Medicament delivery device with container holder

Abstract

A medicament delivery device comprising: a housing; a needle having a retracted position and an extended position; a needle actuator body housed within the housing and configured to move from a pre-use position in which the needle is in the retracted position to a use position in which the needle is in the extended position; a container housed within the housing, wherein the container has a first position and a second position axially spaced from the first position; and an actuator button movable relative to the housing from a first position of the actuator button to a second position of the actuator button to actuate the needle actuator body from the pre-use position to the use position. The actuator button comprises a container retainer configured to restrict movement of the container from the first position of the container to the second position of the container when the needle actuator body is in the pre-use position.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 116,024, filed November 19, 2020, entitled “Drug Delivery Device with Container Holder,” the entire disclosure of which is incorporated herein by reference.

[0003] Background Art of the Invention

[0004] This disclosure of the field

[0005] This disclosure relates to a drug delivery device.

[0006] Description of related technologies

[0007] Various types of automated injection devices 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 automated injector 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 or embodiment, a drug delivery device includes: a housing; a needle having a retracted position and an extended position; a needle actuator body housed within the housing and configured to move from a pre-use position, in which the needle is located in the retracted position, and in the use position, the needle is located in the extended position; a container housed within the housing; and an actuator button movable relative to the housing from a first position to a second position to actuate the needle actuator body from the pre-use position to the use position. The container includes a body, a closure, and a stop movable within the body, wherein the container has a first position and a second position axially spaced from the first position. The actuator button includes a container retainer configured to restrict movement of the container from the first position to the second position when the needle actuator body is in the pre-use position.

[0010] The container retainer may be a protrusion configured to engage the body of the container. The body of the container may include a flange, wherein the container retainer is configured to engage the flange of the container.

[0011] The device may also include a valve assembly comprising a valve sleeve and a valve needle, wherein the container is spaced apart from the valve assembly when the container is in a first position, and the container is engaged with the valve assembly when the container is in a second position.

[0012] The device may further include a drive assembly configured to move the container from a first position to a second position and to move the stop relative to the body of the container. An actuator button may be configured to actuate the drive assembly.

[0013] The needle actuator body may include a protrusion configured to restrict movement of the container from a first position to a second position when the needle actuator body is in the pre-use position. The protrusion of the needle actuator body may be spaced apart from the container holder of the actuator button in a direction extending perpendicular to the longitudinal axis of the housing.

[0014] When the container is in its second position, the actuator button can be spaced apart from the container. The container holder can be integrally formed with the actuator button. Attached Figure Description

[0015] 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:

[0016] Figure 1 This is a perspective view of a drug delivery device according to one aspect or embodiment of this application.

[0017] Figure 2 yes Figure 1 A three-dimensional sectional view of a drug delivery device.

[0018] Figure 3 yes Figure 1 A front sectional view of the drug delivery device.

[0019] Figure 4 yes 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.

[0020] Figure 5 yes Figure 1 A top sectional view of a drug delivery device, showing the drug delivery device in its pre-use position.

[0021] Figure 6 yes Figure 1 A front sectional view of a drug delivery device, showing the drug delivery device in its pre-use position.

[0022] Figure 7 yes 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.

[0023] Figure 8 yes Figure 1 A top sectional view of the drug delivery device, showing the drug delivery device in its initial actuated position.

[0024] Figure 9 yes Figure 1 A front sectional view of the drug delivery device, showing the drug delivery device in its initial actuated position.

[0025] Figure 10 yes 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.

[0026] Figure 11 yes Figure 1 A top sectional view of a drug delivery device, showing the drug delivery device in its use position.

[0027] Figure 12 yes Figure 1 A front sectional view of a drug delivery device, showing the drug delivery device in its use position.

[0028] Figure 13 yes 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.

[0029] Figure 14 yes Figure 1 A top sectional view of the drug delivery device, showing the drug delivery device in its post-use position.

[0030] Figure 15A yes Figure 1 A front sectional view of the drug delivery device, showing the drug delivery device in its post-use position.

[0031] Figure 15B yes Figure 1 A front sectional view of a drug delivery device, showing the drug delivery device in its pre-use position.

[0032] Figure 15C yes Figure 1 A perspective sectional view of a drug delivery device, showing the drug delivery device in its pre-use position.

