Drug delivery device with adhesive assembly

Abstract

A drug delivery device includes a housing, a container housed within the housing, a drive assembly configured to move a stopper within the container, a needle having a retracted position, a needle shield fixed to the housing and housing a portion of the needle, and an adhesive assembly including an adhesive layer fixed to a bottom surface of the housing and an inner liner fixed to the adhesive layer. The inner liner is configured to be removed from the adhesive layer and includes one of a protrusion and an inner liner opening, and the needle shield includes the other of the protrusion and the inner liner opening. The inner liner opening houses the protrusion to secure the inner liner to the needle shield, and the inner liner is configured to separate from the adhesive layer upon removal of the needle shield from the housing.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 116,030, filed November 19, 2020, entitled “Drug Delivery Device with Adhesive Assembly,” the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Technical Background of the Invention

[0004] Field of the Invention

[0005] This disclosure generally relates to a drug delivery device, and more particularly to a drug delivery device having an adhesive liner.

[0006] Description of related technologies

[0007] Various types of automated injection devices or drug delivery systems have been developed to allow drug solutions and other liquid therapeutic preparations to be administered or self-injected by untrained personnel. Typically, these devices include a reservoir pre-filled with the liquid therapeutic preparation and some type of automated needle injection mechanism that can be triggered by the user. When the volume of the fluid or drug to be administered is typically less than a certain volume (e.g., 1 ml (mL)), an autoinjector is usually used, with an injection time typically around 10 to 15 seconds. When the volume of the fluid or drug to be administered exceeds 1 mL, the injection time usually becomes longer, making it difficult for the patient to maintain contact between the device and the target area of ​​the patient's skin. Furthermore, as the volume of the drug to be administered becomes larger, it is desirable to extend the injection time. The traditional method for slowly injecting drugs into a patient is to initiate intravenous injection (IV) and slowly inject the drug into the patient. This procedure is typically performed in a hospital or outpatient setting.

[0008] Some devices allow for self-injection in a home setting and are capable of gradually injecting liquid therapeutic agents into a patient's skin. In some cases, these devices are small enough (in both height and overall size) that patients can "wear" them while the liquid therapeutic agent is being infused into their bodies. These devices typically include a pump or other type of discharge mechanism to force the liquid therapeutic agent out of the reservoir and into the injection needle. Such devices often also include a valve or flow control mechanism and a trigger mechanism that initiates the flow of the liquid therapeutic agent at the appropriate time and initiates the injection. Summary of the Invention

[0009] In one aspect, a drug delivery device includes: a housing having a top surface and a bottom surface; a container housed within the housing, configured to contain a drug, wherein the container includes a stop configured to move within the container; a drive assembly configured to move the stop; a needle having a retracted position and an extended position, wherein in the retracted position the needle is positioned within the housing, and in the extended position a portion of the needle protrudes from the housing; a needle cover secured to the housing and housing a portion of the needle; and an adhesive assembly including an adhesive layer and a liner, the adhesive layer being secured to the bottom surface of the housing, and the liner being secured to the adhesive layer. The liner is configured to be removable from the adhesive layer. The liner includes one of a protrusion and a liner opening, and the needle cover includes the other of the protrusion and the liner opening. The liner opening receives the protrusion to secure the liner to the needle cover. The liner is configured to separate from the adhesive layer when the needle cover is removed from the housing.

[0010] The liner may include the protrusion, and the needle cap may include the liner opening. The liner and the adhesive layer may define a gap opening that accommodates a portion of the protrusion.

[0011] The liner may include: a body covering at least a portion of the adhesive layer; and an extension extending from the body, wherein the extension includes one of the protrusion and the liner opening. The needle cap may be positioned between the body and the extension of the liner. The body of the liner may completely cover the adhesive layer. The protrusion and the liner opening may form a snap-fit ​​engagement.

[0012] In another aspect, an adhesive assembly for a drug delivery device includes a housing, a needle, and a needle cover, the needle having a retracted position and an extended position, in which the needle is positioned within the housing and in which a portion of the needle protrudes from the housing, the needle cover being secured to the housing and receiving a portion of the needle, the adhesive assembly comprising: an adhesive layer configured to be secured to a bottom surface of the housing; and a liner secured to the adhesive layer, wherein the liner is configured to be removed from the adhesive layer. The liner includes a protrusion configured to be received by an opening in the liner defined by the needle cover, wherein the liner is configured to separate from the adhesive layer upon removal of the needle cover from the housing.

