A bi-dose fluid dispensing spray device

Abstract

The invention discloses a bi-dose fluid dispensing spray device (100) designed for nasal delivery of two consecutive precise doses of a fluid medication, wherein the device (100) is manually actuated by holding a finger rest (114) while simultaneously pressing a cartridge plunger (105) with thumb to dispense the medication. The device (100) comprises a dose indicator (115) to display dose availability; a cartridge holder (108) with a flexible gripping flap (116) to securely grip a cartridge / vial (111) of varying diameter; a dose stopper (107) with multi-stage locking and actuation force control ribs (107a and 107b) for controlled dosing, an adjustable tip (113) of actuator (101), equipped with a ring lock system for secure operation; an integrated adjustable nose stopper (109) with a nose rest surface, optionally control the insertion depth of the tip (113) into nostril of the user.

Description

TITLE OF THE INVENTIONA bi-dose fluid dispensing spray devicePRIORITY CLAIM:

[0001] This application claims priority from the provisional application numbered 202541018102 filed with Indian Patent Office, Chennai on 28thFebruary 2025 entitled “d bi-dose fluid dispensing spray device ”, the entirety of which is expressly incorporated herein by reference.PREAMBLE TO THE DESCRIPTION:

[0002] The following specification particularly describes the invention, and the manner in which it is to be performed:DESCRIPTION OF THE INVENTIONTechnical field of the invention

[0003] The present invention generally relates to a fluid dispenser spray device, and more particularly to a bi-dose or dual-dose liquid dispensing spray device for precisely dispensing one dose of the fluid medication per actuation.Background of the invention

[0004] The nasal administration of medication is a route of administration where the medicated product is insufflated through the nose. The nasal administration is generally ideal for the medications that act locally (e.g., antihistamines) as well as systemically (e.g., breakthrough pain management). Systemically, the nasal administration offers several benefits such as bypassing the blood-brain barrier, delivering drugs directly to the central nervous system etc. Therefore, it enables the lower doses of active medication to be used to achieve the same therapeutic effect when compared to other routes of administration such as oral or intravenous delivery, thereby reducing the possible side effects.

[0005] Further, intranasal delivery is one of the most preferred routes of administration by patients and healthcare workers alike, as the intranasal delivery is non-invasive, allowing an easy administration of the medication, and is applicable for various drug types. Additionally, the intranasal delivery is ideal for a range of liquid drug product applications that require precise intranasal dosing to both nostrils or those that require a second dose of product. Unlike the multi -dose nasal spray devices, the bi-dose spray device does not require priming, leading to wastage of the medication, and does not require preservatives in the formulation of the medication with several side effects. Further, upon activation of the spray device by a user, the nasal spray is applied even at lying down position, which is not feasible with the multi-dose nasal spray.

[0006] The nasal spray systems generally comprise of a container, a formulation, and an actuator. The nasal administration of medications is carried out through the nasal applicators, where the nasal applicators facilitate precise and controlled delivery of a liquid medication or other substances directly into the nasal cavity. The nasal sprays come in different application types depending on their formulation and purpose. The main types of nasal applicators include nasal spray commonly used for corticosteroids and decongestants; pump spray commonly used for decongestants, corticosteroids, and antihistamines; mist spray commonly used for saline solutions and medicated nasal sprays; nasal drops delivered in liquid form using a dropper, specifically for children; powder-based spray for dry medicated powders etc., The nasal applicators and fluid dispensing nasal spray systems work together to optimize drug delivery efficiency, absorption, and patient comfort. The medicated fluid is delivered to a user through nasal route through single-dose nasal spray, bi-dose nasal spray, multi-dose nasal spray, bi-directional nasal spray system, breath-actuated nasal spray systems, nasal nebulizers etc.,

[0007] Similar to aerosols, the nasal spray systems rely on the atomization of the formulation to form a plume of specified-sized droplets as it is emitted from the fluid dispensing device. The nasal spray systems differ from aerosols in that manual depression of the device actuator is used to dispense the product instead of the pressure created by a propellant. The lack of a propellant simplifies the formulationto a certain extent, but adds a degree of variability to the expelled plume resulting from patient-to-patient actuation differences, such as force, acceleration, and velocity of actuation. Several parameters may affect the physical characteristics of the plume (e.g., droplet size, spray pattern) including the formulation ingredients, the viscosity and surface tension of the formulation, the design, dimensions, and shape of the actuator, and the technique used to actuate the nasal device. Hence, during formulating the nasal spray products, both the formulation and the device are taken into consideration.

[0008] However, existing bi-dose fluid dispensing nasal spray systems have several drawbacks, such as limitations with medication filled cartridge / vial fitting in the cartridge / vial holder, leading to variations in the force required to activate the spray. An improperly fitted cartridge / vial, whether overfitted or underfitted, might result in inconsistent delivered dose, spray characteristics, including droplet size and spray pattern. Additionally, the placement of the dose indicator in most Bi-dose fluid dispensing nasal spray systems is not user-friendly, as it is typically located on the housing near the nasal tip, making it difficult to view while in use. Additionally, several technologies have been developed to address these limitations.