[0033] Figure 16 yes Figure 1 A partial perspective view of a drug delivery device, showing the top of the housing removed and the drug delivery device in its pre-use position.

[0034] Figure 17 yes Figure 1 A partial perspective view of a drug delivery device, showing the top of the housing removed and the drug delivery device in its pre-use position.

[0035] In all the views used in the various views, corresponding reference numerals refer to corresponding parts. The examples set forth herein illustrate exemplary aspects of this disclosure, and such examples should not be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0036] 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.

[0037] 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.

[0038] refer 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 actuator assembly 18. The drive assembly 12, container 14, valve assembly 16, and needle actuator assembly 18 are at least partially located within 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 person and to deliver a predetermined dose of drug provided in the container 14 into the 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 17 Describe the general operation of device 10.

[0039] Refer again Figures 1 to 17The device 10 is configured to operate by the user engaging actuator 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. Operation of the device 10 can be performed in the same manner as shown and described in U.S. Publication No. 2017 / 0354788, the entire disclosure of which is 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 for providing 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.

[0040] 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, after actuator button 26 is moved, drive assembly 12 is released and engaged with container 14 to move container 14 from a first position to a second position axially spaced from the first position, where container 14 is engaged with valve assembly 16. Moving container 14 toward valve assembly 16 is configured to pierce the closure 36 of container 14 and to fluidly communicate the medication within container 14 with needle 28 via tube 37 or other suitable arrangement. Drive assembly 12 is configured to engage stop 34 positioned within the body 35 or cylinder 35 of container 14, initially moving the entire container 14 to engagement with valve assembly 16 due to the incompressibility of the fluid or medication within container 14. Initial actuation of device 10 is caused by user engagement of actuator button 26, which releases needle actuator assembly 18 and drive assembly 12, as discussed in more detail below. During initial actuation, needle 28 remains in the retracted position and is about to move to the extended position to administer an injection to the user of device 10.

[0041] 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 15A 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 medicine from container 14.

[0042] Refer again Figures 1 to 17 The needle actuator assembly 18 includes a needle actuator body 40, which is housed within the housing 20 and configured to be in a pre-use position from when the needle 28 is in the retracted position. Figures 3 to 6 Move the needle 28 to the extended position of the usage position. Figures 10 to 12 The needle 28 is fully positioned within the housing 20 in the retracted position and at least partially positioned outside the housing 20 in the extended position. The needle actuator body 40 also has a post-use position. Figures 13 to 15A As described above, in the post-use position, the needle 28 is in the retracted position and engaged with the pad 38. The needle actuator body 40 is biased from the pre-use position to the post-use position by a spring 42. As described above, the actuator button 26 is movable relative to the housing 20 from a first position to a second position to actuate the needle actuator body 40 from the pre-use position to the use position. In one aspect or embodiment, moving the actuator button 26 from the first position to the second position moves the needle actuator body 40 to disengage it from the housing 20 or another component, thereby allowing the spring 42 to bias the needle actuator body 40 from the pre-use position to the use position and to the post-use position. As the needle actuator body 40 moves between the two positions, the needle actuator body 40 moves the needle 28 between the retracted and extended positions via a cam arrangement, but other suitable arrangements may be used.

[0043] refer to Figure 5 , Figure 8 and Figure 11 In one aspect or embodiment, valve assembly 16 includes a valve boot 50, a valve needle 52, a valve sleeve 54, and a puncture plate 56; however, other suitable valve arrangements may be used. During use, the closure 36 of container 14 initially contacts the valve boot 50. Figure 8 The closure compresses the valve sleeve 50 until the puncture plate 56 punctures the valve sleeve 50. When container 14 moves... Figure 11 In the indicated position, valve sleeve 50 is fully compressed, valve sleeve 54 is compressed, and valve needle 52 extends through closure 36 of container 14 to provide fluid communication between the contents of container 14 and valve needle 52. As described above, valve needle 52 is in fluid communication with needle 28 via tube 37. In one aspect or embodiment, closure 36 of container 14 includes a foil seal, a diaphragm, and a locking ring, but other suitable arrangements may be used.

