Connector for aseptic transfer of fluids

Abstract

Provides for the sterile transfer of fluids within a drug delivery device. [Solution] A fluid transfer system utilizing a connector arrangement for sterile transfer of fluid between a cannula arrangement and a container, comprising: the cannula arrangement; the container; at least one membrane held between the cannula arrangement and the container, wherein the at least one membrane is pulled out of a housing to establish fluid communication between the cannula arrangement and the container; and at least one clip configured to clamp the at least one membrane between the cannula arrangement and the container.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims priority to U.S. Provisional Application No. 62 / 572,730, entitled "Connector for Aseptic Transfer of Fluids", filed on October 16, 2017, the entire disclosure of which is incorporated herein by reference.

Background Art

[0002] The present disclosure generally relates to drug delivery devices, and more particularly to connector arrangements for aseptic transfer of fluids within drug delivery devices.

[0003] Various types of auto - injection or drug delivery devices have been developed to enable drug solutions and other liquid therapeutic formulations to be administered or self - injected by untrained personnel. Generally, these devices include a reservoir pre - filled with a liquid therapeutic formulation and some type of auto - needle injection mechanism that can be triggered by the user. When the volume of the fluid or drug to be administered is less than a certain volume, such as generally less than 1 mL, an auto - injection device is typically used, which typically has an injection time of about 10 to 15 seconds. When the volume of the fluid or drug to be administered exceeds 1 mL, the injection time generally becomes longer, and as a result, it becomes difficult for the patient to maintain contact between the device and the target area of the patient's skin. Further, as the volume of the drug to be administered increases, an increase in the time for injection is desirable. The conventional method for drugs to be injected slowly into a patient is to start an IV and slowly inject the drug into the patient's body. Such procedures are typically performed in a hospital or outpatient setting.

[0004] Certain devices enable self-injection in a home setting and can inject a liquid therapeutic agent gradually into a patient's skin. In some cases, these devices are small enough (in both height and overall size) to allow them to be "worn" by the patient while the liquid therapeutic agent is being injected into the patient. These devices typically include a pump or other type of discharge mechanism for flowing the liquid therapeutic agent from a reservoir into a syringe needle. Such devices also typically include a valve or flow control mechanism for causing the liquid therapeutic agent to start flowing in a timely manner, and a trigger mechanism for initiating the injection. SUMMARY OF THE INVENTION

[0005] In one aspect, a drug delivery system for injecting a drug includes a housing defining a cavity, a container received within the cavity, the container configured to receive the drug together with a closure of the container, a valve assembly including a passage configured to penetrate the closure of the container received within the cavity, and a connector arrangement provided between the container and the valve assembly, the connector arrangement being movable between a first pre-use position maintaining sterility between the closure of the container and the valve assembly and a second use position enabling fluid communication between the container and the valve assembly.

[0006] In another aspect, the connector arrangement may include at least one membrane held between the container and the valve assembly. The connector arrangement may include two membranes held between the container and the valve assembly. At least the membrane may include flash-spun high-density polyethylene fibers. At least a portion of the connector arrangement may extend out through the housing. The connector arrangement may be pulled out from the housing to move the connector arrangement from the first position to the second position.

[0007] In another aspect, a fluid transfer system that utilizes a connector arrangement for aseptic transfer of fluid between a cannula arrangement and a container includes the cannula arrangement, the container, at least one membrane held between the cannula arrangement and the container, and at least one clip configured to clamp the at least one membrane between the cannula arrangement and the container.

[0008] In another aspect, the at least one membrane may include two membranes. The at least one clip may include two clips. The cannula arrangement may include a flange extending around a portion thereof. The container may include a flange extending around a portion thereof. The at least one clip is configured to engage the flanges of the cannula arrangement and the container and may clamp at least one membrane between the cannula arrangement and the container. The cannula arrangement may include a housing and a cannula slidably disposed within the housing. The at least one membrane may include one of foil, rubber, or polymer. The at least one membrane may be drawn out from the housing to establish fluid communication between the cannula arrangement and the container. The container may include a syringe barrel. A coupling member may be provided at the proximal end of the cannula arrangement and may be provided at the distal end of the container. The coupling members may be configured to engage with each other after at least one membrane is removed from between the cannula arrangement and the container. At least a portion of the at least one membrane may extend through the at least one clip.

Brief Description of the Drawings

[0009] By referring to the following description of embodiments of the present disclosure in conjunction with the accompanying drawings, the above and other features and advantages of the present disclosure and the manner in which they are achieved will become more apparent and the disclosure itself will be better understood.

[0010]

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[0011] The following description is provided to enable one skilled in the art to make and use the described embodiments contemplated for carrying out the present invention. However, various modifications, equivalents, variations, and alternatives will still be readily apparent to one skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0012] For the purposes of the description below, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the present invention as oriented in the drawings. However, it will be understood that the present invention may contemplate various alternative variations unless explicitly specified to the contrary. Also, it will be understood that the specific devices shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Therefore, the specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be regarded as limiting.

