Drug delivery system

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DESCRIPTION

Drug delivery system.

Technical field

The present invention relates to a drug delivery system. More particularly, the invention relates to a drug delivery system that stores a drug or other beneficial agent, and subsequently delivers it to a reservoir that contains a component and allows the drug-component mixture to flow from the reservoir through the drug delivery device to a delivery unit, or other device, to be administered to a patient.

Background of the invention

Medicines or drugs have been stored and administered through different types of systems. Previously, many drug delivery devices were attached to a standard type IV bag in which the beneficial agent mixed with the diluent and then flowed through an outlet port to a delivery unit. Benefit agent and diluent were mixed by inverting the container, the resulting mixture was delivered to the administration unit through an outlet port provided on the diluent container.

Another example of a prior drug delivery device is disclosed in US Patent No. 4,614,267 to Larkin. The Larkin document discloses a drug delivery system comprising a capped vial that is attached to a flexible container. In the Larkin system, the stoppered vial is removed and the beneficial agent flows into the flexible container and then flows out of the outlet port provided on the container, to the patient.

A further drug delivery device is described in US Patent No. 5,484,406 to Wong et al. The Wong document discloses a drug delivery device consisting of a drug container attached to a container comprising a diluent. The drug container has openings so as to provide fluid communication between the drug container and the diluent container. The drug and diluent are mixed in the diluent container with the mixture flowing out of a port of said diluent container to the patient. In contrast, the current drug delivery device can be described as a flow-through system in which drug and diluent flow through the device to the delivery unit.

US Patent No. 4,601,704 discloses a container mixing system for mixing between silos contained in two containers. In a second embodiment, the first container consists of a flexible IV-type container and the second container contains a medicament material in powder form, sealed in an inner tubular element by a pierceable sealing plug and a diaphragm at one end and a piston element at the other end. Furthermore, in fluid communication with the inside of the container an administration port is provided. A piercing pin having a pierceable point will pierce the sealing plug as well as the diaphragm.

Summary of the invention

The present invention consists of a drug delivery system that provides a drug chamber for drugs in liquid, powder or lyophilized form that have to be contained in a stable formulation until they are administered to the patient. In addition to serving as a storage container for the beneficial agent, the present drug delivery system also provides the vehicle for injecting the beneficial agent into a reservoir of fluids intended to be administered to a patient. The present drug delivery device can be described as a flow-through system in which drug and diluent flow through the device to the delivery unit. In the present flow-through system a beneficial agent is delivered to an external reservoir and mixed with a diluent prior to administering the beneficial agent and diluent mixture to a patient. An advantage of the present drug delivery system is that the system is compatible with standard intravenous containers (rigid or flexible) and standard delivery units.

Another advantage of the present flow-through drug delivery system is the elimination of undelivered drug remaining in the drug delivery device. The present drug delivery system delivers the drug to a reservoir comprising a fluid, in which the drug and the fluid are mixed. After mixing the drug and diluent, the mixture flows through the delivery system to the delivery unit, eliminating the inconvenience where the drug drops back into the delivery system without flowing to the delivery unit.

Another advantage of the present system is that the system provides both visual and acoustic evidence that the drug delivery system is activated. When the system is activated, a cap will make a “pop” noise as it is released and the cap will be in the fluid reservoir. Also, a shutdown is triggered

ES 2 316 552 T3 automatic in the delivery system only after administering all of the drug as a whole to an environment external to the drug delivery system. Therefore, the arrangement of the cap on the reservoir, as well as the arrangement of the base of the delivery device in a closed position, will allow the person who is administering the beneficial agent, and someone who checks the system afterwards, to confirm that the drug has been administered to the patient.

The present drug delivery system provides a fully contained and enclosed system for the beneficial agent. Said contained system prevents unwanted exposure of said beneficial agent to the person administering it to the patient.

Furthermore, the present drug delivery system reduces drug losses by providing a device that can be attached to a standard intravenous bag without activation and delivery. If the present drug delivery system is connected to a standard unactivated IV bag, the beneficial agent does not have to be administered immediately and may be available for later use.

