RU2809303C2 - Pooling device for one or multiple medical containers - Google Patents

Abstract

FIELD: fluid container.

SUBSTANCE: device (10) for pooling fluid from a container block (12) having at least one container (14, 16), which contains an inlet port (18) having at least one inlet channel (22, 24) configured capable of receiving fluid or ambient air, and an outlet port (26) having at least one outlet channel (32, 34) configured to deliver fluid to the nozzle. Both inlet and outlet ports (18, 26) are located on the device (10). A cavity (40) is provided for inserting and housing a container block (12) for pooling fluid from at least one container (14, 16). At least one point (48, 50) is located in the cavity, which is configured to pierce the plug (44, 46) of at least one container when the container block moves from an upper position to a lower position.

EFFECT: pooling device for one or multiple medical containers is provided.

57 cl, 20 dwg

Description

CROSS REFERENCE

This application claims benefit from U.S. Provisional Patent Application Serial No. 62/182099, filed June 19, 2015 at 35 USC 119(e), which is incorporated by reference.

BACKGROUND OF THE ART

The present disclosure generally relates to pooling devices used for medical purposes, and more particularly to a device configured to pool contents from medical containers for concurrent use.

In many cases, medical agents or fluids are separated before use for their chemical and physical stability. Thus, the fluids are packaged and stored separately until the fluids are mixed together for intravenous administration to a patient. Traditionally, mixing of fluids is performed by a healthcare professional by injecting a first fluid into a glass vial or container containing a second fluid. After mixing the first and second fluids, the mixed solution is withdrawn into a syringe barrel and injected intravenously into the patient. In some cases, before delivery to the patient, the two solutions are mixed in a large container, such as an intravenous (IV) bag or system, or the mixed solution is transferred into it.

Some medical fluids are administered sequentially without mixing. For example, the first fluid may be initially administered to improve the conditions under which the second fluid is delivered to or processed by the patient. An exemplary assembly of two medical containers for administering first and second fluids is described in co-assigned U.S. Patent No. 8,684,433, which is incorporated by reference. In some cases, multiple vials of medical fluid must be combined to provide the correct dose to a patient. Patients suffering from certain immunodeficiency conditions are treated with infusions of relatively large volumes of immunoglobulin (IG) fluid. The first drug in the form of a fluid is used to improve the body's acceptance of the IG fluid with a relatively high viscosity, which is the second drug. Typically, the healthcare professional administering the fluids ensures the identity and concentration of the fluids, wipes the respective stopper of each container using a disinfectant such as alcohol, pierces the stopper of each fluid delivery container, pools the fluids separately from the respective containers using multiple syringes and pooling bags, and then sequentially administers fluids to the patient. In some cases, the two-container unit is manually lifted or suspended from an IV stand so as to deliver one or more fluids by gravity flow into the pooling bag.

Due to this multi-step process, which is alternatively in some cases performed by the patient at home, the conventional route of administration is prone to poor performance and errors. For example, bottles, vials or other containers may not be handled correctly and may even become damaged or broken. In addition, multiple manual steps are currently required to achieve the required administration sequence under sterile conditions, a significant amount of time is wasted due to multiple manual steps, and significant space is required to store the equipment assembly during use. If the sterile administration of a medical fluid is compromised, bacterial contamination or environmental contamination may result. Any of these problems can have a negative impact on the administration of fluids to the patient and on the health of the patient.

Thus, there is a need to develop an improved pooling device that provides an improved administration method for one or multiple medical containers in a simpler and more reliable manner.

ESSENCE

The present disclosure is directed to a pooling device for pooling a medical fluid from at least one medical container, which integrates the many manual steps discussed above. An important aspect of the present pooling device is that in order to pool medical fluid from a medical container without reloading different medical containers, a central cavity is provided that is configured to receive the medical container. To pierce the stopper of each medical container, an internal tip with a lumen is provided in the cavity, and a locking mechanism is provided to securely hold the medical container in the cavity of the present pooling device.

In some embodiments, two or more of the present pooling devices may be coupled or coupled in a complementary arrangement to sequentially and automatically administer individual medical containers to a user or patient without the need to replace the medical container during operation. By way of example only, the outlet of the present pooling device is connected or connected in series to the inlet of another pooling device to facilitate seamless connection of the fluid path between all associated pooling devices. In this configuration, two or more medical fluids can be administered to the user in relatively large volumes (in the hundreds of ml range) without interruption or manipulation of the medical containers. It is contemplated that the orientation of the associated pooling devices described above may be reversed.

In one embodiment, a pooling device is provided for pooling fluid from a container unit having at least one container that includes an inlet port having at least one inlet port configured to receive fluid or ambient air, and an outlet port having at least one outlet channel configured to deliver fluid to the nozzle. Both the inlet and outlet ports are located on the device. A cavity is provided for inserting and housing a container unit for pooling fluid from at least one container. At least one point is located in the cavity, which is configured to pierce the plug of at least one container when the container block moves from an upper position to a lower position.

In yet another embodiment, a pooling device for pooling a medical fluid is provided, which includes a container block having at least one container configured to store the fluid, wherein the container block is pre-attached to the pooling device. The pooling device also includes an inlet port having at least one inlet port configured to receive fluid or ambient air. An outlet port having at least one outlet channel is provided to deliver fluid to the nozzle. Both inlet and outlet ports are located on the pooling device. A cavity is provided for insertion and placement of the container block from the pre-attached position for the purpose of pooling fluid from at least one container. At least one point is located in the cavity, which is configured to pierce the plug of at least one container when the container block moves from an upper position to a lower position.

In yet another embodiment, a device for pooling a medical fluid is provided that includes a container block having at least one container configured to store the fluid, wherein the container block is pre-attached to the pooling device. An inlet port is provided to receive fluid or ambient air, having at least one inlet port. To deliver fluid to the nozzle, an outlet port is provided having at least one outlet channel. Both inlet and outlet ports are located on the pooling device. A cavity is provided for insertion and placement of the container block from the pre-attached position for the purpose of pooling fluid from at least one container. At least one point is located in the cavity, which is configured to pierce the plug of at least one container when the container block moves from an upper position to a lower position. A pooling device may be complementarily coupled to another pooling device in a sequential arrangement relative to the longitudinal axis of each pooling device to provide a continuous supply of fluid from the coupled pooling devices.

In yet another embodiment, a pooling device is provided for pooling fluid from a container unit having at least one container that includes an inlet port having at least one inlet port configured to receive fluid or ambient air. The pooling device also includes an outlet port having at least one outlet port configured to deliver fluid to the nozzle, and inlet and outlet ports are located on the pooling device. The cavity is configured to insert and accommodate a container block for pooling fluid from at least one container. At least one point is located in the cavity, which is configured to pierce the plug of at least one container when the container block moves from an upper position to a lower position.

More specifically, the inlet port is connected to the outlet port in fluid communication with the at least one tip through a corresponding tube, and the at least one tip has a first tip channel connected to the at least one inlet channel. In addition, the at least one tip has a second tip channel connected to the at least one outlet channel. At least one of the inlet and outlet ports has a protective cap to protect the respective inlet and outlet ports from contamination, and at least one tip generally projects from an inner surface of the base of the pooling device.

The pooling device is provided with a locking mechanism that is configured to securely hold the container unit in the cavity during use, the locking mechanism being preferably located on the inner wall of the cavity. The cavity is configured to insert and accommodate a container block for pooling fluid from a single container. At least one container is configured to store fluid, and the container unit is attached to the pooling device. A locking mechanism is provided for the pooling device, which is configured to block the transition of the container block from an upper position to a lower position.

The container block includes a locking pin that can be inserted into a slot located on the body of the container block. A pressure plate is located on top of the container block for moving the container block from an upper position to a lower position by pushing the pressure plate downward. Preferably, the pooling device may be connected in series with another pooling device in a complementary arrangement to provide a continuous supply of fluid from the coupled pooling devices. Preferably, the inlet port of the first pooling device is configured to be inserted into the outlet port of the second pooling device in a complementary arrangement. The first pooling device and the second pooling device are connected in series together in a complementary arrangement with respect to the longitudinal axis of each pooling device.

For the pooling device, a cap remover is provided that is attached to the at least one container and configured to remove the top cap of the at least one container. The leakage prevention mechanism has a fluid connection unit configured to regulate a fluid passage in the pooling device, and an air connection assembly configured to regulate an air passage passage in the pooling device. The air connection assembly contains an air channel connector connected to the inlet port of the pooling device through a hydrophobic filter.

The fluid connection assembly includes a first fluid check valve coupled to an outlet port of the pooling device to selectively control directional flow of fluid, and a second fluid check valve coupled to the inlet port of the pooling device to selectively control directional flow of fluid. environment. The first fluid check valve has a first fluid path connector configured to be complementarily coupled to a second check valve of another pooling device and the second fluid check valve has a second fluid path connector configured to be complementarily coupled. removably connecting to the first liquid check valve of another pooling device. The response pressure of the first and second liquid check valves is in the range of 3-5 psi.

