Device for administering a medicament

Abstract

Embodiments relate to a device for administering a medicament. The device includes a housing, a plurality of first chambers in the housing, a plurality of plungers movable within the first chambers from a first position to a second position to increase a pressure of a fluid contained in the first chambers, a second chamber configured to contain the medicament and having an outlet, a releasable seal between the plurality of first chambers and the second chamber, the outlet of the second chamber in selective fluid communication with the plurality of first chambers through the releasable seal, wherein movement of the plurality of plungers from the first position to the second position actuates release of the releasable seal to release the fluid from the plurality of first chambers into the second chamber under pressure, thereby entraining the medicament in the fluid and expelling the medicament from the outlet.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to Australian Provisional Patent Application No. 2023904120, filed on 19 December 2023, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] This disclosure relates to an apparatus for administering a drug, such as a drug contained in a powder composition. Background Technology

[0004] Many different devices are known for delivering medications, such as oral inhalation or nasal medication products, including metered-dose inhalers (MDIs), dry powder inhalers (DPIs), soft fog inhalers, and nasal sprays. However, the internal mechanisms and volume requirements of these devices may dictate minimum physical dimensions and / or shapes, which at least make these devices inconvenient for a person to store or carry.

[0005] The aim is to address or improve one or more drawbacks or deficiencies associated with existing drug delivery devices, or at least provide a useful alternative.

[0006] Any discussion of documents, actions, materials, devices, articles, or the like included in this specification shall not be construed as an admission that any or all of these matters constitute part of the prior art or common knowledge in the field relating to this disclosure prior to the priority date of each appended claim. Summary of the Invention

[0007] According to one aspect of this disclosure, an apparatus for administering a drug is provided, the apparatus comprising:

[0008] -case;

[0009] - A plurality of first chambers located in the housing, each of the first chambers being used to contain fluid under pressure;

[0010] - A second chamber, configured to contain the drug and having an outlet.

[0011] - A component that, under pressure, releases the fluid from the plurality of first chambers into the second chamber, thereby entraining the drug in the fluid and discharging the drug from the outlet for administration.

[0012] In some embodiments, the device may include components for pressurizing the fluid in the plurality of first chambers. In an alternative embodiment, pressurized fluid may be provided in each of the first chambers prior to use of the device.

[0013] According to one aspect of this disclosure, a method for administering a drug to a person is provided, the method comprising:

[0014] - Pressurize the fluid contained in the multiple first chambers;

[0015] - Under pressure, the fluid is released from the plurality of first chambers into a second chamber containing the drug and having an outlet; and

[0016] - The drug is entrained in the fluid in the second chamber and discharged from the outlet for administration.

[0017] According to one aspect of this disclosure, an apparatus for administering a drug is provided, the apparatus comprising:

[0018] -case;

[0019] - A plurality of first chambers located within the housing, each of the first chambers containing fluid;

[0020] - A plurality of plungers, each of the plurality of plungers being movable from a first position to a second position within a respective first chamber of the plurality of first chambers to increase the pressure of the fluid contained in the first chamber;

[0021] - A second chamber, configured to contain the drug and having an outlet;

[0022] - At least one releasable seal is located between the plurality of first chambers and the second chamber, the second chamber including an outlet through which fluid selective flow occurs between the releasable seal and the plurality of first chambers.

[0023] Moving the plurality of plungers from the first position to the second position actuates the release of the releasable seal to release the fluid from the plurality of first chambers into the second chamber under pressure, thereby entraining the drug in the fluid and discharging the drug from the outlet for administration.

[0024] According to one aspect of this disclosure, a method for administering a drug is provided, the method comprising:

[0025] - Use multiple plungers to pressurize fluid contained in multiple first chambers located in the housing, each of the multiple plungers being movable from a first position to a second position within a corresponding first chamber in the multiple first chambers to pressurize the fluid contained in the first chamber;

[0026] - Release at least one releasable seal located between the plurality of first chambers and a second chamber containing the drug, the second chamber including an outlet for selective fluid flow through the releasable seal and the plurality of first chambers.

[0027] - The drug is entrained in the fluid in the second chamber and discharged from the outlet for administration.

[0028] The embodiments may include any one or more features defined in the dependent claims.

[0029] Throughout this specification, the word “comprise” or variations such as “comprises” or “comprising” should be understood to imply inclusion of the stated elements, integers or steps or groups of elements, integers or steps, but not to exclude any other elements, integers or steps or groups of elements, integers or steps. Attached Figure Description

[0030] Embodiments of this disclosure will now be described for illustrative purposes only with reference to the accompanying drawings, in which:

[0031] Figure 1 (a) an isometric view, (b) a front view, (c) a side view and (d) a cross-sectional view along line AA of an apparatus for administering a drug according to an exemplary embodiment of the present disclosure, wherein a plurality of plungers of the apparatus are in a first position;

[0032] Figure 2 It shows Figure 1 (a) isometric view, (b) front view, (c) side view and (d) cross-sectional view along line BB of the device, wherein multiple plungers are in the second position;

[0033] Figure 3 It shows Figure 2 (d) Enlarged cross-section M;

[0034] Figure 4 The diagram shows the situation when multiple plungers are in (a) the first position and (b) the second position, respectively. Figure 1 (d) and Figure 2 (d) Enlarged cross-section L;

[0035] Figure 5 The following are shown: (a) isometric view, (b) front view, (c) side view and (d) cross-sectional view along line CC of an apparatus for administering a drug according to an exemplary embodiment of the present disclosure, wherein a plurality of plungers are in a first position;

[0036] Figure 6 It shows Figure 5(a) isometric view, (b) front view, (c) side view and (d) cross-sectional view along line DD of the device, wherein multiple plungers are in the second position;

[0037] Figure 7 The following are shown: (a) isometric view, (b) front view, (c) side view and (d) cross-sectional view along line EE of an apparatus for administering a drug including an actuation prevention mechanism according to an exemplary embodiment of the present disclosure;

