The cracking pressures of the first and second fluid check valves are in the range of 3-5 pounds per square inch.

[0021] The air connection assembly includes an air path plug or end component member having a blind cavity, and the air path plug or end component member is configured to be releasably connected to the air path connector of another collecting device in a complementary manner. The fluid connection assembly includes a first female component having a first female component opening, and the first female component opening is configured to accommodate the insertion of the first male component of the fluid connection assembly. Moreover, the fluid connection assembly includes an assembly locking mechanism, which is configured to releasably connect the first female component and the male component of the fluid connection assembly. Specifically, the first female component has a first sealing clamp, which is configured to prevent the directional fluid flow of the fluid, and the first male component has a second sealing clamp, which is configured to prevent the directional fluid flow of the fluid. In addition, the first female component has a column suspended from the inner upper surface of the first female component, and the first male component has a supporting gasket, which has a central through hole, and the size of the central through hole is set to accommodate the insertion of the column of the first female component. Also included in the air connection assembly is a second female member having a second female member opening configured to accommodate insertion of a second male member of the air connection assembly.

[0022] The hydrophobic filter is disposed in the second female member opening of the second female member, and the second male member is configured to form an airtight interference fit between the sheath and the second female member. Preferably, the second male member is surrounded by a sheath having an annular protrusion. A plurality of fluid and air path conduits are disposed in the collection device, and the path conduits are configured and arranged to fluidically connect at least one of the ventilation path and the fluid path of the collection device to each other.

[0023] Preferably, the air connection assembly is simultaneously connected to and shared by at least two containers of the collection device, and the fluid connection assembly includes a first force-actuated valve connected to the outlet port of the collection device to selectively regulate the bidirectional fluid flow of the fluid. In addition, the fluid connection assembly includes a second force-actuated valve connected to the inlet port of the collection device to selectively regulate the directional fluid flow of the fluid. A one-way check valve is included in the fluid connection assembly, which is connected to the inlet port of the collection device to selectively regulate the directional fluid flow of the fluid.

[0024] At least one pin is surrounded by a pin sheath configured to connect the inlet port and the outlet port of the collection device into fluid communication. The fluid connection assembly includes a pin connector and an access dome valve. Specifically, the access dome valve has an opening configured to accommodate the insertion of the pin connector in a complementary relationship. The fluid connection assembly includes at least one of a hydrophobic filter and a hydrophilic filter. Preferably, the hydrophobic filter is connected to the inlet port of the collection device to selectively adjust the directional air flow of the collection device. Alternatively or additionally, the hydrophilic filter is connected to the outlet port of the collection device to selectively adjust the directional fluid flow of the collection device.

[0025] The tray component includes at least one collection device that is fluidically coupled to the tray component. Preferably, the tray component includes a flow cover having at least one flow passage and being attached to the tray component to facilitate fluid communication. In addition, the tray component includes a positioning valve that is configured to selectively adjust the flow path from at least one container. At least one hydrophobic filter is connected to at least one of the inlet port and the outlet port. Similarly, at least one hydrophilic filter is connected to at least one of the inlet port and the outlet port. In another embodiment, the tray component includes a plurality of collection devices that are fluidically coupled to the tray component. In this configuration, it is preferred that the tray component includes two independent tubes that are configured to transport two independent fluids from the plurality of collection devices to the outlet port.

[0026] In yet another embodiment, a collection device for collecting medicinal fluids is provided, and the collection device includes a container unit having at least one container configured to store fluids, the container unit being attached to the collection device. The inlet port has at least one inlet channel configured to receive fluids or ambient air. The outlet port has at least one outlet channel configured to deliver fluids to an attachment, wherein the inlet port and the outlet port are arranged on the collection device. The cavity is configured to accommodate the insertion of the container unit to collect fluids from the at least one container. At least one pin is arranged in the cavity, and the at least one pin is configured to pierce the stopper of the at least one container when the container unit is transferred from the upper position to the lower position. The collection device can be linked to another collection device in a series arrangement with respect to each collection device, so as to establish an uninterrupted supply of fluids from the linked collection devices. A first wing and a second wing are also included in the collection device, the first wing being configured to accommodate the outlet port, and the second wing being configured to accommodate the inlet port. The second wing is vertically displaced relative to the first wing.

[0027] The foregoing and other aspects and features of the present disclosure will become apparent to those skilled in the art upon consideration of the following detailed description in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 is a perspective view of a first embodiment of a collection device of the present invention, depicting an exemplary dual medical container unit and an exemplary injection tubing set;

[0029] Figure 2 yes Figure 1 A plan view of a collection device of , depicting exemplary inlet and outlet ports for fluid delivery and an integrated pin disposed laterally on an inner surface of the collection device for piercing a stopper of a corresponding medical container;

[0030] Figure 3 yes Figure 2 A partial plan view of a manifold of , depicting an exemplary outlet port disposed on an outer surface of the manifold for removably connecting to an injection tube set;

[0031] Figure 4 is a perspective view of a second embodiment of a collecting device of the present invention having a locking pin, showing an exemplary arrangement of two adjacent collecting devices before connection;

[0032] Figure 5 After the connection Figure 4 A perspective view of a collecting device;

[0033] Figure 6 yes Figure 5 A schematic front view of a collection device of , depicting an exemplary illustration of fluid paths between connected medical containers;

[0034] Figure 7 is a side view of a third embodiment of a manifold device of the present invention, showing another exemplary arrangement of two connected manifold devices having different configurations for locking pins and inlet and outlet ports;

[0035] Figure 8 When adjacent collection devices are connected to each other Figure 7 A rear perspective view of the collecting device;

[0036] Fig. 9 When the adjacent aggregation device is disconnected Figure 7 A rear perspective view of the collecting device;

[0037] Fig.10 yes Figure 5 A schematic front view of a collection device of , depicting a leak prevention mechanism having a fluid connection assembly and an air connection assembly;

[0038] Fig. 10A yes Fig.10 A schematic front view of an anti-leakage mechanism of , depicting an exemplary combination of two force-actuated valves;

[0039] Fig. 10B yes Fig.10 A schematic front view of an anti-leakage mechanism of , depicting an exemplary combination of a force-actuated valve and a one-way check valve;

[0040] Fig. 10C yes Fig.10 A schematic front view of a leak prevention mechanism of , depicting an exemplary combination of a pin connector and an access dome valve;

[0041] Fig.11 When adjacent collection devices are connected to each other via a leak-proof mechanism Fig.10 A schematic front view of a collecting device;

[0042] Fig.12 yes Fig.10 An exploded partial vertical cross section of a fluid connection assembly;

[0043] Fig.13 yes Fig.10 An exploded partial vertical cross section of an air connection assembly;

[0044] Fig.14 yes Fig.10 A vertical cross-section of a leak prevention mechanism showing a fluid path of a fluid connection assembly;

[0045] Fig.15 yes Fig.10 A bottom view of the anti-leakage mechanism;

[0046] Fig.16 is configured to facilitate the use of dual medical container units Fig.10 A bottom view of the anti-leakage mechanism;

[0047] Fig.17A is designed to Figure 1 A top perspective view of an exemplary cap remover for use with a collection device;

[0048] Fig. 17B yes Fig.17A A bottom perspective view of a cap remover;

[0049] Figure 17C-Figure 17D Shows Fig.17A Exemplary uses of a cap remover;

[0050] Fig.18 yes Fig.10 A schematic front view of a leak prevention mechanism of , depicting an exemplary combination of a hydrophobic filter and a hydrophilic filter;

[0051] Fig.19 is an exploded perspective view of an exemplary tray incorporating the aggregation device of the present invention in a tandem arrangement; and

[0052] Fig. 20 is an exploded perspective view of an exemplary modular unit depicting a sink device of the present invention having a hydrophobic filter. DETAILED DESCRIPTION

[0053] Although specific embodiments of the collection device of the present invention have been described herein, other alternative embodiments of all components associated with the collection device of the present invention are interchangeable to accommodate different applications. The term "collection device" as used in this application refers to a device for accessing a medicinal fluid from one or more medical containers in order to infuse the medicinal fluid into a patient. Therefore, collection devices for infusing medicinal fluids from a single container as well as multiple medical containers are contemplated.

