Drug delivery device with container holder

Abstract

The present invention provides a drug delivery device that prevents the container holder from moving when the drug delivery device is dropped or subjected to sudden acceleration or deceleration. [Solution] The drug delivery device (10) includes a housing (20), a needle (28) having a retracted position and an extended position, a needle operating body (40) configured to move from a pre-use position where the needle (28) is in the retracted position to a use position where the needle (28) is in the extended position, a container (14) received within the housing (20), and an operating button (26) movable from a first position to a second position relative to the housing (20) in order to operate the needle operating body (40) from the pre-use position to the use position, wherein the operating button (26) includes a container holder (70) configured to restrict the movement of the container (14) from the first position to the second position when the needle operating body (40) is in the pre-use position.

Description

Technical Field

[0001] Cross - reference to related applications This application claims the priority of U.S. Provisional Application No. 63 / 116,024, entitled "Drug Delivery Device with Container Holder", filed on November 19, 2020, the entire disclosure of which is incorporated herein by reference.

[0002] This disclosure relates to drug delivery devices.

Background Art

[0003] Various types of auto - injection or drug delivery devices have been developed to enable administration or self - injection of pharmaceutical solutions and other liquid therapeutic agents by untrained personnel. Generally, these devices include a reservoir pre - filled with a liquid therapeutic agent and some type of automatic needle injection mechanism that can be triggered by the user. When the amount of fluid or drug to be administered is a fixed amount or less, such as generally 1 mL, an auto - injector is generally used, and the injection time is usually about 10 to 1 second. When the amount of liquid or drug to be administered exceeds 1 mL, generally the injection time becomes longer, and as a result, it becomes difficult for the patient to maintain contact between the device and the target site on the patient's skin. Further, as the amount of drug to be administered increases, it is desirable to lengthen the injection time. The conventional method of slowly injecting the drug into the patient is to start an intravenous drip and slowly inject the drug into the patient's body. Such procedures are usually performed in a hospital or a clinic.

Summary of the Invention

Problems to be Solved by the Invention

[0004] Certain devices enable self-injection in a home setting, allowing for the gradual infusion of a liquid therapeutic formulation into the patient's skin. In some cases, these devices are small enough (both in height and overall size) for the patient to "wear" them while the liquid therapeutic formulation is being injected. These devices typically include a pump or other type of dispensing mechanism to force the liquid therapeutic formulation out of the reservoir into the injection needle. Such devices also typically include a valve or flow control mechanism to begin the flow of the liquid therapeutic formulation at the appropriate time, and a trigger mechanism to initiate the injection. [Means for solving the problem]

[0005] In one embodiment or aspect, the drug delivery device includes a housing, a needle having a retracted position and an extended position, a needle operating body received within the housing and configured to move from a pre-use position where the needle is in the retracted position to a use position where the needle is in the extended position, a container received within the housing, and an operating button movable from a first position to a second position relative to the housing for operating the needle operating body from the pre-use position to the use position. The container includes a body, a closure, and a stopper movable within the body, and the container has a first position and a second position axially separated from the first position. The operating button includes a container holder configured to restrict the movement of the container from the first position to the second position when the needle operating body is in the pre-use position.

[0006] The container holder may be a projection configured to engage with the body of the container. The body of the container may include a flange, and the container holder may be configured to engage with the flange of the container.

[0007] The apparatus may further include a valve assembly comprising a valve boot and a valve needle, wherein when the vessel is in a first position, the vessel is spaced apart from the valve assembly, and when the vessel is in a second position, the vessel engages with the valve assembly.

[0008] The device may further include a drive assembly configured to move a container from a first position to a second position and to move a stopper relative to the body of the container. An operating button may be configured to actuate the drive assembly.

[0009] The needle operating body may include a projection configured to restrict the movement of the container from a first position to a second position when the needle operating body is in the pre-use position. The projection of the needle operating body may be positioned at a distance from the container holder of the operating button, in a direction that extends perpendicular to the longitudinal axis of the housing.