The air connection assembly contains an air channel plug or end component having a blind cavity configured for complementary connection and detachability with the air channel connector of another pooling device. The fluid connection assembly includes a first female element having an opening of the first female element configured to insert and accommodate the first insertable element of the fluid connection assembly. Also, the fluid connection assembly contains a mechanism for fixing the assembly, configured to connect the first female and inserted elements of the fluid connection assembly with the possibility of detachment. Specifically, the first female member has a first sealing device configured to prevent directional flow of fluid, and the first insertion member has a second sealing device configured to prevent directional flow of fluid. In addition, the first female element has a rod hanging on the inner upper surface of the first female element, and the first insertion element has a support washer having a central through hole sized to insert and accommodate the rod of the first female element. The air connection assembly also contains a second female element having a second female element opening configured to insert and accommodate a second insertable element of the air connection assembly.

A hydrophobic filter is located in the second opening of the second female element, and the second insertion element is configured to create an airtight press fit between the cover and the second female element. Preferably, the second insertion element is covered by a cover having an annular projection. A plurality of fluid and air channel tubes are provided in the pooling apparatus, and the channel tubes are designed and configured to accommodate at least one of an air passageway and a fluid passageway of the pooling apparatus in communication of the fluids with each other.

Preferably, the air connection assembly is simultaneously coupled to and common to at least two containers of the pooling device, and the fluid connection assembly comprises a first force-activated valve connected to the outlet port of the pooling device to selectively control directional flow of fluid. Also, the fluid connection assembly includes a second force-activated valve connected to the inlet port of the pooling device to selectively control the directional flow of the fluid. The fluid connection assembly contains a unidirectional check valve connected to the inlet port of the pooling device to selectively control directional flow of fluid.

At least one tip is covered by a tip cover configured to connect the inlet and outlet ports of the pooling device with fluid communication. The fluid connection assembly contains a tip connector and a process dome valve. Specifically, the process dome valve has an opening configured to accept and accommodate a tip connector in a complementary arrangement. The fluid connection assembly contains at least one of a hydrophobic filter and a hydrophilic filter. Preferably, the hydrophobic filter is connected to the inlet port of the pooling device to selectively control the directional flow of air of the pooling device. Alternatively or additionally, a hydrophilic filter is connected to the outlet port of the pooling device to selectively control the directional flow of fluid from the pooling device.

The tray element contains at least one pooling device, which is included in the tray element with fluid communication. Preferably, the tray element includes a flow cover having at least one flow channel and attached to the tray element to facilitate communication of fluids. In addition, the tray element includes a position valve configured to selectively control the flow channel from at least one container. At least one hydrophobic filter is connected to at least one of an inlet port and an outlet port. Likewise, at least one hydrophilic filter is connected to at least one of an inlet port and an outlet port. In yet another embodiment, the tray element includes a plurality of pooling devices built into the fluid communicating trough element. In this configuration, it is preferred that the tray element comprises two separate tubes configured to conduct two separate fluids from the plurality of pooling devices into the outlet port.

In yet another embodiment, a pooling device for pooling a medical fluid is provided, which includes a container block having at least one container configured to store the fluid, the container block being attached to the pooling device. The inlet port has at least one inlet port configured to receive fluid or ambient air. The outlet port has at least one outlet port configured to deliver fluid to the nozzle, with the inlet and outlet ports located on the pooling device. For pooling fluid from at least one container, a cavity is made with the possibility of inserting and placing a container block. At least one point is located in the cavity, which is configured to pierce the plug of at least one container when the container block moves from an upper position to a lower position. A pooling device may be complementarily coupled to another pooling device in a sequential arrangement relative to each pooling device to provide a continuous supply of fluid from the coupled pooling devices. The pooling device also includes a first wing configured to accommodate an outlet port and a second wing configured to accommodate an inlet port. The second wing is vertically offset relative to the first wing.

The foregoing and other aspects and features of the disclosure will become apparent to those skilled in the art from the following detailed description when taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of the present pooling device, depicting an exemplary unit of two medical containers and an exemplary infusion tubing system;

FIG. 2 is a top view of the pooling device of FIG. 1, depicting exemplary fluid delivery inlet and outlet ports and integrated tips positioned laterally on the inner surface of the pooling device for the purpose of piercing the stoppers of respective medical containers;

FIG. 3 is a partial top view of the pooling apparatus of FIG. 2, depicting an exemplary outlet port located on the outer surface of the pooling device for releasable connection to an infusion tubing system;

FIG. 4 is a perspective view of a second embodiment of the present pooling device having a locking pin showing an exemplary arrangement of two adjacent pooling devices before connection;

FIG. 5 is a perspective view of the pooling devices of FIG. 4 after connection;

FIG. 6 is a schematic front view of the pooling devices of FIG. 5 is an exemplary illustration of a fluid path between connected medical containers;

FIG. 7 is a side perspective view of a third embodiment of the present pooling device, illustrating another exemplary arrangement of two connected pooling devices having different configurations for the locking pin and the inlet and outlet ports;

FIG. 8 is a rear perspective view of the pooling devices of FIG. 7 when adjacent pooling devices are interconnected;

FIG. 9 is a rear perspective view of the pooling apparatus of FIG. 7 when adjacent pooling devices are disconnected;

FIG. 10 is a schematic front view of the pooling apparatus of FIG. 5 showing a leakage prevention mechanism having a liquid connection portion and an air connection portion;

FIG. 10A is a schematic front view of the leakage prevention mechanism of FIG. 10 depicting an exemplary combination of two force-activated valves;

FIG. 10B is a schematic front view of the leakage prevention mechanism of FIG. 10 depicting an exemplary combination of a force-actuated valve and a one-way check valve;

FIG. 1°C is a schematic front view of the leakage prevention mechanism of FIG. 10 depicting an exemplary combination of a tip connector and a process dome valve;

FIG. 11 is a schematic front view of the pooling devices of FIG. 10, when adjacent pooling devices are interconnected through a leakage prevention mechanism;

FIG. 12 is an exploded fragmentary vertical cross-sectional view of the fluid connection assembly of FIG. 10;

FIG. 13 is an exploded fragmentary vertical cross-sectional view of the air connection assembly of FIG. 10;

FIG. 14 is a vertical cross-sectional view of the leakage prevention mechanism of FIG. 10 illustrating a fluid passage of a fluid connection assembly;

FIG. 15 is a bottom view of the leakage prevention mechanism of FIG. 10;

FIG. 16 is a bottom view of the leakage prevention mechanism of FIG. 10, configured to support a block of two medical containers;

FIG. 17A is a top perspective view of an exemplary cap puller configured for use with the pooling apparatus of FIG. 1

FIG. 17B is a bottom perspective view of the cap puller of FIG. 17A;

Figures 17C-17D show exemplary uses of the cap puller of FIGS. 17A;

FIG. 18 is a schematic front view of the leakage prevention mechanism of FIG. 10 depicting an exemplary combination of a hydrophobic filter and a hydrophilic filter;

FIG. 19 is an exploded perspective view of an illustrative tray incorporating the present serial pooling apparatus; A

FIG. 20 is an exploded perspective view of an illustrative modular unit depicting the present hydrophobic filter pooling apparatus.

DETAILED DESCRIPTION

Although a specific embodiment of the present pooling apparatus has been described herein, other alternative embodiments of all components associated with the present pooling apparatus are interchangeable to suit different applications. The term "pooling device" as used in this application refers to a device for accessing a medical fluid from one or more medical containers for administering the medical fluid to a patient. Thus, a pooling device is provided for administering medical fluid from a single container as well as from multiple medical containers.

With reference now to Figures 1-3, the present pooling device is generally designated 10 and is configured to pool a medical fluid or substance from a medical container unit generally designated 12 having a first medical container 14 configured to store the first medical fluid. environment, and a second medical container 16 configured to store the second medical fluid. In some embodiments, the present pooling device 10 is a disposable unit to avoid possible contamination due to repeated use. As discussed above, an illustrative unit 12 of two medical containers is described in co-authored US Pat. No. 8,684,433, which is incorporated by reference. While other medical agents are contemplated for use with the present device 10, in one embodiment, the first medical container 16 contains an enzyme that enlarges the pores in the patient's subcutaneous space. Enlarging the pores facilitates delivery by infusion of large volumes of relatively high viscosity IG fluid contained in the second container 14. For example, without enzyme, the expected infusion of IG fluid is approximately 50 ml at one location. However, with the enzyme, infusions in the range of 600 ml can be achieved at a single infusion site.

Although the container unit 12 is shown having two medical containers 14, 16, it is also contemplated that the container unit has a single container (eg, syringe, vial, film bag, ampoule, and the like). In one embodiment, the present pooling device 10 has a substantially rectangular shape when viewed from above, but other suitable shapes are contemplated, such as oval, square, and other geometric shapes. It is also contemplated that any number or combination of medical containers may be used for the present pooling device 10 to accommodate various applications.