Furthermore, the present drug delivery system does not require needles to deliver the drug to a standard IV system. A needle-free system prevents the risk of transmission of different pathogens due to an inappropriate needle handle.

Other advantages of the invention will be realized and achieved by the apparatus and method indicated particularly in the written description and claims thereof, as well as in the accompanying drawings. It will be understood that both the above general description and the following detailed description are examples intended to provide further explanations of the claimed invention.

Brief description of the drawings

Figure 1 depicts an exploded view of one embodiment of the drug delivery system of the present invention;

Figure 2A represents a perspective view of the drug delivery system illustrated in Figure 1 connected to a standard IV bag;

Figure 2B represents a perspective view of the drug delivery system illustrated in Figure 1 activated and supplemented with a standard IV bag and delivery unit;

Figure 3 depicts a perspective view of an embodiment of the drug delivery system of the present invention provided with male and female luer elements that secure the drug delivery system to a standard intravenous bag;

Figure 4 represents a cross-sectional view of the drug delivery system illustrated in Figure 1;

Figure 5 depicts a cross-sectional view of the drug delivery system activated and supplemented with a standard IV bag and delivery unit;

Figure 6 represents an exploded view of a preferred embodiment of the drug delivery system of the present invention provided with an alternative cover that encloses the access port;

Figure 7A depicts a cross-sectional view of the drug delivery system illustrated in Figure 6 prior to activating the system;

Figure 7B depicts a cross-sectional view of the drug delivery system illustrated in Figure 6 after activating the system;

Figure 8 depicts a perspective view of another embodiment of the drug delivery system of the present invention comprising a bellows container;

Figure 9 depicts a perspective view of another embodiment of the drug delivery system of the present invention comprising a flexible container.

Detailed description

The present invention is a drug delivery system, generally designated reference number 10. As illustrated in Figures 2A and 2B, the present drug delivery system 10 can be connected to a reservoir 12 containing a component. 15 such as a diluent, which is mixed with a benefit agent 14 prior to administering the mixture to a patient. The drug delivery system 10 as illustrated in Figure 1, comprises a container 20 with an inner chamber 22, a first end 24, and a second end 28. The container 20 comprises a drug delivery tube 32 that is extends from the first end

ES 2 316 552 T3 of the container to provide a first flow path 21 for the beneficial agent from the container 20 to a reservoir 12, such as a standard IV bag or bottle that is partially filled. The reservoir can consist of any known container. In the preferred embodiment, drug delivery tube 32 comprises a tip 35 that is inserted into a standard IV bag through delivery port 33 (see Figures 2A and 2B). However, drug delivery tube 32 may be attached to the reservoir by other attachment means, such as male and female luers 44, 46 (see Figure 3). In order to maintain the sterility of the tip 35, a sleeve 42 can be attached thereto which is removed before inserting the tip 35 into the standard bag.

The second end 28 of the container 20 is open and receives a plunger 30 (see Figure 4). Plunger 30 comprises a first end 31 with a piston head 34 and a second end or base 36 in opposition to piston head 34. Around the piston 30 a spring 37 is provided to bind said piston 30 away from the first end 24 of container 20. The piston head 34 slides into the interior chamber 22 of the container 20 along an interior surface 40, the piston head 34 and the container 20 defining a drug chamber 38 for containing a beneficial agent or drug 14 to be administered to a patient. Benefit agent or drug 14 can be a lyophilized, liquid, or powdered drug intended to be contained in a stable formulation until administered to the patient. Container 20 can be made of glass, plastic, or other materials compatible with the beneficial agent, and can have a rigid, semi-rigid, or flexible structure.

According to the invention, the administration tube 32 receives a rubber stopper 50. Said rubber stopper 50 arranged in the delivery tube 32 provides a seal between the external environment and the drug chamber 38. The rubber stopper or seal 50 can be fitted such that it is held in position in the delivery tube 32 simply by a frictional force. The rubber stopper 50 serves as a visual and audible signal that the drug delivery system 10 has been activated, which will be described below. Although the present configuration comprises a rubber stopper, obviously other components could be used to seal the drug chamber from the external environment, and to indicate that the system has been activated, such as a rupture membrane or valve.