[0013] Referring to FIGS. 1 through 15, a drug delivery system 10 according to one aspect of the present disclosure includes a drive assembly 12, a container 14, a valve assembly 16, and a needle actuator assembly 18. The drive assembly 12, the container 14, the valve assembly 16, and the needle actuator assembly 18 are at least partially positioned within a cavity defined by a housing 20. The housing 20 includes an upper portion 22 and a lower portion 24, although other suitable arrangements for the housing 20 may be utilized. In one aspect, the drug delivery system 10 is a syringe device configured to be worn or secured to a user and deliver a predetermined dosage of a drug supplied into the container 14 via injection into the user. The system 10 may be utilized to deliver a "bolus injection" in which the drug is delivered within a set time. The drug may be delivered over a period of 45 minutes, although other suitable injection amounts and periods may be utilized. The bolus administration or delivery can be performed with rate controlling or may not have a specific rate control. The system 10 may deliver the drug to the user at a fixed pressure with a variable speed. The general operation of the system 10 is described below in relation to FIGS. 1 through 15.

[0014] Referring again to FIGS. 1 through 15, the system 10 is configured to operate through engagement of the activation button 26 by the user, whereby the needle 28 of the needle assembly 18 pierces the user's skin, and upon activation of the drive assembly 12, the needle 28 is in fluid communication with the container 14 and releases fluid or a medicament from the container 14, and withdrawal of the needle 28 after injection of the medicament is completed. The general operation of the drug delivery system is shown and described in International Publication No. WO 2013 / 155153 and International Publication No. WO 2014 / 179774, which are hereby incorporated by reference in their entirety. The housing 20 of the system 10 includes an indicator window 30 for viewing an indicator arrangement 32 configured to provide an indication to the user regarding the state of the system 10, and a container window 31 for viewing the container 14. The indicator window 30 can be a magnifying lens for providing a clear view of the indicator arrangement 32. The indicator arrangement 32 moves along the needle actuator assembly 18 during use of the system 10 to indicate the pre-use, use, and post-use states of the system 10. The indicator arrangement 32 provides visual indicia regarding the state, although other suitable indicia, such as auditory or tactile, can be provided as alternative or additional indicia.

[0015] Referring to FIGS. 4 through 6, between the pre-use positions of the system 10, the container 14 is spaced from the drive assembly 12 and the valve assembly 16, and the needle 28 is in a retracted position. During initial actuation of the system 10, as shown in FIGS. 7 through 9, the drive assembly 12 engages the container 14 and moves the container 14 toward the valve assembly 16, and the valve assembly 16 is configured to penetrate the closure 36 of the container 14 and place the drug inside the container 14 in fluid communication with the needle 28 via a tube (not shown) or other suitable arrangement. The drive assembly 12 is configured to engage the stopper 34 of the container 14, and the stopper 34 will initially be moved by the incompressibility of the fluid or drug within the container 14 to engage the entire container 14 with the valve assembly 16. Initial actuation of the system 10 is caused by engagement of the actuation button 26 by the user, and engagement of the actuation button 26 by the user releases the needle actuator assembly 18 and the drive assembly 12 as described in more detail below. During initial actuation, the needle 28 is still in the retracted position and is about to move to an extended position for injection by the user of the system 10.

[0016] Between the use positions of system 10, as shown in FIGS. 10 to 12, drive assembly 12 moves stopper 34 inside container 14 to deliver a drug from container 14 through needle 28 to a user, and needle 28 is in an extended position and at least partially outside housing 20. In the use position, valve assembly 16 has already penetrated closure 36 of container 14 to place container 14 in fluid communication with needle 28, such that fluid can be dispensed from container 14, which also enables drive assembly 12 to move stopper 34 relative to container 14. In the post - use position of system 10 shown in FIGS. 13 to 15, needle 28 is in a retracted position and engages pad 38 to seal needle 28 and prevent any residual flow of fluid or drug from container 14. Container 14 and valve assembly 16 can be the container 14 and valve assembly 16 shown and described in International Publication No. WO 2015 / 081337, which is hereby incorporated by reference in its entirety.

[0017] Referring to FIGS. 16 to 17B, in one aspect, connector arrangement 50 is provided between two mating components to provide a sterile connection between the two components during fluid transfer. In one aspect, connector arrangement 50 is provided between syringe barrel or container 52 and cannula arrangement 54. Cannula arrangement 54 includes cannula 53 surrounded by housing 56 together with flange 58. Container 52 also includes a corresponding flange 60. Container 52 and housing 56 each include membranes 62, 64 to provide a sterile seal for the mating portions of container 52 and housing 56. Membranes 62, 64 are made of any suitable material such as foil, rubber, or polymer and while maintaining the sterility of container 52, cannula 53, and housing 56, enable membranes 62, 64 to be removed.