[0010] The operating button may be spaced away from the container when the container is in the second position. The container holder may also be integrally formed with the operating button. [Brief explanation of the drawing]

[0011] The features and other advantages of this disclosure, as well as the methods for achieving them, will become clearer and the disclosure itself will be better understood by referring to the following description of embodiments of this disclosure taken in conjunction with the accompanying drawings. [Figure 1] Figure 1 is a perspective view of a drug delivery device according to one aspect or embodiment of this application. [Figure 2] Figure 2 is a perspective cross-sectional view of the drug delivery device shown in Figure 1. [Figure 3] Figure 3 is a front cross-sectional view of the drug delivery device shown in Figure 1. [Figure 4] Figure 4 is a top view of the drug delivery device shown in Figure 1, with the top of the housing removed and the device in its pre-use position. [Figure 5] Figure 5 is a top cross-sectional view of the drug delivery device shown in Figure 1, and represents the drug delivery device in its pre-use position. [Figure 6] Figure 6 is a front cross-sectional view of the drug delivery device shown in Figure 1, and depicts the drug delivery device in its pre-use position. [Figure 7]Figure 7 is a top view of the drug delivery device shown in Figure 1, with the top of the housing removed and the device in its initial operating position. [Figure 8] Figure 8 is a top cross-sectional view of the drug delivery device shown in Figure 1, and it shows the drug delivery device in its initial operating position. [Figure 9] Figure 9 is a front cross-sectional view of the drug delivery device shown in Figure 1, and it shows the drug delivery device in its initial operating position. [Figure 10] Figure 10 is a top view of the drug delivery device shown in Figure 1, with the top of the housing removed and the device in the position for use. [Figure 11] Figure 11 is a top cross-sectional view of the drug delivery device shown in Figure 1, illustrating the drug delivery device in its operational position. [Figure 12] Figure 12 is a front cross-sectional view of the drug delivery device shown in Figure 1, illustrating the drug delivery device in its operational position. [Figure 13] Figure 13 is a top view of the drug delivery device shown in Figure 1, with the top of the housing removed and the device in the post-use position. [Figure 14] Figure 14 is a top cross-sectional view of the drug delivery device shown in Figure 1, and indicates the drug delivery device in the post-use position. [Figure 15A] Figure 15A is a front cross-sectional view of the drug delivery device shown in Figure 1, and indicates the drug delivery device in the post-use position. [Figure 15B] Figure 15B is a front cross-sectional view of the drug delivery device shown in Figure 1, and depicts the drug delivery device in its pre-use position. [Figure 15C] Figure 15C is a perspective cross-sectional view of the drug delivery device shown in Figure 1, illustrating the device in its pre-use position. [Figure 16] Figure 16 is a partial perspective view of the drug delivery device shown in Figure 1, with the upper part of the housing removed and the drug delivery device in its pre-use position. [Figure 17] Figure 17 is a partial perspective view of the drug delivery device shown in Figure 1, with the upper part of the housing removed and the drug delivery device in its pre-use position.

[0012] Corresponding reference numerals indicate corresponding parts throughout the several views. The examples presented in this specification illustrate exemplary embodiments of the present disclosure, and such examples should not be construed as limiting the scope of the present disclosure in any way. **DETAILED DESCRIPTION**

[0013] The following description is provided to enable a person having ordinary skill 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 be readily apparent to those having ordinary skill 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.

[0014] For the purposes of the following description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "uppermost", "lowermost", "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. It should also 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 should not be considered limiting.

[0015] Referring to Figures 1 to 17, the drug delivery device 10 includes a drive assembly 12, a container 14, a valve assembly 16, and a needle operating body 18. The drive assembly 12, container 14, valve assembly 16, and needle operating body 18 are at least partially housed within a housing 20. The housing 20 includes an upper part 22 and a bottom part 24, but other suitable arrangements of the housing 20 may be used. In one embodiment, the drug delivery device 10 is a syringe device that is worn or fixed to a person and configured to deliver a predetermined dose of a drug provided in the container 14 to the person by injection. The device 10 can be used for a "bolus injection" in which the drug is administered within a set time. The drug can be administered over a period of up to 45 minutes, but other suitable injection doses and injection times may be used. Bolus administration or administration may or may not be speed-controlled. The device 10 can supply the drug to the user at a constant pressure, and the speed is variable. The general operation of device 10 will be described below with reference to Figures 1 to 17.

[0016] Referring again to Figures 1 through 17, the device 10 is operated by the user engaging an operating button 26, which results in the needle 28 of the needle operating assembly 18 piercing the user's skin, and the operation of the drive assembly 12 places the needle 28 in fluid communication with the container 14, allowing fluid or drug to be discharged from the container 14, and after the drug injection is complete, the needle 28 is withdrawn. The operation of the device 10 may be similar to that described in U.S. Patent Application Publication No. 2017 / 0354788, which is incorporated herein by reference in its entirety. The housing 20 of the device 10 includes an indicator window 30 for viewing an indicator arrangement 32 configured to provide the user with an indication of the status of the device 10, and a container window 31 for viewing the container 14. The indicator window 30 may be a magnifying lens for a clear view of the indicator arrangement 32. The indicator arrangement 32 moves with the needle operating assembly 18 during use of the device 10 and indicates the pre-use state, use state, and post-use state of the device 10. The indicator arrangement 32 provides a visual indicator of the state, but other appropriate indicators such as auditory or tactile indicators may be provided as alternative or additional indicators.