[0009] The Patent Application No. US2023390506A1 entitled “ Device for dispensing a fluid product” provides a fluid dispenser device having a reservoir containing at least two doses of fluid, a piston that is mounted to slide in the reservoir, a head that is provided with an orifice and a skirt, a finger-rest being provided on the head. The device has an actuating member axially movable inside the skirt to perform successive actuations, a spring provided to return the actuating member to its starting position after each actuation. The device has an indicator that includes a window and indicator mechanism, the window disposed in the skirt, under said finger rest, the spring co-operating with a shoulder of a sleeve that is fixed in the head, the shoulder disposed axially below the window, so that the spring is never visible in the window.

[0010] The Patent Application No. US7011234B2 entitled “Device for dispensing combined doses of fluid product” discloses a fluid dispenser device comprising abody, dispensing means for dispensing the fluid, a first reservoir containing a first fluid and a second reservoir containing a second fluid, the first and second fluids being to be mixed prior to dispensing so as to form one or more doses of fluid to be dispensed, said fluid dispenser device being characterized in that it further comprises a mixture-forming system for mixing the first and second fluids in one of said reservoirs, said mixture-forming system having a manual actuating element that is mounted to move in a direction that is substantially perpendicular to the direction in which the fluid is dispensed, said manual actuating element being actuatable with one hand and acting, after said first and second fluids have been mixed, to actuate the dispensing means for dispensing the fluid, without any further manipulation of the device being necessary.

[0011] The Patent Application No. US9555950B2 entitled “Fluid product dispensing device” discloses a fluid dispenser device comprising: a reservoir containing at least two doses of fluid; a dispenser member, such as a piston, that is mounted to slide in said reservoir so as to dispense the fluid; a dispenser head that is provided with a dispenser orifice, said head being movable relative to said reservoir so as to move said actuator member in said reservoir and thus dispense the fluid through said dispenser orifice; said dispenser head including at least two viewing windows, said device including an indicator that is movable together with said reservoir, said indicator co-operating with a respective viewing window after each actuation of the device.

[0012] The bi-dose drug dispensing systems have several advantages including cost-effectiveness, as it allows two doses in one device, reducing overall cost compared to two individual units of single-dose sprays systems, highly convenient for two-step treatments, as it is suitable for medications requiring a follow-up dose, provides a backup dose in case the first dose is insufficient, and a second dose is administered without switching the nasal spray system. However, the bi-dose nasal spray systems come with several challenges and issues, including uneven dose delivery of 1stand 2nddose, non-compatibility with different wide tolerance cartridge / vial, increased actuation force and trigger malfunctions resulting in improper dosing, spray consistency and pattern issues after the first spray, userexperience and ergonomics as some dispensing systems require additional steps for the doses following the first dose, leading to confusion or misuse, and dose indicator visibility, as the users may have difficulty tracking remaining doses if the indicator is not optimally placed.

[0013] Thus, in order to overcome the drawbacks of the existing systems and the outlined limitations, there is a need for an efficient bi-dose fluid dispensing spray device with improved grip to hold the cartridge / vial of varying tolerance size and precise dose control in each delivered dose.Summary of the Invention

[0014] The present invention overcomes the drawbacks of the existing systems by providing a bi-dose fluid dispensing spray device, wherein the device comprises an actuator, a needle holder, a needle, a housing, a cartridge plunger, a spring, a dose stopper, a cartridge holder, an integrated adjustable nose stopper containing nose rest surface with varying geometry, numbers and configurations as per the user convenience and requirement, a thumb gripper, a cartridge or vial, a piston, an adjustable tip, a finger rest, a dose indicator, a flexible gripping flap, a dust cap, and a travel stroke control snap lock.

[0015] According to the invention, the actuator triggers the release of a fluid from the cartridge, initiating the dispensing mechanism to ensure precise dose delivery. The needle holder securely holds the needle that delivers the fluid medication. The housing encases the cartridge plunger, that pushes the fluid medication out of the cartridge, while the spring provides the necessary force for this action. The dose indicator located in the cartridge plunger displays the number of doses delivered and the remaining doses in the cartridge. Further, the thumb gripper is inserted into the rear end of the cartridge holder, containing the cartridge, and the entire assembly is placed inside the cartridge plunger. Additionally, the dose stopper controls the dispensed dose, preventing overdosing or unintended fluid release.

[0016] The device further discloses the integrated adjustable nose stopper having the nose rest surface with varying geometry, numbers and configurations as per the user convenience and requirements, providing user comfort and aiding in properpositioning during nasal delivery, thus ensuring accurate administration. The piston facilitates the movement within the cartridge or vial to expel the fluid medication, while the adjustable tip ensures direct delivery into the user's nostrils. The finger rest supports the user while holding the device. Additionally, the flexible gripping flap securely holds the cartridge or vial pre-filled with the fluid medication, wherein the flexible gripping flap facilitates accommodation of variations in the cartridge or vial diameter while maintaining compatibility with the cartridge holder. This ensure the vial is placed firmly in the required fixed position enabling consistent and uniform first and second delivery.

[0017] Further, according to the invention, the integrated adjustable nose stopper is pulled or pushed to lock into position, making the device suitable for both adults and children, as it adjusts at 90° and 180° (two adjacent sides) for user convenience. Additionally, the integrated adjustable nose stopper enables height adjustment, that is crucial for ensuring the spray reaches the intended area for optimal delivery of the fluid medication, and also the nose rest surface with varying geometry, numbers and configurations as per the user convenience and requirements. Further, the dust cap attached to the adjustable nose stopper, shields the adjustable tip from dust, dirt, moisture, and debris that compromises the effectiveness of the fluid medication.

