Fluid transfer system for drug delivery device

Abstract

To provide a valve assembly for drug delivery.SOLUTION: A valve assembly for a drug delivery includes a valve housing having a first side and a second side positioned opposite the first side, a cannula having a first end and a second end positioned opposite the first end, with the cannula defining a central passageway, and a valve sleeve defining a cannula space. The valve sleeve is configured to move from a pre-use position where the first end of the cannula is received within the cannula space to a use position where the first end of the cannula extends outside of the valve sleeve and the cannula space. The valve sleeve is configured to contact a container of the drug delivery device before any other element of the valve assembly when the valve sleeve moves from a pre-use position to the use position.SELECTED DRAWING: Figure 22

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 072,625, entitled "Fluid Transfer System for Drug Delivery Device," filed August 31, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] FIELD OF THE INVENTION FIELD OF THE DISCLOSURE The present disclosure relates generally to drug delivery devices, and more particularly to fluid transfer systems for drug delivery devices. [Background technology]

[0003] 2. Description of Related Art Various types of automatic injection or drug delivery devices have been developed to allow untrained individuals to administer or self-inject medications and other liquid therapeutic formulations. These devices generally include a reservoir prefilled with the liquid therapeutic formulation and some type of automatic needle injection mechanism that can be triggered by the user. When the amount of liquid or medication to be administered is generally less than a certain volume, such as 1 mL, an automatic injector is typically used, and the automatic injector typically has an injection time of approximately 10-15 seconds. When the amount of liquid or medication to be administered exceeds 1 mL, the injection time is generally longer, making it difficult for the patient to maintain contact between the device and the target area of ​​the patient's skin. Furthermore, the larger the amount of medication to be administered, the more desirable the injection time. The traditional method for slowly injecting medication into a patient is to start an IV and slowly infuse 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 environment, gradually injecting a liquid therapeutic formulation into a 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 release mechanism that forces the liquid therapeutic formulation out of a reservoir and into the injection needle. Such devices also typically include a valve or flow control mechanism that causes the liquid therapeutic formulation to begin flowing at the appropriate time, and a trigger mechanism to initiate the injection. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] International Publication No. 2013 / 155153 [Patent Document 2] International Publication No. 2014 / 179774 [Patent Document 3] US Patent Application Publication No. 2017 / 0354788 Summary of the Invention [Problem to be solved by the invention]

[0006] A valve assembly for a drug delivery device, a drug delivery device including a valve assembly for a drug delivery device, and methods for packaging and sterilizing a drug delivery device are provided. [Means for solving the problem]

[0007] Summary of the Invention In one aspect or embodiment, a valve assembly for a drug delivery device includes a valve housing having a first side and a second side opposite the first side, a cannula having a first end and a second end opposite the first end, the cannula defining a central passage, and a valve sleeve defining a cannula space. The valve sleeve is configured to move from a pre-use position in which the first end of the cannula is received within the cannula space to a use position in which the first end of the cannula extends out of the valve sleeve and the cannula space. The valve sleeve is configured to contact a container of the drug delivery device before any other elements of the valve assembly when the valve sleeve moves from the pre-use position to the use position.

[0008] The valve sleeve may be secured to the valve housing. An outermost portion of the valve sleeve may be secured to the valve housing. The valve sleeve may be secured to the valve housing via a retainer that engages the valve sleeve and the valve housing. The valve housing may include a protrusion that engages the retainer.

[0009] The valve sleeve may include a first cylindrical portion having a convex tip, a second portion extending from the first portion, and a third frustoconical portion extending from the second portion. The second portion of the valve sleeve may be a frustoconical section and a cylindrical section. The third portion of the valve sleeve may include at least one recess configured to facilitate collapsing and deformation of the valve sleeve. The valve sleeve may be formed from an elastomeric material.

[0010] In one aspect or embodiment, the drug delivery device includes a housing and a container received within the housing, the container having a first end and a second end opposite the first end. The container includes a barrel having the first end and the second end opposite the first end and configured to receive a medicament, a stopper movable within the barrel to dispense the medicament from the barrel, and a septum received by the second end of the barrel and having a first side and a second side opposite the first side. The container defines an open space extending from the second side of the septum to the second end of the container. The drug delivery device further includes a drive assembly received within the housing and configured to engage with the container and dispense the medicament from the container, and a needle actuator assembly received within the housing, the needle actuator assembly including a patient needle configured to pierce the patient's skin and a valve assembly according to any of the above aspects or embodiments.

[0011] The valve sleeve may engage the septum of the container when the valve sleeve moves from the pre-use position to the use position. The container may further include a locking element having a body and a locking ring, the locking element configured to secure the septum to the barrel of the container.

