Connectors for sterile transfer of fluids

Abstract

To provide aseptic transfer of fluid within a drug delivery device.SOLUTION: A fluid transfer system is provided, utilizing a connector arrangement for aseptic transfer of fluid between a cannula arrangement and a container, the fluid transfer system comprises: 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.SELECTED DRAWING: Figure 16

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 STERILE TRANSFER OF FLUIDS,” filed October 16, 2017, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

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

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

[0004] Certain devices allow for self-injection in a home setting and can gradually inject the liquid therapeutic formulation into the patient's skin. In some cases, these devices are small enough (both in height and overall size) to allow them to be "worn" by the patient while the liquid therapeutic formulation is being injected into the patient. These devices typically include a pump or other type of ejection mechanism to cause the liquid therapeutic formulation to flow from the reservoir into the injection needle. Such devices also typically include a valve or flow control mechanism to timely initiate the flow of the liquid therapeutic formulation, and a trigger mechanism to initiate the injection. Summary of the Invention

[0005] In one embodiment, 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 with the container including a closure, a valve assembly received within the cavity and including a penetration configured to penetrate the closure of the container, and a connector arrangement disposed between the container and the valve assembly, the connector arrangement being movable between a first pre-use position that maintains sterility between the closure of the container and the valve assembly, and a second use position that enables 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 membranes may include flash spun high density polyethylene fibers. At least a portion of the connector arrangement may extend outwardly through the housing. To move the connector arrangement from a first position to a second position, the connector arrangement may be withdrawn from the housing.

[0007] In another aspect, a fluid transfer system utilizing a connector arrangement for sterile transfer of fluid between a cannula arrangement and a container includes a cannula arrangement, a 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 embodiment, 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 may be 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. The cannula arrangement may include a housing and a cannula slidably disposed within the housing. The at least one membrane may include one of a foil, a rubber, or a polymer. The at least one membrane may be withdrawn 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 a proximal end of the cannula arrangement and a coupling member may be provided at a distal end of the container. The coupling members may be configured to engage with one another after the 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] The above and other features and advantages of the present disclosure, as well as the manner in which they are achieved, will become more apparent, and the disclosure itself will be better understood, by referring to the following description of embodiments of the present disclosure in conjunction with the accompanying drawings.

[0010] [Figure 1] FIG. 1 is a perspective view of a drug delivery system according to one embodiment of the present invention. [Diagram 2] 2 is a perspective cross-sectional view of the drug delivery system of FIG. 1 according to one embodiment of the present invention. [Diagram 3] 2 is a front cross-sectional view of the drug delivery system of FIG. 1 according to one embodiment of the present invention. [Figure 4] 2 is a top view of the drug delivery system of FIG. 1 showing the top of the housing removed and the drug delivery system in a pre-use position according to one embodiment of the present invention. [Diagram 5] 2 is a top cross-sectional view of the drug delivery system of FIG. 1 showing the drug delivery system in a pre-use position according to one embodiment of the present invention. [Figure 6] 2 is a front cross-sectional view of the drug delivery system of FIG. 1 showing the drug delivery system in a pre-use position according to one embodiment of the present invention. [Figure 7] 2 is a top view of the drug delivery system of FIG. 1 showing the top of the housing removed and the drug delivery system in an initial operating position according to one embodiment of the present invention. [Figure 8] 2 is a top cross-sectional view of the drug delivery system of FIG. 1 showing the drug delivery system in an initial actuated position according to one embodiment of the present invention. [Figure 9] 2 is a front cross-sectional view of the drug delivery system of FIG. 1 showing the drug delivery system in an initial actuated position according to one embodiment of the present invention. [Figure 10] 2 is a top view of the drug delivery system of FIG. 1 showing the top of the housing removed and the drug delivery system in a use position according to one embodiment of the present invention. [Figure 11] 2 is a top cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a position for use, according to one embodiment of the present invention. [Figure 12] 2 is a front cross-sectional view of the drug delivery system of FIG. 1, showing the drug delivery system in a position of use, according to one embodiment of the present invention. [Figure 13] 2 is a top view of the drug delivery system of FIG. 1 showing the top of the housing removed and the drug delivery system in a post-use position according to one embodiment of the present invention. [Figure 14] 2 is a top cross-sectional view of the drug delivery system of FIG. 1 showing the drug delivery system in a post-use position according to one embodiment of the present invention. [Figure 15]2 is a front cross-sectional view of the drug delivery system of FIG. 1 showing the drug delivery system in a post-use position according to one embodiment of the present invention. [Figure 16] 2 is a side view of a connector for sterile transfer of fluids in the drug delivery system of FIG. 1 according to one embodiment of the present invention. [Figure 17A] 2 is a side view of a connector for sterile transfer of fluids in the drug delivery system of FIG. 1 according to another embodiment of the present invention, the connector being shown in an inactive state. [Figure 17B] FIG. 17B is a side view of the connector of FIG. 17A shown in an active state. [Figure 18] 2 is a side view of a connector for sterile transfer of fluids in the drug delivery system of FIG. 1 according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