[0013] The liner and the adhesive layer can define a gap opening that accommodates a portion of the protrusion. The liner can include: a body that covers at least a portion of the adhesive layer; and an extension extending from the body, wherein the protrusion is positioned on the extension of the liner. The liner can include a fold line that separates the body of the liner from the extension of the liner, and the extension of the liner is configured to fold around the fold line relative to the body of the liner. The body of the liner can completely cover the adhesive layer. The protrusion of the liner can be configured to engage with the needle cap snap. Attached Figure Description

[0014] The above and other features and advantages of this disclosure, as well as the ways in which they are implemented, will become more apparent from the following description of embodiments of this disclosure taken in conjunction with the accompanying drawings, in which:

[0015] Figure 1 This is a perspective view of a drug delivery device according to one aspect of the present invention.

[0016] Figure 2 According to one aspect of the invention Figure 1 A three-dimensional sectional view of a drug delivery device.

[0017] Figure 3 According to one aspect of the invention Figure 1 A front sectional view of the drug delivery device.

[0018] Figure 4 According to one aspect of the invention Figure 1 A top view of the drug delivery device, showing the top of the housing removed and the drug delivery device in its pre-use position.

[0019] Figure 5 According to one aspect of the invention Figure 1 A top sectional view of a drug delivery device, showing the drug delivery device in its pre-use position.

[0020] Figure 6 According to one aspect of the invention Figure 1 A front sectional view of a drug delivery device, showing the drug delivery device in its pre-use position.

[0021] Figure 7 According to one aspect of the invention Figure 1 A top view of the drug delivery device, showing the top of the housing removed and the drug delivery device in the initial actuated position.

[0022] Figure 8 According to one aspect of the invention Figure 1A top sectional view of the drug delivery device, showing the drug delivery device in its initial actuated position.

[0023] Figure 9 According to one aspect of the invention Figure 1 A front sectional view of the drug delivery device, showing the drug delivery device in its initial actuated position.

[0024] Figure 10 According to one aspect of the invention Figure 1 A top view of the drug delivery device, showing the top of the housing removed and the drug delivery device in the use position.

[0025] Figure 11 According to one aspect of the invention Figure 1 A top sectional view of a drug delivery device, showing the drug delivery device in its use position.

[0026] Figure 12 According to one aspect of the invention Figure 1 A front sectional view of a drug delivery device, showing the drug delivery device in its use position.

[0027] Figure 13 According to one aspect of the invention Figure 1 A top view of the drug delivery device, showing the top of the housing removed and the drug delivery device in its post-use position.

[0028] Figure 14 According to one aspect of the invention Figure 1 A top sectional view of the drug delivery device, showing the drug delivery device in its post-use position.

[0029] Figure 15 According to one aspect of the invention Figure 1 A front sectional view of the drug delivery device, showing the drug delivery device in its post-use position.

[0030] Figure 16 This is a top view of an adhesive assembly and a needle cover according to one aspect of the present invention.

[0031] Figure 17 It is along Figure 16 A partial cross-sectional view taken from line 17-17.

[0032] Figure 18 It is along Figure 16 The cross-sectional view taken from line 18-18.

[0033] Figure 19 yes Figure 16A partial cross-sectional view of the adhesive assembly and needle cover, showing the adhesive assembly that secures the liner to the needle cover.

[0034] Figure 20 yes Figure 16 A cross-sectional view of the adhesive assembly and needle cover, showing the adhesive assembly and needle cover fixed to... Figure 1 Drug delivery device. Detailed Implementation

[0035] 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 substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0036] In the following text, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the invention as oriented as shown in the accompanying drawings. However, it should be understood that the invention may take various alternative variations unless explicitly stated to the contrary. It should also be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Therefore, the specific dimensions and other physical characteristics associated with the embodiments disclosed herein should not be considered limiting.

[0037] refer to Figures 1 to 15 According to one aspect of this disclosure, a drug delivery device 10 includes a drive assembly 12, a container 14, a valve assembly 16, and a needle actuator assembly 18. The drive assembly 12, container 14, valve assembly 16, and needle actuator assembly 18 are at least partially positioned within a cavity defined by a housing 20. The housing 20 includes a top 22 and a bottom 24, but other suitable arrangements for the housing 20 may also be used. In one aspect, the drug delivery device 10 is a syringe device configured to be worn or secured to a user and to deliver a predetermined dose of drug provided in the container 14 into the user's body via injection. The device 10 can be used to deliver a "bolus injection," i.e., the drug is delivered over a set time period. The drug can be delivered over a time period of up to 45 minutes, but other suitable injection volumes and durations may also be used. Bolus administration or delivery can be performed with or without specific rate control. The device 10 can deliver the drug to the user at a variable rate under a fixed pressure. Reference is made below. Figures 1 to 15 Describe the general operation of device 10.