[0018] According to the invention, the dose indicator provides colored indications of dose availability through a first dose indicator window and a second dose indicator window, wherein the first dose indicator window remains colored if the two doses are available in the device. Upon completion of the first dose, the first dose indicator window changes color, signaling that a dose has been dispensed, while the second dose indicator window remains colored to show that one dose is still available. After dispensing the second dose, both the first dose indicator window and the second dose indicator window changes color, indicating that all the doses are dispensed from the device. This confirms the intended full dose delivery at each actuation and therefore ensure the required dose reaches to the therapeutic site .

[0019] The device includes a first lock ring to secure the cartridge holder in its initial position. A second lock ring holds the cartridge holder firmly in place andprevents it from moving back with the cartridge plunger after the first dose is dispensed. Further, a third lock ring similarly prevents movement after the second dose is dispensed. When the cartridge plunger is pushed in the upward direction, the first lock ring disengages from its initial position once the applied force reaches a predetermined limit, ensuring an efficient spray pattern by compressing the spring, moving the cartridge plunger, the cartridge holder, and the pre-filled cartridge or vial axially in the upward direction simultaneously, with the help of the piston.

[0020] Further, according to the invention, after the first dose is dispensed, the user releases pressure, allowing the cartridge plunger and the spring to return to their rest positions. However, the cartridge holder, the cartridge, and the piston remain stationary due to the dose stopper and the second lock ring. During the dispensing of the second dose, the user applies pressure on both the finger rest and the cartridge plunger using the thumb gripper. The cartridge holder is secured by the second lock ring, and locks between the locking ribs of the dose stopper. Upon dispensing the second dose, the user releases the cartridge plunger, allowing the spring to return to its rest position. Further, the cartridge holder, cartridge, and piston remain fixed due to the third lock ring.

[0021] The present invention offers several advantages including, the flexible gripping flap securely holds the cartridge or vial of varying diameter while maintaining a consistent cartridge height and fitment of the cartridge onto the device, ensuring the accurate dose delivery. Further, the locking ribs provides multi-stage locking of the cartridge holder and controls the actuation force by attaching to the dose stopper at different heights and / or angles. The dose indicator allows the user to easily check the number of available doses before, during, and after use. Additionally, the adjustable nose stopper enables optional tip height adjustment. Further, the dust cap protects the tip from damage and contamination, enhancing the device's reliability and longevity.

[0022] The invention is explained in detail in the following paragraphs with reference to the accompanying drawings, that illustrate various embodiments and features of the invention.Brief description of the drawings

[0023] The foregoing and other features of embodiments will become more apparent from the following detailed description of embodiments when read in conjunction with the accompanying drawings. In the drawings, like reference numerals refer to like elements.

[0024] FIGURE 1 illustrates a half-section view of the bi-dose fluid dispensing spray device according to an embodiment of the present invention.

[0025] FIGURE 2 illustrates a disassembled view of the bi-dose fluid dispensing spray device according to an embodiment of the present invention.

[0026] FIGURE 3A illustrates the isometric view of the bi-dose fluid dispensing spray device, according to an embodiment of the invention.

[0027] FIGURE 3B illustrates the front view of the bi-dose fluid dispensing spray device disclosing a dose indicator, according to an embodiment of the present invention.

[0028] FIGURES 4A, 4B and 4C illustrates the front view of the bi-dose fluid dispensing spray device disclosing the dose indicator various stages of dose delivery.

[0029] FIGURE 5A and FIGURE 5B illustrates the sectional view of the bi-dose fluid dispensing spray device, according to an embodiment of the invention.

[0030] FIGURE 6A illustrates a section view of the bi-dose fluid dispensing spray device in an initial rest position.

[0031] FIGURE 6B and FIGURE 6C illustrates the sectional view of the Bi-dose fluid dispensing device during actuation of the first dose and after completion of the first dose, respectively.

[0032] FIGURE 6D and FIGURE 6E illustrates the sectional view of the bi-dose fluid dispensing spray device during actuation of the second dose and after completion of the second dose, respectively.

[0033] FIGURE 7 illustrates the sectional view of the bi-dose fluid dispensing spray device and an exploded view disclosing a multi-stage locking system, according to an embodiment of the invention.

[0034] FIGURE 8 illustrates the front view of the cartridge or vial holder of the bi-dose fluid dispensing spray device, according to an embodiment of the invention.

[0035] FIGURES 9A and 9B illustrates the adjustable nose stopper for the bi-dose fluid dispensing spray device, according to an embodiment of the invention.

[0036] FIGURES 10A and 10B illustrates the locking mechanism for the integrated adjustable nose stopper, according to an embodiment of the invention.

[0037] FIGURE 11 illustrates the integrated nose stopper with a dust cap, according to an embodiment of the invention.

[0038] FIGURE 12 illustrates the integrated adjustable nose stopper disclosing various nose rest surface configurations, according to an embodiment of the invention.Detailed description of the invention

[0039] Reference will now be made in detail to the description of the present subject matter. Various changes and modifications obvious to one skilled in the art to which the invention pertains are deemed to be within the spirit, scope and contemplation of the invention.

[0040] The terms “ Bi-dose fluid dispensing spray device", “ Dispensing device" and “Device" are interchangeably used.

[0041] The terms “Adjustable tip" and “Tip" are interchangeably used.