[0038] Figure 8 It shows Figure 7 (d) Enlarged cross-section M;

[0039] Figure 9 A partially transparent isometric view of the nozzle and manifold region of a device for administering a drug according to an example embodiment is shown;

[0040] Figure 10 The following are shown: (a) an isometric view, (b) a side view and (d) a cross-sectional view along line AA of an apparatus for administering a drug, comprising a cartridge, according to an exemplary embodiment of the present disclosure, wherein a plurality of plungers of the apparatus are in a first position;

[0041] Figure 11 It shows Figure 10 (a) a side view of the device, (b) a cross-sectional view along line AA, (c) a front view and (d) a cross-sectional view along line BB, wherein the multiple plungers of the device are in the second position;

[0042] Figure 12 (a) is shown according to some embodiments. Figure 11 (b) is a close-up view of the cross-sectional view. Figure 11 (b) isometric view of the cross section, and (c) with Figure 12 (b) A similar view showing an alternative guide cone;

[0043] Figure 13 It shows Figure 10 (a) isometric view and (b) cross-sectional view of the device, wherein the protective cap is attached to the device;

[0044] Figure 14 An apparatus for administering a drug according to an example embodiment of the present disclosure is shown, which shows (a) an exploded isometric view of a protective cap in a disassembled configuration, and (b) an isometric view of a protective cap assembled with the apparatus.

[0045] Figure 15 It shows Figure 14(a) front exploded view of the device, (b) top view, (c) side view with deformed guide cone, and (d) side view with extended guide cone;

[0046] Figure 16 As shown Figure 14 (b) An isometric cross-sectional view of the assembled device shown;

[0047] Figure 17 It shows (a) as Figure 14 (b) is an isometric cross-sectional view of the assembled device, with the plunger in the first position, and (b) Figure 14 A close-up isometric cross-sectional view of the device, which has no protective cap and the plunger is in the second position;

[0048] Figure 18 A cylinder according to some embodiments is shown, which shows (a) a cross-sectional view of the sealed cylinder, (b) an isometric view of the sealed cylinder, (c) a cross-sectional view of the cylinder with the seal released, (d) an isometric view of the cylinder with the seal released, (e) a cross-sectional view of the sealed cylinder with an alternative membrane seal, (f) an isometric cross-sectional view of the sealed cylinder, (g) an isometric cross-sectional view of the cylinder with the seal released, and (h) an isometric cross-sectional view of the cylinder with the seal further opened.

[0049] Figure 19 A cylinder according to some embodiments is shown, which illustrates (a) a cross-sectional view of the sealed cylinder, (b) an isometric cross-sectional view of the sealed cylinder, (c) an isometric cross-sectional view of the cylinder with the ball seal released and the membrane seal sealed, and (d) an isometric cross-sectional view of the cylinder with both seals released; and

[0050] Figure 20 A cylinder according to some embodiments is shown, which shows (a) a cross-sectional view of the sealed cylinder, (b) a cross-sectional view of the cylinder with the seal released, (c) an isometric cross-sectional view of the sealed cylinder, (d) an isometric cross-sectional view of the cylinder with the sliding pin seal partially displaced and in contact with the ball seal, and (e) an isometric cross-sectional view of the cylinder with the sliding pin seal released and the ball seal also removed and released. Detailed Implementation

[0051] According to an embodiment of the present disclosure, the device 10 for administering a drug is in Figures 1 to 4As shown in the diagram, the device 10 includes a housing 12 and a plurality of first chambers 14 located within the housing 12 for containing fluid under pressure in the first chambers 14. The device 10 also includes a second chamber 18 configured to contain a drug, for example in powder form, and has an outlet 20 and a member 22. The device is used to release fluid from the plurality of first chambers 14 into the second chamber 18 under pressure, thereby entraining the drug in the fluid and discharging the drug from the outlet 20 for administration.

[0052] In the context of this invention, a medicament may include one or any combination of active ingredients, mineral supplements, vitamins, excipients, formulations, and pharmaceutical products. The accompanying drawings illustrate a non-limiting example embodiment of a device 10 for administering a medicament, which is in the form of an orally or nasally delivered powder or contained in a composition of an orally or nasally delivered powder. In some embodiments, device 10 may be a dry powder inhaler (DPI). However, it should be understood that device 10 within the scope of this disclosure can be used for a wide variety of medicaments in various forms. The medicament may be used for a range of conditions where a dose of the medicament may be required in emergency situations to prevent, alleviate, or reverse the course of a disease. For example, the medicament may be adrenaline, which can be used to treat allergies, or it may be a vaccine. Furthermore, the medicament may not necessarily need to be inhaled by the user. By way of example only, the device may administer the medicament to the mucosa of the middle sinus, where it will be absorbed into the bloodstream without needing to be inhaled.

[0053] It should also be understood that, in the context of this invention, fluid refers to any substance that has no fixed shape and yields to external pressure, such as gas or liquid. In a preferred embodiment, the fluid is a gas, such as air.

[0054] refer to Figure 1 and Figure 2 The device 10 of an embodiment of the present invention includes a non-cylindrical housing 12, which has a substantially rectangular cross-sectional profile when viewed from the front (or rear). Each chamber in the first chamber 14 is substantially cylindrical and is arranged in parallel configuration within the housing along the width W direction of the housing 12. Each chamber in the first chamber 14 contains a fluid as air.

[0055] In this embodiment, the first chamber 14 is formed by a corresponding generally cylindrical inner surface of the housing 12, for example, the inner surface of a corresponding hole in the housing 12, but in an alternative embodiment, the first chamber may be defined by the inner surface of a corresponding barrel that may be located within the housing.