[0054] Reference now Figure 1-Figure 3 , the collection device is generally labeled 10 and is designed to collect medicinal fluids or substances from a medical container unit generally labeled 12, the medical container unit having a first medical container 14 and a second medical container 16, the first medical container 14 being configured to store a first medicinal fluid, and the second medical container 16 being configured to store a second medicinal fluid. In some embodiments, the collection device 10 of the present invention is a disposable unit to avoid potential contamination caused by repeated use. As described above, an exemplary dual medical container unit 12 is described in co-assigned U.S. Patent No. 8,684,433, which is incorporated herein by reference. Although other medicinal substances are envisioned for use with the present device 10, in one embodiment, the first medical container 16 contains an enzyme that expands the pores in the subcutaneous space of the patient. The expansion of the pores facilitates the injection delivery of a large volume of relatively high viscosity IG fluid contained in the second container 14. For example, in the absence of an enzyme, the expected injection of IG fluid is about 50 ml at a single site. However, using this enzyme, injections in the range of 600 ml can be achieved at a single injection site.

[0055] Although a container unit 12 having two medical containers 14, 16 is shown, it is also contemplated that the container unit has a single container (e.g., a syringe, a vial, a film bag, an ampoule, etc.). In one embodiment, when viewed from above, the collection device 10 of the present invention has a substantially rectangular shape, but other suitable shapes such as elliptical, square, and other geometric shapes are contemplated. It is also contemplated that any number of medical containers or any combination of medical containers can be used in the collection device 10 of the present invention to accommodate different applications.

[0056] The collection device 10 of the present invention includes an inlet port 18 configured to receive a medicinal fluid or ambient air and disposed on an outer wall 20 of the collection device. In some embodiments, as described in more detail below, when the collection devices are linked together, the inlet port 18 receives fluid from adjacent collection devices ( Figure 4 and Figure 5 ) of a medicinal fluid. Alternatively, the inlet port 18 acts as a vent for extracting ambient air when the collection device 10 is not linked to an adjacent collection device. Figure 6 As shown, when the collection device 10 is linked together, it has been found that appropriate ventilation between the corresponding devices and containers improves the sequential delivery of the medicaments. Depending on the configuration of the container unit 12, the inlet port 18 can have one or more inlet channels 22, 24, which correspond to the medical containers 14, 16 during use.

[0057] To deliver the medicinal fluid from the collection device 10, an output port 26 is provided on the side of the outer wall 20 of the collection device opposite to the inlet port 18, and the output port 26 is configured to deliver the medicinal fluid to another medical accessory, such as an adjacent collection device or a syringe set 28. In some embodiments, the syringe set 28 is detachably connected to the outlet port 26 of the collection device 10 at one end, and is detachably connected to a pumping system (not shown) such as a peristaltic pump or an injection device at the opposite end to extract the medicinal fluid from the collection device 10. Alternatively, a syringe (not shown) can be docked to the outlet port 26 to evacuate the medicinal fluid from the collection device 10.

[0058] Adjusting the flow of the medicinal fluid in the tubing set 28 is achieved by adjusting at least one tubing clamp 30 transversely relative to the longitudinal axis of the corresponding tubing. Other clamping devices that are transferred between the occluding position and the non-occluding position are contemplated as known in the art. As with the inlet port 18, the outlet port 26 may have one or more outlet channels 32, 34 that correspond to the medical containers 14, 16 during use.

[0059] In some embodiments, each channel 22, 24, 32, 34 has an elastically deformable seal 36, such as an O-ring or the like, located at the entrance of the corresponding channel to facilitate a friction fit or sliding connection between the connected inlet port 18 and outlet port 26 or between the outlet port 26 and the injection tube set 28. It is contemplated that a removable protective cover 38 is friction fit over or around each port 18, 26 to protect the corresponding inlet and outlet channels 22, 24, 32, 34 from touch or air contamination.

[0060] In some embodiments, a central opening or cavity 40 configured to accommodate the insertion of the medical container unit 12 is provided to collect the first and second medicinal fluids from the first and second medical containers 14, 16. Before the medical container unit 12 is inserted into the cavity 40, the top cap 42 of the medical container unit is removed to expose the first and second stoppers 44, 46 of the corresponding first and second containers 14, 16. Terminal sterilization of the stoppers 44, 46 is performed using a disinfectant such as alcohol, hydrogen peroxide, etc.

[0061] A first lumen pin or needle 48 is disposed in the cavity 40 for piercing the first stopper 44 of the first medical container 14, and a second lumen pin or needle 50 is disposed in the cavity for piercing the second stopper 46 of the second medical container 16. The two pins 48, 50 are preferably laterally integrally attached to the inner surface 52 of the base 54 of the collection device 10 so that the pins protrude vertically from the base to simultaneously pierce the first and second stoppers 44, 46 of the corresponding first and second medical containers 14, 16. In some cases, the first and second stoppers 44, 46 of the corresponding first and second medical containers 14, 16 are pierced separately to accommodate different applications. In some embodiments, a protective removable sleeve or sheath 56 is provided for each pin 48, 50 to cover the sharp point of each pin.

[0062] The start of the delivery of the medicinal fluid is achieved by inverting the container unit 12 and inserting the container unit into the cavity 40 so that the container unit is transferred from the upper position to the lower position. Specifically, in the illustrated embodiment, during insertion, the first and second stoppers 44, 46 of the first and second containers 14, 16 are pressed against and pierced by the first and second lumen pins 48, 50, respectively. It is also contemplated that the protective seal provided by the sleeve 56 is broken upon inversion and downward insertion of the container unit 12. The biased clip or clamp-type locking mechanism 58 provided on the inner wall 60 of the cavity 40 in the illustrated embodiment is provided to hold the container unit 12 above the base 54 by a certain space so that the containers 14, 16 cannot reach the pins 48, 50 unless the containers are properly positioned above the appropriate pins.

[0063] To facilitate proper orientation of the container in the unit 12, as Figure 2As shown, the dimensions of the cavity 40 are designed so that the container unit 12 is keyed to the cavity so that the container unit 12 can only be inserted in the correct orientation. Once the container 14, 16 is correctly positioned in the cavity 40, the locking clips 58 are urged radially outward by the presence of the container, which allows the container unit 12 to telescope, slide or move downward relative to the base 54, thereby achieving engagement between the container and the designated pins 48, 50. The pins 48, 50 pierce the stoppers 44, 46 of the corresponding containers 14, 16 and initiate the delivery of the corresponding contained medicinal fluid.