[0042] The terms “Integrated adjustable nose stopper", “Adjustable nose stopper" and “Nose stopper" are interchangeably used.

[0043] The present invention overcomes the limitations and drawbacks of the existing fluid dispensing devices to provide an improved and efficient and reliablebi-dose fluid dispensing spray device with improved grip to hold the cartridge or vial of varying size, precise dose control and visualization of the dose availability and ease the compatibility between all age groups.

[0044] FIGURE 1 illustrates a half-section view of the bi-dose fluid dispensing spray device according to an embodiment of the present invention. The bi-dose fluid dispensing spray device (100) comprises an actuator (101), a needle holder (102), a needle (103), a housing (104), a cartridge plunger (105), a spring (106), a dose stopper (107), a cartridge holder (108), an integrated adjustable nose stopper (109) with a nose rest surface, a thumb gripper (110), a cartridge or vial (111) and a piston (H2).

[0045] According to the invention, the actuator (101) triggers the release of the fluid from the cartridge (111), wherein the actuator (101) initiates the dispensing mechanism, ensuring a precise dose delivery. The needle holder (102) holds the needle (103) securely in space, wherein the needle (103) delivers the liquid medication. The housing (104) houses the cartridge plunger (105) pushes the liquid medication out of the cartridge (111) and ensures a controlled and complete dose delivery.

[0046] The spring (106) provides the necessary force to push the cartridge plunger (105) and assists in the delivery of the liquid medication. The dose stopper (107) controls or limits the dose dispensed from the cartridge (111), and prevents overdosing or unintended fluid release. The cartridge holder (108) secures the cartridge (111) filled with the fluid medication in place. Further, the nose stopper (109) provides user comfort and positioning during the nasal delivery, and helps align the device into the nostril (100) for accurate administration. The thumb gripper (110) provides a gripping point for manual activation of the device (100).Further, the piston (112) moves within the cartridge (111) to expel the fluid medication.

[0047] FIGURE 2 illustrates a disassembled view of the bi-dose fluid dispensing spray device (100) according to an embodiment of the present invention, wherein the device (100) discloses the nose stopper that is integrated, lockable withadjustable stroke (109) is fit on the actuator (101) until it meets the groove on the actuator (101). The cartridge plunger (105) along with the spring (106) are inserted into the housing (104), wherein the actuator (101) is attached to the housing (104) through the dose stopper (107). The thumb gripper (110) is inserted into the rear end of the cartridge holder (108) containing the cartridge (111), wherein the said assembly is placed inside the cartridge plunger (105). Further, the needle (103) is inserted into the needle holder (102).

[0048] FIGURE 3A illustrates the isometric view of the bi-dose fluid dispensing spray device, according to an embodiment of the invention. With reference to FIG 3A, the device (100) discloses a tip (113), the integrated adjustable nose stopper (109), a finger rest (114), the housing (104), the cartridge plunger (105) and a dose indicator (115). The tip (113) facilitates the delivery of the fluid medication directly into the nostrils of the user. The finger rest (114) provides support to the user while holding the device and facilitates the actuation of the dose to deliver the fluid medication. Further, the dose indicator (115) is located in the cartridge plunger (105), and discloses the number of doses of the fluid medication delivered and the number of doses of the fluid medication remaining in the cartridge (111).

[0049] FIGURE 3B illustrates the front view of the bi-dose fluid dispensing spray device disclosing a dose indicator, according to an embodiment of the present invention. With reference to FIG 3B, the dose indicator (115) comprises one or more indications including a first dose indicator window (115a) to indicate the availability of the first dose and a second dose indicator window (115b) to indicate the availability of the second dose. The first dose indicator window (115a) and the second dose indicator window (115b) are located on the cartridge plunger (105), wherein both the indicator windows (115a and 115b) are covered by the outer surface of the cartridge holder (108).

[0050] Upon actuation of the first dose, the cartridge holder (108) moves in upward direction linearly until the first dose lock stage is reached, wherein upon completion of the first dose, the second dose indicator window (115b) remains covered by the outer surface of the cartridge holder (108) displaying the color of the cartridge holder (108), whereas the first dose indicator window (115a) color changes to thecolor of the outer surface (or any other specific color) of the thumb gripper (110) located internally, indicating that one dose is dispensed from the device (100) and one dose is available.

[0051] Further, during the actuation of the second dose, the cartridge holder (108) further moves in upward direction linearly until the stop end position of the piston (112), and upon completion of the second dose, the color of the second dose indicator window (115b) changes to the color of the outer surface (or any other specific color) of the thumb gripper (110) located internally, indicating that both the doses are dispensed from the device (100) and the device (100) is empty.

[0052] The dose indicator (115) provides colored indications wherein, during the actuation of the first dose, the first dose indicator window (115a) displays the color of the cartridge holder (108), for example: green, or any other specific color, and upon completion of the first dose, the first dose indicator window (115a) changes to the color of the thumb gripper (110), for example: white, red or any other color indicating that the fluid medication is dispensed. Upon completion of the first dose, the second dose indicator window (115b) remains in the color of the cartridge holder (108).

[0053] Additionally, the dose indicator (115) provides the colored indication on the second dose indicator window (115b) during the actuation of the second dose, and upon completion of the second dose, the second dose indicator window (115b) changes to the color of the thumb gripper (110), indicating that the fluid medication is dispensed.