[0018] Referring again to FIGS. 16 through 17B, during assembly of the connector arrangement 50, a clip 66 or other similar type of connector is attached to engage the respective flanges 58, 60 of the container 52 and housing 56 such that the membranes 62, 64 contact each other. In one aspect, a single clip 66 is provided to clamp the flanges 58, 60 together. In another aspect, two clips 66 are provided to clamp the flanges 58, 60 together. The membranes 62, 64 may extend through one of the clips 66 when the connector arrangement 50 is assembled. Prior to using the cannula arrangement 54, the membranes 62, 64 are removed from the connector arrangement 50 to allow fluid communication between the container 52 and the cannula 53. The membranes 62, 64 can be pulled away from the connector arrangement 50 and can allow the container 52 and housing 56 to move to engage each other. In one aspect, the distal end of the container 52 and the proximal end of the housing 56 may include joints 68, 70 to facilitate engagement between the container 52 and the housing 56. The joints 68, 70 can be any type of engagement and locking mechanism that connects the distal end of the container 52 to the proximal end of the housing 56.

[0019] Referring to FIG. 18, a connector arrangement 50 is shown that is used with the drug delivery system 10 shown in FIGS. 1-15. The connector arrangement 50 is provided between the container 14 and the valve assembly 16. In particular, the membranes 62, 64 are held between the distal end of the container 14 and the proximal end of the valve member 72 of the valve assembly 16. In this manner, the membranes 62, 64 form a pull tab that extends out through the housing 20 of the system 10. The valve assembly 16 is configured to pass through a partition wall 74 held by the closure 36 of the container 14. During the drug delivery process of the system 10, the container 14 is pressed against the valve member 72 to expose a through member 76 housed in the valve member 72. The through member 76 passes through the partition wall 74 of the container 14 to establish fluid communication between the container 14 and the valve assembly 16. However, prior to using the system 10, the membranes 62, 64 are positioned between the container 14 and the valve assembly 16 to maintain the sterility of the components prior to use of the system 10. A portion of the membranes 62, 64 may extend from the housing 20 of the system 10 to allow the user to grip the membranes 62, 64. Prior to use of the system 10, the membranes 62, 64 are pulled from the housing 20 to allow the container 14 and the valve assembly 16 to move towards each other during the drug delivery process of the system 10. In this manner, the membranes 62, 64 are made of flash spun high density polyethylene fibers and allow the membranes 62, 64 to be pulled without breaking or tearing the membranes 62, 64. However, it is contemplated that other suitable materials may also be used for the membranes 62, 64.

[0020] Elements of one disclosed aspect can be combined with elements of one or more other disclosed aspects to form different combinations, all of which are considered to be within the scope of the present invention.

[0021] Although the present disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of the present disclosure. This application is, therefore, intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Furthermore, this application is intended to cover such departures from the present disclosure as come within the customary or conventional practice within the technical field to which the present disclosure pertains and falls within the scope of the appended claims.

Claims

1. A fluid transfer system for a drug delivery system that utilizes a connector arrangement for aseptic transfer of fluid between a cannula arrangement and a container, the cannula arrangement, the container, at least one membrane held between the cannula arrangement and the container, the at least one membrane forming a pull tab that passes through the housing of the drug delivery system and extends outside the housing, at least one clip configured to fix the cannula arrangement to the container and clamp the at least one membrane between the cannula arrangement and the container and comprising, the cannula arrangement is received inside a space defined by the housing, the container is connected to the space defined by the housing via the at least one membrane, the at least one membrane is configured to be removable between the cannula arrangement and the container with the cannula arrangement fixed to the container to establish fluid communication between the cannula arrangement and the container. A fluid transfer system.

2. The fluid transfer system according to claim 1, wherein the at least one membrane is two membranes.

3. The fluid transfer system according to claim 1, wherein the at least one clip is two clips.

4. The cannula arrangement comprises a housing and a cannula slidably disposed within the housing, the housing including a flange extending around a portion thereof, the container includes a flange extending around a portion thereof, The fluid transfer system according to claim 1, wherein the at least one clip is configured to engage the flanges of the cannula arrangement and the container to clamp the at least one membrane between the cannula arrangement and the container.

5. The fluid transfer system according to claim 1, wherein the at least one membrane comprises one of foil, rubber, or polymer.

6. The fluid transfer system according to claim 1, wherein the container comprises a syringe barrel.

7. The fluid transfer system according to claim 1, further comprising a fitting member provided at the proximal end of the cannula arrangement and a fitting member provided at the distal end of the container, the fitting members being configured to engage each other after the at least one membrane is removed between the cannula arrangement and the container.

8. The fluid transfer system according to claim 1, wherein at least a portion of the at least one membrane extends through the at least one clip.

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