[0012] In one aspect or embodiment, a method of packaging and sterilizing a drug delivery device according to any of the above aspects or embodiments includes: a) sterilizing the barrel and septum of the container and disposing them in a first package; b) sterilizing the stopper of the container and disposing them in a second package; c) sterilizing the housing, drive assembly, needle actuator assembly, and valve assembly and disposing them in at least a third package; d) filling the container with a drug; e) assembling the drug delivery device and disposing the drug delivery device in a fourth package; and f) sterilizing the drug delivery device after step e).

[0013] The sterilization of step f) may include a vaporized peracetic acid sterilization process.The fourth package may be formed from a porous material.

[0014] 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 reference to the following description of embodiments of the disclosure, taken in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a perspective view of a drug delivery system according to one aspect or embodiment of the present application. [Figure 2] FIG. 2 is a perspective cross-sectional view of the drug delivery system of FIG. 1. [Figure 3] FIG. 2 is a front cross-sectional view of the drug delivery system of FIG. 1. [Figure 4] 2 is a top view of the drug delivery system of FIG. 1 with the top of the housing removed, showing the drug delivery system in a pre-use position. [Figure 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. [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. [Figure 7] 2 is a top view of the drug delivery system of FIG. 1 with the top of the housing removed, showing the drug delivery system in an initial actuated position. [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. [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. [Figure 10] 2 is a top view of the drug delivery system of FIG. 1 with the top of the housing removed, showing the drug delivery system in the use position. [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. [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 for use. [Figure 13]2 is a top view of the drug delivery system of FIG. 1 with the top of the housing removed to show the drug delivery system in a post-use position. [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. [Figure 15A] 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. [Figure 15B] 2 is a front cross-sectional view of the drug delivery system of FIG. 1 showing the pad with the drug delivery system in a pre-use position. [Figure 15C] 2 is a perspective cross-sectional view of the drug delivery system of FIG. 1 showing the pad with the drug delivery system in a pre-use position. [Figure 16] 2 is a partial cross-sectional view of the drug delivery system of FIG. 1 showing the valve assembly. [Figure 17] 2 is a partial cross-sectional view of the container of the drug delivery system of FIG. 1. [Figure 18] FIG. 2 is a perspective view of a valve assembly of the drug delivery system of FIG. 1. [Figure 19] 2 is a flowchart of a method for assembling and sterilizing the drug delivery device of FIG. 1 according to one aspect or embodiment of the present application. [Figure 20] FIG. 1 is a top view of a retainer of a valve assembly according to one aspect or embodiment of the present application. [Figure 21] FIG. 21 is a cross-sectional view taken along line AA shown in FIG. 20. [Figure 22] 1 is a partial cross-sectional view of a drug delivery system according to a further aspect or embodiment of the present application. [Figure 23] 1 is a partial cross-sectional view of a drug delivery system according to a further aspect or embodiment of the present application. [Figure 24] 1 is a partial cross-sectional view of a drug delivery system according to a further aspect or embodiment of the present application. DETAILED DESCRIPTION OF THE INVENTION

[0016] Detailed Description The following description is provided to enable any person skilled in the art to make and use the described embodiments contemplated for practicing the invention. However, various modifications, equivalents, variations, and alternatives will 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.

[0017] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "sideways," "longitudinal," and their derivatives will refer to the present invention as oriented in the drawings. However, it should be understood that the present invention may contemplate various alternative modifications, except where expressly specified otherwise. It should also be understood that the specific devices illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[0018] 1-16 , drug delivery device 10 includes drive assembly 12, reservoir 14, valve assembly 16, and needle actuator assembly 18. Drive assembly 12, reservoir 14, valve assembly 16, and needle actuator assembly 18 are at least partially disposed within housing 20. Housing 20 includes top 22 and bottom 24, although other suitable arrangements for housing 20 may be utilized. In one aspect, drug delivery device 10 is an injection device configured to be worn or secured to a user and to deliver a predetermined dose of medication provided in reservoir 14 by injection to the user. Device 10 may be utilized to deliver a “bolus injection” in which medication is delivered within a set time period. Medication may be delivered over a period of up to 45 minutes, although other suitable injection volumes and durations may be utilized. Bolus administration or delivery may be performed with or without specific speed control. Device 10 may deliver medication to a user at a constant pressure with variable speed. The general operation of the device 10 is described below with reference to FIGS. 1-16.