[0054] FIGURES 4A, 4B and 4C illustrates the front view of the bi -dose fluid dispensing spray device disclosing the dose indicator various stages of dose delivery. With reference to FIG 4A, the device (100) prior to actuation of the first dose is disclosed, wherein the first dose indication (115a) and the second dose indication (115b) in the dose indicator (115) remains colored indicating that two doses of the fluid medication are remaining in the device (100). With reference to FIG 4B, the device (100) upon completion of the first dose is disclosed, wherein the first dose indication (115a) is changed to for example: white, or any other user-specified color, indicating that the first dose is dispensed from the device (100) and the second dose indication (115b) remains colored indicating that one dose of the fluid medication is remaining in the device (100).

[0055] Further, with reference to FIG 4C, the device (100) upon completion of the second dose is disclosed, wherein the first dose indication (115a) and the second dose indication (115b) are changed to white / other color indicating that two doses of the fluid medication are dispensed from the device (100).

[0056] FIGURE 5A and FIGURE 5B illustrates the sectional view of the bi-dose fluid dispensing spray device, according to an embodiment of the invention. With reference to FIG 5A, the device (100) discloses the spring (106) to maintain the cartridge plunger (105) in position, wherein the cartridge plunger (105) is fixed with the housing (104) at an initial locking position (105c). Further, the cartridge plunger (105) pushes a first shoulder face (105a) to the cartridge holder (108) upon actuation of the first dose, and the cartridge plunger (105) pushes a second should face (105b) to the cartridge holder (108) upon actuation of the second dose.

[0057] Additionally, the device (100) comprises a first lock ring (108a) to hold the cartridge holder (108) in an initial lock position, a second lock ring (108b) to hold the cartridge holder (108) firmly in position and does not allow the movement of the cartridge holder (108) back with the cartridge plunger (105) after completion of the first dose. Further, a third lock ring (108c) to hold the cartridge holder (108) firmly in position and does not allow the movement of the cartridge holder (108) back with the cartridge plunger (105) after completion of the second dose.

[0058] With reference to FIGURE 5B, the device (100) discloses the adjustable nose stopper (109), the finger rest (114), a locking rib (107b) to control the actuation force for each dose, and a locking rib (107a) to lock the cartridge holder (108) at each stage of operation of the device (100).

[0059] FIGURE 6A illustrates a section view of the bi-dose fluid dispensing spray device in an initial rest position. With reference to the FIG 6A, the initial rest position of the device (100) discloses the initial stage lock of the cartridge holder (108), wherein when pressure is applied simultaneously on the finger rest (114) andthe cartridge plunger (105) with the thumb gripper (110) by the user, the cartridge plunger (105) pushes the first shoulder face (105a) to the cartridge holder (108) during the actuation of the first dose. Further, the cartridge holder (108) comprises the first lock ring (108a) in the initial stage assembly, that gets locked between a locking rib (107a) and a locking rib (107b) of the dose stopper (107).

[0060] Additionally, upon pushing the cartridge plunger (105) in upward direction, the first lock ring (108a) displaces from the initial stage lock position when the force applied reaches a predetermined limit in order to achieve an efficient spray pattern, that in turn compresses the spring (106) and moves the cartridge plunger (105), the cartridge holder (108) and the pre-filled cartridge or vial (111) with the help of the piston (112), wherein the said components axially move in the upward direction simultaneously.

[0061] With reference to the FIGURE 6B, first dose completion lock of the cartridge holder (108) is disclosed, wherein the simultaneous upward movement of the the cartridge plunger (105), the cartridge holder (108) and the pre-filled cartridge or vial (111) and the piston (112) is ceased physically by the dose stopper (107) on completion of the first dose spray. Further, the further movement of the cartridge plunger (105) is ceased.

[0062] According to an embodiment of the invention, upon completion of dispensing the first dose, the indication of the dose indicator (115) located in the cartridge plunger (105) changes to (115a) with reference to the rest position of the cartridge holder (108) during the initial stage of the first dose and after the completion of the first dose.

[0063] With reference to FIGURE 6C, the device (100) after the completion of the first dose is disclosed, wherein upon the completion of the first dose, the user releases the pressure applied on the device (100), wherein the cartridge plunger (105) and the spring (106) returns to a rest position. While the cartridge plunger (105) is returning to a rest position, the cartridge holder (108) and the cartridge (111) along with the piston (112) does not move back to initial position, as their movement remains ceased due to the dose stopper (107) with the help of a secondlock ring (108b). Additionally, upon completion of the first dose, the device (100) is ready to dispense the subsequent dose, and is in the position as disclosed in FIG 6C.

[0064] FIGURE 6D and FIGURE 6E illustrates the sectional view of the bi-dose fluid dispensing spray device during actuation of the second dose and after completion of the second dose, respectively. With reference to FIG 6C, the stage of the actuation of the second dose discloses that when the user applies pressure simultaneously on the finger rest (114) and the cartridge plunger (105) with the thumb gripper (110), the cartridge plunger (105) pushes the second shoulder face of the cartridge holder (108). The cartridge holder (108) with the second lock ring (108b) gets locked between the locking rib (107a) and the locking rib (107b) of the dose stopper (107).

[0065] Further, upon applying force to the cartridge plunger (105) in upward direction, the second lock ring (108b) is displaced from the first dose lock position when the applied force reaches the predetermined limit to achieve an efficient spray patter. The upward movement compresses the spring (106) and moves the cartridge plunger (105), the cartridge holder (108) and the pre-filled cartridge or vial (111) with the piston (112) axially, wherein the upward movement is ceased physically by the piston (112) upon completion of the second dose spray.