[0044] refer to Figure 16 and Figure 17 The actuator button 26 includes a container retainer 70 configured to restrict movement of the container 14 from a first position to a second position when the needle actuator body 40 is in the pre-use position. In one aspect or embodiment, the container retainer 70 is configured to prevent the container 14 from moving to engage with the valve assembly 16 before the device 10 is actuated, should the device 10 be dropped or subjected to sudden acceleration or deceleration. Contact between the container 14 and the valve assembly 16 could cause puncture of the valve sheath 50 or other portions of the valve assembly 16, or a portion of the closure 36 of the container 14, which could compromise the sterility of the container 14 or the valve assembly 16. The container retainer 70 is a rectangular protrusion configured to engage with the body 35 of the container 14. In some configurations, the protrusion may be square, cylindrical, or any other suitable shape. In one aspect or embodiment, the container retainer 70 engages with the flange 72 of the container 14. In one aspect or embodiment, the container holder 70 is integrally formed with the actuator button 26, but the container holder 70 may be formed separately from the actuator button 26.

[0045] When the needle actuator body 40 is in the pre-use position and before the device 10 is actuated, if the device 10 falls, the container retainer 70 restricts the movement of the container 14. In one aspect or embodiment, the container retainer 70 is spaced apart from the flange 72 of the container 14 by a predetermined distance to avoid interfering with the container 14 after the device 10 is actuated, and to stop the movement of the container 14 before it engages with the valve assembly 16. A gap should exist between the container retainer 70 and the outer edge of the container 14 so that the container retainer 70 can absorb the load of the cylinder movement. Therefore, during use of the device 10, the actuator button 26 is spaced apart from the container 14.

[0046] refer to Figure 4 and Figure 5The needle actuator body 40 includes a protrusion 80 configured to restrict movement of the container 14 from a first position to a second position when the needle actuator body 40 is in the pre-use position. The protrusion 80 of the needle actuator body 40 extends along a direction perpendicular to the longitudinal axis of the housing 20 and is spaced apart from the container holder 70 of the actuator button 26. In one aspect or embodiment, the protrusion 80 is configured to contact the bottom of the flange 72 of the container 14, while the container holder 70 is configured to contact the top of the flange 72 of the container 14. Providing two-point contact with the container 14 ensures that the container 14 does not contact the valve assembly 16 for any potential orientations in which the device 10 may fall before the device 10 is actuated. As mentioned above, contact only with the bottom of the flange 72 may allow the container 14 to wobble or otherwise move for certain fall orientations of the device 10, which could allow undesirable contact between the container 14 and the valve assembly.

[0047] 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.

[0048] 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: case; The needle has a retracted position and an extended position; A needle actuator body is housed within the housing and configured to move from a pre-use position to a use position, wherein the needle is in the retracted position and the needle is in the extended position in the use position. A container, the container being housed within the shell, the container including a body, a closure and a stop, the stop being movable within the body, the container having a first position and a second position axially spaced from the first position; A valve assembly including a valve sleeve and a valve needle, wherein when the container is in a first position, the container is spaced apart from the valve assembly, and wherein when the container is in a second position, the container is engaged with the valve assembly; and An actuator button is provided, which is movable relative to the housing from a first position to a second position to actuate the needle actuator body from a pre-use position to a use position. The actuator button includes a container holder configured to restrict movement of the container from the first position to the second position when the needle actuator body is in the pre-use position. The container holder includes a protrusion configured to engage the body of the container. The needle actuator body includes the protrusion, which is configured to restrict movement of the container from the first position to the second position when the needle actuator body is in the pre-use position.

2. The drug delivery device according to claim 1, wherein, The body of the container includes a flange, and the container retainer is configured to engage with the flange of the container.

3. The drug delivery device according to claim 1 or 2, further comprising a drive assembly configured to move the container from a first position to a second position, and configured to move the stop relative to the body of the container.

4. The drug delivery device according to claim 3, wherein, The actuator button is configured to actuate the drive component.

5. The drug delivery device according to claim 1, wherein, The protrusion of the needle actuator body extends in a direction perpendicular to the longitudinal axis of the housing and is spaced apart from the container holder of the actuator button.

6. The drug delivery device according to claim 1 or 2, wherein, When the container is in the second position of the container, the actuator button is spaced apart from the container.

7. The drug delivery device according to claim 1 or 2, wherein, The container holder is integrally formed with the actuator button.

Images