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

[0012] Hereinafter, for purposes of description, the terms "upper," "lower," "right," "left," "vertical," (horizontal," "top," "bottom," "lateral," "longitudinal," and their derivatives shall refer to the invention as oriented in the drawings. It will be understood, however, that the invention may be subject to various alternative modifications unless expressly specified to the contrary. It will also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0013] 1-15, a drug delivery system 10 according to one embodiment of the present disclosure includes a drive assembly 12, a reservoir 14, a valve assembly 16, and a needle actuator assembly 18. The drive assembly 12, the reservoir 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 embodiment, the drug delivery system 10 is a syringe device configured to be worn or secured to a user and to deliver a predetermined dose of a drug provided within the reservoir 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 45 minute period, although other suitable injection amounts and durations may be utilized. The bolus administration or delivery may be performed with a rate controlling or may have no specific rate controlling. System 10 can deliver medication to a user at variable rates and at fixed pressure. The general operation of system 10 is described below in conjunction with Figures 1 through 15.

[0014] 1-15, the system 10 is configured to operate through engagement of an actuator button 26 by a user, which causes the needle 28 of the needle assembly 18 to pierce the user's skin, and actuation of the drive assembly 12 causes the needle 28 to fluidly communicate with and expel fluid or medicament from the container 14, and completes withdrawal of the needle 28 after injection of the medicament. The general operation of the medicament delivery system is shown and described in WO 2013 / 155153 and WO 2014 / 179774, which are incorporated herein by reference in their entireties. 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 status of the system 10, and a container window 31 for viewing the container 14. The indicator window 30 may be a magnifying lens to provide 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 a visual indicia regarding the state, although other suitable indications, such as audio or tactile, may be provided as alternative or additional indications.

[0015] 4-6, during a pre-use position 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. 7-9, the drive assembly 12 engages the container 14 and moves it toward the valve assembly 16, which is configured to pierce a closure 36 of the container 14 and place the medicament within 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 a stopper 34 of the container 14, which, due to the incompressibility of the fluid or medicament within the container 14, will initially move the entire container 14 into engagement with the valve assembly 16. Initial actuation of the system 10 is caused by engagement of the actuator button 26 by a user, which 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 injecting a user of the system 10.

[0016] During the use position of the system 10, as shown in Figures 10-12, the needle 28 is in an extended position and at least partially outside the housing 20, while the drive assembly 12 moves the stopper 34 within the container 14 to deliver the medicament from the container 14 through the needle 28 and to the user. In the use position, the valve assembly 16 has already penetrated the closure 36 of the container 14 to place the container 14 in fluid communication with the needle 28, which also allows the drive assembly 12 to move the stopper 34 relative to the container 14 so that fluid can be dispensed from the container 14. In the post-use position of the system 10, shown in Figures 13-15, the needle 28 is in a retracted position and engaged with the pad 38 to seal the needle 28 and prevent any residual flow of fluid or medicament from the container 14. The container 14 and valve assembly 16 may be the container 14 and valve assembly 16 shown and described in WO 2015 / 081337, the entirety of which is incorporated herein by reference.

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

[0018] 16-17B, during assembly of the connector arrangement 50, clips 66 or other similar types of connectors are attached to engage the flanges 58, 60 of the container 52 and the housing 56, respectively, such that the membranes 62, 64 contact one another. In one embodiment, a single clip 66 is provided to clamp the flanges 58, 60 together. In another embodiment, two clips 66 are provided to clamp the flanges 58, 60 together. The membranes 62, 64 may extend through one of the clips 66 once 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 may be pulled away from the connector arrangement 50 to allow the container 52 and the housing 56 to move into engagement with one another. In one embodiment, the distal end of container 52 and the proximal end of housing 56 may include joints 68, 70 to facilitate engagement between container 52 and housing 56. Joints 68, 70 may be any type of engagement and locking mechanism that connects the distal end of container 52 to the proximal end of housing 56.