The present pooling device 10 includes an inlet port 18 configured to receive medical fluid or ambient air, the inlet port being located on an outer wall 20 of the pooling device. In some embodiments, as described in more detail below, when pooling devices are coupled together, inlet port 18 receives medical fluid from an adjacent pooling device (Figures 4 and 5). Otherwise, when the pooling device 10 is not connected to an adjacent pooling device, the inlet port 18 acts as a vent to exhaust ambient air. As described below with respect to FIG. 6, it has been found that when the pooling devices 10 are connected together, proper ventilation of air between the respective devices and containers enhances subsequent drug delivery. Depending on the configuration of the container unit 12, the inlet port 18 may have one or more inlet channels 22, 24 that correspond to the medical containers 14, 16 during use.

To deliver medical fluid from the pooling device 10, an outlet port 26 is located on the opposite side of the outer wall 20 of the pooling device from the inlet port 18, which is configured to deliver the medical fluid to another medical device, such as an adjacent pooling device or system 28. infusion tubes. In some embodiments, the infusion tubing system 28 is removably connected at one end to the outlet port 26 of the pooling device 10 and at the opposite end to a pumping system (not shown), such as a peristaltic pump or infusion device, for drawing medical fluid from devices 10 for pooling. Alternatively, a syringe (not shown) may be coupled to the outlet port 26 to extract medical fluid from the pooling device 10 using vacuum.

Control of the flow of medical fluid in the tube system 28 is achieved by lateral adjustment of at least one clamp 30 relative to the longitudinal axis of the respective tubes. As is known in the art, other clamping devices are provided that transition between a closing position and a non-closing position. As with inlet port 18, outlet port 26 may have one or more outlet ports 32, 34 that correspond to medical containers 14, 16 during use.

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 to the corresponding channel to facilitate a frictional fit or sliding connection between the connected inlet and outlet ports 18, 26. or between the outlet port 26 and the infusion tubing system 28. A removable protective cover 38 is provided to be frictionally installed over or around each port 18, 26 to protect the respective inlet and outlet ports 22, 24, 32, 34 from contact or airborne contamination.

In some embodiments, a central opening or cavity 40 is provided to allow the first and second medical fluids to pool from the first and second medical containers 14, 16 and is configured to receive and receive a medical container unit 12. Before insertion into the cavity 40 of the medical container unit 12, the top cover 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. Final sterilization of the stoppers 44, 46 is performed using a disinfectant such as alcohol , hydrogen peroxide and the like.

To pierce the first plug 44 of the first medical container 14, a first tip or needle 48 with a lumen is located in the cavity 40, and to pierce the second plug 46 of the second medical container 16, a second tip or needle 50 with a lumen is located in the cavity. Both points 48, 50 are preferably attached integrally in a transverse direction to the inner surface 52 of the base 54 of the pooling device 10 such that the points generally project from the base to simultaneously pierce the first and second plugs 44, 46 of the respective first and second medical containers. 14, 16. In some cases, to accommodate different applications, the first and second plugs 44, 46 of the corresponding first and second containers 14, 16 are punched separately. In some embodiments, a protective removable sleeve or cover 56 is provided for each tip 48, 50 to protect the sharp end point of each tip.

Triggering delivery of the medical fluid is achieved by inverting the container block 12 and inserting the container block into the cavity 40 such that the container block moves from an up position to a down position. Specifically, in this illustrated embodiment, during insertion, the first and second plugs 44, 46 of the first and second containers 14, 16 are pressed against and pierced by the first and second lumen tips 48, 50, respectively. It is also provided that the protective seal provided by the sleeve 56 is broken when the container unit 12 is turned over and inserted downwards. In this illustrated embodiment, a displaceable locking mechanism 58 of the snap or clamp type is provided to hold the container block 12 at a distance above the base 54, located on the inner wall 60 of the cavity 40, so that the containers 14, 16 cannot reach the tip 48, 50 if the containers are correctly located above the corresponding tip.

To facilitate proper orientation of the containers in block 12, as seen in FIG. 2, the cavity 40 is sized such that the container block 12 is secured in the cavity so that it can only be inserted in the correct orientation. Once the containers 14, 16 are in the proper position in the cavity 40, the locking clips 58 are pushed radially outward by the presence of the containers, allowing the container block 12 to telescope, slide, or move downward relative to the base 54, providing engagement between the containers and the designated tip 48 , 50. The tips 48, 50 pierce the stoppers 44, 46 of the respective containers 14, 16 and trigger delivery of the respective contained medical fluids.

To facilitate delivery of the first medical fluid, the first tip 48 has a first tip channel 62 connected through corresponding tubes 64 to the first inlet channel 22. In addition, the first tip 48 has a second tip channel 66 connected through corresponding tubes 64 to the first outlet channel 32. In a preferred embodiment, to selectively control the directional flow of a medical fluid, at least one check valve 68 is disposed or installed in the tubing system 64. The term “tube” or “tube system” is intended to include or refer to any fixed or flexible passages or fluid channels such as grooves and the like, either separate from or integrated with the present pooling device 10, having a variety of cross-sectional shapes (eg, round, square or other shapes) depending on the application and design.

The tube system 64 is intended to be configured to interconnect the inlet port 18, the tip 48, 50, and the outlet port 26, as is known in the art. As a result, upon activation of the pooling device 10, a continuous flow path is created from the inlet port 18 to the outlet port 26 with fluid communication with the first container 14. As described in more detail below in the paragraphs associated with Figures 10-16, it is also provided that The tubing system 64 or other suitable locations of the pooling device 10 utilizes a hydrophobic filter to allow air to pass through but prevent medical fluid from flowing out of the pooling device. Additional check valves may be installed underneath the base 54 to prevent medical fluid from passing into the connected adjacent block through the tip 48, 50.

More specifically, as illustrated in FIG. 2, in a configuration where the present pooling device 10 is not coupled to another pooling device, ambient air is drawn into the first container 14 (shown in dotted line in FIG. 2) by the pressurization system through the first inlet port 22, the corresponding tube system 64, and the first channel 62 of the first tip 48. As a result, the first medical fluid in the first container 14 is delivered to the first outlet channel 32 through the second channel 66 of the first tip 48 and associated tubing 64. An exemplary air flow path and the first medical fluid are indicated by arrow A with broken line.

When delivery of the first medical fluid is completed, delivery of the second medical fluid can begin through the adjustment hole and closing of the clamps 30 (FIG. 3). To facilitate delivery of the second medical fluid, the second tip 50 has a first tip channel 70 connected through corresponding tubes 64 to the second inlet channel 24. In addition, the second tip 50 has a second tip channel 72 connected through corresponding tubes 64 to the second outlet channel 34. Therefore, when the pooling device 10 is activated, another continuous flow path is created from the inlet port 18 to the outlet port 26 in fluid communication with the second container 16 (shown in dotted line in FIG. 2).

Specifically, as with the first tip 48, ambient air is drawn into the second container 16 by the pressurization system through the second inlet port 24, associated tubing 64, and the first port 70 of the second tip 50. As a result, the second medical fluid in the second container 16 delivered to the second outlet channel 34 through the second channel 72 of the second tip 50 and corresponding tubing system 64. An exemplary air and second medical fluid flow path is indicated by a broken line arrow B.

Next, with reference to Figures 2 and 4-6, another embodiment of the present pooling device 10 is generally designated 74a, 74b, 74c. In Figures 4-6, respective components of the first, second and third pooling apparatus 74a, 74b, 74c are designated by reference numerals representing the first three letters of the alphabet (ie, "a", "b" and "c"). Components common to the pooling apparatus 10 are designated by identical reference numerals. In the particular embodiment shown in the pooling device 74a, 74b, 74c, a medical container unit 12 having first and second containers 14, 16 is attached to the pooling device 74a, 74b, 74c as a pre-assembled unit.

More specifically, the first and second plugs 44, 46 of the containers 14, 16 are inserted into the cavity 40 of the pooling device 74a, 74b, 74c, and are ready to be pierced by the first and second tips 48, 50 (FIG. 2). In the present pooling device 74a, 74b, 74c, it is provided that each device 74 must be completely sterile, for example, gamma radiation and the like, to ensure a sterile fluid channel. The tips 48, 50 are provided with protective covers 56 that pierce and compress when the containers 14 are pressed, thereby keeping the tips clean and the fluid passage sterile until use.

Next, the device 74 and container unit 12 are assembled and sealed in an air-permeable package and treated with a disinfectant such as hydrogen peroxide vapor and the like to keep the plugs 44, 46 and the tip 48, 50 sanitized until use.