[0064] To facilitate fluid delivery of the first medicinal fluid, the first pin 48 has a first pin channel 62, which is connected to the first inlet channel 22 via a corresponding tubing 64. In addition, the first pin 48 has a second pin channel 66, which is connected to the first outlet channel 32 via a corresponding tubing 64. In a preferred embodiment, at least one check valve 68 is inserted or installed in the tubing 64 to selectively control the directional flow of the medicinal fluid. It is contemplated that the term "tube" or "tubing" includes or refers to any fixed or flexible fluid passage or path, such as a groove, etc., separate from or integral with the collection device 10 of the present invention, which has various cross-sectional shapes (e.g., circular, square or other shapes) depending on the application and construction method.

[0065] It is contemplated that the tubing 64 is configured to interconnect the inlet port 18, the pins 48, 50, and the outlet port 26, as is known in the art. As a result, when the manifold 10 is actuated, a continuous flow path is established from the inlet port 18 to the outlet port 26 in fluid communication with the first container 14. Figure 10-Figure 16 As described in more detail in the related paragraphs, it is also contemplated to use a hydrophobic filter in the tubing 64 or other suitable location of the collection device 10 to allow air to pass through but prevent the medicinal fluid from leaking from the collection device. An additional check valve can be installed below the base 54 to prevent the medicinal fluid from traveling through the pins 48, 50 to the connected adjacent unit.

[0066] More specifically, if Figure 2 As shown, in the configuration where the collecting device 10 of the present invention is not linked to another collecting device, the ambient air is sucked into the first container 14 (at the bottom) through the first inlet channel 22, the corresponding pipe 64 and the first pin channel 62 of the first pin 48 under the action of the pumping system. Figure 2 As a result, the first medicinal fluid in the first container 14 is delivered to the first outlet channel 32 via the second pin channel 66 of the first pin 48 and the corresponding tube 64. Exemplary flow paths of air and the first medicinal fluid are indicated by dashed arrows A.

[0067] When the delivery of the first medicinal fluid is completed, the opening and closing of the tube clamp 30 can be controlled ( Figure 3 ) to start the delivery of the second medicinal fluid. To facilitate the fluid delivery of the second medicinal fluid, the second pin 50 has a first pin channel 70, which is connected to the second inlet channel 24 via a corresponding tube 64. In addition, the second pin 50 has a second pin channel 72, which is connected to the second outlet channel 34 via a corresponding tube 64. Therefore, when the collection device 10 is actuated, a connection with the second container 16 ( Figure 2 A continuous flow path connected to the fluid (shown by dotted lines).

[0068] Specifically, as in the case of the first pin 48, ambient air is drawn into the second container 16 by the pumping system via the second inlet passage 24, the corresponding tube 64, and the first pin passage 70 of the second pin 50. As a result, the second medicinal fluid in the second container 16 is delivered to the second outlet passage 34 via the second pin passage 72 of the second pin 50 and the corresponding tube 64. Exemplary flow paths of the air and the second medicinal fluid are indicated by dashed arrows B.

[0069] Reference now Figure 2 and Figure 4-Figure 6 Another embodiment of the collection device 10 of the present invention is generally designated as 74a, 74b, 74c. Figure 4-Figure 6 , corresponding components of the first, second and third collecting devices 74a, 74b, 74c are indicated by reference numerals with the first three letters (i.e., "a", "b" and "c"). Components common to the collecting device 10 are indicated by the same reference numerals. In the particular embodiment shown in the collecting devices 74a, 74b, 74c, the medical container unit 12 with the first and second containers 14, 16 is attached to the collecting devices 74a, 74b, 74c as a pre-assembled unit.

[0070] More specifically, the first and second plugs 44, 46 of the containers 14, 16 are inserted into the cavities 40 of the collection devices 74a, 74b, 74c and are ready to be inserted by the first and second pins 48, 50 ( Figure 2 ) pierced. In the collection devices 74a, 74b, 74c of the present invention, it is contemplated that each device 74 is terminally sterilized, such as by gamma radiation, to ensure a sterile fluid path. The pins 48, 50 are provided with a protective sheath 56 that is pierced and compressed when the container 14, 16 is pressed, thereby keeping the pins clean and the fluid path sterile before use.

[0071] The device 74 and container unit 12 are then assembled and sealed into a breathable package and treated with a sterilant such as hydrogen peroxide vapor to maintain the plugs 44, 46 and pins 48, 50 in a sterile state prior to use.

[0072] In this configuration, the first and second stoppers 44, 46 of the containers 14, 16 are pre-placed or pre-positioned in an upper position to be pierced by the first and second pins 48, 50. However, a locking mechanism or pin 76 configured to prevent the container unit 12 from being transferred from the upper position to the lower position prevents premature actuation of the collection devices 74a, 74b, 74c prior to use (e.g., during shipping and handling). Thus, the pin 76 performs a function similar to the locking clip 58 discussed above. It is contemplated that the locking pin 76 is inserted into a slot 78 on the body 80 of the container unit 12 disposed between the first and second containers 14, 16, but other suitable configurations of the locking pin are contemplated.

[0073] After the locking pin 76 is disengaged by pulling it out of the body 80, a bead 82 having a plurality of grooves 84 for grip enhancement purposes is provided on the top of the container unit 12, and the bead 82 is pushed downward to transfer the container unit from the upper position to the lower position. This downward movement of the container unit 12 causes the first and second stoppers 44, 46 of the containers 14, 16 to be pierced by the corresponding first and second pins 48, 50.

[0074] In some embodiments of the collection devices of the present invention, such as in the depicted embodiments 74a, 74b, 74c, two or more collection devices may be linked together in series in a complementary relationship relative to the longitudinal axis of each collection device to establish an uninterrupted supply of medicinal fluid from the linked collection devices. Figure 4 and Figure 5 As shown, the inlet port 18a of the first manifold 74a is inserted into and complementarily connected with the outlet port 26b of the second manifold 74b. The inlet port 18b of the second manifold 74b is then inserted into the outlet 26c of the third manifold 74c to facilitate uninterrupted connection of fluid paths between all linked manifolds 74a, 74b, 74c.

[0075] In this configuration, the first, second and third collection devices 74a, 74b, 74c are connected or linked in fluid communication with each other to provide a path for the uninterrupted continuous delivery of medicinal fluids between the collection devices. For example, the first medicinal fluid of the linked first container 14a, 14b, 14c can be infused to the user without interruption or manipulation of the container. Similarly, the second medicinal fluid of the linked second container 16a, 16b, 16c can be infused to the user subsequently. It is envisioned that the collection devices 74a, 74b, 74c can be arranged in any other suitable manner to promote the infusion of medical fluids. In addition, the first and second medicinal fluids can be delivered to the user in reverse order to adapt to the application.

[0076] Reference now Figure 5 and Figure 6 , for the purpose of illustration, an embodiment with flow paths for three linked first containers 14a, 14b, 14c is shown. In this configuration, ambient air is drawn into the first container 14c on the right via the inlet port 18c and the first pin channel 62c of the first pin 48c. The second pin channel 66c of the first pin 48c is connected to the first pin channel 62b of the first pin 48b in the middle first container 14b. Similarly, the second pin channel 66b of the first pin 48b is connected to the first pin channel 62a of the first pin 48a in the left first container 14a.

[0077] Next, the second pin passage 66a of the first pin 48a passes through Figure 6 The outlet port 26a on the left side of the first container 14a is shown connected to the pumping system. Another flow path for the three linked second containers 16a, 16b, 16c is established in a similar manner.