In the preferred embodiment, the plunger 30 comprises a piston head 34 that slides into the chamber 22 of the container 20 to push the beneficial agent or drug 14 out of the container 20 through the first end 24. and enter reservoir 12. In order to prevent unintended or premature administration of the drug the drug delivery system 10 may include a safety ring 52. In the preferred embodiment, the circlip 52 consists of a sleeve 54 wrapped around the container 20 and a tear ring or strip 56. The circlip 52 prevents the plunger 30 from unintentionally advancing the beneficial agent. 14 through container 20. Prior to administering benefit agent 14, tear strip 56 is pulled to remove circlip 52, allowing plunger head 34 to advance toward first end 24 of container 20. As an additional safety feature, In the preferred embodiment, the drug delivery system comprises a closure 58 to cooperate with the plunger member 30. The closure 58 is configured such that it does not fire until all of the drug 14 has been delivered to the exterior of the drug chamber 22. In the preferred embodiment, the closure 58 comprises a pair of upper flaps 60 and a pair of lower fins 61 extending from the outer surface of the container 20 and a slot 80 provided along the plunger 30 to receive the fins 60, 61. During assembly of the present drug delivery system, the lower flaps 61 are disposed in the slot 80. The upper flaps 60 are received in the slot 80 only after substantially all of the beneficial agent has been delivered to the reservoir. The closure 58 could have a wide range of configurations and is not limited to the specific construction described herein.

The second end 36 of the plunger 30 comprises an access port 62 that provides fluid communication with an external environment, such as a standard delivery unit 64. However, the access port 62 could be provided at positions in the delivery system. of drugs that are distinct from the second end 36 of the plunger 30, even in the vicinity of the drug delivery tube 32. In order to further maintain the sterile nature of the system, the access port 62 may comprise a sterile gasket 66, which is removed prior to attaching the delivery unit 64 to the drug delivery system 10. The gasket 66 in the preferred embodiment comprises a cap with a pull ring. In addition, plunger 30 comprises an inner penetrating member 70 axially aligned with access port 62. Since a delivery unit 64 is attached to access port 62, a tip 72 of said delivery unit 64 pushes the inner penetration member 70 through a pierceable member 74 provided in the piston head 34 to create a second path. flow 75 through plunger 30 to access port 62. In the preferred embodiment, pierceable member 74 is rubber such that penetration member 70 remains incorporated into pierceable member 74, providing evidence that drug delivery system 10 has been improperly accessed and tampered with. In order to aid in the visual identification of the position of the penetrating element, the container may comprise a transparent material and the penetrating element 70 may be a different color from the other components of the system. Obviously, this feature is optional and the color or transparency of the materials may vary. For transportation purposes, the entire drug delivery system 10 may be packaged in an aluminum foil wrapper, bag, box, or other packaging means.

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During operation of the preferred embodiment of the present drug delivery system 10, sheath 42 is first removed from tip 35. Tip 35 is inserted into a delivery port 33 in a standard IV bag 12 ( see Figure 2A). At this time, the drug delivery system is connected to the IV bag, but the beneficial agent 14 has not been mixed with the diluent, allowing the beneficial agent to be available later. When the drug has to be delivered, tear ring 56 is pulled to remove safety ring 52. The drug delivery system is then clamped like a syringe, pushing the base 36 of the plunger 30 toward the first end 24 of the container 20. Said action of the plunger creates pressure on the rubber stopper 50 and forces it out of the administration tube 32 and to enter reservoir 12. When the rubber stopper 50 is released, an audible “pop” noise is produced, which constitutes an audible signal indicating activation of the system.