[0066] Additionally, upon completion of the second dose, the user releases the cartridge plunger (105) and the spring (106) returns towards its rest position, as disclosed in FIGURE 6E. While the cartridge plunger (105) is returning to the rest position, the cartridge holder (108) and the cartridge or vial (111) along with the piston (112) does not move back to the rest position as their movement is ceased by the dose stopper (107) through the third lock ring (108c), as disclosed in the FIG 6D. Further, the indication of the dose indicator (115) located in the cartridge plunger (105) changes to (115b) with reference to the rest position of the cartridge holder (108) in the initial stage of the second dose and after the completion of the second dose.

[0067] FIGURE 7 illustrates the sectional view of the bi-dose fluid dispensing spray device and an exploded view (FIGURE 7A) with a top view (FIGURE 7B) disclosing the locking ribs of the device (100) according to an embodiment of the invention. With reference to FIGURE 7, the exploded view FIGURE 7A and the top view FIGURE 7B discloses the locking ribs (107a) and (107b), wherein both the locking ribs (107a) and (107b) are located in the inner wall of the dose stopper (107) at various heights and angles. The inner wall of the dose stopper (107) is split with more than one slits to render the locking ribs (107a and 107b) flexible. The locking rib (107a) facilitates locking the cartridge holder (108) during each stage of operation of the device (100) and the locking rib (107b) facilitates controlling the actuation force and velocity.

[0068] FIGURE 8 illustrates the front view of the cartridge / vial holder of the bidose fluid dispensing spray device, according to an embodiment of the invention. With reference to FIGURE 8, the cartridge holder (108) comprises a flexible gripping flap (116), wherein the flexible gripping flap (116) facilitates securely holding the pre-filled cartridge or vial (111) with a firm grip. The flexible gripping flap (116) enables the cartridge or vial (111) to be compatible with the cartridge holder (108), even if the cartridge or vial (111) has a varying diameter.

[0069] According to the invention, the flexible gripping flap (116) has a flexible geometry and holds the medication filled cartridge or vial (111) in the correct position and also holds it firmly, as it is crucial to get the correct dose delivered for each delivery and also facilitates delivery of consistent spray geometry for efficacy and better therapeutic benefits.

[0070] FIGURES 9A and 9B illustrates the adjustable nose stopper for the bi-dose fluid dispensing spray device, according to an embodiment of the invention. With reference to the FIGURES 9A and 9B the adjustable tip (113) insertion depth control mechanism is disclosed, wherein pressure is applied on both sides of the adjustable nose stopper (109), wherein the adjustable nose stopper (109) is either pulled or pushed to set the lock for the adjustable nose stopper (109) depending on the user i.e., an adult or a child. As disclosed in the FIGURE 9A, the depth of the adjustable nose stopper (109) is higher for an adult, compared to the child asdisclosed in FIGURE 9B, where the adjustable nose stopper (109) is locked closer to the tip (113). Additionally, the adjustable nose stopper (109) is adjusted at 90° and 180° (two adjacent sides), facilitating convenient to use of the device (100) by the user. Further, the adjustable nose stopper (109) eases the compatibility of the device (100) between all age groups.

[0071] FIGURES 10A and 10B illustrates the locking mechanism for the adjustable nose stopper, according to an embodiment of the invention. With reference to the exploded part X of the FIGURE 10A, a travel stroke control snap lock (118) for the adjustable nose stopper (109) is disclosed, wherein the control snap lock (118) holds the adjustable nose stopper (109) in a fixed position. Further, the exploded part Y of the FIGURE 10B discloses a stage lock (118a) for the adjustable nose stopper (109) for a child, facilitating convenient handling of the device (100), and a stage lock (118b) for the adjustable nose stopper (109) for an adult, facilitating user-friendly operation of the device (100). Additionally, the locking mechanism ensures that the first and the second dose are delivered completely, and generates required optimal actuation force for good spray formation, and also provides a gentle and easy way to actuate the device (100) by the user of any age group.

[0072] According to the invention, the integrated adjustable nose stopper (109) enables the height adjustment between adult and child, as the height is important for the spray to reach the intended mucal area for the effective adsorption and absorption of the fluid medication dose.

[0073] FIGURE 11 illustrates the integrated nose stopper with a dust cap, according to an embodiment of the invention. The integrated adjustable nose stopper (109) is fixed to the actuator (101) with a special profiled base locking system, that serves as the adjustable nose rest or stopper. With reference to FIGURE 11 A, the sectional view of the device (100) disclosing the integrated adjustable nose stopper (109) with a dust cap (117), wherein the dust cap (117) covers the tip (113) of the device (100), shielding the device (100) from dust, dirt, moisture, and debris that could interfere with the performance of the fluidmedication. Further, the dust cap (117) prevents any bacterial or viral contamination to the fluid medication in the device (100).

[0074] Additionally, the dust cap (117) helps to maintain hygiene, prevents damage to the tip (113) and also prevents exposure of the tip (113) to the air. When the dust cap (117) is opened by the user to dispense the fluid medication, the base of the unit serves as the adjustable nose stopper (109). Further, the integrated adjustable nose stopper (109) with the dust cap (117) serves the dual purpose of protection of the adjustable tip (13) before use of the device (100) and once opened it serves as the nose stopper (109), according to an embodiment of the invention.