[0078] In operation, the negative pressure or suction pressure generated by the pumping system through port 26a causes the uninterrupted sequential delivery of the first medicinal fluid from the three first containers 14a, 14b, 14c. The system 74a-c has a built-in air / fluid management feature for providing sequential delivery of the medicaments from the corresponding containers 14a-c. For example, initially, the fluid in the first container 14a on the left is sucked downward by the suction pressure applied to the fluid contents of the container 14a via port 26a and pin channel 66a until a vacuum is created above the level of the fluid in the container 14a. The establishment of this vacuum pressure creates suction pressure on the fluid contents of the container 14b via the pin channel 62a and the fluid connection of the inlet channel 18a to the outlet channel 26b and the pin channel 66b.

[0079] Next, the suction pressure on the fluid inclusions in the first container 14b in the middle sucks the inclusions downwards until a similar vacuum is formed above the level of the fluid in the container. Once vacuum is produced in two containers 14a and 14b, suction pressure is produced on the fluid inclusions of container 14c via pin passage 62b and inlet channel 18b to the fluid of outlet channel 26c and pin passage 66c. Because container 14c is ventilated to the surrounding environment by pipeline 18c, only slight vacuum pressure is produced above the liquid inclusions of this container 14c. On the contrary, the suction pressure produced will be communicated with the surrounding environment via pin passage 62c and inlet port 18c, and will cause air to be sucked into this container 14c, and this container will first become empty.

[0080] Container 14c will be empty until the liquid level reaches below the entrance of pin channel 66c, whereby the interior of the next container 14b will be exposed to the surrounding environment via container 14c, thereby allowing the fluid contents of container 14b to be emptied under the action of the suction force of the pumping system. Finally, after container 14b is emptied, container 14a is then emptied in a similar manner. Thus, the three containers 14a, 14b, 14c are automatically infused sequentially in the order from far to near until all containers are empty.

[0081] The different volumetric amounts of each container 14a, 14b, 14c will not affect the sequential fluid delivery process. Exemplary volumetric amounts of standard vials include 25 ml, 50 ml, 100 ml, 200 ml, and 300 ml, but any other suitable size or combination of medical containers is contemplated. Now referring to Figure 2 and Figure 7-9 A further (third) embodiment of the collecting device 74 of the present invention is generally designated 86a, 86b. Figure 7-Figure 9 86a, 86b, corresponding components of the first and second collecting devices 86a, 86b are indicated by reference numerals with the first two letters (i.e., "a" and "b"). Components common to the collecting device 74 are indicated by the same reference numerals. The main distinguishing feature of the collecting devices 86a, 86b is that the collecting devices are linked or daisy-chained together in a series arrangement relative to the longitudinal axis of each collecting device.

[0082] More specifically, each funnel 86a, 86b includes a first or left wing 88a, 88b configured to accommodate the outlet ports 26a, 26b and a second or right wing 90a, 90b configured to accommodate the inlet ports 18a, 18b. Fig. 9In the first collecting device 86a shown in FIG. 8 , the first inlet channel 22a and the second inlet channel 24a are arranged on the second wing 90a, and the first outlet channel 32a and the second outlet channel 34a are arranged on the first wing 88a. The second collecting device 86b has the same configuration for the corresponding inlet channels and outlet channels.

[0083] like Figure 8 and Fig. 9 As shown, in order to establish a daisy chain connection of two adjacent collecting devices 86a, 86b, the second wing 90a of the first collecting device 86a is complementarily connected to the first wing 88b of the second collecting device 86b. More specifically, in a preferred embodiment, the second wing 90a is positioned higher than the first wing 88b relative to an axis transverse to the longitudinal axis of the collecting devices 86a, 86b. It is contemplated that the relative position and configuration of the first and second wings 88b, 90a can be opposite to the above-described orientation.

[0084] It is also preferred that the first inlet channel 22a and the second inlet channel 24a extend downwardly from the lower surface of the second wing 90a, and the first outlet channel 32b and the second outlet channel 34b extend upwardly from the upper surface of the first wing 88b. Thus, the daisy chain connection of the collection devices 86a, 86b is achieved by pressing the second wing 90a of the first collection device downwardly onto the first wing 88b of the second collection device so that the inlet channels 22a, 24a of the first collection device are inserted into the outlet channels 32b, 34b of the second collection device in a complementary arrangement structure.

[0085] Back to Figure 2 , Figure 7 and Fig. 9 Another feature of the collecting device 86a, 86b is that the protective cover 38 has an elongated body that is configured to accommodate the shape or contour of the first wing and the right wing 88a, 88b, 90a, 90b. Optionally, the protective cover 38 has an auxiliary port 92 that is configured to deliver the medicinal fluid from the containers 16a and 16b through the corresponding outlet ports 26a, 26b to, for example, a syringe docked to the auxiliary port 92. The protective cover 38 also has a tube set that is configured to deliver the medical fluid from the other containers 14a and 14b to a syringe pump connected to the patient for injection. Replace the locking pin 76 ( Figure 5 ), a locking spacer 94 is provided to prevent the container unit 12 from being transferred to a lower position. Initially, the locking spacer 94 is inserted into a circumferentially extending annular groove 96 provided on the upper portion 98 of the corresponding collecting device 86a, 86b to lock the container unit 12 in the upper position.

[0086] Operating similarly to the locking pin 76, after the locking spacer 94 is removed from the collecting device 86a, 86b by pulling the ring 100 attached to the spacer, the pressure bar 82 of the container unit 12 is pushed downward to transfer the container unit from the upper position to the lower position. This downward movement of the container unit 12 causes the first and second stoppers 44, 46 of the containers 14, 16 to be pierced by the corresponding first and second pins 48, 50.

[0087] Reference now Figure 2 , Figure 6 and Fig.10 As shown, an exemplary anti-leakage mechanism is generally designated as 102 and is designed to prevent unwanted air or fluid from leaking from the collection device 10. Components common to the collection device 10 are indicated by the same reference numerals. The anti-leakage mechanism 102 includes a fluid connection assembly generally designated as 104 and an air connection assembly generally designated as 106, the fluid connection assembly being configured to control the fluid path in the collection device 10, and the air connection assembly being configured to control the ventilation path in the collection device. It is contemplated that the anti-leakage mechanism 102 can be applied to all embodiments of the collection devices 10, 74, and 86 described above.

[0088] In a preferred embodiment, the fluid connection assembly 104 includes a first fluid valve 108 that is integrated into the outlet port 26 of the first manifold device 74 to selectively regulate the fluid flow of the medicinal fluid from the first container 14. The first fluid valve 108 is normally closed when the first fluid valve 108 is not connected to another device or a tubing connector, and when the first fluid valve 108 is connected to another device or a tubing connector, the first fluid valve 108 is mechanically opened to allow fluid to flow through the connector 114. The fluid connection assembly 104 includes a second fluid check valve 110 that is connected to the inlet port 18 of the first manifold device 74 to selectively regulate the directional fluid flow of the medicinal fluid to the first container 14.

[0089] It is contemplated that the fluid check valve 110 is a one-way valve that allows a fluid path only toward the first container 14, so that when the first and second fluid check valves are in the rest position, the medicinal fluid in the first container does not leak out of the container. The first valve 108 has a first fluid path connector 112 that is configured to be releasably connected to the second check valve 110 of another collection device in a complementary manner. Optionally, the second check valve 110 has a second fluid path connector 114 that is configured to be releasably connected to the first check valve 108 of another collection device in a complementary manner.