[0056] As a component 16 for pressurizing the fluid in the first chamber 14, the device 10 includes a plurality of plungers 16, each of the plurality of plungers 16 being able to pressurize the fluid in a corresponding first chamber 14 from a first position (e.g., Figure 1 (As shown) Move to the second position (as shown) Figure 2 (as shown), to increase the pressure of the fluid contained in the first chamber 14.

[0057] The device 10 includes a nozzle 36, and at least a portion of a second chamber 18 is disposed within the nozzle. For example... Figure 1 As shown in (d) and 2(d), the entire nozzle 36, or at least a portion thereof, may be formed separately from and attached to a portion of the housing 12 and / or manifold 26 of the device 10, although in alternative embodiments, the nozzle 36 may be integrally formed as a single piece with the housing 12 and / or manifold 26. In this embodiment, the outlet 20 of the second chamber 18 is located at the discharge end 38 of the nozzle 36 and is adapted to be received in a person's mouth and / or nose. In some embodiments, the nozzle 36 may be releasable from other parts of the device 10 or movable relative to said other parts (e.g., relative to the housing 12 and / or manifold 26). This may allow the introduction or reintroduction of medication into the second chamber 18 and / or allow the installation of a replacement nozzle.

[0058] To release fluid under pressure from a plurality of first chambers 14 to a second chamber 18 as the plurality of plungers 16 move from a first position to a second position, the device 10 of an embodiment of the present invention includes a releasable seal 22. In this embodiment, as Figure 4 As shown in more detail, the releasable seal 22 is provided by an interference-fit ball. The releasable seal 22 is located between the plurality of first chambers 14 and the second chambers 18, such that the second chambers 18 and their outlets 20 selectively flow through the releasable seal 22 to the plurality of first chambers 14. Specifically, the releasable seal 22 is located at the inlet 24 of the second chamber 18.

[0059] The manifold 26 of the device 10 is located at the distal end of the housing 10 and fluidly connects each of the plurality of first chambers 14 to the inlet 24 of the second chamber 18 via a releasable seal 22. The manifold 26 may be formed separately from and attached to the housing 12 and / or the nozzle 36 of the device 10 as part of the housing and / or the nozzle, but in alternative embodiments, the manifold 26 may be integrally formed as a single piece with the housing 12 and / or the nozzle 36.

[0060] In this disclosure, the term "distal" or "distally" is used to describe an element of the device 10 located relative to the outlet 20 of the device 10 (i.e., toward the application end of the device), and the term "proximal" or "proximal" is used to describe an element of the device 10 located relative to the opposite end of the outlet 20 of the device 10.

[0061] In this embodiment, for example, refer to Figure 3 Five first chambers 14 are disposed in the housing 12, including a central first chamber 143, a first outer first chamber 141 and a second outer first chamber 145 located on opposite sides of the central first chamber 143, and a first inner first chamber 142 and a second inner first chamber 144 located on opposite sides of the central first chamber 143 and respectively between the central chamber 143 and the first outer first chamber 144 and the second outer first chamber 145. The manifold 26 includes a central manifold passage 262 and a first outer passage 261 and a second outer passage 263. The central manifold passage 262 is configured to receive fluid directly from the central first chamber 143. The first outer passage 261 is configured to receive fluid before guiding fluid from both the first outer chamber 141 and the first inner chamber 142 to the central manifold passage 262. Similarly, the second external channel 263 is configured to contain the fluid before guiding fluid from both the second external chamber 145 and the second internal chamber 144 into the central manifold channel 262. The diameter of the central manifold channel 262 is larger than the diameter of each of the first external channel 261 and the second external channel 263 in order to accommodate a larger total amount of fluid contained from both the first external channel 261 and the second external channel 263.

[0062] It should be recognized that the device may have an alternative number of first chambers and corresponding plungers, but specifically, when the device has an odd number of first chambers and corresponding plungers (e.g., 3, 7 or more), a similar configuration of a central first chamber and additional internal / external first chambers on opposite sides of the central first chamber may be adopted, combined with a similar configuration of the manifold passage.

[0063] The channels 261, 262, 263 of manifold 26 may converge smoothly or seamlessly, for example without any sharp internal corners or edges, and may be configured to minimize any unusable volume or “dead space” in manifold 26 that would otherwise cause an undesirable reduction in pressure of the fluid delivered from the plurality of first chambers to second chamber 18.

[0064] The device 10 includes a handle 28 that connects to each of the plurality of plungers 16 at each proximal end of the plunger 16, and in this respect can be considered as sharing the handle 28. The plurality of plungers 16 can be accessed via the handle 28 from, for example... Figure 1 The first position shown is moved to, as Figure 2 The second position is shown, and specifically, it is engaged by the user and pressed or pushed in the distal direction by the handle 28. Figure 2 As shown, the device 10 is configured to prevent each of the plurality of plungers 16 from moving beyond the second position within the respective first chamber 14 when each plunger 16 is in the second position, by means of a handle 28 configured to abut a portion 121 of the housing 12 (e.g., the proximal surface 121 of the housing 12) and / or by means of one or more flanges 264 configured to abut the distal ends of one or more of the plungers 16 adjacent to the distal ends of the respective first chamber 14. For example, one or more flanges 264 may be provided by one or more proximal surfaces of the manifold 26. Thus, movement of each plunger 16 beyond the second position is prevented.

[0065] Device 10 includes an actuator 32 configured to actuate the release of a releasable seal 22 when a plurality of plungers 16 are moved from a first position to a second position. In this embodiment, the actuator 32 is provided with a protrusion 32 extending distally from a first (central) plunger 161 of the plurality of plungers 16. In this embodiment, moving the plurality of plungers 16, including the first plunger 161, from the first position to the second position causes the actuator 32 to interfere with the releasable seal 22 to release the seal 22, specifically through the protrusion 32, which extends through the central channel 261 of the manifold 26 and presses against the ball of the releasable seal 22 and removes the ball from the interference fit, such as... Figure 4 As shown in more detail in (b).