After the rubber stopper 50 is removed from the administration tube 32, the action of the plunger delivers the beneficial agent 14 from the container 20 through the administration tube 32 and into the reservoir 12. The plunger 30 will not close until substantially all benefit agent 14 has exited drug chamber 38 (see Figure 5). When the benefit agent is in powder or lyophilized form, it may be necessary to move the plunger 30 toward the second end 28 of the container 20 to repeat the plunger action. This involves hydrating drug 14, which is accomplished with the aid of spring 37 urging plunger 30 away from first end 24 of container 20. Once all of the beneficial agent 14 has been delivered to the reservoir 12, the upper flaps 60 of the closure will automatically cooperate with the slot 80 (see Figures 2B and 5). At this time, two visual features indicate that the drug delivery system has been activated. One visual feature is the presence of the rubber plug 50 in the reservoir 12. The other visual feature is the closed position of the plunger 30.

Benefit agent 14 and diluent can be further mixed, if necessary, by shaking reservoir 12. After mixing, sterile gasket 66 should be removed, exposing access port 62. Next, the second tip 72 of the delivery unit 64 should be inserted into said access port 62, pushing the penetration element 70 through the pierceable membrane 74 and generating a second flow path 75 between the reservoir 12 and the management unit 64. The built-in penetration element 70 arrangement is a security feature that provides proof of whether someone has previously accessed the drug delivery system. After connecting the beneficial agent delivery system 10 to the standard delivery unit 64, standard procedures for preparing and administering the drug should be followed. The present drug delivery system does not have to be directly connected to a delivery unit, but rather the delivery system could be connected to a pump, burrette, or other device that is used to deliver a beneficial agent to a patient.

Although the present drug delivery system has been described with a reservoir containing a fluid such as a diluent intended to be mixed with a beneficial agent delivered by the drug delivery system, it is understood that the component in the reservoir could comprise a beneficial agent, the delivery system containing and delivering a diluent to the reservoir.

The present drug delivery system can be used with a primary IV bag where the drug is mixed with the corresponding diluent and then administered to the patient. Alternatively, the present drug delivery system could be used with a secondary reservoir where the drug is mixed with the diluent and then delivered to an intravenous line with a primary reservoir. The flow rate of the beneficial agent and diluent to the patient can be controlled by known procedures applied by beneficial agent administrators with a roller clamp, pump, burrette, or other means. Activation of the present drug delivery system can occur at the pharmacy or point of care.

As illustrated in Figures 6, 7A, and 7B, a cap 100 that encloses access port 62 may be added to the present drug delivery system to prevent access port 62 from being punctured inadvertently prior to substantially administering. all beneficial agent to reservoir 12. Cap 100 may be used as an alternative to gasket 66 as illustrated in Figure 4. Cap 100 comprises fastening elements 102 that connect cap 100 to base 36 of plunger member 30, as can be seen in Figure 7A prior to removal of snap ring 56. When plunger 30 has delivered substantially all beneficial agent 14 to reservoir 12, fingers 104 extending from second end 28 of container 20 push fasteners 102 inward away from plunger 30 (see Figure 7B). At this time, the cover 100 can be removed by pulling a flap 106 thereof, which faces the access port 62.

Figure 8 depicts another preferred embodiment of the present drug delivery system, comprising a flexible container 120. Said flexible container 120 comprises a first end 124 with a delivery tube 32 and a second end 128. In this embodiment , a plunger is not required to deliver the beneficial agent to the reservoir. Instead, the beneficial agent is delivered to the reservoir by contracting and expanding the container 120. The resulting mixture of drug and component flows from reservoir 12 into container 120 to access port 162. Another embodiment of the present drug delivery system is illustrated in Figure 9, and comprises a collapsible container 220. Therein In a further embodiment, benefit agent 14 is delivered to reservoir 12 by compressing flip-top container 220 and forcing benefit agent 14 out of container 220. Once the beneficial agent 14 has been mixed with the component in the

In reservoir 12, an administration unit is attached to an access port 262 which allows the mixed beneficial agent and component to flow through container 220 to administration unit 64.

It is understood that the above detailed description and the accompanying examples are provided for illustrative purposes only and are not to be construed as limiting the scope of the invention, which is defined solely by the appended claims. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art.