[0038] Refer again Figures 1 to 15The device 10 is configured to operate by the user engaging an actuation button 26, which causes the needle 28 of the needle actuator assembly 18 to pierce the user's skin, actuating the drive assembly 12 to bring the needle 28 into fluid communication with the container 14 and to expel fluid or medication from the container 14, and to withdraw the needle 28 after the medication injection is completed. The general operation of the drug delivery system is shown and described in international publications Nos. 2013 / 155153 and 2014 / 179774, the entire contents of which are incorporated herein by reference. The housing 20 of the device 10 includes an indicator window 30 for viewing an indicator arrangement 32 configured to provide the user with indications about the status of the device 10, and a container window for viewing the container 14. The indicator window 30 may be a magnifying glass to provide a clear view of the indicator arrangement 32. The indicator device 32 moves together with the needle actuator assembly 18 during use of the device 10 to indicate the pre-use state, the use state, and the post-use state of the device 10. The indicator device 32 provides visual markings about the state, but other suitable markings, such as auditory or tactile markings, may also be provided as alternative or additional markings.

[0039] refer to Figures 4 to 6 During the pre-use position of device 10, container 14 is spaced apart from drive assembly 12 and valve assembly 16, and needle 28 is in the retracted position. During the initial actuation of device 10, as Figures 7 to 9 As shown, the actuation assembly 12 engages the container 14 to move it toward the valve assembly 16, which is configured to pierce the closure 36 of the container 14 and to establish fluid communication between the medication within the container 14 and the needle 28 via a tube (not shown) or other suitable arrangement. The actuation assembly 12 is configured to engage the stopper 34 of the container 14, initially moving the entire container 14 to engagement with the valve assembly 16 due to the incompressibility of the fluid or medication within the container 14. More specifically, the actuation assembly 12 is configured to engage with the spacer 40 housed by the stopper 34. Initial actuation of the device 10 is caused by the user engaging the actuation button 26, which releases the needle actuator assembly 18 and the actuation assembly 12, as discussed in more detail below. During initial actuation, the needle 28 remains in the retracted position and is about to move to the extended position for injection into the user of the device 10.

[0040] During the use of device 10, such as Figures 10 to 12As shown, the needle 28 is located in an extended position at least partially outside the housing 20, wherein the drive assembly 12 moves the stop 34 within the container 14 to deliver medication from the container 14 to the user via the needle 28. In the use position, the valve assembly 16 has pierced the closure 36 of the container 14 to put the container 14 in fluid communication with the needle 28, which also allows the drive assembly 12 to move the stop 34 relative to the container 14 since fluid can be dispensed from the container 14. In the post-use position of the device 10, as... Figures 13 to 15 As shown, needle 28 is in the retracted position and engages with gasket 38 to seal needle 28 and prevent any residual flow of fluid or drug from container 14. Container 14 and valve assembly 16 may be the container and valve assembly shown and described in the international publication WO 2015 / 081337, the entire disclosure of which is incorporated herein by reference.

[0041] refer to Figures 16 to 20 , Figures 1 to 15 The drug delivery device 10 may be provided with a needle cover 42, which is attached to a housing 20 and houses a portion of a needle 28. The housing 20 includes a top surface 44 and a bottom surface 46. The needle cover 42 includes a cylindrical portion 48 housed within the housing 20, which surrounds at least a portion of the needle 28. The needle cover 42 may be attached to the housing 20 by clamping or engaging a portion of the housing 20, or by frictional engagement with an opening in the housing 20. In its pre-use position, the needle cover 42 maintains the sterility of the needle 28 and may also be configured to prevent accidental actuation of the drug delivery device 10. The drug delivery device 10 may also include an adhesive assembly 50 configured to secure the drug delivery device 10 to a patient, enabling the delivery of medication from a container 14 to the patient's subcutaneous tissue and allowing the device 10 to be removed from the patient after drug delivery is complete. The adhesive assembly 50 includes an adhesive layer 52 and a liner 54. The adhesive layer is secured to the bottom surface 46 of the housing 20, and the liner is secured to the adhesive layer 52. The liner 54 is configured to be removed from the adhesive layer 52 to expose the adhesive layer 52 and to allow the adhesive layer 52 to be adhered to a surface (e.g., a patient's skin surface). The liner 54 includes one or more protrusions 60, and the needle cap 42 defines one or more liner openings 62; however, the liner 54 may include one or more liner openings 62, and the needle cap 42 may include one or more protrusions 60. The liner 54 is shown with two protrusions 60, and the needle cap 42 includes two liner openings 62, but one or more protrusions 60 and liner openings 62 may be used. Figure 19 As shown, one or more protrusions 60 are received by one or more liner openings 62 to secure the liner 54 to the needle cover 42. The liner 54 is configured to separate from the adhesive layer 52 when the needle cover 42 is removed from the housing 20.

[0042] refer to Figure 16 , Figure 17 and Figure 19 The liner 54 and the adhesive layer 52 define a gap opening 64 that accommodates a portion of one or more protrusions 60. When one or more protrusions 60 are secured to the needle cover 42, the gap opening 64 provides space for one or more protrusions 60.