[0075] FIGURES 12A-12L illustrates the integrated adjustable nose stopper disclosing various nose rest surface configurations, according to an embodiment of the invention. With reference to FIGURE 12A to 121 discloses the isometric views and the top views of the device (100), the integrated adjustable nose stopper (109) having the nose rest surface with varying configurations. The nose rest surface has various configurations as per the user convenience and requirements. The nose rest surface has varying geometry, numbers and configurations as per the user convenience and requirements.

[0076] According to an embodiment of the invention, the bi-dose fluid dispensing spray device (100) is operated manually, wherein the device (100) is disposable, and is designed to deliver one or more consecutive doses of the fluid or liquid medication. Further the device (100) does not require priming before use. Additionally, according to an embodiment of the invention the device (100) delivers a total dosage of 0.20ml (0.10ml per actuation) fluid or fluid type medication. The device (100) is required to be actuated manually by holding on the finger rest (114) and simultaneously pushing the cartridge plunger (105) with the thumb to deliver a spray of the fluid medication. The dose indicator (115) discloses the available number of doses, wherein the dose indicator (115) changes the color when the device (100) is used.

[0077] Further, the cylindrical shape of the cartridge holder (108) configured with the flexible gripping flap (116) to firmly grip and maintain the height of the prefilled cartridge or vial (111) in place, even if the fitting diameter of the cartridge or vial (111) is with a lower or higher diameter specification. The outer surface of the cartridge holder (108) contains the ring with multiple rib positions wherein the top portion of the rib rings lock with the dose stopper (107) in the initial stage and after each dose is dispensed, and the bottom portion rib rings acts as a shoulder while pushing the cartridge plunger (105) in the upward direction.

[0078] Additionally, the cylindrical shape of the dose stopper (107) offers multiple stage locking and actuation force control ribs (107a and 107b) located in the inner wall at different height levels and / or angles, so that the slits open to enable flexibility to easily control the initial cartridge holder lock and to control the actuation force to activate the device (100). The dose stopper (107) contains a second outer wall with a collar profile facilitating snap lock into the housing (104), wherein the second wall inner diameter helps to guide the outer diameter of the spring (106). Further, the bottom of the wall enables to stop the cartridge plunger (105) travel stroke on actuation of the device (100).

[0079] According to an embodiment of the invention, the adjustable tip (113) of the actuator (101) is configured with a ring lock system, wherein the device (100) is adaptable with various designs of the integrated adjustable nose stopper (109) having the nose rest surface with varying geometry, numbers and configurations as per the user convenience and requirements. The integrated adjustable stroke and lockable nose stopper (109) is optionally used to control the insertion depth of the tip (113) into the nostril of the user. Further, the actuator (101) is designed to adapt with the integrated adjustable nose stopper (109), wherein the height of the tip (113) is adjusted by the user by applying pressure and sliding the sides of the adjustable nose stopper (109) and shifting the adjustable nose stopper (109) either up and / or down and locking in position depending on the user i.e., either an adult and a child, thus facilitating controlling the insertion depth of the tip (113) into the nostril of the user.

[0080] According to some embodiments of the invention, the device (100) is compatible with various fluid medication dose delivery systems such as a unit dose, bi-dose, wherein the fluid medication stored in the cartridge (111) is assembled inthe device (100) prior to dose delivery. Further, the device (100) is applicable for the dosing spray or nasal drops with precise dose control. The use of the device (100) extends to various delivery systems such as nasal delivery, oral delivery, derma delivery, injectable delivery, inhalation delivery, etc.

[0081] The advantages of the present invention include the flexible gripping flap configuration (116) for the cartridge holder (108), helping to hold the pre-filled cartridge or vial (111) of any diameter firmly and maintains the cartridge height to the fixed level, facilitating the exact dose delivery of the first dose and the second dose, and also to deliver the spray to achieve the intended therapeutic level. Another advantage includes the locking ribs (107a and 107b) for multiple stage locking of the cartridge holder (108) and for actuation force control, wherein the locking ribs (107a and 107b) are attached to the dose stopper (107) at different height and / or angle, facilitating precise control for locking the cartridge holder (108) and activating the device (100) with a single part.

[0082] Additionally, the dose indicator windows (115a and 115b) located on the cartridge plunger (105) facilitate easy visualization of the available doses during usage, before usage and after usage of the device (100) by the users and the health care providers. Furthermore, the integrated adjustable nose stopper (109) is optionally used to adjust the height of the tip (113) by adjusting the adjustable nose stopper (109), thus providing control over the tip (113) insertion depth into nostril. Another advantage of the device (100) includes the use of the dust cap (117) to protect the tip (113) from damage and atmospheric contamination.Reference Numbers

Claims

Claims:We Claim:

1. A bi-dose fluid dispensing spray device for nasal delivery of two consecutive doses of a fluid medication, the device (100) comprising:a. an actuator (101) to trigger the release of a fluid from a cartridge or a vial (Hl), wherein the actuator (101) initiates the dispensing mechanism, ensuring a precise dose delivery;b. a housing (104) to enclose a cartridge plunger (105) that pushes the liquid medication out of the cartridge or the vial (111) through a needle (103), where a needle holder (102) securely holds the needle (103);c. a spring (106) to facilitate movement of the cartridge plunger (105), wherein the cartridge plunger (105) along with the spring (106) are inserted into the housing (104);d. a dose stopper (107) to control dispensing of a dose from the cartridge or the vial (111), wherein the actuator (101) is attached to the housing (104) through the dose stopper (107), where a second locking rib (107b) facilitates controlling the actuation force for the dose, and a first locking rib (107a) to lock a cartridge holder (108) at each stage of operation of the device (100), where the locking ribs (107a) and (107b) are located in the inner wall of the dose stopper (107) at one or more heights and angles;e. the cartridge holder (108) configured with a flexible gripping flap (116) to comfortably grip the cartridge or the vial (111) in place, where the diameter of the cartridge or the vial (111) is lower or equal to the inner diameter of the cartridge holder (108), where the cartridge holder (108) further comprises:i. a first lock ring (108a) to hold the cartridge holder (108) in an initial lock position;ii. a second lock ring (108b) to hold the cartridge holder (108) firmly in position and preventing the movement of the cartridge holder (108) with the cartridge plunger (105) after completion of the first dose;iii.a third lock ring (108c) to hold the cartridge holder (108) firmly in position and preventing the movement of the cartridge holder (108) with the cartridge plunger (105) after completion of the second dose; f. an integrated adjustable nose stopper (109) having a nose rest surface facilitating alignment of the device (100) for accurate administration, wherein the integrated adjustable nose stopper (109) is secured to the actuator (101) upon meeting one or more grooves on the actuator (101); g. a thumb gripper (110) to provide a gripping point for manual activation of the device (100), wherein the thumb gripper (110) is inserted into the rear end of the cartridge holder (108) containing the cartridge or vial (111), where the cartridge holder (108) securely holds the cartridge or vial (111); h. a piston (112) facilitating movement within the cartridge or vial (111) to dispense the fluid medication;i. an adjustable tip (113) facilitating the delivery of the fluid medication directly into the nostrils of the user, wherein the adjustable tip (113) is attached to the integrated adjustable nose stopper (109) that is optionally attached to a dust cap (117) to protect the adjustable tip (113) from contamination;j . a finger rest (114) provides support to a user while holding the device (100) and facilitates the actuation of the dose to deliver the fluid medication; k. a dose indicator (115) for displaying the availability of a number of doses of the fluid medication in the cartridge or vial (111), wherein the dose indicator (115) further comprises:i. a first dose indicator window (115a) to indicate the availability of the first dose; andii. a second dose indicator window (115b) to indicate the availability of the second dose.whereby, the first dose indicator window (115a) and the second dose indicator window (115b) are located on the cartridge plunger (105), and are covered by the outer surface of the cartridge holder (108);l. a stage lock (118a) for the adjustable nose stopper (109), facilitating convenient handling of the device (100) for a child, and a stage lock (118b) facilitating convenient handling of the device (100) for an adult;wherein, the device (100) provides improved grip to hold the cartridge or the vial (111) of varying size by the cartridge holder (108), enables precise dose control using the dose stopper (107) and facilitates visualization of the dose availability using the dose indicator (115).

2. The device (100) as claimed in claim 1, wherein the cartridge plunger (105) is fixed with the housing (104) at an initial locking position (105c), wherein the cartridge plunger (105) pushes a first shoulder face (105a) to the cartridge holder (108) upon actuation of the first dose, and the cartridge plunger (105) pushes a second should face (105b) to the cartridge holder (108) upon actuation of the second dose.

3. The device (100) as claimed in claim 1, wherein the cartridge plunger (105) exerts pressure on a first shoulder face (105a) to the cartridge holder (108) during the actuation of the first dose, where the first lock ring (108a) is sealed between the first locking rib (107a) and the second locking rib (107b) of the dose stopper (107).

4. The device (100) as claimed in claim 1 , wherein the dose stopper (107) includes one or more collars that facilitates fastening through a snap lock into the housing (104), where the inner diameter of the dose stopper (107) guides the outer diameter of the spring (106).

5. The device (100) as claimed in claim 1, wherein the simultaneous upward movement of the cartridge plunger (105), the cartridge holder (108) and the prefilled cartridge or the vial (111) and the piston (112) is ceased physically by the dose stopper (107) upon completion of the dose spray.

6. The device (100) as claimed in claim 1, wherein the cartridge holder (108) moves in upward direction linearly until the first dose lock stage is reached, and upon completion of the first dose, the second dose indicator window (115b) remains covered by the outer surface of the cartridge holder (108) displaying the color of the cartridge holder (108), where the color of the first dose indicator window (115a) changes to the color of the outer surface of the thumb gripper (HO).

7. The device (100) as claimed in claim 1, wherein the cartridge holder (108) moves in upward direction linearly until the stop end position of the piston (112), and upon completion of the second dose, the color of the second dose indicator window (115b) changes to the color of the outer surface of the thumb gripper (110).

8. The device (100) as claimed in claim 1, wherein the integrated adjustable nose stopper (109) allows the user to adjust the height of the adjustable tip (113) by pressing and shifting the integrated adjustable nose stopper (109) with the nose rest surface, to an upward and / or downward lock position for varied insertion depth of the adjustable tip (113).

9. The device (100) as claimed in claim 1, wherein the adjustable tip (113) is configured with the first lock ring (108a), the second lock ring (108b), and the third lock ring (108c) enabling control over the adjustable tip (113) insertion depth into the nostril of the user.

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