[0090] During use, the first fluid valve 108 prevents fluid from flowing from the first container 14 when the manifold 74 is not connected to another manifold. The valve opens mechanically when connected to another device 74 to allow free fluid flow. The second fluid check valve 110 prevents leakage from the connector 114 when the device 74 is not connected to another manifold, and also prevents unwanted leakage between connected manifolds 74. An exemplary cracking pressure of the fluid check valve 110 is about 3-5 pounds per square inch (PSI) to allow the valve to be opened by fluid pressure generated by a connected pump.

[0091] To selectively adjust the directional air flow of the collection device 74, the air connection assembly 106 includes an air path connector 116, which is connected to the inlet port 18 of the first collection device 74 via a hydrophobic filter 118. Specifically, the hydrophobic filter 118 is connected to the air path connector 116 at one end and to the pin 48 downstream of the fluid check valve 110 at the opposite end. As is known in the art, the hydrophobic filter 118 allows air to pass through, but prevents fluid from passing through the filter. Therefore, the hydrophobic filter 118 prevents the medicinal fluid from leaking undesirably from the air path connector 116. Alternatively, other suitable hydrophilic filters are also contemplated to accommodate different applications.

[0092] An air path plug or end piece 120 having a blind cavity 122 is provided in the air connection assembly 106, and the air path plug or end piece 120 is configured to be releasably connected to an air path connector 116 of another collection device in a complementary manner. When the air path plug 120 is matingly or complementarily connected to the air path connector 116, the ventilation path in the collection device 74 is blocked or blocked by the blind cavity 122, thereby effectively preventing air leakage.

[0093] Reference now Figure 2 , Figure 6 and Fig.11 , it is envisioned that the first aggregation device 74a is linked or daisy-chained to the second aggregation device 74b ( Fig.11). The corresponding components of the anti-leakage mechanisms 102a, 102b and the first and second collection devices 74a, 74b are indicated by the reference numerals plus the first two letters (i.e., "a" and "b"). In this construction, the air path plug 120b of the second air connection component 106b is matched or complementarily connected to the air path connector 116a of the first air connection component 106a. Therefore, when the first and second collection devices 74a, 74b are linked or daisy-chained, the ventilation paths of the connected collection devices are automatically closed or blocked, except for the ventilation path of the farthest device in the daisy-chained devices (e.g., the ventilation path defined by the air path connector 116b of the second air connection component 106b).

[0094] As for the fluid path, the first fluid path connector 112b of the first fluid valve 108b of the second fluid connection assembly 104b is matched or complementarily connected to the second fluid path connector 114a of the second fluid check valve 110a of the first fluid connection assembly 104a. It is also contemplated that the pumping system is connected to the first fluid path connector 112a of the first fluid valve 108a of the first fluid connection assembly 104a in fluid communication with the container 14a.

[0095] In this configuration, the connected first valves 108a, 108b are mechanically opened by the first fluid path connectors 112a, 112b to allow fluid communication between the pumping system and the manifolds 74a, 74b. However, neither of the second check valves 110a, 110b need to be mechanically opened, since the one-way second check valve 110a already provides fluid flow from the second manifold 74b to the first manifold 74a. Only the first valves 108a, 108b that do not allow fluid to flow out of the containers 14a, 14b are mechanically opened.

[0096] As similarly described above, ambient air is drawn into the container 14b of the second collection device 74b via the air path connector 116b and the hydrophobic filter 118b of the air connection assembly 106b. At the same time, the second check valve 110b of the second fluid connection assembly 104b of the second collection device 74b prevents fluid from leaking from the container 14b. As a result, the negative pressure (such as a vacuum) generated by the pumping system causes uninterrupted sequential delivery of the medicinal fluid from the containers 14a, 14b without any unwanted fluid leakage.

[0097] Reference now Fig.10 and Fig.12As shown, preferably, the fluid connection assembly 104 includes a female member 124 having a female member opening 126, which is configured to accommodate the insertion of a male member 128 of the fluid connection assembly. In order to securely attach the female member 124 to the male member 128, a snap-fit ​​assembly locking mechanism, generally designated as 130, is provided in the fluid connection assembly 104, and the snap-fit ​​assembly locking mechanism is configured to releasably connect the female member 124 and the male member 128 together.

[0098] In a preferred embodiment, the locking mechanism 130 includes at least one locking tab or protrusion 132 disposed on the inner surface of the side wall 134 of the female member 124 and at least one depression or groove 136 disposed on the outer surface of the male member 128. When the male member 128 is slidingly inserted into the female member opening 126, the locking tab 132 and the corresponding depression 136 of the locking mechanism 130 are cooperatively latched to securely hold the female member 124 and the male member 128 in place, thereby initiating the directional fluid flow of the medicinal fluid indicated by arrow C. Other locking mechanism structures are contemplated, such as annular locking and release grooves, side wings, etc.

[0099] An important aspect of the fluid connection assembly 104 is that the female member 124 has a first sealing fixture 138, which is attached to the outer upper surface of the female member for providing a fluid-tight compression seal. It is envisioned that the first sealing fixture 138 has a first concave side 140 and an opposite first convex side 142, and the seal is designed to be opened when pressure is applied to the first concave side or convex side 140, 142. Preferably, the first sealing fixture 138 has a generally dome shape and is made of a flexible elastomeric material. It is envisioned that a first slit or gap 144 of a predetermined length is disposed approximately at the center of the first sealing fixture 138, so that the slit is tightly closed at rest, but opens when pressure is applied to the first concave side or convex side 140, 142.

[0100] More specifically, when the first sealing clamp is in the rest position, the first slit 144 of the first sealing clamp 138 prevents fluid flow of the medicinal fluid. However, when negative pressure generated by the pumping system is applied to the convex side 142 of the first sealing clamp 138, the first slit 144 opens to allow fluid flow of the medicinal fluid, as shown by arrow C. Other suitable types of check valves are contemplated, such as spring-loaded ball check valves, duckbill valves, umbrella valves, diaphragm valves, etc., to suit the application.

[0101] It is also contemplated that the female member 124 has a tubular post 146 that depends from the approximate center of the interior upper surface of the female member 124 within the female member opening 126 along the longitudinal axis of the female member. Preferably, the tubular post 146 has an inclined or sloped outer surface 148 with an introduced geometry, thereby forming a funnel-shaped outer wall. Specifically, the outer diameter of the tubular post 146 gradually increases toward the interior upper surface of the female member 124. Other suitable geometric shapes for the post 146 are also contemplated, such as square, rectangular, hexagonal.

[0102] Another important aspect of the fluid connection assembly 104 is that the male member 128 is generally tubular and has a second sealing fixture 150, which is attached to the inner surface of the male member for providing a fluid-tight compression seal. Like the first sealing fixture 138, the second sealing fixture 150 has a second concave side 152 and an opposite second convex side 154. As described above, the second sealing fixture 150 has the same construction as the first sealing fixture 138 and operates in the same manner as the first sealing fixture. However, it is noted that the first and second sealing fixtures 138, 150 are arranged in opposite orientations to prevent fluid from leaking from the fluid connection assembly 104.