[0019] 1-16 , device 10 is actuated by a user engaging activation button 26, which causes needle 28 of needle actuator assembly 18 to pierce the user's skin, and drive assembly 12 is configured to place needle 28 in fluid communication with container 14 and expel fluid or medication from container 14, completing the withdrawal of needle 28 after injection of the medication. The general operation of drug delivery systems is shown and described in U.S. Patent Nos. 6,275,999 and 6,329,262, which are incorporated herein by reference in their entireties. The operation of device 10 is also shown and described in U.S. Patent No. 6,275,999, which is incorporated herein by reference in its entirety. The housing 20 of device 10 includes a viewing window 30 for viewing a display 32 configured to provide a user with an indication regarding the status of device 10 and for viewing container 14. The viewing window 30 may be a magnifying lens to provide a clear view of display 32. Display device 32 moves with needle actuator assembly 18 during use of device 10 to indicate the pre-use, use, and post-use states of device 10. Display device 32 provides a visual indicator of the state, although other suitable indicators, such as audio or tactile, may be provided as alternative or additional indicators.

[0020] 4-6, during the pre-use position of the device 10, the container 14 is spaced from the drive assembly 12, and the valve assembly 16 and needle 28 are in a retracted position. During initial actuation of the device 10, as shown in FIGS. 7-9, the drive assembly 12 engages the container 14 and moves the container 14 toward the valve assembly 16, which is configured to puncture the septum 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 device. The drive assembly 12 is configured to engage the stopper 34 of the container 14 or a spacer assembly 42 engaged with the stopper 34, which initially moves the entire container 14 into engagement with the valve assembly 16 due to the incompressibility of the fluid or medicament within the container 14. Initial actuation of the device 10 is triggered by engagement of the actuator button 26 by the user, which releases the needle actuator assembly 18 and the drive assembly 12, as described in more detail below. During the initial actuation, needle 28 is still in the retracted position and is about to move to the extended position to inject the user of device 10 .

[0021] During the use position of device 10, as shown in FIGS. 10-12, needle 28 is in an extended position at least partially outside housing 20, and drive assembly 12 moves stopper 34 within container 14 to deliver medication from container 14 through needle 28 to the user. In the use position, valve assembly 16 has already punctured septum 36 of container 14, placing container 14 in fluid communication with needle 28, which also allows drive assembly 12 to move stopper 34 relative to container 14 so that fluid can be dispensed from container 14. In the post-use position of device 10, as shown in FIGS. 13-15, needle 28 is in a retracted position and engages pad 38 to seal needle 28 and prevent residual flow of fluid or medication from container 14.

[0022] 16 and 18 , as described above, the valve assembly 16 operates to facilitate fluid communication between the container 14 and the needle actuator assembly 18. The valve assembly 16 includes a valve housing 52, a cannula 54, and a valve sleeve 60. The valve housing 52 has a first side 62 and a second side 64 disposed opposite the first side 62. The valve housing 52 may be formed integrally with the housing 20 of the instrument 10 or may be formed as a separate component. The cannula 54 has a first end 66 and a second end 68 disposed opposite the first end 66. The cannula 54 defines a central passage 70. The first end 66 of the cannula 54 is sharp and configured to pierce the septum 36 of the container 14. The second end 68 of the cannula 54 is received by and secured to the valve housing 52. Valve housing 52 is in fluid communication with needle actuator assembly 18 via tubing (not shown), providing a fluid flow path from cannula 54 to needle actuator assembly 18. In one aspect or embodiment, valve assembly 16 includes only valve housing 52, cannula 54, and valve sleeve 60, with no other elements or components forming part of valve assembly 16.

[0023] 16 and 18 , the valve sleeve 60 defines a cannula space 86 and is configured to move from a pre-use position in which the first end 66 of the cannula 54 is received within the cannula space 86 to a use position in which the first end 66 extends outside the valve sleeve 60 and cannula space 86. The valve sleeve 60 may be formed from an elastomeric material, such as a rubber material, although other suitable materials or combinations of materials may also be utilized. The valve sleeve 60 is configured to contact the container 14 before any other element of the valve assembly 16 when the valve sleeve 60 moves from the pre-use position to the use position. The valve sleeve 60 includes a cylindrical first portion 88 having a convex tip 90, a second portion 92 extending from the first portion 88, and a frusto-conical third portion 94 extending from the second portion 92. The second portion 92 is frusto-conical and cylindrical. The third portion 94 of the valve sleeve 60 may include one or more recesses 96 to facilitate collapsing and deformation of the valve sleeve 60. In one aspect or embodiment, after actuation of the drug delivery device 10, the drive assembly 12 moves the container 14 until the valve sleeve 60 engages the septum 36 of the container 14, which causes the valve sleeve 60 to move from a pre-use position to a use position such that the cannula 54 pierces the septum 36 of the container 14 and places the medication within the container in fluid communication with the cannula 54. The valve sleeve 60 is configured to ensure that the cannula 54 and flow path of the device 10 remain uncontaminated during operation of the device 10.