In this configuration, the first and second plugs 44, 46 of the containers 14, 16 are pre-installed or pre-positioned in an upper position to be pierced by the first and second points 48, 50. However, a locking mechanism or pin 76 configured to block the transition of the container unit 12 from the upper position to the down position, prevents premature activation of the pooling device 74a, 74b, 74c before use (eg during transport and handling). Thus, the pin 76 performs a similar function to securing the clamps 58 discussed above. The locking pin 76 is intended to fit into a slot 78 located on the body 80 of the container unit 12 between the first and second containers 14, 16, but other suitable locking pin configurations are contemplated.

After disengaging the locking pin 76 by pulling it from the housing 80, a pressure plate 82 having a plurality of grooves 84 for gripping purposes is positioned on top of the container block 12 and is pushed down to move the container block from an up position to a down position. This downward movement of the container block 12 causes the first and second plugs 44, 46 of the containers 14, 16 to be pierced by the corresponding first and second points 48, 50.

In some embodiments of the present pooling device, as in the illustrated embodiments, two or more pooling devices 74a, 74b, 74c may be connected in series together with a complementary arrangement relative to the longitudinal axis of each pooling device to provide a continuous supply of medical fluid from connected devices for pooling. For example, as illustrated in Figures 4 and 5, the inlet port 18a of the first pooling device 74a is inserted and complementarily connected to the outlet port 26b of the second pooling device 74b. In turn, the inlet port 18b of the second pooling device 74b is inserted into the outlet 26c of the third pooling device 74c to facilitate seamless connection of the fluid path between all associated pooling devices 74a, 74b, 74c.

In this configuration, the first, second and third pooling devices 74a, 74b, 74c are connected or coupled in fluid communication with each other to provide a passage between the pooling devices for continuous, continuous delivery of medical fluids. For example, the first medical fluids of the associated first containers 14a, 14b, 14c can be administered to the user without interruption or manipulation of the containers. Likewise, second medical fluids of associated second containers 16a, 16b, 16c can subsequently be administered to the user. It is contemplated that the pooling devices 74a, 74b, 74c may be positioned in any other suitable manner to facilitate administration of medical fluids. In addition, the first and second medical fluids may be delivered to the user in reverse order to suit the application.

Next, with reference to Figures 5 and 6, an embodiment with a flow channel for three associated first containers 14a, 14b, 14c is shown for illustrative purposes. In this configuration, ambient air is drawn into the right first container 14c through the inlet port 18c and the first passage 62c of the first tip 48c. The second channel 66c of the first tip 48c is connected to the first channel 62b of the first tip 48b in the middle first container 14b. Likewise, the second channel 66b of the first tip 48b is connected to the first channel 62a of the first tip 48a in the left first container 14a.

Further, the second port 66a of the first tip 48a is connected to the injection system through an outlet port 26a shown to the left of the first container 14a in FIG. 6. Similarly, another flow channel is created from three connected second containers 16a, 16b, 16c.

During operation, the negative or suction pressure generated by the pumping system through port 26a causes subsequent continuous delivery of the first medical fluid from the first three containers 14a, 14b, 14c. The system 74a-c has a built-in air/fluid control feature to facilitate subsequent delivery of the drug from the respective containers 14a-c. For example, initially, the fluid in the left first container 14a is drawn in by suction pressure applied through the port 26a and passage 66a to the liquid contents of the container 14a until the vacuum is higher than the level of the fluid in the container 14a. The build-up of this vacuum pressure creates a suction pressure on the liquid contents of the container 14b due to the liquid connection of the tip channel 62a and the inlet channel 18a with the outlet channel 26b and the tip channel 66b.

Further, the suction pressure applied to the liquid contents in the middle first container 14b draws the contents until a similar vacuum is obtained above the level of the fluid in that container. Once a vacuum is created in both containers 14a and 14b, suction pressure is applied to the liquid contents of container 14c by fluid coupling of the tip port 62b and the inlet port 18b with the outlet port 26c and the tip port 66c. Since container 14c is exposed to the atmosphere via line 18c, only a small vacuum pressure is created above the liquid contents of container 14c. Instead, the suction pressure generated will communicate with the environment through the tip passage 62c and the inlet port 18c and will cause air to be drawn into this container 14c, and this container will be emptied first.

Container 14c will be emptied until the liquid level is below the inlet of tip channel 66c, causing the interior of the next container 14b to become exposed to the outside environment through container 14c, allowing the liquid contents of container 14b to be emptied by the suction force of the pumping system. . Finally, after container 14b is emptied, container 14a is then emptied in the same way. Accordingly, the three containers 14a, 14b, 14c are sequentially automatically inserted in order from farthest to nearest until all containers are emptied.

The different volumetric quantity of each container 14a, 14b, 14c does not affect this process of sequential fluid delivery. Exemplary volumetric sizes of standard bottles include 25, 50, 100, 200 and 300 milliliters, but any other suitable size or combination of medical containers is provided. Next, with reference to Figures 2 and 7-9, another (third) embodiment of the present pooling device 74 is generally designated 86a, 86b. In Figures 7-9, respective components of the first and second pooling devices 86a, 86b are designated by reference numerals with the first two letters of the alphabet (ie, "a" and "b"). Components common to the pooling device 74 are designated by identical reference numerals. The main difference present in the pooling devices 86a, 86b is that the pooling devices are connected or daisy-chained together in a serial arrangement with respect to the longitudinal axis of each pooling device.

More specifically, each pooling device 86a, 86b includes a first or left wing 88a, 88b configured to receive an outlet port 26a, 26b, and a second or right wing 90a, 90b configured to receive an inlet port 18a, 18b. As with the first pooling device 86a shown in FIG. 9, the first and second inlet ports 22a, 24a are located on the second wing 90a, and the first and second outlet ports 32a, 34a are located on the first wing 88a. The second pooling device 86b has the same configuration of corresponding inlet and outlet channels.

As illustrated in Figures 8 and 9, to create a series connection of two adjacent pooling devices 86a, 86b, the second wing 90a of the first pooling device 86a is complementarily connected to the first wing 88b of the second pooling device 86b. More specifically, in a preferred embodiment, the second wing 90a is located higher than the first wing 88b with respect to an axis transverse to the longitudinal axis of the pooling device 86a, 86b. It is contemplated that the relative position and configuration orientations of the first and second wings 88b, 90a may be reversed from those described above.

It is also preferable that the first and second inlet ports 22a, 24a extend downward from the bottom surface of the second wing 90a, and the first and second outlet ports 32b, 34b extend upward from the top surface of the first wing 88b. Thus, the series connection of the pooling devices 86a, 86b is achieved by pressing the second wing 90a of the first pooling device onto the first wing 88b of the second pooling device so that the inlet channels 22a, 24a of the first pooling device are inserted into the outlet channels 32b, 34b a second pooling device with a complementary arrangement.

Referring back to Figures 2, 7 and 9, another feature of the pooling device 86a, 86b is that the protective cover 38 has an elongated body configured to receive the outline or profile of the first and right wings 88a, 88b, 90a, 90b. Optionally, the protective cap 38 has an auxiliary port 92 configured to deliver medical fluid from the containers 16a and 16b through a corresponding outlet port 26a, 26b into a syringe, for example, mated to the auxiliary port 92. The protective cap 38 also has a set of tubes configured with the ability to deliver medical fluid from other containers 14a and 14b to an infusion pump connected to the patient for infusion. In place of the locking pin 76 (FIG. 5), a locking spacer 94 is provided to prevent the container block 12 from moving to a downward position. First, the locking spacer 94 is inserted into the circumferential annular groove 96 located on the upper portion 98 of the corresponding pooling device 86a, 86b to lock the container unit 12 in the upper position.

Operating similarly to the locking pin 76, to move the container unit from the upper position to the lower position after removing the locking pad 94 from the pooling devices 86a, 86b, by pulling the ring 100 attached to the pad, the pressure plate 82 of the container unit 12 is pushed downward. This downward movement of the container block 12 causes the first and second plugs 44, 46 of the containers 14, 16 to be pierced by the corresponding first and second points 48, 50.

Referring now to FIGS. 2, 6, and 10, an exemplary leakage prevention mechanism is designated generally 102 and is configured to prevent unwanted leakage of air or fluid from the pooling device 10. Components common to the pooling apparatus 10 are designated by identical reference numerals. The leakage preventing mechanism 102 includes a fluid connection unit, generally designated 104, configured to adjust a fluid passage in the pooling device 10, and an air connection unit, generally designated 106, configured to adjust an air passage in the pooling device. pooling. The leakage prevention mechanism 102 is intended to be applicable to all embodiments of the pooling devices 10, 74, 86 described above.

In a preferred embodiment, the fluid connection assembly 104 includes a first fluid valve 108 integrated into the outlet port 26 of the first pooling device 74 to selectively control the passage of medical fluid from the first container 14. The first fluid valve 108 is typically closed when not connected with another device or tubing connector, and mechanically opens to allow fluid to pass through connector 114 when connected to another device or tubing connector. The fluid connection assembly 104 includes a second fluid check valve 110 coupled to the inlet port 18 of the first pooling device 74 to selectively control the directed flow of medical fluid into the first container 14.