[0103] More specifically, the first sealing fixture 138 is disposed on the outer upper surface of the female member 124 such that the first convex side 142 faces upward along the longitudinal axis of the female member in the direction of fluid flow as indicated by arrow C. Conversely, the second sealing fixture 150 is disposed on the inner surface of the male member 128 such that the second convex side 154 faces downward along the longitudinal axis of the male member against the direction of fluid flow as indicated by arrow C. Thus, at rest, the second slit or gap 156 of the second sealing fixture 150 prevents fluid flow of the medicinal fluid from the male member 128, and the first slit or gap 144 of the first sealing fixture 138 prevents fluid flow of the medicinal fluid from the female member 124.

[0104] It is also envisioned that the male member 128 has a female member opening 158, which is configured to accommodate the insertion of the tubular column 146 of the female member 124. An elastic support washer 160 having a central through hole 162 is disposed near the upper end of the inner surface of the male member 128. Since the size of the central through hole 162 of the support washer 160 is set to accommodate the insertion of the tubular column 146 of the female member 124, the inner diameter of the through hole is slightly smaller than the minimum outer diameter of the tubular column. Therefore, when the tubular column 146 of the female member 124 is gradually inserted into the central through hole 162 of the support washer 160, a fluid-tight interference fit is formed between the tubular column and the support washer. When the tubular column 146 is fully inserted, it forces the slit 156 to open and allows fluid communication between the female member 124 and the male member 128.

[0105] Reference now Fig.10 and Fig.13 Preferably, the air connection assembly 106 includes a female member 164 having a female member opening 166 configured to accommodate insertion of a male member 168 of the air connection assembly. An important aspect of the female member 164 of the air connection assembly 106 is that the hydrophobic filter 118 is disposed near the lower end of the inner surface of the female member 164. For example, the hydrophobic filter 118 can be attached to the inner surface of the female member 164 by chemical adhesive, solvent bonding, ultrasonic welding, or other conventional fastening techniques.

[0106] The rigid cylindrical body 170 of the male member 168 is surrounded by a flexible elastomeric sheath 172 having an annular protrusion 174 such that when the male member 168 is gradually inserted into the female member opening 166, the annular protrusion forms an airtight interference fit between the sheath and the female member 164. Therefore, it is preferred that the outer diameter of the annular protrusion 174 is slightly larger than the inner diameter of the female member opening 166. Although the hollow interior 176 of the male member 168 is shown for illustrative purposes, any suitable solid or semi-solid material can be separately inserted into the interior of the male member or formed integrally with the interior of the male member to suit the application.

[0107] Reference now Figure 2 , Figure 10-12 and Fig.14 ,exist Fig.14 104. As described above, it is envisioned that a pumping system is connected to the male member 128 of the fluid connection assembly 104. The pumping system will have a tubing set with a female connector 124 that is similar to the female connector 124 on the collection device. When the tubing set with the female connector 124 is connected to the collection device, the internal tubular post 146 of the female connector 124 will force open the slit 156 in the male connector 128 of the collection device, thereby allowing the flow of the medicinal fluid from the medical container 14 via the second pin channel 66 and the outlet port 26.

[0108] When the female member 124 of the fluid connection assembly 104 is connected to the male member 128 of another adjacent collection device 74, the negative pressure causes the first sealing clamp 138 of the female member to open. As a result, the medicinal fluid from the adjacent collection device will flow into the medical container 14 via the first pin channel 62 and the inlet port 18 to establish an uninterrupted supply of medicinal fluid from the linked or daisy-chained collection devices. It is envisioned that the sealing clamps 138, 150 and the gasket 160 are made of a flexible elastic material (such as a synthetic resin or plastic, rubber, etc.). Other suitable materials adapted to the application are also envisioned.

[0109] It is contemplated that the fluid path of the medicinal fluid of the collection device 74 is incorporated into the injection molded component as an integrated unit. For example, in some embodiments, the male member 128 of the fluid connection assembly 104 is preferably integrally attached laterally to the base 54 of the collection device 74 so that the male member protrudes vertically from the base. In such a structure, as shown in FIG. Figure 8 and Fig. 9 Similarly shown, when the female and male members 124, 128 are connected to each other, an enhanced secure coupling of the linked collection device is achieved, thereby preventing unwanted disassembly of the linked device. It is also contemplated that the relative position and configuration of the female and male members 124, 128 can be reversed from the above orientation.

[0110] Reference now Figure 10-12 , Fig.14 and Fig.15 , it is contemplated that a plurality of fluid and air path grooves 178 are molded into the base 54 of the manifold 74 to form at least a portion of the fluid path for the medicinal fluid. In this configuration, the inlet port 18 and the outlet port 26 are integrated into the grooves 178 as a single unit, so that the fluid and air paths from the pin 48 to the fluid and air connection assemblies 104, 106 are seamlessly transferred.

[0111] More specifically, with respect to the fluid path, the female member opening 126 of the female member 124 of the fluid connection assembly 104 is connected to the first pin channel 62 of the pin 48 via a groove 178 that is in fluid communication with the medical container 14, and the second pin channel 66 of the pin 48 is connected to the male member opening 158 of the male member 128 of the fluid connection assembly using another groove, thereby forming a continuous fluid path from the female member 124 to the male member 128.

[0112] For the ventilation path, the female member opening 166 of the female member 164 of the air connection assembly 106 is connected to the first pin channel 62 of the pin 48 via a groove 178 that is in fluid communication with the medical container 14, so that when the female member of the air connection assembly is not blocked by the male member 168 of the air connection assembly, ambient air is drawn into the medical container 14.

[0113] In some embodiments, a protective plate 180 ( Fig.14 ) to cover and seal the fluid and air paths defined by the groove 178. The plate 180 is attached to the base 54 by chemical adhesive, solvent bonding, ultrasonic welding or other conventional fastening techniques. Depending on the shape of the groove, the shape of the plate 180 is variable, but other suitable geometric shapes (e.g., square, rectangular or oval) are contemplated to suit the application.

[0114] Reference now Figure 1 , Figure 2 , Fig.14 and Fig.16 , another exemplary layout of the groove 178 of the anti-leak mechanism 102 is shown, wherein the groove is constructed and arranged to facilitate the dual medical container unit 12. The corresponding parts of the fluid connection assembly 104 are indicated by the reference numerals plus the first two alphabetical letters (i.e., "a" and "b"). The important aspect of the groove structure is that, although two separate or different fluid connection assemblies 104a, 104b are included in the anti-leak mechanism 102, only one air connection assembly 106 is included and the one air connection assembly 106 is shared by the first and second pins 48, 50.

[0115] Specifically, the female member opening 166 of the female member 164 of the air connection assembly 106 is connected to the first pin channel 62 of the first pin 48 and the first pin channel 70 of the second pin 50 via the groove 178, so that the ambient air received through the female member of the air connection assembly flows simultaneously into both the first and second medical containers 14, 16. Although a "T" shaped vent path layout of the groove 178 is shown for illustrative purposes, other suitable arrangements (such as "Y" shaped and "V" shaped layouts) are contemplated to suit the application.

[0116] Reference now Figure 2 , Figures 10A-10C and Fig.14 It is also contemplated that the fluid connection assembly 104 includes a first force actuated valve 182 ( Fig. 10A ), the first force-actuated valve 182 is connected to the outlet port 26 of the manifold 74 for selectively regulating the directional fluid flow of the fluid. In a similar configuration, the fluid connection assembly 104 includes a second force-actuated valve 184 ( Fig. 10A ), the second force-actuated valve 184 is connected to the inlet port 18 of the manifold 74 for selectively regulating the directional fluid flow of the fluid.