[0043] Refer again Figures 16 to 20 The liner 54 includes a body 70 and an extension 72, the body covering at least a portion of the adhesive layer 52, the extension extending from the body 70. The extension 72 of the liner 54 includes one or more protrusions 60. When the liner 54 is secured to the needle cover 42 via the one or more protrusions 60, the needle cover 42 is positioned between the body 70 of the liner 54 and the extension 72 of the liner 54. However, the adhesive assembly 50 may be configured such that when the needle cover 42 is secured to the liner 54, the extension 72 is positioned between the body 70 and the needle cover 42, and one or more protrusions 60 extend from the extension 72 toward the needle cover 42. The body 70 of the liner 54 completely covers the adhesive layer 52, but other suitable configurations may also be used in which the body 70 of the liner 54 only covers a portion of the adhesive layer 52. One or more protrusions 60 and one or more liner openings 62 form a snap-fit ​​engagement that secures the liner 54 to the needle cover 42. The lining 54 includes a fold line 74 that separates the body 70 of the lining 54 from the extension 72 of the lining 54, wherein the extension 72 of the lining 54 is configured to fold around the fold line 74 relative to the body 70 of the lining 54.

[0044] When the needle cap 42 is removed from the drug delivery device 10 by grasping and removing it from the bottom surface 46 of the housing 20, the extension 72 of the liner 54 will move with the needle cap 42 because the extension 72 is connected to the needle cap 42 via one or more protrusions 60 and one or more liner openings 62. The continued movement of the needle cap 42 and the extension 72 of the liner 54 causes the extension 72 of the liner 54 to peel the body 70 of the liner 54 from the adhesive layer 52. The extension 72 of the liner 54 is attached to the outer edge of the body 70 of the liner 54, which facilitates the peeling of the liner 54 from the adhesive layer 52, but other suitable arrangements may also be used.

[0045] Elements of one aspect disclosed may be combined with elements of one or more other aspects disclosed to form different combinations, all of which are considered to be within the scope of the invention.

[0046] Although this disclosure has been described as having an exemplary design, it may be further modified within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover such deviations from this disclosure that are within the known or customary practices in the field to which this disclosure pertains and fall within the limitations of the appended claims.

Claims

1. A drug delivery device, comprising: A housing having a top surface and a bottom surface; A container, housed within the housing, configured to contain a drug, the container including a stop configured to move within the container; A drive assembly configured to move the stop; A needle having a retracted position and an extended position, wherein in the retracted position the needle is positioned within the housing, and in the extended position a portion of the needle protrudes from the housing; A needle cover, which is fixed to the housing and accommodates a portion of the needle; as well as An adhesive assembly including an adhesive layer and a liner, the adhesive layer being secured to the bottom surface of the housing, the liner being secured to the adhesive layer, the liner being configured to be removed from the adhesive layer, wherein the liner includes a protrusion, and the needle cover includes a liner opening receiving the protrusion to secure the liner to the needle cover, wherein the liner is configured to separate from the adhesive layer when the needle cover is removed from the housing, and wherein the liner and the adhesive layer define a gap opening receiving a portion of the protrusion.

2. The apparatus according to claim 1, wherein, The liner includes: a body covering at least a portion of the adhesive layer; and an extension extending from the body, the extension including one of the protrusion and the liner opening.

3. The apparatus according to claim 2, wherein, The needle cover is positioned between the body of the liner and the extension of the liner.

4. The apparatus according to claim 2, wherein, The main body of the liner completely covers the adhesive layer.

5. The apparatus according to claim 1, wherein, The protrusion and the lining opening form a snap-fit ​​engagement.

6. An adhesive assembly for a drug delivery device including a housing, a needle, and a needle cover, the needle having a retracted position and an extended position, wherein in the retracted position the needle is positioned within the housing, and in the extended position a portion of the needle protrudes from the housing, the needle cover being secured to the housing and receiving a portion of the needle, the adhesive assembly comprising: An adhesive layer configured to be fixed to the bottom surface of the housing; as well as A liner, the liner being secured to the adhesive layer, the liner being configured to be removed from the adhesive layer, the liner including a protrusion configured to be received by an opening in the liner defined by the needle cover, wherein the liner is configured to separate from the adhesive layer when the needle cover is removed from the housing, wherein the liner and the adhesive layer define a gap opening that receives a portion of the protrusion.

7. The component according to claim 6, wherein, The liner includes: a body covering at least a portion of the adhesive layer; and an extension extending from the body, the protrusion being positioned on the extension of the liner.

8. The component according to claim 7, wherein, The lining includes a fold line that separates the body of the lining from the extension of the lining, the extension of the lining being configured to fold around the fold line relative to the body of the lining.

9. The component according to claim 7, wherein, The main body of the liner completely covers the adhesive layer.

10. The component of claim 6, wherein, The protrusions of the liner are configured to engage with the needle cap snap.

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