The fluid check valve 110 is intended to be a one-way valve providing a fluid path only towards the first container 14 such that the medical fluid in the first container does not leak out of the container when the first and second fluid check valves are in position. in a resting position. The first valve 108 has a first fluid path connector 112 configured to be complementarily and releasably connected to a second check valve 110 of another pooling device. Optionally, the second check valve 110 has a second fluid path connector 114 configured to be complementarily and releasably coupled to the first check valve 108 of another pooling device.

During use, the first fluid valve 108 prevents fluid from flowing from the first container 14 when the pooling device 74 is not connected to another pooling device. The valve mechanically opens to allow fluid to flow freely when connected to another pooling device 74. The second fluid check valve 110 prevents leakage from connector 114 when device 74 is not connected to another pooling device and also prevents unwanted leakage between connected pooling devices 74. pooling. An exemplary operating pressure of the fluid check valve 110 is approximately 3-5 pounds per square inch (PSI), causing the valve to open under the fluid pressure generated by the connected pump.

To selectively control the directional flow of air of the pooling device 74, the air connection assembly 106 includes an air channel connector 116 connected to the inlet port 18 of the first pooling device 74 through a hydrophobic filter 118. Specifically, the hydrophobic filter 118 is connected at one end to the air channel connector 116, and at the opposite end with a tip 48 at the outlet of the fluid check valve 110. As is known in the art, the hydrophobic filter 118 allows air to pass through but prevents fluid from passing through the filter. Thus, the hydrophobic filter 118 prevents unwanted leakage of medical fluid from the air channel connector 116. Alternatively, other suitable hydrophilic filters are also provided to suit different applications.

The air connection assembly 106 is provided with a plug or air channel end member 120 having a blind cavity 122 and configured to be complementarily and releasably coupled to the air channel connector 116 of another pooling device. When the air channel plug 120 and the air channel connector 116 are mated or complementarily connected, the air channel in the pooling device 74 is closed or blocked by the blind cavity 122, thereby effectively preventing air leakage.

Next, with reference to Figures 2, 6 and 11, it is provided that the first pooling device 74a is connected or connected in series with the second pooling device 74b (FIG. 11). The corresponding components of the leakage prevention mechanism 102a, 102b and the first and second pooling devices 74a, 74b are designated by reference numerals with the first two letters of the alphabet (ie, “a” and “b”). In this configuration, the air passage plug 120b of the second air connection assembly 106b is mated or complementarily connected to the air passage connector 116a of the first air connection assembly 106a. Thus, when the first and second pooling devices 74a, 74b are coupled or connected in series, the air ducts of the connected pooling devices are automatically closed or blocked except for the air duct of the outermost device of the series-connected devices (e.g., the air duct formed by the air vent connector 116b channel of the second air connection node 106b).

Regarding the fluid passage, the first fluid passage connector 112b of the first fluid valve 108b of the second fluid connection assembly 104b is mated or complementarily connected to the second fluid passage connector 114a of the second fluid check valve 110a of the first fluid connection assembly 104a. It is also provided that the injection system is connected to the first fluid path connector 112a of the first fluid valve 108a of the first fluid connection assembly 104a in communication with the container 14a.

In this configuration, the connected first valves 108a, 108b are mechanically opened by the first fluid channel connectors 112a, 112b, allowing fluid communication between the pumping system and the pooling devices 74a, 74b. However, mechanical opening of any of the second check valves 110a, 110b is not required because the flow of fluid from the second pooling device 74b to the first pooling device 74a is already adapted by the unidirectional second check valve 110a. Only the first valves 108a, 108b are mechanically opened, which do not allow fluid to flow from the containers 14a, 14b.

As described above, ambient air is drawn into the container 14b of the second pooling device 74b through the air channel connector 116b and the hydrophobic filter 118b of the air connection unit 106b. At the same time, the second check valve 110b of the second fluid connection assembly 104b of the second pooling device 74b prevents leakage of fluid from the container 14b. As a result, the negative pressure, such as vacuum, created by the injection system causes continuous subsequent delivery of medical fluids from the containers 14a, 14b without any unwanted fluid leakage.

Referring now to FIGS. 10 and 12, it is preferred that the fluid connection assembly 104 includes a female member 124 having a female member opening 126 configured to insert and receive a fluid connection assembly insertion member 128. To securely attach the female member 124 to the insertion member 128, a snap assembly locking mechanism is provided in the fluid connection assembly 104, generally designated 130 and configured to releasably connect the female and insertion members 124, 128 together.

In a preferred embodiment, the locking mechanism 130 includes at least one locking tab or protrusion 132 located on the inner surface of the side wall 134 of the female member 124, and at least one notch or groove 136 located on the outer surface of the insertion member 128. When the insertion member 128 is slidably inserted into the opening 126 of the female member, the locking tab 132 and the corresponding cutout 136 of the locking mechanism 130 engage with the lock to securely hold the female and insertion members 124, 128 in place, thereby triggering the directed passage of the medical fluid, as indicated by arrow C. Other designs of the locking mechanism are provided, such as ring locking and releasing grooves, side wings and the like.

An important aspect of the fluid connection assembly 104 is that the female member 124 has a first sealing device 138 attached to the outer top surface of the female member to provide a pressure-tight seal. The first sealing device 138 is provided to have a first concave side 140 and an opposing first convex side 142, and the seal is operable when pressure is applied to the first concave or convex side 140, 142. Preferably, the first sealing device 138 is substantially dome-shaped and made of a flexible, resilient material. The first cut or gap 144, having a predetermined length, is provided to be located substantially in the center of the first sealing device 138 such that the cut is tightly closed at rest, but open when pressure is applied to the first concave or convex side 140, 142.

More specifically, the first cut 144 of the first sealing device 138 prevents the passage of medical fluid when the first sealing device is in a resting position. However, when the negative pressure created by the injection system is applied to the convex side 142 of the first sealing device 138, the first cut 144 opens, allowing the passage of medical fluid, as indicated by arrow C. Other suitable types of check valves are provided to suit the application, such as spring-loaded ball check valves, duck nose valves, umbrella valves, diaphragm valves and the like.

It is also provided that the female element 124 has a tubular rod 146 hanging substantially in the center of the inner upper surface of the female element 124 inside the female element opening 126 along the longitudinal axis of the female element. Preferably, the tubular rod 146 has an inclined or beveled outer surface 148 with a geometry suitable for insertion, resulting in a funnel-shaped outer wall. Specifically, the outer diameter of the tubular rod 146 gradually increases toward the inner upper surface of the female member 124. The rod 146 is also provided with other suitable geometric shapes such as square, rectangular, polygonal shapes.

Another important aspect of the fluid connection assembly 104 is that the insertion element 128 is substantially tubular and has a second sealing device 150 attached to the inner surface of the insertion element to provide a pressure-tight seal. As with the first sealing device 138, the second sealing device 150 has a second concave side 152 and an opposing second convex side 154. As described above, the second sealing device 150 has the same configuration as the first sealing device 138 and employs the same method as the first sealing device. sealing device. However, it should be noted that to prevent fluid leakage from the fluid connection assembly 104, the first and second sealing devices 138, 150 are arranged in opposite orientations.

More specifically, the first sealing device 138 is located on the outer upper surface of the female element 124 such that the first convex side 142 faces upward along the longitudinal axis of the female element in the fluid flow direction, as indicated by arrow C. In contrast, the second sealing device 150 located on the inner surface of the insertion member 128 such that the second convex side 154 faces downward along the longitudinal axis of the insertion member against the direction of flow of the fluid, as indicated by arrow C. Thus, at rest, the second cut or gap 156 of the second sealing device 150 prevents the passage of medical fluid from the insertion member 128, and the first cut or gap 144 of the first sealing device 138 prevents the passage of medical fluid from the female member 124.

It is also provided that the insertion member 128 has an opening of the female member 158 configured to insert and accommodate the tubular rod 146 of the female member 124. An elastic support washer 160 having a central through hole 162 is located near the upper end of the inner surface of the insertion member 128. Since the central through the hole 162 of the support washer 160 is sized to accept and accommodate the tubular rod 146 of the female member 124, the inner diameter of the through hole being slightly smaller than the smallest outer diameter of the tubular rod. Thus, when the tubular rod 146 of the female member 124 is gradually inserted into the central through hole 162 of the support washer 160, a sealed press fit is formed between the tubular rod and the support washer. When the tubular rod 146 is fully inserted, it forces the slit 156 open and provides fluid communication between the female member 124 and the insertion member 128.

Referring now to FIGS. 10 and 13, it is preferred that the air connection assembly 106 comprises a female member 164 having a female member opening 166 configured to receive and receive an air connection assembly insertion member 168. An important aspect of the female element 164 of the air connection assembly 106 is that a hydrophobic filter 118 is located near the lower end of the inner surface of the female element 164. For example, the hydrophobic filter 118 can be attached to the inner surface of the female element 164 by chemical adhesive, solvent bonding, ultrasonic welding, or other conventional fastening technology.