[0066] Therefore, moving the plurality of plungers 16 from the first position to the second position causes a pressurization of the fluid in the plurality of first chambers 14 and a subsequent release of the releasable seals 22, so that once under pressure, the fluid is released from the plurality of first chambers 14 into the second chamber 18. This, in turn, causes the drug located in the second chamber 18 to be entrained in the fluid and causes the drug to be discharged from the outlet 20 for administration.

[0067] By providing multiple first chambers 14, such as the substantially cylindrical first chambers 14 described above, the device 10 can have a non-cylindrical housing 12, while still allowing efficient pressurization of the fluid in each of the first chambers 14 by utilizing the inherent sealing and pressure distribution capabilities of a circular or cylindrical shape. This, in turn, allows for reduced physical size and shape requirements compared to known MDIs, DPIs, and nasal sprays.

[0068] In some embodiments, the size of device 10 allows it to be easily placed in a storage location before use, such as in a pocket, wallet, or phone case accessory. For example, at least when viewed from the front and / or back, and including when, for example, an optional cap (not shown) is positioned above nozzle 36 and / or manifold 26, device 10 may have a credit card-like size and / or appearance. This device may conform to the ISO / IEC 7810 ID-1 standard, which governs the size of cards such as ID cards and credit cards, thereby allowing a length L1 dimension of less than 86 mm and a width W dimension of less than 55 mm when the plurality of plungers 16 are in the first position. For example, device 10 may have a length L1 dimension of 85.60 mm and a width W dimension of 53.98 mm. However, it should be appreciated that device 10 may have, for example, a larger size while still being smaller and / or different in shape from one or more known MDIs, DPIs, and nasal sprays. Figure 1 As shown in (b), the length L1 extends between the proximal and distal ends of the device 10, and the width direction W extends perpendicularly to the proximal and distal ends of the device 10 between the lateral edges 122 and 123 of the device 10.

[0069] The housing 12 or a portion thereof may be formed of a suitable rigid or robust material, such as plastic, which can prevent the housing 12 from warping or bulging and generally protect the plurality of first chambers 14.

[0070] The handle 28 can be configured to include a support 30, which in this embodiment is provided by a recess in the surface of the handle 28. The recess 30 is located at the center of the handle 28 in the width direction W of the device 10, and thus close to the first plunger 161 of the central first chamber 141. In this way, when using one or more fingers to move multiple plungers 16 using the handle 28, the fingers can be influenced by the support 30 to press the central region of the handle 28, thus achieving relatively symmetrical or uniform movement of the multiple plungers 16. This contrasts with a scenario where the user may easily press the outer region of the handle 28, which may cause asymmetrical or inconsistent movement of the multiple plungers 16 from a first position to a second position, and may cause various problems such as blockage and insufficient pressurization of the fluid in the first chamber 14.

[0071] The device 10 can be configured such that movement of the plurality of plungers 16 from a first position to a second position actuates the release of the releasable seal 22 when the fluid is substantially at a predetermined pressure in the plurality of first chambers 14. The predetermined pressure can be selected such that the fluid flow through the second chamber 18 ensures efficient and consistent discharge of the drug from the outlet 20 when the pressurized fluid is released from the plurality of first chambers 14. For this purpose, an actuator 32, as a protrusion extending from the distal end of the first plunger 161, can be configured to extend through a central channel 262 of the manifold 26 and actuate the release of the releasable seal 22 only when the first plunger has moved at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% of the distance between the first and second positions. This distance can be selected to correspond to a pressure sufficient to ensure that substantially all the drug contained in the second chamber 18 is entrained in the fluid and discharged from the outlet 20 for administration when the fluid is released from the plurality of first chambers. In an exemplary embodiment of the invention, the predetermined pressure may be sufficient to ensure that fluid flows over and through the powdered drug located in the second chamber 18 and delivers substantially all of the powdered drug through the outlet 20 at a rate suitable for oral or nasal administration.

[0072] In one embodiment, the device 10 can be configured such that complete movement of the plurality of plungers 16 from a first position to a second position actuates the release of the releasable seal 22, and thus such that when the plurality of plungers 16 reach the second position, the fluid is substantially at a predetermined pressure in the plurality of first chambers 14. In an embodiment in which the device 10 is "credit card" sized, complete movement of the plurality of plungers 16 from the first position to the second position may, for example, involve moving each of the plurality of plungers 16 approximately 10 mm within the corresponding first chamber 14. Therefore, it may be necessary to ensure that the plurality of plungers 16 do not move through the second position, which can be prevented, for example, by the construction of the handle 28 such that when each plunger 16 is in the second position as described above, the handle abuts a portion 121 of the housing 12. This can further ensure that the protrusion 32 does not travel through points that could block the outlet 20 and / or affect the flow of fluid over and through the powdered drug, causing failure of proper drug administration.

[0073] As can be understood from the above description, device 10 can be configured to provide optimal pressurization of the fluid in a plurality of first chambers 14, for example, based on the volume of the first chambers 14 and the distance between the first and second positions, and thus allow for the dispensing of a drug for administration at a rate and volume effective and appropriate for a particular one or more persons. Device 10 can be configured to achieve this in a consistent manner while minimizing user error.

[0074] Now for reference Figure 5 and Figure 6This illustrates an apparatus 100 according to another embodiment of the present disclosure. Apparatus 100 is similar to that in the reference numeral [reference numeral]. Figures 1 to 4 The device 10 is described, and similar reference numerals are intended to indicate similar features. The device 100 of this embodiment differs from the device 10 of the previous embodiment in terms of the construction of its housing 120 and handle 280 and the relationship between the housing 120 and the handle 280.