[0117] For example, Fig. 10BAs shown, the second force-actuated valve 184 is disposed between the second fluid check valve 110 and the first pin 48 and is connected to the inlet port 18, so that the fluid flow from the connector 114 is controlled by the operation of the second force-actuated valve 18 to prevent the fluid from leaking from the fluid connection assembly 104. Preferably, a one-way check valve 186 is connected to at least one of the inlet port 18 and the outlet port 26 of the manifold 74 to selectively regulate the directional fluid flow of the fluid.

[0118] Specifically, to actuate the second force-actuated valve 184 and thereby allow fluid to flow in the inlet port 18, the first medical container 14 is pushed downward to transfer the first medical container from the upper position to the lower position, as shown by arrow D ( Fig. 10B ). This downward movement of the first medical container 14 causes the top 188 of the first medical container 14 to depress the corresponding force-actuated valve 184 and allow fluid to flow from the connector 114. In contrast, when the second force-actuated valve 184 is not actuated, fluid flow in the inlet port 18 is prevented. Other suitable locations along the fluid or air flow connected to the inlet port 18 and the outlet port 26 are also contemplated to accommodate different applications.

[0119] Similarly, Fig. 10A The actuation of the first or second force-actuated valve 182, 184 shown in FIG. 1 is achieved by matching or complementarily connecting the first fluid path connector 112 of the fluid connection assembly 104 of the manifold 74 with the second fluid path connector 114 of the fluid connection assembly 104 of another manifold 74. As discussed above, in Fig.11 An exemplary connection of two adjacent collecting devices 74a, 74b to one another is shown in FIG.

[0120] It is also contemplated that at least one of the pins 48, 50 is protected by a pin sheath 190 (at Fig.14 The pin guard 190 is surrounded by a first pin 48 (shown in phantom in the figure), and is configured to connect the inlet port 18 and the outlet port 26 of the collection device 74 into fluid communication. For example, in the initial position, the pin guard 190 simultaneously and securely surrounds the first pin channel 62 and the second pin channel 66 of the first pin 48, thereby allowing air flow or fluid flow between the inlet port 18 and the outlet port 26 of the collection device 74.

[0121] However, if Fig. 10B As shown, the pin sheath 190 can be pierced and compressed when the container 14 is pressed down. As described above, when the first medical container 14 is transferred from the upper position to the lower position as shown by arrow D, the pin sheath 190 is also moved from the top 188 of the container 14. Fig.14 Push down to the upper position shown in Fig. 10BBy this movement of the container 14, the pin guard 190 is broken and fluid flow between the inlet and outlet ports 18, 26 is enabled.

[0122] Reference now Fig. 10C and Fig.14 , the fluid connection assembly 104 includes a pin connector 192 and an access dome valve 194. Preferably, the pin connector 192 is connected to the inlet port 18 of the manifold 74, and the inlet dome valve 194 is connected to the outlet port 26 of the manifold. As described above, the access dome valve 194 has a Fig.14 The second sealing fixture 150 of the snap-fit ​​locking mechanism 130 is similarly constructed. In this construction, the access dome valve 194 has an opening or through hole 162 that is configured to receive insertion of the pin connector 192 in complementary relation.

[0123] Reference now Figure 1 , Figure 8 and Figures 17A-17D , the collection device 74 includes a cap remover 198, which is attached to at least one of the collection devices and is configured to remove the top cap 42 of the corresponding container. In a preferred embodiment, the cap remover 198 includes a central cavity 200 having a head region 202 and a tail region 204, wherein the head region and the tail region are preferably arranged inwardly around the cavity in opposite orientations to each other. In use, the head region 202 of the cap remover 198 engages or grasps the top cap 42 and pivots about a point near the tail region 204 to open the top cap, as shown by arrow E ( Fig. 17C ). Although for illustrative purposes Figures 17A-17C The cap remover 198 is shown as being substantially circular or oval in shape, but other suitable shapes or designs are contemplated, such as polygonal or irregular shapes, to suit the application.

[0124] like Fig.17D As shown, it is also contemplated that the head region 202 of the cap remover 198 is preferably integrally formed with the base 54 of the collection device 10. In this configuration, the head region 202 of the cap remover 198 is fixedly attached to the base 54 of the collection device 10, and there is no tail region 204. During use, the top cap 42 of the medical container unit 12 is positioned in an inverted position close to the collection device 10 so that the head region 202 at the base 54 can be closely engaged or matched with the top cap of the container. Next, the container 14 is pivoted relative to the top cap 42 about a point opposite to the head region 202 so that the container is pulled away from the collection device 10 to open the top cap, as shown by arrow E'.

[0125] Reference now Figure 1 , Fig.10 and Fig.18 , it is contemplated that in some embodiments, the fluid connection assembly 104 includes at least one of a hydrophobic filter 206 and a hydrophilic filter 208. In some embodiments, the hydrophobic filter 206 is connected to the inlet port 18 of the collection device 10 to selectively adjust the directional air / fluid flow of the collection device. Conversely, the hydrophilic filter 208 is connected to the outlet port 26 of the collection device 10 to selectively adjust the directional fluid and air flow of the collection device.

[0126] In a configuration and arrangement for facilitating the dual medical container unit 12 Fig.18 In the exemplary configuration of , the first hydrophobic filter 206' is connected to the first inlet port 18' of the first medical container 14 configured to store a first medicinal fluid. Similarly, the second hydrophobic filter 206" is connected to the second inlet port 18". of the second medical container 16 configured to store a second medicinal fluid. Thus, advantageously, the first hydrophobic filter 206' and the second hydrophobic filter 206" allow air to escape without any unwanted fluid leakage from the inlet ports 18', 18".

[0127] To selectively control the directional fluid flow of the first or second medicinal fluid, the hydrophilic filter 208 is connected to the first outlet port 26' of the first medical container 14 and the second outlet port 26" of the second medical container 16. In this configuration, the hydrophilic filter 208 advantageously allows air to escape until it is wetted by the first or second medicinal fluid, after which the hydrophilic filter only allows the medicinal fluid to travel through the fluid path connector 112.

[0128] By way of example only, when the first medical container 14 is emptied of fluid, the hydrophilic filter 208 prevents air from passing through the hydrophilic filter and being infused into the patient. This air blockage also prevents any fluid flow and causes the pump to sound an alarm, which signals the patient / caregiver to move the positioning valve 216 to open the flow path to the second medical container 16. Then, the pump operation is resumed to infuse the contents of the second medical container 16. If the hydrophilic filter 208 is also installed in the outlet port 216 ", when the medical container 16 is emptied, the hydrophilic filter prevents air from passing through the filter and being infused into the patient. This air blockage prevents any fluid flow and causes the pump to sound an alarm, which signals the patient / caregiver that the injection of the second medical fluid is complete. Other suitable arrangements of the hydrophobic filter 206 and the hydrophilic filter 208 are also contemplated to accommodate different applications.