The rigid cylindrical body 170 of the insertion member 168 is enclosed by a flexible, resilient boot 172 having an annular protrusion 174 such that when the insertion member 168 is progressively inserted into the bore 166 of the female member, the annular protrusion creates an airtight press fit between the boot and the female member 164. Thus, it is preferred so that the outer diameter of the annular protrusion 174 is slightly larger than the inner diameter of the female member hole 166. Although the hollow interior 176 of insertion member 168 is shown for illustrative purposes, any suitable solid or semi-solid material may be separately inserted or integrally formed with the interior of the insertion member to suit the application.

Next, with reference to figures 2, 10-12 and 14, in fig. 14 shows an exemplary fluid path of a fluid connection assembly 104. As discussed above, it is provided that the injection system is connected to the insertion element 128 of the fluid connection assembly 104. The injection system must have a set of tubes with a female connector 124 similar to the connector on pooling devices. When the set of tubes with the female connector 124 is connected to the pooling device, the tubular rod 146 within the female connector 124 will force open the slit 156 in the insertion connector 128 of the pooling device, thereby allowing the medical fluid from the medical container 14 to pass through the second channel 66 of the tip and outlet port 26.

When the female element 124 of the fluid connection assembly 104 is connected to the insertion element 128 of another adjacent pooling device 74, the negative pressure causes the first female element sealing device 138 to open. As a result, medical fluid from the adjacent pooling device will flow into the medical container 14 through the first tip channel 62 and inlet port 18 to provide a continuous supply of medical fluid from the associated or series-connected pooling devices. The sealing devices 138, 150 and washer 160 are intended to be made of flexible, resilient materials such as synthetic resin or plastic, rubber and the like. Other suitable materials are also available to suit the application.

The medical fluid path of the pooling device 74 is provided to be included in the injection molded assembly as a single unit. For example, in some embodiments, the insertion member 128 of the fluid connection assembly 104 is preferably laterally attached integrally to the base 54 of the pooling device 74 such that the insertion member generally protrudes from the base. In this configuration, as similarly shown in Figures 8 and 9, when the female and insertion members 124, 128 are connected to each other, improved secure connection of the associated pooling devices is achieved, thereby preventing unwanted disassembly of the associated devices. It is also provided that the orientation of the relative position and configuration of the female and insertion elements 124, 128 can be reversed from that described above.

Referring now to Figures 10-12, 14 and 15, a plurality of fluid and air channel grooves 178 are formed in the base 54 of the pooling device 74 to form at least a portion of a medical fluid channel. In this configuration, the inlet port 18 and the outlet port 26 are integrated into the grooves 178 as a single unit such that the fluid and air passages from the tip 48 flow smoothly into the fluid and air connection assemblies 104, 106.

More specifically, with respect to the fluid channel, the opening 126 of the female element 124 of the fluid connection assembly 104 is connected to the first channel 62 of the tip 48 through a groove 178 in fluid communication with the medical container 14, and the second channel 66 of the tip 48 is connected to the opening 158 of the insertion element. 128 of the fluid coupling assembly using another groove, thereby forming a continuous fluid path from the female member 124 to the insertion member 128.

Regarding the air passageway, the opening 166 of the female member 164 of the air connection assembly 106 is connected to the first passage 62 of the tip 48 through a groove 178 in fluid communication with the medical container 14 such that ambient air is drawn into the medical container 14 when the insertion member 168 the air connection assembly does not clog the female element of the air connection assembly.

In some embodiments, the back plate 180 (FIG. 14) is used to cover and seal the fluid and air passages formed by the grooves 178. Attachment of the plate 180 to the base 54 is achieved using chemical adhesive, solvent bonding, ultrasonic welding, or other conventional techniques. fastenings The shape of the plate 180 may vary depending on the shape of the grooves, but other suitable geometric shapes such as square, rectangular or oval shapes are provided to suit the application.

Next, with reference to Figures 1, 2, 14 and 16, another exemplary diagram of the grooves 178 of the leakage prevention mechanism 102 is illustrated, in which the grooves are designed and configured to assist an assembly 12 of two medical containers. The corresponding components of the fluid connection assembly 104 are designated by reference numbers with the first two letters of the alphabet (ie, “a” and “b”). An important aspect of this groove configuration is that although the leakage prevention mechanism 102 contains two separate or different fluid connection assemblies 104a, 104b, there is only one air connection assembly 106 that is common to the first and second tips 48, 50.

Specifically, the opening 166 of the female element 164 of the air connection assembly 106 is connected to both the first channel 62 of the first tip 48 and the first channel 70 of the second tip 50 through grooves 178 such that external air received through the female element of the air connection assembly simultaneously passes both into the first and second medical containers 14, 16. Although a "T"-shaped arrangement of the vent channels of the grooves 178 is shown for illustrative purposes, other suitable arrangements such as "Y"- and "V"-shaped patterns.

Further, with reference to Figures 2, 10A-1°C and 14, it is also provided that to selectively control the directional flow of fluid, the fluid connection assembly 104 includes a first force-activated valve 182 (FIG. 10A) connected to the outlet port 26 of the device 74 for pooling. In a similar configuration to selectively control the directional flow of fluid, the fluid connection assembly 104 includes a second force-activated valve 184 (FIG. 10A) connected to the inlet port 18 of the pooling device 74.

For example, as illustrated in FIG. 10B, to prevent leakage of fluid from the fluid connection assembly 104, a second force-actuated valve 184 is located between the second fluid check valve 110 and the first tip 48 and is connected to the inlet port 18 such that the flow of fluid from the connector 114 is controlled by the operation of the second force-actuated valve. activated valve. Preferably, to selectively control the directional flow of fluid, a unidirectional check valve 186 is connected to at least one of the inlet port 18 and the outlet port 26 of the pooling device 74.

Specifically, to activate the second force-activated valve 184 and thereby allow fluid to pass into the inlet port 18, the first medical container 14 is pushed down to move the first medical container from an up position to a down position, as indicated by arrow D (FIG. 10B). This downward movement of the first medical container 14 causes the portion 188 of the first medical container 14 to be pressed into the corresponding force-activated valve 184 and permits the passage of fluid from the connector 114. Conversely, when the second force-activated valve 184 is not activated, fluid is prevented from passing into the inlet port 18. To accommodate other applications, other suitable connection points to inlet port 18 and outlet port 26 are also provided along the fluid or air flow.

Likewise, activation of the first or second force-activated valve 182, 184 shown in FIG. 10A is achieved by mating or complementarily interconnecting the first fluid path connector 112 of the fluid connection assembly 104 of the pooling device 74 with the second fluid path connector 114 of the fluid connection assembly 104 of the other pooling device. As discussed above, FIG. 11 shows an exemplary interconnection of two adjacent pooling devices 74a, 74b.

It is also provided that at least one of the tips 48, 50 is covered by a tip cover 190 (shown in dotted line in FIG. 14) configured to connect the inlet and outlet ports 18, 26 of the pooling device 74 in fluid communication. For example, in the initial position, the tip sheath 190 simultaneously and securely closes the first channel 62 and the second channel 66 of the first tip 48, thereby allowing air or fluid to pass between the inlet and outlet ports 18, 26 of the pooling device 74.

However, as shown in FIG. 10B, when the container 14 is pressed, the tip sheath 190 may be pierced and compressed. As discussed above, when the first medical container 14 moves from the upper position to the lower position, as indicated by arrow D, the tip sheath 190 is also pushed downward by the upper portion 188 of the container 14 from the upper position shown in FIG. 14 to the lower position shown in FIG. 10B. Due to this movement of the container 14, the tip cover 190 is torn, and the passage of fluid between the inlet and outlet ports 18, 26 is achieved.

Referring now to FIGS. 1°C and 14, the fluid connection assembly 104 includes a tip connector 192 and a process dome valve 194. Preferably, the tip connector 192 is coupled to the inlet port 18 of the pooling device 74 and the process dome valve 194 is coupled to outlet port 26 of the pooling device. As described above, the process dome valve 194 has a configuration similar to the second sealing device 150 of the snap locking mechanism 130 shown in FIG. 14. In this configuration, process dome valve 194 has an opening or through hole 162 configured to receive and accommodate a tip connector 192 in a complementary arrangement.

Referring now to FIGS. 1, 8, and 17A-17D, the pooling device 74 includes a lid remover 198 attached to at least one of the pooling devices and configured to remove the top lid 42 of a corresponding container. In a preferred embodiment, cap remover 198 includes a central cavity 200 having a head zone 202 and a tail zone 204, with the head and tail zones located, preferably internally, in opposite orientations from each other around the cavity. In use, the head zone 202 of the cap puller 198 engages or grips the top cap 42 and rotates about a point near the tail zone 204 to open the top cap, as indicated by arrow E (FIG. 17C). Although a generally round or oval shape of cap puller 198 is shown for illustrative purposes in Figures 17A-17C, other suitable shapes or designs are provided, such as multi-sided or irregular shapes, to suit the application.