[0075] In this embodiment, the device 100 includes a cover portion 40, with the plurality of plungers 16 in a first position ( Figure 5 When (as shown in the diagram), the cover portion conceals at least a portion of the proximal end of the plunger 16 and the handle 280. When the plurality of plungers 16 are in the second position (as shown in the diagram), Figure 6 As shown in the diagram, the cover portion 40 also conceals a larger portion or all of the handle portion 28. In this embodiment, the cover portion 40 is provided by a proximal portion (e.g., a recess) of the housing 120, but it should be understood that this is not necessarily the case, and in alternative embodiments, the receiving portion 40 may be detachable from the housing 120.

[0076] In addition to concealing the components of the concealed device 100, the cover portion 40 can also guide the movement of the handle 280 so that the plurality of plungers 16 move substantially uniformly and symmetrically from a first position to a second position. The guiding function of the cover portion 40 can be achieved by configuring the handle 280 to slidably fit into the cover portion 40, for example, in a relatively tight manner. In this embodiment, the cover portion 40 includes a recess 41 that receives the user's finger when the user presses the handle 280 into the cover portion 40 to move the plurality of plungers 16 from the first position to the second position. The recess 41 is located at the center of the cover portion 40 in the width direction W of the device 100, and thus close to the first plunger 161 of the central first chamber 141. In this way, and when moving the plurality of plungers 16 using one or more fingers of a person with the handle 280, it is necessary for one or more fingers to press the central region 2801 of the handle 280, such as a recessed central region 2801, thereby causing relatively uniform or symmetrical movement of the plurality of plungers 16.

[0077] Therefore, the cover portion 40 helps guide and thus prevents problems such as blockage of the plungers 16. Furthermore, by concealing the proximal ends of the multiple plungers 16 by the cover portion 40, the risk of fingers or objects becoming trapped within the device mechanism can be reduced. Moreover, since the handle 280 can be substantially completely concealed by the cover portion 40 when the multiple plungers 16 are in the second position, the cover portion 40 not only helps to provide a clear indication to the user that the device 100 has been operated and is no longer intended for use, but also limits any opportunity for the user to return the multiple plungers 16 to the first position, for example, by preventing gripping and proximal movement of the handle 280.

[0078] Now for reference Figure 7 and Figure 8 This illustrates another embodiment of the device 110 according to the present disclosure. Device 110 is again similar to the above reference. Figures 1 to 4 The device 10 is described, and similar reference numerals are intended to indicate similar features (some plungers 16 are not shown). Figure 6 (as shown in (d), and omitted only for the purpose of aiding understanding of an exemplary embodiment of the invention). However, device 110 differs from device 10 of earlier embodiments in that it includes an actuation prevention mechanism and a different type of releasable seal.

[0079] More specifically, the device 10 includes an actuation prevention mechanism that inhibits the movement of a plurality of plungers 16 from a first position to a second position prior to release. In an exemplary embodiment of the invention, the actuation prevention mechanism includes a blocking structure 42 releasably positioned between the handle 28 and the housing 12, the blocking structure inhibiting relative movement between the handle 28 and the housing 12 prior to release. In this embodiment, the blocking structure 42 is arranged to clamp in place between the handle 28 and the housing 12 and includes opposing wings 421, 422 joined together at a lateral edge 423 of the blocking structure 42 and separated at opposing edges 424 of the blocking structure 42. The opposing wings 421, 423 are configured to be located on opposite sides of the proximal regions of the plurality of plungers 16, respectively. The blocking structure 42 includes surface markings 44 that may indicate instructions and / or directions for releasing the blocking structure 42, such as by using arrows and / or the word “pull”. Alternatively or concurrently, the blocking structure may include surface markings 44, which are raised or recessed, to provide gripping features for finger engagement to release the blocking structure 42.

[0080] The actuation prevention mechanism 42 can prevent accidental discharge of the drug before it is released from the device 110, which may be crucial, for example, for people who rely on the use of the device to provide emergency assistance by administering the drug.

[0081] In this example embodiment, the releasable seal 220 of device 110 is in Figure 8 The diagram is shown in more detail and includes a puncturable membrane adjacent to the inlet 24 of the second chamber 18. In this embodiment, the actuator 32 also includes a protrusion extending from the distal end of the first plunger 161, which actuates the release of the releasable seal 22 by puncturing the membrane as it extends through the passage of the manifold 260, in a manner similar to that described above with reference to the foregoing embodiments.

[0082] In previous embodiments, the second chamber 18 is typically cylindrical in shape. In alternative embodiments, and referring to... Figure 9The illustration shows a nozzle 360 ​​and manifold 260 for a device according to an embodiment of the present disclosure, wherein the second chamber 180 may have a non-cylindrical shape. In this particular embodiment, the second chamber 180 has an elliptical or teardrop prism shape. This shape of the second chamber 180 is more suitable for containing drugs in powder form than a cylindrical shape, and wherein the device has a “credit card” shape or size as described above.

[0083] In some alternative embodiments, the device for administering the drug may be substantially similar to one or more of the devices according to the foregoing embodiments; however, instead of a device having components such as plungers to pressurize the fluid in the plurality of first chambers during use, the device may include a plurality of pre-pressurized first chambers. The pre-pressurized first chambers may be pre-pressurized at a predetermined pressure to allow the drug for administration to be discharged at a rate and volume suitable for one or more particular individuals. For example, the pre-pressurized first chambers may be provided by a corresponding pressurized gas canister, and the device may include a user-actuable trigger to cause the discharge of pressurized gas, for example, through a manifold of the type described above, into a second chamber containing the drug in powder form as described above. The pre-pressurized first chambers may be distributed within the housing of the device in a manner similar to the first chamber 14 described with respect to the previous embodiments, and thus allow the device to have a similar shape or size.

[0084] Now for reference Figures 10 to 13 This illustrates an apparatus 1000 according to another embodiment of the present disclosure. Apparatus 1000 is similar to that in the reference numerals. Figure 5 and Figure 6 The device 100 is described, and similar reference numerals are intended to indicate similar features. The device 1000 of this embodiment differs from the device 100 of the previous embodiment in the construction of its second chamber 1018 and nozzle 1036.