[0019] Referring to FIG. 18, a connector arrangement 50 is shown in use 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 embodiment, the membranes 62, 64 form a pull tab that extends outwardly through the housing 20 of the system 10. The valve assembly 16 is configured to pierce a septum 74 held in 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 piercing member 76 housed in the valve member 72. The piercing member 76 pierces the septum 74 of the container 14 to establish fluid communication between the container 14 and the valve assembly 16. However, prior to use of the system 10, the membranes 62, 64 are disposed between the container 14 and the valve assembly 16 to maintain 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 a user to grasp 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 toward each other during the drug delivery process of the system 10. In this embodiment, the membranes 62, 64 are made of flash spun high density polyethylene fibers, allowing the membranes 62, 64 to be pulled without breaking or tearing the membranes 62, 64. However, it is contemplated that other suitable materials may be used for the membranes 62, 64.

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

[0021] While the present disclosure has been described as having an exemplary design, the disclosure can be further modified within the spirit and scope of the disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the disclosure as come within practice or custom in the art to which the disclosure pertains and which fall within the scope of the appended claims.

Claims

1. 1. A fluid transfer system for a drug delivery system utilizing a connector arrangement for sterile transfer of fluid between a cannula arrangement and a container, comprising: the cannula arrangement comprising a housing and a cannula slidably disposed within the housing; The container having a partition; at least one sealing membrane held between the cannula arrangement and the container and sealingly covering an end of the cannula arrangement and an end of the container to maintain sterility of the cannula, the housing of the cannula arrangement, and the container, the at least one sealing membrane extending through a housing of the drug delivery system to the outside of the housing of the drug delivery system; at least one clip configured to secure the cannula arrangement to the container and clamp at least one sealing membrane between the cannula arrangement and the container; Equipped with the at least one sealing membrane is configured to be removable from between the cannula arrangement and the container while the cannula arrangement is secured to the container to establish fluid communication between an interior of the housing of the cannula arrangement and the septum of the container; A fluid transfer system, wherein an end of the container and an end of the cannula arrangement are separated from one another by clamping the at least one sealing membrane, and upon removal of the at least one sealing membrane, the container and the housing of the cannula arrangement move into contact with one another.

2. The fluid transfer system of claim 1 , wherein the at least one sealing membrane comprises two membranes.

3. The fluid transfer system of claim 1 , wherein the at least one clip comprises two clips.

4. The housing of the cannula arrangement includes a flange around a portion of which the cannula arrangement extends; the container includes a flange extending around a portion thereof; 2. The fluid transfer system of claim 1, wherein the at least one clip is configured to engage the cannula arrangement and the flange of the container to clamp the at least one sealing membrane between the cannula arrangement and the container.

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

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

7. 2. The fluid transfer system of claim 1, further comprising a coupling member provided at a proximal end of the cannula arrangement and a coupling member provided at a distal end of the container, the coupling member configured to connect the cannula arrangement to the container after the at least one sealing membrane is removed from between the cannula arrangement and the container.

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

9. 1. A fluid transfer system for a drug delivery system utilizing a connector arrangement for sterile transfer of fluid between a cannula arrangement and a container, comprising: the cannula arrangement comprising a housing having an open end, a cannula slidably disposed within the housing, and a first sealing membrane attached to the open end of the housing of the cannula arrangement; the container having a second sealing membrane covering an end of the container; the first sealing membrane and the second sealing membrane extend through a housing of the medication delivery system to an exterior of the housing of the medication delivery system; at least one clip remote from the cannula arrangement and the container, the at least one clip configured to secure the cannula arrangement to the container and to clamp a first sealing membrane and a second sealing membrane between the cannula arrangement and the container; Equipped with A fluid transfer system, wherein a first sealing membrane and a second sealing membrane are configured to be removable from between the cannula arrangement and the container while the cannula arrangement is secured to the container to unseal and open the open end of the housing of the cannula arrangement and the end of the container.

10. 10. The fluid transfer system of claim 9, wherein the container and the housing of the cannula arrangement are separated from one another with the first and second sealing membranes clamped therebetween, and upon removal of the first and second sealing membranes, the container and the housing of the cannula arrangement move into engagement with one another.

Images