As shown in FIG. 17D, it is also provided that the head area 202 of the lid remover 198 is preferably integrally formed with the base 54 of the pooling device 10. In this configuration, the head region 202 of the cap remover 198 is fixedly attached to the base 54 of the pooling device 10 without the tail region 204. During use, the top cap 42 of the medical container unit 12 is positioned in an inverted position next to the pooling device 10, so that the head region 202 at the base 54 may engage or fit tightly against the top lid of the container. Next, the container 14 is rotated about a point opposite the head area 202 relative to the top cover 42 so that the container is pulled out from the puller 10 to open the top cover, as indicated by arrow E'.

Referring now to FIGS. 1, 10, and 18, it is contemplated that in some embodiments, the fluid connection assembly 104 comprises at least one of a hydrophobic filter 206 and a hydrophilic filter 208. In some embodiments, the hydrophobic filter 206 is coupled to an inlet port 18 of the device 10 for pooling to selectively control the directional flow of air/fluid of the pooling device. Conversely, a hydrophilic filter 208 is connected to an outlet port 26 of the pooling device 10 to selectively control the directional flow of fluid and air from the pooling device.

In the exemplary configuration of FIG. 18, which is designed and configured to facilitate an assembly 12 of two medical containers, a first hydrophobic filter 206' is connected to a first inlet port 18' for a first medical container 14 configured to store a first medical fluid. Likewise, a second hydrophobic filter 206'' is connected to a second inlet port 18'' for a second medical container 16 configured to store a second medical fluid. Thus, it is preferable that the first and second hydrophobic filters 206', 206'' allow air to pass without any unwanted leakage of fluid from the inlet ports 18', 18''.

To selectively control the directional flow of fluid from the first or second medical fluid, a hydrophilic filter 208 is connected to both the first outlet port 26' for the first medical container 14 and the second outlet port 26'' for the second medical container 16. In this configuration The hydrophilic filter 208 preferably allows air to pass until it is moistened by the first or second medical fluid, at which point the hydrophilic filter allows only the medical fluid to pass through the fluid path connector 112.

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 entering the patient. This air blockage also stops all fluid flow and causes the pump to audibly alarm, which signals the patient/caregiver to move the position valve 216 to open the flow path into the second medical container 16. The pump then resumes infusing the contents of the second medical container 16 If a hydrophilic filter 208 is also installed in the outlet port 216'', then when the medical container 16 is emptied, the hydrophilic filter prevents air from passing through the filter and entering the patient. This air blockage also stops all flow of fluid and causes the pump to audibly alarm, which signals to the patient/caregiver that the infusion of the second medical fluid is complete. Other suitable hydrophobic and hydrophilic filter arrangements 206, 208 are also provided to suit different applications.

Referring now to Figures 1, 6, 7, 10, 11 and 19, the tray member 210 is provided to include at least one present pooling device 74 coupled in series arrangement incorporating the pooling device into the tray member in fluid communication avg. In fig. 19, although four (4) pooling devices 74 are included in the tray member 210, any number or embodiment of pooling devices is provided to suit an application. A flow cover 212 having at least one flow channel or passage 214 is attached to the tray member 210 to facilitate the communication of fluids between the pooling devices 74. Preferably, a first flow path 214' is provided to connect the first medical containers 14, and a separate second flow path 214' is provided to connect the second medical containers 16. In this example, tray member 210 includes a plurality of pooling devices 74 integrated into the fluid communicating tray member. In addition, the tray member 210 includes two separate tubes or passages 214', 214'' configured to conduct two separate fluids from the first and second medical containers 14, 16 into the outlet port 52. Components common to the pooling device 10 are shown in Figures 1, 6 and 11 are designated by identical reference numerals.

Preferably, the tray member 210 includes a position valve 216 configured to selectively provide or control a path for fluid from at least one of the first and second medical containers 14, 16. For example, the position valve 216 is a manual switch or stop valve, having a rotary valve configured to selectively allow and block the passage of fluid from the first and/or second medical containers 14, 16. The position valve 216 is also provided to provide valve access to prevent the passage of fluid when the tube set 28 is disconnected from the tray member 210. In a preferred embodiment, a tip cover 218 is provided to protect the tip sheath 190 and the tip 48, 50. As an example, in FIG. 19, the fluid path connector 112 is replaced by a position valve 216 from one channel to another at 108. The position valve 216 is provided to have a luer lock connector and is axially rotatable so that the user can adjust how fluid is delivered to the user.

With further reference to Figures 1, 4, 7-9 and 20, it is preferable that the pooling device 74, 86a be designed and constructed as a composite, interlockable modular unit. Components common to the pooling devices 10, 74, 86a are designated by identical reference numerals. As similarly shown in Figures 4 and 7-9, the pooling device 86a is provided to include a first wing 88a configured to receive an outlet port 26a and a second wing 90a configured to receive an inlet port 18a.

To prevent unwanted leakage of the first and second medical fluids, as shown in FIG. 20, for example, a first hydrophobic filter 118' is located in the inlet port 18a and connected to the first tip 48, and a second hydrophobic filter 118'' is located in the second wing 90a and connected to the second tip 50. Other suitable hydrophobic filter arrangements are provided to suit different applications. filters 118', 118''.

As shown in FIG. 20, it is provided that to facilitate the passage of fluid from the respective tip 48, 50, the pooling device 86a includes a flow cap 212 having at least one dedicated flow channel or passage 214', 214''. Each flow channel 214', 214'' is bifurcated or separated according to the channels 62, 66, 70, 72 of the corresponding tip 48, 50 using a separating element 220. It is also provided that at least one protective plate or cover 222 is provided to seal the open channels or fluid or air passages associated with the pooling device 86a. In addition, at least one closure member 224 is removably provided to block a fluid or air passage or passage associated with the pooling device 86a.

Although a specific embodiment of the present pooling apparatus has been described herein, it will be apparent to those skilled in the art that changes and modifications may be made therein without departing from the broad aspects of the present disclosure, and as set forth in the following claims inventions.

Claims (87)