[0129] Reference now Figure 1 , Figure 6 , Figure 7 , Fig.10 , Fig.11 and Fig.19 , it is contemplated that the tray member 210 includes at least one collecting device 74 of the present invention linked in a series arrangement, thereby incorporating the collecting device into the tray member in a fluid communication manner. Fig.19 , while four (4) collection devices 74 are incorporated into the tray member 210, any number or embodiments of collection devices are contemplated to suit the application. A flow cover 212 having at least one flow path or passage 214 is attached to the tray member 210 to facilitate fluid communication between the collection devices 74. Preferably, a first flow passage 214' is provided for connecting the first medical container 14, and a separate second flow passage 214" is provided for connecting the second medical container 16. In this example, the tray member 210 includes a plurality of collection devices 74 incorporated into the tray member in fluid communication. In addition, the tray member 210 includes two separate conduits or passages 214', 214", which are configured to transport two separate fluids from the first and second medical containers 14, 16 to the outlet port 52. With Figure 1 , Figure 6 and Fig.11 Components common to the illustrated collecting devices 10 are denoted by the same reference numerals.

[0130] The tray member 210 preferably includes a positioning valve 216 that is configured to selectively allow or regulate a fluid path from at least one of the first and second medical containers 14, 16. For example, the positioning valve 216 is a manual switch or stopcock with a twist valve that is configured to selectively allow and prevent fluid flow from the first and / or second medical containers 14, 16. It is also contemplated that when the tubing set 28 is separated from the tray member 210, the positioning valve 216 provides valve access to prevent fluid flow. In a preferred embodiment, a pin cap 218 is provided to protect the pin sheath 190 and the pins 48, 50. As an example, in Fig.19 In the embodiment of the present invention, the fluid path connector 112 for one path to another at point 108 is replaced by a positioning valve 216. It is envisioned that the positioning valve 216 has a Luer lock connector and is axially rotatable so that the user controls which fluid is delivered to the user.

[0131] Reference now Figure 1 , Figure 4 , Figure 7-Figure 9 and Fig. 20 Preferably, the collection devices 74, 86a are constructed and arranged as stackable, linkable modular units. Components common to the collection devices 10, 74, 86a are indicated by the same reference numerals. Figure 4 and Figure 7-Figure 9Similarly shown in FIG. 8 , it is contemplated that the funneling device 86a includes a first wing 88a configured to accommodate the outlet port 26a and a second wing 90a configured to accommodate the inlet port 18a.

[0132] In order to prevent unwanted leakage of the first and second medicinal fluids, as Fig. 20 As shown, for example, a first hydrophobic filter 118' is disposed at the inlet port 18a and connected to the first pin 48, and a second hydrophobic filter 118" is disposed at the second wing 90a and connected to the second elongated needle 50. Other suitable arrangements of the hydrophobic filters 118', 118" are contemplated to suit different applications.

[0133] like Fig. 20 As shown, it is contemplated that the collection device 86a includes a flow cover 212 having at least one dedicated flow path or passage 214', 214" to facilitate fluid flow from the corresponding pins 48, 50. Each flow path 214', 214" is bifurcated or separated according to the pin channels 62, 66, 70, 72 of the corresponding pins 48, 50 using a separator member 220. It is also contemplated that at least one protective plate or cover 222 is provided to seal the exposed fluid or air path or passage associated with the collection device 86a. In addition, at least one cap member 224 is provided to removably block the fluid or air path or passage associated with the collection device 86a.

[0134] While particular embodiments of the collecting device of the present invention have been described herein, it will be appreciated by those skilled in the art that changes and modifications may be made thereto without departing from the broader aspects of the disclosure and as set forth in the appended claims.

Claims

1. A device for collecting medicinal fluids, comprising: First entrance; First exit; a first cavity configured to accommodate insertion of a first container unit, wherein the first container unit includes at least one first container configured to store a first fluid; a first pin disposed in the first cavity and configured to pierce a stopper of the first container when the first container unit is transferred from an upper position to a lower position, wherein the first pin comprises a first channel and a second channel, wherein the first channel is connected to the first inlet and the second channel is connected to the first outlet; a second cavity configured to accommodate the insertion of a second container unit, wherein the second container unit includes at least one second container configured to store a second fluid; a second pin disposed in the second cavity and configured to pierce the stopper of the second container when the second container unit is transferred from an upper position to a lower position, wherein the second pin includes a third channel connected to the first inlet via the first channel and the second channel, and the second pin includes a fourth channel connected to the first outlet, wherein the second channel is connected to the first outlet via the third channel and the fourth channel; and A pin sheath of the second pin, the pin sheath of the second pin covers the second pin and connects the third channel and the fourth channel of the second pin in a fluid communication manner to allow fluid to flow from the second channel of the first pin to the first outlet.

2. The device according to claim 1, wherein: The pin sheath of the second pin is removable from the second pin.

3. The device according to claim 1, wherein: The pin sheath of the second pin is configured to be pierced and compressed when the second container unit is transferred from the upper position to the lower position. 4 . The device according to claim 1 , further comprising a pin cap configured to protect the second pin and a pin sheath of the second pin.

5. The device according to claim 1, wherein: The first container unit includes a third container configured to store a third fluid, and the device further includes: Second entrance; Second exit; and a third pin disposed in the first cavity and configured to pierce a stopper of the third container when the first container unit is transferred from an upper position to a lower position, wherein the third pin comprises a fifth channel and a sixth channel, wherein the fifth channel is connected to the second inlet and the sixth channel is connected to the second outlet. 6 . The device according to claim 5 , further comprising a pin sheath of the third pin, the pin sheath of the third pin covering the third pin and connecting the fifth channel and the sixth channel of the third pin in a fluid communication manner.

7. The device according to claim 5, wherein: The second container unit includes a fourth container configured to store a fourth fluid, and the device further includes: A fourth pin, the fourth pin being disposed in the second cavity and being configured to pierce the stopper of the fourth container when the second container unit is transferred from an upper position to a lower position, wherein the fourth pin comprises a seventh channel and an eighth channel, wherein the seventh channel is connected to the second inlet and the eighth channel is connected to the second outlet.

8. The device according to claim 7, further comprising a pin sheath of the fourth pin, the pin sheath of the fourth pin covering the fourth pin and connecting the seventh channel and the eighth channel of the fourth pin in a fluid communication manner.

9. The device according to claim 8, wherein: The fifth channel is connected to the second inlet, the sixth channel is connected to the seventh channel, and the eighth channel is connected to the second outlet.

10. The device according to claim 8, further comprising a pin sheath of the third pin, the pin sheath of the third pin covering the third pin and connecting the fifth channel and the sixth channel of the third pin in fluid communication, wherein: The pin sheath of the second pin is configured to be pierced and compressed when the second container unit is transferred from the upper position to the lower position, The pin sheath of the third pin is configured to be pierced and compressed when the first container unit is transferred from the upper position to the lower position, and The pin sheath of the fourth pin is configured to be pierced and compressed when the second container unit is transferred from the upper position to the lower position.

11. The device according to claim 8, further comprising the first container unit and the second container unit, wherein: The first fluid and the second fluid are the same type of first fluid, and wherein the third fluid and the fourth fluid are the same type of third fluid, and wherein the first fluid and the third fluid are different fluids.

12. The device according to claim 1, wherein: The first pin and the second pin protrude perpendicularly from an inner surface of a base of the device.

13. The device according to claim 1, wherein: The device has a locking clip configured to securely retain the first container unit in the first cavity during use.

14. The device according to claim 13, wherein: The locking clip is disposed on the inner wall of the first cavity.

15. The device of claim 1, further comprising a tray member including the first cavity and the second cavity coupled in fluid communication therein.

16. The device of claim 1, further comprising a second outlet, a first flow path, and a separate second flow path, wherein: The first flow path delivers the first fluid from the first container to the first outlet, and the separate second flow path delivers the second fluid from the second container to the second outlet.

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