[0085] In this embodiment, the device 1000 further includes a cartridge 1010 defining a second chamber 1018 and configured to contain a drug. The cartridge 1010 may be formed separately from the housing 120 and subsequently mounted in the housing 120 to allow selective fluid flow to the plurality of first chambers 14 via a releasable seal 1022.

[0086] This arrangement reduces manufacturing costs because the cartridge 1010 can be manufactured in a cleanroom facility and internally sealed with the drug, while the rest of the device 1000 can be manufactured separately with less stringent requirements, as these parts do not come into direct contact with the drug. The sealed cartridge 1010 can then be stored and transported separately if needed, reducing the storage space required to maintain the drug under suitable storage conditions (e.g., temperature). Preparing a sealed cartridge containing the drug reduces the likelihood of drug leakage, contamination, and poisoning by keeping the cartridge in a sealed environment until administration.

[0087] In this embodiment, the cylinder 1010 includes a releasable seal 1022 that releasably seals the inlet 1024 of the second chamber 1018 (the inlet 1024 is defined by the cylinder 1010).

[0088] The cylinder 1010 also defines an outlet 1020 of the second chamber 1018 and includes a second releasable seal 1021 covering the outlet 1020. In this embodiment, the nozzle outlet 20 at the discharge end 38 of the nozzle is further downstream of the cylinder outlet 1020.

[0089] When the plunger 16 moves from the first position to the second position, this actuates the release of the second releasable seal 1021 (and the releasable seal 1022 at the inlet 1024) to release fluid under pressure from the plurality of first chambers 14 into the second chamber 1018 and out through the nozzle outlet 20, thereby entraining the drug in the fluid and expelling the drug from the nozzle for administration.

[0090] The following is for illustrative purposes only, regarding Figures 18 to 20 Various optional cartridges are described. However, it should be understood that any suitable cartridge with a releasable seal can be used.

[0091] The cylinder 1010 may be located partially or completely within the nozzle 1036, or upstream of the nozzle 1036, between the first chamber 14 and the nozzle outlet 20.

[0092] The cylinder outlet 1020 is located at the nozzle outlet 20 at the discharge end 38 of the nozzle 1036 or upstream of the nozzle outlet, the nozzle being configured to be received in a person's mouth and / or nose.

[0093] The device 1000 is configured such that moving a plurality of plungers 16 from a first position to a second position actuates the release of a second releasable seal 1021 to allow medication to be discharged from outlet 1020 (and nozzle 1036) for administration.

[0094] In some embodiments, the device 1000 is configured such that, upon actuation of the plunger 16, the second seal 1021 is released simultaneously with or after the first seal 1022. In some embodiments, the device may be configured such that the second seal 1021 is released before the first seal 1022.

[0095] The device 1000 may further include a guide cone 1038 at or near the outlet 1020 to facilitate positioning of the device 1000 in a person's nose for drug administration. For example, the guide 1038 may surround the nozzle outlet 20. The guide cone may be configured to provide visual and tactile guidance to the correct depth of insertion into the nose and to indicate insertion until the guide cone seals the nostril and / or is fully inserted into the nostril.

[0096] The guide cone 1038 shown is substantially conical, but may alternatively be defined by other non-conical geometries.

[0097] The guide cone 1038 can be positioned around the discharge end 38 of the nozzle 1036 to facilitate positioning the nozzle 1036 in the user's nose.

[0098] The guide cone 1038 may be formed at least partially of an elastic, flexible material. Any suitable material may be used, including, for example, polymers, elastomers, silicones, or rubbers.

[0099] The guide cone 1038 may be at least partially formed of an elastically deformable material and is configured to partially collapse to fit within a removably coupled cap, the cap having a relatively small dimension in one direction relative to the width of the guide cone. That is, at least a portion of the guide cone 1038, formed of an elastically flexible material, may be configured to be compressed to fit into the cap, for example, as... Figure 15 As shown. In other words, when in an uncompressed state, the diameter of the guide cone 1038 can be larger than at least one external dimension of the cap.

[0100] The guide cone 1038 can be in a substantially solid form, such as Figure 12 As shown in (c), it may also include thin-walled or shell-like structures, such as Figure 12 As shown in (b). The guide cone 1038 may be formed together with the nozzle 1036, or alternatively, it may be formed separately and attached by any suitable means, including welding, adhesive bonding, interference fit or friction fit, or fitted over a complementary mating surface with protrusions or ridges to resist removal of the guide cone 1038.

[0101] refer to Figure 13(Guide cone not shown) The device 1000 may further include one or more protective caps to protect the device 1000 and reduce the possibility of unintentional actuation before use. Two caps are shown, including a nozzle cap 1136 and a handle cap 1140.

[0102] Nozzle cap 1136 is removably attached to housing 120 to cover and protect nozzle 1036. Handle cap 1140 is removably attached to housing to cover handle 280 and prevent accidental pressing of handle 280.

[0103] refer to Figures 14 to 17 The following illustrates an apparatus 1400 according to another embodiment of the present disclosure. Apparatus 1400 is similar to that in the reference numeral [reference numeral]. Figures 10 to 13 The device 1000 is described, and similar reference numerals are intended to indicate similar features. The device 1400 of this embodiment differs from the device 1000 of the previous embodiment in its proportions and the construction of its nozzle 1436.

[0104] Figure 14 A nozzle cap 1136 and a handle cap 1140 are shown, similar to the cap of device 1000. The nozzle cap 1136 and handle cap 1140 can be coupled to housing 120 by any suitable means, including, for example, snap-fit ​​connection, snap-fit, or interference fit. In some embodiments, the nozzle cap 1136 and handle cap 1140 can be connected to housing 120 with a frangible connector, which can be broken to allow use of device 1400.