1. A device (10) for dispensing fluid from a container block (12) having at least one container (14, 16), wherein said dispensing device contains: an inlet channel (22) configured to receive fluid or ambient air; an outlet channel (32) configured to deliver fluid; a cavity (40) configured to insert a container block (12) for dispensing fluid from at least one container (14, 16); at least one tip (48, 50) located in said cavity and configured to pierce the plug (44, 46) of at least one container when the container block moves from an upper position to a lower position; And two separate flow channels configured to conduct two separate fluids from said at least one container into said outlet channel. 2. The device according to claim 1, in which the specified inlet channel is connected to the specified outlet channel with communication of fluids with the specified at least one tip (48, 50) through a corresponding tube (64). 3. The device according to claim 1 or 2, wherein said at least one tip (48, 50) has a first tip channel (62, 70) connected to said inlet channel (22). 4. The device according to claim 1 or 2, wherein said at least one tip (48, 50) has a second tip channel (66, 72) connected to said outlet channel (32). 5. The device according to claim 1 or 2, wherein at least one of said inlet and outlet channels has a protective cover (38) to protect said respective inlet and outlet channels (22; 32) from contamination. 6. The device according to claim 1 or 2, additionally comprising an inner surface (52) and a base (54); wherein said at least one tip (48, 50) typically protrudes from the inner surface (52) of the base (54) of said dispensing device (10). 7. The device according to claim 1 or 2, wherein said dispensing device (10) has a locking mechanism (58) configured to securely hold the container unit (12) in said cavity (40) during use. 8. The device according to claim 7, wherein said locking mechanism (58) is located on the inner wall (60) of said cavity (40). 9. The device according to claim 1 or 2, in which the specified cavity (40) is configured to insert a container block (12) for dispensing fluid from a single container (14, 16). 10. Device according to claim 1 or 2, wherein said at least one container (14, 16) is configured to store fluid, and the container unit (12) is attached to said dispensing device (10). 11. The device according to claim 1 or 2, wherein said dispensing device (10) comprises a locking mechanism (76) configured to block the transition of the container block (12) from an upper position to a lower position. 12. The device according to claim 1 or 2, in which the container block (12) includes a locking pin (76) inserted into a slot (78) located on the body (80) of the container block (12). 13. The device according to claim 1 or 2, further comprising a pressure plate (82) located on top of the container block (12) for moving the container block (12) from an upper position to a lower position by pushing said pressure plate downward. 14. Apparatus according to claim 1 or 2, wherein said dispensing device (10) may be connected in series with another dispensing device in a complementary arrangement to provide a continuous supply of fluid from the associated dispensing devices (74a, 74b, 74c) . 15. The apparatus of claim 14, wherein said inlet port of the first dispensing device (74a) is configured to be inserted into said outlet port of the second dispensing device (74b) in a complementary arrangement. 16. The apparatus of claim 14, wherein the first dispensing device (74a) and the second dispensing device (74b) are connected in series together in a complementary arrangement with respect to the longitudinal axis of each dispensing device. 17. Device according to claim 1 or 2, wherein said dispensing device (10) comprises a cap remover (198) attached to at least one container (14, 16) and configured to remove the top cap (42) by at least one container. 18. The device according to claim 1 or 2, further comprising a leakage prevention mechanism (102), having a fluid connection unit (104) configured to regulate a fluid channel in the dispensing device (10), and an air connection unit (106). , configured to regulate the channel for the passage of air in the dispensing device. 19. The device of claim 18, wherein said air connection assembly (106) comprises an air channel connector (116) connected to said inlet channel of said device (10) for dispensing through a hydrophobic filter (118). 20. The apparatus of claim 18, wherein said fluid connection assembly (104) comprises a first fluid check valve (108) connected to said outlet port of said dispensing device (10) for selectively controlling directional flow of fluid. 21. The apparatus of claim 18, wherein said fluid connection assembly (104) comprises a second fluid check valve (110) connected to said inlet port of said dispensing device (10) for selectively controlling directional flow of fluid. 22. The apparatus of claim 20, wherein said first fluid check valve (108) has a first fluid passage connector (112) configured to be complementarily and releasably connected to a second check valve (110) of the other dispensing device . 23. The apparatus of claim 21, wherein said second fluid check valve (110) has a second fluid passage connector (114) configured to be complementarily and releasably connected to the first fluid check valve (108) of another dispensing devices. 24. The apparatus of claim 20, wherein the response pressure of said first fluid check valve (108) is in the range of 3-5 psi. 25. The device according to claim 18, in which said air connection unit (106) contains an air channel plug (120) having a blind cavity (122) configured for complementary connection, with the possibility of detachment, with a connector (116) of the air channel of another dispensing devices. 26. The apparatus of claim 18, wherein said fluid connection assembly (104) comprises a first female element (124) having a first female element opening (126) configured to receive a first insertion element (128) of said fluid connection assembly. 27. The device according to claim 26, wherein said fluid connection assembly (104) comprises a assembly locking mechanism (130) configured to releasably connect said first female and insertable elements of said fluid connection assembly. 28. The device according to claim 26, wherein said first female element has a first sealing device (138) configured to prevent directional flow of fluid. 29. The device according to claim 26, wherein said first insertion element has a second sealing device (150) configured to prevent directional flow of fluid. 30. The device according to claim 26, wherein said first female element has a rod (146) hanging on the inner upper surface of said first female element (124). 31. The device of claim 30, wherein said first insertion member has a support washer (160) having a central through hole (162) sized for insertion of said rod of said first female member. 32. The device of claim 18, wherein said air connection assembly comprises a second female element (164) having a second female element opening (166) configured to receive a second insertion element (168) of said air connection assembly. 33. The device of claim 32, wherein the hydrophobic filter (118) is located in said second opening of said second female member. 34. The device of claim 32, wherein said second insertion member is configured to create an airtight press fit between said boot and said second female member. 35. The device according to claim 32, wherein said second insertion element is covered by a cover (172) having an annular projection (174). 36. The apparatus of claim 18, wherein said dispensing device is provided with a plurality of tubes (64) with fluid and air passages, the passage tubes being designed and configured to accommodate at least one of an air passage and a passage for fluid of said dispensing device with communication of the fluids with each other. 37. The device according to claim 36, wherein said air connection assembly (106) is simultaneously connected to and common to at least two containers of said dispensing device. 38. The apparatus of claim 18, wherein said fluid connection assembly (104) comprises a first force-activated valve (182) coupled to said outlet port of said dispensing device to selectively control directional flow of fluid. 39. The apparatus of claim 18, wherein said fluid connection assembly (104) comprises a second force-activated valve (184) coupled to said inlet port of said dispensing device to selectively control directional flow of fluid. 40. The apparatus of claim 18, wherein said fluid connection assembly (104) comprises a unidirectional check valve (186) coupled to said inlet port of said dispensing device to selectively control directional flow of fluid. 41. The device according to claim 18, wherein said at least one tip is covered by a tip cover (190) configured to connect said inlet and outlet channels of said dispensing device with fluid communication. 42. The device of claim 18, wherein said fluid connection assembly comprises a tip connector (192) and a process dome valve (194). 43. The apparatus of claim 42, wherein said process dome valve (194) has an opening configured to accept said tip connector (192) in a complementary arrangement. 44. The device of claim 18, wherein said fluid connection assembly comprises at least one of a hydrophobic filter (118, 206) and a hydrophilic filter (208). 45. The apparatus of claim 44, wherein said hydrophobic filter (118, 206) is coupled to said inlet port of said dispensing device to selectively control the directional flow of air of said dispensing device. 46. The apparatus of claim 44, wherein said hydrophilic filter (208) is coupled to said outlet port of said dispensing device to selectively control the directional flow of fluid of said dispensing device. 47. The device of claim 44, further comprising a tray member (210) containing at least one said dispensing device integrated into said tray member in fluid communication. 48. The apparatus of claim 47, wherein said tray member (210) includes a flow cover (212) having at least one flow path and attached to said tray member to facilitate fluid communication. 49. The device of claim 47, wherein said tray member (210) comprises a position valve (216) configured to selectively control a flow path from said at least one container. 50. The device of claim 44, wherein at least one hydrophobic filter (118, 206) is connected to at least one of said inlet channel and said outlet channel. 51. The device of claim 44, wherein at least one hydrophilic filter (208) is connected to at least one of said inlet channel and said outlet channel. 52. Device (10) for dispensing medical fluid, containing: a container block (12) having at least one container (14, 16) configured to store fluid, said container block being attached to said dispensing device; an inlet channel (22) configured to receive fluid or ambient air; an outlet channel (32) configured to deliver fluid; a cavity (40) configured to insert said container block (12) for dispensing fluid from said at least one container (14, 16); And at least one point (48, 50) located in said cavity and configured to pierce the plugs (44, 46) of said at least one container when said container block moves from an upper position to a lower position, wherein said dispensing device (10) is complementarily connected to another dispensing device with a sequential dispensing arrangement for the purpose of organizing a continuous supply of fluid from the associated dispensing devices. 53. The device according to claim 52, wherein said dispensing device (10) comprises a first wing (88) configured to receive said outlet channel and a second wing (90) configured to receive said inlet channel. 54. The device according to claim 52 or 53, wherein said second wing (90) is vertically offset relative to said first wing (88). 55. Device (10) for dispensing fluid, containing: an inlet channel (22) configured to receive ambient air; an outlet channel (32) configured to deliver fluid; tray element (210); a first cavity (40) integrated with the tray element and configured to receive a first block (12) of containers; wherein the first block of containers includes a first container (14) configured for storing a first liquid, and a second container (16) configured for storing a second liquid; a first tip (48) located in the first cavity and configured to pierce the plug (44) of the first container when the first block of containers is moved from an upper position to a lower position; a second tip (50) located in the first cavity and configured to pierce the plug (46) of the second container when the first block of containers is moved from an upper position to a lower position; a second cavity (40) combined with the tray element and configured for inserting a second block (12) of containers; wherein the second block of containers includes a third container (14) configured for storing a third liquid, and a fourth container (16) configured for storing a fourth liquid; a third tip (48) located in the second cavity and configured to pierce the plug (44) of the third container when the second block of containers is moved from an upper position to a lower position; And a fourth point (50) located in the second cavity and configured to pierce the plug (46) of the fourth container when the second block of containers is moved from an upper position to a lower position. 56. Device (10) for dispensing fluid from a container block (12), having at least one container (14, 16), wherein said device contains: an inlet channel (22) configured to receive fluid or ambient air; an outlet channel (32) configured to deliver fluid; a cavity (40) configured to insert a container block (12) for dispensing fluid from at least one container (14, 16); And at least one tip (48, 50) located in said cavity and configured to pierce the plug (44, 46) of at least one container when the container block moves from an upper position to a lower position; wherein said at least one tip is covered by a tip cover (190) configured to connect said inlet and outlet channels of said dispensing device with fluid communication. 57. Device (10) for dispensing fluid from a container block (12) having at least one container (14, 16), wherein said device contains: a tray element (210) containing a plurality of dispensing devices (10) built into said fluid communicating tray element, each dispensing device comprising: an inlet channel (22) configured to receive fluid or ambient air; an outlet channel (32) configured to deliver fluid; a cavity (40) configured to insert a container block (12) for dispensing fluid from at least one container (14, 16); And at least one point (48, 50) located in said cavity and configured to pierce the plug (44, 46) of at least one container when the container block moves from an upper position to a lower position.