[0017] Referring to Figures 4 to 6, during the pre-use position of the device 10, the container 14 is spaced apart from the drive assembly 12 and the valve assembly 16, and the needle 28 is in the extended position. As shown in Figures 7 to 9, during the initial operation of the device 10, the drive assembly 12 is released after the operation button 26 is moved and engages with the container 14, moving the container 14 from a first position to a second position axially spaced apart from the first position, with the container 14 engaged with the valve assembly 16. As the container 14 is moved toward the valve assembly 16, the closure 36 of the container 14 is passed through, and the drug inside the container 14 is configured to fluidly communicate with the needle 28 via the tube 37 or other appropriate arrangement. The drive assembly 12 is configured to engage with a stopper 34 located within the body or barrel 35 of the container 14, and due to the incompressibility of the fluid or drug inside the container 14, the entire container 14 first moves to engage with the valve assembly 16. The initial operation of the device 10 is triggered by the user engaging the operation button 26, which releases the needle operating assembly 18 and the drive assembly 12, as will be described in more detail later. During the initial operation, the needle 28 is still in the retracted position and attempts to move to the extended position to inject into the user of the device 10.

[0018] As shown in Figures 10 to 12, during use, the needle 28 is in an extended position at least partially outside the housing 20, and the drive assembly 12 moves the stopper 34 in the container 14 to deliver the drug from the container 14 through the needle 28 to the user. In use, the valve assembly 16 has already penetrated the closure 36 of the container 14 to create fluid communication between the container 14 and the needle 28, so that fluid can be dispensed from the container 14, and the drive assembly 12 can also move the stopper 34 relative to the container 14. In the post-use position of the device 10 shown in Figures 13 to 15A, the needle 28 is in a retracted position, engaged with the pad 38 to seal the needle 28 and prevent residual leakage of fluid or drug from the container 14.

[0019] Referring again to Figures 1 to 17, the needle operating assembly 18 includes a needle operating body 40 that is housed within the housing 20 and configured to move from a pre-use position (Figures 3 to 6) where the needle 28 is in the retracted position to a use position (Figures 10 to 12) where the needle 28 is in the extended position. In the retracted position, the entire needle 28 is located within the housing 20, and in the extended position, at least a portion of it is located outside the housing 20. The needle operating body 40 also has a post-use position (Figures 13 to 15A) where the needle 28 is in the retracted position and engages with the pad 38, as described above. The needle operating body 40 is biased from the pre-use position to the post-use position by a spring 42. As described above, the operating button 26 is movable relative to the housing 20 from a first position to a second position in order to actuate the needle operating body 40 from the pre-use position to the use position. In one embodiment, the movement of the operating button 26 from a first position to a second position moves the needle operating body 40 so as to release it from engagement with the housing 20 or another component, allowing the spring 42 to bias the needle operating body 40 from the pre-use position to the use position and the post-use position. The needle operating body 40 moves the needle 28 between the retracted position and the extended position via a cam mechanism as the needle operating body 40 moves between the retracted position and the extended position, although other suitable arrangements may also be utilized.

[0020] Referring to Figures 5, 8, and 11, in one embodiment, the valve assembly 16 includes a valve boot 50, a valve needle 52, a valve sleeve 54, and a through plate 56, although other suitable valve arrangements may be used. During use, the closure 36 of the container 14 first contacts the valve boot 50 (Figure 8), compressing the valve boot 50 until the through plate 56 penetrates it. When the container 14 moves to the position shown in Figure 11, the valve boot 50 is fully compressed, the valve sleeve 54 is compressed, and the valve needle 52 extends through the closure 36 of the container 14, establishing fluid communication between the contents of the container 14 and the valve needle 52. As described above, the valve needle 52 is in fluid communication with the needle 28 via the tube 37. In one embodiment, the closure 36 of the container 14 includes a foil seal, a partition, and a lock collar, although other suitable arrangements may be used.