[0024] In one aspect or embodiment, the outermost portion 98 of the valve sleeve 60 is secured to the valve housing 52. The outermost portion 98 of the valve sleeve 60 may be secured to the valve housing 52 by adhesive, fasteners, or other suitable devices. In one aspect or embodiment, the valve sleeve 60 is secured to the valve housing 52 via a locking engagement between the valve sleeve 60 and the valve housing 52, as described in more detail below.

[0025] 4, 5, and 17, the container 14 has a first end 102 and a second end 104 disposed opposite the first end 102. The container 14 includes a barrel 106 having a first end 108 and a second end 110 disposed opposite the first end 108, the barrel 106 being configured to receive a medicament. The container 14 includes a stopper 34 movable within the barrel 106 to dispense the medicament from the barrel 106, and a septum 36 received by the second end 110 of the barrel 106. The septum 36 has a first side 112 and a second side 114 disposed opposite the first side 112. The container 14 defines an open space 116 extending from the second side 114 of the septum 36 to the second end 104 of the container 14. The valve sleeve 60 is configured to directly contact the second side 114 of the septum 36 when the valve sleeve 60 moves from the pre-use position to the post-use position. The container 14 also includes a locking element 118 having a body 120 and a locking ring 122. The locking element 118 is configured to secure the septum 36 to the barrel 106 of the container 14. In one aspect or embodiment, the container 14 does not include any seal, such as a foil seal, covering a portion of the septum 36 or a portion of the locking element 118.

[0026] Referring to FIG. 19, in a further aspect or embodiment of the present application, a method of packaging and sterilizing a drug delivery device 10 includes: a) sterilizing the barrel 106 and septum 36 of the container 14 and disposing them in a first package; b) sterilizing the stopper 34 of the container 14 and disposing them in a second package; c) sterilizing the housing 20, drive assembly 12, needle actuator assembly 18, and valve assembly 16 and disposing them in at least a third package; d) filling the container 14 with a drug; e) assembling the drug delivery device 10 and disposing the drug delivery device 10 in a fourth package; and f) after step e), sterilizing the drug delivery device 10.

[0027] The sterilization in step f) may be performed using a vaporized peracetic acid sterilization process, although other suitable sterilization processes may be utilized. The fourth package may be formed from a porous material, allowing sterilization of the assembled device 10 after packaging. In one aspect or embodiment, the sterilization in step f) is performed using a vaporized peracetic acid sterilization process, a nitrogen dioxide sterilization process, a vaporized hydrogen peroxide process, and / or an ethylene oxide sterilization process. In one aspect or embodiment, the fourth package and the first, second, and third packages may be formed in part from a nonwoven high-density polyethylene fiber material, such as Tyvek®, available from DuPont. Other packaging options include pouches or trays made from a laminate of multiple polymers, such as plastics like polyethylene, polyethylene terephthalate glycol, and the like, optionally with breathable portions made, for example, of Tyvek®. In one aspect or embodiment, step (e) includes placing the drug delivery device 10 in a clamshell tray and then placing the drug delivery device 10 and clamshell in a pouch, where the clamshell and pouch may be made from "Tyvek" (registered trademark).

[0028] In one aspect or embodiment, the method includes separately sterilizing and packaging the upper portion 22 of the housing 20 for later assembly with other components. The spacer assembly 42 may also be separately sterilized and packaged for later assembly with other components.

[0029] In one aspect or embodiment, prior to assembling the drug delivery device, the method includes mechanical adjustments, such as adjustment of the spacer assembly 42 and / or fitting of various components.

[0030] In one aspect or embodiment, the method further comprises performing a mechanical sterility integrity test, such as a pressure decay test or a dye test.

[0031] 20-22 , a retainer 130 for the valve assembly 16 of the drug delivery device 10 is shown, according to one aspect or embodiment. The retainer 130 is ring-shaped, although other suitable shapes may be utilized. The retainer 130 includes a tapered outer surface 132 configured to engage a corresponding tapered surface 134 of the valve housing 52. As shown in FIG. 22 , the retainer 130 is positioned within the valve housing 52, with the tapered outer surface 132 engaging the tapered surface 134 of the valve housing 52 and the retainer 130 engaging the outermost portion 98 of the valve sleeve 60 to secure the valve sleeve 60 to the valve housing 52.