[0105] Figure 15 The diameter of the guide cone 1038 in its uncompressed state is shown, which is wider than the thickness of the device 1400 and the nozzle cap 1136. Figure 15 (b) and 15 (d)), and then as Figure 15 (c) shows compression for assembly as Figure 15 In the nozzle cap 1136 shown in (a).

[0106] Figure 16 A cross-section of the device 1400 is shown in an isometric perspective view, which shows the device 1400 before the removal of caps 1136, 1140 and the actuation device.

[0107] Compared to the single-piece nozzle shown in the previous embodiments, nozzle 1436 is formed from multiple components. In some embodiments, the nozzle may be integrally formed with the manifold and housing. In some embodiments, the nozzle may be formed from individual components assembled together to form the nozzle, such as... Figure 16 and Figure 17 As shown,

[0108] For example, nozzle 1436 includes a first component 1441, which is integrally formed with the manifold and defines an inner bore to accommodate other components. Nozzle 1436 further includes a second component 1442 and a third component 1443, which are separately formed and assembled within the bore of the first component 1441 to form a nozzle and define a seat for the cylinder 1010 and a channel allowing fluid to flow through nozzle 1436.

[0109] In some embodiments, it may be preferred to form the nozzle in a single component to simplify manufacturing. In some embodiments, a multi-component nozzle assembly may be preferred because it allows the use of different materials with potentially more suitable properties (e.g., dimensional stability) and allows for individual machining, which can permit more precise tolerances if desired. The component can be formed, for example, from any suitable material, including polymers, ceramics, or metals such as stainless steel.

[0110] For example, components 1441, 1442, and 1443 can be assembled together using adhesives and / or interference or friction fits.

[0111] Similarly, for example, the cylinder 1010 can be mounted using adhesives and / or interference fits or friction fits.

[0112] In some embodiments, the nozzle may be formed separately from the manifold and housing, and connected to the manifold to form a device. In some embodiments, the cartridge may contain the nozzle. In other words, the cartridge may define the nozzle, or the nozzle may define the cartridge. This allows the cartridge and nozzle to be manufactured separately and sealed with a drug contained within the cartridge, and then assembled to the manifold / housing, which in turn allows the nozzle and cartridge to be replaced with a new nozzle / cartridge for reuse of the housing / plunger assembly.

[0113] Now for reference Figures 18 to 20 Various cylinders according to some embodiments are shown. Any other suitable cylinders with various releasable seals can be used with the device.

[0114] Figure 18 A cylinder 1810 is shown with a membrane seal 1022a at inlet 1024 and a membrane seal 1021a at outlet 1020. The membrane can be released or burst by an actuator (e.g., push rod 32), or alternatively configured to release when a predetermined pressure differential across the membrane is reached.

[0115] Figure 19A cylinder 1910 is shown with a membrane seal 1021b at outlet 1020 and a ball seal 1022b at inlet 1024. The ball seal 1022b comprises a spherical element that is interference-fitted into a recess at inlet 1024, the interference fit providing sufficient resistance to hold the seal under pressure until removed by an actuator. The membrane seal 1021b can be released or burst by an actuator (e.g., push rod 32), or alternatively configured to release upon reaching a predetermined transmembrane pressure differential.

[0116] Figure 20 A cylinder 2010 is shown with a ball seal 1021c at outlet 1020 and a sliding pin seal 1022c at inlet 1024. The sliding pin seal 1022c comprises a cylindrical portion disposed abutting against a corresponding cylindrical bore at inlet 1024. The sliding pin seal 1022c is disposed in the bore by an interference fit or friction fit having sufficient friction to resist increased pressure in the first chamber 14 until it is removed by sliding it out of the bore and into the second chamber 1018 via an actuator.

[0117] The ball seal 1021c includes a spherical element that is disposed in a groove at the outlet 1020 by an interference fit, the interference fit providing sufficient resistance to hold the seal under pressure until it is removed by a sliding pin 2022 extending from the sliding pin seal 1022.

[0118] The length of the sliding pin 2022 can be selected to contact and remove the ball seal 1021c at the same time as, after, or before the sliding pin seal 1022c is released, so as to control the release of fluid into the second chamber 1018, out through the outlet 1020, and out through the nozzle 1036 for drug administration.

[0119] Any of the described seals (or any other suitable seal) may be used to replace any of the seals in any other described embodiments. For example, a sliding pin seal may be used to break the membrane seal at the outlet.

[0120] It should be understood that many other types of seals can be used in the sealing cylinder and released through any suitable release mechanism.

[0121] Any feature described with respect to any embodiment may be used in combination with or in place of features of other described embodiments.

[0122] Those skilled in the art will understand that many variations and / or modifications can be made to the above embodiments without departing from the broad general scope of this disclosure. Therefore, the embodiments of the present invention should be considered illustrative rather than restrictive in all respects.

Claims

1. A device for administering a medicament, the device comprising: - a housing; - a plurality of first chambers located in the housing, each of the first chambers comprising a fluid; - a plurality of plungers, each of the plurality of plungers being movable within a respective first chamber of the plurality of first chambers from a first position to a second position to increase a pressure of the fluid contained in the first chamber; - a second chamber configured to contain the medicament and having an outlet; - at least one releasable seal located between the plurality of first chambers and the second chamber, the second chamber comprising the outlet in selective fluid flow communication with the plurality of first chambers through the releasable seal, wherein moving the plurality of plungers from the first position to the second position actuates a release of the releasable seal to release the fluid from the plurality of first chambers into the second chamber under pressure, thereby entraining the medicament in the fluid and causing the medicament to be expelled from the outlet for administration.

2. The device of claim 1, wherein the housing is non-cylindrical and each of the plurality of first chambers is substantially cylindrical.

3. The device of claim 1 or 2, wherein the housing has a substantially rectangular cross-sectional profile, the plurality of first chambers being arranged in a parallel configuration along a width of the housing.