[0021] Referring to Figures 16 and 17, the operating button 26 includes a container holder 70 configured to restrict the movement of the container 14 from a first position to a second position when the needle operating body 40 is in the pre-use position. In one aspect or embodiment, the container holder 70 is configured to prevent the container 14 from moving to engage with the valve assembly 16 before the device 10 is operated if the device 10 is dropped or subjected to sudden acceleration or deceleration. Contact between the container 14 and the valve assembly 16 could impair the sterility of the container 14 or the valve assembly 16 by puncturing the valve boot 50 or other parts of the valve assembly 16, or by puncturing part of the closure 36 of the container 14. The container holder 70 is a rectangular projection configured to engage with the body 35 of the container 14. In certain configurations, the projection can be square, cylindrical, or any other suitable shape. In one aspect or embodiment, the container holder 70 engages with the flange 72 of the container 14. In one embodiment, the container holder 70 is formed integrally with the operation button 26, but the container holder 70 may be formed separately from the operation button 26.

[0022] When the needle operating body 40 is in the pre-use position and the device 10 is not yet activated, the container holder 70 restricts the movement of the container 14 in the event that the device 10 is dropped. In one aspect or embodiment, the container holder 70 is positioned a predetermined distance from the flange 72 of the container 14 to avoid interference with the container 14 after the device 10 is activated, while preventing the movement of the container 14 before engagement with the valve assembly 16. There should be a gap between the container holder 70 and the outer circumference of the container 14 that allows the container holder 70 to absorb the load of barrel movement. Therefore, the operating button 26 is positioned away from the container 14 while the device 10 is in use.

[0023] Referring to Figures 4 and 5, the needle operating body 40 includes a projection 80 configured to restrict the movement of the container 14 from a first position to a second position when the needle operating body 40 is in the pre-use position. The projection 80 of the needle operating body 40 is positioned at a distance from the container holder 70 of the operating button 26 in a direction extending perpendicular to the longitudinal axis of the housing 20. In one embodiment, the projection 80 is configured to contact the bottom of the flange 72 of the container 14, and the container holder 70 is configured to contact the top of the flange 72 of the container 14. Providing two contact points with the container 14 prevents the container 14 from contacting the valve assembly 16 before the device 10 is operated in all directions in which the device 10 may fall. Contact only with the bottom of the flange 72 may allow the container 14 to swing or otherwise move in certain directions in which the device 10 may fall, which may allow undesirable contact between the container 14 and the valve assembly as described above.

[0024] An element of one disclosed aspect can be combined with an element 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.

[0025] While this disclosure has been described to have an exemplary structure, it is subject to further modification within its spirit and scope. Therefore, this application is intended to encompass any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure that fall within the scope of the appended claims, provided that such deviations are within the realm of known or customary practices in the relevant art.

Claims

1. Drug delivery devices are Housing and A needle having a retracted position and an extended position, A needle operating body is housed within the housing and configured to move from a pre-use position where the needle is in the retracted position to a use position where the needle is in the extended position, A container to be received within the housing, the container comprising a body, a closing portion, and a stopper movable within the body, the container having a first position and a second position spaced axially apart from the first position, and being movable in the axial direction, An operating button is provided that is movable in the axial direction from a first position to a second position relative to the housing in order to operate the needle operating body from the pre-use position to the use position, and includes a container holder configured to restrict the movement of the container from the first position to the second position when the needle operating body is in the pre-use position, A drug delivery device equipped with the following features.

2. The drug delivery device according to claim 1, wherein the container holder comprises a projection configured to engage with the body of the container.

3. The drug delivery device according to claim 2, wherein the body of the container is provided with a flange, and the container holder is configured to engage with the flange of the container.

4. The valve assembly further includes a valve boot and a valve needle, When the container is in the first position, the container is separated from the valve assembly. The drug delivery device according to any one of claims 1 to 3, wherein when the container is in the second position, the container engages with the valve assembly.

5. The drug delivery device according to any one of claims 1 to 4, further comprising a drive assembly configured to move the container from a first position to a second position, and configured to move the stopper relative to the body of the container.

6. The drug delivery device according to claim 5, wherein the operation button is configured to activate the drive assembly.

7. The drug delivery device according to any one of claims 1 to 6, wherein the needle operating body is provided with a projection configured to restrict the movement of the container from the first position to the second position when the needle operating body is in the pre-use position.

8. The drug delivery device according to claim 7, wherein the projection of the needle operating body is positioned at a distance from the container holder of the operating button in a direction that extends perpendicular to the longitudinal axis of the housing.

9. The drug delivery device according to any one of claims 1 to 8, wherein when the container is in the second position, the operating button is positioned at a distance from the container.

10. The drug delivery device according to any one of claims 1 to 9, wherein the container holder is integrally formed with the operating button.

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