[0032] 23 , in one aspect or embodiment, the valve housing 52 further includes a protrusion 140 extending radially inward from the valve housing 52. The protrusion 140 is configured to engage and hold the retainer 130 in place when the retainer 130 is fully inserted into the valve housing 52. The protrusion 140 may be a continuous ring or may be one or more protrusions.

[0033] 24 , rather than securing the outermost portion 98 of the valve sleeve 60 within the valve housing 52, in one aspect or embodiment, the outermost portion 98 of the valve sleeve 60 is secured to the exterior surface 142 of the valve housing 52. The valve sleeve 60 may be secured to the exterior surface 142 via engagement with a portion of the valve housing 52, adhesive, fasteners, a retainer 130, or any other suitable device.

[0034] Elements of one disclosed embodiment may be combined with elements of one or more other disclosed embodiments to form different combinations, all of which are contemplated within the scope of the present invention.

[0035] While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of the disclosure.

[0036] 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 variations from the present disclosure within known or customary practice in the art to which this disclosure pertains and that fall within the limits of the appended claims.

Claims

1. 1. A valve assembly for a drug delivery device, cooperating with a container of the drug delivery device, the valve assembly comprising: a valve housing having a first side and a second side disposed opposite the first side; a cannula having a first end and a second end disposed opposite the first end, the cannula defining a central passage, the first end of the cannula configured to puncture a septum of the container; a valve sleeve defining a cannula space, the valve sleeve configured to move from a pre-use position in which the first end of the cannula is received within the cannula space to a use position in which the first end of the cannula extends outside the valve sleeve and the cannula space; the valve sleeve is configured to contact a container of the drug delivery device before any other element of the valve assembly when the valve sleeve moves from the pre-use position to the use position; the valve sleeve includes a cylindrical first portion having a convex tip, a second portion extending from the first portion, and a frusto-conical third portion extending from the second portion; The valve assembly of claim 1, wherein the first end of the cannula is received within the cylindrical first portion when the valve sleeve is in the pre-use position.

2. 2. The valve assembly of claim 1, wherein the valve sleeve is fixed to the valve housing.

3. 3. The valve assembly of claim 2, wherein an outermost portion of the valve sleeve is secured to the valve housing.

4. 3. The valve assembly of claim 2, wherein the valve sleeve is secured to the valve housing via a retainer that engages the valve sleeve and the valve housing.

5. 5. The valve assembly of claim 4, wherein the valve housing includes a projection that engages the retainer.

6. 2. The valve assembly of claim 1, wherein the second portion of the valve sleeve includes a frustoconical section and a cylindrical section.

7. 10. The valve assembly of claim 1 or 6, wherein the third portion of the valve sleeve includes at least one recess configured to facilitate collapsing and deformation of the valve sleeve.

8. A valve assembly according to any one of claims 1 to 7, wherein the valve sleeve comprises an elastomeric material.

9. 1. A drug delivery device comprising: Housing and a container received within the housing, the container having a first end and a second end opposite the first end, the container comprising: a barrel configured to receive a medicament, the container having a first end and a second end opposite the first end; a stopper movable within the barrel to dispense the medicament from the barrel; and a septum received by the second end of the barrel, the septum having a first side and a second side opposite the first side, the container defining an open space extending from the second side of the septum to the second end of the container; a drive assembly received within the housing and configured to engage the container to dispense medicament from the container; a needle actuator assembly received within the housing, the needle actuator assembly including a patient needle configured to pierce the skin of a patient; A drug delivery device comprising a valve assembly according to any one of claims 1 to 8.

10. 10. The drug delivery device of claim 9, wherein the valve sleeve engages the septum of the container when the valve sleeve moves from a pre-use position to a use position.

11. 10. The drug delivery device of claim 9, wherein the container further comprises a locking element having a body and a locking ring, the locking element configured to secure the septum to the barrel of the container.

12. A method for packaging and sterilizing a drug delivery device according to any one of claims 9 to 11, comprising the steps of: a) sterilizing the barrel and the septum of the container and placing them in a first package; b) sterilizing the stopper of the container and placing it in a second package; c) sterilizing and disposing the housing, drive assembly, needle actuator assembly, and valve assembly into at least a third package; d) filling the container with a drug; e) assembling the drug delivery device and placing the drug delivery device in a fourth package; f) after step e), sterilizing the drug delivery device.

13. 13. The method of claim 12, wherein the sterilization in step f) comprises a vaporized peracetic acid sterilization process.

14. 14. The method of claim 12 or claim 13, wherein the fourth package comprises a porous material.

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