4. The device of any one of claims 1 to 3, wherein the device has a length dimension of less than 86 mm and a width dimension of less than 55 mm when the plurality of plungers are in the first position.

5. The device of any one of the preceding claims, comprising a common handle connected to each of the plurality of plungers, wherein the plurality of plungers are movable from the first position to the second position by the handle.

6. The device of claim 5, comprising a cover portion for housing the handle when the plurality of plungers are in the second position.

7. The device of claim 6, wherein the cover portion substantially conceals the handle when the plurality of plungers are in the second position.

8. The device of claim 6 or 7, wherein the housing portion is configured to guide the handle to move the plurality of plungers substantially uniformly from the first position to the second position.

9. The device of any one of claims 5 to 8, wherein the handle is only accessible proximate to one or more plungers of one or more central first chambers of the plurality of first chambers when the plurality of plungers are in the first position.

10. The device of any one of claims 5 to 9, wherein the handle comprises a cradle proximate to one or more plungers of one or more central first chambers of the plurality of first chambers.

11. The device of claim 10, wherein the cradle comprises a recess in a surface of the common handle.

12. The apparatus according to any one of claims 5 to 11, wherein the apparatus is configured to prevent each of the plurality of plungers from moving beyond the second position in the respective first chamber.

13. The apparatus of claim 12, wherein the handle is configured to abut a portion of the housing when each of the plurality of plungers is in the second position to prevent each of the plurality of plungers from moving beyond the second position.

14. The apparatus according to any one of the preceding claims, comprising an actuation prevention mechanism that inhibits the plurality of plungers from moving from the first position to the second position prior to release of the actuation prevention mechanism.

15. The apparatus of claim 14, wherein the actuation prevention mechanism comprises a blocking structure releasably positioned between the handle and the housing, and suppressing relative movement between the common handle and the housing prior to release of the blocking structure.

16. The apparatus according to any one of the preceding claims, wherein the second chamber includes an inlet and the releasable seal is located at or adjacent to the inlet, and wherein the apparatus includes a manifold that fluidly connects each of the plurality of first chambers to the inlet via the releasable seal.

17. The device of claim 16, wherein the housing includes a nozzle, wherein at least a portion of the second chamber is located in the nozzle, the outlet of the second chamber is disposed at or upstream of the discharge end of the nozzle, the nozzle being received in a person's mouth and / or nose.

18. The apparatus of claim 16 or 17, further comprising an actuator configured to actuate the release of the releasable seal as the plurality of plungers move from the first position to the second position.

19. The apparatus of claim 18, wherein at least one of the plurality of plungers, a first plunger, includes the actuator at its distal end, the actuator being configured to actuate the release of the releasable seal when the first plunger moves from the first position to the second position.

20. The apparatus of claim 19, wherein the actuator of the first plunger is configured to actuate the release of the releasable seal only when the first plunger has moved at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% of the distance between the first position and the second position.

21. The apparatus of claim 19 or 20, wherein the actuator includes a protrusion extending from the distal end of the first plunger, the protrusion being configured to interfere with the releasable seal to release the seal.

22. The device of claim 21, wherein the protrusion is configured to extend through a channel in the manifold to interfere with the releasable seal.

23. The apparatus of any one of claims 18 to 22, wherein the releasable seal comprises a puncturable membrane, and the actuator actuates the release of the releasable seal by puncturing the membrane.

24. The apparatus of any one of claims 18 to 22, wherein the releasable seal comprises an interference-fit ball, and the actuator actuates the release of the releasable seal by removing the ball from the interference fit.

25. The apparatus according to any one of the preceding claims, wherein the apparatus is configured such that, when the fluid is at a predetermined pressure in the plurality of first chambers, movement of the plurality of plungers from the first position to the second position actuates the release of the releasable seal.

26. The apparatus of claim 25, wherein the predetermined pressure is sufficient to ensure that substantially all of the drug contained in the second chamber is entrained in the fluid and discharged from the outlet.

27. The device according to any one of the preceding claims, wherein the drug is an orally or nasally delivered drug powder.

28. The device according to any one of the preceding claims, further comprising a tube defining the second chamber and containing the drug.

29. The apparatus of claim 28, wherein the releasable seal between the plurality of first chambers and the second chamber is a first releasable seal, and the cylinder includes the first releasable seal.

30. The apparatus of claim 29, wherein the cylinder defines the outlet and includes a second releasable seal covering the outlet.

31. The apparatus of claim 28, 29 or 30, wherein the housing comprises a nozzle, and at least a portion of the cylinder is located in the nozzle.

32. The apparatus of claim 31, wherein when it is subordinate to claim 30, the outlet is located at or upstream of the discharge end of the nozzle, the nozzle being received in a person's mouth and / or nose.

33. The apparatus of claim 30, 31 or 32, wherein moving the plurality of plungers from the first position to the second position actuates the release of the second releasable seal to allow the drug to be discharged from the outlet for administration.

34. The apparatus of claim 33, wherein the apparatus is configured such that the second seal is released simultaneously with or after the first seal.

35. The device according to any one of claims 28 to 34, wherein the cylinder is formed separately from the housing and is subsequently installed in the housing to allow selective fluid flow between the plurality of first chambers and the second chamber via the releasable seal.

36. The device according to any one of the preceding claims, wherein the housing includes a nozzle, wherein a guide cone is positioned about the discharge end of the nozzle to facilitate positioning the nozzle in the user's nose.

37. The device of claim 36, wherein the guide cone is at least partially formed of an elastic flexible material.

38. The device of claim 37, comprising a cap configured to cover the nozzle, wherein at least a portion of the guide formed of an elastic flexible material is configured to be compressed to fit into the cap.

39. The apparatus of claim 38, wherein the diameter of the guide cone in its uncompressed state is greater than at least one external dimension of the cap.

Images